Abstract:
A bladder plication system to treat ISD in a patient is provided. The device can include a needle introducer device, and a plication device. The needle introducer device is advanced through the bladder, with the plication device contained and deployable within the needle introducer device. Once inserted in the bladder and positioned, the needle is passed through portions of the bladder wall. The plication device is then deployed through a distal end of the introducer device, wherein the bladder wall is folded near the inner sphincter to reduce forces on the bladder and resolve the patient&#39;s SUI.

Description:
PRIORITY 
       [0001]    This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/426,175, filed Dec. 22, 2010 and entitled “Pelvic Tissue Plication System,” which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to surgical methods and apparatus and, more specifically, to a bladder plication device system adapted to treat intrinsic sphincteric deficiency. 
       BACKGROUND OF THE INVENTION 
       [0003]    Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor. 
         [0004]    Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems. 
         [0005]    Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed. 
         [0006]    In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times. 
         [0007]    Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) occurs when the patient is physically stressed. 
         [0008]    Intrinsic Sphincteric Deficiency (ISD) is a condition resulting from an intrinsic defect in the sphincteric mechanism that results in an open bladder neck. This, along with urethral mobility, can be caused by damage to the pelvic floor and urethral ligaments, which can result in SUI. 
         [0009]    There is a need for a device and surgical procedure designed to treat such pelvic orders, including ISD in a patient. 
       SUMMARY OF THE INVENTION 
       [0010]    The present invention describes various embodiments of a bladder plication system to treat ISD in a patient. The system can include a needle introducer device, and a plication device. The needle introducer device is advanced into the bladder, via the urethra, with the plication device deployable from within the needle introducer device. Once inserted in the bladder and positioned, the needle is passed through a portion of the bladder wall at a first location and then back again into the bladder through a second location of the bladder wall proximate the first location. The distance between the first location and the second location generally defined the size of the plication, e.g., the size of the bladder wall fold brought together. The plication device is then deployed through a distal end of the introducer device, wherein the bladder wall is folded near the inner sphincter to reduce forces on the bladder and resolve the patient&#39;s SUI. 
         [0011]    The plication device can be constructed in a generally rivet-shaped configuration to define a first head portion, an intermediate body member, and a second head portion. The head portions and/or the intermediate body member can be constructed of a polymer metal material such the head portions are hingedly or pivotally displaceable or movable relative to the body member. Such a hingable configuration facilitates substantial collapse of the plication device onto itself to facilitate deployment and placement. 
         [0012]    In certain embodiments, the plication device can include one or more adjustment features, enabling a user (e.g., physician) to adjust the spacing between the respective head portions to correspondingly adjust the compression on the tissue trapped therebetween during the plication folding process, and to allow for various sized tissue or bladder wall folds during the procedure. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  illustrates the bladder and associated anatomy. 
           [0014]      FIGS. 2-6  show plication devices and corresponding features or structures in accordance with embodiments of the present invention. 
           [0015]      FIG. 7  shows a needle introducer and deployment device in accordance with embodiments of the present invention. 
           [0016]      FIGS. 8-11  show a plication or folding procedure of the bladder wall using a plication device in accordance with embodiments of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0017]    Referring generally to  FIG. 1 , a diagram is shown of the human bladder and associated anatomy, including the inner or internal urethral sphincter S. The internal sphincter muscle is located at the junction of the urethra with the urinary bladder and when functioning properly is the primary muscle for prohibiting the release of urine. The sphincter is made up of a ring-like band of muscle fibers that are under involuntary or autonomic control, with the sphincter normally in a closed position and needing stimulation to open. An intrinsic defect in the sphincteric mechanism can result in an open bladder neck and, thus, SUI. 
         [0018]    Referring generally  FIGS. 2-11 , various embodiments of a bladder plication system  10  are disclosed. In general, the plication system  10  can include at least one needle introducer device  12  and at least one plication device  14 . Various portions of the systems  10  can be constructed of metal or polymer materials, such as polypropylene, polyethylene, fluoropolymers, Nitinol or like compatible materials. The plication device  14  is generally deployed into the bladder via the urethra to plicate or fold one or more portions of the bladder wall W as described herein. 
