Abstract:
A method and device provides features for the temporary “parking” of sutures with respect to a cannula. In the preferred embodiments the features are slots that maintain tension on, and orientation of, sutures placed therein. The slots or features may be integral with the cannula or part of a separate device which may be removably affixed to the external portion of a cannula. In addition, the opening(s) used for instrument-passing are off-center, thereby reducing if not elimination outward sprays during use. The invention eliminates the multiple steps inherent in current suture management techniques for arthroscopic procedures, particularly rotator cuff repair and assists in tensioning/advancement of tissue into its repair site.

Description:
REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 10/875,766, filed Jun. 24, 2004 now U.S. Pat. No. 7,704,263, which claims priority from U.S. Provisional Patent Application Ser. No. 60/484,243, filed Jul. 2, 2003, the entire content of both of which are incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The disclosed invention relates to arthroscopic surgery, and more particularly, to the control of sutures to prevent tangling during arthroscopic procedures including rotator cuff repair, labral repair and other soft tissue apposition. 
     BACKGROUND OF THE INVENTION 
     The advantages of arthroscopic surgery are significant, however, the procedure has been technically demanding, particularly with respect to rotator cuff repair. The introduction of second-generation anchors with improved holding power and larger eyes which allow sutures to slide easily through them, and clear cannulas which improve visualization, have made the procedure easier. Until recently, however, passing suture through the cuff has been a challenging, multi-step process beyond the skill (or patience level) of many surgeons. This is especially true for surgeons who only infrequently do rotator cuff repairs. 
     In 2001 in the state of New York, 9,207 cuff repairs were performed by 859 surgeons. During this time period, 90 percent of the New York doctors who performed rotator cuff repairs performed 24 or fewer cuff repairs each, an average of less than one every two weeks. The infrequency with which these doctors perform the procedure generally prevents them from developing the skills necessary to perform the procedure arthroscopically. The recent introduction to the market of instruments which are able to pass braided suture without the use of a shuttle (a device which is first passed through the cuff, and is then used to pull the suture through the cuff) has removed much of the difficulty. The ExpresSew™ by Surgical Solutions, LLC (Valencia, Calif.) is able to directly pass braided suture through a cuff. The Needle Punch™ by Arthrex Incorporated (Naples, Fla.) is able to grasp the cuff, pass braided suture through the cuff, and bring the suture out through the cannula used for access (the working cannula). 
     While the problem of passing a suture through a cuff arthroscopically has been largely eliminated, suture management has become critical to the technical success of the surgery. Indeed, tangled sutures can terminate an arthroscopic procedure. This problem is compounded by the fact that many anchors now are loaded with two sutures so as to create two vertical stitches which can be slightly separated so as to distribute the load over a greater area of the tendon. This improves the strength of the repair, but at the same time gives the surgeon four suture “legs” with which to deal. 
     Arthroscopic rotator cuff repairs are performed in a space which is filled with pressurized liquid, generally normal saline, the surgeon working through various small incisions or portals. Pressurization of the joint and leakage of liquid from the joint is controlled by cannulae which are inserted into the portals, the cannulae having seals through which instruments and sutures may be passed. 
     Common suture management techniques call for removal of sutures from the working cannula in order to avoid tangles. The sutures are then retrieved one at a time as needed. Some advocate making extra punctures for the sole purpose of temporarily storing sutures to avoid tangles. Others recommend retrieving one suture through the mid-glenoid working cannula, and retrieving the other limbs through the anterior superior cannula, after which the cannula is removed and reinserted leaving the sutures through the portal outside the cannula. Transporting sutures from one cannula to another or to alternative portals can occupy large blocks of time during a given operation. Also, removing and reinserting a cannula may increase trauma to local tissues. There is a need for a more efficient suture management system, minimizing the multiple extra steps inherent in the currently recommended techniques and their associated increased trauma. 
