Abstract:
A suture anchor cartridge having a rectangular case portion that includes a top portion and a rectangular bottom portion, the bottom portion including an opening, and the top portion being slidably connected with the bottom portion. A suture anchor is suspended in the opening in the bottom portion. The suture anchor being held at a distal end and at a proximal end by the suture anchor cartridge, and a suture-threading loop is disposed within the bottom portion.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    Field of the Invention 
         [0002]    The invention relates to a sterile packaging unit containing a suture threader and a suture anchor for easy application of a suture to the anchor and a method for using the cartridge. 
         [0003]    Description of the Background Art 
         [0004]    The field of arthroscopy has advanced quickly in recent years, demanding quicker, easier and minimally invasive techniques for increasingly common joint surgeries. Since speed and efficiency translate into quicker recover times and overall better patient experiences, saving time and avoiding mistakes greatly improves operating success. 
         [0005]    Soft tissue, such as a tendon or ligament, can rupture and become damaged or detached from a patient&#39;s bone as a result of injury or a medical procedure. Injuries of this type include, torn rotator cuffs, labral tears, bicep tendon tears and quadricep ruptures. Surgical treatment of a torn rotator, for example, is designed to reattach the damaged tendon(s) back to the humeral head (ball of the shoulder joint) from which it was torn. Other torn tendons and ligaments require similar procedures. 
         [0006]    Bone anchors are one medical implant than can be used to attach soft-tissue to the bone. These anchors are designed to hold the tissue onto the bone at its point of reattachment to allow the tissue to heal and naturally reattach itself to the bone. Alternatively, sutures may be threaded through the soft tissue and tied to an anchor implanted in the bone. 
         [0007]    Two points in a normal operation procedure present difficulty and are prone to mistakes. The first is knotting the suture onto the suture anchor or alternatively threading the suture through an eyelet in the anchor. The second is keeping the driver and suture threads in-place and connected to the anchor while adjusting the suture and implanting the anchor in the bone. 
         [0008]    After threading the suture through the tendon or ligament to be reattached, the surgeon must tie the suture off to the anchor before inserting the anchor into the bone. Bone anchors are tiny and the holes or mounts to which the suture is tied are even smaller. Therefore, tying the suture off requires extreme dexterity and hand-eye coordination on the part of the surgeon. 
         [0009]    One prior art device for aiding the surgeon is disclosed in U.S. Pat. No. 5,741,300 and provides a surface for holding the suture anchor and a threading loop for assisting the surgeon in threading and knotting the suture. The disclosed process, however, still requires threading the loop and knotting the suture to the anchor to prepare the anchor for implantation. Furthermore, the anchor itself is not securely fastened to the holder but simply held by gravity, thus providing the surgeon with little stability beyond the larger holding area. 
         [0010]    Knotless suture anchors have been introduced but these present their own difficulties. To provide knotless fastening of the suture, suitable locking bridges are needed between the outer face of the body of the anchor element and the inner face of the sleeve. These make release from this locked position difficult or impossible. Additionally, locking the suture into the anchor requires clamping that can damage the suture by the shearing of the inner screw against the sleeve. 
         [0011]    Thus, the prior art devices remain difficult to use and prone to mistakes and damage. The invention described below offers several features to increase usability and efficiency as well as guarantee the safe implantation of the device in the patient. The benefits of these improvements include faster and cleaner surgeries as well as reductions in risk and device malfunction. 
       SUMMARY OF INVENTION 
       [0012]    According to an exemplary embodiment, the suture anchor cartridge includes a rectangular case portion that includes a top portion and a rectangular bottom portion, the bottom portion including an opening, and the top portion being slidably connected with the bottom portion. A suture anchor is suspended in the opening in the bottom portion. The suture anchor being held at a distal end and at a proximal end by the suture anchor cartridge, and a suture-threading loop being disposed within the bottom portion. 
         [0013]    According to an exemplary embodiment, both free ends of the suture-threading loop are knotted to the top portion such that the suture-threading loop passes underneath the top portion after the top portion is slid forward. Additionally, the exemplary cartridge is arranged such that the suture-threading loop passes through an eyelet disposed in the distal end of the suture anchor. 
         [0014]    An exemplary embodiment of the suture anchor cartridge also provides a slot in the bottom portion aligned with the suture anchor body and terminating at the proximal end of the suture anchor. Additionally, a groove is disposed on the bottom surface of the bottom portion to receive the suture-threading loop. Additionally, a clip is disposed on the bottom of the bottom portion for attachment to a driver shaft. 
         [0015]    Furthermore, the cartridge can include a sterile packaging unit with the contents being sterile as well. Accordingly, the rectangular case portion, the suture anchor and the suture-threading loop are sterile. 
         [0016]    An exemplary embodiment of the suture anchor includes a distal end that is breakable at a predetermined point, the distal end being held by the suture anchor cartridge. Once broken and separated, the suture anchor is ready for the threading of the suture using the pre-threaded suture threading loop. Once threaded, the suture and suture anchor are no longer connected to the cartridge and are ready for implantation. 
