Abstract:
Devices and methods for treating conditions, such as overactive bladder, caused by afferent nerve signals involving the creation of dissection planes that interrupt the afferent nerve signals.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional Application Ser. No. 61/935,753 filed Feb. 4, 2014, entitled Devices And Methods For Treating Conditions Caused By Affarent Nerve Signals, which is hereby incorporated herein by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The modified Inglemann-Sundberg (IS) procedure created a submucosal dissection plane in the trigone region of the bladder, for purposes of interrupting the afferent nerves emanating from the bladder trigone, as a treatment for OAB (Over active bladder). This dissection plane was created with basic surgical technique, via the superior portion of the vagina. A flap was created then re-approximated to result in a dissection layer within the congruent tissue of the vagina and trigone of the bladder. While apparently successful clinically, few physicians have adopted this. Even early study authors apparently do not continue to perform this procedure. 
         [0003]    Some limiting factors in adoption of this procedure is its relative invasiveness, use of rudimentary surgical tools, together with the challenge of creating the dissection plane essentially blindly, without clear visual bladder landmarks from the vaginal approach. 
       OBJECTS AND SUMMARY OF THE INVENTION 
       [0004]    Disclosed here are several concepts that mainly emulate the clinical result of the modified IS procedure, but do so in a way that would be more precise, less invasive, and/or easier to perform, as well as other potential advantages. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0005]    These and other aspects, features and advantages of which embodiments of the invention are capable of will be apparent and elucidated from the following description of embodiments of the present invention, reference being made to the accompanying drawings, in which 
           [0006]      FIG. 1  is a diagram depicting the female urogenital anatomy; 
           [0007]      FIG. 2  is a diagram of a female bladder; 
           [0008]      FIG. 3  is a diagram depicting the location of the trigone region of a female bladder in relation to the rest of the female urogenital anatomy; 
           [0009]      FIG. 4  is a diagram of an embodiment of a device of the invention being inserted into a female urogenital region; 
           [0010]      FIG. 5  is a diagram of a dissection layer formed by an embodiment of a method of the invention; 
           [0011]      FIG. 6  is a diagram of multiple dissection layers formed by an embodiment of a method of the invention; 
           [0012]      FIG. 7  is an elevation of an embodiment of a visualization scope of the invention; 
           [0013]      FIG. 8  is a section of the embodiment of  FIG. 7  taken along section lines A-A; 
           [0014]      FIGS. 9-10  are elevations of an embodiment of a catheter of the invention; 
           [0015]      FIG. 11  is a diagram of an embodiment of a visualization scope of the invention being used in an embodiment of a method of the invention; 
           [0016]      FIG. 12  is a diagram of an embodiment of a guidewire of the invention placed in a female urogenital region by an embodiment of a method of the invention; 
           [0017]      FIG. 13  is a diagram of an embodiment of a catheter of the invention being used in an embodiment of a method of the invention; 
           [0018]      FIGS. 14-15  depict an embodiment of a cutting device of the invention being used in an embodiment of a method of the invention; 
           [0019]      FIGS. 16-17  are elevations of an embodiment of a cutting device of the invention with cutaways showing internal components; 
           [0020]      FIGS. 18-20  depict an embodiment of a cutting device of the invention being used in an embodiment of a method of the invention; 
           [0021]      FIG. 21  is a perspective view of an embodiment of a cutting device of the invention; 
           [0022]      FIG. 22  is an elevation of an embodiment of a cutting device of the invention; 
           [0023]      FIG. 23  is a bottom view of an embodiment of a cutting device of the invention; 
           [0024]      FIG. 24  is an end view showing lumens of an embodiment of a cutting device of the invention; 
           [0025]      FIG. 25  is an end view of an embodiment of a cutting device of the invention; 
           [0026]      FIGS. 26-28  are perspective views of an embodiment of a cutting device of the invention; and, 
           [0027]      FIG. 29  is a perspective view of an embodiment of a cutting device of the invention. 