     Performing an arthroscopic rotator cuff repair is a multi-step process. The bone bed is prepared using a high-speed buf, adjacent to the articular surface of the humeral head. Anchors are placed in the bone bed, each anchor generally loaded with two strands of suture so that four tails are created. One leg of each suture is passed through the cuff, suitably spaced so as to distribute the load over a greater area of the tendon. One set of sutures is pulled laterally as traction sutures to retain tension and position of the cuff during suture knot tying of the second set of sutures. Traction suture tension is generally maintained by an assistant holding onto the suture legs which pass from the working cannula. The traction sutures are tied after the first set of sutures. The process of applying traction and tying suture pairs is repeated until all sutures are tied. There is currently no method for applying tension to a traction suture which does not require an assistant to hold the suture. 
     The use of a traction suture also frequently leads to excessive leaking and spraying from the working cannula since the suture under tension often distorts the seal through which the suture passes thereby allowing the flow of liquid. 
     It is, accordingly, an object of this invention to produce a method for suture management which prevents tangling of sutures and allows tensioning of a traction suture without manual assistance. 
     It is also an object of this invention to produce a method for tensioning a traction suture while minimizing fluid leakage from the joint. 
     It is also an object of this invention to produce a method for tensioning a traction suture while maintaining fluid pressure within the joint. 
     It is also an object of this invention to produce a method for suture management which prevents tangling of sutures but does not require transporting of sutures from the working cannula to avoid tangles. 
     It is also an object of this invention to produce a method for suture management which prevents tangling of sutures and thereby reduces procedure time and complexity. 
     It is, accordingly, an object of this invention to produce a device for suture management which prevents tangling of sutures and allows tensioning of a traction suture without manual assistance. 
     It is also an object of this invention to produce a device for tensioning a traction suture while minimizing fluid leakage from the joint. 
     It is also an object of this invention to produce a device for tensioning a traction suture while maintaining fluid pressure within the joint. 
     It is also an object of this invention to produce a device for suture management which prevents tangling of sutures but does not require transporting of sutures from the working cannula to avoid tangles. 
     It is also an object of this invention to produce a device for suture management which prevents tangling of sutures and thereby reduces procedure time and complexity. 
     It is yet a further object of this invention to produce a device for suture management which minimizes or prevents outward spraying during use. 
     SUMMARY OF THE INVENTION 
     These and other objects are achieved in the invention herein disclosed which is a method and device for management of sutures within the working cannula through the temporary “parking” of sutures within slots on the exterior portion of the cannula, the slots maintaining tension on, and orientation of, sutures placed therein. In one embodiment the slots are integral with the cannula. In another the slots are part of a separate device which may be removably affixed to the external portion of a cannula. In yet another embodiment the cannula with integral slots has a seal configured to minimize leakage through the seal when sutures, especially traction sutures, are used in the cannula. In still another embodiment the slots are part of a separate device which removably mounts to a cannula and also includes a means for suppressing spray which escape from the cannula seal during use. 
     Maintaining tension on a given suture and controlling the orientation of each suture with respect to its neighbor reduces the likelihood of tangles even when all sutures are contained within the same cannula that is being used to pass instruments (the working cannula). As each suture is inserted two tails (or legs) are created. For a rotator cuff repair involving the supraspinatus tendon, one limb is below and one on top of the tendon. As the sutures are inserted this orientation is easily recognized and can be maintained by the disclosed device with slight tension on each suture limb. The tension prevents loops of suture from forming. Therefore the insertion of additional sutures is collinear with the existing sutures and tangles do not occur. As the sutures are tied down, the knots slide smoothly as the limbs&#39; orientations have been maintained and the limbs are not crossed. 
     When a suture pair is to be used as a traction suture, the legs are pulled to achieve the desired displacement of the cuff and the sutures temporarily secured to the suture isolator. The axial force on the cannula due to tension in the traction suture may cause the cannula to advance into the portal. This can be prevented by affixing a suitable clamp or spacer to the cannula proximal to the portal. 
