Abstract:
Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. Apparatus according to the present disclosure include at least one fastener including a first fastener portion having an anchoring leg portion, a second fastener portion including an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another to selectively fix the position of the first fastener portion relative to the second fastener portion. The apparatus has a first member for engaging the first fastener portion and a second member for engaging the second fastener portion. The first member and the second member are movable with respect to one another to move the first fastener portion and second fastener portion with respect to one another.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the benefit of and priority to U.S. patent application Ser. No. 60/390,106 filed on Jun. 19, 2002, the entire contents of which are incorporated herein by reference. 
     
    
     BACKGROUND  
       [0002]     1. Technical Field  
         [0003]     The present disclosure relates to apparatus and methods used for joining tissue portions and more particularly, to anastomotic devices and methods for positioning and joining two hollow body parts.  
         [0004]     2. Background of Related Art  
         [0005]     Anastomosis is the bringing together and/or joining of two hollow or tubular structures. When it is desired to suture a body conduit, typically for attachment to another body conduit, sutures are placed around the circumference of the conduit in order to maintain the patency of its lumen or channel. It can be appreciated that the sutures made on top of the conduit (i.e., on the side facing the surgeon) are made relatively more easily than the sutures made underneath the conduit (i.e., on the side facing away from the surgeon).  
         [0006]     The complexity of joining two body vessels is made manifestly apparent in a surgical procedure referred to generally as a radical prostatectomy (i.e., a well established surgical procedure for patients with localized prostatic carcinoma). In general, radical prostatectomy procedures require the removal of cancerous tissue while preserving sexual function and continence in the patient. There are two primary types of radical prostatectomy approaches for the removal of prostate cancer, the retropubic approach and the perineal approach.  
         [0007]     In the retropubic approach, a long up-and-down incision is made in the midline of the abdomen from the navel to the pubic bone. After the lymph nodes have been removed for study by the pathologist and a determination has been made to proceed with the removal of the prostate gland, the space underneath the pubic bone is cleaned and dissected and the removal of the entire prostate gland is generally begun at the end that is farthest from the bladder, i.e., next to the external urethral sphincter. Next, the prostatic urethra is divided, the prostatic urethra and the prostate gland through which it goes are then pulled upwards toward the bladder while the dissection continues behind the prostate gland, separating it from the layer of tissue that is connected to the rectum on its other side. As the dissection continues between the prostate and the rectum, the seminal vesicles, which are behind the base of the bladder, will be removed along with the prostate gland. Once the seminal vesicles are free, the entire prostate gland and the seminal vesicles are removed. The bladder neck is then stitched closed to a small enough diameter so that it is about the same size as the stump of the urethra from which the prostate was detached. The bladder neck is then pulled down into the pelvis and positioned against the urethral stump and stitched thereto. This stitching is done typically around a Foley catheter which has been inserted through the penis all the way into the bladder.  
         [0008]     In the perineal approach, an inverted “U” shaped incision is made going right over the anus, with the center of the “U” about three centimeters above the margin of the anus. The prostate gland is then freed from its surrounding structures by gentle dissection, and the urethra at the end of the prostate farthest from the bladder is isolated and divided. The bladder neck is freed from the prostate, and, once the prostate gland has been removed and the bladder neck has been closed sufficiently so that the size of its opening approximates the size of the urethral opening, the urethra and the bladder neck are stitched together. Once again, a Foley catheter is left in place postoperatively for about two weeks.  
         [0009]     In each of the above described procedures, it is the attachment of the urethral stump to the bladder neck which is particularly difficult and complex. This difficulty is complicated by the tendency of the urethral stump to retract into adjacent tissue. As a result, considerable time and effort must be expended to re-expose the urethral stump and begin the re-anastomosis procedure. Further complicating this procedure is the fact that the urethral stump is hidden beneath the pubic bone thus requiring that the surgeon work at a difficult angle and in positions that are uncomfortable and limiting.  
