Patent Abstract:
An instrument and method for suturing wound closures is provided having a handle, shaft and suture engagement mechanism. The instrument provides for multiple placements or “bites” of suture in tissues to enable a wide variety of suturing techniques, including the ability to “run” a suture. The instrument further facilitates suture knot tying. The method of this instrument provides for rapid and effective remote suture placement and knot tying.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     Not applicable. 
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable. 
     REFERENCE TO A “SEQUENCE LISTING” 
     Not applicable. 
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention relates generally to surgical suturing instruments and more particularly to a surgical suturing instrument in which a needle can be selectively engaged with a fitting at the end of the suture for pulling the suture through a tissue section and released from the suture for permitting subsequent stitches to be made. 
     2. Description of Related Art 
     Invasive therapeutic interventions typically provide for the removal of problematic tissue structures from the body followed by a need to reconstruct the involved tissues. Many alternatives are available for reconstructive interventions. Bandages can often close external wounds. The use of sutures placed within wound edges to draw tissues together to permit enhanced healing has become commonplace in modern medicine. Metallic or plastic staples and clips also can be used to appose tissue for healing. 
     To minimize the invasiveness of therapeutic procedures, efforts to create smaller access wounds that minimize iatrogenic tissue disruption have lead to better patient outcomes. For example, a minimally invasive surgical procedure, like laparoscopic partial colonic resection with intestinal reconnection (anastomosis), can facilitate less peri-operative pain, more rapid return of normal functions, earlier return to home and work. The placement of sutures during laparoscopic surgery can be slow, tedious and often not successful. Existing specialized instruments for minimally invasive surgery (Sauer) have recognized limitations. An instrument to enable the rapid, precise placement of multiple suture bites with the same suture and then facilitate rapid, secure knot creation would be a significant advance. 
     BRIEF SUMMARY OF THE INVENTION 
     Briefly stated and in accordance with certain presently preferred embodiments of the invention, a surgical suturing instrument includes an elongated shaft, a tissue engaging gap formed in an end of the shaft, a needle reciprocally movable across the gap from a proximal end of the gap to a distal end of the gap, the needle having a ferrule engaging tip and a ferrule receiving aperture at a distal end of the gap for selectively holding and releasing a ferrule so that in a first mode the needle engages the ferrule and draws the suture across the gap and in a second mode, the ferrule is retained in the aperture and the needle separates from the ferrule and is retracted across the gap leaving the ferrule in the aperture. 
     In accordance with another aspect of the invention, a surgical suturing instrument for placing multiple suture loops in tissue comprises on elongated shaft, a reciprocal suture pick up member mounted on the shaft, a suture holder engaged by the reciprocating suture pick up member for selectively coupling a suture to the pick up member for drawing the suture through a first tissue section and releasing the suture from the pick up member for repeated coupling and drawing the suture through a second tissue section spaced from the first tissue section. 
     In accordance with another aspect of the invention, a surgical suturing instrument includes reciprocating tissue penetrating member, a suture holder, and apparatus for alternately coupling the reciprocating tissue penetrating member to the suture holder for drawing a length of suture through a tissue section and releasing the reciprocating tissue penetrating member from the suture holder. 
     In accordance with another aspect of the invention, a method of closing a wound includes the steps of disposing a suture on one side of a tissue section proximal to the wound, passing a needle through the section of tissue proximal to the wound, capturing the suture with the needle, drawing the suture through the section of tissue, releasing the suture from the needle, and repeating the passing capturing drawing and releasing steps. 
     In accordance with another aspect of the invention, a method of securing a suture at a wound site comprises passing an end of the suture through bolster and securing the suture with a bolster disposed between the end of the suture and the wound. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
       The foregoing objects, features and advantages of the invention will become more apparent from a reading of the following description in connection with the accompanying drawings, in which: 
         FIG. 1  is a perspective view of the tissue suturing instrument in accordance with the present invention; 
         FIG. 2  is a partial side view of the tissue suturing instrument of  FIG. 1  in which the right cover of the housing of the instrument is removed; 
         FIG. 3  is an exploded perspective view of the tissue suturing instrument of  FIG. 1  in which the right cover of the housing is removed; 
         FIGS. 4A–4C  are perspective views of the thumb slide holder of  FIG. 3  showing this component from the top left, top right and bottom right perspectives, respectively; 
         FIG. 5A  is a partially exploded perspective view of the thumb slide mechanism of  FIG. 3  highlighting the thumb button and the retaining lock features; 
         FIG. 5B  is a perspective view of an assembled thumb slide mechanism of  FIG. 3  showing the thumb button in its fully out position; 
         FIG. 6A  is a left perspective view of the thumb slide mechanism of  FIG. 3  with its balled needle fully back and its accompanying lever fully out; 
         FIG. 6B  is a left perspective view of the thumb slide mechanism of  FIG. 3  with its balled needle fully forward and its accompanying lever fully retracted; 
         FIG. 7A  is a right perspective view of the thumb slide mechanism of  FIG. 3  with its thumb button and ferrule stripper fully back and its accompanying lever fully out; 
         FIG. 7B  is a right perspective view of the thumb slide mechanism of  FIG. 3  with it thumb button and ferrule stripper fully forward and its accompanying lever fully retracted; 
         FIG. 8A  is an exploded perspective view of the distal tip of the instrument of  FIG. 1  showing the distal tube, jaw, needle, ferrule stripper and ferrule retainer; 
         FIG. 8B  is a perspective view of the underside of the distal tip of  FIG. 1  showing the ferrule stripper alignment ramp and the ferrule holding compartment; 
         FIG. 9A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed and both the thumb button and the lever are fully out; 
         FIG. 9B  is a right perspective view of the distal tip of the components of  FIG. 9A  showing the ferrule in its compartment; 
         FIG. 9C  is a partial cross-sectional view of the distal tip of the components of  FIG. 9A  with the ferrule in its compartment and the needle and ferrule stripper fully back; 
         FIG. 9D  is a side view of the proximal components of  FIG. 9A  showing the lever and thumb button fully out; 
         FIG. 9E  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with its thumb slide holder removed, the lever partially retracted and the thumb button fully out; 
         FIG. 9F  is a right perspective view of the distal tip of the components of  FIG. 9E  with the needle partially advanced and the ferrule in its compartment; 
         FIG. 9G  is the partial cross-sectional view of the distal tip of the components of  FIG. 9E  showing the ferrule in its compartment, the needle partially advanced and the ferrule stripper fully back; 
         FIG. 9H  is a side view of the proximal components of  FIG. 9E  showing the lever partially retracted and the thumb button fully out; 
         FIG. 9J  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever fully retracted and the thumb button fully out; 
         FIG. 9K  is a right perspective view of the distal tip of the components of  FIG. 9J  showing the needle fully advanced and engaging the ferrule in its compartment; 
         FIG. 9L  is a partial cross-sectional view of the distal tip of the components of  FIG. 9J  with the needle engaging the ferrule in its compartment and the ferrule stripper fully back; 
         FIG. 9M  is a side view of the proximal components of  FIG. 9J  showing the lever fully retracted and the thumb button fully out; 
         FIG. 10A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, with the thumb button fully out, the lever partially forward and the needle attached to the ferrule and suture partially back; 
         FIG. 10B  is a right perspective view of the distal tip of the components of  FIG. 10A  showing the needle attached to the ferrule with suture partially retracted; 