     The invention herein disclosed eliminates the multiple steps inherent in current suture management techniques for rotator cuff repair. This results in decreased opportunities for errors and significant time savings for the surgeon. Because the sutures are managed within the working cannula, removal and reinsertion of cannulas for suture control with the associated increased trauma to local tissues, are avoided. Also, according to a preferred embodiment of the invention, the opening(s) used for instrument-passing are off-center, thereby reducing if not elimination outward sprays during use. 
     These and other objects and features of the invention will become more fully apparent when the following detailed description is read in conjunction with the accompanying figures and examples. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is plan view of a suture isolator constructed in accordance with the principles of this invention 
         FIG. 2  is a proximal axial view of the object of  FIG. 1 ; 
         FIG. 3  is a side-elevational sectional view of the object of  FIG. 1 ; 
         FIG. 4  is a plan view of an arthroscopy cannula of the type used with the invention herein disclosed; 
         FIG. 5  is a proximal axial view of the object of  FIG. 4 ; 
         FIG. 6  is a perspective view of the object of  FIG. 4 ; 
         FIG. 7  a plan view of the object of  FIG. 1  assembled to the object of  FIG. 4 ; 
         FIG. 8  is a proximal axial view of the objects of  FIG. 7 ; 
         FIG. 9  is a perspective view of the objects of  FIG. 7 ; 
         FIG. 10  is a plan view of an alternate embodiment constructed in accordance with the principles of this invention; 
         FIG. 11  is a proximal axial view of the object of  FIG. 10 ; 
         FIG. 12  is a side sectional view of the object of  FIG. 10 ; 
         FIG. 13  is a perspective view of the object of  FIG. 10  assembled to the object of  FIG. 4 ; 
         FIG. 14  is a plan view of another alternate embodiment constructed in accordance with the principles of this invention; 
         FIG. 15  is a proximal axial view of the object of  FIG. 14 ; 
         FIG. 16  is a perspective view of the object of  FIG. 14 ; 
         FIG. 17  is an expanded proximal axial view of the object of  FIG. 14  showing suture placement in the seal during use; 
         FIG. 18  is a perspective view of the object of  FIG. 14  during use; 
         FIG. 19  is a proximal axial view of an alternate embodiment; 
         FIG. 20  is a perspective view of the object of  FIG. 19 ; 
         FIG. 21  is a proximal axial view of an alternate embodiment; 
         FIG. 22  is a perspective view of the object of  FIG. 21 ; 
         FIG. 23  show a top view of the rotator cuff edge; 
         FIG. 24  shows anchors deployed; 
         FIG. 25  shows the rotator cuff edge reduced into its insertion area by tensioning sutures; 
         FIG. 26  is a distal axial view of an alternate embodiment; 
         FIG. 27  is a perspective view of the objects of  FIG. 26 ; 
         FIG. 28  is a top view of the objects of  FIG. 26 ; 
         FIG. 29  is a side elevational sectional view of the objects of  FIG. 26  at location A-A; 
         FIG. 30  is a distal axial view of the embodiment of  FIG. 26  mounted to a cannula; 
         FIG. 31  is a perspective view of the objects of  FIG. 30 ; 
         FIG. 32  is a top view of the objects of  FIG. 30 ; 
         FIG. 33  is a side elevational sectional view of the objects of  FIG. 30 ; and 
         FIG. 34  is a distal axial view of an alternate embodiment similar to the embodiment of  FIGS. 26 to 34  but with a modified splash guard. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring to  FIGS. 1 through 3 , suture isolator  1  has a proximal end  2 , a distal end  4 , outer diameter  6  and length  8 . Distal portion  10  has a recess  12  formed therein, recess  12  having a cylindrical portion  14  of diameter  16  and a tapered portion  17  in which the diameter increases to diameter  18 . Proximal portion  20  has a cylindrical recess  22  of diameter  24  formed therein so as to produce proximal rim  26 . Proximal rim  26  has a plurality of slots  28  of depth  30  having a distal portion  32  of width  34  and a tapered proximal portion  36 . Width  34  of distal portion  32  is less than the thickness of the suture generally used for arthroscopic rotator cuff repair so that suture removably placed in slots  28  is held securely. Isolator  1  is made of a rigid metallic or polymeric material. 