         [0010]     Various devices have been proposed for facilitating this procedure. In U.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed a suturing device including a shaft with portions defining an interior channel extending between a proximal and a distal end of the shaft. This channel includes a generally axial lumen which extends to the proximal end of the shaft and a generally transverse lumen which extends from the axial lumen distally outwardly to an exit hole at the outer surface of the shaft. A needle and suture can be back loaded to the transverse lumen of the channel while a generally non-compressible member can be movably mounted in the axial lumen of the channel. At the proximal end of the shaft a handle is provided with means operative to push the member distally through the lumen to deploy or expel the needle.  
         [0011]     In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a suture guide with a curved distal portion. The distal portion of the suture guide has a plurality of exterior axial grooves which can be used to align and guide a curved needle and attached suture. In order to drive the urethral stump to an accessible position, the device is provided with a plurality of outwardly extendable members which engage the lumen of the urethra. These members make it possible to push the urethral stump into approximation with the bladder neck.  
         [0012]     In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed a surgical device for the ligation of a dorsal vein and subsequent anastomosis. This device contains a pair of enclosed needles each having an attached suture which needles may be driven from the shaft of the device into adjacent tissue.  
         [0013]     In general, none of the devices disclosed in the prior art references above is simple to use or makes the anastomosis of the urethral stump to the bladder neck easier. As such, each surgical procedure using prior art devices continues to be time consuming and requires great skill in order to be performed. Accordingly, the need exists for anastomosis devices which overcome the drawbacks of the prior art devices and which are quick and simple to use.  
       SUMMARY  
       [0014]     Apparatus and methods for performing a surgical anastomotic procedure are disclosed herein. According to one aspect of the present disclosure, an apparatus for approximating body vessels includes at least one fastener. Each fastener includes a first fastener portion having an anchoring leg portion, and a second fastener portion having an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another for selectively fixing the position of the first fastener portion and the second fastener portion with respect to one another. The apparatus further includes a first member configured and adapted to engage the first fastener portion, and a second member configured and adapted to engage the second fastener portion, the first member and the second member being movable with respect one another to move the first fastener portion and second fastener portion with respect to one another.  
         [0015]     It is envisioned that each first fastener portion and second fastener portion has a locking leg portion and a first position in which the anchoring leg portion is adjacent the locking leg portion and a second position in which the anchoring leg portion is spaced a distance from the locking leg portion.  
         [0016]     Each of the anchoring leg portions of the first and second fastener portions can include a sharpened tip, wherein the sharpened tips are oriented substantially toward one another. Each anchoring leg portion can be integrally connected to the respective locking leg portion.  
         [0017]     In certain embodiments, the apparatus further includes an insertion sleeve. Accordingly, it is envisioned that each anchoring leg portion can be biased to a position spaced from the respective locking leg portion and collapsible to a position in close proximity to the respective locking leg portion.  
         [0018]     It is envisioned that each fastener can be made from stainless steel, titanium, polyglycolic acid and polylactic acid.  
         [0019]     In certain embodiments, the first fastener portion and the second fastener portion include inter-engaging fixing elements. The fixing elements can include a series of projections formed along a surface of the first fastener portion, and a locking passage formed along a surface of the second fastener portion, the locking passage being configured and dimensioned to receive an end of the first fastener portion therein. The locking passage can include at least one projection extending from an inner surface thereof and the at least one projection is configured and dimensioned to engage the series of projections formed along the surface of the first fastener portion. Desirably, the fixing elements are saw toothed. Accordingly, the fixing elements permit movement of the first fastener portion relative to the second fastener portion in a first direction, while preventing movement in a second direction.  
         [0020]     It is envisioned that each of the first fastener portion and the second fastener portion can have a locking leg portion pivotably connected to the respective anchoring leg portion.  
         [0021]     Each anchoring leg portion can include a suture secured thereto.  
         [0022]     In certain embodiments, the apparatus can further include an insertion sleeve. It is envisioned that a plurality of fasteners can be radially disposed about the lumen of the insertion sleeve.  