       
    
    
     DESCRIPTION OF EMBODIMENTS 
       [0028]    Specific embodiments of the invention will now be described with reference to the accompanying drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the embodiments illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements. 
         [0029]      FIG. 1  illustrates in sagittal section, the female urogenital organs. Bladder B, urethra UR, vagina V, and uterus UT.  FIG. 2  shows the bladder B in frontal-axial section (parallel to urethra), illustrating the trigonal area or region T on the surface of the bladder, defined approximately by the triangle of the ureteral ostia UO, and bladder neck BN. The bladder anatomy of the male is similar. 
         [0030]    Afferent nerves emanate from various locations within the bladder, but afferent nerves that emanate from the trigonal region T (dashed line in  FIG. 3 ), are believed to play a particularly important role in modulating the urge to urinate. These afferent nerves travel from the bladder surface (mucosal layer) into the submucosal tissue and potentially into the vaginal layer coextant with the bladder trigonal tissue. Disruption of some or all of these nerves is believed to interfere with the pathological hyperactive voiding urge mechanism in people with over active bladder (OAB). 
         [0031]    A first embodiment of a method of the invention shown in  FIG. 4 . Here, a balloon catheter  10  is placed in the submucosal tissue in the trigone region T. Upon inflation (using suitable inflation medium such as liquid or air), a dilated balloon  12  forms a dissection plane within the tissue, thus disrupting the afferent nerves therein. The balloon is then deflated and removed, resulting in the dissection layer  14  shown in  FIG. 5 . The balloon catheter  10  may be positioned in one or multiple locations.  FIG. 6  shows the resultant dissected regions  14  of multiple placements and dilations. Multiple regions may be parallel, or “fanned out”, as shown. The dissected regions or planes  14  may overlap, or be discontinuous (as shown). The size of the dissected plane(s) may be influenced by the balloon size, as well the number and position of the placements. The dissected plane(s) may be completely within the trigone region T, or may extend beyond the trigone region T. One or more dissected planes  14  may also be outside the trigone region T. The dissection plane(s) may be anywhere within the tissue of the bladder trigone, or in the vaginal wall. The plane(s) may be just under the mucosal layer, or at the junction of the vagina and bladder tissue. These layers may have a natural “separability” to facilitate relatively controlled dissectioning of the tissue. 
         [0032]    The dissection plane(s)  14  may be stabilized following the dissecting procedure by temporary placement of a Fogarty balloon in the bladder to keep the dissected tissues in approximation. In this, as well as other embodiments of the invention, other suitable devices may also be used from either the bladder side and/or the vaginal side. 
         [0033]    The dilation catheter  10  (which may also be an expandable mechanical dilator), may be placed with the aid of various devices, as described below. A representative visualization scope such as a cystoscope  20  is shown in  FIGS. 7 and 8 . This device  20  may include a channel  22  for an endoscope  24  (or could have built-in visualization), one or more channels  26  for infusion/aspiration, and one or more channels (lumens) for delivery of “working devices” (working channel)  28 . 
         [0034]    The dilation catheter  10 , seen in  FIG. 9  (uninflated balloon  12 ) and  10  (inflated balloon  12 ) may include a lumen for use with a guide wire  16 . The guide wire lumen may extend the entire length of the balloon catheter, as is shown in the figures, or may emerge alongside, some distance from the tip, as is often the case with balloon catheters used in vascular procedures (aka “monorail style”). This shorter wire lumen allows for easier installation of the balloon catheter over the proximal end of the guide wire after the guide wire has been placed at a desired target location. 
