Abstract:
Suturing instruments in accordance with the invention are dimensioned and configured to apply sutures to approximate, ligate, or fixate tissue in, for example, open, mini-incision, trans-vaginal, laparoscopic, or endoscopic surgical procedures. In some embodiments, the suturing instruments include a distal portion that is deflectably and/or pivotally coupled to the remainder of the instrument for improved maneuverability and functionality during surgery. In other embodiments, the suturing instruments are capable of housing multiple needle and suture assemblies and/or reloading the needle and suture assembly without removing the instrument from the surgical site.

Description:
CROSS-REFERENCE TO RELATED APPLICATION  
       [0001]    This application incorporates by reference, and claims priority to and the benefit of, provisional U.S. patent application Ser. No. 60/388,458, which was filed on Jun. 12, 2002. 
     
    
     
       TECHNICAL FIELD  
         [0002]    The invention relates to medical devices and, more specifically, to devices for approximation, ligation, or fixation of tissue using sutures.  
         BACKGROUND INFORMATION  
         [0003]    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.  
           [0004]    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.  
           [0005]    Suturing instruments, and more specifically suturing instruments used in endoscopic procedures, are generally rigid and do not provide the operator a range of motion to access difficult to reach parts of the anatomical region requiring sutures. Accordingly, multiple instruments of various configurations and sizes must be used to access all of the necessary tissue areas. These limitations of suturing instruments complicate the endoscopic procedure for the surgeon by requiring the insertion and removal of multiple instruments from a surgical site as the target suturing area changes during the course of the surgical procedure.  
           [0006]    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.  
           [0007]    Thus, suturing remains a delicate and time-consuming aspect of most surgeries, including those performed endoscopically. Accordingly, there is an unresolved need in the art to provide a suturing instrument with improved maneuverability, efficiency, and functionality during a surgical procedure.  
         SUMMARY OF THE INVENTION  
         [0008]    The invention generally relates to surgical instruments for performing a surgical procedure, such as placing one or more sutures through tissue. The suturing instruments disclosed herein are dimensioned and configured to apply sutures to approximate, ligate, or fixate tissues in, for example, open, mini-incision, trans-vaginal, laparoscopic, or endoscopic surgical procedures.  
           [0009]    More particularly, in some embodiments, the invention is directed to suturing instruments that include a distal portion that is deflectably and/or pivotally coupled to the remainder of the instrument for improved maneuverability and functionality during surgery  
           [0010]    In other embodiments the invention is directed to suturing instruments capable of housing multiple needle and suture assemblies and/or reloading the needle and suture assembly without removing the instrument from the surgical site. Such suturing instruments allow 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.  
           [0011]    In general, in a first aspect, the invention features a suturing instrument that includes an elongate body member having a middle portion and a distal portion. The distal portion extends distally from the middle portion and is deflectable at a predetermined angle relative to the middle portion. The predetermined angle of deflection of the distal portion may range from about −90° to about 90°. The suturing instrument also includes a needle deployment mechanism disposed at least partially within the elongate body member. The needle deployment mechanism is connectable to a needle for moving the needle out of the distal portion of the elongate body member.  
           [0012]    In one embodiment according to the first aspect of the invention, the elongate member also includes at least one tension member that is slidably disposed at least partially in the elongate member and is connected to its distal portion. In this embodiment, the suturing instrument may include at least one deflection control member coupled to the tension member and disposed opposite the distal portion of the elongate body member for controlling deflection of the distal portion.  
           [0013]    In another embodiment according to the first aspect of the invention, the distal portion is pivotable about a first axis that is perpendicular to the longitudinal axis of the elongate body member. In this embodiment, the suturing instrument may include a first pivot control lever disposed opposite the distal portion of the elongate body member, and a pivot wire rotatably disposed in the elongate body member and coupled to the distal portion. The first pivot control lever may be coupled to the pivot wire for controlling pivoting of the distal portion.  
           [0014]    In yet another embodiment according to the first aspect of the invention, the distal portion includes a first beveled surface for contacting the middle portion and the middle portion includes a second beveled surface for contacting the distal portion. According to one feature of this embodiment, a first angle defined by the first beveled surface and a second angle defined the second beveled surface are substantially equal. The sum of the angles may substantially equal 90°. According to another feature, the elongate body member includes a first resilient member for biasing the distal portion towards the middle portion along a longitudinal axis of the elongate member. The suturing instrument of this embodiment may also include a deflection control mechanism coupled to the distal portion for deflecting the distal portion at the predetermined angle relative to the middle portion by rotating the distal portion about a longitudinal axis of the elongate body member.  
           [0015]    In still another embodiment according to the first aspect of the invention, the elongate body member includes a locking mechanism for securing the distal portion at the predetermined angle relative to the middle portion. The locking mechanism may include a first plurality of teeth disposed on the first beveled surface and a second plurality of teeth disposed on the second beveled surface that are configured to mesh with the first plurality of teeth. Alternatively, the locking mechanism may include a plurality of detents that are defined by the first beveled surface and are circumferentially disposed about the first beveled surface; and a ball disposed in the second beveled surface and dimensioned to fit at least one of the plurality of detents. In this feature, the second beveled surface may define an aperture for receiving the ball therein. Also, a second resilient member may be disposed in the aperture for biasing the ball into engagement with the at least one of the plurality of detents.  
           [0016]    In yet another embodiment according to the first aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion. The needle deployment mechanism optionally includes an actuator coupled to the needle carrier and disposed opposite the distal portion. The actuator may be at least partially housed by a handle disposed opposite the distal portion.  
           [0017]    The invention is also related generally to a method for placing sutures in tissue. The method includes the step of providing a suturing instrument having an elongate body member that includes a middle portion and a distal portion extending distally from the middle portion and deflectable at a predetermined angle relative to the middle portion; and a needle deployment mechanism disposed at least partially within the elongate body member and connectable to a needle for moving the needle out of the distal portion. The method further includes the steps of disposing a needle within the distal portion; disposing the suturing instrument in a body; deflecting the distal portion of the suturing instrument thereby positioning the distal portion proximal to the tissue; and actuating the needle deployment mechanism thereby moving the needle out of the distal portion and through the tissue.  
           [0018]    In general, in a second aspect, the invention features a suturing instrument that includes an elongate body member having a longitudinal axis. The elongate body member has a distal portion that is pivotable about at least one axis that is substantially perpendicular to the longitudinal axis of the elongate body member. The suturing instrument also includes a needle deployment mechanism disposed at least partially within the elongate body member. The needle deployment mechanism is connectable to a needle for moving the needle out of the distal portion. Also, the elongate body member may include a handle disposed opposite the distal portion.  
           [0019]    In one embodiment according to the second aspect of the invention, the suturing instrument also includes a pivot control lever disposed opposite the distal portion of the elongate body member for controlling pivoting of the distal portion. In a first version of this embodiment, the suturing instrument includes a pivot mechanism disposed in the elongate body member and coupled to the distal portion. The pivot control lever may be coupled to the pivot mechanism for controlling pivoting of the distal portion. In a second version of this embodiment, the elongate body member may include an inner portion coupled to the distal portion, and an outer portion coupled to the pivot control lever and slidably disposed at least partially along the inner portion. According to one feature, the suturing instrument also has a linkage coupled to the outer portion and the distal portion. The linkage is configured to cause the distal portion to pivot about the first axis when the outer portion is displaced relative to the inner portion. According to another feature, the suturing instrument also includes a resilient member for biasing the outer portion towards the proximal portion of the elongate body member.  
           [0020]    Further, in various features of the needle deployment mechanism of this embodiment of the suturing instrument, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion.  
           [0021]    According to one particular feature of the second version of this embodiment, the needle deployment mechanism also has a resilient loop of material disposed at least partially within the elongate body member and coupled to the needle carrier. The needle deployment mechanism also includes an actuator that is coupled to the needle carrier via the resilient loop of material to move the needle carrier of the distal portion. The actuator may be at least partially housed by the handle.  
