Abstract:
A suturing device includes a housing; a helical needle rotatably mounted relative to the housing; and a drive assembly for rotating the needle relative to the housing whereby the helical needle carries a suture through tissue to be sutured. The needle rotates relative to the housing in an axially fixed position and carries a suture for rapid and reliable deployment to close a wound or incision.

Description:
REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims benefit of provisional application Ser. No. 60/663,661 filed Mar. 21, 2005. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     The invention relates to suturing and more specifically to a suturing device which can be used to safely and securely suture both open procedures and vascular procedures.  
         [0003]     Various approaches are used to suture such procedures. Manual approaches are time intensive and the time taken to close a wound or incision is of course critical.  
         [0004]     Mechanical approaches to suturing are not as reliable as would be desired and are also potentially limited in their environments of use.  
         [0005]     It is the primary object of the invention to provide a suturing device which is both fast and reliable so that wounds and incisions can be rapidly and securely sutured.  
         [0006]     Other objects and advantages of the invention will appear below.  
       SUMMARY OF THE INVENTION  
       [0007]     According to the invention, the foregoing objects and advantages have been attained.  
         [0008]     The invention relates to a suturing device having a helical or coiled needle and a drive system which drives the coiled needle with an attached suture. The coiled needle is driven by two shafts positioned on the outside of the coil which have grooves cut into them at the same helix as the needle but in a counter direction. Inside the coil is a partial shaft (half round) that forces or holds the needle in position against and engaged with the outside rollers. The rollers have a roughened or serrated surface as does the outside of the coil. The inside of the coil is smooth as is the needle contact surface of the half round arbor. The friction between the outside of the coil of the needle and the grooves in the driving rollers power the needle rotation. The needle does not advance or retract, but simply rotates in place and positions the suture as desired.  
         [0009]     The device can be used with large needles for open procedures as well as with relatively small needles for vascular suturing where the entire device can be deployed through an artery, for example to repair a heart valve where the only invasion would be through an artery in the groin area. Of course, this is an example only and other uses exist well within the scope of the present invention.  
         [0010]     Thus, according to the invention, a suturing device is provided which comprises a housing; a helical needle rotatably mounted relative to the housing; and a drive assembly for rotating the needle relative to the housing whereby the helical needle carries a suture through tissue to be sutured. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0011]     A detailed description of the present invention follows with reference to the attached drawings wherein:  
         [0012]      FIG. 1  is a perspective view of a suturing device according to the invention;  
         [0013]      FIG. 2  is a further perspective view of the apparatus of  FIG. 1  with the housing removed to illustrate internal components;  
         [0014]      FIG. 3  is a further perspective view of an apparatus according to the invention;  
         [0015]      FIG. 4  is a perspective view of a portion of the housing of the embodiment of  FIG. 3 ;  
         [0016]      FIG. 5  is a perspective view of a portion of the housing of the embodiment of  FIG. 3 ;  
         [0017]      FIG. 6  is a perspective view of a portion of the housing of the embodiment of  FIG. 3 ;  
         [0018]      FIG. 7  illustrates a helical needle according to the invention;  
         [0019]      FIG. 8  illustrates a drive member for an apparatus according to the invention;  
         [0020]      FIG. 9  illustrates a drive shaft according to the invention;  
         [0021]      FIG. 10  illustrates an alternate embodiment of the invention wherein the needle has a sharp tip which faces proximally on the device; and  
         [0022]      FIG. 11  illustrates an alternate housing component which is preferred for the embodiment of  FIG. 10 . 
     
    
     DETAILED DESCRIPTION  
       [0023]     The invention relates to a suturing device and, more particularly, to a device which can be used to deploy sutures in a wide variety of locations and in a rapid and secure manner.  
         [0024]     Referring to the drawings,  FIGS. 1 and 2  illustrate one embodiment of a suturing device  10  according to the invention having a helical or coiled needle  12  and a drive system which drives the coiled needle with an attached suture. A housing  11  of device  10  is illustrated in  FIG. 1  and removed in  FIG. 2  to show internal structure and components. In this description, ends of the device will be referred to as proximal and distal. As used herein, distal refers to a direction toward the end of device  10 , while proximal refers to a direction away from the end of device  10 , back along housing  11  and drive member  30 .  
