Abstract:
A suturing instrument including multiple needle and suture assemblies that are at least partially disposed within the suturing instrument allows a surgeon to place multiple sutures intercorporally without having to remove the instrument from a surgical site and reload the instrument between placing each suture. The suturing instrument includes an elongate body member that includes a distal portion defining an opening. The suturing instrument further includes a first needle disposed within the opening, a second needle disposed within the opening, and a needle deployment mechanism disposed at least partially within the elongate body member and connectable sequentially to the first needle and the second needle.

Description:
CROSS-REFERENCE TO RELATED CASE 
     This is a continuation of and claims the benefit of and priority to U.S. patent application Ser. No. 10/210,984, filed on Aug. 2, 2002, now U.S. Pat. No. 7,041,111 the entirety of which is incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The invention relates to devices and methods for placing sutures. 
     BACKGROUND INFORMATION 
     Suturing of body tissue is a time consuming aspect of many surgical procedures. For many surgical procedures, it is necessary to make a large opening in the human body to expose the area that requires surgical repair. There are instruments available that allow for viewing of certain areas of the human body through a small puncture wound without exposing the entire body cavity. These instruments, called endoscopes, can be used in conjunction with specialized surgical instruments to detect, diagnose, and repair areas of the body that previously required open surgery to access. 
     Some surgical instruments used in endoscopic procedures are limited by the manner in which they access the areas of the human body in need of repair. In particular, the instruments may not be able to access tissue or organs-located deep within the body or that are in some way obstructed. Also, many of the instruments are limited by the way they grasp tissue, apply a suture, or recapture the needle and suture. Furthermore, many of the instruments are complicated and expensive to use due to the numerous parts and/or subassemblies required to make them function properly. Suturing remains a delicate and time-consuming aspect of most surgeries, including those performed endoscopically. 
     Many medical procedures require that multiple sutures be placed within a patient. Typical suturing instruments enable a surgeon to place only one suture at a time. With such suturing instruments, the surgeon is required to remove the instrument from a surgical site and reload the instrument between placing each suture. Further, the surgeon may be required to use forceps or other instruments to help place the suture. In some instances, the forceps or other instruments may require an additional incision to access the surgical site. 
     SUMMARY OF THE INVENTION 
     The invention generally relates to a suturing instrument that can house multiple needle and suture assemblies. The suturing instrument allows a surgeon to place multiple sutures without having to reload the instrument after each suture is placed, which is more efficient and less invasive than a procedure where the surgeon has to remove the instrument from the surgical site to reload. This is particularly helpful when the surgical site is located deep within a body and not easily repeatably accessible. 
     In one aspect, the invention is directed to a suturing instrument including an elongate body member, a first needle, a second needle, and a needle deployment mechanism. The elongate body member includes a distal portion that defines an opening. The first needle and the second needle are disposed within the opening. The needle deployment mechanism is at least partially disposed within the elongate body member and is connectable sequentially to the first needle and the second needle. The needle deployment mechanism moves the first needle and then the second needle out of the opening. 
     In various embodiments, the distal portion may further define a tunnel in communication with the opening. The tunnel may be disposed adjacent the opening, and the second needle and/or additional needles may be disposed within the tunnel. The suturing instrument may also include a needle catch disposed on the distal portion of the elongate body member. The needle catch is configured to receive the first needle and the second needle. The suturing instrument may also include a third needle disposed within the opening and connectable to the needle deployment mechanism. In one embodiment, the needle deployment mechanism includes a needle carrier and an actuator coupled to the needle carrier. The needle carrier may be disposed at least partially within the opening and the actuator may be disposed in a proximal portion of the elongate body member. The needle carrier may include a distal portion that defines a lumen for receiving at least one of the first needle and the second needle. The distal portion of the needle carrier may further define a slot in communication with the lumen for loading a suture. 