         [0023]     It is envisioned that each first fastener portion can include a lip extending from the first fastener pWon and the first member can include an anvil having a hook formed at a distal end thereof for engaging the lip of the first fastener portion. It is further envisioned that each second fastener portion can include a lip extending from the second fastener portion and the second member can include a pusher having a recess formed in a distal end thereof for engaging the lip of the second fastener portion.  
         [0024]     In certain embodiments, the apparatus can further include fixing elements on each of the first and second fastener portions. The fixing elements can include a series of projections formed along a surface of the first fastener portion, and a locking passage formed along a surface of the second fastener portion, the locking passage being configured and dimensioned to receive an end of the locking leg portion of the first fastener portion therein. The locking passage includes at least one projection extending from an inner surface thereof which at least one projection is configured and dimensioned to engage the series of projections formed along the surface of the first fastener portion. The locking passage is defined by a pair of side walls extending from the locking leg portion of the second fastener portion and an end wall interconnecting and extending between the pair of side walls, the at least one projection of the locking passage being formed on an inner surface of the end wall.  
         [0025]     According to another aspect of the present disclosure, a method of approximating a first body vessel and a second body vessel is provided. The method includes the step of providing an apparatus for approximating the first body vessel and the second body vessel. The apparatus includes at least one fastener having a first fastener portion having an anchoring leg portion, and a second fastener portion having an anchoring leg portion, wherein the first and second fastener portions are operatively associated with one another for selectively fixing the position of the first fastener portion and the second fastener portion with respect to one another, a first member configured and adapted to engage the first fastener portion, and a second member configured and adapted to engage the second fastener portion, the first member and the second member being movable with respect to one another to move the first fastener portion and second fastener portion with respect to one another.  
         [0026]     The method further includes the steps of passing the apparatus through the first body vessel and through an opening in the second body vessel such that the anchoring leg portion of the first fastener portion is positioned within the second body vessel, withdrawing the first member to drive the anchoring leg portion of the first fastener portion into the wall of second body vessel, advancing the second member to drive the anchoring leg portion of the second fastener portion into the wall of the first body vessel, and approximating the first member and the second member to approximate the anchoring leg portions of the first and second fastener portions with one another and to approximate the first and second body vessels with one another, wherein the fixing elements engage one another and inhibit separation of the first and second body vessels from one another.  
         [0027]     It is envisioned that the anchoring leg portions can be biased to an expanded position and the fastener can be disposed within an insertion sleeve so as to maintain the fastener in a collapsed position. The method can further include the step of withdrawing the insertion sleeve so as to allow the anchoring leg portion to expand.  
         [0028]     These and other features of the apparatus disclosed herein, will become apparent through reference to the following description of embodiments, the accompanying drawings and the claims. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0029]     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.  
         [0030]      FIG. 1  is a top plan view of a fastener, in accordance with an embodiment of the present disclosure, shown in a separated condition;  
         [0031]      FIG. 2  is a side elevational view of the fastener of  FIG. 1 ;  
         [0032]      FIG. 3  is a top plan view the fastener of  FIGS. 1-2 , shown in a coupled condition;  
         [0033]      FIG. 4  is a side elevational view of the fastener of  FIGS. 1-3 ;  
         [0034]      FIG. 5  is an enlarged cross-sectional view of the indicated area of  FIG. 3 ;  
         [0035]      FIG. 6  is an enlarged end view of the fastener of  FIGS. 1-5 ;  
         [0036]      FIG. 7  is a cross-sectional side elevational view illustrating the positioning of the insertion tool and fastener into a hollow body organ;  
         [0037]      FIG. 8  is a cross-sectional side elevational view illustrating the positioning of the insertion tool and the fastener as well as the expansion of the distal of the fastener in the hollow body organ in order to anchor the distal end of the fastener in the walls of the hollow body organ;  
         [0038]      FIG. 9  is a cross-sectional side elevational view illustrating the expansion of the proximal end of the fastener in order to anchor the proximal end of the fastener to the walls of the body lumen;  
         [0039]      FIG. 10  is a cross-sectional side elevational view illustrating the approximation of the hollow body organ to the body lumen;  
         [0040]      FIG. 11  is a cross-sectional side elevational view illustrating the retraction of the insertion tool;  
         [0041]      FIG. 12  is a cross-sectional side elevational view illustrating the final anastomosed hollow body organ and body lumen with the fastener anchored in position;  
         [0042]      FIG. 13A  is a side elevational view of a proximal leg of a fastener in accordance with an alternative embodiment of the present disclosure; and  
         [0043]      FIG. 13B  is a side elevational view of a distal leg of a fastener in accordance with the alternative embodiment of the present disclosure. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0044]     Preferred embodiments of the presently disclosed anastomosis apparatus will now be described in detail with reference to the drawing figures wherein like reference numerals identify similar or identical elements. In the drawings and in the description which follows, the term “proximal”, as is traditional, will refer to the end of the surgical device or instrument of the present disclosure which is closest to the operator, while the term “distal” will refer to the end of the device or instrument which is furthest from the operator.  