           [0022]    According to another feature, the needle deployment mechanism also includes a needle carrier control rod that is slidably disposed at least partially within the elongate body member and coupled to the needle carrier. The needle carrier control rod may optionally be made of a superelastic material, such as a nickel-titanium alloy. The needle carrier control rod is configured to move the needle carrier when the needle carrier control rod is slidably advanced. The needle deployment mechanism may include an actuator coupled to the needle carrier control rod to advance the needle carrier control rod. The actuator is disposed opposite the distal portion of the elongate member, for example, at least partially housed by the handle.  
           [0023]    According to yet another feature of the second version of this embodiment, the needle deployment mechanism also includes a camshaft disposed within the distal portion of the elongate body member and coupled to the needle carrier and a drum rotatably disposed within the distal portion of the elongate body member and coupled to the camshaft for moving the camshaft when the drum rotates. The needle deployment mechanism according to this feature further includes a push wire slidably disposed within the elongate body member and having a distal end coupled to the drum for causing the drum to rotate. The needle deployment mechanism may also include an actuator coupled to a proximal end of the push wire for advancing the push wire. The actuator is disposed opposite the distal portion of the elongate member, for example, at least partially housed by the handle.  
           [0024]    In another embodiment according to the second aspect of the invention, the distal portion of the suturing instrument includes a first gear that is rotatable about a first axis substantially perpendicular to the longitudinal axis of the elongate body member. According to one feature of this embodiment, a middle portion of the elongate body member includes a second gear rotatable about the longitudinal axis and meshed with the first gear. According to this feature, the distal portion pivots about the first axis when the second gear rotates about the longitudinal axis. Optionally, the suturing instrument includes a pivot control mechanism disposed at least partially within the middle portion and coupled to the second gear for causing the second gear to rotate about the longitudinal axis, a pivot control lever disposed opposite the distal portion of the elongate body member and coupled to the pivot control mechanism for controlling pivoting of the distal portion.  
           [0025]    In yet another embodiment according to the second aspect of the invention, the distal portion is rotatable about the longitudinal axis of the elongate body member. In this embodiment, the suturing instrument may include a rotation control mechanism disposed opposite the distal portion of the elongate body member, and a rotation rod rotatably disposed in the elongate body member and coupled to the distal portion. The rotation control mechanism may be coupled to the rotation rod for controlling rotation of the distal portion.  
           [0026]    In general, in a third aspect, the invention features a suturing instrument for use with an endoscope. The suturing instrument according to this aspect of the invention includes an elongate body member having a flexible tubular member and a distal portion attached to a distal end of the flexible tubular member. The flexible tubular member is dimensioned to slidably and rotationally fit within a working channel of an endoscope. The suturing instrument according to this aspect of the invention also includes a needle deployment mechanism disposed at least partially within the elongate body member and connectable to a needle for moving the needle out of the distal portion.  
           [0027]    In one embodiment according to the third aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion; a carrier drive wire slidably disposed within a lumen defined by the flexible tubular member and coupled to the needle carrier; and an actuator coupled to the carrier drive wire. According to one feature of this embodiment, the elongate body member may include a proximal portion including a handle at least partially housing the actuator. The tubular member may be releasably attached to the proximal portion. Optionally, the distal portion is rotatable about a longitudinal axis of the elongate body member relative to the proximal portion. The suturing instrument may also include a rotation control mechanism disposed in the proximal portion of the elongate body member for controlling rotation of the distal portion. Also, according to this feature, the proximal portion includes a carrier drive wire socket releasably coupled to the proximal portion for receiving the carrier drive wire. The proximal portion may also include a locking socket that is rotationally and releasably coupled to the carrier drive wire socket and serves to secure a proximal end of the tubular member. Further, the proximal portion may also include a scope adapter for securing the proximal portion to the working channel of the endoscope.  
           [0028]    In another embodiment according to the third aspect of the invention, the distal portion of the elongate body member is pivotable about a first axis, which is substantially perpendicular to a longitudinal axis of the elongate body member.  
           [0029]    Also, the invention features a method for placing sutures in tissue. The method includes the step of providing an endoscope defining a working channel through. The working channel of the endoscope has an opening at a distal end of the endoscope. The method further includes the step of providing a suturing instrument that includes an elongate body member having a flexible tubular member with a distal end and a proximal end; the flexible tubular member dimensioned to slidably and rotationally fit within the working channel of the endoscope, and a distal portion attached to the distal end of the flexible tubular member. The suturing instrument also includes a needle deployment mechanism disposed at least partially within the elongate body member and connectable to a needle for moving the needle out of the distal portion. The method also includes the steps of inserting the proximal end of the flexible tubular member into the opening; passing the flexible tubular member through the working channel of the endoscope, disposing a needle within the distal portion, disposing the endoscope within a body, positioning the distal portion proximal to the tissue, and actuating the needle deployment mechanism thereby moving the needle out of the distal portion and through the tissue.  
           [0030]    In various embodiments according to the foregoing aspects of the invention, the suturing instrument includes a needle disposed within the distal portion. Also, the distal portion of the suturing instrument of claim may include a needle catch configured to receive a needle, the needle catch defining a retention slot including at least two flexible edges.  
           [0031]    In general, in a fourth aspect, the invention features a suturing instrument that includes an elongate body member having a distal portion. The distal portion includes a needle catch defining an aperture. The suturing instrument according to this aspect of the invention includes a needle deployment mechanism disposed at least partially within the elongate body member for moving a needle out of the distal portion and to the needle catch as well as a needle reloading mechanism disposed at least partially within the elongate body member for pushing the needle into the aperture of the needle catch. The needle catch is optionally slidably movable along a longitudinal axis of the elongate body member.  
           [0032]    In one embodiment according to the fourth aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion. The needle deployment mechanism also includes an actuator that is coupled to the needle carrier and disposed opposite the distal portion of the elongate body member. The needle carrier has a distal end that, optionally, defines a lumen for receiving the needle therein.  
           [0033]    In another embodiment according to the fourth aspect of the invention, the needle reloading mechanism includes a pusher rod and a rod actuator for moving the pusher rod towards the distal portion of the elongate body member. According to one feature of this embodiment, the rod actuator is disposed opposite the distal portion of the elongate body member substantially perpendicularly to the pusher rod. According to another feature, the pusher rod comprises a substantially concave distal end. Also, according to yet another feature, the needle reloading mechanism has a hook coupled to a resilient member for biasing the pusher rod away from the distal portion of the elongate body member.  
           [0034]    In still another embodiment according to the fourth aspect of the invention, the needle catch defines a retention slot including at least two flexible edges for retaining the needle therein, the retention slot in communication with the aperture. At least one of the flexible edges may have at least one protrusion extending into the retention slot. According to another feature of this embodiment, the suturing instrument includes a needle disposed within the distal portion. The needle has a suture attached thereto and is releasable from the needle catch by pulling on the free end of the suture after the needle reloading mechanism pushes the needle into the aperture.  
           [0035]    In yet another embodiment according to the fourth aspect of the invention, the suturing instrument also includes a handle disposed opposite the distal portion of the elongate body member, which at least partially houses the needle deployment mechanism and the needle reloading mechanism.  
           [0036]    In general, in a fifth aspect, the invention features a suturing instrument that includes an elongate body member having a distal portion. The distal portion includes a first operative portion and a second operative portion. The suturing instrument also includes a needle deployment mechanism that is disposed at least partially within the elongate body member and includes a first needle carrier disposed at least partially within the first operative portion and connectable to a first needle for moving the first needle out of the first operative portion, and a second needle carrier disposed at least partially within the second operative portion and connectable to a second needle for moving the second needle out of the second operative portion.  
           [0037]    In a first embodiment according to the fifth aspect of the invention, the suturing instrument includes a handle that is disposed opposite the distal portion of the elongate body member and at least partially houses the needle deployment mechanism.  
           [0038]    In a second embodiment according to the fifth aspect of the invention, the first operative portion and the second operative portion of the distal portion form a unitary operative portion.  