         [0017]    Further scope of the applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]    The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention, and wherein: 
           [0019]      FIG. 1  shows an exploded view of the suture anchor; 
           [0020]      FIG. 2  shows the suture anchor secured in the anchor cartridge; 
           [0021]      FIG. 3  shows the suture anchor cartridge with driver inserted; 
           [0022]      FIG. 4  shows the suture anchor cartridge with pre-threaded suture guiding loop; 
           [0023]      FIG. 5  shows the suture anchor cartridge and where the pre-threaded loop is tied off; 
           [0024]      FIG. 6  shows the suture anchor cartridge after sliding the top cover forward; 
           [0025]      FIG. 7  shows the suture anchor cartridge with the anchor broken out and ready for the suture to be inserted; 
           [0026]      FIG. 8  shows the suture anchor cartridge attached to the driver; 
           [0027]      FIG. 9  shows the suture anchor cartridge with a suture inserted into the pre-threaded loop; 
           [0028]      FIG. 10  shows the suture anchor cartridge detached from the driver and drawing the suture through the eyelet of the suture anchor; 
           [0029]      FIG. 11  shows the final result of the method using the suture anchor cartridge with suture threaded and ready for implantation. 
       
    
    
     DETAILED DESCRIPTION 
       [0030]    In the exemplary design shown in  FIG. 1 , the suture anchor  5  comprises an inner screw  3 , an outer sleeve  2  and a detachable extension  1  for securing the anchor in the cartridge. On the left is a view before insertion of the inner screw and on the right is a view after insertion of the inner screw. The proximal end of the suture anchor provides a square head for insertion into a driver device. 
         [0031]    The outer sleeve in this example includes grooves for engaging the bone tissue upon insertion. The head portion of the bone anchor includes an eyelet for receiving the suture thread which extends perpendicular to the longitudinal axis of the screw body. 
         [0032]    The suture anchor  5  is also shown in  FIG. 2  both inside and outside the cartridge  6 . When manufactured, the suture anchor is be provided inside the cartridge along with a pre-threaded loop and surrounded by a sterile packaging unit (not shown). The left view of the cartridge is a top view showing the sliding lid portion and the cartridge body. The right view of the cartridge  6  is an underside view with thread slot visible. 
         [0033]    In the assembled, ready-to-use state of the cartridge, the suture anchor  5  is positioned within a cartridge cavity that is located centrally within the cartridge  6 . Here the suture anchor  5  is secured at its distal end with a short pin-like tip in a wall of the case of the cartridge  6 . The suture anchor and the pin-like tip are connected to each other via a predetermined breaking point. The cartridge also contains a laterally located access-opening for viewing and detaching the suture anchor secured within the case. 
         [0034]    The anchor driver  7  is then inserted into the cartridge  6  as shown in  FIG. 3 . The driver device can then be pushed forward until its distal end is totally inserted in the lumen of the socket provided by the suture anchor. The length of the distal end of the driver device preferably corresponds to the depth of the cavity in the cartridge. Likewise, the tip of the driver is dimensioned with proper depth and width such that it fits snugly on the socket of the bone anchor. 
         [0035]    The cartridge is provided with a thread  8  that is looped within the cartridge and pre-inserted through the suture anchor eyelet. This configuration is shown in  FIG. 4 . The thread  8  is preferably easier to grip and handle (e.g. thicker, stiffer, more controllable) than the suture itself. Alternatively, the thread  8  could be a thin wire. These materials would allow the surgeon to feed the suture through the loop more easily, and pass the thread back through the suture anchor eyelet once it was detached. 
         [0036]    In order to maintain the thread  8  in position through the anchor eyelet, both free ends of the thread are knotted to the sliding top portion of the cartridge when manufactured. This arrangement is shown in  FIG. 5 . The resulting loop is disposed within the a groove in the bottom of the cartridge but not fixed to it. 
         [0037]    In the next step, the slidable lid is moved from a proximal position to a distal position as seen in  FIG. 6 . The suture anchor and the inserted driver device are then exposed. By leveraging out the driver device, the suture anchor preferably breaks at the predetermined breaking point which allows the suture anchor to be removed from the cavity. The driver device and suture anchor now constitute a functional device for a surgery. 
         [0038]    After separation of the driver and anchor from the cartridge, the cartridge can then be clipped onto the shaft of the driver device as shown in  FIG. 7 . In this position, the cartridge can be moved along the shaft of the driver device. When moving the cartridge proximally, the thread is pulled out from the grooves on the bottom. After the separation of the driver and anchor, most of the thread will have been pulled out of the bottom of the cartridge leaving a loop outside the eyelet. 
         [0039]    The thread and anchor are then usable by the surgeon. The suture  10  is then passed though the loop in the thread  8  as shown in  FIG. 9 . The cartridge can then be removed or unclipped as shown in  FIG. 10 . As the cartridge is moved away from the driver and anchor assembly, the suture is drawn through the eyelet. Additionally, if one free end of the suture is held, then the other end of the suture will be drawn through the eyelet. 
         [0040]    Once a free end of the suture is completely drawn through the eyelet, the thread  8  and cartridge  6  assembly are separated from the driver  7 , suture  10  and anchor  5  assembly. This final result is apparent in  FIG. 11 . The threaded suture is then ready for the surgeon to implant the anchor into the bone. 
         [0041]    The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.