         [0019]    As shown in  FIGS. 2-6 , the plication device  14  can be constructed in a generally rivet-shaped configuration to define a first head portion  20 , an intermediate body member  22 , and a second head portion  24 . The head portions  20 ,  24  and/or the intermediate body member  22  can be constructed of a polymer metal material such the head portions  20 ,  24  are hingedly or pivotally displaceable or movable relative to the body member  22 . Such a hingable configuration facilitates substantial collapse of the plication device  14  onto itself to facilitate deployment and placement. In certain embodiments, this movement or adjustment is made possible by the material construction itself. For instance, the body member  22 , or a region or juncture  25  at which the head portions  20 ,  24  connect to the body member  22 , can be generally flexible or constructed of a thin material (polymer or metal), thereby providing a level of “give” or hinging action at the juncture, or a portion of the body member  22 . 
         [0020]    In other embodiments, the body member  22  can include a living hinge portion  22   a  at or proximate the junctures  25  where the body member  22  meets the head portions  20 ,  24 . Further, various embodiments of the plication device  14  can include movable ball, or ball and socket, mechanisms or features  22   b  to facilitate hinging of the head portions  20 ,  24  relative to the body member  22 . 
         [0021]    Various other embodiments can include an attachment feature  23  adapted to selectively receive an elongate member  27 , such as a wire, rod or like member, to facilitate control over the plication device  14  during deployment and positioning. The member  27  can be generally rigid, partially flexible, partially rigid, or take on like constructs and characteristics to facilitate use as the means of controlling and moving the plication device  14 . 
         [0022]    The plication device  14  and its components can take on a variety of shapes and sizes, and can be constructed of any compatible metal, polymer or like material having generally flexible or rigid characteristics. Various sized plication devices  14  can be used to provide different spacing options between the head portions  20 ,  24 , thereby allowing for larger or smaller tissue or bladder wall folds therebetween. 
         [0023]    In certain embodiments, as shown in  FIG. 6 , the plication device  14  can include one or more adjustment features  30 , enabling a user (e.g., physician) to adjust the spacing between the respective head portions  20 ,  24  to correspondingly adjust the compression on the tissue trapped therebetween during the plication folding process, and to allow for various sized tissue or bladder wall folds during the procedure. This may be important to ensure that the plicated tissue is secure, and to ensure that there is no leaking from the bladder through any tissue puncture created during the procedure. In one embodiment, the adjustment feature  30  can include a plurality of teeth or angled portions  32  provided along all or a portion of the body member  22 . These teeth portions  32  are adapted to engage with corresponding or matingly compatible portions or like features in an aperture  34  of one or both of the head portions  20 ,  24  (e.g., head portion  24 ). In general, this mating teeth configuration will enable sliding or otherwise moving one of the head portions (e.g., head portion  24 ) closer to the other head portion (e.g., head portion  20 ) along the body member  22  to reduce the space therebetween (and with tissue therebetween as well), but the moving head portion (e.g., head portion  24 ) will not move back in the opposite direction to increase the distance between the heads or loosen the compression on the trapped fold of tissue. 
         [0024]    Various embodiments can include other adjustment features  30  to permit adjustment of the distance between the head portions  20 ,  24 , before or during the procedure. For instance, the body member  22  can include a threaded portion adapted to threadably engage with one or both of the head portions  20 ,  24  such that a screw or like interface (or one of the head portions  20 ,  24  itself) can be turned to selectively move the respective head portion  20 ,  24  (e.g., head portion  24 ) closer to or farther from the opposing head portion (e.g., head portion  20 ). Other embodiments can include one or more biasing members, such as a spring, along a portion of the body member  22  to provide selective biasing adjustment of the distance between the head portions  20 ,  24 . Various fasteners, linear adjustment devices and mechanisms, and like mechanisms, devices and techniques known to those of skill in the art can be employed to provide the disclosed distance adjustment between the head portions  20 ,  24 . 
