Abstract:
A surgical suturing instrument has a needle which traverses at tissue receiving gap and picks up suture distal to the gap. This invention provides an automated mechanism enabling the suture to be removed from the needle after the needle is retracted proximal to the tissue gap. This mechanism provides enhanced device reloading and other potential uses.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    None. 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    None 
       NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT 
       [0003]    None 
       REFERENCE TO A “SEQUENCE LISTING” 
       [0004]    None 
       BACKGROUND OF THE INVENTION 
       [0005]    1. Field of the Invention 
         [0006]    This invention relates generally to surgical suturing instruments and more particularly to a surgical suturing instrument of the type in which a reciprocating needle picks up a ferrule at the end of a suture, from a magazine disposed at a distal end of the instrument and pulls the ferrule and associated suture back across a gap. The invention also provides a stripper for detaching the ferrule from the needle at the proximal end of the gap. 
         [0007]    2. Description of Related Art 
         [0008]    Surgical suturing instruments that use a reciprocating needle for penetrating a tissue segment, picking up a suture by attaching to a ferrule attached to the end of the suture and pulling the suture back through the tissue are known. Recently, improved instruments of this type as shown, for example, in U.S. Pub. No. 2005/0154403 have been developed that include a mechanism for detaching the ferrule from the needle at the distal end of the instrument. These instruments have enabled an expanded variety of stitches to be placed. 
         [0009]    To enable an even greater variety of stitches to be placed by the instrument, there is a further need, for a surgical suturing instrument that can provide multiple sutures and in which ferrules can be detached from the needle at the proximal end of the gap. Heretofore, a couple of manual techniques have been used to remove ferrules from needles proximal to the tissue gap; namely, physically pulling the ferrule from the tip of the needle by grasping and tensioning the suture, and grasping the ferrule itself, often with a needle driver or surgical clamp to physically remove it from the end of the needle. While each of these is effective, each requires access to the suture or the ferrule, respectively, and therefore requires that the instrument be withdrawn from the site where the sutures are being placed. With the ferrule and suture removal from the needle more automated through one aspect of this invention, another aspect of this invention, multiple suture loads in the device, offers an improved opportunity to expedite suturing. This proximal ferrule release mechanism is useful in unloading the ferrules from the needle prior to reloading the device inside or outside of the patient. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    The instruments to which this invention is addressed offer many novel features that improve a surgeon&#39;s ability to place multiple suture bites for suture placement during minimally invasive surgery. Since more automated ferrule release helps enable multi-fire devices, the proximal ferrule release will be addressed first. This new ferrule release enhancement addresses the need to mechanically remove the ferrule from the needle on the proximal side of the gap. Previously, ferrules required mechanical removal from needles retracted into the proximal jaw by pulling the suture attached to the ferrule away from the needle or using a clamp to directly pull the ferrule off. This new more automated mechanical ferrule release mechanism assists in the instrument reloading process and may be used in future devices as alternative means of multiple suture placement. 
         [0011]    It is an object of this invention to provide a surgical suturing instrument that can separate the ferrule from the needle at the proximal side of the gap without withdrawing the instrument from the suturing site. 
         [0012]    Briefly stated and in accordance with one aspect of this invention, a surgical suturing instrument includes a housing having a handle and an actuating member, an elongated guide member attached to the housing and having a distal end, a tip having a tissue engaging gap disposed the distal end of the elongated guide member, and a needle extending from the housing through the guide member, across the gap, to the distal end of the tip, the needle reciprocally movable across the gap from a proximal end of the gap to the distal end of the gap by movement of the actuating member from a rest position to a retracted position and movable proximally from the proximal end of the gap into the guide member by movement of the actuating member from the rest position to an extended position in a direction opposite the retracted position. 
         [0013]    In accordance with another aspect of this invention, the surgical suturing instrument includes a ferrule stripper engaging the needle for removing the ferrule from attachment with the needle as the actuating member is moved from the rest position to the extended position. 
