Abstract:
A surgical instrument and method of using same are provided. The instrument includes a jaw portion extending along an axis and a handle portion rotatably connected with the jaw portion and configured to at least partially rotate about the axis with respect to the jaw portion. A needle assembly can be configured to pass through the jaw portion and along the axis by cooperation with the handle portion. The jaw portion, or a shaft portion connecting the jaw portion and the handle portion, can include at least one spring-assisted bearing and the handle portion can include at least one depression configured to engage the at least one spring-assisted bearing in an orientation that temporarily locks the shaft portion with respect to handle portion. A method includes rotating the handle portion with respect to the jaw portion and actuating the instrument to pass a portion of a suture through tissue.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of the filing date of U.S. Provisional Patent Application No. 61/296,718 filed Jan. 20, 2010, the disclosure of which is hereby incorporated herein by reference. 
     
    
     BACKGROUND OF TEE INVENTION 
       [0002]    The present invention relates to suture passer assemblies and methods of using same. More particularly, the present invention relates to a front-loading suture passer device having a distal end that is rotatable with respect to the handle. 
         [0003]    There are known surgical instruments that allow a surgeon to pass a suture through tissue, for example during an arthroscopic rotator cuff repair. Such instruments may include a tissue grasping portion such as a pair of jaws that allows for the tissue to be grasped while a piercing instrument punctures through the tissue. The procedures in which these instruments are used are often arthroscopic in nature, and are often performed through a cannula, which may only be placed in certain positions and orientations due to the patient&#39;s anatomy. This requires that the surgical instrument be positioned according to the constraints of the surgical site, which limits the number of positions from which the surgical instrument may be operated. As a result, there are often constraints on the surgeon that result from the particulars of the surgery and the surgical instrument itself. 
         [0004]    Therefore, a need exists for a surgical instrument and associated method of use that allows the surgeon greater flexibility in determining the operating position of the instrument. Such a device would allow the surgeon to perform a suturing procedure by operating a handle portion of the instrument from a multitude of positions with respect to the grasping portion of the instrument. Such a device would be more ergonomic and would allow a surgeon to exert greater control over the procedure. Such a device would also allow for greater flexibility in positioning a patient for surgery and for selecting more convenient arthroscopic port holes for access to the surgical site. 
       BRIEF SUMMARY OF TEE INVENTION 
       [0005]    A first aspect of the present invention is a surgical instrument including a jaw portion extending along an axis and having a distal end and a proximal end, the distal end having an upper jaw and a lower jaw having a forked end, and a handle portion rotatably connected with the proximal end of the jaw portion such that the handle portion is configured to at least partially rotate about the axis with respect to the jaw portion. 
         [0006]    In accordance with certain embodiments of this first aspect, the instrument may further include a shaft portion extending along the axis between the handle portion and the jaw portion, the shaft portion being rotationally coupled to the proximal end of the jaw portion. The instrument may further include a needle assembly configured to pass through the shaft portion and the lower jaw, wherein the needle assembly is adapted to be passed along the axis by cooperation of the needle assembly with the handle portion. The needle assembly may be rotatable with respect to the handle portion. The lower jaw may include a non-circular needle channel, and the needle assembly may include a non-circular needle blade slidable within the needle channel, wherein the needle assembly is rotationally coupled with the jaw portion and rotationally connected to the handle portion due to the mating configuration between the needle channel and needle blade. The lower jaw may include a needle channel and the forked end may define first and second arms having a space therebetween that intersects the needle channel, wherein the space is configured to accept a suture for engagement with the needle assembly. 
         [0007]    The shaft portion may include at least one spring-assisted bearing and the handle portion may include at least one depression configured to engage the at least one spring-assisted bearing in an orientation that temporarily locks the shaft portion with respect to handle portion. The at least one spring-assisted bearing and the at least one depression may be engageable in a finite number of orientations about the axis that temporarily lock the shaft portion with respect to handle portion. The handle portion may be further rotated with respect to the jaw portion through application of a force to overcome the connection between the at least one spring-assisted bearing and the at least one depression in the temporarily locked orientation. The handle portion may be configured to rotate at least 90 degrees about the axis with respect to the jaw portion. The handle portion may be configured to rotate at least 180 degrees about the axis with respect to the jaw portion. The handle portion may be configured to fully rotate about the axis with respect to the jaw portion. 
