Abstract:
Implantable devices and methods for fixation of soft tissue to soft tissue or soft tissue to bone tissue. Generally, the devices can include a body having at least a first area with a plurality of projections extending from the first area for attaching to the soft tissue, and a second area discrete from the first area. The body has physical characteristics sufficient to approximate or to support the soft tissue adjacent the first area with respect to the second area. The plurality of projections are configured to attach to the soft tissue and to distribute tension between the first area and the soft tissue. A soft tissue to bone tissue approximation device is configured to be attached to bone tissue and, using a plurality of projections, also attached to soft tissue.

Description:
[0001]    The present application is a continuation of U.S. Ser. No. 09/969,947, filed on Oct. 3, 2001, now pending, which is a continuation-in-part of PCT Serial No. PCT/US99/24098 filed on Oct. 18, 1999, now expired, which is a continuation-in-part of U.S. Ser. No. 08/928,866, filed on Sep. 12, 1997, now U.S. Pat. No. 6,083,244, which is based on provisional patent application Serial No. 60/026,101, filed Sep. 13, 1996, now abandoned, and provisional patent application Serial No. 60/043,086, filed on Apr. 8, 1997, now abandoned. The disclosures of each of these prior related applications are hereby fully incorporated by reference herein. 
     
    
     
       FIELD OF THE INVENTION  
         [0002]    The present invention generally relates to tendon or ligament repair apparatus and methods. More specifically, the invention relates to the repair of severed or otherwise damaged tendons or ligaments and the attachment of tendons or ligaments to bone. As used herein, the terms “tendon” and “ligament” are used in a generally interchangeable manner.  
         BACKGROUND OF THE INVENTION  
         [0003]    The repair of tendons or ligaments is a challenging and complication prone area of surgery. As one example, the dilemma in flexor tendon repair surgery in the hand is to adequately connect a severed tendon without compromising the functionality of the hand due to surgical intervention and repair techniques. Over the past 40 years, there have been only improvements in the basic suture techniques to repair tendons. In order to make any substantial improvement in the art of repairing a severed tendon one must first understand the composition and structure of tendons and ligaments.  
           [0004]    Tendons can sustain high tensile forces resulting from muscle contraction, yet are flexible enough to bend around bony surfaces and deflect beneath retinacula to change the final direction of muscle pull. Tendons attach muscle to bone and transmit tensile loads from muscle to bone thereby producing joint movement. Ligaments attach bone to bone and can flex to allow natural movement of the bones that they attach, but are strong and inextensible so as to offer suitable resistance to applied forces. Ligaments augment the mechanical stability of the joints. The biomechanical behavior of tendons and ligaments is viscoelastic or rate dependent, that is, their strength and stiffness increase with an increased loading rate. Bundles of collagen fibers embedded in a connecting matrix, known as ground substance, provide the load carrying elements of natural tendons and ligaments. The arrangement of the collagen fibers is nearly parallel in tendons, equipping them to withstand high unidirectional loads. The less parallel arrangement of the collagen fibers in ligaments allows these structures to sustain predominant tensile stresses in one direction and smaller stresses in other directions. The ground substance in both tendons and ligaments acts generally as a cementing matrix holding the collagen fibers together. The ground substance retains large amounts of water essential to the non-compressive hydraulic function of the moving tissue. Also included in the tendon composition are elastic fibers, tenocytes, small blood vessels and nerves. In general, the cellular material (fibroblasts) occupies about 20% to 38% depending on references, of the total tissue volume, while the ground substance matrix accounts for the remaining 62% to 80%. About 70% of the ground substance matrix consists of water absorbed in an open polysaccharide matrix.  
           [0005]    Two types of tendons exist in the hand for connecting phalanx (finger) bones to the appropriate muscles. Flexor tendons, which are connected to the volar or palm side of the fingers, lend the ability to curl the fingers towards the palm. Extensor tendons, which are connected to the dorsal or backside of the fingers, return the curled fingers back into a straight position. Sheaths and retinacula restrain most tendons in the hand to some extent and keep them close to the skeletal plane so that they maintain a relatively constant moment arm rather than bowstringing across the joints. The pulley system of the flexor tendon sheath in the finger is the most highly developed of these restraints. The flexor tendon sheath pulley system permits the flexor tendons to maintain a relatively constant moment arm and helps minimize stress risers between tendon and sheath. This system serves three important functions. First, it allows smooth tendon gliding or lubrication; second, the retinacular reinforcing pulleys maintain the flexor tendons close to the surface of the finger bones, preventing bowstringing; and third, it provides an enclosed synovial fluid environment for tendon nutrition and lubrication. As the finger moves, each tendon slides a certain distance, which defines the “excursion of the tendon”. Excursion takes place simultaneously in the flexor and extensor tendons during joint motion. The tendons of the agonist, or contracting muscle, displace in one direction. The tendons of the antagonist or resisting muscles displace in the opposite direction to accommodate the motion.  
           [0006]    Today, the most common methods of repairing torn, severed or otherwise damaged tendons involve approximating the severed ends of the tendons and suturing one side of the tendon to the other thereby returning the tendon to its natural position. A popular suture technique is the so-called Kessler technique and slight modifications thereof. Some of the other techniques include the Becker, Savage, lateral trap, double loop locking suture, four-strand interlock and variations of the Halsted technique. Other methods place prosthetic material either within or around the tendon. Polyester strips and sleeves along with polyester mesh have been used to reinforce the suture/tendon interface to provide a stronger repair.  