         [0014]    In accordance with another aspect of the invention, the ferrule stripper comprises a resilient member having a ferrule engaging portion riding on the needle proximal to the needle tip. 
         [0015]    In accordance with another aspect of the invention, the needle has a flat surface adjacent the tip of the needle exposing a proximal edge of the ferrule when the ferrule is attached to the needle and in which the stripper engages the proximal edge of the ferrule to remove the ferrule from the tip of the needle. 
         [0016]    In accordance with another aspect of the invention, the actuating member is pivotally mounted on the housing. 
         [0017]    In accordance with another aspect of the invention, a first spring biases the actuating member from the retracted position to the rest position. 
         [0018]    In accordance with another aspect of the invention, a second spring biases the actuating member from the extended position to the rest position. 
         [0019]    In another aspect of the invention a spring biases the handle from the retracted position to the extended position and a latch stops the handle at the rest position until the latch is released. Further movement of the slidable latch aids in retracting the needle to strip the ferrule. 
         [0020]    In accordance with another aspect of this invention, multiple ferrules with sutures are located in a magazine at the distal end of the device to enable multiple suture placements without reloading more sutures into the device tip. Springs or other mechanisms can be used to reposition subsequent ferrules in line with the needle for pick-up. Single ferrules on single sutures or two ferrules on opposite ends of the single suture or various combinations could be deployed. 
         [0021]    In accordance with another aspect of the invention, the housing comprises a handle that can be gripped and the actuating member operated with one hand. 
         [0022]    While the novel aspects of the invention are set forth with particularity in the appended claims, the invention itself together with further objects and advantages thereof may be more readily understood by reference to the following detailed description of several embodiments of the invention taken in connection with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING 
         [0023]      FIG. 1  is an exploded view of the tip of a surgical suturing instrument in accordance with this invention showing the components thereof; 
           [0024]      FIG. 2  is a cutaway perspective view of a surgical suturing instrument in accordance with this invention with an actuating lever in the rest position; 
           [0025]      FIG. 3  is a cutaway perspective view of a surgical suturing instrument in accordance with this invention with an actuating lever in an extended position; 
           [0026]      FIG. 4  is an enlarged view of the tip of the instrument with a portion thereof cut away showing the relationship of the ferrule stripper to the needle at the resting position; 
           [0027]      FIG. 5  is a view similar to  FIG. 4  showing the ferrule stripper engaging the ferrule; 
           [0028]      FIG. 6  is a view similar to  FIGS. 4 and 5  showing the ferrule detached from the tip of the needle, which is fully retracted; 
           [0029]      FIGS. 7-9  are sectional views corresponding to  FIGS. 4-6 ; 
           [0030]      FIG. 10A  is a fragmentary view, partly in section showing a latch in accordance with this invention; 
           [0031]      FIG. 10B  is a cutaway perspective view of an instrument in accordance with this invention showing a latch in accordance with an embodiment of the invention; 
           [0032]      FIG. 11A  is a view similar to  FIG. 10A  showing the latch in an engaged position; 
           [0033]      FIG. 11B  is a view similar to  FIG. 10B  showing the latch in an engaged position with the handle in an extended position; 
           [0034]      FIG. 12  is a partly sectioned view of an instrument tip showing the ferrule magazine in accordance with the invention; 
           [0035]      FIG. 13  is a section taken along line A-A of  FIG. 12 ; 
           [0036]      FIG. 14  is a section taken along line B-B of  FIG. 12 ; 
           [0037]      FIG. 15  is a bottom view of the tip shown in  FIG. 12 . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0038]      FIG. 1  is an exploded enlarged view of the tip  10  of the surgical suturing instrument in accordance with this invention. The tip  10  which may be a machined or molded piece has a preferably cylindrical proximal portion  12  that fits within the distal end of a shaft tube  16  carrying a needle  18 . The proximal portion  12  of the tip  10  has a diameter adapted to fit within the inside diameter of the shaft tube  16 , and a distal portion  20  has a larger diameter terminating in a proximal shoulder  22  that abuts the distal end  14  of the shaft tube  16 . The distal portion  20  includes a tissue receiving gap  15  and terminates in a suture/ferrule receiving tip  26  having a latch  28  disposed therein for holding a suture  30  with attached ferrule  32  for pickup by a needle in a manner well known to those skilled in the art. 