         [0008]    A second aspect of the present invention is a suture passer assembly including a jaw portion extending along an axis and having a proximal end, a handle portion rotatably connected with the proximal end of the jaw portion such that the handle portion is configured to at least partially rotate about the axis with respect to the jaw portion, and a needle assembly configured to pass through the jaw portion and adapted to be passed along the axis by cooperation of the needle assembly with the handle portion. 
         [0009]    In accordance with certain embodiments of this second aspect, the instrument may further include a shaft portion extending along the axis between the handle portion and the jaw portion, the shaft portion being rotationally coupled to the proximal end of the jaw portion. The shaft portion may include at least one spring-assisted bearing and the handle portion may include at least one depression configured to engage the at least one spring-assisted bearing in an orientation that temporarily locks the shaft portion with respect to handle portion. The at least one spring-assisted bearing and the at least one depression may be engageable in a finite number of orientations about the axis that temporarily lock the shaft portion with respect to handle portion. The handle portion may be further rotated with respect to the jaw portion through application of a force to overcome the connection between the at least one spring-assisted bearing and the at least one depression in the temporarily locked orientation. 
         [0010]    The handle portion may be configured to rotate at least 90 degrees about the axis with respect to the jaw portion. The handle portion may be configured to rotate at least 180 degrees about the axis with respect to the jaw portion. The handle portion may be configured to fully rotate about the axis with respect to the jaw portion. The needle assembly may be rotatable with respect to the handle portion. The jaw portion may include a lower jaw having a non-circular needle channel, and the needle assembly may include a non-circular needle blade slidable within the needle channel, wherein the needle assembly is rotationally coupled with the jaw portion and rotationally connected to the handle portion due to the mating configuration between the needle channel and needle blade. The jaw portion may include a lower jaw having a forked end and a needle channel, the forked end defining first and second arms having a space therebetween that intersects the needle channel, wherein the space is configured to accept a suture for engagement with the needle assembly. 
         [0011]    A third aspect of the present invention is a method of using a surgical instrument including the steps of rotating a handle portion of the instrument with respect to a jaw portion of the instrument about an axis, the jaw portion extending along the axis and having a distal end and a proximal end, the distal end having an upper jaw and a lower jaw, the handle portion rotatably connected with a proximal end of the jaw portion; positioning a suture at the distal end of the lower jaw; actuating a jaw lever of the handle portion to cause the upper and lower jaws to close on a portion of tissue; and actuating a handle lever of the handle portion to pass a needle assembly along the axis through the lower jaw to pass a portion of the suture through the portion of tissue. 
         [0012]    In accordance with certain embodiments of this third aspect, the step of rotating may include engaging at least one spring-assisted bearing of the jaw portion with at least one depression of the handle portion in a first orientation of the instrument that temporarily locks the jaw portion with respect to handle portion. The method may further include the step of further rotating the handle portion with respect to the jaw portion from the orientation to a second orientation of the instrument that temporarily locks the jaw portion with respect to handle portion. The step of further rotating may include applying a force to overcome the connection between the at least one spring-assisted bearing and the at least one depression in the first temporarily locked orientation. The step of further rotating may occur after the step of actuating the jaw lever. The step of rotating may include rotating the handle portion with respect to the needle assembly about the axis. 
         [0013]    The lower jaw may have a forked end, and the step of positioning may include positioning a suture between arms of the forked end for engagement with the needle assembly. The step of actuating the handle lever may include positioning the suture within a notch in the needle assembly. The method may further include the step of loading the needle assembly into the instrument by sliding a distal end of the needle assembly through the jaw portion and engaging a proximal end of the needle assembly with the handle portion. The method may further include the steps of releasing the handle lever to retract the needle assembly from the portion of tissue and releasing the jaw lever to release the grasp of the upper and lower jaws on the portion of tissue. The method may further include the step of positioning the upper and lower jaws adjacent to the portion of the suture passed through the tissue and actuating the jaw lever to cause the upper and lower jaws to close on the portion of the suture. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    A more complete appreciation of the subject matter of the present invention and the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which: 
           [0015]      FIG. 1  is a front perspective view of a suture passer assembly assembled with a needle assembly in accordance with an embodiment of the present invention. 