         FIG. 10C  is a partial cross-sectional view of the distal tip of the components of  FIG. 10A  showing the needle attached to the ferrule and suture partially retracted and the ferrule stripper fully back; 
         FIG. 10D  is a side view of the proximal components of  FIG. 10A  showing the lever partially back and the thumb button fully out; 
         FIG. 10E  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever fully out and the thumb button fully out; 
         FIG. 10F  is a right perspective view of the distal tip of the components of  FIG. 10E  showing the needle attached to the ferrule and suture fully retracted and the ferrule stripper fully back; 
         FIG. 10G  is a perspective side view of the distal tip of the components of  FIG. 10E  showing the needle attached to the ferrule and suture fully retracted and the ferrule stripper fully back; 
         FIG. 10H  is a side view of the proximal components of  FIG. 10E  showing the lever fully out and the thumb button fully out; 
         FIG. 11A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever partially retracted, the needle with its ferrule and suture partially advanced and the thumb button fully out; 
         FIG. 11B  is a right perspective view of the distal tip of the components of  FIG. 11A  showing the needle attached to the ferrule and the suture partially advanced; 
         FIG. 11C  is a partial cross-sectional view of the distal tip of the components of  FIG. 11A  showing the needle attached to the ferrule and the suture partially advanced and the ferrule stripper fully back; 
         FIG. 11D  is a side view of the proximal components of  FIG. 11A  showing the lever partially retracted and the thumb button fully out; 
         FIG. 11E  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed and the lever fully retracted and the thumb button fully out; 
         FIG. 11F  is a right perspective view of the distal tip of the components of  FIG. 11E  with the needle fully advanced along with its attached ferrule and suture; 
         FIG. 11G  is a partial cross-sectional view of the distal tip of the components of  FIG. 11E  showing the needle along with its attached ferrule and suture fully advanced into the ferrule compartment; 
         FIG. 11H  is a side view of the proximal components of  FIG. 11E  showing the lever fully retracted and the thumb button fully out; 
         FIG. 11J  is a close-up side view of the lock features of the components of  FIG. 11H  showing the flat engagement surface of the actuating member raising the proximal spring lock to disengage it from the timing tube; 
         FIG. 12A  is a right partial view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever fully retracted, the needle with its attached ferrule and suture fully advanced and the thumb button partially advanced; 
         FIG. 12B  is a right perspective view of the distal tip of the components of  FIG. 12A  showing the needle with its ferrule and suture fully advanced into the ferrule compartment and the ferrule stripper partially advanced; 
         FIG. 12C  is a partial cross-sectional view of the distal tip of the components of  FIG. 12A  showing the needle attached to the ferrule and suture fully advanced and the ferrule stripper partially advanced; 
         FIG. 12D  is a side view of the proximal components of  FIG. 12A  showing the lever fully retracted and the thumb button partially forward; 
         FIG. 12E  is a close-up side view of the lock features of the components of  FIG. 12D  showing the flat engagement surface of the actuating member raising the proximal spring lock and the timing tube partially forward; 
         FIG. 12F  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever fully retracted, the needle with its attached ferrule and suture fully advanced, and the thumb button and ferrule stripper fully forward; 
         FIG. 12G  is a right perspective view of the distal end of the components of  FIG. 12F  showing the needle with its ferrule and suture fully advanced and the ferrule stripper fully advanced and engaging the ferrule; 
         FIG. 12H  is a partial cross-sectional view of the distal tip of the components of  FIG. 12F  showing the needle attached to the ferrule and the suture and the ferrule stripper fully advanced engaging the ferrule; 
         FIG. 12J  is the side view of the proximal components of  FIG. 12F  showing both the lever and the thumb button fully forward; 
         FIG. 12K  is a close-up side view of the lock features of  FIG. 12J  showing the flat engagement surface of the actuating member raising the proximal spring lock, the timing tube fully forward and engaging the released distal spring lock; 
         FIG. 13A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever partially released, the needle partially retracted, the ferrule stripper engaging the ferrule in its ferrule compartment and the thumb button fully forward; 
         FIG. 13B  is a right perspective view of the distal tip of the components of  FIG. 13A  showing the needle partially retracted and the ferrule stripper fully forward; 
         FIG. 13C  is a partial cross-sectional view of the distal tip of the components of  FIG. 13A  showing the needle partially retracted and the ferrule stripper fully forward engaging the ferrule in its compartment; 
         FIG. 13D  is a side view of the proximal components of  FIG. 13A  showing the lever partially out and the thumb button fully forward; 
         FIG. 13E  is a close-up side view of the lock features of  FIG. 13D  showing the convex engagement surface of the actuating member raising the distal spring lock and the thumb button released but still fully forward; 
         FIG. 13F  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever, needle, thumb button and ferrule stripper partially back; 
         FIG. 13G  is a right perspective view of the distal tip of the components of  FIG. 13F  with the needle and ferrule stripper partially retracted and the ferrule back into its compartment; 
         FIG. 13H  is a partial cross-sectional view of the distal tip of the components of  FIG. 13F  showing the needle and the ferrule stripper partially back and the ferrule and suture in the ferrule compartment; 
         FIG. 13J  is a side view of the proximal components of  FIG. 13F  showing the lever and the thumb button partially back; 
         FIG. 13K  is a close-up side view of the lock features of  FIG. 13F  showing the engagement surfaces of the actuating member not raising either of the spring locks; 
         FIG. 13L  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder removed, the lever, needle, thumb button and ferrule stripper fully back and the ferrule and suture reloaded into the ferrule compartment; 
         FIG. 13M  is a perspective view of the distal tip of the components of  FIG. 13L  showing the needle and ferrule stripper fully retracted and the ferrule and suture in the ferrule compartment; 
         FIG. 13N  is a partial cross-sectional view of the distal tip of the components of  FIG. 13L  showing the needle and ferrule stripper fully back and the ferrule and suture in the ferrule compartment; 
         FIG. 13P  is a side view of the proximal components of  FIG. 13L  showing the lever and the thumb button fully back; 
         FIG. 13R  is a close-up side view of the lock features of  FIG. 13L  showing the proximal spring clip engaging the timing tube; 
         FIGS. 14A–14E  show an example of the suturing procedure using the tissue suturing instrument of  FIG. 1  for placement of suture at the first site of the wound closure; 
         FIGS. 15A–15E  show an example of the suturing procedure using the tissue suturing instrument of  FIG. 1  for placement of suture at the second site of the wound closure; 
         FIGS. 16A–16D  show an example of the suturing procedure using the tissue suturing instrument of  FIG. 1  for placement of suture at the third site of the wound closure; 
         FIGS. 17A–17D  show an example of the suturing procedure using the tissue suturing instrument of  FIG. 1  for placement of suture at the fourth site of the wound closure; 
         FIGS. 18A–8E  show an example of the use of the instrument of  FIG. 1  to enable suture loop construction to initiate the tying of a suture knot; 
         FIGS. 19A–19F  show an example of the instrument of  FIG. 1  to construct further suture loops used to secure a suture knot; 
         FIG. 20  shows the suturing instrument of  FIG. 1  used with a surgical grasper, which pulls on the free end of the suture to deliver the suture knot to the wound closure site; 
         FIG. 21  shows both the suturing instrument of  FIG. 1  and a surgical grasper pulling on either ends of the suture to lock the knot in place to secure the wound closure; 
         FIGS. 22A–22C  show an alternate method of securing the ends of the suture used in the suturing procedure illustrated in  FIGS. 14A–17D  by crimping a sleeve member over the ends of the suture; 
