Patent Publication Number: US-9833233-B2

Title: Methods and devices for tissue suturing

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62/057,394 filed Sep. 30, 2014 and U.S. Provisional Patent Application No. 62/057,387 filed Sep. 30, 2014, the entire disclosures of which are incorporated by reference herein. 
    
    
     BACKGROUND 
     The present disclosure relates to methods and devices for use in endoscopic surgery, in particular to methods and devices for suturing tissue to construct an anastomosis. 
     Technical Field 
     Numerous surgical procedures have been developed to replace veins and arteries that have become blocked by disease. As a result of aging and/or disease, veins and arteries may become blocked by plaque deposits, stenosis, or cholesterol. In some instances, these blockages can be treated with artherectomy, angioplasty or stent placement, and coronary bypass surgery is not required. Coronary bypass surgery may be required when these other methods of treatment cannot be used or have failed to clear the blocked vein or artery. In coronary bypass surgery, a vein is harvested from elsewhere in the body and grafted into place (i.e., between the aorta and the coronary artery) beyond the point of blockage by constructing an anastomosis. 
     Coronary bypass surgery requires a length of vein or artery for the graft. It is preferred to use a vein taken from the patient undergoing the bypass surgery, because they will not likely be rejected by the body after transplantation and grafting onto the aorta and coronary artery. 
     The left internal thoracic artery (LITA) is often harvested for coronary bypass surgery. However, the saphenous vein in the leg is also a good substitute for small veins or arteries such as the coronary arteries, and is often used in coronary bypass surgery. The cephalic vein in the arm is an alternative that is sometimes used. 
     Typically, sternotomy is utilized in coronary bypass surgery where harvesting and suturing is done by hand. However, sternotomy is a highly invasive procedure requiring extended recovery time. 
     Endoscopic procedures, such as thoracoscopy, enable a clinician to construct an anastomosis in an operation that requires only a few small incisions, and increases the patency of the vein. Endoscopic surgical techniques for operations such as gall bladder removal and hernia repair are now common. The surgeon performing the operation makes a few small incisions and inserts long tools, including forceps, scissors, and staplers into the incision and deep into the body. Viewing the tools through an endoscope, or a video display from an endoscope, the surgeon can perform all the cutting and suturing operations necessary for a wide variety of operations. The procedures are also referred to as endoscopic surgery, laparoscopic surgery, minimally invasive surgery, or video-assisted surgery. References to endoscopic surgery and endoscopes below is intended to encompass all of these fields, and all operations described below with reference to endoscopes can also be accomplished with laparoscopes, gastroscopes, and any other imaging devices which may be conveniently used. 
     Minimally invasive procedures for vein removal have been proposed. U.S. Pat. No. 5,373,840 shows a method of cutting the saphenous vein at one end, and grasping the vein with graspers or forceps, then sliding a ring over the vein while securing the vein at the same time. 
     SUMMARY 
     The present disclosure relates to a suturing device including a handle assembly, an elongated shaft extending from the handle assembly, and an end effector assembly disposed on a distal end of the elongated shaft. The handle assembly includes a trigger assembly. The end effector assembly includes at least one guide rod extending distally from the elongated shaft, at least one first guide tube extending distally from the elongated shaft, a guide rack disposed on the at least one guide rod, and an anchor disposed on a distal end of the at least one guide rod. The at least one first guide tube houses at least one elongated member. The guide rack includes at least one first aperture configured for locating the at least one guide rod and at least one second aperture configured for locating the at least one first guide tube. The anchor is circumferentially offset from the guide rack and is configured for disposal within tubular tissue. The anchor includes at least one aperture housing a second guide tube. The second guide tube is attached to a suture having a first end and a second end. A first actuation of the trigger assembly longitudinally extends the anchor into an incision in tubular tissue and longitudinally advances the guide rack such that tubular tissue is captured between the guide rack and the anchor. A second actuation of the trigger assembly deploys the at least one elongated member to puncture tubular tissue to mate with the at least one aperture of the anchor such that extraction of the at least one elongated member simultaneously draws out the first end of the suture through the punctured tubular tissue. 
     In disclosed aspects, the end effector assembly further includes a guide plate having a plurality of apertures configured for guiding the at least one guide rod and the at least one first guide tube. 
