Abstract:
The present invention provides methods, devices, and systems for supporting the urethra in a patient to treat urinary incontinence. Support of the urethra involves forming a loop under the urethra with a structure referred to as a urethral support and applying an upward force with the support to hold the urethra in a more desired position. The present invention utilizes the space of Retzius within which portions of the urethral support are positioned. Ingrowth by surrounding tissues to the urethral support material provide further stability and such ingrowth, combined with the position of the support, allow sufficient tension to be applied to support to hold the urethra in place. Placement of such a urethral support is achieved by minimally invasive techniques, such as with the use of laparoscopic instruments. Such techniques allows placement of the urethral support by accessing the space of Retzius through the vaginal wall without penetrating the abdominal wall. Such techniques also avoid perforations of nearby organs, such as the bladder, by utilizing specialized penetration devices.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention generally relates to methods, devices and systems for the treatment of urinary incontinence. In particular, the present invention provides methods, devices and systems for supporting the urethra in the female anatomy. More particularly, the present invention provides such treatment in a laparoscopic or a minimally invasive manner. 
     Urinary incontinence arises in both women and men with varying degrees of severity and from different causes. In men, the condition occurs almost exclusively as a result of prostatectomies which result in mechanical damage to the sphincter. In women, the condition typically arises after pregnancy where musculo-skeletal damage has occurred as a result of inelastic stretching of the structures which support the genitourinary tract. Specifically, pregnancy can result in inelastic stretching of the pelvic floor, the external vaginal sphincter, and most often, the tissue structures which support the bladder and bladder neck region. In each of these cases, urinary leakage typically occurs when a patient&#39;s intra-abdominal pressure increases as a result of stress, e.g. coughing, sneezing, laughing, exercise, or the like. 
     Treatment of urinary incontinence can take a variety of forms. Most simply, the patient can wear absorptive devices or clothing, which is often sufficient for minor leakage events. Alternatively, or additionally, patients may undertake exercises intended to strengthen the muscles in the pelvic region, or may attempt behavior modification intended to reduce the incidence of urinary leakage. In cases where such noninterventional approaches are inadequate or unacceptable, the patient may undergo surgery to correct the problem. A variety of procedures have been developed to correct urinary incontinence in women. Several of these procedures are specifically intended to support the bladder neck region. For example, sutures, straps, or other artificial structures are sometimes looped around the bladder neck and affixed to the pelvis, the endopelvic fascia, the ligaments which support the bladder, or the like. In other cases, the structures are extended over the pubis and through the abdominal wall. The ends of the structure are then available outside the abdominal wall where they may be tightened and fixed for permanent implantation. Other procedures involve surgical injections of bulking agents, inflatable balloons, or other elements to mechanically support the bladder neck. 
     Each of these procedures has associated shortcomings. Surgical operations which involve suturing of the tissue structures supporting the urethra or bladder neck region require great skill and care to achieve the proper level of artificial support. In other words, it is necessary to occlude the urethra or support the tissues sufficiently to inhibit urinary leakage, but not so much that normal intentional voiding of urine is made difficult or impossible. Balloons and other bulking agents which have been inserted can migrate or be absorbed by the body. The presence of such inserts can also be a source of urinary tract infections. 
     For these reasons, it would be desirable to provide improved methods, devices and systems for treating urinary incontinence. In particular, it would be desirable to provide such treatment in a minimally invasive manner, preferably utilizing laparoscopic or a least invasive manner to minimize patient trauma. It would further be desirable to provide treatment methods which reduce the potential to perforate the bladder and avoid puncturing the abdominal wall. It would also be desirable to provide methods and devices which avoid the potential drawbacks of bone anchors, such as infection and osteitis pubis. At least some of these objectives will be met by the methods, devices and systems of the present invention described hereinafter. 
     2. Description of the Background Art 
     A method for implanting an artificial sphincter to control urinary incontinence is described in U.S. Pat. No. 5,123,428. The first procedure employs a trocar or laparoscope to insert and position an inflatable balloon in the patient&#39;s space of Retzius. The patient&#39;s anterior bladder is connected to the patient&#39;s abdominal wall by a patch to effectively lengthen and stabilize the urethra. The second procedure is to implant a fluid reservoir and manually-actuable valve subcutaneously and connect them to the balloon in a closed system. 