         [0025]     The coiled needle  12  is in this embodiment driven by two shafts  14  positioned on the outside of the coil which have grooves  16  cut into them at the same helix as the needle but in a counter direction of course, a single shaft or more than two shafts could also be used within the broad scope of the present invention. A drive member  30  discussed further below is engaged with shafts  14  and, as shown by arrows in  FIG. 2 , can be rotated to result in rotation of shafts  14 . Rotation of shafts  14  results in rotation of needle  12  as desired.  
         [0026]     Inside the coil is preferably a partial shaft  18  which is also referred to herein as an arbor. Arbor  18  is preferably partial-round, for example half-round, in shape and holds the needle in position against and engaged with the outside shafts  14 . The shafts  14  preferably have a roughened or serrated surface, as does the outside of the coil  12 , at contact points between same whereby friction between the surfaces is increased so as to assist the shafts  14  in driving helical needle  12  as desired.  
         [0027]     The inside of helical needle  12  is preferably smooth as is the needle contact surface or radially outwardly facing surface of the half round arbor or half round shaft  18 . Shaft  18  with a smooth or frictionally reduced surface advantageously defines a needle guiding surface which serves to hold needle  12  in place during operation of the device to position a suture as desired. The friction between the outside of the coil of the needle  12  and the grooves in the driving shafts  14  power rotation of the needle when shafts  14  are rotated.  
         [0028]     Coiled needle  12  does not advance or retract relative to housing  11  of the device, but simply rotates in place and positions the suture through tissue as desired. Movement of device  10  along the wound or incision allows needle  12  to place the desired suture through both sides of the incision or suture such that, when needle passes beyond the end of the incision or wound, needle can be advanced out of the tissue leaving the desired suture behind.  
         [0029]     As shown in the drawings, needle  12 , shafts  14  and half round shaft  18  can be positioned within housing  11  and any suitable drive mechanism can be used to impart rotation to shafts  14  as desired. It should be readily apparent that device  10  according to the invention can be used in a wide range of surgical procedures.  
         [0030]     In use, a suture can be provided with a T end which can be used for anchoring the suture in tissue. Alternatively, if there is no T end for anchoring, then a multitude of loops can be used to anchor the suture into the tissue.  
         [0031]     Device  10  is used to pierce the tissue with 2 or 3 loops and to pull the T end until it anchors. This procedure can be repeated first to lock the sutures in place and then to further secure the suturing as desired.  
         [0032]     If sutures are to be used which have no T end, a plurality of loops can first be made to lock the initial suture into the tissue. Device  10  can then be used to form a loop where desired and make a running stitch as needed. Following this, the suture can be tightened so as to complete the suturing.  
         [0033]     As with the first case, additional loops can be formed over the initial loops to lock the suture in place, at which time remaining suture can be cut away and the procedure is complete.  
         [0034]     It should be appreciated that the suture can be attached to either the proximal or distal end of the needle, and both embodiments are illustrated and described further herein. Further, the drive structure can be reversed, with the driver positioned inside the coil and smooth rollers on the outside, which would be considered well within the scope of the present invention.  
         [0035]      FIG. 3  further illustrates the embodiment of the present invention as illustrated in  FIGS. 1 and 2 , wherein device  10  has a housing  11  rotatably supporting a helical needle  12  as discussed above. Needle  12  is preferably rotatable relative to housing  11  while being held against axial displacement relative to housing  11 . Separate components of device  10  are discussed below and separately illustrated in  FIGS. 4-9 .  
         [0036]      FIG. 4  separately illustrates a housing body  13  according to the invention. Body  13  has an internal passage for accommodating a drive member as will be discussed further below, and also preferably defines rotation chambers  15  for rotatably receiving shafts  14 . Body  13  preferably has a rounded proximal end as shown to facilitate use in laparoscopic procedures and the like. As shown, rotation chambers  15  are advantageously substantially parallel to each other and spaced around a circumference of helical needle  12  so as to support and stabilize helical needle  12  through shafts  14 .  
         [0037]      FIG. 5  illustrates an end cap member  17  which can be included in housing  11  according to the invention. End cap member  17  advantageously cooperates with body  13  to complete rotation chambers  15  and also can define half round shaft or arbor  18  as discussed above to provide a desired needle support surface. End cap member  17  preferably further has an end plate  19  which can be sized to smoothly cover the end of body  13  as shown for example in  FIG. 3 .  