         [0035]    The guide wire  16  may be flexible and steerable, with a pre-formed curve  18  at the distal end. The guide wire may be initially placed transurethrally with the aid of the cystoscope  20 , as shown in  FIG. 11 . Initially the cystoscope  20  is placed in the urethra to a site where entry of the guide wire  16  is desired to be placed submucosally. The guide wire may have a sharpened tip  19  to aid in penetrating the surface and advancing submucosally. A cautery device or other tissue penetrator may also be used to initially access the submucosal space. Imaging may also be used to facilitate navigation and placement, such as fluoroscopy or ultrasound. 
         [0036]    Once the guide wire  16  is positioned, the cystoscope  20  may be removed, or may be left in place and the balloon catheter  10  advanced over the guide wire  16  and within the working channel  28 .  FIG. 12  shows the cystoscope  20  removed.  FIG. 13  shows the balloon catheter  10  advanced over the guide wire to the target site for dilation. Positioning of the balloon  12  may be aided with markers (not shown) on the guide wire that at a known distance from the tip, coupled with a known length of balloon catheter, resulting in the tip of the balloon catheter being positioned a known distance from the guide wire.  FIG. 4  shows the balloon in an inflated condition. 
         [0037]      FIG. 5  is a side view showing the dissection plane  14  within the tissue between the bladder trigone region and the vagina. And, as mentioned above,  FIG. 6  shows the areas in an exemplary treatment with three dissection regions  14  following three balloon placements and inflations. 
         [0038]    As with other embodiments of the invention, similar techniques could be performed via a trans-vaginal approach, where the balloon catheter is placed into the same region, but via the superior portion of the vagina. 
         [0039]      FIGS. 14 and 15  illustrate an alternative embodiment of the invention. Here, a cutting device  30  is positioned in the submucosal space of the bladder trigone T. Cutting device  30  may be positioned in similar locations as described above in connection with the balloon embodiments. 
         [0040]    Cutting device  30  may be one of the cutting devices used in other minimally invasive surgical procedures, such as those used through working channels of cyctoscopes for other urological or gynecological procedures, or other scope devices used in other human minimally invasive surgical procedures. Such devices may be steerable and/or deflectable. Furthermore they may also incorporate cautery or other energy combined with cutting to achieve cutting while minimizing bleeding. 
         [0041]    The cutting device  30  may be positioned with the aid of a cystoscope  20 , an exemplary version of which was illustrated in  FIGS. 7 and 8 , via a working channel  28 . Cutting device  30  may be further positioned with the aid of a guide wire  16 , similar to that described in connection with the balloon catheter embodiments. The cutting device  30  may also be advanced in a tissue plane that has a natural “separability”, such as between the bladder mucosa and submucosa, or between the bladder trigone submucosa and the vaginal submucosa. 
         [0042]      FIGS. 16 and 17  illustrate a novel and particularly useful embodiment of a cutting device  30  for making submucosal dissection planes. Cutting device  30  includes  2  laterally extendable blades  32 , with cutting surfaces on their outer (lateral) aspects. When the cutting device is placed in a target position, it is initially “closed”, as shown in  FIG. 16 . Then the device is “opened”, by relative movement between the activation tethers  34  and the body, creating a dissection plane wider than the device. The activation tethers pull on the lever arms  38  of the cutting blades, and the cutting blades rotate outward about a pivot  40 . The cutting device may be further advanced to make a more elongate dissection plane. The cutting device may be repositioned to make multiple laterally displaced cutting planes  14 , as shown in  FIG. 6 . Such dissection planes  14  may ultimately be conjoined to form one relatively large dissection plane in the submucosal region of the bladder trigone. 
         [0043]      FIGS. 18-19  show another embodiment  50  of a cutting device. Here, the blades  52  may be relatively long, and as such may create a larger dissection plane  14  in the submucosal surface when the blades are opened laterally, as shown in  FIGS. 18-20 . 
         [0044]    As with the balloon embodiments, these cutting device embodiments may also be used from the vaginal side of the bladder trigone to create one or more submucosal dissection planes. 