         FIGS. 23A–23D  illustrate a running suturing procedure created using the tissue suturing instrument of  FIG. 1  being secured by bolsters and a crimped sleeve member; 
         FIG. 24A  is a perspective view of the distal tip of the second preferred embodiment of the tissue suturing instrument of  FIG. 1  in which a stripper wedge causes a flexible member to grasp the ferrule; 
         FIG. 24B  is a partial cross-sectional view of the distal tip of the second preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the needle engaging the ferrule and partial deployment of the stripper wedge; 
         FIG. 24C  is a partial cross-sectional view of the distal tip of the second preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the stripper wedge engaging the flexing member which grasps the ferrule and allows the needle to retract leaving the ferrule in its ferrule compartment; 
         FIG. 25A  is a perspective view of the distal tip of the third preferred embodiment of the tissue suturing instrument of  FIG. 1  in which a stripper rod passes through the distal tip and engages the proximal face of the ferrule to enable stripping; 
         FIG. 25B  is a broken-out section of the distal tip of the third preferred embodiment of the tissue suturing instrument of  FIG. 1  in which a stripper rod rests in its internal chamber as the needle engages the ferrule in its ferrule pocket; 
         FIG. 25C  is a broken-out section of the distal tip of the third preferred embodiment of the tissue suturing instrument of  FIG. 1  in which the stripper rod protrudes from its internal chamber to engage the proximal face of the ferrule as the needle disengages the ferrule and retracts; 
         FIG. 26  is a partially exploded isometric view of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  in which a cam and follower mechanism and faceted needle are utilized to allow for automatic ferrule pick-up and release; 
         FIG. 27A  is a close-up isometric view of the cam and follower mechanism of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  illustrating the needle fully retracted; 
         FIG. 27B  is a close-up perspective view of the tip of faceted needle of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  shown in its ferrule engaging configuration; 
         FIG. 27C  is a close-up isometric view of the cam and follower mechanism of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  illustrating the needle partially advanced and the follower mechanism actuating the cam and rotating the needle; 
         FIG. 27D  is a close-up perspective view of the tip of faceted needle shown partially rotated as it is advancing; 
         FIG. 27E  is a close-up isometric view of the cam and follower mechanism of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  illustrating the needle fully advanced; 
         FIG. 27F  is a close-up perspective view of the tip of faceted needle of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  shown fully advanced and rotated to its ferrule stripping configuration; 
         FIG. 28  is a close-up perspective view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing a partially advanced faceted needle, the ferrule in its ferrule compartment and a ferrule latch adjacent to the ferrule pocket; 
         FIG. 29A  is a close-up perspective view of the stripping mechanism of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the ferrule latch disengaged and allowing the faceted needle to retrieve the ferrule; 
         FIG. 29B  is a close-up perspective view of the stripping mechanism of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the ferrule latch engaged and enabling the stripping of the faceted needle from the ferrule; 
         FIG. 30A  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle fully retracted and the ferrule in its ferrule compartment; 
         FIG. 30B  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle fully extended, disengaging the ferrule latch, and connecting with the ferrule in its ferrule compartment; 
         FIG. 30C  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle beginning to retract with its attached ferrule and suture; 
         FIG. 30D  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle retracting with its attached ferrule and suture and the ferrule latch returning to its normal state; 
         FIG. 30E  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle fully retracted with its attached ferrule and suture; 
         FIG. 30F  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle extending and returning the ferrule and its suture to the ferrule compartment; 
         FIG. 30G  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle fully extended, the ferrule and its suture returned to the ferrule compartment and the ferrule latch engaged with the proximal face of the ferrule; 
         FIG. 30H  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle retracting and the ferrule latch retaining the ferrule in its ferrule compartment; 
         FIG. 30J  is a partial cross-sectional view of the distal tip of the fourth preferred embodiment of the tissue suturing instrument of  FIG. 1  showing the faceted needle fully retracted and awaiting the next cycle of firing of the instrument; 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The first preferred embodiment of this invention, suturing instrument  16 , is represented in  FIGS. 1–13R . Referring to  FIGS. 1–3 , show the suturing instrument  16 , which represents the S EW -R IGHT ® SR•5® manufactured by LSI  SOLUTIONS , Inc. (formerly LaserSurge, Inc.) of Victor, N.Y., that has been modified to provide a means for selectably stripping its ferrule  103  from the needle  34  at its tissue engaging end  16   a . The tissue engaging end  16   a  and needle  34  thereto may be similar to that shown in U.S. Pat. Nos. 5,431,666, 5,766,183, European Patent No. EP 0669101, filed Feb. 23, 1995 and granted Oct. 14, 1998, or U.S. patent application Publication No. US 2002/0107530 A1, filed Feb. 2, 2001, which are herein incorporated by reference. 
     The housing  30  has a body shaped like a pistol having a handle portion  30   a , and may be made of a two-piece construction of molded plastic. A needle  34  extends from housing  30  through the shaft  16   b  into the tissue engaging end  16   a . Needle  34  has a non-tissue engaging end  34   b  in the housing  30  having a spherical member  34   a , such as a ball or bearing, respectively, attached thereto. The needle  34  and spherical member  34   a  may be made of metal, such as surgical stainless steel. The spherical member  34   a  may have a bore into which the non-tissue engaging end  34   b  of the needle  34  extends and joins thereto, such as by welding or brazing. 
     The suturing instrument  16  includes an actuating member  36  representing a lever  36   a  having two pins  36   b  extending into holes  30   b  in the sides of housing  30  upon which the actuating member  36  is pivotally mounted in the housing  30 . Actuating member  36  has a portion which extends through a lever opening  30   c  ( FIG. 2 ) in housing  30  to enable pivotal movement about pins  36   b . An extension spring  38  is provided which hooks at one end in a notch  36   c  of actuating member  36  and is wound at the other end around a pin  40  located in holes  30   f  in the sides of housing  30 , such that the actuating member  36  is spring biased to retain actuating member  36  normally in a forward position, fully out, as shown for example in  FIG. 2 . The body of housing  30  has a front pivot stop  30   e  ( FIG. 3 ) providing a stop that limits the pivotal movement of the actuating member  36 . A notch  36   c  is provided in the actuating member  36  which is shaped to receive the non-engaging end of needle  34 , i.e., spherical member  34   a , to be driven forward by an operator pulling actuating member  36  to pivot actuating member  36  towards handle portion  30   a . The groove  36   d  ( FIG. 3 ) is provided by two fingers  36   e  into which the needle  34  near the spherical member  34   a  may lie. 
     As shown in  FIGS. 4B and 4C , a thumb slide holder  42  is fixed in housing  30  by two flanges  42   a  above actuating member  36 . As best shown in  FIG. 4A , the thumb slide holder  42  has a chamber  42   b  with a groove  42   d  formed by fingers  42   e  which allow the needle  34  to be received in chamber  42   b  to restrict movement of the needle  34  when held therein. The lower surface  42   f  of thumb slide holder  42  is curved and faces correspondingly curved upper surface  36   f  of actuating member  36 , such that the actuating member  36  is slidable along lower surface  42   f  responsive to the operator pulling the actuating member  36 . 
     The adapter  48  has a bore extending there through in which a needle spreader  50  is located. Needle spreader  50  has two channels  50   b  and  50   c  into which needle  34  and ferrule stripper  35  are respectively located to increase the distance between the needle  34  and the ferrule stripper  35  as they extend toward thumb slide holder  42 , such that the needle  34  and ferrule stripper  35  are properly aligned. 