           [0016]      FIG. 2  is a front perspective view of the suture passer assembly shown in  FIG. 1 . 
           [0017]      FIG. 3  is a side elevational view of the suture passer assembly shown in  FIG. 1 . 
           [0018]      FIG. 4  is a side sectional view of the suture passer assembly shown in  FIG. 1  taken along the line  4 - 4 . 
           [0019]      FIG. 5  is a side partial-sectional view of a handle portion of the suture passer assembly shown in  FIG. 1 . 
           [0020]      FIG. 6  is a side sectional view of a shaft portion and a jaw portion of the suture passer assembly shown in  FIG. 1 . 
           [0021]      FIG. 7  is a side sectional view of the proximal end of the shaft portion shown in  FIG. 6 . 
           [0022]      FIG. 8  is a side sectional view of the jaw portion and the distal end of the shaft portion shown in  FIG. 6 . 
           [0023]      FIG. 9  is a front perspective view of the jaw portion and the distal end of the shaft portion shown in  FIG. 6 . 
           [0024]      FIG. 10  is a top perspective view of a bottom jaw with a needle guide of the suture passer assembly shown in  FIG. 1 . 
           [0025]      FIG. 11  is a side sectional view of the connection between the handle portion and the shaft portion of the suture passer assembly shown in  FIG. 1 . 
           [0026]      FIG. 12  is a top perspective view of a rotator and a lock nut of the suture passer assembly shown in  FIG. 1 . 
           [0027]      FIG. 13  is a top perspective sectional view of the rotator and lock nut shown in  FIG. 12  taken along the line  13 - 13 . 
           [0028]      FIG. 14  is a top perspective view of a collar of the suture passer assembly shown in  FIG. 1 . 
           [0029]      FIG. 15  is a top view of an upper jaw of the suture passer assembly shown in  FIG. 1 . 
           [0030]      FIG. 16  is a top perspective view of the upper jaw shown in  FIG. 15 . 
           [0031]      FIG. 17  is a top perspective view of the needle assembly of the suture passer assembly shown in  FIG. 1 . 
           [0032]      FIG. 18  is a top perspective view of a needle blade of the needle assembly shown in  FIG. 17 . 
           [0033]      FIG. 19  is a top perspective view of a needle knob of the needle assembly shown in  FIG. 17 . 
           [0034]      FIG. 20  is a top perspective view of the distal end of the needle blade shown in  FIG. 18 . 
       
    
    
     DETAILED DESCRIPTION 
       [0035]      FIGS. 1-20  show a suture passer assembly  100  and components thereof, where assembly  100  includes a handle portion  10 , a shaft portion  50 , a jaw portion  80 , and a needle assembly  94 . Jaw portion  80  is depicted in a closed configuration in  FIGS. 1-4  and in an open configuration in  FIGS. 6 ,  8 , and  9 . Needle assembly  94  is adapted to be operated by handle portion  10 , extend through shaft portion  50 , and cooperate with jaw portion  80  to pass a suture through tissue. Shaft portion  50  is coupled to jaw portion  80 , and as a unit, shaft portion  50  and jaw portion  80  are rotatably connected with handle portion  10 . This allows shaft portion  50  and jaw portion  80  to be rotated with respect to handle portion  10 , which rotation occurs about a central axis  62  (shown in  FIG. 1 ) of a shaft  60  of shaft portion  50 . Thus, a surgeon may ergonomically perform a suturing procedure by grasping and operating handle portion  10  from any number of locations about axis  62  that are independent of the position and orientation in which jaw portion  80  opens and closes.  FIG. 2  shows suture passer assembly  100  without needle assembly  94 . 
         [0036]    As shown in  FIG. 5 , which includes a sectional view within dashed region X, handle portion  10  includes handle lever  12 , handle body  14 , and jaw lever  16 . Handle lever  12  is the proximal-most component of suture passer assembly  100  and is pivotally connected to handle body  14  through handle pin  18 . As shown in  FIGS. 4 and 5 , handle lever  12  includes a first lever arm  17   a  (not shown) opposite a second lever arm  17   b.  Arms  17   a,    17   b  are connected to either side of a lower portion  19  of handle body  14 , such that, in order, handle pin  18  extends through lever arm  17   a,  lower portion  19 , and lever arm  17   b.  A cavity  13 , as shown in  FIGS. 1 ,  2 , and  4 , is disposed in the upper portion of handle lever  12 . 