     In disclosed aspects, the at least one guide rod extends through the guide rack and operatively couples with the anchor. 
     In disclosed aspects, the anchor includes an atraumatic tip. 
     In disclosed aspects, the at least one elongated member is a flexible needle configured for puncturing tissue. 
     In disclosed aspects, mating the at least one elongated member with the at least one aperture of the anchor results in a press fit between the at least one elongated member and the at least one second guide tube of the anchor. 
     In disclosed aspects, further including a probe configured for locating the first end of the suture such that disposing the probe into a graft tubular tissue and passing the first end of the suture through a graft tubular tissue joins a graft tubular tissue with a tubular tissue. 
     The present disclosure also relates to a method of suturing tubular tissue. The method includes providing a suturing device for tubular tissue having a handle assembly, an elongated shaft extending from the handle assembly, and an end effector assembly disposed on a distal end of the elongated shaft. The end effector assembly includes at least one guide rod extending distally from the elongated shaft, at least one first guide tube extending distally from the elongated shaft, a guide rack disposed on the at least one guide rod, and an anchor disposed on a distal end of the at least one guide rod. The at least one first guide tube houses at least one elongated member. The guide rack includes at least one first aperture configured for locating the at least one guide rod and at least one second aperture configured for locating the at least one first guide tube. The anchor is circumferentially offset from the guide rack and is configured for disposal within tubular tissue. The anchor includes at least one aperture housing a second guide tube. The second guide tube is attached to a suture having a first end and a second end. The method also includes creating an incision in tubular tissue, extending the anchor into an incision in tubular tissue, advancing the guide rack such that tubular tissue is secured between the guide rack and the anchor, puncturing tubular tissue with the at least one elongated member, mating the at least one elongated member with the at least one aperture of the anchor, extracting the at least one elongated member, and extracting the suture through the punctured tubular tissue. 
     In disclosed aspects of the method, providing a suturing device includes a trigger assembly operatively coupled to the handle assembly and actuating the trigger assembly extends the anchor into an incision in tubular tissue. 
     In disclosed aspects of the method, further including securing tubular tissue between the anchor and the guide rack. 
     In disclosed aspects of the method, further including extending the at least one guide tube and seating the at least one guide tube into the at least one aperture of the guide rack. 
     In disclosed aspects of the method, further including translating the at least one elongated member through and along the at least one guide tube. 
     In disclosed aspects of the method, further including frictionally engaging the at least one elongated member with the second guide tube. 
     The present disclosure also related to an end effector for suturing tissue. The end effector includes an elongated shaft and an assembly attachable to an end of the elongated shaft. The assembly includes at least one guide rod extending distally from the elongated shaft, at least one first guide tube extending distally from the elongated shaft, and an anchor disposed on a distal end of the at least one guide rod. The at least one first guide tube houses at least one elongated member. The anchor is configured for being disposed within tubular tissue. The anchor includes at least one aperture housing a second guide tube. The second guide tube is attached to a suture having a first end and a second end. The anchor is extendable into an incision in tubular tissue. The at least one elongated member is deployable to puncture tubular tissue and mate with the at least one aperture of the anchor such that extraction of the at least one elongated member simultaneously draws out the first end of the suture through the punctured tubular tissue. 
     In disclosed aspects, the assembly includes a guide rack disposed on the guide rod, the guide rack having at least one first aperture configured for locating the at least one guide rod and at least one second aperture configured for locating the at least one first guide tube. 
     In disclosed aspects, the anchor is circumferentially offset from the guide rack. 
     In disclosed aspects, the guide rack is advanceable such that tubular tissue is captured between the guide rack and the anchor. 
     In disclosed aspects, the assembly further includes a guide plate having a plurality of apertures configured for guiding the at least one guide rod and the at least one first guide tube. 
     In disclosed aspects, the at least one guide rod extends through the guide rack and operatively couples with the anchor. 
     In disclosed aspects, mating the at least one elongated member with the at least one aperture of the anchor results in a press fit between the at least one elongated member and the at least one second guide tube of the anchor. 
