Abstract:
The present invention provides a device for impart tension to a flexible material, for example, a suture. The device may be used during surgical procedures to ensure the proper tension is exerted.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to a device for imparting tension to a suture. More particularly, the invention relates to an integrated suture tensioning device that creates and maintains suture connection during surgical applications. 
       BACKGROUND OF THE INVENTION 
       [0002]    It is a common requirement to use devices for tensioning flexible material during surgery to secure tissue, such as a tendon, ligament, or bone under tension to a neighboring tissue (e.g., another bone or bone surface). Suture or other flexible material (i.e., cable, fiber tape, or any other suitable flexible material) can be used to secure tissue (e.g. ligament, tendon, bone) to a nearby bone or other medical device such as a bone plate or expanded washer resting on the surface of a nearby bone. This flexible material will often be tensioned between the neighboring tissue (at one end) and a bone or medical device at the other end. This tension has been accomplished either manually or by a number of devices, such as an adjustment wheel device that has sutures secured to them and are rotated to provide tension to the suture. 
         [0003]    Manual tensioning of sutures often results in imprecise tension or a loss of tension during a surgical procedure, for example, as a permanent fixation member is applied. In addition, often such devices require the user to use both of their hands during the tensioning step in a procedure. The use of both hands during a procedure may require an additional person to be present. Further, in some instances it may be difficult to have more than one set of hands involved during a surgical procedure having limited space. This is particularly true when the device needs to create and maintain tension on a suture or flexible material throughout the procedure. 
         [0004]    Therefore, there remains a need for a convenient and effective device for creating and then maintaining tension on a suture or flexible material, ideally with one hand. The device would preferably be operable by one individual to securely create and maintain tension on a suture or flexible material while the permanent fixation member is applied. 
       SUMMARY OF THE INVENTION 
       [0005]    In one embodiment, a device tensioning flexible material (e.g., a suture) of the invention will typically comprise a housing that defines a channel and a shaft slidably disposed in the channel. In one embodiment, the housing may comprise an upper portion, a lower portion, a proximal end and a distal end. The channel may be defined by any portion of the housing, for example, the upper portion of the housing may have a channel extending axially therethrough. A device of the invention may comprise a handle, for example, the lower portion of the housing may comprise a handle. The shaft comprises a proximal end and a distal end and is slidably supported in the housing channel. In some embodiments, the shaft may comprise a plurality of notches that may be disposed along all or a portion of one or more surfaces of the shaft. In some embodiments, the shaft may comprise an engagement member at the proximal end of the shaft. 
         [0006]    A device of the invention may comprise a tension anchor. In use, a flexible material to be tensioned may be attached to the tension anchor such that the suture remains fixed with respect to the housing. The tension anchor may be located on any portion of the housing, for example, on a surface of the upper housing. In some embodiments, a tension anchor may comprise a tension carriage member which may slidably engage the upper portion of the housing. 
         [0007]    A device of the invention will typically comprise a trigger member comprising an upper portion and a lower portion. In some embodiments, the upper portion includes a drive ratchet comprising a ratchet pawl pivotally mounted thereto. Typically, a spring may be compressibly disposed between the trigger member and the handle for biasing the trigger member and the handle apart. In use, depression of the trigger member causes the ratchet pawl to engage a notch on the shaft and urges the housing toward the distal end of the shaft. 
         [0008]    In another aspect, the present invention provides a method of tensioning a suture or flexible material with a tensioning device including positioning the tensioning device such that an engagement member of the device is adjacent to a subject having a suture extending therefrom, attaching the suture to tension anchor and depressing the trigger member to provide tension on the suture. Such methods will typically include maintaining tension on the suture until the suture can be fixed with a tension securing means. Examples of tension securing means include, but are not limited to, a threaded sleeve and screw (e.g., a set screw) construct adapted to engage the suture in a compression fit, a button, or other fixation device known to those skilled in the art. 
         [0009]    In another aspect, the present invention provides a method of tensioning a suture or flexible material with a tensioning device in combination with a bone plate, threaded sleeve and a tension securing means. Such methods will typically include positioning the tensioning device such that an engagement member of the device is adjacent to the threaded sleeve through which a suture extends, attaching the suture to the tension anchor and depressing the trigger member to provide tension on the suture. Such methods may also comprise maintaining tension on the suture until the suture can be fixed with a tension securing means and securing the suture with a tension securing means. 
         [0010]    In another aspect, the present invention provides a method of tensioning a suture or flexible material with a tensioning device in combination with a washer and a threaded sleeve. Such methods will typically include positioning the tensioning device such that an engagement member of the device is adjacent to the washer and threaded sleeve through which a suture extends, attaching the suture to the tension anchor and depressing the trigger member to provide tension on the suture. Such methods may also comprise maintaining tension on the suture until the suture can be fixed with a tension securing means and securing the suture with a tension securing means. 