     In other embodiments, the second needle transitions from the opening to the lumen after the first needle is deployed from the elongate body member. The first needle and second needle may each include a distal portion and a suture attached thereto. The opening may include a bottom surface defining a slot for loading a suture. In additional embodiments, the elongate body member includes one or more bends. The suturing instrument can be adapted to access remote organs or tissue within a body. The distal portion of the elongate body member may be rotatable relative to a remainder of the elongate body member. Further, the suturing instrument may include a handle disposed opposite the distal portion of the elongate body member. The handle can at least partially house the needle deployment mechanism. The suturing instrument can be used, for example, to access areas within the patient&#39;s body to ligate, fixate, or approximate tissue. 
     These and other objects, along with advantages and features of the present invention herein disclosed, will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the drawings, like reference characters-generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings, in which: 
         FIG. 1A  is a schematic plan view of one embodiment of a suturing instrument in accordance with the invention; 
         FIGS. 1B and 1C  are schematic cross-sectional views of a proximal portion and a distal portion of the suturing instrument of  FIG. 1A ; 
         FIG. 2A  is an enlarged cross-sectional view of the distal portion of the suturing instrument of  FIG. 1A ; 
         FIG. 2B  is a schematic top view of the suturing instrument of  FIG. 2A  taken at line B-B; 
         FIG. 3A  is a schematic plan view of a needle coupled to a suture for use in a suturing instrument in accordance with the invention; 
         FIG. 3B  is a schematic perspective view of a needle catch for use with the suturing instrument of  FIG. 1A ; 
         FIG. 4A-4E  are partial schematic cross-sectional views of the distal portion of the suturing instrument of  FIG. 1A  during various operational phases; 
         FIG. 5A  is a partial schematic cross-sectional view of a distal portion of a suturing instrument in accordance with another embodiment of the invention; and 
         FIG. 5B-5F  are partial schematic perspective views of the distal portion of the suturing instrument of  FIG. 5A . 
     
    
    
     DESCRIPTION 
       FIG. 1A  depicts a suturing instrument  100  including a handle  102 , an elongate body member  104 , and a needle deployment mechanism  110 . The suturing instrument  100  also includes a distal portion  106  and a proximal portion  108 . The elongate body member  104  is mechanically coupled to the handle  102  at the proximal portion  108  and the suturing components are ate least partially disposed within the distal portion  106  of the suturing instrument  100 . 
     The handle  102  could take a variety of forms, for example, the handle  102  could be one of the types used with Boston Scientific Corporation suturing systems, in particular the Capio® Push &amp; Catch suturing system. Generally, the needle deployment mechanism  110  extends longitudinally-through the elongate body member  104  to the distal portion  106  of the suturing instrument  100 , where the needle deployment mechanism  110  is coupled to a needle  128  ( FIG. 3A ). The needle deployment mechanism  110  moves the needle  128  between a retracted position and a deployed position. The needle deployment mechanism  110  is shown in greater detail in  FIGS. 1B and 1C . 
     Referring to  FIG. 1B , the proximal portion  108  of the suturing instrument  100  includes the handle  102 , the elongate body member  104 , a suture clip  144 , and the needle deployment mechanism  110 . The suture clip  144  may be coupled to the handle  102  or the elongate body member  104  and is used to hold an end of one or more sutures prior to placement in a patient. The needle deployment mechanism  110  includes an actuator  112  (button  117 , shaft  116 ), a bearing  118 , a button end  119 , and a hole  121 . The bearing  118  rides along a cylindrical surface  105  that is formed by the inside diameter of the elongate body member  104 . A wireform  103  is inserted into the hole  121 , coupling it to the actuator button  117 . A spring  115  encircles the wireform  103 , abuts the button end  119 , and is compressed between the button end  119  and a spring washer  113 . The spring washer  113  is seated upon a center tube  107 . The center tube  107  is housed by the cylindrical surface  105  and is constrained in the distal portion  106 . A pusher wire  111  is attached to the wireform  103  by means of a weld, a coupling, adhesive or other means, and is slidably disposed within a guidance sleeve  109 , the sleeve  109  being disposed within a cylindrical surface  123  formed by the inside diameter of the center tube  107 . In one embodiment, the pusher wire  111  is constructed of nitinol, so chosen for its combination of properties that allow for bendability and high column strength when constrained. Nitinol is a nickel-titanium alloy. 
