Abstract:
Methods, systems, and apparatuses are provided for attaching tissue, for example to bone. For example, devices are provided for anchoring filament to tissue or bone. Suture anchors are provided, and multi-component suture anchors are provided with sutures and components that fit together through an interference fit.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 10/629,978 filed on Jul. 30, 2003 and entitled “Self-Locking Suture Anchor,”now U.S. Pat. No. 7,081,126, which is a continuation of U.S. Pat. No. 6,660,023 filed on Feb. 27, 2003 and entitled “Self-Locking Suture Anchor,” which is a continuation of U.S. Pat. No. 6,527,794 filed on Aug. 10, 1999 and entitled “Self-Locking Suture Anchor.” These references are hereby incorporated by reference in their entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates to surgical fasteners, e.g., anchors that secure sutures to bone, a meniscus, or other tissue. It further relates to a suture anchor that attaches a suture to tissue without the use of knots, and to methods of securing tissue using one or more anchors and a length of suture. 
     Many surgical procedures require the attachment of soft tissue, e.g., ligament or tendon grafts, to bone. This is typically accomplished by anchoring a suture in bone, for example with a screw, pin, or other bone anchoring device, and looping the suture around or stitching the suture to the soft tissue. When this process is completed, the surgeon generally must knot the suture to secure the tissue. This knotting process can be difficult and tedious, particularly during laparoscopic or endoscopic procedures, where the surgeon must remotely manipulate the suture using tools inserted through an endoscopic tube. Further, as many as six knots are often required to secure one suture. These knots may “stand proud” above the tissue and interfere with movement and healing. 
     One advance which has been proposed is the anchor apparatus disclosed by Goble, et al., in U.S. Pat. No. 5,702,397. That apparatus comprises an anchor body through which a suture passes, and which contains a clamping mechanism such as a spherical element within the anchor body. When the suture is pulled in a proximal direction, the clamp is urged into contact with the anchor body, thereby holding the suture in place. When the suture is pulled in a distal direction, the clamp disengages, and the suture can move freely through the anchor body. At least one end of the suture is stitched and/or knotted to soft tissue. 
     Several knotless suture anchor assemblies have recently been proposed by Thal in U.S. Pat. Nos. 5,569,306; 5,658,313; 5,665,112; and 5,683,419. These describe suture anchors which secure a filament having a small loop at one end. In some embodiments, another length of suture ends in a small block, which is passed through the loop to secure the tissue. While these structures can be secured without knots, the block used to secure the suture may itself stand proud above the tissue, causing discomfort and interfering with healing. In other embodiments, the anchor itself is passed through the small loop, creating a larger loop which is used to hold tissue. 
     U.S. Pat. No. 5,709,708, also by Thal, describes a suture anchor utilizing a continuous loop of suture material, which secures the tissue in a similar manner. As in the other Thal knotless anchors, the tension of the suture is dependent on the length of specially provided suture, which cannot be adjusted. Thus, these anchors cannot be used in surgical operations in which it is necessary to tighten a loop of suture to secure soft tissue. 
     The tying of suture knots presents difficulties in other surgical procedures, as well. For example, tears occur commonly in the menisci of athletes. The simplest method of repairing such a tear is to stitch it closed by passing a length of suture through the tissue and tying. However, the needles used in such surgery are very difficult to manipulate during endoscopic surgery, and the knots used to secure the suture may interfere with healing as described above. These difficulties are particularly severe in the restricted space of the joint capsule of the knee, a common location for such injuries. Other devices such as darts and clamps have also been proposed for this purpose; see for example U.S. Pat. Nos. 5,154,189; 5,269,783; and 5,702,462. Like suture knots, these devices may cause considerable discomfort during healing of the tear. Further, if made of non-bioabsorbable materials, a second surgery must be performed to remove the devices from the meniscus after healing. 
     A need thus exists for an improved technique and apparatus for securing tissues without the use of knots. A further need exists for such techniques and apparatus which also permit the position of the suture to be readily adjusted. A still further need exists for such apparatus which is small enough to avoid discomfort, which is amenable to fabrication from bioabsorbable materials, and which can be used either in bone or in soft tissue. 
     SUMMARY OF THE INVENTION 
     The above needs are among those met by the invention, which provides an anchoring device that can be embedded in bone or soft tissue, that permits suture length and/or tension to be readily adjusted, and that can be secured without the use of knots. 