         [0037]    In its lower portion, handle body  14  includes first stops  20   a  (not shown) and  20   b  (shown in  FIG. 5 ) adjacent lower portion  19 . First stops  20   a,    20   b  are configured to abut first walls  22   a  (not shown) and  22   b  of handle lever  12 , which coincide respectively with the upper portions of lever arms  17   a  and  17   b,  when handle lever  12  and handle body  14  are pivoted toward one another. Likewise, as shown in  FIG. 4 , handle body  14  includes in the lower portion thereof a second stop  21  that is configured to abut a second wall  23  of handle lever  12  when handle lever  12  and handle body  14  are pivoted away from one another. Second wall  23  is positioned on handle lever  12  between lever arms  17   a  and  17   b.  First stops  20   a,    20   b  and first walls  22   a,    22   b  are generally horizontally oriented, while second stop  21  and second wall  23  are generally vertically oriented. Further, in its upper portion, handle body  14  includes a horizontal entry  15  generally aligned with axis  62  of shaft  60  in the assembled condition of assembly  100 . 
         [0038]    Disposed in a substantially horizontal orientation between handle lever  12  and handle body  14  are a handle spring  24  and a dowel pin  26 , as shown in  FIGS. 4 and 5 . Handle spring  24  is normally biased to separate or force apart handle lever  12  and handle body  14  with respect to the axis of rotation at handle pin  18  into a position where second stop  21  contacts second wall  23 . Dowel pin  26  is disposed within handle spring  24  to prevent handle spring  24  from bending or rotating in a direction perpendicular to the general direction of its axial compression/extension. 
         [0039]    Jaw lever  16  is connected to handle body  14  via jaw lever pin  28 , and is similarly biased to separate from handle body  14  with respect to the axis of rotation at lever pin  28  due to the force of a jaw lever spring  30 . The stiffness in jaw lever spring  30  is preferably less than the stiffness in handle spring  24 . The result of the differing stiffnesses causes jaw lever  16  to move relative to handle body  14  before handle lever  12  moves relative to handle body  14  when the three components are squeezed together by a surgeon&#39;s hand, that is, when forces are applied to handle lever  12  and jaw lever  16  simultaneously in an effort to move them toward one another. Conversely, the result of the differing stiffnesses causes handle lever  12  to move relative to handle body  14  before jaw lever  16  moves relative to handle body  14  when the three components are released by the surgeon&#39;s hand. Essentially, when a surgeon squeezes and subsequently releases handle portion  10 , the operation of assembly  100  will be: (1) jaw portion  80  closes; (2) needle assembly  94  moves distally toward jaw portion  80  to engage the tissue; (3) needle assembly  94  retracts proximally from jaw portion  80 ; and (4) jaw portion  80  opens. Thus, the construction of suture passer assembly  100  ensures that jaw portion  80  will be closed during needle engagement and retraction, i.e., movement of needle assembly  94 . 
         [0040]    As shown in  FIGS. 4 ,  5 ,  11 , and  14 , a collar  32  is disposed within and rotationally coupled to the distal-most portion of handle body  14 . A set screw  34  is screwed through a screw bore  14   a  in handle body  14  and into a set screw bore  32   a  in collar  32 , which is shown more clearly in  FIG. 11 . Each of the above-described elements of handle portion  10  are configured such that handle portion  10  rotates about axis  62  of shaft  60  as a single unit. 
         [0041]    As shown in  FIGS. 6 and 7 , shaft portion  50  includes a jaw actuator connector  52 , a jaw spring  54 , a lock nut  56 , a jaw actuator  74 , and shaft  60 . Jaw actuator connector  52  includes a necked down area at a neck  53  that engages with a forked end  36  of jaw lever  16 , as shown in  FIG. 11 . Jaw actuator connector  52  abuts and is connected to the proximal end of jaw actuator  74 , which extends through shaft  60 . Jaw spring  54  is disposed about the proximal end of jaw actuator  74  and between the distal end of jaw actuator connector  52  and lock nut  56 . As shown in  FIG. 11 , lock nut  56  presses against washer  38 , which in turn presses against the proximal portion of collar  32 . When a distal force is applied to jaw actuator connector  52 , lock nut  56  is prevented from moving distally relative to handle portion  10  when it is pressed against collar  32  via washer  38 , and jaw spring  54  is therefore compressed. Such a distal force also causes jaw actuator  74  to move distally within shaft  60 . 