         [0038]     Proximally extending structures  20  can be positioned on end cap member  17  as shown in  FIG. 5 , and structures  20  can be sized to extend into rotation chambers  15  so as to rigidly mount end cap member  17  relative to body  13  as desired.  
         [0039]      FIG. 6  shows a hub  22  which can also form a part of housing  11  according to the invention. As shown, hub  22  is advantageously a substantially ring shaped member and defines outward partial-round surfaces  24  which form a portion of rotation chamber  15  for shafts  14  as discussed above. Hub  22  also preferably is sized to fit circumferentially within housing  11 . Further, hub  22  can be provided with a sloped distally facing sloped surface  26  which is positioned to coincide with a similarly sloped surface of housing  11 , in this case defined on body  13 . These surfaces coincide and are preferably positioned proximal of helical needle  12  such that there is a smooth transition from the zone of needle  12  to an outside zone of housing  11 . According to this embodiment of the invention, hub  22  is a separate piece from body  13 . Alternatively, these pieces of housing  11  can be formed as a single part if desired.  
         [0040]      FIG. 7  illustrates a needle  12  according to the invention, which can be a simple helical structure having a sharp tip  28  at one end. Needle  12  can be used to carry a suture in a manner known to a person skilled in the art so that the suture is positioned as desired relative to a wound and/or surgical incision when needle  12  is passed through both sides of the wound or incision while carrying the suture. Subsequent rotation of needle  12  relative to housing  11  brings the suture with it and thereby closes the wound or incision as desired, and the procedure is complete when the apparatus has traversed the entire length of the wound or incision.  
         [0041]     It should be appreciated that various shape tips can be used with needle  12 .  
         [0042]      FIG. 8  further illustrates a driver member  30  for use in driving shafts  14  of device  10  according to the invention. Drive member  30  preferably is provided as a substantially round member rotatably relative to housing  11  and engaged with shafts  14  such that rotation of drive member  30  relative to housing  11  causes rotation of shafts  14  relative to housing  11 . Drive member  30  can advantageously be provided as a shaft rotatable relative to body  13 , preferably rotatable within body  13 , and having a series of teeth  32  at a distal end thereof. Referring also to  FIG. 9 , a preferred shaft  14  is illustrated. As shown, shaft  14  can be provided having a toothed end  34 , preferably facing proximally. Teeth  32  of drive member  30  can be engaged with toothed end  34  of each shaft  14  such that rotation of a single drive member  30  can drive a plurality of shafts  14  according to the invention.  
         [0043]     Still referring to  FIG. 9 , shafts  14  preferably have a substantially smooth section  35  which is located substantially half way along same, and grooves  16  or threads which advantageously serve to drive rotation of helical needle  12  relative to housing  11  when drive member  30  is rotated relative to housing  11 .  
         [0044]     In the embodiment discussed above, needle  12  is positioned with sharp tip  28  facing the distal end of device  10 , and in use device  10  will need to be moved in that direction along an incision or wound to be sutured or closed.  
         [0045]      FIG. 10  illustrates an alternative embodiment wherein needle  12  is positioned with sharp tip  28  facing proximally. In use with this embodiment, device  10  is moved proximally along a wound or incision to be closed. Device  10  of  FIG. 10  can be provided with similar components to those discussed above in connection with the embodiment of  FIG. 3 . Alternatively, and as shown in  FIG. 11 , housing  11  can have different components and structure. For example, hub  22   a  in this embodiment can have a distally extending structure  36  which defines arbor  18 , that is, the smooth surface about which helical needle  12  rotates. Structure  36  can be provided having a passage  38  passing through same as illustrated to allow sutures or other probes, guides or the like to be deployed through structure  36  and out of the distal end of the apparatus. Further, in this embodiment, no end cap member  17  is needed.  
         [0046]     It should be appreciated that device  10  according to the invention can be produced at different scales for use in different types of procedures. For external procedures, device  10  can be relatively large if desired for a particular use. For laparoscopic procedures, device  10  according to the invention is advantageously sized to fit within a typical cannula for carrying out a desired procedure.  
         [0047]     Device  10  can also be provided with housing  11  made from a suitable material based upon the intended use. Thus, material for device  10  according to the invention should be selected based upon environment of use, whether device  10  is to be sterilized and re-used, and the like.  
         [0048]     It should also be appreciated that this disclosure is made in terms of preferred embodiments of the invention which are intended to be illustrative, and not limiting, upon the broad scope of the invention which is defined by the appended claims.