     Referring to  FIG. 1C , the distal portion  106  of the suturing instrument  100  of  FIG. 1A  includes the elongate body member  104 , the needle deployment mechanism  110 , an articulation mechanism  114 , a curved portion  126 , and a needle catch  122 . Referring again to the needle deployment mechanism  110 , the pusher wire  111  is attached by welding or other means to a coupling  150 , which is slidably disposed within a track  152 . The coupling  150  is attached to a carrier wire  154 , which by virtue of its attachment to the coupling  150  is also slidably disposed within the track  152 . The carrier wire  154  is mechanically coupled to an extendable needle carrier  124  by means of a weld, a coupling, adhesives, or other means. The coupling  150  abuts a backstop washer  156  that is slidably disposed about the pusher wire  111  and is contained within a pocket  160  that includes a back wall  162 , against which the backstop washer  156  rests. The track  152  terminates distally in a pocket  164  that includes a wall  166 . A downstop washer  158  is slidably disposed about the carrier wire  154  and constrained within the pocket  164 . 
     In some embodiments, the suturing instrument  100  may include the articulation mechanism  114 . The articulation mechanism  114  is disposed in the elongate body member  104  proximate the distal portion  106  ( FIG. 1C ). The articulation mechanism  114  facilitates the rotation (in the directions indicated by arrow  182 ) and positioning of the distal end  106  of the suturing instrument  100 . In addition, the elongate body  104  can be substantially linear or may include one or more bends. The articulation mechanism  114  and/or bend(s) can facilitate access to deep and/or difficult to reach areas within the patient. 
     Referring to  FIGS. 2A and 2B , the curved portion  126  defines a channel  178 , an opening (or needle exit port  120 ) including a tunnel or (needle compartment  140 ), a needle input/output slot  142 , and a suture slot  146 . The curved portion  126  also defines an opening  176  for receiving tissue ( FIG. 1C ). The curved portion  126  also includes a knot pusher  184 . The needle carrier  124  is disposed within the channel  178  in the curved portion  126 . A distal portion  180  of the needle carrier  124  defines a lumen  138  for holding a needle  128   a ,  128   b , or  128   c  (generally needle  128 ). 
     Referring to  FIG. 3A , in one embodiment, the needle  128  includes a tip  130  and a shaft  134  coupled to the tip  130 , thereby forming a shoulder  132 . The shaft  134  is coupled to a suture  136   a ,  136   b ,  136   c  (generally suture  136 ). The needle  128  is inserted into the lumen  138  and held by a slight friction fit. The suture  136  extends out of a needle carrier suture slot  148  and the suture slot  146 . Needles  128   b  and  128   c  are stored in the needle compartment  140  prior to being deployed. 
