Abstract:
An interarticular ligament prosthesis is formed from a plurality of high strength high modulus polymeric fibers. The fibers are independent and free from intrinsic inter-fiber shear coupling found in braided or bonded fibers. The ligament prosthesis is installed with tubular, bone screw anchors. The fibers of the ligament prosthesis pass through the central hole of the anchors and are knotted at one end. The exit holes of the anchors include ceramic eyelets with polished edges. The edges are rounded to a defined radius for desired fatigue life of the prosthesis.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS 
       [0001]    This application claims priority to U.S. Provisional patent application Ser. No. 60/913,275, filed Apr. 21, 2007. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention relates to an Anterior Cruciate Ligament (ACL) prosthesis and an anchor to fix its ends into bones. More particularly, it relates to an ACL prosthesis formed of a plurality of independent filaments and an anchor for minimizing wear and failure. 
         [0004]    2. Discussion of Related Art 
         [0005]    Anterior Cruciate Ligament (ACL) in the human knee joint, commonly called Cranial Cruciate Ligament in the canine stifle, is frequently torn in trauma, or, as it happens in dogs, fails after a degenerative process of still unknown etiology. Direct repair is usually not possible—when attempted, it predictably fails. 
         [0006]    In human orthopedics, the standard procedure calls for replacement by an allograft, a part of the patellar ligament, or a part of the tendon removed from hamstring muscles. The procedure results in a stable knee, but the long term performance is often unsatisfactory with over a half of cases resulting in arthrosis of the joint. 
         [0007]    In dogs the standard procedure is either an extracapsular suture (usually placed on the lateral side of the joint) approximating the function of the ligament, or one of the geometry modifying surgical techniques, e.g. Tibial Plateau Leveling Osteotomy (TPLO), Cranial Closing Wedge Osteotomy (CWO), or Tibial Tuberosity Advancement (TTA). Intra-articular prostheses are also occasionally used, but those generally end up in failure. Extracapsular sutures also fail. These are intended to provide stability of the joint for several weeks while waiting for fibrosis to form around the joint, which then should provide for long term stability. Arthrosis of the joint at longer term, at a year or so, is the rule rather exception. 
         [0008]    There are a variety of anchors used to fix the ends of an ACL prosthesis into bones. Most commonly, they are so-called interference screws, designed to be inserted along the prosthesis (transplanted tendon or ligament, or an artificial ligament) within an anchor hole, or tunnel, drilled in the bone. The interference screw jams the prosthetic tissue against the bone within the anchor hole.  FIG. 1  shows an ACL bone anchor  1  of the interference screw type inserted into bone  3  in the direction  5  so as to jam the prosthetic tissue  2  within the hole  4  which can then resist pull-out force  6 . Such screws are made either from metal, most commonly titanium, or bioresorbable polymers. 
         [0009]    Another common technique is so-called cross-pin used to anchor a loop of the prosthetic tissue within a hole drilled in the femoral condyle. In all cases, prosthetic tissue exits the tunnel by bending over the edge of the bone; healing/remodeling of the bone is expected to fill the gaps and to result in a natural-like anchorage of the ligament in the bone.  FIG. 2  shows an ACL anchor  7  of the transverse, or cross pin type, inserted into the bone of the femoral condyle  12  through a hole  10 . A front section  8  of the anchor  7  passes through a loop of prosthetic tissue  9  inserted through hole  11 . In this manner the prosthetic tissue can support the pull  13 . 
         [0010]    Neither of these techniques is suitable for a permanent anchorage of an artificial ACL replacement. Bending of the prosthesis over the edge of the hole will lead to both, bone loss due to contact resorption and mechanical damage—ultimately failure—of the prosthesis due to bending and wear at the edge of the hole. 
         [0011]    An alternative method of using screw anchors with the prosthesis fixed in their central, axial hole also do not provide for a durable anchorage, because in all known designs the bending of the prosthesis over the edge of the hole exceeds the fatigue limit of even the best materials used for prosthesis. 