         [0045]      FIGS. 21-25  illustrate yet another alternative embodiment  60  for a cutting tool. Here cutting tool  60  may include a positioning guide  62 . Positioning guide  62  may include a suction paddle  64  for engagement with the bladder mucosa, and a cutting blade  66  (shown retracted) within a cutting blade lumen  68 , and a visualization device  70  such as an endoscope. 
         [0046]    In operation, the positioning guide  62  is placed into the bladder transurethrally to a site of interest, such as adjacent the trigone region. If a dissection plane is to be made, the suction paddle  64  is placed against the bladder mucosa in the region to be submucosally dissected. Note that the endoscope  70  may be movable longitudinally within the scope channel  72  to help with precise placement of the distal tip of the suction paddle  64 , as seen in  FIG. 26 . Advancing the endoscope  70  to near the tip can be particularly advantageous to accurately position the tip relative to the ureteral orifices in order to avoid damage to them. 
         [0047]    Once in a desired location, the suction paddle  64  is activated by applying suction to the suction lumen  74  ( FIGS. 24 ). Valves (not shown) operative with the lumen  74  may be incorporated. Apertures  76  in the tissue face of the suction paddle  64  then securely engage the mucosal tissue. The blade is then advanced, as seen in  FIG. 28 . 
         [0048]    Because the cutting blade lumen is parallel to but offset from the tissue face, as shown in FIG. P 3 , the cutting blade cuts a dissection plane at a predetermined depth submucosally. A handle mechanism (not shown) may be incorporated to manage and control the positions of the proximal ends of the cutting blade and/or the endoscope. 
         [0049]    The positioning guide  62  can be placed in multiple locations by repeatedly removing suction, manipulating the guide, re-applying suction, and re-advancing the blade. In this manner, multiple submucosal dissection planes can be generated in the bladder trigone area. 
         [0050]    As with other embodiments above, the cutting blade  66  may incorporate cautery, such as monopolar RF applied to the blade, or bipolar RF energy applied from the blade to the suction head. In such a case, portions of the cutting blade and suction head are appropriately conductive, and adjoining surfaces are appropriately electrically insulated. 
         [0051]    Also, as with other embodiments above, the positioning guide embodiments may be utilized via a trans-vaginal approach. 
         [0052]    In yet a further embodiment, the positioning guide  62  described above, with the suction paddle  64 , may be used with other cutting mechanisms that are placed submucosally via the cutting channel. An appropriately sized cutting channel is incorporated, depending on the size and shape of the cutting device to be used. 
         [0053]    For example,  FIG. 29  shows the cutting device  60  employing a translatable cutting mechanism  80 . In addition to being able to be advanced and retracted longitudinally, as shown by arrow  82 , the cutting mechanism  80  as able to be translated from side to side as shown in arrow  84 . In order to maximize translation, a pivot point (not shown) is located as near the distal opening of the lumen  68  when the mechanism  80  is advanced longitudinally to its distal extent. The sides of the lumen  68  may act as translation limits. In this way, the desired degree of translation may be controlled by the amount the mechanism  80  is advanced distally. Retracting the mechanism  80  proximally reduces the degree to which the mechanism  80  may be translated side-to-side. 
         [0054]    It is understood that mechanism  80  may comprise a blade or needle and may be energized for ablation, to form a lesion, or cauterization. If a needle is used as the mechanism  80 , the translation feature is used prior to advancing the needle out of the lumen  68 , and is thus used to control the angular direction the needle travels out of the lumen. In this way, several injection lines may be effected without repositioning the positioning guide  62 . 
         [0055]    Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof. For example, one alternative to the methods of the invention may include trans-urethral trigonal resection—whether by mechanical or energy delivery (including cryo) means. Resection may involve removal or destruction of a layer of desired thickness (ranging from the 1 mm mucosal thickness to the 5-6 mm complete bladder wall thickness) which would include nerves and nerve endings involved in OAB. As an additional example, the devices described above may be modified (e.g. by making longer and/or flexible) for use in the male anatomy.