Abstract:
A suture management system useful in endoscopic surgery, particularly in arthroscopic instability and rotator cuff procedures comprises a plurality of elongated tubes, sometimes referred to herein as suture organizers. The tubes can have a suture loop through them to ensnare matching suture ends of a given suture so that the tube can be slid down over the matching suture ends and into a cannula. The tube with the matched suture ends can be clamped over the suture strands to fixate the tube as another suture is manipulated through the tissue and then in turn has its matching suture ends pulled through another tube for subsequent tie-off. A rack is provided to hold the tubes with loops therein before use.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The field of this invention is surgical procedures, particularly endoscopic surgical procedures, involving the use of multiple sutures and devices to keep suture strands bundled until tied to prevent tangling.  
           [0003]    2. Description of the Prior Art  
           [0004]    Endoscopic surgery and, in particular, arthroscopic surgery often involves working in confined spaces while trying to embed suture anchors, penetrate soft tissue and tie off sutures. It will be understood that, generally, a suture extends through an eyelet at the proximal end of an anchor (embedded in bone) such that the suture is folded back on itself at some point between the suture ends. At least one of the ends is passed through tissue and is tied to the other end to anchor the tissue. Certain procedures such as rotator cuff and instability require numerous sutures, which sometimes are not tied off immediately after being placed through tissue. The need to delay tying-off occurs to enhance visibility at a crowded work site and because subsequent sutures are more easily placed if previous adjacent sutures are not tied off at that time. The problem that occurs, without the present invention, is the management of pairs of suture ends for ultimate tying-off. While different colors can be used for sutures to distinguish them on a scope, the confined space and the limit of the colors available make it difficult to match two ends of a given suture that may be intertwined with ends of an unrelated suture.  
           [0005]    When repairing rotator cuffs, anchors are placed in the bone, sometimes as many as five, and each suture (attached to a given anchor) has its ends taken out the cannula to be tied at the end of the operation. This technique has the benefit of not closing the torn tendon down to bone too early or too tightly, thereby making it easier to pass the stitching tool under the tendon. Larger anchors have been developed, doubling the number of sutures to manage since each anchor can accommodate two sutures. With larger suture anchors having so many sutures, it is difficult to wait until the end of the procedure before tying the sutures. A technique was developed to allow tying the sutures throughout the surgery. Although this technique worked well, it had two major drawbacks. First, once a suture is tied down it is more difficult to pass the rest of the stitches. Also, each time a pair of suture ends is passed the surgeon has to turn off the pump, move the scope, turn the pump back on, clean the blood out of the bursa and then tie the next set of sutures. It would save time and be much more efficient if the sutures could all be tied at once, at the end of the case. Without the present invention, it is difficult to wait to the end of the case because management of suture end pairs for proper tie-off is difficult.  
           [0006]    In addition to managing sutures during rotator cuff surgery, there was also a need to manage them while doing instability surgery. During that operation two or three sutures are placed in the back of the shoulder at the beginning of a case but are not tied until the end of the case. When the anterior portion of the reconstruction is finished and the surgeon returns to the back of the shoulder to tie the suture, it is often difficult to determine which suture pairs go together, since there are four to six sutures present coming out of the portal. Sometimes the suture strands are twisted one on the other, making for a very confusing situation.  
           [0007]    In the past, sutures were packaged in multi-suture holders but these products merely organized discrete sutures until the surgeon needed them in a procedure. Examples of such suture packaging are shown in U.S. Pat. Nos. 5,123,528; 5,413,214; 5,848,714 and 5,566,822. These devices had no suture management capabilities when the sutures were taken out and used in a procedure (in an anchor, for example). Somewhat more relevant were anastomosis catheters which separated individual sutures until a suture needle was pushed out of a respective slot in the catheter to grab the tissue (for example, urethra). Examples of such devices are U.S. Pat. Nos. 5,545,171 and 6,080,167. These devices were designed with a specific procedure in mind and had to have all the sutures organized in discrete passages before the catheter was inserted in the patient. They were not adapted to manage untied sutures during a procedure that needed to be tied off at a later time.  