       SUMMARY OF THE INVENTION 
       [0012]    The present invention substantially overcomes the problems of existing ACL prostheses by providing a prosthesis made from high performance polymeric fibers. According to one aspect of the invention, the ACL prosthesis is formed of a plurality of independent filaments or fibers. Such fibers may include oriented, high modulus, ultra high molecular weight polyethylene available from either DSM, Netherlands as DYNEEMA, or from Honeywell, USA as SPECTRA. The invention further includes anchors for use with the ACL prosthesis. The anchors are tubular so that the ACL prosthesis can be threaded through the anchor and fixed within the bone. According to one aspect of the invention, the anchor has a radius at the edge of the exit hole to prevent wear of the ACL prosthesis. According to one aspect of the invention, the radius at the edge of the exit hole from the anchor exceeds a given ratio to the fiber diameter. According to another aspect of the invention, the ratio has an order of magnitude of about 100. According to another aspect of the invention, the fibers of the ACL prosthesis have a diameter on the order of 10 micrometers and the radius is on the order of 1 mm. 
         [0013]    According to another aspect of the invention the anchors are made from titanium, or a titanium alloy. According to another aspect of the invention, the anchors include a separate eyelet at an exit hole. The eyelet is made from a ceramic providing a smooth, hard surface for the radius. According to another aspect of the invention, the eyelet is of ruby or sapphire. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]      FIG. 1  is a cross sectional view of a state of the art interference screw for anchoring a ligament replacement tissue within a bone tunnel. 
           [0015]      FIG. 2  is a cross sectional view of a state of the art transverse pin for anchoring ACL replacement in the lateral condyle of the femur. 
           [0016]      FIG. 3(   a ) is a cross sectional view of an ACL anchor in the bone according to an embodiment of the present invention. 
           [0017]      FIG. 3(   b ) is a top view of an ACL anchor according to an embodiment of the present invention. 
           [0018]      FIGS. 4(   a )- 4 ( d ) are views of an ACL prosthesis according to an embodiment of the present invention in the knee. 
           [0019]      FIG. 5  is a partial cross sectional view of an anchor and ACL prosthesis according to an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0020]    The present invention includes a novel ACL prosthesis and an anchor therefor. The ACL prosthesis is formed of a plurality of independent filaments. Individual filaments have small diameters in order to limit the bending strain. Multiple filaments operate together to provide the necessary strength for the ACL prosthesis. The filaments are not braided or bonded in order to increase the bending strength. A novel anchor attaches the ACL prosthesis to the bone. 
         [0021]      FIG. 3(   a ) shows a cross sectional view of the bone anchor  21  according to an embodiment of the invention inserted into bone  33 . The body  20  of the anchor is threaded, the threads being preferably self-tapping. A hole  29  is drilled through the whole anchor. At the tip of the anchor, the hole  29  is conical  22 , and has a well-rounded edge. The head  34  of the anchor has a recess for accepting a ring or eyelet  23 . The eyelet  23  has a central hole of diameter  30 , which is smaller than the diameter  31  of the hole  29 . The eyelet entry edge is rounded with radius  24 . Prosthesis  25  passes through the hole in the eyelet and the hole  29  in the anchor body. At the tip of the anchor a knot  26  prevents pull-out under tension  27  on the prosthesis  25 . The prosthesis  25  may swing through an angle  28  from the end of the anchor  21 . 
         [0022]      FIG. 3(   b ) is a top view of the anchor  21 . A set of grooves  35  are formed in the head  34  of the anchor  21 . To install the anchor, a hole  32  is drilled in the bone  33 . A special screwdriver engages the grooves  35  in order to rotate the anchor  21  to drive it into the hole  32 . 
         [0023]      FIGS. 4(   a ) and  4 ( b ) show lateral and frontal views, respectively, of the knee joint with the prosthetic ligament  45  according to an embodiment of the invention fixed to the tibia  42  with the anchor  44  and to the femur  41  with the anchor  43 . With the movement of the joint, shown in  FIGS. 4(   c ) and  4 ( d ), the later being in full flexion, the angle  47  between the anchor  44  and the ligament  45 , and the angle  46  between the anchor  43  and the ligament  45  change, implying flexion of the ligament over the edge of the anchor. It is also clear, but not shown in the frontal view that the ligament will undergo some rotational movement at the exit of the anchor. The prosthesis and anchor of the present invention minimize the strain and wear on the ligament from flexion and rotational movement. 
         [0024]    The relationship between the prosthetic ligament and the anchor are illustrated in  FIGS. 5(   a ) and  5 ( b ). The ceramic eyelet  23  is rounded with the radius  24  at the exit of the prosthetic ligament  50 . Movement of the ligament through the angle  28  in the cross-sectional view results in the bending of the fibers within the ligament bundle. If the diameter of the fiber  51  is d, and the radius  24  of the rounded eyelet exit is R the maximum strain experienced by the filament bending over the edge is approximately equal to d/2R. If the fatigue limit on the strain in the fiber is ε max , the radius of the edge should be: 
         [0000]        R&gt;d/ 2ε max .