     In disclosed aspects, further includes a probe configured for locating the first end of the suture such that disposing the probe into a graft tubular tissue and passing the first end of the suture through a graft tubular tissue joins a graft tubular tissue with a tubular tissue. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Various embodiments of the surgical devices are described herein with reference to the drawings wherein: 
         FIG. 1  illustrates a suturing device for tubular tissue in accordance with one embodiment of the present disclosure; 
         FIGS. 2A and 2B  are perspective views of a distal end of the suturing device of  FIG. 1  shown in engagement with tubular tissue; 
         FIG. 3  is a perspective view of a distal end of the suturing device of  FIGS. 1 and 2  shown in engagement with tubular tissue having sutures extracted therefrom; 
         FIG. 4  illustrates a suturing device for tubular tissue in accordance with an embodiment of the present disclosure; 
         FIG. 5A  illustrates a perspective view of a distal end of the suturing device of  FIG. 4  in the open position; 
         FIG. 5B  illustrates a perspective view of a distal end of the suturing device of  FIG. 4  in the approximated position; 
         FIG. 6  is a side view of a junction between tubular tissue and graft tubular tissue; and 
         FIG. 7  illustrates suturing devices with their distal ends inserted through access devices and positioned in a thoracic cavity of a patient in accordance with embodiments of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the presently disclosed suturing device are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein the term “distal” refers to that portion of the device that is farther from the user, while the term “proximal” refers to that portion of the device that is closer to the user. 
     Referring initially to  FIGS. 1-3 , one embodiment of a suturing device  10  is shown for use with various surgical procedures and generally includes a handle assembly  100 , an elongated shaft  200  extending distally from handle assembly  100  and defining a longitudinal axis “A-A.” An end effector assembly  300  is disposed on a distal end of the elongated shaft  200 . 
     As shown in  FIGS. 2A and 2B , in one embodiment, end effector assembly  300  includes a plurality of guide rods  310 , a plurality of guide tubes  320 , a plurality of elongated members  330  disposed within guide tubes  320 , a guide rack  340  disposed on guide rods  310 , an anchor  360 , and a guide plate  380 . 
     Guide rods  310  are configured to provide structure and support for the components of end effector assembly  300  as the components translate in response to actuation of a trigger assembly  110  of handle assembly  100 . Though the embodiment in  FIG. 2A  shows three guide rods  310 , it is contemplated that end effector assembly  300  would properly function with a greater or lesser number of guide rods  310 . In one embodiment, guide rods  310  are stainless steel rods. However, it is contemplated that any appropriate biocompatible material may be used. In one embodiment, end effector assembly also includes a guide plate  380 . Guide plate  380  includes a plurality of apertures  382  configured to direct the guide tubes  320  toward guide rack  340 . 
     Continuing with  FIGS. 2A and 2B , guide rack  340  is slidably disposed on guide rods  310  and is movable along guide rods  310  to secure tubular tissue “T” between anchor  360  and guide rack  340  such that movement of tubular tissue “T” is limited during the use of suturing device  10 . Guide rack  340  defines a plurality of guide rod apertures  342 . Guide rod apertures  342  are correspondingly sized for guide rods  310  such that the plurality of guide rods  310  are able to pass through the plurality of guide rod apertures  342 . 
     Guide rack  340  also defines a plurality of guide tube apertures  344 . Guide tube apertures  344  are correspondingly sized for guide tubes  320 . As shown in  FIG. 2B , in one embodiment, guide tube apertures  344  are sized to seat guide tubes  320  while elongated members  330  extend entirely through guide rack  340 . For example, in one embodiment, guide tubes  320  are approximately 23 AWG polyimide guide tubes. In this embodiment, guide tube apertures  344  are correspondingly sized such that guide tubes  320  extend only partially through guide rack  340 . Though the embodiments in  FIGS. 2A, 2B, and 3  depicts end effector assembly  300  to include eight guide tubes  320 , it is contemplated that any appropriate number of guide tubes  320  may be used (i.e., more or less than 8 guide tubes  320 ). 
     In one embodiment, as shown in  FIG. 2B , elongated members  330  are flexible nitinol rods including a sharp tip (not shown). The flexibility of guide tubes  320  and elongated members  330  enables suturing device  10  to be used in a wide variety of configurations. 
     Elongated members  330  extend through guide rack  340  to puncture tubular tissue “T” and mate with a plurality of anchor apertures  362  formed on anchor  360 . As shown in  FIG. 2B , each anchor aperture  362  houses a suture guide tube portion  364 . In one embodiment, suture guide tube portions  364  are approximately 80 AWG polyimide tubes. Suture guide tube portions  364  are sized such that insertion of the elongated members  330  into the suture guide tube portions  364  creates a press fit between the two components. 
