Abstract:
One embodiment of the present subject matter includes an implantable, adjustable sling for a body which includes an implantable sling cup connected to a first strap and a second strap, the first strap and the second strap adapted to be anchored within the body and at least one adjustable element forming an integral portion of the first strap.

Description:
RELATED APPLICATIONS 
       [0001]    This application is a Continuation of U.S. application Ser. No. 09/561,551, filed on Apr. 28, 2000, which claims the benefit of priority, under 35 U.S.C. Section 119(e), to U.S. Provisional Patent Application Ser. No. 60/131,915, filed on Apr. 30, 1999, which applications are incorporated herein by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to treatment of urinary stress incontinence and in particular to a method and apparatus for treatment of stress urinary incontinence using an adjustable sling. 
       BACKGROUND 
       [0003]    Urinary stress incontinence arises when an increase in abdominal pressure, such as from laughing, coughing, lifting, or exercise, results in urinary leakage. Normally, the urethra, which is the urinary lumen which passes urine from the bladder, will not leak with ordinary increases in abdominal pressure, also referred to as stress. However there are two conditions, referred to as type II and type III that commonly lead to incontinence. 
         [0004]    Type II incontinence, also referred to as hypermobility, occurs when the support structures of the pelvic floor have been weakened, for instance from childbirth. This allows the bladder to descend below its normal location in the abdominal cavity and the bladder neck, where it joins the urethra, to funnel open under increased abdominal pressure. 
         [0005]    Type II incontinence has most often been treated by a class of surgical procedures called suspensions of which there are many variations. Variations such as the Marshal-Marchetti-Krantz or the Burch procedures are quite invasive, requiring an abdominal incision. Other variations, generally called needle suspensions and including the Stamey and Raz procedures, are less invasive and may be done on an outpatient basis. Generally these procedures place sutures into tissue on either side of the urethra near the bladder neck and then lift or suspend the urethra and bladder from a higher anchoring point such the pubic bone, coopers ligament or the rectus abdominis muscle. This support compensates for weakness of the pelvic floor. 
         [0006]    Unfortunately it has been found that these procedures, especially the needle suspensions, often fail over time because the sutures pull through the tissue on either side of the bladder neck or the tissue continues to sag between these points. Another concern is that if the bladder neck is lifted too high the patient may be put into urinary obstruction. Still another concern is that too much elevation may induce urge incontinence where the patient feels a need to urinate even when the bladder is not full. These later conditions may not be detected until after the surgery and the patient is up and around. In order to address some of these problems patents U.S. Pat. Nos. 4,938,760 and 4,969,892 propose a mechanism for allowing postoperative adjustment to the degree of suspension. 
         [0007]    The other common cause of stress incontinence, type III also called intrinsic sphincter deficiency, occurs when the urinary sphincter which controls flow of urine from the bladder is dysfunctional. This may be caused by trauma, urethral scarring or any of a number of neurological conditions. For type III incontinence the most common treatment has been a class of surgical procedures called slings. 
         [0008]    Generally a sling or strap of material is placed between the urethra and vagina and the ends are attached to the same selection of higher anchoring points as for a suspension procedure. Pressure of the sling on the underside of the urethra causes closing or coaptation of the urethra to compensate for the dysfunctional sphincter. Another way to achieve coaptation would be to provide an expandable element or elements such as balloons on the sling underneath or alongside the urethra. The sling may be made from artificial material such as polypropylene mesh, autologous tissue harvested from the patient such as rectus fascia, or cadaveric fascia latta. 
         [0009]    While originally intended to provide coaptation for treating type III incontinence it has been recognized that slings also provide the support function sought by suspension procedures. While slings are somewhat more invasive than needle suspensions, they provide more reliable support since the sling is a continuous piece of material that goes underneath the urethra rather than being attached to fallible tissue alongside. At the same time it has also been recognized that mast stress incontinent patients do not have pure type II or type III but rather some of both. Often treating one of these conditions will unmask the presence of the other. 
         [0010]    For these reasons surgeons are more and more turning to slings to treat both types of stress incontinence. Nevertheless slings are still prone to some of the same problems as suspensions. Often it is not possible to tell if there has been enough coaptation or suspension to provide continence without urinary obstruction before the patient has recovered. Another problematic disorder which may result from the foregoing procedures is called “postsurgical urgency,” which is caused by improperly applied pressure to the periurethral tissues in which innervation is very dense causing hyperactivity of the bladder and urethra. This disorder causes the patient to feel an urgency to void when their bladder does not require voiding. 