     Referring again to  FIGS. 1B ,  1 C,  2 A, and  2 B, in operation, a user (such as a physician or other medical personnel) actuates the needle deployment mechanism  110  by pushing on the button  117 , which via the attachment to the wireform  103  which is attached to the pusher wire  111 , moves the coupling  150  along the track  152  concomitantly moving the carrier wire  154 , which slidably moves the needle carrier  124  through the needle exit port  120 . The user continues to push the button  117  until the needle  128  enters the needle catch  122 . The needle catch  122 , as shown in  FIG. 3B , includes openings  170  defined by successive ribs  172 . The needle catch  122  receives the needle  128  (coupled to the suture  136 ) through opening  170 , the ribs  172  deflect slightly to allow the needle  128  to pass through. After the formed shoulder  132  has passed the ribs  172 , the ribs  172  spring back to their original position defining the openings  170 , and the needle  128  remains captured in the needle catch  122 . The user releases the button  117  and the spring  115  urges the button  117  proximally, moving the pusher wire  111 , the coupling  150 , the carrier wire  154 , and the needle carrier  124  proximally along with the button  117  to the retracted position. As the needle carrier  124  moves back to the retracted position, the needle  128  slides out of the lumen  138 . The openings  170  are chosen to be smaller in dimension than the formed shoulder  132 . This causes the needle catch  122  to retain the needle  128  because the flat rear surface of the shoulder  132  prevents the needle  128  from passing back through the opening  170 . When it is necessary to remove the needle  128  from the needle catch  122 , the needle  128  may be moved toward an enlarged portion  174  of opening  172 . The enlarged portion  174  is sized to allow the formed shoulder  132  to pass through without resistance. The needle catch  122  is preferably constructed of thin stainless steel of high temper, such as ANSI 301 full hard. The needle catch  122  may be fabricated by means of stamping, laser machining, or chemical etching. 
     The suturing instrument&#39;s component materials should be biocompatible. For example, the handle  102 , the elongate body member  104 , and portions of the needle deployment mechanism  110  may be fabricated from extruded, molded, or machined plastic material(s), such as polypropylene, polycarbonate, or glass-filled polycarbonate. Other components, for example the needle  128 , may be made of stainless steel. Other suitable materials will be apparent to those skilled in the art. The material(s) used to form the suture should be biocompatible. The surgeon will select the length, diameter, and characteristics of the suture to suit a particular application. Additionally, the mechanical components and operation are similar in nature to those disclosed in U.S. Pat. Nos. 5,364,408 and 6,048,351, each of which is incorporated by reference-herein in its entirety. 
     Referring to  FIGS. 2A-2B  and  4 A- 4 E, the present invention enables a user to place multiple sutures  136  in a patient without removing the suturing instrument  100  from the patient. The user loads the suture  136   c  through the first suture slot  146   a  until the suture  136   c  emerges from the second suture slot  146   b . The user then inserts the needle  128   c  through the needle input/output slot  142  into the needle compartment  140 . The user repeats this process for additional sutures  136  and needles  128 . The user can repeat this process for loading the first suture  136   a  and the first needle  128   a , or the user can insert the first needle  128   a  directly into the needle carrier  124 . In either case, the sutures  136   a ,  136   b ,  136   c  extend out of the second suture slot  146   b . If the needle  128   a  is loaded into the needle compartment  140 , the user pulls on the first suture  136   a  (held by the suture clip  144 ) to cause the first needle  128   a  to slide down an inclined needle shelf  204  and out of the needle compartment  140  through the needle output slot  142  into the lumen  138  of the needle carrier  124 . The suture  136   a  extends out of the needle suture slot  148  and the second suture slot  146   b.    
     In another embodiment, the suture  136   a  could be pulled by attaching the suture  136   a  to a spool mounted on the elongate body member  104  and winding the spool. In still other embodiments, the suture  136   a  could be pulled by other mechanical means known in the art, such as by a lever, for example. After the needles  128   a ,  128   b ,  128   c  and sutures  136   a ,  136   b ,  136   c  are loaded into the suturing instrument  100 , portions of the sutures  136   a ,  136   b ,  136   c  extending out the suture slot  146   b  are held by the suture clip  144  ( FIG. 1B ). The needle carrier  124 , which is part of the needle deployment mechanism  110 , is sequentially connectable to the needles  128  stored in the needle compartment  140 . This means that each needle  128  stored in the needle compartment  140  is connected to, and then deployed by, the needle carrier  124  one at a time in the order the needles  128  are dispensed from the needle compartment  140 . 