     Referring to  FIGS. 4 through 6 , cannula  40  has an elongated tubular distal portion  42  of diameter  44  and a proximal portion  46  of diameter  48 , diameter  48  being slightly greater than diameter  16  and slightly less than diameter  18  of distal circular recess of suture isolator  1  ( FIGS. 1 through 3 ). Near proximal end  50  of distal portion  42 , inflow tube  52  provides a means for supplying irrigant to the inner lumen of distal portion  42 . Deformable polymeric seal  54  having a plurality of slits  55  closely conforms to instruments placed therethrough so as minimize leakage of fluid from the site. 
     Referring to  FIGS. 7 through 9 , suture isolator  1  is removably affixed to cannula  40 , cylindrical portion  14  of recess  12  of isolator  1  ( FIGS. 1 through 3 ) deformably mating to the proximal portion of proximal portion  46  of cannula  40 , diameter  48  of portion  46  being slightly larger than diameter  16  of recess  12  ( FIGS. 1 through 3 ). Mounting of isolator  1  to cannula  40  is facilitated by tapered portion  17  of recess  12 . 
     In another embodiment, shown in  FIGS. 10 through 12 , suture isolator  60 , made from a suitable resilient polymeric material such as neoprene which deforms to allow the passage of instruments, has a tubular distal portion  62  having an inner cylindrical diameter  64 , and a closed-end proximal portion  66  having a proximal wall  68  wherein is formed opening  70 . Diameter  64  is somewhat smaller than diameter  48  of proximal portion  46  of cannula  40  ( FIGS. 4 through 6 ). Opening  70  has a plurality of radial slots  72  having a width  74  less than the thickness of the suture generally used for arthroscopic rotator cuff repair so that suture removably placed in slots  72  is held securely. 
     The configuration of isolator  60  made from resilient polymeric material differs from that of isolator  1  made from rigid material. Note that whereas slots  28  of isolator  60  ( FIGS. 1 through 3 ) are oriented axially and positioned in proximal rim  26 , slots  72  are oriented radially and positioned in proximal wall  68 . If an suture isolator made of a resilient material is formed like isolator  1  with radial slots in the proximal rim, stretching the isolator so that it mounts to the larger diameter of the proximal portion of a cannula may cause unacceptable widening of the slots so that suture placed therein is not securely grasped. 
     Referring to  FIG. 13 , suture isolator  60  is removably mounted to cannula  40 , distal portion  62  deformably mating to the proximal portion  46  of cannula  40 , diameter  48  of portion  46  ( FIGS. 7 through 9 ) being larger than diameter  64  of distal portion  62  of isolator  60 . 
     Because of the resilient material of which isolator  60  is formed, the holding power of slots  72  may be insufficient for maintaining tension in some traction sutures. Accordingly, another embodiment (not shown) uses a combination of isolator  1  ( FIGS. 1 through 3 ) and isolator  60 , isolator  1  having a distal recess configured to be removably mounted to tubular distal portion  62  of isolator  60 . Sutures are passed through slots  72  of isolator  60  and removably affixed to slots  28  of isolator  1 , isolator  60  aiding in isolation of the sutures and preventing leakage from the seal from spraying from the isolator. 
     In yet another embodiment shown in  FIGS. 14 through 16 , the suture retaining slots are integral to the cannula. Cannula  80  has an elongated tubular distal portion  82  of diameter  84  and a proximal portion  86  of diameter  88 . Near proximal end  90  of distal portion  82 , inflow tube  92  provides a means for supplying irrigant to the inner lumen of distal portion  82 . Deformable polymeric seal  94  closely conforms to instruments placed therethrough so as minimize leakage of fluid from the site. Proximal-most surface  96  of proximal portion  86  has a circular recess  98  formed therein so as to form a circumferential rim  100  wherein are a plurality of slots  102 , slots  102  being similar in form to slots  28  of isolator  1  ( FIGS. 1 through 3 ). That is, slots  102  have a narrow distal portion having a width suited to releasably securing therein suture generally used for arthroscopic rotator cuff repair, and a tapered proximal portion to aid in positioning the suture within the slot. 