           [0039]    In a third embodiment according to the fifth aspect of the invention, the suturing instrument includes an actuator coupled to the first needle carrier and the second needle carrier and disposed opposite the distal portion of the elongate body member. According to one feature of this embodiment, the actuator includes a first sub-actuator coupled to the first needle carrier and a second sub-actuator coupled to the second needle carrier. The first needle carrier and the second needle carrier are actuatable either sequentially or simultaneously.  
           [0040]    In a fourth embodiment according to the fifth aspect of the invention, the suturing instrument includes a first needle disposed within the first operative portion, and a second needle disposed within the second operative portion. According to one feature of this embodiment of the suturing instrument, a first suture is attached to the first needle and a second suture is attached to the second needle. According to another feature of this embodiment, the suturing instrument includes a suture having a first end attached to the first needle and a second end attached to the second needle.  
           [0041]    In a fifth embodiment according to the fifth aspect of the invention, the distal portion of the suturing instrument includes a first needle catch configured to receive a first needle; and a second needle catch configured to receive a second needle. Optionally, the first needle catch and the second needle catch form a unitary needle catch. At least one of the first needle catch and the second needle catch may define a retention slot including at least two flexible edges.  
           [0042]    In a sixth embodiment according to the fifth aspect of the invention, the first operative portion of the distal portion defines a first needle port and the second operative portion of the distal portion defines a second needle port. In this embodiment, the distance between the first needle exit port and second needle exit port is laterally adjustable by deflecting at least one of the first operative portion and the second operative portion outwardly from the elongate body member. According to one feature of this embodiment, the suturing instrument includes a deflecting mechanism for adjusting the distance between the first needle exit port and the second needle exit port. A deflection actuator disposed opposite the distal portion of the elongate body member may be included for actuating the deflecting mechanism. The deflecting mechanism may include, for example, a wedge, a cam, an elbow linkage, a rotational separator, and a track-and-follower assembly.  
           [0043]    Lastly, in general, in a sixth aspect, the invention features a suturing instrument that includes an elongate body member having a distal portion. The distal portion includes a needle catch. The suturing instrument also includes a cartridge that is disposed at least partially within the distal portion and houses a first needle and a second needle, as well as a needle deployment mechanism that is disposed at least partially within the elongate body member and is connectable sequentially to the first needle and the second needle for moving the first needle and then the second needle from the cartridge out of the distal portion to the needle catch. The cartridge may be removable from the distal portion of the elongate body member or integrally formed within the distal portion. Also, the distal portion of the elongate body member is optionally rotatable relative to a remainder of the elongate body member.  
           [0044]    Further, in one embodiment of the sixth aspect of the invention, the needle deployment mechanism includes a needle carrier that is disposed at least partially within the distal portion of the elongate body member and is slidably movable out of the distal portion and an actuator coupled to the needle carrier and disposed opposite the distal portion of the elongate body member.  
           [0045]    In another embodiment of the sixth aspect of the invention, the cartridge defines an exit aperture for receiving at least one of the first needle and the second needle. According to one feature of this embodiment, the cartridge further defines a loading slot connected to the exit aperture. At least of the first needle and the second needle can be received in the loading slot. The second needle transitions from the needle loading slot to the exit aperture after the first needle is deployed from the cartridge. In one version of this feature, the suturing instrument includes a pusher for transitioning the second needle from the needle loading slot to the exit aperture after the first needle is deployed from the cartridge through the opening. Optionally, the pusher includes a push plate for contacting the second needle and a resilient member for biasing the push plate towards the exit aperture. In another version of this feature, the suturing instrument includes a suture having one end attached to the second needle, so that the second needle is transitioned from the loading slot to the exit aperture after the first needle is deployed from the cartridge by pulling on the free end of the suture. The suturing instrument may also include a means for pulling the free end of the suture optionally attached to the elongate body member and disposed opposite the distal portion thereof, such as, for example, a spool or a lever.  
           [0046]    In yet another embodiment of the sixth aspect of the invention, the cartridge also contains a third needle. In this embodiment, the needle deployment mechanism is connectable sequentially to the first needle and the second needle and the third needle for moving the first needle and then the second needle and then the third needle from the cartridge out of the distal portion to the needle catch.  
           [0047]    In still another embodiment of the sixth aspect of the invention, the suturing instrument includes a handle that is disposed opposite the distal portion of the elongate body member and at least partially houses the needle deployment mechanism.  
           [0048]    The invention also features a method for placing sutures in multiple tissue sites. The method includes the step of providing a suturing instrument having an elongate body member with a distal portion. The distal portion of the suturing instrument includes a needle catch. The suturing instrument also has a cartridge disposed at least partially within the distal portion. The cartridge includes a first needle disposed within the cartridge and a second needle disposed within the cartridge. Also, the suturing instrument includes a needle deployment mechanism disposed at least partially within the elongate body member and connectable sequentially to the first needle and the second needle. The method of the invention further contemplates the steps of disposing the suturing instrument in a body, positioning the distal portion proximal to a first tissue site in the body, actuating the needle deployment mechanism thereby moving the first needle out of the cartridge to the needle catch, positioning the distal portion proximal to a second tissue site in the body without withdrawing the suturing instrument from the body, moving the second needle in the cartridge, and actuating the needle deployment mechanism thereby moving the second needle out of the cartridge to the needle catch.  
           [0049]    In various embodiments according to the foregoing aspects of the invention, the elongate body member is adapted to access remote organs or tissue within a body. Also, the suturing instrument disclosed above may include one, two, or more bends.  
           [0050]    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  
       [0051]    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:  
         [0052]    [0052]FIG. 1A is a schematic plan view of one embodiment of a suturing instrument in accordance with the invention;  
         [0053]    [0053]FIG. 1B is a schematic cross-sectional view of a proximal portion of the suturing instrument of FIG. 1A;  
         [0054]    [0054]FIG. 1C is a schematic cross-sectional view of a distal portion of the suturing instrument of FIG. 1A;  
         [0055]    [0055]FIG. 2A is a schematic plan view of a needle coupled to a suture for use in a suturing instrument in accordance with the invention;  
         [0056]    [0056]FIG. 2B is a schematic perspective view of a needle catch for use with the suturing instrument of FIG. 1A;  
         [0057]    [0057]FIG. 3A is a schematic perspective view of a distal portion of a suturing instrument including a multi-load needle cartridge in accordance with the invention;  
         [0058]    [0058]FIG. 3B is an enlarged cross-sectional view of the suturing instrument of FIG. 3A;  
         [0059]    [0059]FIG. 4A is a schematic perspective view of a distal portion of a multi-needle suturing instrument in accordance with the invention;  
         [0060]    [0060]FIG. 4B is a schematic perspective view of an alternative multi-needle suturing instrument having two operative portions in accordance with the invention;  
         [0061]    [0061]FIG. 4C is an enlarged schematic perspective view of the operative portions of the suturing instrument of FIG. 4B in an aligned position;  
         [0062]    [0062]FIG. 4D is an enlarged schematic perspective view of the operative portions of the suturing instrument of FIG. 4B in a spread position;  
         [0063]    [0063]FIG. 4E is a schematic perspective view of a single suture placement in tissue;  
         [0064]    [0064]FIG. 4F is a schematic perspective view of a double suture placement in tissue;  