         [0039]    The proximal portion  12  includes a cavity  34  for receiving a ferrule stripping spring  36 . The spring  36  has an elongated flat portion, a bend  40 , and a slightly shorter needle engaging portion terminating in a lip  42 . The ferrule stripping spring  36  is resiliently deformable by bringing the two legs of its generally v-shape together. The spring  36  fits within the cavity  34  with the long portion  38  up, and the lip  42  exposed in a recess in the proximal portion of the tip  10 . 
         [0040]    The operation of the ferrule stripping spring  36  will be described in more detail below. 
         [0041]      FIG. 2  is a cutaway isometric view of a surgical suturing instrument  50  in accordance with this invention. The shaft tube  16  and distal tip  26  illustrated in  FIG. 1  appear. The proximal portion  52  of the shaft tube  16  is engaged with the tip  56  of a grippable handle  54  through which the proximal end  58  of the reciprocating needle  18  is passed to an upper needle end receiving portion  60  of an operating lever  62  pivotally mounted in the handle  54  at a lever pivot point  64 . Preferably, the proximal end  58  of the needle  18  has an enlarged head, not visible, received in a cavity  60  in the upper end of the operating lever  62 . The operating lever includes a spring attachment projection  66  on which one end of a retracting spring  68  is engaged, the opposite end of the spring  68  being fixed to a post  70  in the lower portion of the handle  54 . The retraction spring  68  urges the operating lever  62  from a retracted position to a rest position that is, with the operating lever  62  extended so that the needle  18  is retracted to the proximal end of the gap. A flexible stop  72  is mounted to the handle and engages the upper portion of the operating lever  62  to restrain further extension of the lever. The flexible stop exerts force on the lever that can be overcome by further manual movement of the lever  62  to an extended position in a direction away from the handle  54  such as by gripping the lever and pulling on it. The further movement of the lever  62  further retracts the needle  18  into the proximal portion of the tip to strip off the ferrule  32  in a manner that will be discussed below. 
         [0042]      FIG. 3  shows the instrument of  FIG. 2  with the operating lever  62  moved to the full forward extended position fully retracting the needle  18  against the bias of the flexible stop  72  which is shown now bent to accommodate full needle retraction. 
         [0043]      FIG. 4  is an enlarged view of the distal end of the surgical suturing instrument  50  showing the elements thereof in the rest position, that is, with the needle  18  retracted to the proximal end of the gap  15  but not pulled back against the resilient stop. As can be seen, the flexible ferrule stripping spring  42  lip engages the shaft of the needle  18  proximal to the ferrule engaging tip. A flat spot  80  is formed on the needle shaft between the point at which the spring lip engages the needle  18  and the proximal end of the ferrule  34  for facilitating stripping of the ferrule from the needle as will be shown below. 
         [0044]      FIG. 5  shows the distal end of the surgical suturing instrument as the needle  18  is drawn back from the rest position shown in  FIG. 4  towards the fully retracted ferrule stripping position. It can be seen that the ferrule engaging lip  42  of the resilient spring  36  engages the flat  80  on the shaft of the needle  18  so that the distal end of the spring lip engages the proximal end of the ferrule  32 . 
         [0045]    As shown in  FIG. 6 , as the needle is retracted further against the resilient stop, the needle engaging lip  42  of the spring  36  pushes the ferrule off the end of the needle. 
