Abstract:
An improved device and method are provided for securing the urethra to the bladder in surgery. 
     A trocar is provided for insertion into the urethra. The trocar is removably secured to the urethra for advancement of the proximal end toward the bladder. A sheath is inserted and secured to the bladder in order to assist in the advance of the bladder toward the urethra. The improved system permits medical personnel to clamp the urethra and bladder without the need for insertion of time consuming and laborious sutures. A method of securing the urethra and bladder using the disclosed apparatus is also provided.

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 09/618,373, filed Jul. 17, 2000, now U.S. Pat. No. 6,461,367 titled METHOD AND DEVICE FOR URETHRAL-VESICLE ANASTOMOSIS, which application in turn claims the benefit of U.S. Provisional Application Ser. No. 60/144,429, filed Jul. 16, 1999, titled METHOD FOR URETHRAL-VESICLE ANASTOMOSIS. The entirety of each of the above-mentioned applications is hereby incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention generally relates to the reconnection of the urethra and bladder after a radical retropubic prostatectomy. Specifically, the invention relates to a method and device for performing a urethral-vesicle anastomosis. 
     2. Description of the Related Art 
     In a radical retropubic prostatectomy, the surgeon removes all or most of the patient&#39;s prostate. Because the urethra travels through the prostate immediately before reaching the bladder, the upper part of the urethra is removed in the surgery. In order to restore proper urinary functions, the bladder and the urethra must be reconnected. 
     Heretofore, surgeons would execute painstaking suturing operations with tiny, fine needles to reconnect these anatomical bodies. It has been found that the use of sutures for this purpose has caused certain problems in recovery. These problems include necrosis of the sutured tissues, stricture of the urethra which impedes the flow of fluid through it, and a urethra-bladder connection which is not fluid-tight. In addition, when suturing the urethra to the bladder the surgeon often inadvertently pierces the nearby neurovascular bundle, which can cause incontinence or impotence. 
     The suturing process itself has also been found to be cumbersome, requiring the surgeon to grasp and stretch the bladder and urethra together before making the fine sutures. 
     With radical retropubic prostatectomies becoming more common, a quicker and simpler way to reconnect the bladder and the urethra is needed. 
     SUMMARY OF THE INVENTION 
     One aspect of the present invention is an improved method for the anastomosis of the urethra to the bladder following a prostatectomy. 
     A further aspect of the present invention is an anastomosis procedure that eliminates the use of sutures in the urethra-bladder junction. 
     A still further aspect of the present invention is an anastomosis procedure with an improved means of grasping the urethra and bladder, bringing them together and holding them for the connection process. 
     A method and device are provided for the anastomosis of the urethra and bladder after radical retropubic prostatectomy. The surgeon inserts a trocar into the urethra and secures the bladder to the trocar with an external ring, or, alternatively, with at least one prong associated with the trocar. The surgeon then inserts a sheath into the bladder and secures the bladder to the sheath with at least one prong. The trocar and the sheath are then advanced toward each other, and fit together in an end-to-end fashion. When the urethral tissue and the bladder tissue are in close proximity, the urethra and the bladder are reconnected using at least one clip. The urethra is secured to the bladder 
     In accordance with one preferred embodiment, a method is provided for securing the urethra to the bladder of a patient. The method comprises the steps of inserting a first approximation device into the urethra, securing the urethra to the first approximation devices inserting a second approximation device into the bladder and securing the bladder to the second approximation device. The method further comprises the step of advancing the second approximation device toward the first approximation device so that a distal end of the urethra comes in close proximity to a distal end of the bladder. The final step of the method comprises securing the urethra to the bladder. 
     In accordance with yet another preferred embodiment, a method for securing the urethra to the bladder of a patient comprises the steps of inserting a first approximation device into the urethra, securing the urethra to the first approximation device, inserting a second approximation device into the bladder and securing the bladder to the second approximation device. The method further comprises advancing the first approximation device and the second approximation device toward one another so that a distal end of the urethra comes in close proximity to a distal end of the bladder. Finally, the urethra is secured to the bladder. 