         [0042]    Shaft portion  50  further includes a rotator  58  and a rotator knob  64 , as shown in  FIGS. 6 ,  7 , and  11 . A portion of rotator  58  is disposed within a central bore  33  of collar  32 , and jaw actuator  74  extends through rotator  58 . The proximal end of rotator  58  is fitted with lock nut  56  (also shown in  FIGS. 12 and 13 ), which contacts the proximal portion of collar  32  via washer  38  and prevents rotator  58  from moving distally with respect to collar  32  when lock nut  56  contacts washer  38 . A collar spring  66  is disposed within the distal portion of collar  32  and is biased to extend between adjacent internal faces of collar  32  and rotator  58  to force such elements apart from one another. Again, lock nut  56  and washer  38  prevent separation between collar  32  and rotator  58 . However, axial rotation between collar  32  and rotator  58  is permitted. 
         [0043]    The distal, wider portion of rotator  58  includes two proximally facing bores  68   a,    68   b,  as shown in  FIGS. 12 and 13 , which each may house bearings or balls  70   a,    70   b  and ball springs  72   a,    72   b.  Within bores  68   a,    68   b,  balls  70   a,    70   b  are located proximally of ball springs  72   a,    72   b,  which act against an inside face of bores  68   a,    68   b  to force balls  70   a,    70   b  in a proximal direction. On the distal face of collar  32  are depressions or detents  40   a,    40   b,  as shown in  FIGS. 11 and 14 , which are indentations in collar  32  that mate with a surface of balls  70   a,    70   b.  When balls  70   a,    70   b  are positioned adjacent to detents  40   a,    40   b,  ball springs  72   a,    72   b  act to force balls  70   a,    70   b  into detents  40   a,    40   b,  thus creating a spring-assisted ball or bearing. The force by which balls  70   a,    70   b  are held within detents  40   a,    40   b  by ball springs  72   a ,  72   b  act to temporarily lock and substantially prevent rotation of rotator  58  with respect to collar  32 , and accordingly shaft portion  50  with respect to handle portion  10 . Substantial prevention of the rotation of shaft portion  50  with respect to handle portion  10  does not require complete prevention of rotation, but rather requires enough connection between the portions to prevent rotation due to the normal use of the device by the surgeon during a surgical procedure, thus creating a temporary locked position of assembly  100 . Handle portion  10  can be further rotated with respect to shaft portion  50  and jaw portion  80  through application of a force to overcome the connection between the spring-assisted balls  70   a,    70   b  and depressions  40   a,    40   b  in the temporarily locked orientation. 
         [0044]    The present invention preferably includes four detents  40   a,    40   b,    40   c,    40   d  to allow for positioning of rotator  58  into four particular positions with respect to collar  32 . However, there may be any number of detents  40  in collar  32 . The present invention also allows for any number of bores  68  and corresponding balls  70  and ball springs  72  in rotator  58 . The number of balls  70  may be greater than, equal to, or less than the number of detents  40  in suture passer assembly  100 . Further, the stiffness of ball spring  72  may be chosen according to the amount of force desired to hold collar  32  with respect to rotator  58 . The ease of rotation between handle portion  10  and shaft portion  50  may therefore be determined by the components. While the depicted embodiment of assembly  100  includes four “locked” positions each  90  degrees from one another about axis  62 , it will be understood that shaft portion  50  can be rotated and “locked” with respect to handle portion  10  in any desirable number of positions, such as every 15 degrees, 30 degrees, 45 degrees, 60 degrees, 180 degrees, etc. 
         [0045]    As shown in  FIGS. 6 and 7 , jaw actuator  74  includes a proximal cylindrical portion  76  and a distal U-shaped portion  78 . Proximal cylindrical portion  76  is disposed against jaw actuator connector  52  and is relatively shorter than distal U-shaped portion  78 , which extends toward jaw portion  80 . 