     A suture routing tube  47  is provided for suture thread in housing  30 . Suture routing tube  47  has one end received in a valve assembly  19 , at the bottom of handle portion  30   a  of housing  30  and then extends through the suture routing tube notch  30   d  ( FIG. 3 ) along the interior of the left side of housing  30 , and a groove  50   a  along needle spreader  50  ( FIG. 3 ). The other end of the suture routing tube  47  is then mounted in suture routing tube hole  51   a  through gasket  51 . Gasket member  51  further has two holes  51   b  and  51   c  through which needle  34  and ferrule stripper  35 , respectively extend. The gasket  51  may be made of medical grade rubber, such as Santoprene. 
     A longitudinal guide member  53  is provided multiple tracks along its length, including two tracks  53   a  and  53   b  for needle  34  and ferrule stripper  35 , respectively, and a suture track  53   c  for suture  105  extending from opening  51   a  of gasket  51 . The guide member  53  may be made of extruded flexible material, such as Tecoflex®. A D-tube  52  is provided which is D-shaped at one end  52   a  is registered into a corresponding shaped opening in adapter  48 , and a threaded nut  54  having an opening which extends over D-tube  52 , screws onto the end of the adapter  48  to secure D-tube  52  to housing  30 . With the gasket  51  loaded first into D-tube  52 , guide member  53  extends from the gasket  51  through the D-tube  52 . In this manner, tracks  53   a ,  53   b , and  53   c  each form a channel with the interior surface of D-tube  52 . D-tube  52  may be made of stainless steel, or other rigid material, and has for example, D-tube  52  has an outside diameter of 0.203 inches. (Note for other applications, such as flexible endoscopy, this tube could be flexible.) Inside D-tube  52 , gasket  51  has a ring  51   d , which frictionally engages the interior surface of D-tube  52 . Hole  51   a  of the gasket  51  is of a diameter such that the suture tube  47  tightly fits therein and provides a seal around suture tube  47 . The suture tube  47  may be held in place in hole  51   a  by friction, but adhesive may also be used. Holes  51   b  and  51   c  are of a larger diameter than the needle  34 , except for a small section of holes  51   b  and  51   c  where the diameter reduces to form flaps of gasket material which seal around needle  34  and ferrule stripper  35 , respectively. This enables movement of the needle  34  and ferrule stripper  35  tube back and forth while maintaining a seal about the needle  34  and ferrule stripper  35 . One feature of the gasket  51  is that it enables sealing the shaft  16   b  as well. 
     The guide member  53  is received into the D-tube  52 , such that guide member  53  abuts gasket  51  and engages distal tip  98 . Distal tip  98  is attached to the D-tube  52  by mechanical fastening by forming small dents  52   c  in the metal of the D-tube  52  with a press into recessed four pockets  98   b  ( FIG. 3 ), i.e., two on each side of the distal tip  98 . 
     An optional valve assembly  19  can be provided at the bottom of handle portion  30   a , as shown in  FIG. 3 , having a valve seat  19   a  and a valve controller  19   b . Valve seat  19   a  is composed of medical grade rubber, such as Santoprene®, and has a through hole extending into an interior chamber. A valve controller  19   b  composed of molded plastic, or other rigid material, has a circular section through an opening and a surface forming a cam that can be turned to select a valve fully open to intermediate partially open to a fully closed position. The suture routing tube  47  is received in hole  76  of valve seat  19   a , as shown in  FIG. 3 , such that suture  105  material from the tube can pass through openings of the valve seat  19   a  and then through the valve controller  19   b . 
     Referring to  FIGS. 2 and 3 , the tissue engaging end  16   a  of the suturing instrument  16  is shown having the distal tip  98  which is mounted in a D-tube  52 , such that the front section  98   a  of the distal tip  98  extends from D-tube  52 . 
     Referring to  FIGS. 4A–4C , the thumb slide holder  42  is shown. The thumb slide holder  42  may be made of a one-piece construction of molded plastic. The thumb slide holder  42  is fixed in the housing  30  above the actuating member  36  by two opposing flanges  42   a , as best shown in  FIG. 4B . 
     As best represented in  FIG. 4A , the thumb slide holder  42  has a chamber  42   b  through which the positive stop  41  b of the timing tube  41   c  is located. One groove  42   d  formed by two fingers  42   e  allows the needle  34  ( FIG. 3 ) to pass through the thumb slide holder  42  through the groove  36   d  formed by the two fingers  36   e  of the actuating member  36  and enables the spherical member  34   a  to rest in the notch  36   c  of the actuating member  36 . The lower curved surface  42   f  extends over the curved upper surface  36   f  of the actuating member  36  to further retain the needle  34  and spherical member  34   a  in the notch  36   c  throughout the entire range of motion of the actuating member  36 . 
     The housing  42   g  of the thumb slide holder  42  is fashioned to accommodate and guide the thumb button  41   e  ( FIG. 3 ). The thumb button stop  42   k  serves as a motion-limiting surface to prevent the thumb button  41   e  from traveling farther than intended. The thumb slide holder  42  has a bore  42   c  for the timing tube  41   c  ( FIG. 3 ) is located. Contained within the housing  42   g  is a raised region  42   h  to enable alignment of the return spring  46  ( FIG. 3 ) and resting surface  42   j  which seats and retains the return spring  46 . 
       FIG. 4C  shows a perspective view of the thumb slide holder  42  and timing tube stop  42   l  which provides a positive engagement surface for the positive stop  41   b  to limit the advance of the timing tube  41   c . The thumb slide holder  42  may further have a channel  42   p  forward of the groove  42   d  to provide clearance for suture routing-tube  47  ( FIG. 3 ). The body of the thumb slide holder  42  has lock spring bores  42   n  and spring lock channels  42   m  to provide for the assembly, alignment, and retaining of the lock springs  45  and distal spring lock  43  and proximal spring lock  44 , respectively and best represented in  FIGS. 5A and 5B . 
       FIG. 5A  shows the push button assembly  41  interfacing with other components. The timing tube  41   c  is shown with the thumb button  41   e  attached thereto. Housed inside the thumb button  41   e  is the return spring  46  which serves as a return mechanism for the assembly. The ferrule stripper  35  is received into the distal opening  41  d and coupled to the timing tube  41   c  via an insert molding or adhesive process. The lock springs  45  are inserted into the thumb slide holder  42  and followed with the proximal spring lock  44  and the distal spring lock  43 . With the proximal spring lock  44  and the distal spring lock  43  inserted in the thumb slide holder  42  and compressed, the push button assembly  41  with attached ferrule stripper  35  is inserted into the thumb slide holder  42  such that the positive stop  41   b  passes into the chamber  42   b  and the proximal spring lock engages in the spring lock engagement slot  41   a . The ferrule stripper  35  continues through the adapter  48 . 
       FIG. 5B  shows a perspective view of the underside of assembled push button assembly  41 , thumb slide holder  42 , adapter  48 , nut  54 , and D-tube  52  and highlights the relative location of the proximal spring lock  44  and distal spring lock  43 . 
     Referring to  FIGS. 6A and 6B , the operation of the actuating member  36  and the needle  34  is described. As the actuating member  36  is engaged, rotating about the pins  36   b , the needle  34  and the attached spherical member  34   a  are advanced as the spherical member  34   a  is in contact with the notch  36   c  of the actuating member  36 . 