     In accordance with still another preferred embodiment, there is provided a system for securing the urethra of a patient to the bladder of the patient. This system comprises a first approximation device adapted to be inserted into the urethra of the patient and a ring. The ring is suitable for placement on a exterior of the urethra for securing the urethra to the first approximation device. The system further comprises a second approximation device adapted to be inserted into the bladder. The second approximation device has at least one prong on a cannula of the second approximation device. The prong secures the second approximation device to the bladder. The system further comprises at least one clip. The clip is suitable to secure the urethra to the bladder once the urethra and bladder are within close proximity. 
     In accordance with still another preferred embodiment, there is provided a system for securing the urethra of a patient to the bladder of the patient. The system comprises of first approximation device that has a generally rigid cannula and at least one prong. The prong is moveable from a retracted position to an extended position on a exterior surface of the cannula to secure the urethra to the first approximation device. The system also comprises a second approximation device that has a generally rigid cannula and at least one prong. The prong is moveable from a retracted position to an extended position on an exterior surface of the cannula to secure the bladder to the second approximation device. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a schematic view of a trocar and sheath as used to join the bladder and urethra in accordance with the present invention; 
     FIG. 2 is a cross-sectional view of the trocar and sheath, and the juncture of the bladder and urethra; 
     FIG. 3 is a side elevation view of a sheath; 
     FIG. 4 is a perspective view of a sheath; 
     FIG. 5 is a close-up perspective view of the distal end of a sheath; 
     FIG. 6 is a side cross-sectional view of a sheath; 
     FIG. 7 is a detail cross-section view of the proximal end of a sheath; 
     FIG. 8 is a second detail cross-section view of the proximal end of a sheath, oriented 90° to the view in FIG. 7; 
     FIG. 9 is a detail cross-section view of the distal end of a sheath; 
     FIG. 10 is a perspective view of another embodiment of a trocar in accordance with the invention; 
     FIGS. 11A and 11B are cross-sectional views of the joining of the bladder and urethra tissues, employing another embodiment of the trocar and sheath; 
     FIG. 12 is a perspective view of a dual approximator; 
     FIG. 13 is a perspective view of a dual approximator, with the bladder everting device displaced in the distal direction; 
     FIG. 14 is a cross-sectional view of a dual approximator; 
     FIG. 15 is a detail cross-sectional view of the proximal end of a dual approximator; 
     FIGS. 16A-16C are side elevation, side cross-section, and perspective views of a bushing and everting wire assembly for use with a dual approximator; 
     FIG. 17 is a detail cross-sectional view of the distal end of a dual approximator; and 
     FIG. 18 is a cross-sectional view of the use of the dual approximator to join the bladder to the urethra. 
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
     FIG. 1 depicts, among other things, the relevant anatomical structures of a patient following a radical retropubic prostatectomy. The urethra  10  has been separated from the bladder  12  by virtue of the removal of the prostate (not shown). The urethra  10  must therefore be re-attached to the bladder  12  at the bladder outlet  14 . 
     To rejoin the bladder and urethra, a urethra approximation trocar  16 , comprising a proximal end  18  and a tapered distal end  20 , may be inserted into the urethra  10  via the urethral outlet in a manner known to those skilled in the art. The trocar  16  is preferably constructed of a stiff plastic or metal to provide sufficient rigidity despite a cross-sectional area small enough to permit the trocar  16  to pass through the urethra. The trocar  16  is advanced within the lumen of the urethra  10  so that the tapered or rounded distal end  20  of the trocar  16  emerges from the urethral passage. The urethra  10  is then secured to the trocar  16  in a manner which will prevent the urethra  10  from sliding backwards, away from the tapered distal end  20  of the trocar  16 , when the trocar is subsequently advanced toward the bladder  12 . Preferably, this is accomplished by a removable external ring  22  placed around the urethra  10  near the distal end  20 , securing the urethra  10  to the trocar  16 . Another method to secure the urethra with respect to the trocar is by means of one or more everting prongs extendable from the outer surface of the trocar  16  near the distal end  20 . (This is similar to the everting prongs  30  extendable from the sheath  24 , the operation of which will be discussed in greater detail below.) The prongs evert the urethra tissue from the trocar shaft, pushing it out radially to facilitate attachment. 