           [0008]    An objective of the present invention is to simply provide such a suture management system to avoid mix-ups of unmatched pairs of sutures being tied together. Another objective is to have the suture organizers assembled in a rack and to provide them in a variety of colors to make them readily accessible and distinguishable on a scope.  
         SUMMARY OF THE INVENTION  
         [0009]    These and other objects of the invention are achieved by the preferred embodiment disclosed herein which is a suture management system useful in arthroscopic surgery, particularly in instability and rotator cuff procedures. The system comprises a plurality of elongated tubes, sometimes referred to herein as suture organizers. The tubes can have a suture loop through them to facilitate the suture through the tube by ensnaring matching suture ends of a given suture so that the tube can be slid down over the matching suture ends and into a cannula. The tube with the matched suture ends can be clamped onto the suture strands to fixate the tube so another suture can be manipulated through the tissue and then in turn have its matching suture ends pulled through another tube for subsequent tie-off. A rack is provided to hold the tubes with loops therein before use. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 shows a suture organizer with a loop inserted into it ready to grasp matching ends of a suture shown before the tube is advanced through a cannula.  
         [0011]    [0011]FIG. 2 shows the use of the suture organizers in an instability procedure.  
         [0012]    [0012]FIG. 3 is a view of FIG. 2 later in the procedure showing the use of multiple suture organizers.  
         [0013]    [0013]FIG. 4 is a view of FIG. 3 later in the procedure showing one side tied off and the suture organizers on the opposite side holding suture ends together prior to tying-off.  
         [0014]    FIGS.  5 - 7  show variations of racks to hold suture organizers prior to use.  
         [0015]    [0015]FIG. 8 shows the use of a suture organizer in place in rotator cuff surgery.  
         [0016]    [0016]FIG. 9 shows an alternate embodiment of a suture organizer. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0017]    [0017]FIG. 8 shows an application of the present invention to rotator cuff surgery. While the invention is described in terms of an arthroscopic shoulder procedure, as will be understood below, the invention is suitable for other endoscopic procedures and for open surgical procedures. A suture anchor  10  is secured in a known manner to the bone  12 . Ends  14  and  16  of suture  18  extend from anchor  10 . A suture organizer  20  is slipped over ends  14  and  16  before they are tied off. Insertion of the suture ends  14  and  16  into tube  20  is shown in FIG. 1 with the use of a threading tool comprising a loading suture  24  folded into a collapsible loop  22  which extends out of distal end  26  of organizer  20 . Ends  14  and  16  of suture  18  are inserted into loop  22  and loop  22  is pulled through the lumen  19  of organizer  20 . Alternatively, loop  22  may be provided in the form of a rod (not shown) extending through the lumen of the organizer  20  and having at its distal end a collapsible loop of shape memory material such as nitinol. The organizer  20  is pushed along suture ends  14  and  16  toward the work site and through a cannula, such as for example 28 shown for an instability procedure in FIG. 2.  
         [0018]    Regardless of the type of surgery being performed, the procedure of using the organizers is similar. A suture can be anchored to bone as shown in FIG. 8 and left to be tied later in the procedure while an organizer  20  holds the respective ends such as  14  and  16  as a matched pair. FIGS.  2 - 4  show an instability surgery but do not show the anchors holding the various sutures described below. Cannulas  28  and  30  provide access to the site through small incisions made in the patient. Another incision allows for the insertion of a combination light and scope  32  to allow the site to be viewed by the surgeon on a monitor (not shown). In FIG. 2, suture ends  34  and  36  have been sewn through tissue  38  and an organizer  40  has been run down ends  34  and  36  from outside cannula  28 . A hollow suture needle  42  holding suture  44  has been inserted through the tissue  38 . After removal of the needle, the ends of suture  44  will be routed through organizer  46 , as shown in FIG. 3. Yet another organizer  48  holds suture ends  50  and  52  of yet another suture that is subsequently sewn. FIG. 3 shows a surgical bur  54  inserted through cannula  30  to prepare the bone  56  for the conclusion of the instability procedure. FIG. 4 shows that sutures  58 ,  60  and  62  have been sewn through the tissue  38  and tied off with the excess already removed. Subsequently, each pair of suture ends can be brought through the cannula  28  at which time the particular organizer associated with the suture ends can be removed and several knots can be pushed down to tie one suture pair at a time while the remaining untied sutures have their end pairs held together and out of the way by their respective organizers. Each of the organizers can be held in position outside the patient by being clamped on the suture ends extending through it, after the organizer is fully advanced. Such clamping could be accomplished by a separate clamp  70  (FIG. 1) or by a simple forceps tool (not shown) or by forming the proximal end  71  of the organizer into a smaller diameter or crimped end  73  to frictionally engage the suture (best seen in FIG. 9). Each organizer can also serve as a guide for insertion of a cannula, if needed during the procedure. This can be done just prior to tying off a pair of suture ends by grasping the organizers and directing them out, one at a time through the cannula. Using this procedure avoids confusion and assures that proper suture ends are tied.  