         [0065]    [0065]FIG. 5A is a schematic cross-sectional perspective view of a distal portion of a suturing instrument including a needle reloading mechanism in accordance with the invention;  
         [0066]    [0066]FIG. 5B is a schematic perspective view of a pusher rod for use with the suturing instrument of FIG. 5A;  
         [0067]    [0067]FIG. 5C is a schematic cross-sectional perspective view of a proximal portion of the suturing instrument of FIG. 5A;  
         [0068]    FIGS.  5 D- 5 F are schematic plan views of the needle reloading mechanism of the suturing instrument of FIGS.  5 A- 5 C in operation;  
         [0069]    [0069]FIG. 5G is a schematic cross-sectional view of a modified handle for use with the suturing instrument of FIGS.  5 A- 5 C;  
         [0070]    [0070]FIG. 5H is a schematic plan view of a modified elongate body member for use with the suturing instrument of FIGS.  5 A- 5 C;  
         [0071]    [0071]FIG. 6A is a schematic perspective view of one embodiment of a suturing instrument having a deflectable and pivotable distal portion in accordance with the invention;  
         [0072]    [0072]FIG. 6B is an enlarged schematic perspective view of the deflectable distal portion of the suturing instrument of FIG. 6A;  
         [0073]    [0073]FIG. 6C is a schematic perspective view of the proximal portion of the suturing instrument of FIG. 6A;  
         [0074]    [0074]FIG. 6D is a schematic perspective view of the deflection and rotation mechanisms of the suturing instrument of FIG. 6A;  
         [0075]    [0075]FIG. 6E is a schematic perspective view of an alternative embodiment of a suturing instrument having a deflectable distal portion;  
         [0076]    FIGS.  6 F- 6 H are schematic perspective views of the deflectable distal portion of the suturing instrument of FIG. 6E in different positions;  
         [0077]    [0077]FIG. 6I is a schematic cross-sectional view of the suturing instrument of FIG. 6E;  
         [0078]    [0078]FIG. 6J is a schematic cross-sectional view of one embodiment of a locking mechanism for use with a suturing instrument in accordance with the invention;  
         [0079]    [0079]FIG. 6K is a schematic cross-sectional view of an alternative embodiment of the locking mechanism of FIG. 6J;  
         [0080]    [0080]FIG. 7A is a schematic perspective view of a suturing instrument having a distal portion that is pivotable about one axis in accordance with the invention;  
         [0081]    [0081]FIGS. 7B and 7C are enlarged schematic perspective views of the pivotable distal portion of the suturing instrument of FIG. 7A;  
         [0082]    [0082]FIG. 7D is a schematic perspective view of a suturing instrument including a distal portion that is pivotable about two axes in accordance with the invention;  
         [0083]    FIGS.  7 E- 7 H are enlarged schematic perspective views of the distal portion of the suturing instrument of FIG. 7D;  
         [0084]    FIGS.  8 A- 8 C are schematic plan views of a suturing instrument including an alternative embodiment of a pivotable distal portion in accordance with the invention;  
         [0085]    [0085]FIG. 8D is an enlarged schematic view of the distal portion of the suturing instrument of FIG. 8A;  
         [0086]    [0086]FIG. 8E is an enlarged schematic cross-sectional view of the distal portion of the suturing instrument of FIG. 8C;  
         [0087]    [0087]FIG. 9A is a schematic plan view of a suturing instrument including an alternative embodiment of a pivotable distal portion of a suturing instrument in accordance with the invention;  
         [0088]    [0088]FIG. 9B is an enlarged schematic partial cross-sectional view of the distal portion of the suturing instrument of FIG. 9A;  
         [0089]    [0089]FIG. 9C is an enlarged schematic partial cross-sectional view of the distal portion of the suturing instrument of FIG. 9A in a pivoted position; FIG. 10A is a schematic cross-sectional view of an alternative embodiment of a pivotable distal portion of a suturing instrument in accordance with the invention;  
         [0090]    [0090]FIG. 10B is a schematic cross-sectional view of the pivotable distal portion of FIG. 10A in a pivoted position;  
         [0091]    [0091]FIG. 11 A is a schematic cross-sectional view of an alternative embodiment of a pivotable distal portion of a suturing instrument including a drum-and-camshaft needle deployment mechanism in accordance with the invention;  
         [0092]    [0092]FIG. 11B is a schematic cross-sectional view of the distal portion of the suturing instrument of FIG. 11 A with a needle deployment mechanism in a deployed position;  
         [0093]    [0093]FIG. 12A is a schematic perspective view of a suturing instrument configured for use with an endoscope in accordance with the invention;  
         [0094]    [0094]FIG. 12B is a schematic perspective view of a distal portion of the suturing instrument of FIG. 12A attached to a sheath having a carrier drive wire disposed therein; and  
         [0095]    [0095]FIG. 12C is a schematic perspective view of a pivotable distal portion of the suturing instrument of FIG. 12A. 
     
    
     DESCRIPTION  
       [0096]    Referring to FIG. 1A, in one embodiment, a suturing instrument  100  includes a handle  102 , an elongate body member  104 , and a needle deployment mechanism  110  disposed within the elongate body member  104  and the handle  102 . 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 at least partially disposed within the distal portion  106  of the suturing instrument  100 .  
         [0097]    The handle  102  can take a variety of forms, for example, the handle  102  could be one of the types compatible with suturing systems available from Boston Scientific Corporation of Natick, Mass. in particular with the Capio® Push &amp; Catch suturing system. A suture clip  144  may be coupled to the handle  102  or the elongate body member  104  and used to hold an end of one or more sutures  136  prior to placement in a patient. 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  (shown in FIG. 2A). The needle deployment mechanism  110  moves the needle  128  between a retracted position and a deployed position. One possible needle deployment mechanism  110  is shown in greater detail in FIGS. 1B and 1C.  
         [0098]    Referring to FIG. 1B, in one embodiment, the proximal portion  108  of the suturing instrument  100  includes the handle  102 , the elongate body member  104 , the suture clip  144 , and the needle deployment mechanism  110 . The needle deployment mechanism  110  includes an actuator button  117  and a shaft  116  that together form an actuator  112 . The needle deployment mechanism  110  also includes a bearing  118  and a button end  119  that defines a hole  121  formed therein. The hole  121  is preferably formed along the central longitudinal axis of the button end  119 . The bearing  118  rides along the surface of a lumen  105  that is defined by the inside diameter of the elongate body member  104 . A wireform  103  is inserted into the hole  121  of the button end  119 , so that the wireform  103  is coupled 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 lumen  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 the surface of a lumen  123  defined by the inside diameter of the center tube  107 .  
         [0099]    In one embodiment, the pusher wire  111  is constructed of an elastic material having “superelastic” properties. Such a material may include alloys of In—Ti, Fe—Mn, Ni—Ti, Ag—Cd, Au—Cd, Au—Cu, Cu—Al—Ni, Cu—Au—Zn, Cu—Zn, Cu—Zn—Al, Cu—Zn—Sn, Cu—Zn—Xe, Fe 3 Be, Fe 3 Pt, Ni—Ti—V, Fe—Ni—Ti—Co, and Cu—Sn. In the illustrative embodiment, the superelastic material is a nickel and titanium alloy, commonly known as Nitinol® available from Memry Corp of Brookfield, Conn. or SMA Inc. of San Jose, Calif., so chosen for its combination of properties that allow for bendability and high column strength when constrained. The ratio of nickel and titanium in Nitinol® may vary. One preferred example includes a ratio of about 50% to about 56% nickel by weight. Nitinol® also possesses shape retention properties.  
         [0100]    Referring to FIG. 1C, the distal portion  106  of the elongate body member  104  includes the distal components of the needle deployment mechanism  110  (described in detail below), an operative portion  126 , and a needle catch  122 . In one embodiment, the operative portion  126  has an arcuate shape and partially encircles a suturing field  176 . The operative portion  126  also defines a lumen  178  therein having a needle exit port  120  at an opening into the suturing field  176 . A needle  128  is disposed in the needle exit port  120  and is held in place by a slight friction fit. In one embodiment, the suture  136  is attached to the needle  128 . The free end of the suture  136  extends out of a suture slot  146 .  
         [0101]    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 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 .  
         [0102]    The carrier wire  154  is mechanically coupled to an extendable needle carrier  124  by welding, coupling, use of adhesives, or by other means. The needle carrier  124  is slidably disposed in the lumen  178  of the operative portion  126  and has a lumen  125  formed at a distal end of the needle carrier  124 . The lumen  125  is dimensioned to releasably receive the non-penetrating end of the needle  128 . The needle carrier  124  is configured to push the needle  128  out of the needle exit port  120  through tissue proximate the suturing field  176 , and into the needle catch  122 , as will be described in further detail below. In one embodiment, the needle  128  is held within the lumen  125  by a slight friction fit.  