       FIGS. 7A and 7B  illustrate the operation of the push button assembly  41  and the ferrule stripper  35 . The actuating member  36  is engaged, rotating about the pins  36   b  until the flat engagement surface  36   g  comes into contact with and forces the proximal spring lock  44  out of the spring lock engagement slot  41   a  ( FIG. 5A ) allowing the forward motion of the push button assembly  41  and the coupled ferrule stripper  35 . This forward motion is limited primarily by the engagement of distal spring lock  43  with spring lock engagement slot  41   a  ( FIG. 5A ). Advancement of timing tube  41   c  is also limited by engaging the adapter  48 . 
       FIG. 8A  shows the assembly of the distal tip  98  and the ferrule retainer  99  with the D-tube  52 , the needle  34 , and the ferrule stripper  35 . The distal tip  98  has a gap  104  in a c-shaped jaw  104  having two openings  98 c at one side of the gap through which each needle  34  and ferrule stripper  35  may extend The needle  34  and the ferrule stripper  35  are received into the needle/stripper openings of the distal tip  98  and the distal tip  98  is then coupled to the D-tube  52  which may be achieved by mechanical fastening forming small dents in the metal of the D-tube  52  with a press into four recessed pockets  98 b, i.e., two on each side of the distal tip  98 . The ferrule retainer  99  is inserted into the ferrule retainer hole  98   e  until the ring  99   a  seats into the opening created where the ferrule retainer hole  98   e  intersects the ferrule pocket  107  as best shown in  FIG. 8B . The suture  105  attached to the ferrule  103  enters the ferrule compartment  107  through the open slot located on the side of the ferrule chamber opposite from the ferrule retainer  99 . 
       FIGS. 9A–13R  represent highlights of twelve sequential steps overviewing the loading, reloading and locking operations through one complete cycle of use of instrument  16 . For example, the first three steps presented in  FIGS. 9A–9M , illustrate the needle  34  first advancing into the ferrule  103 . 
       FIGS. 9A–9D  show the instrument loaded and ready for use, the first step.  FIG. 9A  shows a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed and both the thumb button  41   e  and the lever  36   a  are fully out; the proximal spring lock  44  engages the timing tube  41   c .  FIG. 9B  is a right perspective view of the distal tip  98  of the components of  FIG. 9A  showing the ferrule  103  in its ferrule compartment  107  and the jaw  104 .  FIG. 9C  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 9A  with the ferrule  103  in its ferrule compartment  107 , and the needle  34  and ferrule stripper  35  fully back.  FIG. 9D  is a side view of the proximal components of  FIG. 9A  showing the lever  36   a  and thumb button  41  fully out. Proximal spring lock  44  is shown engaging spring lock engagement slot  41   a  of timing tube  41   c.    
       FIGS. 9E–9H  show partial advancement of the needle  34  as part of the second step.  FIG. 9E  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with its thumb slide holder  42  removed, the lever  36   a  partially retracted and the thumb button  41   e  fully out.  FIG. 9F  is a right perspective view of the distal tip  98  of the components of  FIG. 9E  with the needle  34  partially advanced and the ferrule  103  in its ferrule compartment  107 .  FIG. 9G  is the partial cross-sectional view of the distal tip  98  of the components of  FIG. 9E  showing the ferrule  103  in its ferrule compartment  107 , the needle  34  partially advanced and the stripper  35  fully back.  FIG. 9H  is a side view of the proximal components of  FIG. 9E  showing the lever  36   a  partially retracted and the thumb button  41   e  fully out. 
       FIGS. 9J–9M  show the needle  34  fully advanced and engaged inside of the ferrule  103  as part of the third step.  FIG. 9J  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a  fully retracted and the thumb button  41   e  fully out.  FIG. 9K  is a right perspective view of the distal tip  98  of the components of  FIG. 9J  showing the needle  34  fully advanced to engage the ferrule  103  in its ferrule compartment  107 ; best shown in  FIG. 9L .  FIG. 9L  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 9J  with the needle  34  engaging the ferrule  103  in its ferrule compartment  107  and the ferrule stripper  35  fully back.  FIG. 9M  is a side view of the proximal components of  FIG. 9J  showing the lever  36   a  fully retracted and the thumb button  41   e  fully out. Note that the flat engagement surface  36   g  is shown raising the proximal spring lock  44  out of the spring lock engagement slot  41   a.    
     The next two steps presented in  FIGS. 10A–10H , illustrate the needle  34 , now attached to the ferrule  103  and its suture  105 , being retracted fully back.  FIGS. 10A–10D  show the needle  34  pulling its ferrule  103  back through jaw  104 .  FIG. 10A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, with the thumb button  41   e  fully out, the lever  36   a  partially forward and the needle  34  attached to the ferrule  103  and suture  105  partially back.  FIG. 10B  is a right perspective view of the distal tip  98  of the components of  FIG. 10A  showing the needle  34  attached to the ferrule  103  with suture  105  partially retracted.  FIG. 10C  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 10A  showing the needle  34  attached to the ferrule  103  and suture  105  partially retracted and the ferrule stripper  35  fully back.  FIG. 10D  is a side view of the proximal components of  FIG. 10A  showing the lever  36   a  partially back and the thumb button  41   e  fully out; 
       FIGS. 10E–10H  show this instrument  16  with the ferrule  103  and its suture  105  attached to the fully retracted needle  34 .  FIG. 10E  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a  fully out and the thumb button  41   e  fully out.  FIG. 10F  is a right perspective view of the distal tip  98  of the components of  FIG. 10E  showing the suture  105  fully retracted and the ferrule stripper  35  fully back.  FIG. 10G  is a perspective side view of the distal tip  98  of the components of  FIG. 10E  showing the needle  34  attached to the ferrule  103  and suture  105  fully retracted and the ferrule stripper  35  fully back.  FIG. 10H  is a side view of the proximal components of  FIG. 10E  showing the lever  36   a  fully out and the thumb button  41   e  fully out. 
       FIGS. 11A–11J  show the next two steps representing reinsertion of the ferrule  103  into it ferrule compartment  107 .  FIGS. 11A–11E  show the partial advancement of the needle  34  with its attached ferrule  103  and suture  105 .  FIG. 11A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a  partially retracted, the needle  34  with its ferrule  103  and suture  105  partially advanced and the thumb button  41   e  fully out.  FIG. 11B  is a right perspective view of the distal tip  98  of the components of  FIG. 11A  showing the needle  34  attached to the ferrule  103  and the suture  105  partially advanced.  FIG. 11C  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 11A  showing the needle  34  attached to the ferrule  103  and the suture  105  partially advanced and the ferrule stripper  35  fully back.  FIG. 11D  is a side view of the proximal components of  FIG. 11A  showing the lever  36   a  partially retracted and the thumb button  41   e  fully out. 
       FIGS. 11E–11J  show the needle  34  fully advanced attached to the ferrule  103  and its suture  105 . Note that at this step of the operation,  FIG. 11J  is provided to show an enlarged view of the distal spring lock  43  and proximal spring lock  44 .  FIG. 11E  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed and the lever  36   a  fully retracted and the thumb button  41   e  fully out.  FIG. 11F  is a right perspective view of the distal tip  98  of the components of  FIG. 11E  with the needle  34  fully advanced into the ferrule  103 .  FIG. 11  G is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 11E  showing the needle  34  along with its attached ferrule  103  and suture  105  fully advanced into its ferrule compartment  107 .  FIG. 11H  is a side view of the proximal components of  FIG.11E  showing the lever  36   a  fully retracted and the thumb button  41   e  fully out.  FIG. 11J  is a close-up side view of the lock features of the components of  FIG. 11H  showing the flat engagement surface  36   g  of the actuating member  36  raising the proximal spring lock  44  to disengage it from the spring lock engagement slot  41   a  of the timing tube  41   c.    