     Referring to  FIG. 17 , seal  94  has a plurality of slits  95  forming a plurality of flaps  93 , slits  95  terminating in angled slits  97 . During use a suture  99  which has been retrieved through cannula  80  is positioned within a slit  97  and secured in a slot  102  to maintain tension in and orientation of suture  99 . When the suture has been secured, flaps  93  can return to and maintain their closed positions so as to minimize leakage through the seal. This is in contrast to seal  54  of cannula  50  ( FIGS. 4 through 6 ) in which a suture passing through the seal and maintained under tension will frequently hold flaps  53  open thereby causing leakage through the seal. 
     Use of the suture isolator during arthroscopic repair of a rotator cuff tear is shown in  FIG. 18 . Use is illustrated using the embodiment of  FIG. 17 , cannula  80  having integral suture retaining slots. Use of the other embodiments, each with the associated cannula, is identical to that illustrated. Cannula  80  is positioned in a portal so as to function as the working cannula, used for passing instruments and sutures. Rotator cuff  110  has a tear  112 . Trough  114  has been created in humeral head  116  and an anchor such as the Arthex Corkscrew Suture Anchor™ loaded with two sutures  118  and  120  is inserted into humeral head  116  in trough  114 . Sutures  118  and  120  slide freely in the eyelet of the anchor and are differently colored to allow easy identification of the leg pair of a given suture. Suture legs  122  and  124  form a pair, and legs  126  and  128  form another pair. 
     In  FIG. 18 , leg  122  has been retrieved through cannula  80  and removably secured in slot  130 , slight tension being maintained in leg  122 . Using a suture passing instrument such as the Arthex Needle Punch™, leg  124  has been passed through cuff  110 , retrieved through cannula  80 , and removably secured in slot  132  with slight tension being maintained in leg  124 . Insertion of the instrument, passing of the suture, and retrieval of the leg are accomplished without interference from leg  122  because leg  122  is colinear with the cannula and the instrument motions, and slight tension is maintained in leg  122 . Subsequently, legs  126  and  128  will be retrieved in the same manner as legs  122  and  124 . Suture  118  is then used as a traction suture. The tension in legs  122  and  124  is increased so as to move the edge of cuff  110  to the insertion point. The cuff is then secured in place using suture  120  by sliding knots in the usual manner. Tangling during knot tying is prevented by separation of the sutures and slight tension maintained in the sutures by the suture isolator cannula. Suture  118  is then tied in the same manner as suture  120 . 
       FIGS. 23 ,  24  and  25  represent a diagrammatic sequence showing how the invention can be used to organize sutures and apply tension to the rotator cuff edge to accomplish reduction of the rotator cuff edge to its insertion area when doing a multi-anchor repair.  FIG. 23  demonstrates a top view of the rotator cuff edge  160 , the cuff insertion area  161  and the anticipated anchor insertion points  170  and  171 .  FIG. 24  shows anchors  172  and  173  deployed. Sutures  175 ,  176 ,  177  and  178  have been passed through the rotator cuff and diagrammatically secured by the invention represented by the solid line  180 .  FIG. 25  shows the rotator cuff edge reduced into its&#39; insertion area by tensioning sutures  175 ,  176 ,  177  and  178 . Each suture pair is locked into the invention  180 , holding tension on each suture pair, spreading the reduction force over multiple points. In addition, the patient&#39;s arm can be abducted during this maneuver to bring the insertion area closer to the rotator cuff edge. The suture pairs can then be tied down and cut, one pair at a time. The untied suture pairs hold the rotator cuff edge reduced, facilitating the knot tying process. 