     FIG. 1 also depicts a urethra approximation sheath  24  having an everting knob  26  on the proximal end  28  and multiple everting prongs  30  near the distal end  32 . The distal end  32  also forms a cavity  34  which is sized so as to snugly receive the tapered end  20  of the trocar  16  (see FIG.  2 ). As with the trocar  16 , the sheath  24  is preferably constructed of a stiff plastic or metal to provide sufficient rigidity despite a cross-sectional area small enough to permit the sheath  24  to pass through the bladder outlet  14 . 
     To insert the sheath  24 , the surgeon first makes an abdominal incision  36  to gain access to the bladder  12 . The sheath  24 , with everting prongs  30  in a retracted position, is inserted into the incision  36  and is advanced toward the bladder outlet  14  so that the distal end  32  of the sheath  24  emerges from the bladder outlet  14 . By manipulation of the everting knob  26 , the everting prongs  30  are extended from the sheath  24  and positioned inside the bladder  12  such that they engage the bladder tissue near the bladder outlet  14 , securing the bladder  12  with respect to the sheath  24 . The everting prongs  30  thus prevent the bladder  12  from sliding backward on the sheath  24 , away from the distal end  32  of the sheath  24 , when the sheath  24  is subsequently advanced toward the urethra  10 . In addition, the everting prongs  30  pull the tissue of the bladder  12  both longitudinally and radially to facilitate the eventual application of one or more clips to the junction of the bladder and urethra (see FIG.  2 ). 
     With further reference now to FIG. 2, the surgeon advances the sheath  24  toward the trocar  16 , stretching the bladder  12  in the process. In one embodiment, the surgeon also moves the trocar  16  toward the sheath  24 , stretching the urethra  10  in the process. When the trocar  16  and the sheath  24  meet, the tapered distal end  20  of the trocar  16  enters the cavity  34  in the distal end  32  of the sheath  24 , to an extent sufficient to enable the urethral tissue and the bladder tissue to press together as shown. Fit together in this manner, the trocar  16  and the sheath  24  can retain the tissues in this orientation suitable for the connection process, in a “hands-free” manner. The tissues of the urethra  10  and the bladder  12  are subsequently clamped together using one or more external clips  38 , around the circumference of the urethra-bladder attachment. The application of the clips may effect disengagement of the bladder tissue  12  from the everting prongs  30 . In one embodiment, VCS clips are used to secure the urethral tissue to the bladder. The clips  38  may be applied either individually, or simultaneously in a “one-shot” fashion. 
     After the application of the clips  38 , the external ring  22  is removed, releasing the trocar  16  from the urethra  10 . The surgeon is now able to remove the trocar  16  via the urethral outlet in a manner known to those skilled in the art. Similarly, the sheath  24  may be moved in the proximal direction, after retracting the everting prongs  30  by manipulation of the everting knob  26 . The sheath  24  exits the bladder  12  through the incision  36 . 
     FIGS. 3-9 show the components of the sheath  24  in detail. The sheath  24  has an elongated cannula  40  with a cavity  34  in the distal end  32  and an everting knob  26  near the proximal end  28 . FIGS. 3,  4  and  6  show a sheath  24  which is straight; advantageously, the sheath may be curved as seen in FIG. 1, to promote ease of insertion and use. (Similarly, the straight instruments seen in FIGS. 10,  12 ,  13  and  14  may also be curved, to obtain the same advantages.) The everting knob  26  engages threads  42  near the proximal end of the sheath so that rotating the everting knob  26  causes it to advance in the desired direction (either distally or proximally) along the threaded portion of the sheath  24 . Knurling  44  is provided on both the cannula surface and the everting knob to facilitate easy gripping of the knob and sheath during surgery. Best shown in FIG. 5, a number (preferably  4 - 6 ) of openings  46  are distributed radially about the circumference of the cannula  40 , near the distal end  32 . The openings  46  permit everting prongs (not shown) to extend from, or retract into, the cannula  40  when the everting knob  26  is rotated. 