         [0046]    The proximal end of shaft  60  is rotationally coupled within the distal end of rotator  58 , as shown in  FIG. 7 , and may be connected thereto through a weld. Rotator knob  64  is also rotationally coupled to shaft  60  and may be welded thereto. An adjacent connection between rotator knob  64  and rotator  58  may also be welded. 
         [0047]    As shown in  FIGS. 8-10 , jaw portion  80  includes an upper jaw  81  and a lower jaw  86 , which is cylindrical at its proximal end and welded thereat about shaft  60 . Upper jaw  81  is pivotally connected to lower jaw  86  via a jaw pin  82 , which is located distally of shaft  60 . A needle guide  83  is connected to lower jaw  86 , preferably by welding, to provide a needle track  84 , which is curved upward at its distal end. 
         [0048]    Upper jaw  81  is connected to jaw actuator  74  through a jaw link  85 , shown in  FIG. 8 . Jaw link  85  is pivotally connected to jaw actuator  74  through a first pin  85   a  and is pivotally connected to upper jaw  81  through a second pin  85   b.  Thus, jaw link  85  allows for a translational movement of jaw actuator  74  to be converted into pivotal movement of upper jaw  81 , such pivotal movement being about jaw pin  82 . Movement of jaw actuator  74  therefore allows upper jaw  81  to open and close with respect to lower jaw  86 . 
         [0049]    Lower jaw  86  includes a forked end  87  split into a first arm  88   a  and a second arm  88   b,  as shown in  FIGS. 9 and 10 . Each arm  88   a,    88   b  includes a rising portion  89   a,    89   b  through which the lateral edges of needle track  84  extend. Needle track  84  thus includes a horizontal portion  84   a,  a curved portion  84   b,  and a vertical exit portion  84   c.  Defined by forked end  87 , a space  90  extends proximally into lower jaw  86  between rising portions  89   a  and  89   b.  Space  90  extends proximally of vertical exit portion  84   c  and at least partially through curved portion  84   b,  as shown in  FIG. 10 . Needle guide  83  also includes a guide notch  83   a  that extends into needle guide  83  along vertical exit portion  84   c  and at least a portion of curved portion  84   b.  Guide notch  83   a  communicates with space  90 . 
         [0050]    As shown in  FIGS. 9 ,  15 , and  16 , upper jaw  81  includes a forked end  91  having a first arm  92   a  and a second arm  92   b.  The distalmost portions of arms  92   a  and  92   b  extend towards one another to define a space  93  between arms  92   a  and  92   b.  The bottom face of each of arms  92   a  and  92   b  includes a set of teeth  93   a,    93   b  which aid in gripping tissue disposed between upper jaw  81  and lower jaw  86 . Further, arms  92   a  and  92   b  of upper jaw  81  are disposed to be seated outside, or to at least partially overlap in a horizontal plane, the respective rising portions  89   a  and  89   b  when upper jaw  81  is closed with respect to lower jaw  86 . 
         [0051]    Shown in  FIGS. 17-20 , needle assembly  94  includes a needle grip  95 , a needle shaft  96 , and a needle blade  97 . At least needle blade  97  is preferably flexible, yet rigid enough to pierce tissue without breaking. Needle blade  97  is configured in a flat, non-circular construction that cooperates with the relatively flat and wide, non-circular configuration of needle track  84 . As shown in  FIGS. 18 and 20 , the distal portion of needle blade  97  includes a relief  97   a,  a suture notch  97   b,  and a tip  98 . Suture notch  97   b  is configured to engage a suture initially disposed in space  90  of lower jaw  86  after needle blade  97  and suture notch  97   b  pass through and exit needle track  84 . 
         [0052]    As shown in  FIG. 20 , relief  97   a  is provided so that the distal portion of needle blade  97  may allow for bending in a medial-lateral direction without breaking due to stress or fatigue in needle blade  97 . Suture notch  97   b  is generally configured to extend in from the side of needle blade  97  in a medial/proximal direction so as to carry a suture disposed within suture notch  97   b  in a distal direction. Needle blade  97  further has an edge  99  that extends proximally from tip  98  to the alternate side of needle blade  97 , and towards the side of needle blade  97  that includes suture notch  97   b.  In this configuration, edge  99  is disposed distally of suture notch  97   b  such that when needle blade  97  is passed through tissue, edge  99  cuts a hole or slot in the tissue so that any proximally-positioned portions of needle blade  97  easily pass through the tissue. 