         [0103]    [0103]FIG. 2A depicts one embodiment of the needle  128  for use in a suturing instrument in accordance with the invention. In this embodiment, the needle  128  includes a penetrating tip  130  and a shaft  134  coupled to the tip  130 , thereby forming a shoulder  132 . The shaft  134  is coupled to the suture  136 . Other configurations of the needle  128  can also be used without deviating from the scope of the invention. As shown in FIG. 1C, in one embodiment, when the needle  128  is disposed in the needle exit port  120 , the free end of the suture  136  extends out of a needle carrier suture slot  148  and the suture slot  146 .  
         [0104]    Referring to FIG. 2B, the needle catch  122  includes openings  170  defined by successive ribs  172 . When 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 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 openings  170  are chosen to be smaller in dimension than the 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 the opening  170 . The enlarged portion  174  is sized to allow the shoulder  132  to pass through without resistance. The needle catch  122  may be 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.  
         [0105]    Referring again to FIGS.  1 A- 1 C and  2 A- 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 , is attached to the pusher wire  111 , moves the coupling  150  along the track  152  concomitantly moving the carrier wire  154 , which in turn slidably moves the needle carrier  124  through the lumen  178  towards the needle exit port  120 . The user continues to push the button  117  until the needle carrier  124  receives the needle  128  in the lumen  125 , and further until the needle  128  penetrates tissue proximate the suturing area  176  and then enters and is retained in the needle catch  122 . Then, the user releases the button  117  and the spring  115  urges the button  117  proximally, thereby 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  125  and the needle is released from the needle carrier  124 .  
         [0106]    In one embodiment, after one or more sutures  136  have been placed, the user withdraws the suturing instrument  100  from the patient. The user then detaches one or more sutures  136  from one or more needles  128  and ties a knot or knots in the sutures  136 . The user can then use a knot pusher  184  to push one or more knots into the patient as the knots are tightened.  
         [0107]    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, polyethylene, 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, and commonly owned U.S. patent application Ser. No. 10/210,984, each of which is incorporated by reference herein in its entirety.  
         [0108]    [0108]FIGS. 3A and 3B depict two embodiments of a suturing instrument having a multi-load cartridge  140  in accordance with the invention. Such a suturing instrument advantageously allows the user to place multiple sutures without removing the suturing instrument from the surgical site. According to both embodiments, the suturing instrument  100  includes the cartridge  140  that houses two or more needles  128  disposed therein. Referring to FIG. 3A, the cartridge  140  is integrally formed within the distal portion  106 . In this embodiment, the distal portion  106  defines a sidewall access opening  141  to allow the user to load one or more needles  128  into the cartridge  140 . Referring to FIG. 3B, the cartridge  140  is either integrally formed or removably disposed at a distal end  142  of the operative portion  126 . Having a removable cartridge allows the user to choose a cartridge having a specific number of needles for a specific application. Also, the suturing instrument  100  may be reusable with different needle cartridges.  
         [0109]    Referring still to FIG. 3B, the multi-load needle cartridge  140  defines an exit aperture  145  and a needle loading slot  147 . The multi-load needle cartridge  140  is designed to hold essentially any number of needles, for example, 2-20 needles. The multi-load needle cartridge  140  is preloaded and capable of feeding the needle and suture assembly into the needle carrier  124 . In one embodiment, the cartridge  140  can be reloaded by the user in situ by adding needles  128  using, for example, the sidewall access opening  141  (FIG. 3A) or the exit port  120  (FIG. 3B). The multi-load needle cartridge  140  may include a push plate  196  and a spring  198  that biases the push plate  196  towards the exit aperture  145 .  
         [0110]    Both embodiments operate in essentially the same manner, enabling a user to place multiple sutures  136  in a patient without removing the suturing instrument  100  from the surgical site. As described above, the preloaded multi-load needle cartridge  140  can include one or more needles  128  each with the suture  136  coupled thereto. Referring to FIG. 3B, in one embodiment, the needle cartridge  140  includes three needles  128   a ,  128   b ,  128   c . Sutures  136   a ,  136   b ,  136   c  extend out of the suture slot  146 . Alternatively, the sutures  136  may run through the elongate body member  104 . The first needle  128   a  is disposed in the exit aperture  145 , and the remaining needles  128   b ,  128   c  are disposed in the loading slot  147 .  
         [0111]    The needle carrier  124 , which is part of the needle deployment mechanism  110 , is sequentially connectable to the needles  128  stored in the cartridge  140 . This means that each needle  128  stored in the needle cartridge  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 cartridge  140 .  
         [0112]    In operation, the user inserts the elongate body member  104  into a patient and orients the elongate body member  104  so that the tissue to be sutured is disposed proximate the suturing field  176  and the needle exit port  120  is proximate to or in contact with the tissue. The user then pushes the button  117  (FIG. 1B), as described above. Pushing the button  117  causes the needle carrier  124  to receive the needle  128   a  in the lumen  125  and then to extend out of the needle exit port  120  and push the needle  128   a  through the tissue. As the first needle  128   a  is pushed through the tissue, the first needle  128   a  pulls the first suture  136   a  through the tissue. 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 . The user then retracts the needle carrier  124  by releasing the button  117 , as previously described.  
         [0113]    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. When the needle carrier  124  returns to a fully retracted position, the spring  198  causes the needle push plate  196  to push the second needle  128   b  into the exit aperture  145 . The needle  128   b  is thereby forced through the loading slot  147  and either into the lumen  125  of the needle carrier  124  or in position to be captured by the needle carrier  124 . The second suture  136   b  extends out of the suture slot  146 . The user then advances the needle carrier  124  as described above until the second needle  128   b  is captured by the needle catch  122 . 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 . This procedure can be repeated for the third needle  128   c , or for as many needles as may be stored in the needle cartridge  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 in the suture(s)  136 . The user can then use the knot pusher  184  to push the knot(s) in the patient as the knot(s) is tightened.  
         [0114]    Alternatively, other mechanisms could be used to advance the needle  128  from the needle cartridge  140  to the carrier  124 . In one embodiment, the needles  128  in the needle cartridge  140  are held in the loading slot  147  by a friction fit and are pushed into the exit aperture  145  when the needle push plate  196  is activated by the user. For example, instead of the spring  198 , a dispensing control rod coupled to a button on the handle  102  and the push plate  196  may be provided. Alternatively, a spring release mechanism coupled to the spring  198  and a button on the handle  102  may be provided to enable the user to release the spring  198  so that the push plate loads the needle  128  into the exit aperture  145  to be received in the lumen  125  of the needle carrier  124 . In another embodiment, the user may load the needle  128  into the exit aperture  145  by pulling the free end of the suture  136 . In yet another embodiment, the suturing instrument  100  may include a means for pulling the free end of the suture  136  such as, for example, a spool or a lever attached to the elongate body member and disposed, for example, on or within the handle  102   
         [0115]    Referring to FIG. 4A, in another embodiment, the operative portion  126  of the distal portion  106  of the suturing instrument  100  includes a mechanism for deploying two or more needles  128 . The needles  128  can be deployed sequentially or simultaneously. The deployment mechanism includes a separate needle carrier  124   a ,  124   b  for each needle  128 . The handle  102  can include one button  117  to advance both needles  128  or the handle  102  can include two buttons  117   a ,  117   b  to advance the needles  128  sequentially or simultaneously (if pressed at the same time). Passing two single armed needles into an incision site enables a user to place, for example, two ligating sutures simultaneously, withdrawing the device, and tying two knots. Ligating between the sutures is possible in a shorter time-frame.  