         [0011]    Other features and advantages of the invention will become apparent to those skilled in the art from the following description of the invention, which refers to the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  illustrates a perspective view of a device of the present invention. 
           [0013]      FIG. 2  illustrates a cross-sectional view of the device. 
           [0014]      FIG. 3  illustrates an exploded perspective view of the device. 
           [0015]      FIG. 4  illustrates a partial perspective view of an adapter member of the device. 
           [0016]      FIG. 5  illustrates the tensioning device of the invention being used to impart tension to a suture that is being used to support a fractured clavicle. 
           [0017]      FIG. 6  illustrates a perspective view of the tensioning device of the invention being secured to a threaded sleeve and bone plate. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0018]      FIGS. 1 to 4  show a device according to an embodiment of the present invention. As shown in  FIG. 1 , a tensioning device  10  may comprise a housing  11  having an axially extending channel  17  ( FIG. 2 ) formed from a proximal end  15  to a distal end  14 . As shown, the housing  11  comprises a handle  16 , a lower portion  11   b , an upper portion  11   a , recessed indentations  12  and a slot  13  extending along a side  18  of the upper portion  11   a  of the housing  11 . 
         [0019]    A device of the invention will include a shaft. The shaft may have any cross-section, for example, may have a square cross-section and is disposed in the housing. Other contemplated cross-sections include, but are not limited to, circular, oval, and polygonal (e.g., hexagonal). As shown in the figures, a generally rectangular shaft  20  includes a proximal end  24 , a distal end  22  and engagement member  21 . The shaft  20  includes a plurality of notches  23  which extend along at least a portion of at least one side of the shaft  20 . The engagement member  21  includes engagement fingers  25  and lip  26 . The notches  23  may be angled toward the distal end  22  of the shaft  20 . The shaft  20  may be rotated prior to use to provide an alternative position of the engagement member  21 . The housing  11  is slidably supported on the shaft  20  from the shaft&#39;s proximal end  24  to the shaft&#39;s distal end  22 . The housing  11  is biased in the distal direction of the shaft  20  by a trigger member  30  pivotally connected to the housing  11 . 
         [0020]    The present invention further contemplates a cannulated shaft. A cannulated shaft may define a bore extending axially therethrough. In some embodiments, the bore of a cannulated shaft may extend from the distal end of the shaft to the proximal end of the shaft. In other embodiments, the bore of the cannualted shaft may extend through a portion of the length of the shaft, for example, from the proximal end or near the proximal end of the shaft to approximately one eight, one fourth, one half or three quarters of the length of the shaft measured from the proximal end. A flexible material (e.g., a suture) may be disposed in the bore of a cannulated shaft. 
         [0021]    As shown in  FIGS. 1-3 , the trigger member  30  includes a drive ratchet  31  pivotally connected to the trigger member  30  at an upper portion  33  that is engageable with a spring  51  biased ratchet pawl  50 . The trigger member  30  further includes a spring clip  34  attached to an upper inside surface of the trigger member  30  by a screw  36 . The ratchet pawl  50  includes a protrusion  52 . The drive ratchet  31  includes a finger compression portion  37  and a hook member  35  and is adapted to be pressed against the ratchet pawl  50  by the spring clip  34  when the trigger member  30  is in a non-compressed position. Hook member  35  is adapted to engage notches  23  of shaft  20  to slide housing  11  at least one notch  23  toward the shaft&#39;s  20  distal end. A tension anchor is shown as a tension carriage member  60  may be slidably supported on the slot  13  of the housing  11 . The tension carriage member  60  comprises a three-side adjustable post having top post  61  and at least one side post  62 . Top post  61  may be attached to the tension carriage member  60  by screw means or any other means contemplated. In the illustrated embodiment, top post  61  is screwed down through an aperture  63  and positioned in at least one of the recessed indentation  12  of housing  11 . A two piece spring member  40  comprises a female spring member  41  and a male spring member  42  which connect on at least a portion of one another. The spring member  40  is positioned between the trigger member  30  and handle  16  for biasing the trigger member  30  and handle  15  apart. The male spring member  42  and the female spring member  41  are secured to the trigger member  30  and handle  16  by at least one screw  44 . 