         [0019]    For shoulder arthroscopic procedures the organizers should be in the range of 5 to 9 inches (12.7 to 22.86 cm) and preferably about 7 inches (17.78 cm) long. They can vary in diameter, although an outside diameter of about 0.083 inches (2.1 mm) and an inside diameter of about 0.063 inches (1.6 mm) (i.e. about the size found in a 14 gauge angiocatheter) is preferred for two strands of #2 suture. The inside diameter (lumen) of a 12 gauge catheter would be suitable for #5 suture. Various lengths and diameters (6 to 22 gauge, for example) may be used depending upon the procedure and surgeon preference. The organizers should preferably be made of biocompatible plastic and need to be reasonably rigid to facilitate use, handling and storage whether or not a rack such as rack  62  is used as shown in FIGS.  5 - 7 . The rack  62  can be a rectangular block with slots  64  into which the organizers  66  can be snapped or otherwise received, and placed in a sterile package. The curvature in the embodiment of FIG. 6 allows the ends  68  to be further apart for simpler grasping. Optionally, as shown in FIG. 7, the curvature of the rack  62  can be about a line parallel to the plane of curvature shown in FIG. 6, so as to preserve the parallel alignment of the organizers.  
         [0020]    The length of organizers in a set or kit can vary to address the need of the particular application. The organizers can be produced in different colors to more easily distinguish them and to insure the desired organizer has in fact been grasped. The lumen size can be varied. More than two ends of a single suture could be run through a single organizer. For example, a particular anchor may fixate two sutures of different colors with the two pairs of ends extending through a single organizer. In that situation the color is used to insure the correct pair get tied together and the remaining pair gets tied immediately thereafter. Depending upon the parameters ultimately selected, the suture organizers could also be used in open surgical procedures, whether or not suture anchors are used.  
         [0021]    Each organizer can be individually sheathed to maintain it in a sterile condition, whether packed individually or in sets in a rack  62 . Each organizer is preferably packaged with a loop  22  extending from one end and a small clip  70 , shown schematically in FIG. 1, and constructed similarly to a clamp on an intravenous drip. A series of protrusions on the exterior of the organizer can keep the clip  70  from falling off when not in the clamped position around a pair of suture ends to fixate the organizer. Clearly such a clamp is unnecessary if one uses an embodiment such as that shown in FIG. 9 (a restricted end).  
         [0022]    While organizers  20  have been shown as having a single lumen  19  for accommodating a pair of suture ends, it will be understood that such organizers could have one lumen per suture end. Such a single lumen organizer used for a single suture end would double the number of organizers for a given procedure and, therefore, may not be suitable for certain applications even though it would ensure no tangling of sutures. Alternatively, an organizer could be provided with two or more lumens: one lumen for each suture end. Each lumen could be provided with its own threading tool. Using multi-lumen tubes one could accommodate various numbers of sutures within a single tube.  
         [0023]    Depending upon the rigidity of the organizers, it may be desirable to utilize a supplemental tubular support (not shown) of greater rigidity. The supplemental support could be used temporarily by receiving within its lumen an organizer to thereby hold the organizer and its suture fairly straight to enable them to be easily passed through a cannula (in a portal during an arthroscopic shoulder procedure, for example).  
         [0024]    It will be understood by those skilled in the art that numerous improvements and modifications may be made to the preferred embodiment of the invention described herein without departing from the spirit and scope thereof.