       FIGS. 12A–12K  illustrate the next two steps to complete advancement of the ferrule stripper  35 .  FIGS. 12A–12E  show the advancing of the push button assembly  41  to partially advance towards stripping the ferrule  103  from the fully advanced needle  34 .  FIG. 12A  is a right partial view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a  fully retracted, the needle  34  with its attached ferrule  103  and suture fully advanced and the thumb button  41   e  partially advancing the ferrule stripper  35 .  FIG. 12B  is a right perspective view of the distal tip  98  of the components of  FIG. 12A  showing the needle  34  with its ferrule  103  and suture  105  fully advanced into its ferrule compartment  107  and the ferrule stripper  35  partially advanced.  FIG. 12C  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 12A  showing the needle  34  attached to the ferrule  103  and suture  105  fully advanced and the ferrule stripper  35  partially advanced. 
       FIG. 12D  is a side view of the proximal components of  FIG. 12A  showing the lever  36   a  fully retracted and the thumb button  41   e  and its attached timing tube  41   c  partially forward.  FIG. 12E  is a close-up side view of the lock features of the components of  FIG. 12D  showing the flat engagement surface  36   g  raising the proximal spring lock  44  out of the spring lock engagement slot  41   a  and the timing tube  41   c  partially forward. 
       FIGS. 12F–12K  show the full advancement of both the needle  34  and ferrule stripper  35 .  FIG. 12F  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a  fully retracted, the needle  34  with its attached ferrule  103  and suture  105  fully advanced, and the thumb button  41   e  advancing its ferrule stripper  35  fully forward.  FIG. 12G  is a right perspective view of the distal end of the components of  FIG. 12F  showing the needle  34  with its ferrule  103  and suture  105  fully advanced and the ferrule stripper  35  fully advanced and engaging the proximal edge of the ferrule  103 , as best shown in  FIG. 12H .  FIG. 12H  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 12F  showing the needle  34  attached to the ferrule  103  and the suture  105  and the ferrule stripper  35  fully advanced and flexed onto the needle  34  to engage the proximal edge of the ferrule  103 .  FIG. 12J  is the side view of the proximal components of  FIG. 12F  showing both the lever  36   a  and the thumb button  41   e  fully forward.  FIG. 12K  is a close-up side view of the lock features of  FIG. 12J  showing the actuating member  36  raising the proximal spring lock  44 , allowing the distal spring lock  43  to engage the spring lock engagement slot  41   a  in the timing tube  41   c . Note a relief  36   j  in the top of the actuating member  36  allows the distal spring lock  43  to travel downward and engage the spring lock engagement slot  41   a.    
     The last three steps,  FIGS.13A–13R , illustrate the complete retraction of both the needle  34  and ferrule stripper  35 .  FIGS. 13A–13E  show the lever  36   a  partially forward to retract the needle  34  to strip the ferrule.  103  by engaging ferrule  103  with the fully advanced ferrule stripper  35 .  FIG. 13A  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a  partially released, the needle  34  partially retracted, the ferrule stripper  35  engaging the ferrule  103  in its ferrule compartment  107  and the thumb button  41   e  fully forward. 
       FIG. 13B  is a right perspective view of the distal tip  98  of the components of  FIG. 13A  showing the needle  34  partially retracted from its ferrule  103  (not visible in this view) and the ferrule stripper  35  fully forward.  FIG. 13C  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 13A  showing the needle  34  partially retracted and the ferrule stripper  35  fully forward engaging the ferrule  103  in its ferrule compartment  107 .  FIG. 13D  is a side view of the proximal components of  FIG. 13A  showing the lever  36   a  partially out and the thumb button  41   e  fully forward.  FIG. 13E  is a close-up side view of the lock features of  FIG. 13D  showing the convex engagement surface  36   h  of the actuating member  36  ( FIG. 13D ) raising the distal spring lock  43  to disengage the spring lock engagement slot  41   a  of the timing tube  41   c.    
       FIGS. 13F–13K  show both the needle  34  and ferrule stripper  35  partially returning with the ferrule  103  replaced back into its ferrule compartment  107 .  FIG. 13F  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a , needle  34 , thumb button  41   e  and ferrule stripper  35  partially back.  FIG. 13G  is a right perspective view of the distal tip  98  of the components of  FIG. 13F  with the needle  34  and ferrule stripper  35  partially retracted and the ferrule  103  back into its ferrule compartment  107 .  FIG. 13H  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 13F  showing the needle  34  and the ferrule stripper  35  partially back and the ferrule  103  and suture  105  in the ferrule compartment  107 .  FIG. 13J  is a side view of the proximal components of  FIG. 13F  showing the lever  36   a  and the thumb button  41   e  partially back.  FIG. 13K  is a close-up side view of the lock features of  FIG. 13F  showing the engaging surfaces  36   f – 36   h  of the actuating member  36  not raising the proximal spring lock  44  or the distal spring lock  43  with the spring lock engagement slot  41   a  released. 
       FIGS. 13L–13R  show the instrument reloaded, ready for use and are identical to  FIGS. 9A–9D , respectively, while  FIG. 13R  highlights re-engagement of the proximal spring lock  44  with the spring lock engagement slot  41   a .  FIG. 13L  is a right perspective view of the drive mechanism of the instrument of  FIG. 3  with the thumb slide holder  42  removed, the lever  36   a , needle  34 , thumb button  41   e  and ferrule stripper  35  fully back and the ferrule  103  and suture  107  reloaded into the ferrule compartment  107 .  FIG. 13M  is a perspective view of the distal tip  98  of the components of  FIG. 13L  showing the needle  34  and ferrule stripper  35  fully retracted and the ferrule  103  and suture  107  in the ferrule compartment  107 .  FIG. 13N  is a partial cross-sectional view of the distal tip  98  of the components of  FIG. 13L  showing the needle  34  and ferrule stripper  35  fully back and the ferrule  103  and suture  107  in the ferrule compartment.  FIG. 13P  is a side view of the proximal components of  FIG. 13L  showing the lever  36   a  and the thumb button  41   e  fully back.  FIG. 13R  is a close-up side view of the lock features of  FIG. 13L  showing the proximal spring lock  44  engaging the spring lock engagement slot  41   a  of the timing tube  41   c.    
     Now referencing  FIGS. 14A–17D , showing the multiple placement of sutures to form a wound closure.  FIGS. 14A–14E  illustrate the use of this instrument for the placement of the first suture of a wound closure and the readiment of the instrument for subsequent bites.  FIG. 14A  shows the distal tip  98  of the instrument  16  above a wound closure  110 . Note the distal side of the wound closure  110  has crosshatching for purposes of this illustration.  FIG. 14B  shows the device  16  with the needle  34  passing through the first bite  124  of the distal side of the wound  110 .  FIG. 14C  shows the needle  34  retracted back with its ferrule  103  and suture  105  pulled through the wound  110 .  FIG. 14D  shows the needle  34  now advanced through to place the ferrule  103  back into its ferrule compartment  107 .  FIG. 14E  shows the needle  34  back after having its ferrule  103  stripped. The instrument is now ready for another bite. 