     A sling having a web for moving an organ or vessel, and sutures connected to the web for maintaining the organ in its displaced position, are described in U.S. Pat. No. 5,337,736. An implant for suspension of the urinary bladder is described in U.S. Pat. No. 5,840,011. 
     An insertion apparatus for a female bladder control device is described in U.S. Pat. Nos. 5,618,257 and 5,846,180. The insertion apparatus includes an outer tube for insertion into the urethra of a patient, the outer tube having a retention collar for limiting the depth of insertion of the outer tube. 
     A surgical instrument and a method for treating female urinary incontinence is described in U.S. Pat. No. 5,899,909. When practicing the method the instrument is manipulated so as to position a tape to form a loop around the urethra. The tape is extended over the pubis and through the abdominal wall where it is tightened. Then, the tape ends are cut at the abdominal wall and the tape is left implanted in the body. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention provides methods, devices, and systems for supporting the urethra in a patient to treat urinary incontinence. Support of the urethra involves forming a loop under the urethra with a structure referred to as a urethral support and applying an upward force with the support to hold the urethra in a more desired position. Such a force may be achieved by securely positioning portions of the urethral support within the abdominal anatomy and applying tension to such portions to support the urethra. The present invention utilizes the space of Retzius within which portions of the urethral support are positioned. Ingrowth by surrounding tissues to the urethral support material provide further stability and such ingrowth, combined with the position of the support, allows sufficient tension to be applied to the support to hold the urethra in place. Placement of such a urethral support is achieved by minimally invasive techniques, such as with the use of laparoscopic instruments. Such techniques allow placement of the urethral support by accessing the space of Retzius through the vaginal wall without penetrating the abdominal wall. Such techniques also avoid perforations of nearby organs, such as the bladder, by utilizing specialized penetration devices. 
     In one aspect of the present invention, a passageway is created within the abdominal anatomy through which at least a portion of the urethral support is advanced and positioned for implantation. Such a passageway is created to extend from the vagina, through the vaginal wall and body tissue or fat layers, to the space of Retzius generally located between the bladder and the pubic bone. By accessing the space of Retzius through the vagina rather than through the abdominal wall, the procedure is less invasive and traumatic to the patient leaving no visible scars. However, such access requires attention to nearby organs which must be avoided to prevent perforation or damage. This may be achieved with the use of specialized penetration devices. 
     To begin, a penetration device is inserted through the vaginal wall, comprising an endopelvic fascia layer and a mucosal layer. In one embodiment, the penetration device comprises a Veress-style needle. As the needle is advanced beyond the vaginal wall, through body tissue and fat layers, a plunger guards the needle for atraumatic passage through fatty tissues or along tissue planes. Thus, resilient organs, such as the bladder, are pushed way from the needle by the plunger, avoiding perforation. In addition, the penetration device may include a depth stop which defines a maximum depth of penetration by the penetration device. The depth stop provides a stopping surface which rests against the vaginal wall and prevents further insertion of the needle. 
     The penetration device typically includes a sheath mounted on the needle so that the sheath is positioned within the passageway as it is created. Thus, the penetration device may then be withdrawn leaving the sheath behind in the passageway formed from the space of Retzius to the vagina. At this point, a blunt dilator is inserted into the sheath to dilate the passageway and a portion of the space of Retzius. The dilator is then exchanged with a delivery catheter which is used to place at least a portion of the urethral support within the space of Retzius. 
     In another aspect of the present invention, the urethral support comprises a number of embodiments. In one embodiment, the urethral support comprises at least one anchor patch. Typical anchor patches are rectangular in shape and are comprised of a flexible, porous material having at least one side with a frictional surface to prevent slippage between tissue layers. In addition, the anchor patch may have sutures attached, typically at one end of the patch. The anchor patch is then positioned in the passageway so that at least a portion of the patch resides with the space of Retzius and the sutures are positioned such that their free ends exit through at least the endopelvic fascia layer of the vaginal wall. Thus, the patch, including the sutures, extends through the abdominal anatomy to one side of the urethra. Generally, another anchor patch is positioned in the same manner through a second passageway on the opposite side of the urethra. Then, the free ends of the sutures are utilized to provide support under the urethra. For example, the free ends may be fastened to the vaginal wall wherein the anchor patches are adjusted to apply tension to the patches and upward force on the urethra. Alternatively, the sutures may be connected, such as by a band or similar device which is positioned under the urethra for attachment to the suture ends. Again, the anchor patches may then be adjusted to apply tension to the patches and upward force on the urethra. 