         [0011]    Amelioration of the foregoing problems generally entails a second open surgical procedure to reduce the pressure on the bladder neck and proximal urethra. Thus, there is a need in the art for an improved sling for the treatment of urinary stress incontinence. 
       SUMMARY 
       [0012]    The present invention provides a method and apparatus for an adjustable sling for treatment of urinary stress incontinence. The method and apparatus provide for sling adjustment peri-operatively and post-operatively for treatment of different urinary stress incontinence types and provide adjustable urethral positioning and adjustable urethral coaptation. The present system includes apparatus and methods for postoperative adjustment of sling tension using adjustable elements in the sling assembly. The present system also provides a number of demonstrative embodiments for an adjustable sling where positioning of the bladder is controlled using the adjustable sling and where coaptation of the urethra is controlled by postoperative inflation of one or more balloons mounted in a sling cup. 
         [0013]    Methods and apparatus are provided for adjusting the adjustable sling after surgical implantation. In one embodiment a self sealing septum is located near the skin for convenient filling using a syringe. Multiple port embodiments are also discussed. 
         [0014]    This summary is intended to be an overview of the subject matter of the present system and is not intended to be exhaustive or limiting. The invention is determined by the scope of the appended claims and their equivalents. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWING 
         [0015]      FIG. 1  is a side cross sectional drawing of a female anatomy showing the bladder, urethra, vagina, and pubic bone in a patient with pelvic floor dysfunction and loss of support giving rise to urethral hypermobility, thus resulting in the displacement of the bladder. 
           [0016]      FIG. 2  is a side cross sectional drawing of the female anatomy demonstrating a sling to lift and support the bladder with respect to the pubic bone and to diminish the curvature of the urethra and the bladder neck. 
           [0017]      FIG. 3  shows a top cross sectional drawing of the female anatomy from a view where the urethra is normal to the plane of the drawing and showing a cross section of an adjustable sling with an expandable element according to one embodiment of the present system. 
           [0018]      FIG. 4  shows a top view of the adjustable sling according to the one embodiment shown in  FIG. 3 . 
           [0019]      FIG. 5  shows a top cross sectional drawing of the female anatomy from a view where the urethra is normal to the plane of the drawing and showing a cross section of an adjustable sling according to one embodiment of the present system. 
           [0020]      FIG. 6  shows a top cross sectional drawing of the female anatomy from a view where the urethra is normal to the plane of the drawing and showing a cross section of an adjustable sling according to one embodiment of the present system. 
           [0021]      FIG. 7  is a flow chart showing one example of a procedure for adjusting one embodiment of the adjustable sling. 
           [0022]      FIG. 8A  is a cross sectional view of an adjustable sling according to one embodiment of the present system to demonstrate an uninflated state. 
           [0023]      FIG. 8B  is a cross sectional view of the adjustable sling of  FIG. 8A  demonstrating one inflated state. 
           [0024]      FIG. 8C  is a top view of the adjustable sling of  FIG. 8A  according to one embodiment of the present system. 
           [0025]      FIG. 9A  is a top view of the adjustable sling according to one embodiment of the present system. 
           [0026]      FIG. 9B  and  FIG. 9C  show a side cross sectional drawing of the female anatomy demonstrating the adjustable sling of  FIG. 9A  to lift and support the bladder with respect to the pubic bone and to diminish the curvature of the urethra at the bladder neck, the adjustable sling also providing adjustable urethral coaptation. 
           [0027]      FIG. 10A  is a cross sectional view of an adjustable sling according to one embodiment of the present system to demonstrate an uninflated state. 
           [0028]      FIG. 10B  is a cross sectional view of the adjustable sling of  FIG. 10A  demonstrating one inflated state. 
           [0029]      FIG. 10C  is a top view of the adjustable sling of  FIG. 10A  according to one embodiment of the present system. 
           [0030]      FIG. 11A  is a cross sectional view of an adjustable sling according to one embodiment of the present system to demonstrate an uninflated state. 
           [0031]      FIG. 11B  is a cross sectional view of the adjustable sling of  FIG. 11A  demonstrating one inflated state. 
           [0032]      FIG. 11C  is a top view of the adjustable sling of  FIG. 11A  according to one embodiment of the present system. 
           [0033]      FIG. 12  is a diagram of a one embodiment of a multiple port system. 
       
    
    
     DETAILED DESCRIPTION  
       [0034]    This detailed description provides a number of different embodiments methods and apparatus related to the present system. The embodiments provided herein are not intended in an exclusive or limited sense, and variations may exist in organization, dimension, chemical composition, and mechanical design and configuration, without departing from the claimed invention, the scope of which is provided by the appended claims and their equivalents. 