     Now referencing  FIGS. 15A–15E , the device  16  is again placed into the wound  110  this time with the proximal side of the wound  110  in the instrument&#39;s jaw  104 . The needle  34  will enter the tissue  120  as shown in  FIG. 15A , traverse the tissue  120  and enter the ferrule compartment  107  as shown in  FIG. 15B .  FIG. 15C  illustrates the needle  34 , ferrule  103  and suture  107  pulled back leaving suture  105  through the first bite  126  on the proximal side of the wound closure  110 .  FIG. 15D  shows the needle  34  advanced yet again.  FIG. 15E  shows the ferrule  103  back in its ferrule compartment  107 . 
       FIG. 16A–16D  shows the second suture placement on the distal side of the wound  110 .  FIG. 16A  shows the needle  34  traversing the second site  127  on the distal wound  110  aspect.  FIG. 16B  shows the suture  105  through the second bite  127  on the distal side of the wound  110 .  FIG. 16C  shows the needle  34 , ferrule  103  and suture  105  advanced to the ferrule pocket.  FIG.16D  shows the instrument again ready for the bite. 
       FIG. 17A–17D  show the second bite  128  on the proximal side of the wound closure  110 .  FIG. 17A  shows the needle  34  going through the second site  128  of the proximal side of the wound closure  110 .  FIG. 17B  shows the needle  34 , ferrule  103  and suture  105  advanced back into its ferrule compartment  107 .  FIG.17C  shows the instrument with the ferrule  103  reloaded and the needle  34  and ferrule stripper  35  retracted back.  FIG.17D  illustrates the appearance of the wound closure  110 . If the sutures  105  were to be tied at this time, this type of closure is commonly called a figure of eight suture closure. If the process were to continue with further placements of suture  105  running along the distal and proximal aspects of the wound closure, this type of closure is typically be called a running suture wound closure. 
     Now referencing  FIGS. 18A–21 ,  FIG. 18A  shows the instrument  16  of this invention with the distal tail of the suture  105  exposed and the distal tip  98  of the instrument  16  ready for knot tying.  FIGS. 18A–19B  show the first throw of the knot tying process.  FIGS. 19C–19F  show the second throw of the knot tying process.  FIGS. 21 and 22  show the cinching down of the knot. In  FIG. 18B , a surgical grasper  129 , is used to grab the free end of the suture  105  and to wrap the suture  105  around the jaw  104  of the instrument  16 . Note that to construct the unique knot of this invention, which we have named the “Super Surgeon&#39;s knot,” the first wrapping of suture  105  around the jaw  104  consists of two complete loops wrapped around the jaw  104 .  FIG. 18C  shows the advancement of the needle  34 , ferrule  103  and suture  105  back into its ferrule compartment  107 , best shown in  FIG. 18A , after the double wrap has been placed around the jaw  104  of the instrument  16 .  FIG. 18D  shows the now stripped ferrule  103  in its ferrule compartment  107 .  FIG. 18E  shows the knot forming double loops being slid down towards the wound closure site  110 .  FIG. 19A  shows the grasper  129  further cinching the knot down to the wound closure site  110 .  FIG. 19B  shows the suture  105  now fully retracted back on its needle  34  to further expose the jaw  104  of the knot tying instrument  16 .  FIG. 19C  shows a second wrapping of a single loop placed around the distal tip  98  of the instrument  16  to secure the knot.  FIG. 19D  shows the needle  34  again advanced to replace the ferrule  103  in its ferrule compartment  107  along with the suture  105 .  FIG. 19E  shows the ferrule  103  in its ferrule compartment  107  with the needle  34  and ferrule stripper  35  now back.  FIG. 19F  shows the second throw, a single loop throw, of the Super Surgeon&#39;s knot being slid over the ferrule  103  and suture  105  down towards the wound closure  110 .  FIG. 20D  illustrates that by pulling on the surgical grasper  129  on the free end of the suture  105 , the suture loops are further slid towards and down onto the wound closure  110  to begin to pull (also called approximate or appose) the edges of the wound  110  together, but not fully locking the knot in place.  FIG. 21  shows by pulling on the surgical grasper  129  holding the free end of the suture  105 , and now by simultaneously pulling on instrument  16  holding the ferrule  103  end of the suture  105 , both ends of the suture  105  are drawn tight, thereby locking the Super Surgeon&#39;s knot in place. The distinct advantage of the Super Surgeon&#39;s knot is that it permits the user to place the knot above the wound closure and appropriately appose the wound edge by pulling only on the free end of the suture, and then, once the correct tissue apposition is achieved, the user can pull on the ferrule end of the suture to lock the knot down. Locking down the Super Surgeon&#39;s knot alone provides adequate holding force, at least temporarily, to hold together many types of wound closures. For example, a Super Surgeon&#39;s knot made with 2-0 STRONGSORB® suture by LSI  SOLUTIONS , Inc., achieves an average tissue holding strengths of approximately 0.5 kg knot holding force to temporarily secure and tissue edges together. Subsequent throws on top of the Super Surgeon&#39;s knot will add additional knot holding force up to the native strength of the suture (e.g., with 2-0 STRONGSORB®, up to 5 to 6 kg tensile pull). No other knot is known (to the inventors) that can be constructed under such surgically relevant conditions and provides excellent tissue holding force immediately when the first throws are drawn together by pulling on both ends of the suture. 
       FIGS. 22A–22C  illustrate an alternate method of securing the free ends of the suture  105  left by the instrument  16 , used to close the wound  110  in the tissue  120 .  FIG. 22A  represents an instrument  130 , which crimps a sleeve member  121  to secure suture  105  together and is commercially available as a Ti-K NOT ® TK·5®. Device manufactured by LSI  SOLUTIONS , Inc., under at least the following patents U.S. Pat. Nos. 5,520,702; 5,643,289 and 5,669,917. The free ends of the suture  105  are passed through the instrument  130  and the instrument  130  is passed closer to the wound closure  110 .  FIG. 22B  illustrates the instrument  130  being applied directly to the wound closure  110  and both free ends of the suture  105  drawn tight, removing any slack and drawing the opposing sides of the wound closure  110  closer together.  FIG. 22C  shows the sleeve member  121  crimped around the suture  105  at the wound closure  110 . Note that the suture  105  has been trimmed. 
     After using instrument  16  to place suture  105  for running a wound closure  110 , one or both ends of the suture  105  may remain unsecured. These free ends of the suture  105  can be attached to pledgets or bolsters  122   a  and  122   b  to prevent their ability to be pulled into or away from the wound site  110 . A pledget is typically a pliable, non-reactive piece of material, such as polyester mesh, Gortex®, or the like, that is often used in conjunction with sutures or staples to augment wound closures. In this invention, a bolster  122   a  is attached (e.g., by tying or sewing) to one end of an additional segment of suture  123   a . By placing the free end of this bolstered suture  123   a , along with one free end of the suture  105 , the bolster  122   a  and its attached suture  123   a  can be passed down using suture  105  as a guide. Bolster  122   a , suture  123   a  and one end of suture  105  can be secured at one end of the wound site  110  with a sleeve member  121 . The bolster  122   a  can hold this end of the running suture  105  from being pulled into the wound  110 . By repeating a similar bolstered suture  123   b  placement at the opposite end of the wound  110 , the second bolster  122   b  and its suture  123   b  can hold the second suture  105  end from being pulled into the wound  110 . Bolsters  122   a  and  122   b  secured at each end of the wound  110 , prevent the suture  105  from being pulled out of the wound  110  from either direction. 