     In another embodiment, the urethral support comprises a sling which is used to form a loop under the urethra for support. Similar to the anchor patch, the sling may be comprised of a flexible, porous material having a frictional surface to prevent slippage. However, such a sling typically comprises two ends, each of which are implanted within the space of Retzius. One end of the sling is deployed within the passageway so that the sling extends from the space of Retzius to one side of the urethra and through the vaginal wall. The other end of the sling is positioned in the same manner through a second passageway on the opposite side of the urethra. Thus, the sling forms a loop underneath the urethra. The sling may then be adjusted to apply tension to the sling and upward force on the urethra. In any case, the portion of the urethral support positioned under the urethra may be covered by the mucosal layer to protect the implanted device and provide a seamless interface for the patient. 
     Other objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a schematic side view illustration of the relevant parts of the female abdominal anatomy and shows insertion of the penetration device through the vaginal wall. 
     FIG. 2 is a schematic front view illustration of a Veress-style needle penetration device inserted through the body tissues to create a passageway on one side of the urethra. 
     FIG. 3 illustrates the positioning of the sheath in the passageway from the space of Retzius through the vaginal wall. 
     FIG. 4 illustrates the insertion of a blunt dilator into the sheath. 
     FIG. 5 illustrates the insertion of the delivery catheter into the sheath including the urethral support deployable within the space of Retzius. 
     FIG. 6 is a schematic side view illustration of an anchor patch positioned so that at least a portion of the anchor patch is within the space of Retzius and sutures are positioned within the passageway exiting through the vaginal wall. 
     FIG. 7 is a front view schematic illustration of a positioned anchor patch as in FIG.  6 . 
     FIG. 8 illustrates the positioning of a second anchor patch on the opposite side of the urethra from the first anchor patch. 
     FIG. 9 illustrates one embodiment of supporting the urethra with the anchor patches wherein the anchor patches are sutured to the vaginal wall. 
     FIG. 10 illustrates an embodiment of supporting the urethra by positioning a band under the urethra and attaching the sutures from the first and second anchor patches to the band. 
     FIG. 11 is a schematic side view illustration of a sling positioned so that its first end is within the space of Retzius and its second end exits through the vaginal wall. 
     FIG. 12 is a schematic front view illustration of the sling positioned as in FIG.  11 . 
     FIG. 13 illustrates the positioning of the second end of the sling within the space of Retzius so that the sling forms a loop under the urethra. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention generally provides methods, devices and systems for treating urinary incontinence, particularly in the female patient. Referring to FIG. 1 the relevant parts of the female lower anatomy is depicted diagrammatically in a side view. Identified parts include a bladder  10 , a vagina  12 , a uterus  14 , a urethra  16 , a pubic bone  18 , and an abdominal wall  20 . The urethra  16  is surrounded by endopelvic fascia  22 , as shown. A mucosal layer  24  lines the vagina  12 , wherein the mucosal layer  24  and endopelvic fascia  22  make up the vaginal wall  26 . Body tissue, such as fat  28 , surround portions of the bladder  10  and other anatomical parts in the abdomen. In particular, a pad of fat  28 , which is several millimeters thick, resides between the endopelvic fascia  22  and the bladder  10 . Tissue planes exist between the pubic bone  18  and the bladder  10  which may be separated leading to a space of Retzius  30 . The space of Retzius  30  may be used as a location for implanting devices of the present invention as will be described hereinafter. 