     As seen in FIG. 6, an everting tube  48  is disposed within a lumen  50  of the cannula  40  and is coaxial with the cannula  40 . The everting tube  48  fits snugly within the lumen  50  but can easily move longitudinally within the cannula  40  in both the distal and proximal directions. Near its proximal end the lumen  50  widens at a neck  52  to take on a larger-diameter cross section proximal of the neck  52 . Correspondingly, the everting tube  48  widens to form a stub  54  disposed within the larger-diameter portion of the lumen  50 . The neck  52  coacts with the stub  54  to limit the travel of the everting tube  48  in the distal direction. 
     FIGS. 7 and 8 show the proximal end  28  of the sheath  24  in detail. Note that FIGS. 7 and 8 are oriented 90° with respect to one another, so that FIG. 7 may be considered a side view and FIG. 8 a top view. A longitudinal slot  56  is formed in the wall of the cannula  40  near the proximal end  28 . The slot  56  permits an allen screw  58  to extend from a threaded hole  60  in the stub  54  beyond the external wall of the cannula  40  and into a space  62  formed by a radial groove  64  in the everting knob  26 , between distal and proximal walls  66 ,  68 . 
     With the screw  58  in place, one can cause the everting tube  48  to move in either the distal or proximal direction by manipulating the everting knob  26 . If the everting knob  26  is rotated so as to advance in the distal direction, the proximal wall  68  of the radial groove  64  bears on the screw  58  as the everting knob advances distally, causing the everting tube  48  to move distally within the lumen  50 . Similarly, if the everting knob  26  is rotated so as to advance in the proximal direction, the distal wall  66  of the radial groove  64  will bear on the screw  58 , causing the everting tube  48  to move proximally within the lumen  50 . 
     Referring momentarily to FIG. 6, it can be seen that the distal end of the everting tube  48  is connected to a bushing  70 , which is disposed within the lumen  50  and is moveable both distally and proximally therein. Best seen in FIG. 9, the bushing  70  forms a longitudinal socket  72  and two threaded holes  74  intersecting the socket  72 . The socket  72  receives the proximal ends of a number of everting wires  76 , and screws  78  threaded into the holes  74  clamp the everting wires  76  into the bushing  70 . 
     The everting wires  76  extend distally from the bushing  70  into angled channels  80  that correspond to the openings  46  in the distal end of the cannula  40 . The angled channels  80  force the distal ends of the everting wires, when moved distally, to extend from the cannula so as to form everting prongs  30  (see FIG.  2 ). Similarly, the everting wires  76  retract into the angled channels  80  when moved proximally. 
     Thus it can be seen that rotation of the everting knob  26  in the desired direction will extend or retract the everting prongs  30 . When the everting knob  26  is rotated in a direction causing the everting tube  48  to move distally, the everting tube  48  pushes the bushing  70  in the distal direction, forcing the everting wires  76  to extend from the openings  46  and form everting prongs. By rotating the everting knob  26  in the opposite direction, the everting tube  48  moves proximally and pulls the bushing  70  proximally as well, causing the everting wires  76  to retract into the angled channels  80 . 
     FIG. 10 shows an alternative embodiment of the trocar  16 , which employs the same everting-prong mechanism as the sheath discussed above. This type of trocar also has a tapered distal tip  20  which fits snugly into the cavity formed in the distal end of the sheath. 
     FIG. 11A depicts the use of the everting-prong mechanism of the sheath  24  with the bladder tissue  12 . Additionally, FIG. 11A shows the use of that version of the trocar  16  employing a similar mechanism, with the urethra  10 . After positioning the distal end  32  of the sheath  24  near the bladder outlet  14 , the surgeon extends the everting prongs  30 , which engage the bladder tissue  12 , everting the bladder outlet  14  and holding it in a suitable position for attachment to the urethra  10 . When using a trocar  16  equipped with everting prongs  30 , the surgeon inserts the trocar  16  into the urethra  10  and positions the distal end  20  near the opening of the urethra  10 . In a similar manner the everting prongs  30  are extended so as to evert the tissue near the end of the urethra  10  in the desired position for reattachment. 