     Suture guide tube portions  364  are each attached to a suture  366 . As a result of the press fit between elongated members  330  and suture guide tube portions  364 , extracting elongated members  330  also draws out a plurality of first ends  368  of sutures  366  through punctured tubular tissue “T.” This inside-out technique of suturing tubular tissue “T” maximizes intimal contact between tubular tissue “T” and a graft tubular tissue “GT” ( FIG. 6 ) thereby increasing the likelihood of anastomotic patency relative to methods which do not provide such intimal contact. 
     As shown in  FIG. 3 , first ends  368  of sutures  366  are drawn out through the punctured tubular tissue “T” and located on a probe  390 . Similar to anchor  360 , probe  390  includes a plurality of probe apertures  392 . Probe apertures  392  are configured for seating first ends  368  of sutures  366 . As a result, first ends  368  of sutures  366  are located in probe  390  while second ends  369  of sutures  366  remain located in anchor  360 . 
     As will be detailed below with reference to  FIGS. 3-5 , probe  390  is configured to mate with a suturing device  20 . Suturing device  20  is configured for retrieving the first ends  368  of sutures  366  from the inside of graft tubular tissue “GT.” 
     One embodiment of suturing device  20  is shown in  FIG. 4  for use with various surgical procedures and generally includes a handle assembly  600 , an elongated shaft  500  extending distally from handle assembly  600  and defining a longitudinal axis “B-B.” An end effector assembly  700  is disposed on a distal portion  502  of the elongated shaft  500 . 
     An embodiment of end effector assembly  700  is shown in  FIGS. 5A and 5B . End effector assembly includes a mating plate  710  extending distally from elongated shaft  500  ( FIG. 4 ). Mating plate  710  is a rigid structure configured for supporting a hinge  720 . Hinge  720  is operatively coupled to a clamshell  722 . Clamshell  722  includes a first clamshell half  724  and a second clamshell half  726  and is configured for opening and approximating first and second clamshell halves  724  and  726 . For example, in  FIG. 5A , first and second clamshell halves  724  and  726  are shown in the spaced apart position and in  FIG. 5B , first and second clamshells halves  724  and  726  are shown approximated around a graft tubular tissue “GT.” In one embodiment as shown in  FIG. 5B , end effector assembly  700  also includes a guide plate  760  defining a plurality of apertures  762  configured to direct the guide tubes  730  toward clamshell  722 . 
     Similar to guide rack  340 , first and second clamshell halves  724  and  726  define a plurality of clamshell apertures  728  configured for locating a plurality of guide tubes  730  extending from elongated shaft  500  and a plurality of elongated members  740  ( FIG. 5B ) extending from elongated shaft  500  and disposed within guide tubes  730 . In one embodiment, guide tubes  730  are polyimide guide tubes similar to guide tubes  320  of suturing device  10 . In one embodiment, elongated members  740  are flexible nitinol rods including a sharp tip (not shown). The flexibility of guide tubes  730  and elongated members  740  enables suturing device  20  to be used in a wide variety of configurations. Guide tubes  730  are configured to sit into clamshell apertures  728  to direct elongated members  740  into clamshell apertures  728 . It is contemplated that subsequent to locating the guide tubes  730  using the clamshell apertures  728 , guide tubes  730  may be secured in position by welding, an adhesive, or another suitable arrangement for joining. It is also contemplated that the guide tubes  730  may bend upon extension to increase the radius that the elongated members  740  travel within the respective guide tubes  730 , thereby effectively reducing friction inside the guide tubes  730  between the elongated members  740  and inner walls of guide tubes  730 . 
     As noted above, probe  390  is configured to mate with suturing device  20  to retrieve sutures  366  from within graft tubular tissue “GT.” In order to achieve radial alignment between the probe apertures  392  and the clamshell apertures  728 , probe  390  defines a slot  396  ( FIGS. 3 and 5B ) extending therethrough and configured for coupling with mating plate  710 . In one embodiment, as shown in  FIG. 5B , slot  396  and mating plate  710  are configured to mate via a male-female mechanism and are sized accordingly. Approximating first and second clamshell halves  724  and  726  around graft tubular tissue “GT” and mating with probe  390  compressibly secures tubular graft tissue “GT.” 