     In one aspect of the invention, a suture anchor suitable to be embedded in bone has a cavity which holds a filament (e.g., a suture) by interference fit. The anchor holds the suture tightly enough to resist “operational” forces to which the suture is subjected subsequent to deployment, e.g., during movement of the bones and/or soft tissues to which the suture is attached. However, the interference fit is weak enough to allow the suture to be pulled longitudinally through the cavity by a stronger force. 
     In use, such an anchor can be placed with some slack in the suture. The suture can then be tightened by pulling on one of its ends (with the larger force). It is an advantage of the invention that the tightening of the suture can be reversed, simply by pulling on a loop formed by the suture or by pulling on its opposite end. The suture does not loosen in normal use, however, since the forces required to move during deployment are greater than those exerted by the bones and/or tissues to which it is attached. 
     In a related aspect, the anchor may hold the suture at two points, forming a loop. The loop can be disposed around tissue and, then, tightened by pulling one end of the suture, thereby securing the tissue. Again, if the loop is drawn too tight, it can be loosened by pulling firmly. 
     The invention also provides methods for attaching soft tissue to bone. In these methods, an anchor of the type described above can be emplaced in bone. The soft tissue is secured by stitching or by catching a portion of the tissue in a loop of suture, which is subsequently tightened. The suture can be tightened or loosened as necessary during deployment, and need not be knotted. 
     These and other aspects of the invention are evident in the drawings and in the description that follows. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is best understood with reference to the drawings, in which: 
         FIGS. 1 and 2  are illustrations of suture anchors according to the invention, adapted to be embedded in bone; 
         FIG. 3  is an illustration of a suture anchor according to the invention before deployment; and 
         FIGS. 4A-4C  illustrate a deployment process for the anchors shown in  FIGS. 1 and 2 . 
     
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       FIG. 1 a    shows a cutaway view of a suture anchor according to the invention. The anchor comprises an anchoring element  10 , which is adapted to be embedded in a bone tunnel or in soft tissue, and comprises an axial channel  12 . In the embodiment shown, element  10  comprises a series of ridges  14  on its outer surface, which aid in securing the element, for example, in a bone tunnel. It will be understood that the ridges  14  are not a necessary element of the anchor, and may be omitted if desired. The anchor  10  further comprises an insertion stem  16 . When the anchor is in the deployed position shown in  FIG. 1 a   , the insertion stem  16  is held within the axial channel  12 , e.g., by interference fit. In preferred embodiments, the insertion stem  16  is slightly larger than the axial channel  12 , so that the stem  16  forces the anchoring element  10  to expand when it is inserted therein, thereby securing the anchor firmly in the bone tunnel. 
     The anchor further comprises a filament  18 , e.g., a suture, disposed between the anchoring element  10  and the insertion stem  16 . In the preferred embodiment shown in  FIGS. 1 a  and 1 b   , the insertion element comprises a suture channel  20 . This channel guides the suture  18 , and holds it in compression against the anchoring element  10 . The configuration of anchoring element  10 , insertion stem  16 , and suture  18  can be seen clearly in  FIG. 1 b   , which shows a cross-sectional view of the anchor at the point indicated by the arrows of  FIG. 1 a   . The mild compression of the suture  18  in the channel  20  provides a frictional resistance to prevent movement of the suture when tension is applied to one of its free ends  22 . This frictional resistance is overcome when a tension greater than the threshold tension is applied to a free end of the suture. The suture  18  may then slide longitudinally through the channel  20 , allowing the length of the free ends  22  to be adjusted. 
     It will be understood that the configuration of suture  18  in  FIG. 1  represents only one of many possible embodiments of the invention. In particular, it will often be preferable to pass the suture between the insertion stem  16  and the anchoring element  10  multiple times, for example, in order to form a loop segment. In other embodiments of the invention, the compression of the suture may be stronger, so that the threshold tension which would be necessary to move the suture is close to or exceeds the breaking strength of the suture. In such embodiments, the length of the free ends is no longer adjustable once the compression on the suture is applied. 
     In one such embodiment, the suture (or other filament) may be formed with a small loop at one end, which is used to secure the suture to the anchor. This embodiment is illustrated in  FIGS. 2 a  and 2 b   ; the former depicting a cross-section of the anchor along the axis of symmetry; and the latter depicting a transverse section. The head of suture  18  comprises a small loop  28 ; e.g., disposed at the distal end of the anchor. The suture passes between the insertion stem  16  and the anchoring element  10 , forms a loop segment  26 , and passes back between the insertion stem and the anchoring element. The suture then passes through head loop  28 , back up between the insertion stem  16  and the anchoring element  10 , and ends in free end  22 . The loop segment  26  can be tightened by pulling free end  22 , and loosened by pulling the loop segment  26  itself. Because of the mechanical advantage afforded by looping of the suture, the force required to loosen the suture by pulling on loop  26  is twice the force required to tighten the suture by pulling on free end  22 . In the embodiment shown, the suture passes through two channels  23 ,  25  in the anchor  16 ; one of these channels  25  could be eliminated so that the suture would pass around the head of the anchor. 