         [0035]      FIG. 1  is a side cross sectional drawing of a female anatomy showing the bladder, urethra, vagina, and pubic bone in a patient with pelvic floor dysfunction and loss of support giving rise to urethral hypermobility, thus resulting in the displacement of the bladder. When the patient is laughing, coughing, lifting, or exercising, the abdominal pressure is increased momentarily. For patients with type II stress incontinence, the result may be a shifting or “hypermobility” of the bladder near the region of the bladder neck, which results in unwanted urine leakage. This problem is reduced by adding lift and support to the area of the bladder near the bladder neck using a sling. 
         [0036]      FIG. 2  is a side cross sectional drawing of the female anatomy demonstrating a sling to lift and support the bladder and to diminish the curvature of the urethra and the bladder neck. The bladder is lifted in  FIG. 2 , as compared to the bladder position in  FIG. 1 . The urethra near the bladder neck is also supported by the sling and the tissue near the vagina is no longer compressed by the bladder. Attachment of the sling may be made using bone anchoring or suturing to the pubic bone, by attachment to strong ligaments of the female anatomy, such as the Cooper&#39;s ligaments, or by attachment to the rectus abdominous muscle. A variety of attachment apparatus and methods are provided in the present description. 
         [0037]      FIG. 3  shows a top cross sectional drawing of the female anatomy from a view where the urethra  8  is normal to the plane of the drawing and showing a cross section of an adjustable sling with an expandable element  10  according to one embodiment of the present system. In this embodiment the expandable element  10  is supported by the attachment straps  14  and is positioned between the vagina  7  and the urethra  8  in the region of the bladder neck. Tightening the attachment straps  14  provides a support of the urethra  8  and bladder neck due to forces on the attachment straps  14  and the expandable element  10 . The position of the urethra  8  with respect to the pubic bone is adjusted during surgery by controlling the tension on the attachment straps  14 , which are connected to the anchors  13 , in this embodiment. 
         [0038]    The expandable element  10  is made of any biocompatible material which is suitable for implantation and has the requisite mechanical properties for strength, elasticity, and durability. Some suitable materials include silicone and polyurethane. The element is connected to a conduit  11  which terminates in a port, such as a septum  12 . The septum  12  is made of a self sealing material which serves as a port for a source of flowable material for adjusting the size of the expandable element and which self seals upon removal of the source of flowable material. The self-sealing material is silicone in one embodiment, however, other materials may be used without departing from the present system. In some embodiments, the flowable material used is a saline solution. Other flowable materials are used in different embodiments, including, but not limited to x-ray contrast media, and/or hydrophilic particle suspensions. Combinations of flowable materials may be used in certain embodiments. 
         [0039]    Fluid communication between the septum  12 , conduit  11 , and expandable element  10  is such that the expandable element may be expanded by adding a flowable material using a source accessing the port (septum  12 ) or contracted by withdrawing flowable material from the source accessing the port (septum  12 ). In one embodiment, this adding or withdrawing is an adjustment to the size of the expandable element which is performed postoperatively. In one embodiment this is performed using a syringe  15  containing a flowable material. 
         [0040]    Adjustment of the expandable element is facilitated by positioning the septum under the skin and in a region convenient for access by a syringe, such as the labia majora or mons pubis. Other locations and methods for positioning may be used without departing from the present teachings. Thus, conduit  11  is long enough for positioning the septum in a desirable location and tunneling through the tissue back towards the anterior surface of the pubis. This provides a system in which size of the expandable element is adjustable after the implantation of the device. Therefore, the urethra  8  may be displaced in either direction by adding or subtracting flowable material to the expandable element through the septum after surgery. This postoperative adjustment may be made by locating the septum near its expected location and using the syringe  15  to add or withdraw flowable material, adjusting the position of the urethra  8  and the coaptation of the urethra  8  near the bladder neck. 
         [0041]    Although  FIG. 3  shows anchoring to the pubic bone  16 , other embodiments employ other anchoring points, such as the Cooper&#39;s ligaments. The straps  14  are anchored to the pubic bone  16  using bone anchors, sutures, or glue. Other attachments may be used without departing from the present system. In one embodiment, the attachment straps are made of nylon. In other embodiments, stainless steel or polypropylene are used. Attachment of the straps  14  to the expandable element is accomplished by use of surgical needles. Alternatively, the expandable element is integrated into the straps  14 , where in one embodiment the straps  14  shown on either side of the expandable element form a single continuous strap on which the expandable element, or elements, is positioned/secured. 