         [0116]    In operation, this embodiment functions largely the same way as the embodiments previously described. For simultaneous advancement, the user advances the needle carriers  124  by pressing the button(s)  117  (FIG. 1A) until the needles  128  are driven through the tissue and captured by the needle catch  122 . After the needles  128  are captured in the needle catch  122 , the needle carriers  124  are retracted. For sequential advancement, the user advances one needle carrier  124   a  by pressing one button  117   a  until the first needle  128   a  is driven through the tissue and captured by the needle catch  122 . The user then retracts the first needle carrier  124   a . The user then advances the second needle carrier  124   b  by pressing the second button  117   b  until the second needle  128   b  is driven through the tissue and captured by the needle catch  122 . The user then retracts the second needle carrier  124   b.    
         [0117]    Referring to FIGS.  4 B- 4 D, in another embodiment, the distal portion  106  includes two separate operative portions  126   a ,  126   b  separated a wedge  200 . The operative portions  126   a ,  126   b  include the needle exit ports  120   a ,  120   b  that are deflectable or spreadable outward relative to the elongate member  104  to adjust the distance between the exit ports  120   a ,  120   b . The user may control the amount of separation between the operative portions  126   a ,  126   b  and, therefore, the distance between the exit ports  120   a ,  120   b  with a control lever  202  in the handle  102 . Other mechanisms that can be used to deflect the operative portions  126   a ,  126   b  include, but are not limited to, a cam or link, an elbow linkage, a rotational separation along a longitudinal axis  350  of the device, a pre-made track and follower assembly, or a manual separator. In a particular embodiment, the user actuates the control lever  202 , thereby advancing the wedge  200  and widening the space between the two operative portions  126   a ,  126   b.    
         [0118]    One benefit of the embodiments depicted in FIGS.  4 A- 4 D and described above is that spreading the operative portions  126   a ,  126   b  allows a user to create a controlled or predetermined distance between the needle carriers&#39; tissue entrance points. This feature enables the placing of sutures  136  at different spacing sequences. In addition, these embodiments also provide a means to place a double-armed suture (a suture with a needle at each end) in a patient. Referring to FIGS. 4E and 4F, the needle deployment mechanism  110  generally functions the same way as previously described and can be used to place a single suture  136  coupled to two needles  128   a ,  128   b  through tissue  204  (FIG. 4E) or to place two sutures  136   a ,  136   b  coupled to two needles  128   a ,  128   b , respectively (FIG. 4F) through tissue  204 . Referring to FIG. 4E, where a single suture  136  is attached to the two needles  128   a ,  128   b , the suture  136  is placed perpendicularly to the longitudinal axis  350  of the suturing instrument. Referring to FIG. 4F, where separate sutures  136   a ,  136   b  are attached to each of the two needles  128   a ,  128   b , the sutures  136   a ,  136 b can be placed in essentially any orientation relative to the longitudinal axis  350  of the suturing instrument.  
         [0119]    Referring to FIGS.  5 A- 5 H, in yet another embodiment, the suturing instrument  100  is modified to allow the user to place a so-called “whip stitch,” i.e., a continuous running suture. Typically, the suturing instrument must be removed from the surgical site so the user may disengage the needle from the needle catch and either reload the existing needle into the needle carrier or load a new needle and suture into the instrument. In this embodiment, the user can remove the needle from the catch and reload the needle into the needle carrier without removing the suturing instrument  100 . This allows the user to place a running stitch. This embodiment may be combined with any number of the other embodiments described herein.  
         [0120]    Generally, the instrument is used to secure tissue with a continuous running suture by passing the suture through tissue, catching the suture needle, ejecting the needle from the catch in situ, and reloading the needle into the carrier. The suturing instrument  100  essentially operates in the same manner as the other instruments described herein. The instrument is modified, however, to add a needle reloading mechanism  205  described in detail below that, when advanced, pushes the needle  128  along the needle catch  122  to an opening that permits the needle to be discharged from the catch  122 . The needle  128  can be discharged by, for example, pulling on the suture  136 . Continued pulling on the suture  136  can reposition the needle  128  into the end of the needle carrier  124 . The reloaded carrier  124  can then be advanced again, continuing suture placement through multiple tissue passes, resulting in a whip stitch.  
         [0121]    [0121]FIG. 5A depicts the distal portion  106  of the suturing instrument  100 . The needle carrier  124  and needle catch  122  are disposed in the distal portion  106 . The needle catch  122  is similar to the catch described hereinabove with respect to FIG. 2B; however, the catch  122  is slightly modified to include two protrusions  210  disposed between the ribs of the center opening  213  to create a narrow portion in the opening  213 . The protrusions  210  prevent the needle  128  from moving to the larger opening , i.e., the needle reloading aperture  174 , in the catch  122  before the suturing instrument  100  is ready for reloading. In one embodiment, the needle catch  122  is slidably movable towards the needle exit port  120 .  
         [0122]    [0122]FIG. 5B depicts a needle reloading mechanism  205 . The mechanism  205  includes a pusher rod  208  and an actuator  206 . The actuator  206  is generally perpendicularly disposed relative to the rod  208  and is attached to the rod  208  by, for example, welding or other attachment means. Additionally, the mechanism  205  includes a hook  211  that couples to a spring  207  located within the handle  102  (FIG. 5C). The spring  207  acts to return the mechanism  205  to its original position once the actuator  206  is released. In a particular embodiment, the mechanism  205  is slidably disposed within the suturing instrument  100 .  
         [0123]    Referring to FIG. 5C, the proximal portion  101  of the suturing instrument  100  is modified compared to the embodiment shown in FIG. 1A. Specifically, the handle  102  is modified to house at least a portion of the mechanism  205 , as well as to include a slot  209  to house the actuator  206 .  
         [0124]    FIGS.  5 D- 5 F are enlarged partial views of the needle catch  122  and pusher rod  208 . As shown, the needle  128  is held within the center opening  213  of the catch  122  between two ribs or flexible edges  172 . The pusher rod  208  includes a concave distal end that at least partially surrounds the needle  128  when the rod  208  is advanced into contact with the needle  128  (FIG. 5E). The pusher rod  208  pushes the needle  128  along the center opening  213  to the larger opening  174 . The needle  128  is moved past the protrusions  210  by the force of the pusher rod  208 . The force causes the ribs  172  to spread slightly to allow the needle  128  to pass. When the pusher rod  208  is fully advanced, the needle  128  will be positioned within the reloading aperture  174  (FIG. 5F). Alternatively, the needle  128  could be held within one of the lateral openings  215 ,  217  in a catch  122  further modified to include protrusions  210  in the lateral openings  215 ,  217 . The pusher mechanism  205  can also be modified to push a needle  128  held in one or both of the lateral openings  215 ,  217 .  
         [0125]    [0125]FIG. 5G depicts the modified handle  102 . As described hereinabove, the handle  102  includes the slot  209  for the actuator  206  and a void  217  for housing the proximal portion of the rod  208  and the spring  207  and hook  211 . While the actuator  206  described herein is slidably disposed within the handle  102 , other mechanical linkages are contemplated, for example, a push button and push wire assembly. The dimensions shown are for illustrative purposes only and are not meant to be limiting.  
         [0126]    [0126]FIG. 5H depicts the modified elongate body member  104  compared to the embodiment depicted in FIG. 1A. The body member  104  is modified to house at least partially the pusher mechanism  205 , specifically the pusher rod  208 . The body member  104  includes a slot  219  that runs substantially the entire length of the body member  104 . The pusher rod  208  is slidably disposed within the slot  219 .  