       FIGS. 3 a  and 3 b    illustrate a different embodiment of the anchor, in which the suture is secured by a small knot  27  rather than a loop.  FIG. 3 a    is a plan view of the anchor, and  FIG. 3 b    is a longitudinal cross-section. 
       FIGS. 4 a -4 c    illustrate a deployment process for the anchors shown in  FIGS. 1 and 2 . Only a portion of the suture is shown in  FIGS. 4 a -4 c   ; preferably, the suture will be looped in the fashion shown in  FIG. 2  or  FIG. 3 .  FIG. 4 a    shows an anchor placed in bone tunnel  32 , connected to deployment apparatus  34 .  FIG. 4 b    illustrates the insertion element  16  being pulled into the axial channel  12  of anchoring element  10 . Tension is applied to the stem of insertion element  16  (in the direction shown by arrow A) by the colleted stem-pulling portion of the deployment device  34 , while the anchoring element  10  is held substantially immobile within bone hole by the anchor-holding portion of that device. These forces act to move the insertion element  16  in the direction of arrow A such that larger diametered portion of insertion element is pulled into the axial channel  12  of anchoring element  10 . As a result, the wall of the anchoring element  10  expands outwardly and into the walls of the bone hole  32 . As shown in  FIG. 4 c   , the insertion stem is pulled proximally through the axial bore  12 , until further motion is retained by abutment of flange  36  with the distal end of anchoring element  10 . At this point, the deployment device continues to exert tension on the stem  16 , causing frangible portion  38  to shear. This facilitates removal of the excess portion of the stem  16  and, likewise, disengages the deployment device  34 . The suture  18  can be adjusted by pulling firmly on free end  22 . 
     The suture anchors of the invention can be provided in a variety of sizes and materials, depending on the intended application. For example, a typical anchor intended to be embedded in the shoulder blade, for use in repair of the rotator cuff of an adult, might have a length in the range of 8-15 mm and a diameter in the range of 3-6 mm. Such an anchor might be capable, for example, of holding a #2 suture with a threshold force in the range of 25-35 lbs. (As it is used herein, the term “threshold force” describes a pulling force above which a filament moves longitudinally through an anchor, and below which the filament substantially does not move through the anchor). It is generally desirable for the anchor to consist of biocompatible material, e.g., implant grade high density polyethylene, low density polyethylene (PE 6010 and PE 2030), polypropylene (13R9A and 23M2: all made by Rexene, Dallas, Tex.) or surgical implant grade steel. In some embodiments, the anchor may comprise a bioabsorbable material, e.g., poly-1-lactide or a lactide-glycolide composition. 
     In an exemplary embodiment of the methods of the invention, the anchor illustrated in  FIGS. 3 a  and 3 b    can be used to repair a torn rotator cuff by reattachment of the rotator cuff to the scapula. An anchor such as that illustrated in  FIG. 3 a   , which holds a loop of suture by interference fit, is embedded in a tunnel drilled, for example, in the scapula. The loop of suture and the free end of the suture extend out from the scapula at the proximal end of the anchor. 
     When the anchor is disposed in the bone tunnel, a portion of the torn rotator cuff is passed through the suture loop. The loop is then tightened by pulling with a force greater than the threshold force on the free end of the suture. This tightens the loop, drawing the tissue against the anchor and securing it to the bone without knotting the suture. The free end of the suture may then be trimmed, if desired. 
     The invention may be used with various anchor designs, depending on the nature of the surgical repair. In particular, designs similar to those described in U.S. application Ser. No. 08/813,914, now U.S. Pat. No. 5,935,129, e.g., at FIG. 5 and in the accompanying text, and in U.S. application Ser. No. 08/814,149, now U.S. Pat. No. 5,911,721, and in the accompanying text, both of which are incorporated herein by reference, may be adapted to hold a suture in accordance with the teachings herein. 
     Other embodiments of the invention will be apparent to those skilled in the art from a consideration of the specification or practice of the invention disclosed herein. For example, while the invention has been described primarily in the contexts of securing soft tissue to bone and of repairing tears in soft tissue, it may also be used to secure or repair cartilage, ligaments, or other tissues. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.