|Publication number||US20080167518 A1|
|Application number||US 12/054,662|
|Publication date||Jul 10, 2008|
|Filing date||Mar 25, 2008|
|Priority date||Apr 30, 1999|
|Also published as||DE60041917D1, EP1189552A1, EP1189552B1, US7395822, WO2000066030A1|
|Publication number||054662, 12054662, US 2008/0167518 A1, US 2008/167518 A1, US 20080167518 A1, US 20080167518A1, US 2008167518 A1, US 2008167518A1, US-A1-20080167518, US-A1-2008167518, US2008/0167518A1, US2008/167518A1, US20080167518 A1, US20080167518A1, US2008167518 A1, US2008167518A1|
|Inventors||John H. Burton, Timothy C. Cook|
|Original Assignee||Uromedica, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (39), Classifications (9)|
|External Links: USPTO, USPTO Assignment, Espacenet|
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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's is used. Other ranges may be employed without departing from the present system.
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.
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.
One embodiment of an adjustable sling is demonstrated in
When properly tensioned, the sling cup 120 provides support and lift to the bladder neck distributed across face 143 (shown in
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.
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.
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.
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|U.S. Classification||600/31, 600/37|
|International Classification||A61F2/02, A61F2/00|
|Cooperative Classification||A61F2250/0003, A61F2/004, A61F2/0045|
|European Classification||A61F2/00B6B4, A61F2/00B6B2|