     Other configurations are possible in which the positions of the suture retaining slots are varied. For instance  FIGS. 19 and 20  show a cannula  140  in which a circumferential rim  142  is added to the proximal end of the cannula and a plurality of circumferential slots  144  are formed in the rim. In another embodiment, cannula  150 , shown in  FIGS. 21 and 22 , a plurality of cylindrical protrusions  152  are formed on the circumferential surface  158  of the cannula proximal portion  154 , with slots  156  formed in the protrusions. In this embodiment suture retrieved through the cannula is positioned in the slots in the seal as in cannula  80  ( FIGS. 14 through 18 ), is wrapped around a protrusion  152  and positioned in slot  154 . Those of skill in the art will recognize that in all cases where a suture organizer is shown integral to a cannula, it may alternatively be removably secured thereto, and vice versa. 
     When the suture isolator of  FIGS. 1 through 3  is used with the cannula of  FIGS. 4 through 6  as shown in  FIGS. 7 through 9 , fluid may spray in an uncontrolled fashion through seal  54  when a suture is tensioned. This spray is a nuisance, as it may soak items in the area including the surgeon. In an alternate embodiment of the invention herein described, a deformable spray shield prevents uncontrolled spraying of fluid which leaks past the cannula seal. Referring to  FIGS. 26 through 29 , suture isolator  201  has a proximal end  202 , a distal end  204 , outer diameter  206  and length  208 . Distal portion  210  has a recess  212  formed therein, recess  212  having a cylindrical portion  214  of diameter  216  and a tapered portion  217  in which the diameter increases to diameter  218 . Proximal portion  220  has a cylindrical recess  222  of diameter  224  formed therein so as to produce proximal rim  226 . Proximal rim  226  has a plurality of slots  228  of depth  230  having a distal portion  232  of width  234  and a tapered proximal portion  236 . Width  234  of distal portion  232  is less than the thickness of the suture generally used for arthroscopic rotator cuff repair so that suture removably placed in slots  228  is held securely. 
     Isolator  201  is made of a rigid metallic or polymeric material. Spray shield  240 , made from a suitable elastomeric material, has a plurality of slits  242  forming a plurality of flaps  244 , slits  242  terminating in angled slits  246 . Ring  250  retains splash guard  240  in cylindrical portion  214  of recess  212 . When viewed axially as in  FIG. 26 , isolator  201  has an instrument-passing area  252  with opening  254  in spray shield  240 , and suture-parking areas  256 ,  258  and  260  comprising slits  242 , angled slits  246  and slots  228 . In the preferred embodiment four areas are provided in separate quadrants, though other geometries are possible so long as opening  254  is off center. Also, as with other embodiment described herein, The distal portion of the isolator may be an add-on piece or integrally formed. 
     Referring now to  FIGS. 30 through 33  showing suture isolator  201  removably mounted to the proximal end of cannula  40  ( FIGS. 4 through 6 ), proximal portion  46  of cannula  40  is slightly greater than diameter  216  of cylindrical portion  214  of distal recess  212  of suture isolator  201 , and slightly less than diameter  218  of tapered portion  217  of recess  212  ( FIG. 29 ). Suture isolator  201  is removably mounted to cannula  40  as shown in the figures, proximal portion  46  of cannula  40  contacting and nesting against ring  250  of isolator  201 . Spray shield  240  of isolator  201  is positioned proximal to seal  54  of cannula  40 . 
     During use instruments are passed through isolator  201  and cannula  40  using opening  254  in area  252  of isolator  201 , spray shield  240  deforming as required to allow easy passage of the instruments. Sutures which have been retrieved are positioned in angled slits  246  and slots  228  so as to maintain slight tension on the sutures. When the sutures have been secured in slots  228 , flaps  244  return to and maintain their closed positions so as to prevent uncontrolled spraying of liquid leaking past seal  54  of cannula  40 . In an alternate embodiment shown in  FIG. 34 , suture isolator  301  with spray shield  340  has openings  346  for suture passage at the ends of slits  342 , rather than the angled slits  246  of isolator  201  ( FIGS. 26 through 29 ). Such a configuration is also possible with the other embodiments described herein, including, for example, isolator  80  shown in  FIG. 17 .