     Elongated members  740  are extendable through clamshell apertures  728  and to puncture graft tubular tissue “GT” to extract first ends  368  of sutures  366  from inside tubular graft tissue “GT.” Referring to  FIG. 3 , the extraction of sutures  366  from inside graft tubular tissue “GT” utilizes a similar process to that of the extraction of sutures  366  from inside tubular tissue “T.” Each probe aperture  392  houses a suture guide tube portion  394 . Suture guide tube portions  394  are sized such that insertion of elongated members  740  into the suture guide tube portions  394  creates a press fit between the two components. Each suture guide tube portion  394  is attached to a suture  366 . As a result of the press fit between elongated members  740  and suture guide tube portions  364 , extraction of elongated members  740  from probe  390  draws out sutures  366  through punctured tubular graft tissue “GT.” As shown in  FIG. 6 , this operation creates a junction between tubular tissue “T” and graft tubular tissue “GT.” 
     With additional reference to  FIG. 7 , in operation, an endoscope  40  is used to locate the target tubular tissue “T.” Once located, an incision “N” is made in target tubular tissue “T” as shown in  FIG. 2A . In one embodiment, incision “N” is approximately 2-3 mm. Upon actuation of trigger assembly  110 , anchor  360  of suturing device  10  is extended from guide rack  340  into incision “N” of tubular tissue “T.” Guide rack  340  is then translated along guide rods  310  towards anchor  360  to secure tubular tissue “T” between guide rack  340  and anchor  360 . Once tubular tissue “T” is secured, elongated members  330  are deployed through guide tubes  320  and travel along guide tubes  320  into guide rack apertures  344 . While guide tubes  320  sit on guide rack apertures  344 , elongated members  330  extend through guide rack apertures  344  to puncture tubular tissue “T” and mate with suture guide tube portions  364 . Due to the press fit between suture guide tube portions  364  and elongated members  330 , extracting elongated members  330  out of anchor  360  simultaneously draws out the suture guide tube portions  364  and the sutures  366  attached therewith. Once first ends  368  of sutures  366  are outside of tubular tissue “T,” guide rack  340  is translated away from anchor  360  and anchor  360  is withdrawn from inside tubular tissue “T” through incision “N.” As a result of this first procedure, a circular pattern is created by sutures  366  around incision “N” of tubular tissue “T.” However, in some embodiments, sutures  366  may also create an elliptical, oval, or any other suitable pattern. 
     In preparation for the second procedure, first ends  368  of sutures  366  are seated into probe apertures  392  as shown in  FIG. 3 . Probe  390  is disposed in an open end of tubular graft tissue to mate with suturing device  20 . As shown in  FIG. 7 , suturing device  20  is inserted into the surgical field near the location of tubular graft tissue “GT.” Trigger assembly  610  of suturing device  20  is first actuated to open first and second clamshell halves  724  and  726  and actuated again to approximate first and second clamshell halves  724  and  726  concentrically around graft tubular tissue “GT” and probe  390 . Concomitantly, mating plate  710  couples with slot  396  in a male-female mechanism ( FIG. 5B ). Once graft tubular tissue “GT” is secured between probe  390  and approximated first and second clamshell halves  724  and  726 , elongated members  740  are deployed. Elongated members  740  extend through and along guide tubes  730  into clamshell apertures  728 . While guide tubes  730  sit on clamshell apertures  728 , elongated members  740  extend through and into clamshell apertures  728  to puncture tubular graft tissue “GT.” Inside tubular graft tissue “GT,” elongated members  740  mate with suture guide tube portions  394 . Due to the press fit between suture guide tube portions  394  and elongated members  740 , extracting the elongated members  740  from within tubular graft tissue “GT,” simultaneously draws out the suture guide tube portions  394  and the sutures  366  attached therewith. When first ends  368  of sutures  366  are outside of tubular graft tissue “T,” first and second clamshell halves  724  and  726  are opened and probe  390  is withdrawn from inside tubular graft tissue “GT.” At the completion of the second procedure, a junction “J” ( FIG. 6 ) is formed between tubular tissue “T” and tubular graft tissue “GT.” A suture tying device  30  is then inserted into the surgical field to tie sutures  366  to complete the construction of the anastomosis. 
     While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.