         [0053]    The proximal end of needle blade  97  is disposed between two legs  96   a  and  96   b  of needle shaft  96 , as shown in  FIG. 18 . The proximal end of needle shaft  96  is disposed within a bore  95   a  of needle grip  95 , as shown in  FIG. 19 , and may be secured within bore  95   a  via cross pin  95   b.  Needle grip  95  includes a body  95   e  having a protrusion  95   c,  a neck  95   f , and a knob  95   d.  Each component of needle assembly  94  is rotationally coupled, and protrusion  95   c  therefore gives an indication as to the direction that the superior surface of needle blade  97  faces. Knob  95   d  fits within cavity  13  of handle lever  12 , which allows needle assembly  94  to move in a proximal-distal direction with respect to jaw portion  80  according to the position of handle lever  12 . Knob  95   d  and neck  95   f  are adapted to allow for the rotation of needle assembly  94  relative to handle portion  10 . Neck  95   f  of needle grip  95  fits into the edge of cavity  13  in handle lever  12  and allows the needle to rotate about an axis coincident to or generally parallel to axis  62  while still being able to be actuated in the proximal-distal direction by handle lever  12 . The interference fit of knob  95   d  and neck  95   f  with cavity  13  allows for proximal and distal forces to be applied to needle assembly  94 , while the general axial nature of needle assembly  94  allows for rotation of same with respect to handle portion  10 . The components of needle assembly  94  may be flexible to allow for the above-described movement. 
         [0054]    In use, a surgeon may load needle assembly  94  into handle portion  10 , shaft portion  50 , and jaw portion  80 , or needle assembly  94  may be packaged in a pre-assembled manner. Needle assembly  94  is loaded by threading tip  98  through entry  15  of handle body  14 , and sliding needle assembly  94  distally through shaft  60  and along axis  62 . Once needle grip  95  is disposed above cavity  13  in handle lever  12 , needle grip  95  is lowered into cavity  13  and is retained due to the relatively rigid nature needle assembly  94  disposed within shaft portion  50 , which maintains needle grip  95  in its position within cavity  13 . Needle grip  95  may be additionally removeably secured within cavity  13  by a press fit interference. Needle assembly  94  is thus loaded and ready to be passed through tissue. 
         [0055]    The surgeon may then select the rotational orientation of handle portion  10  with respect to shaft portion and jaw portion  80 . This is accomplished by grasping rotator knob  64  and handle portion  10 , and rotating one with respect to the other. When the surgeon rotates rotator knob  64  to overcome the force of ball springs  72   a,    72   b,  balls  70   a ,  70   b  disengage from adjacent detents  40   a,    40   b  and may be rotated into position adjacent to alternate detents  40 . Of course, it is possible for suture passer assembly  100  to be utilized without a mating connection between balls  70  and detents  40 . The surgeon will receive tactile feedback when a mating engagement or release between balls  70  and detents  40  occurs. It will be understood that the configuration of additional balls  70  and detents  40  may allow suture passer assembly  100  to have additional “lockable” positions. The flat construction of needle blade  97  and the similarly flat construction of the cross section of needle track  84  allows for rotational coupling between jaw portion  80  and needle assembly  94 . Thus, when the coupled shaft portion  50  and jaw portion  80  are rotated with respect to handle portion  10 , such rotation also rotates needle assembly  94  so that it maintains its alignment and orientation with respect to shaft portion  50  and jaw portion  80 , thereby causing knob  95   d  to rotate within cavity. 
         [0056]    Of course, the rotatable nature of suture passer assembly  100  allows for rotation to occur between the respective portions either before, during, or after a procedure. For reasons that will be understood by those of ordinary skill in the art, the positioning of jaw portion  80  during a surgical procedure may make it difficult to operate suture passer assembly  100  if handle portion  10  is positioned in a manner that makes suture passer assembly  100  difficult to grasp for the surgeon. If a more suitable rotational position of handle portion  10  is anticipated prior to surgery, the surgeon can place handle portion  10  in such position at that time. However, if it becomes clear during surgery that a different position of handle portion  10  is more advantageous, such rotation can occur while the procedure is in progress. 