       FIGS. 24A–24C  illustrate a second preferred embodiment of this invention. The main difference between this embodiment and the first preferred embodiment, is that instead of stripping the ferrule  103  with the ferrule stripper  35  traversing the gap and engaging the ferrule  103 , the member that directly contacts the ferrule  103  for ferrule stripping is incorporated in the distal tip  98 . The thumb button  41   e  drive mechanism for this embodiment can be the same as in the first preferred embodiment.  FIG. 24A  shows a perspective of the distal jaw, which looks similar to the first embodiment, except instead of a slope to direct the stripper wedge  131  towards the ferrule, the stripper wedge  131  enters a chamber  141  and subsequently wedges member  133  against ferrule  103  to permit removal of the needle  34 .  FIG. 24B  shows needle  34  engaging ferrule  103  in ferrule compartment  107  with the stripper wedge  131  traveling toward chamber  141 .  FIG. 24C  shows the ferrule  103  held in its ferrule compartment  107  by stripper wedge  131  forcing over member  133 . Needle  34  can now be extracted from ferrule  103 . Stripper wedge  131  can be subsequently withdrawn leaving the ferrule  103  in it reloaded position. 
       FIGS. 25A–25C  illustrate a third preferred embodiment of this invention. In this embodiment, unlike the prior two, the ferrule stripping element does not traverse the gap in the distal tip  98 . Rather, in this embodiment, the stripper wedge  131 , which can be a semi-flexible material, such as memory metal, Nitinol, or the like, passes through a channel in the bridge that traverses behind the gap in the jaw. This ferrule stripping embodiment can also be advanced towards the ferrule using a mechanism similar to the already described thumb slide mechanism  41  ( FIG. 3 ).  FIG. 25A  shows needle  34  after being retracted back and stripped off ferrule  103  held in its ferrule compartment  107  by the flexible integrated stripper  135 .  FIG. 25B  is a partial sectional view of needle  34  engaging ferrule  103  in its ferrule compartment  107 . The flexible integrated stripper  135  is shown retracted into the bridge channel  134  to permit the needle  34  to pull the ferrule  103  out of its ferrule compartment  107 .  FIG. 25C  illustrates a partially retracted needle after its ferrule  103  is stripped by the flexible integrated stripper  135 . 
       FIGS. 26–30J  describe a fourth preferred embodiment of this invention. Unlike the previous three embodiments, this fourth version does not require an additional manual mechanism, like the thumb slide mechanism, to enable ferrule stripping. Instead of pushing a button to activate a stripper, this instrument is more automated to enable stripping the ferrule  103  imply squeezing the lever  36   a  a second time. 
       FIG. 26  shows this instrument in a perspective view illustrating window  136  in the right handle half; a comparable window (not shown) is located in the opposite location on the left handle half. These windows permit an instrument user to view from either handle an asymmetric rotating disc  138   a  that indicates whether the cam needle  139  is in the stripper or non-stripper orientation. Also, note rod  137  mounts into the right handle half to engage the slots in the rotating cam  138 . When lever  36   a  rotates back, cam  138  drives forward, lifts towards the mid stroke, then lowers and rotates about rod  137 , as seen in  FIGS. 27A–27C . 
       FIG. 27A  shows the rod  137  engaging the distal slot in cam  138 . The rotating indicator disc  138   a  is vertically oriented indicating a non-faceted edge of the cam needle  139  faces the ferrule latch  140  ( FIG. 27A ; also see  FIGS. 28–31J ). Release of the lever  36   a  permits the cam needle  139  and its rotational cam  138  to travel back and elevates slightly at mid stroke, where rod  137  enters an obliquely oriented slot, to begin rotating the rotational cam  138  and its attached cam needle  139  ( FIG. 27E ). By completion of the lever  36   a , the full rotation of the rotational cam  138  ( FIG. 27A ), the needle facet  139   b  ( FIG. 27F ) is now oriented towards the ferrule latch  140 , which permits ferrule stripping. 
       FIG. 28  shows the partially retracted cam needle  139  having its ferrule  103  held by ferrule latch  140 . Note this illustration shows a pocket  142  recessed in the distal tip  98  for holding the ferrule latch  140 . 
       FIG. 29A  shows cam needle  139  oriented with a non-faceted shoulder  139   c  engaging and lifting the ferrule engaging surface  140   g  of the ferrule latch  140 . The ferrule  103  is not held by the ferrule latch  140 , because the ferrule  103  latch  140  is compressed by the non-faceted shoulder  139   c  pushing against timing surface  140   b . The ferrule  103  is able to be pulled from its ferrule compartment  107  by cam needle  139 .  FIG. 29B  shows the distal end of the fourth preferred embodiment with cam needle  139  retracting back through the gap and the ferrule latch  140  engaging into the proximal edge of ferrule  103 .  FIG. 29B  highlights cam needle  139  oriented to have a facet  139   b  towards the ferrule latch  140 , to not engage timing surface  140   b  so that the ferrule engagement surface  140   g  contacts the proximal edge of ferrule  103 . Surfaces  140   f  and  140   e  provide contacts to help maintain latch placement in its pocket  142 . 
       FIGS. 30A–30J  show one complete cycle of the cam needle  139  traversing the jaw  104 , picking up a ferrule  103 , the ferrule  103  being returned to its ferrule compartment  107  and the ferrule  103  being stripped by the ferrule latch  140 . This cycle reloads the ferrule  103  for another stitch placement.  FIG. 30  shows the retracted cam needle  139  oriented with a non-faceted shoulder  139   c  facing the ferrule latch  140 , which secures the ferrule  103  with its suture  105  in its ferrule compartment  107  in the distal tip  98 .  FIG. 30B  shows cam needle  139  fully advanced into ferrule  103 , with its non-faceted shoulder  139   c  compressing ferrule latch  140 .  FIG. 30C  shows cam needle  139  pulling ferrule  107  and suture  105  back beyond the compressed ferrule latch  140 . At approximately the midpoint of the cam needle  139  retraction, cam needle  139  begins its rotation with ferrule  103  and suture  105  rotating with cam needle  139 .  FIG. 30E  shows cam needle  139  along with its ferrule  103  and suture  105  fully retracted back with its  900  rotation completed.  FIG. 30F  shows cam needle  139 , ferrule  103  and suture  105  advancing back into ferrule compartment  107 . A faceted shoulder  139   a  of cam needle  139  now faces the ferrule latch  140 .  FIG. 30G  shows the cam needle  139 , ferrule  103  and suture  105  fully placed back into its ferrule compartment  107 . The faceted shoulder  139   a  of cam needle  139  does not cause ferrule latch  140  to compress up or deflect away from the proximal edge of ferrule  103 .  FIG. 30H  shows the retraction of ferrule  103  stopped by ferrule latch  140 , stripping ferrule  103  from its partially retracted cam needle  139 .  FIG. 30J  shows the cam needle  139  now fully retracted back and rotated back 180° so that the opposite side of the non-faceted shoulder  139   c  is oriented towards the ferrule latch. The ferrule  103  is reloaded back into its ferrule compartment  107  and cam needle  139  is ready to advance through more tissue  120 , picking up ferrule  103  and pulling it along with its suture  105  back through another bite of tissue  120 .

Technology Classification (CPC): 1