     After everting both the bladder and urethra tissue, the surgeon brings the trocar  16  and sheath  24  together so that the tapered distal end  20  of the trocar  16  fits into the cavity  34  of the sheath, and the bladder and urethra tissue meet. Upon joining the trocar and sheath, the surgeon has both hands free to perform final alignment of the bladder and urethra tissue, and apply the clips  38  as shown in FIG.  11 B. 
     FIGS. 12-14 show yet another embodiment of the instruments to be used in the present invention. This embodiment enables a surgeon to perform the operation without making an incision in the bladder (otherwise needed to insert the sheath) by combining the functions of the trocar and the sheath in a dual approximator  100  to be used transurethrally. 
     The dual approximator  100  has an elongated cannula  102  with a rounded distal end  104 , two sets of openings  106  in the surface of the cannula  102  for the bladder and urethra everting prongs  108 ,  110 , and a bladder everting knob  112  and a urethra everting knob  114  near the proximal end. As seen in FIG. 13, The cannula  102  is separable at a point  116  between the two sets of openings  106 , into a bladder everting unit  118  and a urethra everting unit  120 . This separation feature permits the bladder everting unit  118  to move distally, into the bladder opening as necessary. Preferably, the bladder and urethra everting prongs  108 ,  110  are radially staggered with respect to one another so that the two sets of prongs will not “collide” when extended. 
     The urethra everting unit  120  resembles the sheath described above, with some additions best seen in FIG. 14. A central channel  122  runs along the centerline of the urethra everting unit  120 , through the distal end  124 , bushing  126 , everting tube  128  and stub  130 . A bladder everting knob  112  is located proximal of a urethra everting knob  114 , and engages threads on the outer surface of the cannula  102  so that rotation of the bladder everting knob  112  causes it to advance in the desired direction (either distally or proximally) along the threaded portion of the cannula  102 . Best seen in FIG. 15, a radial channel  134 , longitudinal slot  136 , screw  138 , and block  140  coact in a manner similar to that disclosed above with respect to the everting knob  26  on the sheath  24 , to cause the block  140  to move longitudinally within the lumen  142  of the cannula  102  in response to rotation of the bladder everting knob  112  in the desired direction. 
     Attached to the block  140  is a bladder everting rod  144  which runs through the central channel  122  and out the distal end  124 , continuing into the bladder everting unit  118  (see FIG.  14 ). To accommodate the central channel  122  and bladder everting rod  144 , the bushing  126  is modified as shown in FIGS. 16A-16C, and  17 . Urethra everting wires  146  are bent 90° at the proximal ends and are received in slots  148  formed at the distal end of the bushing  126 . The central channel  122  and the bladder everting rod  144  (best seen in FIG. 17) pass through the bushing  126 , and the bladder everting rod  144  continues distally through a space  150  formed between the urethra everting wires  146 . This arrangement of the bushing  126  and urethra everting wires  146  permits the bladder everting rod  144  and urethra everting wires  146  to move freely with respect to each other within the cannula  102  without interference. 
     Referring again to FIGS. 12-14, the bladder everting unit  118  is located at the distal end of the dual approximator  100 , and has a relatively short cannula  152  with a lumen  154  and a rounded distal tip  104 . The proximal end  156  is tapered, in the same way as the distal end of the trocar  16 , to fit within the cavity  158  formed in the distal end  124  of the urethra everting unit  120 . Near the proximal end  156  are located a number (preferably  4 - 6 ) of openings  106  distributed radially about the circumference of the cannula  152 . As seen in FIG. 17, the central channel  122  continues from an opening  160  in the proximal tip, along the longitudinal axis of the bladder everting unit  118 , to the proximal end of the lumen  154 . 
     A bushing  162  is disposed within the lumen  154  and is moveable both distally and proximally therein. The bladder everting rod  144  passes through the central channel  122 , into the lumen  154 , and to the bushing  162 . The bushing  162  forms a longitudinal socket  164  and two threaded holes  166  which intersect with the socket  164 . The socket  164  receives the distal ends of a number of bladder everting wires  168  and the bladder everting rod  144 , and screws  170  threaded into the holes  166  clamp the wires  168  and rod  144  into the bushing  162 . 