 
         [0000]    With the best expectations of high performance polymeric fibers, the fatigue limit on the strain in the fiber is on the order of 0.015, thus the radius of the eyelet exit edge, R, should be at least 30 times larger than the diameter of the filament, d. The strongest filaments of e.g. highly oriented polyethylene are on the order of 0.015 mm in diameter. For those, the radius should have at the least about 0.5 mm. However, this would leave no capacity to resist any tension. A factor of 2 in the radius, i.e. about 1 mm would allow maximum tension in fatigue to be about one half of its nominal value—a reasonable compromise. 
         [0025]    Let the fatigue strain at expected number of cycles in use be ε max , the fiber diameter d, and the factor for allowed functional tension k. Then the radius of curvature, R, of the edge of the eyelet should be: R&gt;(k/2)(d/ε max ). The factor k must be larger than 1, preferably in the range from 2 to 4. The number of fibers needed within a given prosthesis would be determined based on the estimate of the tensile forces it must resist in fatigue. 
         [0026]    Existing prosthetic ligaments are either monofilament (used only in veterinary applications) or braided multifilament. Neither type can offer satisfying performance at the anchor exit. For the monofilament fibers the radius of the exit edge required is simply not possible in most situations, i.e. those ligaments will predictably fail in use. Braiding as conventionally done will effectively increase the diameter of the fiber and will also lead to failure. Another serious drawback of braiding is the increased risk of infection—bacteria within a braided suture are not accessible to immune system cells and can thus remain a threat as long as the prosthesis is in the joint. To further increase resistance to infection, fibers, at least some of them, could be prepared with a content of silver, known to have antibacterial properties. All or a portion of the multifilament prosthesis can be held together with a gelatin or other substance which will dissolve within the body. This makes the suture easier to use and to tie, yet allows the filaments to separate in order to achieve improved wear and failure resistance. 
         [0027]      FIG. 5(   b ) shows that the motion of the prosthetic ligament will also have a component  28   a  leading to sliding at the exit. To minimize potential damage due to wear the surface of the eyelet should be both hard and polished, hence ceramic is a preferred material for the eyelet, either monocrystalline, such as ruby or sapphire, or polycrystalline, such as alumina or zirconia. 
         [0028]    In the preferred execution the prosthetic ligament,  45  would be pre-assembled with the femoral anchor  43 . After the anchor  43  is screwed into the femur from within the knee joint, the second anchor  44  is screwed into the tibia from proximal to distal, the free end of the ligament is passed through the hole in  44 , the ligament is tensioned as needed and a knot is tied and pushed to the distal exit from the anchor  44 . The knot can be secured by melting over it a polymer sleeve of melting temperature lower than that of the suture itself. For example if the suture is made from oriented, high modulus, ultra high molecular weight polyethylene with melting temperature of about 150 deg C. the sleeve can be made from a low molecular weight polyethylene melting at about 110 deg C. However, in most applications a simple knot will suffice since the exit of the hole in the anchor is conical and will tend to lock the knot and prevent it from getting loose. 
         [0029]    Preferred fiber for construction of the prosthetic ligament of the invention is that of oriented, high modulus, ultra high molecular weight polyethylene, such as DYNEEMA® of DSM, Netherlands, or SPECTRA® from Honeywell, USA. Preferred diameter of the fiber is between 10 and 20 micrometers, preferably about 15 micrometers. Fibers are left free from each other, as in yarn, i.e. no diffusion bonding nor braiding is used in production. The ends may be fused, preferably with an aid of low molecular polyethylene, to facilitate tying of the knots and insertion through the anchors. 
         [0030]    Other suitable polymeric fibers are polyethylene teraphtalate (polyester), polyamide (NYLON®), aramid (KEVLAR®), or silk. Resorbable fibers can also be used, e.g. those based on polylactic acid or polyglycolic acid. 
         [0031]    The same principles of design of the prosthetic ligament and its anchor can be used in other joints, e.g. for replacement of the so-called round ligament in the hip joint, frequently ruptured by trauma in dogs. 
         [0032]    Having disclosed at least one embodiment of the present invention, various adaptations, modifications, additions, and improvements will be readily apparent to those of ordinary skill in the art. Such adaptations, modifications, additions and improvements are considered part of the invention which is only limited by the several claims attached hereto.