         [0045]     An anastomosis apparatus  100 , in accordance with an embodiment of the present disclosure, is shown in  FIGS. 1-12 . Although anastomosis apparatus  100  offers significant advantages to a radical prostatectomy procedure, it will be understood that the device is applicable for use in any anastomotic procedure where two body vessels are to be brought together and joined.  
         [0046]     As seen in  FIGS. 1-6 , anastomosis apparatus  100  includes at least one fastener  102  and preferably a plurality of fasteners  102  radially disposed about a lumen  184  of an insertion sleeve  180  (see  FIG. 7 ). Each fastener  102  includes a first fastener portion  104  and a second fastener portion  106 . First fastener portion  104  of fastener  102  includes a locking leg portion  108  and an anchoring leg portion  110  integrally formed with locking leg portion  108 . In particular, locking leg portion  108  includes a proximal end  112  and a distal end  114  from which anchoring leg portion  110  extends. Anchoring leg portion  110  includes a distal end  116  integrally coupled to distal end  114  of locking leg portion  108  and a sharpened proximal tip  118 . Desirably, sharpened proximal tip  118  of anchoring leg portion  110  is oriented towards proximal end  112  of locking leg portion  108 . Anchoring leg portion  110  has a first position “A” in which sharpened proximal tip  118  is spaced a distance from locking leg portion  108  and can be collapsed to a second position “C” (as seen in phantom in  FIGS. 2 and 3 ) in which sharpened proximal tip  118  is in close proximity to locking leg portion  108 .  
         [0047]     Preferably, locking leg portion  108  of first fastener portion  104  includes fixing elements for engaging second fastener portion  106 . The fixing elements in certain embodiments comprise a series of projections  120  formed along a side thereof and extending from proximal end  112  toward distal end  114 . First fastener portion  104  of fastener  102  further preferably includes a lip  122  projecting distally from distal end  110  of locking leg portion  108 .  
         [0048]     Second fastener portion  106  of fasteners  102  includes a locking leg portion  124  and an anchoring leg portion  126  integrally formed with locking leg portion  124 . In particular, locking leg portion  124  includes a distal end  128  and aproximal end  130  from which anchoring leg portion  126  extends. Anchoring leg portion  126  includes a proximal end  132  integrally coupled to proximal end  130  of locking leg portion  124  and a sharpened distal tip  134 . Desirably, sharpened distal tip  134  of anchoring leg portion  126  is oriented towards distal end  128  of locking leg portion  124 . Anchoring leg portion  126  has a first position “A” in which sharpened distal tip  134  is spaced a distance from distal end  128  of locking leg portion  124  and can be collapsed to a second position “C” (as seen in phantom in  FIGS. 2 and 4 ) in which sharpened distal tip  134  is in close proximity to locking leg portion  124 .  