     The bladder everting wires  168  extend proximally from the bushing  162  into angled channels  172  corresponding to the openings  106  in the proximal end of the bladder everting unit  118 . The angled channels  172  force the proximal ends of the everting wires  168 , when moved proximally, to extend from the cannula  152  so as to form everting prongs  108 . Similarly, the bladder everting wires  168  will retract into the angled channels  172  when moved distally. 
     Thus, by reference especially to FIGS. 14 and 17, it can be seen that rotation of the bladder everting knob  112  in the desired direction will extend or retract the bladder everting prongs  108 . When the bladder everting knob  112  is rotated in a direction causing the bladder everting rod  144  to move proximally, the bladder everting rod  144  will pull the bushing  162  in the proximal direction, forcing the bladder everting wires  168  to extend from the openings  106  and form bladder everting prongs  108 . By rotating the bladder everting knob  112  in the opposite direction, the bladder everting rod  144  moves distally and pushes the bushing  162  distally as well, causing the bladder everting wires  168  to retract into the angled channels  172 . 
     The bladder everting knob  112  also expands or contracts the distance between the urethra everting unit  120  and the bladder everting unit  118 . When the bushing  162  in the bladder everting unit  118  remains relatively immobile, rotation of the bladder everting knob  112  so as to move the bladder everting rod  144  distally or proximally, causes a corresponding distal or proximal movement of the bladder everting unit  118 . 
     FIG. 18 details the use of the dual approximator  100  in performing the anastomosis procedure. The surgeon inserts the dual approximator  100  into the lumen of the urethra  10 , through the urethral outlet, in a manner known to those skilled in the art. The dual approximator  100  is advanced within the lumen of the urethra  10  until the distal end of the dual approximator  100 , including the bladder everting unit  118 , emerges from the opening. Next the surgeon rotates the bladder everting knob so as to move the bladder everting unit  118  distally and create a suitable gap between the bladder everting unit  118  and the urethra everting unit  120 . The bladder everting unit  118  is then inserted into the bladder opening  14 , to a point where the openings  106  in the bladder everting unit  118  are properly aligned within the bladder  12 . The surgeon then rotates the bladder everting knob to extend the bladder everting wires  168  from the openings  106 , forming everting prongs  108 , until the tips of the prongs  108  contact and evert the bladder tissue  12 . Similarly, the surgeon rotates the urethra everting knob to evert the end of the urethra  10  as desired. The surgeon then brings the everted bladder and urethra tissue  12 ,  10  together by further rotating the bladder everting knob until the tapered proximal end  156  of the bladder everting unit  118  meets the cavity  158  in the distal end of the urethra everting unit  120 . At this point the surgeon will have both hands free to perform final alignment of the bladder and urethra tissue  12 ,  10 , and apply the clips  38  in a similar manner as shown in FIG.  11 B. After applying the clips  38 , the surgeon rotates the bladder everting knob to retract both sets of everting wires, and then withdraws the dual approximator  100  from the urethra  10 . 
     The clips  38  perform a holding function, in a manner similar to sutures but without penetration of the vessel walls. One example of a suitable clip for use in this procedure is disclosed in U.S. Pat. No. 4,983,176, titled DEFORMABLE PLASTIC SURGICAL CLIP, the entirety of which is hereby incorporated herein by reference. 
     The present invention utilizes a simple, effective mechanical arrangement for reconnecting the bladder to the urethra. By eliminating the painstaking, cumbersome suturing techniques, urethral-vascular anastomosis techniques are improved. Furthermore, in the disclosed procedure, there is provided improved apparatus for grasping and everting the urethra and bladder tissues, leaving the surgeon&#39;s hands free for performing the reconnection step of the anastomosis process. 
     By utilizing the disclosed techniques and apparatus, the number of steps in the anastomosis procedure is decreased, minimizing cost and reducing the required time for the procedure. The present invention eliminates many complications associated with other anastomosis techniques, such as stapling or suturing. Because the clips do not penetrate the vessel walls, there is a decreased likelihood of clotting, which may cause stricture. The clips also reduce the occurrence of necrosis, which occurs when insufficient blood is supplied to the joined tissues. In addition, the use of clips eliminates the possibility of piercing the neurovascular bundle with the suture needle(s), which piercing can cause impotence and/or incontinence. 
     Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.