         [0046]      FIGS. 7 through 9  are sectional views of the stripping action of the surgical suturing instrument in accordance with this invention corresponding to  FIGS. 4 through 6 .  FIG. 7  shows the needle  18  at the rest position with the tip  42  of the ferrule stripping spring  38  engaging the outside diameter of the needle  18 , but not yet contacting the ferrule. 
         [0047]      FIG. 8  shows the needle  18  retracted to the point where the ferrule stripping spring lip  42  initially engages the proximal edge of the ferrule  32 . 
         [0048]      FIG. 9  shows the needle  18  retracted fully and disengaged from the ferrule which was pushed off of the needle tip by the distal edge of the stripping spring lip  42 . 
         [0049]      FIGS. 10A  and B are partially cutaway views of the surgical suturing instrument  50  in accordance with another aspect of this invention. The instrument shown in  FIGS. 10A  and B is designed to permit the ferrule stripping operation to be performed with one hand, that is, without the need for pulling the operating lever  62  forward to strip the ferrule  32  from the tip of the reciprocating needle  18 . 
         [0050]    As shown in the figures, a slidable lever stop  90  engages the proximal portion  58  of the upper part of the actuating lever  62  when the lever is in the rest position, that is, with the needle  18  retracted to the proximal portion of the tissue receiving gap  15 , but with the ferrule still in place on the tip of the needle. The slidable lever stop  90 , which is generally C-shaped, has first and second curved edge portions  92 ,  94  adapted to be operated by the digits, or the thumb of a user, a connecting portion  96  connecting the two operating portions, and a stop  98  on the connecting portion engaging the upper portion  58  of the lever. The instrument, with the upper portion of the lever pulled back against the stop by the spring is shown in  FIG. 10A . In this position, the ferrule  32  remains on the tip of the needle  18 . 
         [0051]    To strip the ferrule off the needle, the stop  90  is pushed downwardly as shown in  FIG. 11A , or from left to right as shown in  FIGS. 10-13  for example by pushing the curved end portion  92  with the thumb, thereby simultaneously (or at least approximately simultaneously) releasing the stop  98  from the corner  100  of the upper portion  58  of the operating lever  62  and at the same time engaging a forward portion  102  of the upper portion  58  of the operating lever to assist the spring  68  in moving the needle to a further retracted position thereby stripping the ferrule off the needle. 
         [0052]      FIGS. 11A and 11B  shows the position of the slide mechanism  90  when the needle  18  is fully retracted. To release the needle for placing a subsequent suture, the slide  90  is moved in the opposite direction, up or left as shown in  FIGS. 11A and 11B , while the operating lever  62  is pulled slightly towards the handle to allow the slide to return to the position shown in  FIGS. 10A and 10B . 
         [0053]    This invention allows the reciprocating needle  18  to sequentially pick up the ends of a plurality of sutures by providing a means for stripping a ferrule from the end of the needle at the proximal edge of the tissue receiving gap  15 .  FIGS. 12-15  show an embodiment of the invention having a magazine formed in the distal end of the tip  10  into which a plurality of ferrules  116  can be loaded, each having a suture attached, for sequential pick-up by reciprocating motion of the needle  18 . The distal end of the tip includes a magazine  112  in the form of a slot into which the plurality of ferrules  116 , in this case  4 , are loaded. While in this embodiment a single column of ferrules is shown, other arrangements are possible holding more. A spring  110  urges the ferrules  116  towards the bottom of the magazine slot  112  for sequential pick-up by the needle  18 . A latch spring  118  as best shown in Sec. A-A, holds the ferrules  116  in place until the bottom edge of the spring  118  is displaced upwardly by the tip of the needle  18 , thus releasing one ferrule at a time. Section B-B shows an end view of the ferrules  116  held by the compressed spring  110  in magazine  112 . 
         [0054]    While the invention has been described in connection with certain presently preferred embodiments thereof, those skilled in the art will recognize that certain modifications and changes may be made, therein without departing from the true spirit and scope of the invention, which accordingly is intended to be defined solely by the appended claims.