         [0127]    Operation of the instrument is described generally with reference to FIGS.  5 A- 5 H. The basic operation is similar to that described hereinabove with reference to FIGS.  1 A- 1 C, insofar as the user presses the button  117  thereby advancing the needle carrier  124  and pushing the needle  128  into the catch  122 . After the user drives the needle through the tissue  204  and into the catch  122 , the user positions the distal portion  106  of the suturing instrument  100  so that the tissue  204  is no longer in the surgical field  176 . During operation, the suture  136  is preferably maintained in tension. A free end of the suture  136  remains outside of the surgical site and accessible to the user. Next, the user advances the needle reloading mechanism  205  into contact with the needle  128  by pushing the actuator  206  distally. Once the pusher mechanism  205  is fully advanced, the needle  128  is positioned within the needle reloading aperture  174 . In this position, the free end of the suture  136  can be pulled to release the needle  128  from the catch  122  and, in turn, lead the needle  128  into the needle carrier. In addition, the needle carrier can be partially advanced to assist reloading of the needle  128  into the carrier. Also, the distal end of the needle carrier  124  can be modified to facilitate reloading. For example, the distal end of the carrier  124  and the lumen  125  could be enlarged to create a sufficient lead in for recapturing the needle  128 . Further, as described above, the needle catch  122  may be slidable distally to position the needle  128  close to the carrier  124  before releasing the needle  128 . After the needle  128  is recaptured in the lumen  125  of the needle carrier  124  and the needle carrier  124  is fully retracted into the operative portion  126 , the user maneuvers the suturing instrument  100  and/or the tissue  204  so that the tissue  204  is disposed again proximate the suturing field  176  and the exit port  120  is proximate to the next stitching position in the tissue  204 .  
         [0128]    Referring to FIGS. 6A and 6B, in another embodiment, the suturing instrument  100  includes a distal portion  106  that is independently deflectable and/or pivotable relative to the elongate member  104 . Specifically, the distal portion  106  includes a deflectable portion  300  that connects the elongate body member  104  to the distal portion  106 . The distal portion  106  is deflectable relative to the elongate member  104  in the “A-P” and “I-S” directions. Also, the operative portion  126  of the distal portion  106  may be pivotable about pivot nodes that define an axis  330  perpendicular to the longitudinal axis  350  of the elongate member  104 . Alternatively, the operative portion  126  of the distal portion  106  may be pivotable about a pin  402  that is perpendicular to the longitudinal axis  350  of the elongate member  104  and defines the axis  330 .  
         [0129]    Referring to FIGS. 6C and 6D, movements of the distal portion  106  are controlled by one or more deflection control members  302 ,  306 , and/or a pivot control lever  304  included in the proximal portion  108 , for example, in the handle  102 . The deflection control members  302  are coupled to a tension roller  315 . The deflection control members  306  are coupled to a tension roller  311 . Tension members  335  are connected to the tension rollers  311 ,  315 , extend through the elongate member  104 , and are coupled to a front portion  301   a  of a deflectable portion  300  for causing the distal portion  106  to deflect. The pivot control lever  304  is coupled to a pivot wire  334  that extends along the longitudinal axis  350  of the elongate member  104  and is coupled to the operative portion  126  of the distal portion  106  to cause it to pivot. The tension members  335  and the pivot wire  334  pass through a wire equalizer  313  disposed within the elongate body member  104  and are formed from, for example, stainless steel or Nitinol® alloy  
         [0130]    In operation, the user can pivot the operative portion  126  of the distal portion  106  about the axis  330  perpendicular to the longitudinal axis  350  of the elongate body member  104  by manipulating the pivot control lever  304  in the handle  102 . The pivot control lever  304 , when turned, causes the pivot wire  334  to pull or push the operative portion  126 , thereby rotating it around the axis  330 .  
         [0131]    The deflection control members  302 ,  306  cause the tension rollers  311 ,  315  to turn when the deflection control members  302 ,  306  are turned, thereby causing the distal portion  106  to bend. Specifically, the user can bend the deflectable portion  300  of the distal portion  106  at its rear portion  301   b  up to +/−90 degrees (A-P direction) by manipulating the deflection control member  302 , that causes the tension roller  315  to rotate and either tighten the tension member  335   a  and relax the tension member  335   p , or tighten the tension member  335 p and relax the tension member  335   a . The user can also bend the deflectable portion  300  at its rear portion  301   b  up to +/−90 degrees (I-S direction) by manipulating the deflection control member  306 , that causes the tension roller  311  to rotate and either tighten the tension member  335   i  and relax the tension member  335   s , or tighten the tension member  335   s  and relax the tension member  335   i.    
         [0132]    Referring to FIGS.  6 E- 6 H, in another embodiment, the suturing instrument  100  includes a distal portion  106  having a beveled surface  307   a  for contacting the elongate body member  104  and the elongate body member includes a beveled surface  307   b  for contacting the distal portion. According to one feature of this embodiment, the acute angle defined by the beveled surface  307   a  and the acute angle defined the beveled surface  307   b  are substantially equal. In one embodiment, each of these angles substantially equals 45 degrees. The surfaces  307   a ,  307   b  are secured against each other by a spring  310  disposed in the elongate member  104 . In an aligned position, the surfaces  307   a ,  307   b  are aligned such that the distal portion  106  and the elongate body member  104  combine to produce a shaft that is substantially linear. The handle  102  includes a deflection control lever or member  312  that is coupled to a first end of a rod  320  that extends through the elongate member  104 . A second end of the rod  320  is coupled to the distal portion  106 . When the user manipulates the deflection control lever  312 , the distal portion  106  rotates and, by virtue of the contacting beveled surfaces  307   a ,  307   b , a rotation point  308  forms, thereby enabling suturing of tissue at any angle relative to the elongate body member&#39;s longitudinal axis  350  (or angles of surface contact).  
         [0133]    In the embodiment shown in FIG. 6J, the suturing device  100  includes a locking mechanism that includes a ball  314  and a plurality of detents  316 . The ball  314  is coupled to the beveled surface  307   b  of the elongate member  104  at a point radially outward from the longitudinal axis  350  of the distal portion  106 . The ball  314  is positioned on the elongate member  104  to allow it to contact the beveled surface  307   a  of the distal portion  106 . Each of the plurality of detents  316  may be disposed equally about the circumference about the beveled surface  307   a  of the distal portion  106 . The circle of detents  314  may be centered on the longitudinal axis of the distal portion  106 . Each detent  316  may have a radial distance from the longitudinal axis of the distal portion  106  equal to that of the ball  314 . As the user deflects the distal portion  106  by manipulating the deflection control lever  312 , the ball  314  moves out of one detent  316  and into another detent  316 . The detents are spaced such that the distal portion rotates in a stepwise manner. Each step may be a fixed number of degrees of rotation. In another embodiment, the ball  314  is coupled to a spring  318  disposed in an aperture  321  formed in the beveled surface  307   b . The spring  318  provides enough force to keep the ball  314  socketed in one of the detents when the user is not trying to change the angle of the distal portion  106  relative to the longitudinal axis  350  of the elongate body member  104 . The spring  318  is, however, compressible such that the ball  314  is at least partially withdrawn into the aperture  321  and the user can easily change the angle of the distal portion  106  relative to the longitudinal axis  350  of the elongate body member  104  by moving the ball  314  from one detent  316   a  to another detent  316   b.    
         [0134]    In another embodiment, shown in FIG. 6K, the distal portion  106  and the elongate member  104  may include meshed teeth  319   a ,  319   b  that engage to lock the distal portion  106  and the elongate member  104  at a particular angle. In operation, the user pushes the distal portion  106  distally from the elongate member  104 , so the beveled surfaces  307   a ,  307   b  do not contact each other and the teeth  319   a ,  319   b  no longer engage, and then deflects the distal portion  106  to a desired angle. Then, when the beveled surfaces  307   a ,  307   b  are brought into contact with each other, the teeth  319   a ,  319   b  engage or mesh to lock the distal portion  106  in place.  
         [0135]    Referring to FIGS.  7 A- 7 C, in another embodiment, the suturing instrument  100  includes a distal portion  106  that is independently pivotable about the axis  330  perpendicular to the longitudinal axis  350  of the elongate member  104  and rotatable about the longitudinal axis  350  of the elongate member  104 . In one version of this embodiment, the degree of pivot is controlled by a pivot control lever  400  located on the handle  102  and coupled to a pivot control mechanism disposed within the elongate member  104 . The pivot control mechanism is coupled to the distal portion  106 . When the user manipulates the pivot control lever  400  slidably moving the pivot control mechanism within the elongate member  104 , the distal portion  106  pivots about the pivot axis  330 . This embodiment enables the suturing of tissue at angles up to 90 degrees from the longitudinal axis  350  of the elongate body member  104 . The suturing instrument  100  also allows for removal from a 10 mm trocar without repositioning the distal portion  106 .  