         [0049]     Preferably, locking leg portion  124  of second fastener portion  106  includes a locking passage  136  formed along a side surface thereof. As seen in  FIG. 6 , locking passage  136  is defined by an upper wall  138  extending from an upper surface of locking leg portion  124 , a lower wall  140  extending from a lower surface of locking leg portion  124  and an interconnecting side wall  142  extending between the terminal ends of upper wall  138  and lower wall  140 . Locking passage  136  includes at least one, and desirably a plurality of fixing elements for engaging the fixing elements of the first fastener portion  104 . The locking passage  136  shown has fixing elements in the form of a plurality of projections  144  formed along an inner surface of interconnecting side wall  142  and oriented toward locking leg portion  124 . Locking passage  136  is sized and dimensioned to slidably receive end of first fastener portion  104  therethough. In particular, when locking leg portion  108  of first fastener portion  104  is inserted into locking passage  136  of second fastener portion  106 , projections  120  of locking leg portion  108  engage projections  144  of locking passage  136  to thereby effectively lock first fastener portion  104  of fastener  102  in position with respect to second fastener portion  106  of fastener  102 .  
         [0050]     Similar to first fastener portion  104  of fastener  102 , second fastener portion  106  of fastener  102  includes a lip  148  projecting proximally from proximal end  130  of locking leg portion  124 .  
         [0051]     As seen in  FIG. 5 , it is contemplated that projections  120  of locking leg portion  108  and projections  144  of side wall  142  of locking passage  136  are teeth-like (e.g., saw toothed) projections  146   a,    146   b,  respectively, configured and adapted to permit locking leg portion  108  to be inserted into locking passage  136  and hindering withdrawal of locking leg portion  108  therefrom. In particular, projections  146   a,    146   b  are configured and adapted to permit locking leg portion  108  to slide in direction “D” while locking passage  136  is permitted to slide in direction “E”. However, once projections  146   a  and projections  146   b  engage one another, projections  146   a,    146   b  prevent locking leg portion  108  from sliding in a direction opposite to direction “D” and prevent locking passage  136  from sliding in the direction opposite from “E”. In other words, projections  146   a,    146   b  are configured and adapted to allow uni-directional movement of locking leg portion  108  relative to locking passage  136  and in turn unidirectional movement of first fastener portion  104  relative to second fastener portion  106 .  
         [0052]     While projections  120  of locking leg portion  108  and locking passage  136  are shown and described as being formed along a side surface of first fastener portion  104  and second fastener portion  106 , respectively, it is envisioned and within the scope of the present disclosure that projections  120  can be provided along any surface of locking leg portion  108  of first fastener portion  104  and locking passage  136  can be provided along any surface of locking leg portion  124  of second fastener portion  106 .  
         [0053]     First fastener portion  104  and second fastener portion  106  of fastener  102  can be made from any surgical grade material, such as stainless steel or titanium. It is envisioned that first and second fastener portions  104 ,  106  are preferably made from a medical grade bio-absorbable material, such as, for example, polyglycolic acid (PGA) and/or polylactic acid (PLA). Preferably, the material and dimensions of fasteners  102  are selected such that fasteners  102  will dissolve after a predetermined period of time while retaining their structural integrity for a period of time sufficient to assure proper healing of the anastomosis site.  
         [0054]     As seen in phantom in  FIG. 7 , anastomosis apparatus  100  includes a first member or anvil  150 , a second member or pusher  170 , and a shaft  190  for mounting the fasteners  102  in an insertion sleeve  180 . The anvil  150  and pusher  170  are shown in phantom in  FIGS. 3 and 4 . Anvil  150  includes an elongate body portion  152  and a hook  154  formed at a distal end  156  thereof. Hook  154  of anvil  150  is configured and adapted to engage lip  120  of first fastener portion  104  of fastener  102 . Pusher  170  includes an elongate body portion  172  and a recess  174  formed at a distal end  176  thereof. Recess  174  of pusher  170  is configured and adapted to engage lip  146  of second fastener portion  106  of fastener  102 .  