     Referring again to FIG. 1, methods of the present invention include creating a passageway from the vagina  12  to the space of Retzius  30 . Such a passageway may be created by penetrating through the vaginal wall  26  with the use of a penetration device  32 . The penetration device  32  may have any useful shape, such as straight or curved, for accessing the vaginal wall  26  through the opening to the vagina  12 . FIG. 2 illustrates a cross-sectional front view of the female lower anatomy correlating to FIG.  1 . Again, the penetration device  32  is inserted through the mucosal layer  24  of the vaginal wall  26 . The device  32  is advanced through the endopelvic fascia  22  and portions of the fat  28  layer on one side of the urethra  16 , as shown. The penetration device  32  may comprise any number of suitable embodiments for such use. In a preferred embodiment, the penetration device  32  comprises a Veress-style needle  34 . Veress-style needles  34  are used in laparoscopic procedures in an effort to reduce the risk of perforating significant veins and arteries during passage of the needle. Such a needle  34  typically includes a sharpened elongate needle  36  and a spring-loaded plunger  38  which guards the needle  36  during insertion. As shown, as the Veress-style needle  34  is advanced, the plunger  38  guards the needle  36  for atraumatic passage through soft tissues. The plunger  38  maintains this position to maneuver around resilient organs, such as the bladder  10 , without perforating or causing trauma to the organs. As illustrated in FIG. 2, the bladder  10  may be pushed away from the needle  34  during creation of the passageway to the space of Retzius  30 . The spring-loaded plunger  38  will retract and allow penetration by the sharpened needle  36  when in contact with less resilient body tissues. 
     In addition, the penetration device  32  may include a depth stop  60  to allow a maximum depth of penetration by the penetration device  32 . The maximum depth should allow penetration from the vagina  12  through the mucosal layer  24  and the layer of endopelvic fascia  22  but not enough to perforate the wall of the bladder  10 . The nominal thickness of the endopelvic fascia  22  is typically 3-5 mm and the thickness of the surrounding fat  28  is generally in the range of 2-3 mm. Therefore the desired maximum depth of penetration is about 8 mm. The depth stop  60  may be incorporated in or fixed to the penetration device  32  providing a stopping surface  62  which rests against the vaginal wall  26  and prevents further insertion. It may be appreciated that the depth stop  60  may take a number of forms to prevent over-insertion of the penetration device  32 . 
     A sheath  64  may also be mounted on the penetration device  32 , particularly on the sharpened elongate needle  36  as shown. Thus, the sheath  64  is advanced along with the penetration device  32  as the passageway is created from the vagina  12  to the space of Retzius  30 . Referring now to FIG. 3, the sheath  64  may be left behind in the passageway after the penetration device  32  is removed. The sheath  64  thus provides a pathway through which additional devices and treatment catheters may be passed. 
     As shown in FIG. 4, a blunt dilator  66  is then inserted into the sheath to atraumatically dilate the passageway and access the space of Retzius  30 . The dilator  66  may be appropriately curved as shown for access through the opening to the vagina  12 . Since an end of the sheath  64  is disposed in the space of Retzius  30 , the dilator  66  is then passed through the space of Retzius  30  for a distance of approximately 8 to 10 cm until a space is accessible between the public bone  18  and the bladder  10 . 
     As shown in FIG. 5, the dilator  66  is then exchanged with a delivery catheter  80 . The delivery catheter  80  is used to place at least a portion of a urethral support  84  within the space of Retzius  30 . The urethral support  84  includes a number of embodiments which support the urethra  16  to treat urinary incontinence. In one embodiment the urethral support  84  comprises an anchor patch  86 , as shown in FIG.  6 . The anchor patch  86  may be comprised of a flexible, porous material having at least one side with a frictional surface. Such a frictional surface may prevent slippage of the anchor patch  86  between tissue layers during initial placement of the patch  86  and during the period of tissue ingrowth following implantation. Typical anchor patches  86  are rectangular in shape and have dimensions of approximately 1 cm in width and 16 cm in length. FIG. 6 illustrates such an anchor patch  86  deployed from the delivery catheter  80  wherein at least a portion of the anchor patch  86  is within the space of Retzius  30 . In addition, the anchor patch  86  may have sutures  88  attached thereon. Typically the sutures  88  are attached to one end of the anchor patch  86  and are positioned in the passageway so that their free ends exit through the vaginal wall  26 , as shown. 
     FIG. 7 provides a front view of the deployed anchor patch  86  of FIG.  6 . As shown, the anchor patch  86  is positioned above the urethra  16  and the sutures  88  are positioned along a passageway which passes to one side of the urethra  16  and exits below the urethra  16  through the vaginal wall  26 . This anchor patch  86  may be referred to as a first anchor patch  90 . Referring now to FIG. 8, the methods depicted in FIGS. 1-7 may then be repeated on the opposite side of the urethra  16  to position another anchor patch  86  which may be referred to as a second anchor patch  92 . Thus, the first and second anchor patches  90 ,  92  are positioned so that a portion of each patch is within the space of Retzius  30  and that they are placed approximately 2-6 cm apart to straddle the urethra  16 . Likewise, first sutures  94  attached to the first anchor patch  90  and second sutures  96  attached to the second anchor patch  92  are positioned within the formed passageways so that they both exit through the vaginal wall  26  as shown. 