         [0042]    The expandable element changes in sizes when flowable material is added or withdrawn. In one embodiment, the expandable element varies in sizes between approximately 8-15 mm in thickness. Other ranges may be used without departing from the present system. The expandable element may change in volume in various ranges. In one embodiment a range of 2-20 cc&#39;s is used. Other ranges may be employed without departing from the present system. 
         [0043]      FIG. 4  shows a top view of the adjustable sling according to the one embodiment shown in  FIG. 3 . The figure is not necessarily drawn to scale and the size of the expandable element and straps may vary without departing from the present invention. 
         [0044]      FIG. 5  shows a top cross sectional drawing of the female anatomy from a view where the urethra is normal to the plane of the drawing and showing a cross section of an adjustable sling according to one embodiment of the present system. In this embodiment, strap  54  is modified to include an adjustable element  50  for adjusting the tension in strap  54  and for changing the displacement of the urethra  8 , accordingly. Adjustment of element  50  is performed by adding or subtracting flowable material to element  50  using septum  52  in fluid communication with conduit  51 . 
         [0045]    In one embodiment element  50  is a bellows with a length that is a function of the flowable material added to the bellows. This provides an adjustment of the lift or support of the bladder near the bladder neck in this embodiment. 
         [0046]    It is understood that element  50  may be located on different portions of strap  54  in some embodiments. Other embodiments include the use of element  50  on both strap  54  and strap  55 . Another embodiment includes the use of multiple elements  50  to provide additional displacement of urethra  8 . In some embodiments, sling  56  is not adjustable. In some embodiments, sling  56  is a conventional sling. In some embodiments, sling  56  is adjustable, including any of the embodiments provided in this specification. 
         [0047]      FIG. 6  shows a top cross sectional drawing of the female anatomy from a view where the urethra is normal to the plane of the drawing and showing a cross section of an adjustable sling according to one embodiment of the present system. In this embodiment, an adjustable anchor  63  is incorporated into a single connection point for straps  64 . Sling  66  is connected to the straps  64 . The tension on sling  66  is adjustable by changing settings at adjustable anchor  63 . 
         [0048]      FIG. 7  shows one embodiment of a process for adjusting both the lift and support of the bladder/bladder neck and the coaptation of the urethra near the bladder neck. In this embodiment, an adjustable mount for the sling and an expandable element are used to provide adjustment of the lift and support and to provide adjustment of the coaptation of the urethra. The adjustable sling is implanted and the lift and support provided by the sling is initially adjusted. The expandable element is only partially filled. After implantation, the urethral function is measured. The lift and support of the sling is adjusted first and then the coaptation is adjusted by filling or withdrawing flowable material from the expandable element. 
         [0049]      FIG. 8-11  are shown to demonstrate different adjustable slings and are not necessarily drawn to scale. The following discussion is applicable to the remaining figures in different embodiments and is not limited to  FIG. 8 . 
         [0050]    One embodiment of an adjustable sling is demonstrated in  FIG. 8 .  FIG. 8A  is a cross sectional view of an adjustable sling according to one embodiment of the present system to demonstrate an uninflated state. In this embodiment, sling cup  120  contains an integrated conduit portion  141  which provides an interface for fluid communication between balloon  110  and conduit  140  which terminates in port  150 . In some embodiments, port  150  is a self sealing septum. Attachment tabs  130  are connected to straps (not shown) by suture in one embodiment. In one embodiment, tabs  130  contain a perforation so that straps may be tied to each tab  130 . The sling is secured using any of the connection systems and methods described in this specification, including all of the adjustable apparatus and methods taught herein. 
         [0051]    When properly tensioned, the sling cup  120  provides support and lift to the bladder neck distributed across face  143  (shown in  FIG. 8C ). Coaptation of the urethra near the bladder neck is further adjustable using balloon  110  which is inflated to provide force on urethra  8  to assist in providing adequate coaptation for alleviating type III urinary stress incontinence. In one embodiment port  150  is located at a position which is easy to access by a source of flowable material, such as a syringe. Using this embodiment, urethral coaptation is substantially independently adjustable of the lift and support of the bladder by cup  120 .  FIG. 8B  is a cross sectional view of the adjustable sling of  FIG. 8A  demonstrating one inflated state. In one embodiment, the coaptation of urethra  8  is adjustable after the implantation of device to provide enhanced coaptation without requiring another surgery. 