         [0055]     As seen in  FIGS. 7-11 , insertion sleeve  180  includes a distal end  182 , a proximal end (not shown) and defines a lumen  184  extending therethrough which defines a central axis. Shaft  190  is configured and adapted to be slidably received in lumen  184  of insertion sleeve  180 . It is envisioned that shaft  190  include a plurality of radially oriented longitudinally extending grooves (not shown) formed therein. Accordingly, each groove of shaft  190  can be configured and adapted to receive a respective anvil  150 , pusher  170  and fastener  102 . Preferably, shaft  190  is sized such that when shaft  190  is inserted into sleeve  180 , anchoring leg portion  108  of first fastener portion  104  and anchoring leg portion  124  of second fastener portion  106  are in the second position “C” (see  FIG. 7 ).  
         [0056]     Anvil  150  and pusher  170  are arranged with respect to one another so as to form a recess for receiving fastener  102  between hook  154  and recess  174 . Fastener  102  is disposed in the recess so that first fastener portion  104  and second fastener portion  106  are engaged with one another, leaving room for advancing the anchoring leg portions toward one another. A plurality of fasteners  102  are disposed in insertion sleeve  180 , with the shaft  190  disposed between the fasteners  102  and their corresponding anvil and pusher. (see  FIG. 7 ).  
         [0057]     A preferred method of use and operation of anastomosis apparatus  100  in performing a radical prostatectomy anastomosis will now be described in greater detail with reference to  FIGS. 1-12  and in particular with reference to  FIGS. 7-12 . Anastomosis apparatus  100  can be used in either the retropubic or the perineal prostatectomy approaches, or any approach in which the bladder and urethra must be approximated. With the prostate removed, the bladder neck “N” of the bladder “B” is first reconstructed by everting the inner mucosal lining of bladder “B” and suturing it down to the outer wall of bladder “B”, using known surgical techniques. Likewise, urethral stump “S” of urethra “U” is reconstructed by everting the inner mucosal lining of urethral stump “S” and suturing it down to the outer wall of urethra “U”, using known surgical techniques.  
         [0058]     Preferably, with bladder neck “N” reconstructed, bladder neck “N” is sized to properly accommodate and retain distal end  180  of sleeve  180  within bladder “B” using a standard tennis racket type closure (i.e., the opening of the bladder neck constituting the head of the tennis racket and a radial incision extending from the bladder neck constituting the handle portion of the tennis racket). The size of the bladder neck will vary depending on the patient. Typically, the bladder neck “N” is sized to be approximately 7-8 mm in diameter.  
         [0059]     With bladder neck “N” reconstructed, apparatus  100  is passed trans-urethrally through urethra “U” until distal end  182  of insertion sleeve  180  extends out of urethral stump “S” and into bladder “B” through bladder neck “N”, as seen in  FIG. 7 .  
         [0060]     With apparatus  100  so positioned, insertion sleeve  180  is withdrawn in a proximal direction to expose sharpened proximal tips  118  of first fastener portions  104 . The anchoring leg portions  110  are biased to the first position “A” so that when sharpened proximal tips  118  are exposed from within insertion sleeve  180 , anchoring leg portions  110  of first fastener portions  104  are deployed to the first position “A”. (see  FIG. 8 ). With anchoring leg portions  110  deployed, hooks  154  of anvils  150  are withdrawn in a proximal direction to engage lips  122  of first fastener portions  104  and to drive sharpened proximal tips  118  through the wall of bladder “B”, see  FIG. 9 .  
         [0061]     As seen in  FIG. 9 , insertion sleeve  180  is further withdrawn in a proximal direction until sharpened distal tips  134  and anchoring leg portion  126  of second fastener portion  106  are exposed. The anchoring leg portions  126  are biased to the first position “A” so that when anchoring leg portions  126  are completely exposed from within insertion sleeve  180 , anchoring leg portions  126  of second fastener portions  106  are deployed to first position “A”. (see  FIG. 9 ). With anchoring leg portions  126  deployed, pushers  170  are advanced in, a distal direction to engage lips  148  and to drive sharpened distal tips  134  through the wall of urethral stump “S”.  