     The user then inserts the elongate body member  104  into a patient and orients the elongate body member  104  so that the needle exit port  120  is proximate to or in contact with the tissue  206  to be sutured. The user then pushes the button  117  ( FIG. 1B ), as described above. Pushing the button  117  causes the needle carrier  124  (holding the first needle  128   a ) to extend out of the needle exit port  120  and push the needle  128   a  through the tissue  206 . As the first needle  128   a  is pushed through the tissue  206 , the first needle  128   a  pulls the first suture  136   a  through the tissue  206 . As the user continues to push the button  117 , the needle carrier  124  continues to advance out of the needle exit port  120  and directs the first needle  128   a  and the first suture  136   a  toward the needle catch  122 . The user-continues to push the button  117  until the first-needle  128   a  contacts and becomes captured by the needle catch  122  ( FIG. 4B ). The user then retracts the needle carrier  124  by releasing the button  117 , as previously described. 
     After the user retracts the needle carrier  124 , the first needle  128   a  and the first suture  136   a  are left captured within the needle catch  122 , with the first suture  136   a  extending through the tissue  206  ( FIG. 4C ). When the needle carrier  124  returns to a fully retracted position, the user pulls on the second suture  136   b  to cause the second needle  128   b  to slide down the inclined needle shelf  204  and out of the needle compartment  140  through the needle input/output slot  142  and into the lumen  138  of the needle carrier  124 . The second suture  136   b  extends but of the needle carrier suture slot  148  and the second suture slot  146   b . The user then advances the needle carrier  124  as described above until the second needle  128   b  is captured by the needle catch  122  ( FIG. 4D ). The user then retracts the needle carrier  124  as described above leaving the second needle  128   b  and the second suture  136   b  captured by the needle catch  122  ( FIG. 4E ). This procedure can be repeated for the third needle  128   c , or for as many needles as may be stored in the needle compartment  140 . 
     After one or more sutures  136  have been placed, the user withdraws the suturing instrument  100  from the patient. The user detaches the suture(s)  136  from the needle(s)  128  and ties a knot or knots into the suture(s)  136 . The user can then use the knot pusher  184  to push the knot(s) into the patient as the knot(s) is tightened. 
     Referring to  FIGS. 5A-5F , in an alternative embodiment, the distal portion  106  of the suturing instrument  100  includes a curved portion  200 . The curved portion  200  defines a needle compartment  188 , a needle output slot  190 , a needle loading slot  192 , a first suture slot  196  ( FIG. 5B ), and a second suture slot  198 . In this embodiment, a needle  128   a  is inserted into the needle carrier  124  with a suture  136   a  extending through the needle carrier suture slot  148 , the first suture slot  196  and the second suture slot  198 . An additional needle  128   b  is inserted into the needle compartment  188  through the needle loading slot  192  with a suture  136   b  extending through the first suture slot  196  and the second suture slot  198  ( FIG. 5B ). 
     In operation, this alternative embodiment functions largely the same way as the embodiment previously described. The user advances the needle carrier  124  by pressing the button  117  ( FIG. 1A ) until the first needle  128   a  along with the first suture  136   a  is driven through the tissue and captured by the needle catch  122  ( FIG. 5D ). After the needle  128   a  and the suture  136   a  are captured in the needle catch  122 , the needle carrier  124  is retracted so that the second needle  128   b  can be loaded into the needle carrier  124  ( FIG. 5E ). When the needle carrier  124  is fully retracted, the user pulls the second suture  136   b  causing the second needle  128   b  to slide into the needle carrier  124  from the needle compartment  188  through the needle loading slot  190 . The user again advances the needle carrier  124  out of the needle exit port  120 , through the tissues, and into the needle catch  122  ( FIG. 5F ). The user then retracts the needle carrier  124  leaving the needle  128   b  and coupled suture  136   b  captured by the needle catch  122 . In other embodiments, more needles  128  and sutures  136  can be loaded into the needle compartment  188 . 
     Other embodiments incorporating the concepts disclosed herein may be used without departing from the spirit and scope of the invention. The described embodiments are to be considered in all respects as only illustrative and not restrictive.