         [0052]    The drawing of the balloon  110  is not necessarily to scale, and the location, size, and maximum size of the balloon  110  may differ without departing from the present system. For example, different shaped balloons may be employed and other variations may be used, such as balloons which expand to a predetermined shape. Several embodiments are possible without departing from the present teachings. 
         [0053]    Cup  120  is made of any biocompatible material. In one embodiment cup  120  is flexible for ease of implantation. Implantation of such device may be performed through a vaginal incision method. In another embodiment, cup  120  is semi-rigid to accommodate the integrated conduit portion  141 . 
         [0054]      FIG. 8C  is a top view of the adjustable sling of  FIG. 8A  according to one embodiment of the present system. The size, shape and position of balloon  110  with respect to surface  143  may change without departing from the present system. 
         [0055]      FIG. 9A  is a top view of the adjustable sling according to one embodiment of the present system. In this embodiment, multiple balloons  110   a  and  110   b  are used to better control the coaptivity of the urethral portion near the bladder. Multiple ports  150   a  and  150   b  are also used to independently control the expansion of each balloon. In one embodiment a septum having dual ports is used to provide fluid communication to the plurality of balloons, as is shown in  FIG. 12 . 
         [0056]      FIG. 9B  and  FIG. 9C  show a side cross sectional drawing of the female anatomy demonstrating the adjustable sling of  FIG. 9A  to lift and support the bladder with respect to the pubic bone and to diminish the curvature of the urethra at the bladder neck, the adjustable sling also providing adjustable urethral coaptation. This figure shows the mechanical forces on the bladder neck portion of the urethra due to the sling straps and due to the effect of the balloons  110   a  and  110   b  on the urethra. In one embodiment, the inflation of the balloons is independently adjustable to provide the proper amount of coaptation. 
         [0057]      FIG. 10A  is a cross sectional view of an adjustable sling according to one embodiment of the present system to demonstrate an uninflated state. In this embodiment all of the balloons are connected to the same conduit, however, other connections may be made without departing from the present system. The additional balloons  111  and  112  provide additional coaptation control by applying force from a plurality of directions. In one embodiment, balloons  111  and  112  are connected to a first common conduit and a first port, and balloon  110  is connected to a separate, second conduit and a separate, second port. This allows balloons  111  and  112  to fill evenly and independently of balloon  110 . 
         [0058]      FIG. 10B  is a cross sectional view of the adjustable sling of  FIG. 10A  demonstrating one inflated state. Sling cup  120  has a surface  143  ( FIG. 10C ) which provides the lift and support of the bladder when properly connected to straps (not shown) at tabs  130 . The additional coaptive forces on the urethra  8  due to the inflation are shown with arrows. 
         [0059]      FIG. 10C  is a top view of the adjustable sling of  FIG. 10A  according to one embodiment of the present system. The shapes, placement, and sizes of the balloons may change without departing from the present system. 
         [0060]      FIG. 11A  is a cross sectional view of an adjustable sling according to one embodiment of the present system to demonstrate an uninflated state. In this embodiment, a plurality of ports and independent conduits are used to independently fill each balloon. However, it is noted that it may be advantageous in other embodiments to connect conduits to balloons  111  and  112  to provide even filling. Furthermore, in some embodiments a septum having a plurality of ports may be used to have a common position where each balloon may be filled, as is shown in  FIG. 12 . Additional ports may be added to the structure of  FIG. 12 . 
         [0061]      FIG. 11B  is a cross sectional view of the adjustable sling of  FIG. 11A  demonstrating one inflated state. Sling cup  120  has a surface  143  ( FIG. 10C ) which provides the lift and support of the bladder when properly connected to straps (not shown) at tabs  130 . The additional coaptive forces on the urethra  8  due to the inflation are shown with arrows. 
         [0062]      FIG. 11C  is a top view of the adjustable sling of  FIG. 11A  according to one embodiment of the present system. The shapes, placement, and sizes of the balloons may change without departing from the present system. 
       CONCLUSION 
       [0063]    Upon reading and understanding the present description, those skilled in the art would recognize that minor variations in the apparatus, processes, and applications described herein may exist without departing from the claimed invention and its equivalents. The embodiments described herein are intended to demonstrate the present invention, and are not intended in an exclusive or limited sense. For example, a change in the positioning of adjustable elements, filling fluids, shapes, conduit layout and connectivity, and filling systems may occur without departing from the present system. Furthermore, the shapes, placement, and sizes of the balloons may change without departing from the present system.