         [0062]     With sharpened proximal tips  118  of first fastener portions  104  penetrating the wall of bladder “B” and with sharpened distal tips  134  penetrating the wall of urethral stump “S”, hooks  154  of anvils  150  are approximated toward recesses  174  of pushers  170  to thereby approximate anchoring leg portions  110  of first fastener portion  104  and anchoring leg portions  126  of second fastener portion  106  towards one another. Concomitantly, as anchor leg portions  110  and  126  are approximated towards one another bladder neck “N” is approximated towards urethral stump “S”. (see  FIG. 10 ). In accordance with the present disclosure, approximation of anchor legs  110  and  126  towards one another results in projections  120  and  144  incrementally engaging one another and maintaining the position of anchor leg  110  relative to anchor leg  126 . Accordingly, projections  120  and  144  prevent bladder “B” from separating from urethra “U”.  
         [0063]     After bladder neck “N” has been approximated toward urethral stump “S”, pushers  170  and shaft  190  are withdrawn from insertion sleeve  180  and anvils  150  unhooked from lips  122 . (see  FIG. 11 ). Thereafter, anvils  150  and insertion sleeve  180  are withdrawn from urethra “U”.  
         [0064]     An alternate embodiment of a fastener  200 , in accordance with the present disclosure, is shown in  FIGS. 13A and 13B . Unlike fastener  102  from above, fastener  200  includes a first fastener portion  202  and a second fastener portion  204 . First fastener portion  202  includes a locking leg portion  206  and an anchoring leg portion  208  pivotally coupled to a proximal end of locking leg portion  206 . In the embodiment shown, anchoring leg portion  208  is pivotally coupled to locking leg portion  206  by a pivot pin  210 , but other means known in the art may also be used. Alternatively, locking leg portion  206  or anchoring leg portion  208  can be provided with an integrally formed pin that extends outwardly for receipt in an aperture formed in the other of locking leg portion  206  or anchoring leg portion  208 . First fastener portion  202  includes a suture  212  connected to anchoring leg portion  208  for pulling on anchoring leg portion  208  and lifting a distal end of anchoring leg portion  208  away from locking leg portion  206  (e.g., from first position “A” to second position “C”). It is contemplated that the proximal end of locking leg portion  206  includes a stop (not shown) for stopping the lifting of anchoring leg portion  208  beyond a predetermined amount.  
         [0065]     As seen in  FIG. 13B , second fastener portion  204  includes a locking leg portion  214  and an anchoring leg portion  216  pivotally coupled to a distal end of locking leg portion  214  by a pivot pin  218 . Alternatively, locking leg portion  214  or anchoring leg portion  216  can be provided with an integrally formed pin and extending outwardly for receipt in an aperture formed in the other of locking leg portion  214  or anchoring leg portion  216 . Second fastener portion  204  further includes a suture  220  connected to anchoring leg portion  216 , extending around the distal end of locking leg portion  214 , for pulling on anchoring leg portion  216  and lifting a proximal end of anchoring leg portion  216  away from locking leg portion  214  (e.g., from first position “A” to second position “C”). It is contemplated that the distal end of locking leg portion  214  includes a stop (not shown) for stopping the lifting of anchoring leg portion  216  beyond a predetermined amount.  
         [0066]     While apparatus in accordance with the present disclosure have been described as being used in connection with a radical prostatectomy procedure, it is envisioned that apparatus having similar structures and modes of operation can be used in various other surgical procedures. It will be understood that various modifications may be made to the embodiments of the presently disclosed anastomosis device and method disclosed herein. For example, one or more fasteners may be arranged in the insertion sleeve. In further embodiments, the insertion sleeve is sized to accommodate the fastener without requiring the anchoring leg portions to collapse to position “C”. The fastener may comprise a single part with a corrugated, hinged or collapsible portion. The fasteners, in certain embodiments, comprise a fixing element comprising a separate part.  
         [0067]     Therefore, the above description should not be construed as limiting, but merely as an exemplification of a preferred embodiment. Those skilled in the art will envision other modifications within the scope of the present disclosure.