     The first anchor patch  90  and the second anchor patch  92  are then used to provide structural support for the urethra in treating urinary incontinence. This may be achieved by a number of methods. For example, as shown in FIG. 9, the first suture  94  and the second suture  96  may each be attached to the vaginal wall  26  below the urethra  16 . Such attachment may comprise attaching the sutures  94 ,  96  to the endopelvic fascia  22  and covering the sutures  94 ,  96  with the mucosal layer  24 . Tension may be applied one or both patches  90 ,  92  by shortening the sutures  94 ,  96 . This in turn provides various levels of support for the urethra  16 , the more tension that is applied the stronger the support. 
     Alternatively, the urethra  16  may be supported by positioning a band  110  under the urethra  16 , for example as shown in FIG.  10 . Here, the band  110  is attached to the first sutures  94  at one of its ends and the second sutures  96  at its opposite end. However, it may be appreciated that the sutures  94 ,  96  may be attached to the band  110  at any locations along the band  110 . Typically the band  110  is positioned within the vaginal wall  26  between the endopelvic fascia  22  and the mucosal layer  24 . For example, the band  110  may be tunneled between the layers  22 ,  24  or the mucosal layer  24  may be peeled back for placement of the band  110  against the endopelvic fascia  22  wherein the mucosal layer  24  is then laid over the band  110 . Again, by applying tension to one or both anchor patches  90 ,  92 , the urethra  16  is structurally supported by the uplifted band  110 . 
     In another embodiment, shown in FIGS. 11-13, the urethral support  84  comprises a sling  120  which is used to form a loop under the urethra  16  for support. Similar to the anchor patch  86 , the sling  120  may be comprised of a flexible, porous material having at least one side with a frictional surface. Again, such a frictional surface may prevent slippage of the sling  120  between tissue layers during initial placement of the sling  120  and during the period of tissue ingrowth following implantation. Typical slings  120  are rectangular in shape and have dimensions of approximately 1 cm in width and 15 cm in length. Thus, such slings  120  may have a first end  122  and a second end  124  as shown. 
     Positioning of such a sling  120  may be similar to positioning a first and second anchor patch  90 ,  92  as described above. In this manner, a passageway on one side of the urethra  16  may be formed according to the methods previously illustrated in FIGS. 1-5. As shown in FIG. 5, the urethral support  84  is deployed from a delivery catheter  80  into the space of Retzius  30 . Referring now to FIG. 11, the urethral support  84 , in this case the sling  120 , is deployed so that at least a portion of the first end  122  is positioned within the space of Retzius  30  and the sling  120  lies in the passageway extending from the space of Retzius  30  through the vaginal wall  26  and out of the vagina  12  opening wherein the second end  124  lies outside of the body. FIG. 12 illustrates a front view of the sling  120  as positioned in FIG.  11 . As shown, the sling  120  is positioned to one side of the urethra  16 . At this point a second passageway is created through the vaginal wall and body tissue to a second location within the space of Retzius  30 . This may again be achieved in a manner set forth in FIGS. 1-5. The second end  124  is then deployed within the space of Retzius  30  approximately 2-6 centimeters from the first end  122 . As shown in FIG. 13, the sling  120  forms a loop under the urethra  16 . Tension may be applied to the first and/or second ends  122 ,  124  by adjusting the position of the ends within the space of Retzius  30  or by shortening the length of the sling  120 . In either case, upward force may be applied to the urethra  16  for structural support. As shown, the sling  120  is typically placed within the vaginal wall  26 , between the endopelvic fascia  22  and the mucosal layer  24 . In some cases, the sling  120  is tunneled between the layers  22 ,  24  or the mucosal layer  24  may be peeled back for placement of the sling  120  against the endopelvic fascia  22  wherein the mucosal layer  24  is then laid over the sling  120 . 
     The frictional surfaces of the anchor patches or the sling assist in holding the support in place during tensioning. The support is then left in place as a long-term or short-term implant. Tissue ingrowth into the support occurs over the following 3-6 weeks to more securely hold the support in place. 
     Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.