         [0057]    With needle assembly  94  preferably in its operative position with respect to handle portion  10 , a suture may be positioned within space  90  of lower jaw  86 , and in particular, within guide notch  83   a.  The suture is preferably disposed such that one end hangs through space  90  and below lower jaw  86 . The other end of the suture is positioned to one side of lower jaw  86  proximally of either of rising portions  89   a  or  89   b.  Therefore, the suture is positioned to intersect needle track  84  at some point along curved portion  84   b.  The suture is thus in position to be picked up by needle blade  97 , and more specifically, within suture notch  97   b,  when needle assembly  94  is passed distally with respect to jaw portion  80 . A suture may alternatively be disposed proximate to the surgical site, and lower jaw  86  can be navigated during the procedure to position the suture within space  90  of lower jaw  86  prior to deployment of needle assembly  94 . 
         [0058]    With the suture in position with respect to suture passer assembly  100 , the surgeon navigates jaw portion  80  toward the tissue to be sutured. Typically, this occurs via a cannula to the surgical site. While jaw portion  80  is biased to be in an open configuration when no pressure is applied by the surgeon to jaw lever  16 , the surgeon preferably pulls jaw lever  16  to close jaw portion  80  to reduce its profile when jaw portion  80  is navigated toward the surgical site. This also helps to more securely hold the suture in its position within space  90  of lower jaw  86 . Once at the surgical site, jaw portion  80  can be opened by the surgeon releasing pressure on jaw lever  16 . After upper jaw  81  and lower jaw  86  are appropriately positioned with respect to the tissue, jaw lever  16  is pulled proximally by the surgeon, thereby closing upper jaw  81  with respect to lower jaw  86 . This is accomplished as jaw lever  16  pivots about jaw lever pin  28  and forked end  36  of jaw lever  16  forces jaw actuator connector  52  in the distal direction, which in turn moves jaw actuator  74 , jaw link  85 , and upper jaw  81 . 
         [0059]    When upper jaw  81  closes with respect to lower jaw  86 , the tissue is clamped therebetween, and teeth  93   a,    93   b  aid in grasping tissue. Space  93  of upper jaw  81  is disposed immediately above rising portions  89   a,    89   b  of lower jaw  86  such that at least a portion of the tissue is forced into space  93 , further enhancing the exact grip on the tissue and applying tension to the area of tissue to be punctured by needle blade  97 . In this configuration, vertical exit portion  84   c  of needle track  84  is preferably positioned adjacent to the intended puncture site in the tissue. 
         [0060]    While the surgeon maintains the position of the tissue by maintaining his grasp of jaw lever  16 , the surgeon further squeezes handle portion  10 , pivoting handle lever  12  with respect to handle body  14  and thereby advancing needle assembly  94  distally. Needle blade  97  is advanced along horizontal portion  84   a  of needle track  84 , through curved portion  84   b  and through vertical exit portion  84   c  where tip  98  pierces the tissue. Once suture notch  97   b  passes through and exits vertical exit portion  84   c,  it encounters the suture disposed in space  90  and the suture enters suture notch  97   b . Further advancement of needle assembly  94  passes suture notch  97   b  and the suture through the punctured hole in the tissue. 
         [0061]    At this point with the suture disposed through the tissue, the surgeon relaxes his grip on handle portion, which allows handle spring  24  to force handle lever  12  in a distal direction, which thereby retracts needle assembly  94  from the tissue. However, the suture remains disposed through the punctured hole in the tissue as needle blade  97  is retracted through the punctured hole and back into needle track  84 . The surgeon then further relaxes his grip on handle portion  10 , allowing jaw lever spring  30  to force jaw lever  16  in a proximal direction, which thereby opens upper jaw  81  with respect to lower jaw  86  and releases the grasp of jaw portion  80  on the tissue. Suture passer assembly  100  is then pulled proximally and away from the tissue, while the suture is left positioned through the puncture hole in the tissue. 
         [0062]    After suture passer assembly  100  has been retracted, the passed portion of the suture can be captured via jaw portion  80  of suture passer assembly  100 . Otherwise, an additional tool can be utilized by the surgeon to capture the passed suture, either during or after operation of suture passer assembly  100 . 
         [0063]    Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made and are encouraged to be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by herein disclosure and/or the appended claims.