         [0025]    As shown in  FIGS. 7-11 , embodiments of a procedure and devices of the system  10  can be utilized to treat defects in the described internal sphincteric mechanism to resolve SUI in the patient. For instance, as shown in  FIG. 8 , the introducer needle device  12  can include a needle portion  40  having an internal lumen  41  adapted to receive and facilitate deployment of the plication device  14 . The needle device  12  can include a handle portion  42  having an actuator  44 . The actuator  44  can be in operable communication with the elongated member  27 , controlling extension and retraction of the member  27 . The needle device  12  can include blunt or piercing tips, and other features and mechanisms to facilitate device deployment and use. 
         [0026]    In use, the plication device  14  is received in the lumen  41  of the needle portion  40  of the device  12  (e.g., generally collapsed) for use during the plication procedure. The member  27  is attached to one of the head portions  20 ,  24 , or another portion of the plication device  14 , to facilitate movement of and control of the device  14 . The distal end or tip  46  of the needle device  12  can be advanced or pierced through a first bladder wall portion B 1 , traverse through a length of the bladder (within the interior of the bladder), and out through a second bladder wall portion B 2 , as shown in  FIG. 8 . 
         [0027]    As shown in  FIG. 9 , the plication device  14  can then be deployed out the distal end  46  of the needle device  12 . The first head portion  20  can be extended out (pushed by member  27 ) from the second bladder wall portion B 2  to rest or engage against the outside surface of the bladder wall W. Various protrusions, anchors, or material constructs can be employed to facilitate engagement with the bladder wall. 
         [0028]    Upon deploying the first head portion  20 , the needle device  12  can be backed out such that the second head portion  24  remains secured within the needle lumen  41  until the distal end  46  exists out through the first bladder wall portion B 1 , as shown in  FIGS. 9-10 . At this point, the second head portion  24  can be deployed from the distal end  16  for securement or engagement against the outside surface of the bladder proximate the first bladder wall portion B 1 . The member  27  can be removed from the second head portion  24 , e.g., via a pulling force, cutting, snap disengagement, unlatching, twisting, and the like. As such, the bladder wall, between bladder wall portions B 1  and B 2 , can be cinched or folded onto itself to define the plicated or folded tissue T to reduce slack and tighten up the target bladder wall region. This procedure can be repeated for multiple target sites or bladder wall portions, including those at or proximate the internal sphincter mechanism, using additional plication devices  14 . 
         [0029]    This system  10  and surgical procedure has many advantages, including not requiring an incision (surgical entry through the urethra), reduced invasiveness, direct treatment of ISD, and less anesthesia and recovery time requirements for the patient than other surgical procedures. 
         [0030]    While embodiments of the system  10  are described in relation to treating ISD and SUI, other applications for treating other pelvic or applicable tissue areas are envisioned as well. 
         [0031]    The various systems, devices, tools, features and methods disclosed hereinbelow and directed to pelvic implant and repair systems (e.g., for male and female), are envisioned for use with the present invention, including those disclosed in U.S. Pat. Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525, 7,025,063, 6,691,711, 6,648,921, and 6,612,977, International Patent Publication Nos. WO 2008/057261 and WO 2007/097994, and U.S. Patent Publication Nos. 2010/0105979, 2002/151762 and 2002/147382. Accordingly, the above-identified disclosures are fully incorporated herein by reference in their entirety. 
         [0032]    The systems  10 , their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulating devices to treat incontinence and prolapse as disclosed in the previously-incorporated references are envisioned for use with the present invention as well. Further, the system and its components or structures can be constructed of known and compatible materials know to those skilled in the art, including metals, polymers, and the like. 
         [0033]    All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications. 
         [0034]    Obviously, numerous modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.