         [0136]    Referring to FIGS.  7 D- 7 H, in an alternative embodiment, the suturing instrument  100  includes a pivoting and rotating distal portion  106 . The suturing instrument  100  also includes a pivot control lever  504 , a rotation control lever  506 , and a needle deployment trigger  502 . The user can pivot the distal portion  106  by manipulating the pivot control lever  504  on the handle  102 . The distal end  106  can be pivoted to a position perpendicular to the tissue plane to be sutured. The internal operation of the pivoting mechanism is similar to embodiments discussed above. The user can also rotate the distal portion  106  by manipulating the rotation control lever  506  also disposed on the handle  102 , that is coupled to a rotation mechanism, which, in turn, is coupled to the distal portion  106 . The needle  128  is deployed by pulling the needle deployment trigger  502 . The needle deployment mechanism operates similar to other embodiments previously described.  
         [0137]    Referring to FIGS.  8 A- 8 E, in another embodiment, the suturing instrument  100  includes a pivoting distal portion  106  and a pivot control lever  508 . The elongate member  104  includes an outer portion  516  and an inner portion  518 , and is coupled to the distal portion  106  at a pivot point  514  and via linkage  512  (FIG. 8D). The user controls the pivoting action by manipulating the pivot control lever  508 , thereby causing the outer portion  516  to slide relative to the inner portion  518 . Pushing the control lever  508  causes the outer portion  516  to push the linkage  512 , which, in turn, pushes the distal portion  106 . As the distal portion  106  is pushed by the linkage  512 , the distal portion pivots about the pivot point  514 . The distal portion  106  can pivot up to 90 degrees relative to the longitudinal axis  350  of the elongate body member  104 . Pulling the control lever  508  causes the outer portion  516  to pull the linkage  512 , which pulls the distal portion  106 . As the distal portion  106  is pulled by the linkage  512 , the distal portion  106  pivots about the pivot point  514  and returns to its original position. In one embodiment, the control lever  508  maybe be coupled to the outer portion  516  via a pin  509  or other attachment means. Alternatively, the control lever  508  is not coupled to the outer portion  516 , but is pushed into contact with the outer portion  516  via, for example, the pin  509 . Further, the outer portion  516  may be biased against the control lever  508  by a spring that causes the distal portion  106  to return to its starting position when the control lever  508  is released.  
         [0138]    According to this embodiment of the invention, in one version, the needle deployment mechanism  110  includes a loop  510  for advancing the needle carrier  124 . The loop  510  is formed from a resilient material, such as rubber. The loop  510  is coupled to the button  117  at the proximal end of the elongate member  104  and coupled to the needle carrier  124  at a distal end. In operation, the user presses the button  117 , which causes the loop  510  to advance. As the loop  510  advances, the needle carrier  124 , which is coupled to the loop  510 , also advances until the needle  128  in the needle carrier  124  is captured by the needle catch  122 . After the needle  128  is captured in the needle catch  122 , the user releases the button  117  and the loop  510  retracts thereby causing the needle carrier  124  to also retract.  
         [0139]    Referring to FIGS.  9 A- 9 C, in another version of this embodiment, the needle deployment mechanism  110  in the distal portion  106  includes a first gear  520 , a second gear  524 , and a linkage  522 . The linkage  522  is coupled to the first gear  520  and the needle carrier  124 . In operation, the user manipulates the button  117 , which causes the second gear  524  to turn. The second gear  524  engages the first gear  520 , thereby causing the first gear  520  to turn and pivot the distal portion  106 . As the first gear  520  turns, the linkage  522  moves and advances the needle carrier  124  until the needle  128  is captured by the needle catch  122 . After the needle  128  is captured by the needle catch  122 , the user releases the button  117  and the first gear  524  and the second gear  520  turn in the opposite direction causing the linkage  522  to retract the needle carrier  124 .  
         [0140]    Referring to FIGS. 10A and 10B, in yet another embodiment, the needle deployment mechanism in the distal portion  106  includes a superelastic pusher  602 . A proximal end of the superelastic pusher  602  is coupled to the button  117  (shown in FIG. 1B) and a distal end of the superelastic pusher  602  is coupled to the needle carrier  124 . In operation, the user pushes the button  117 , which causes the superelastic pusher  602  to advance the needle carrier  124  until the needle  128  is captured in the needle catch  122 . After the needle  128  is captured by the needle catch  122 , the user releases the button  117  and the superelastic pusher  602  retracts the needle carrier  124 . This embodiment operates similarly to the embodiment described with reference to FIGS.  1 A- 1 C. The superelastic pusher can be formed from an elastic material having “superelastic” properties, such as Nitinol®.  
         [0141]    Referring to FIGS. 1A and 1B, in another embodiment, the needle deployment mechanism in the distal portion  106  includes a drum  608  and a camshaft  604 . The drum  608  is coupled to a distal end of a push wire. A proximal end of the push wire is coupled to the button  117 . The drum  608  is also coupled to the camshaft  604  and the camshaft  604  is coupled to the needle carrier  124 . In operation, the user pushes the button  117 , which causes the push wire to rotate the drum  608 . As the drum  608  rotates, the camshaft  604  moves and advances the needle carrier  124  until the needle  128  is captured in the needle catch  122 . After the needle  128  is captured by the needle catch  122 , the user releases the button  117  and the push wire rotates the drum  608  in the opposite direction, thereby causing the camshaft  604  to retract the needle carrier  124 . The push wire can be formed from, for example, stainless steel or nickel-titanium alloy.  
         [0142]    Referring to FIGS.  12 A- 12 C, in still another embodiment, the suturing instrument  100  is configured to be used with an endoscope  708 . A proximal portion  712  of the suturing instrument  100  includes the handle  102 , a carrier drive wire socket  702  attached to a distal end  752  of the handle  102 , and an actuator  112  including a needle deployment button  117 . The proximal portion  712  also includes a scope adapter  706  having a distal end  718  that is connectable to an access port  724  of the endoscope  708  and a proximal end  720  that is connectable to the carrier drive wire socket  702 .  
         [0143]    The suturing instrument further includes an elongate member  714  that includes a carrier drive wire  710 , which can be formed from, for example, stainless steel or a nickel-titanium alloy, covered by a flexible sheath  704 . The sheath  704  is coupled to a distal portion  716 . The carrier drive wire  710  is connectable to the needle carrier for moving a needle from the distal portion in accordance with any of the embodiments disclosed herein. Also, the distal portion  716  can be stationary, pivoting, or rotatable in accordance with any of the embodiments disclosed herein  
         [0144]    In operation, the elongate member  714  is fed into a distal end  722 , through a working channel  726 , and out of an access port  724  of the endoscope  708 . The distal end  718  of the adapter  706  is coupled to the access port  724  of the endoscope  708  and the carrier drive wire  710  is fed through the adapter  706 . The carrier drive wire  710  is then coupled the carrier drive wire socket  702  and the proximal portion  712  of the suturing instrument  100  is secured to the proximal end  720  of the adapter  706 . The endoscope  708  can then be inserted into a patient. The adapter  706  can include any standard or custom fittings necessary to couple to the access port  724  and the proximal portion  712  of the suturing instrument  100 . For example, the adapter  706  can include a luer fitting or a treaded fitting to couple to the endoscope  708 .  
         [0145]    In one embodiment, the sheath  704  is fixedly coupled to the distal portion  716 , and the distal portion  716  can be rotated by rotating the flexible sheath  704 , using, for example, a rotation controller  760  disposed in the scope adapter  706 . In another embodiment, the handle  102  of the suturing instrument  100  includes two subassemblies. The subassemblies include a thumb-button/finger grasper assembly and a thumb-button/scope assembly.  
         [0146]    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. Therefore, it is intended that the scope of the invention be only limited by the following claims.