         [0022]    During operation of the device  10  when the trigger member  30  is depressed the trigger member  30  causes the drive ratchet  31  to engage a notch  23  of shaft  20  with hook member  35  and urges the housing  11  toward the distal end  22  of the shaft  20 . In this state, the ratchet pawl  50  is lowered to a point where the protrusion  52  is disengaged from contacting the shaft&#39;s notches  23  which permits movement of the housing  11  away from the proximal end of the shaft  20 . During operation, a suture (not shown) is secured to a tension anchor, for example, to a post member  61  or  62  of tension carriage member  60  and a pulling force is applied to the suture, thereby providing and maintaining tension to the suture. 
         [0023]    Referring now to  FIGS. 3 and 4 , device  10  of the present invention provides several advantages, including a capability of creating and maintaining tension on a suture or flexible material. Further, creating and maintaining tension on a suture or flexible material can be accomplished with one hand of a user. The device  10  may further comprise an adapter member  70 . The adapter member  70  may comprise a spring member  71  for snap fit connection with the engagement member  21  of the shaft  20 . The adapter member  70  may be used to secure connection of the device  10  to a surgical plate, washer or screw. In the illustrated embodiment, the adapter  70  includes an engagement member  72  generally shaped to be fitted to a generally circular member. Engagement member  72  may be provided with a recessed portion into which a washer member may fit. During use the adapter member  70  engages with, for example, a washer member (not shown), which prevents rotation of the washer member while the suture is being tensioned and tension securing means is applied. It being understood that other alternative configurations of engagement members may be used to provide a secured connection. 
         [0024]    A method of tensioning a suture technique employed in a clavicle fracture repair, for example, is now described with reference to  FIG. 5  and according to an embodiment of the present invention. The present invention may be used to secure, however, any type of tissue, for example bone, cartilage, ligament, graft or tendon, such as a biceps tendon, a rotator cuff or a AC separation, which require suture attachment and appropriate tension. 
         [0025]      FIG. 5  illustrates a partial perspective view of the bones of the shoulder anatomy illustrating a clavicle  1101  with a fracture  1201  showing the tensioned placement of a bone plate  901  and a suture or other flexible material  1401  undergoing a fracture repair and suture tensioning procedure according to the present invention. The bone plate  901  has been secured to the superior aspect of the clavicle  1101  with a plurality of bone screws  1501  and  1502  inserted into any of a plurality of openings  902  and  905  in openings  902  and  905  in the bone plate  901  and into the clavicle  1101 . As known in the art, the bone plate  901  may be a bone screw or plug, for example, employed with or without the bone plate  901 . 
         [0026]    According to a preferred method of tensioning a suture of the present invention, a length of flexible material  1401  is employed in connection with the bone plate  901  and is placed through an opening  903  of the bone plate  901  through a pre-drilled hole along the fracture  1201  and secured through, around another bone or with an anchor in the bone, for example, a coracoid process  1102 . The engagement member  21  of the shaft  20  is positioned in the bone plate opening  903  and a length of flexible material  1401  is secured around tension carriage&#39;s post  61  or  62 . 
         [0027]    For the purposes of illustration and without limitation, the term “suture” or “flexible material” as used herein may be a cable, filament, thread, wire, fiber tape or any other flexible member suitable for bone fixation in the body. 
         [0028]    After securing the flexible material  1401  around the through the post  61  or  62  of the tension carriage  60 , the user grasps the trigger  30  with one hand, for example the right hand, and compressing the trigger  30  inward to exert tension on the flexible material  1401 . Housing  11  slides upward and away from the bone plate  901 . As the housing  11  increases its distance from the bone plate  901 , tension in the flexible material is increased. Once the desired amount of tension is achieved a securing means can be placed in the opening  903  to maintain the tension between the coracoid process  1102  and the clavicle  1101 . In this manner, the flexible material  1401  is precisely tensioned and positioned at an appropriate distance from the bone sections  1102  and  1101 . One preferred example of a securing means is a knotless fixation device as shown in published United States patent application US 20100262185 which is specifically incorporated herein by reference in its entirety. 
         [0029]    Referring now to  FIG. 6 , a further embodiment of the device  10  according to the present invention is shown. The engagement member  21  of the shaft  20  is shown in locking engagement with the flange of sleeve  101 . During use in this embodiment the engagement fingers  25  are placed against the side of the flange and lip  26  of engagement member  21  is placed on top and around the sleeve&#39;s flange to place downward pressure on the sleeve  101 . A suture or flexible material may then be extended up through the interior of the sleeve  101  and secured to the device  10  at the tension anchor  60 . Once the suture or flexible material is secured to the device  10  the suture can be tensioned according to the aforementioned method and a securing means may be inserted into the sleeve  101  to provide permanent tension to suture. Tension can be maintained on the suture until the securing means firmly engages the sleeve so as to prevent slippage of the suture once the tension is released. 
         [0030]    Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred, therefore, that the present invention be limited not by the specific disclosure herein, but only by the appended claims.