           [0007]    After flexor tendon repair, resistance to tendon gliding increases at the repair site. Repair techniques that use an increased number of suture strands, or increased amounts of suture material or prosthetic material promote greater glide resistance. In particular, adhesions form due to the tendon&#39;s natural response to healing, i.e., the ingrowth of cells and vessels from surrounding connective tissue. Current literature suggests adhesions may constitute an inflammatory process at the site of repair and an extension of the intrinsic tendon healing process to the surrounding tissue.  
           [0008]    An ideal repair would exhibit high strength, flexibility, and a joining of the tendon ends without any foreign material on the outside surface of the tendon. Physical therapy should begin immediately after the repair to prevent the tendon from adhering to the tendon sheath creating adhesions that limit the full excursion of the tendon in its sheath. For this reason, the repair site must withstand the immediate tensile stress being applied to it during physical therapy. In a relaxed state, a flexor tendon experiences about one pound of constant tension. When a person applies a light grip, such as by grasping a key, about three to four pounds of tensile force is applied to the tendon. A strong grip can apply over ten pounds of tensile force to a tendon.  
           [0009]    Since most suture-based tendon repairs reach their tensile limit at about 6 lbs., surgeons must balance the desire to have full and immediate active motion to prevent adhesions against the need for immobilization to prevent rupture of the repair. Earlier loading of a repaired tendon promotes a more rapid increase in repair strength. For a tendon to properly rejoin, the opposed tendon ends do not have to touch but they do need to be approximated within 1-2 mm of each other to properly reattach. An ideal tendon repair would hold the lacerated tendons together to begin healing and tissue generation but slowly release tension allowing the tendon to become the primary load bearing structure. Tendons will heal at a rate that is proportional to the load being applied during physical therapy.  
           [0010]    Another major problem is the softening of the damaged tendon ends, which begins shortly after the damage or injury occurs and continues for approximately the next twelve days. This softening results in a weakening of the tendon fibers, which contributes to the formation of a gap at the repair site during the early phases of tendon healing. It is believed that gaps form at the site of repair due to a loss of purchase by the grasping portion of the suture at the tendon-suture interface. The grasping suture may even completely tear out, resulting in a failure of repair. A term for this failure is “rake-out”. Rake-out is a failure mode associated with suture tendon repair in which the end of the severed tendon has weakened and the suture tends to pull out of the tendon ends. This splits the tendon and results in an undesirable gap or total failure. Another common type of suture repair failure is of a suture knot.  
           [0011]    The effectiveness of a suture depends on many factors, such as the suture material, the technique with which the suture is inserted, and knot strength. Immediately after a tendon is repaired, the strength of the repair depends almost entirely on the suture technique. The ideal suture knot should terminate securely, be strong, easy to handle and inelastic. The suture material used today is generally braided polyester or a monofilament polypropylene. Using current suture techniques, absorbable suture materials do not have enough residual tensile strength over time to resist gapping and rupturing. The ideal suture technique should be easy to use, minimize interference with tendon vascularity and be completely internal to the tendon without increasing the bulk of the tendon. Locating the knots outside the tendon rather than within the repair site may result in higher ultimate tensile strength but will also increase the risk of adhesions and increase the friction through the pulleys. This latter characteristic is known as “work of flexion”.  
           [0012]    Most suture methods employ an internal suture with external knots distal and proximal to the laceration or within the laceration. The surgeon typically uses a continuous running external suture at the junction of the repair, known as an epitendinous suture, to approximate the tendon ends. The use of the epitendinous suture increases the tensile strength of the repair and helps to resist gapping, but it can also increase the risk of adhesions and is difficult to master and very tedious to execute. The evolution of tendon repair with sutures starts with the two-strand technique. Some of the variations of this technique are the Bunnell, Kessler, and Tsuge methods. When two-strand repairs fail, the failure usually occurs at the knots. Studies have shown that the initial strength of these repairs is proportional to the number of suture strands that cross the repair site. This has led to a trend of doubling, tripling, and even quadrupling the number of strands placed across the repair site. With these multiple strand techniques, Savage, Becker and Ketchum have shown significant tensile strength over the two-strand methods but they are more difficult to perform and add material to the outside surface of the tendon with more exposed knots. These techniques focus primarily on the increased effect on tensile strength and disregard the increased resistance to the tendon gliding through the pulleys. Therefore, the quest continues for the ideal suture technique having the tensile strength required to allow the patient to start physical therapy immediately, and having the low profile necessary to minimize adhesions that compromise the ability of the tendon to glide through the pulleys.  
           [0013]    Techniques have also been developed that incorporate an internal or external prosthetic splint. Low porosity woven polyester, which is the same material used for aortic graft repair, is being used as an artificial splint. There are basically two methods of splint repair. The internal splint technique is accomplished by placing a horizontal slit transversely in each tendon stump proximal and distal to the laceration site. A rectangular piece of polyester splint is placed into this slit on both sides of the tendon. Sutures are then placed perpendicular to the graft along each tendon thereby attaching the splint to the tendon. The sutures attach the splint, which is basically a flexible tensile member, to the interior surface of the tendon. These suture knots are then tied on the outside of the tendon for ease of placement and an epitendinous suture is placed at the junction of the repair. As previously mentioned, the external knots will increase the risk for adhesions and also increase the work of flexion. The material of the tendon splint is inert and similar to the suture material being used in other techniques and its internal position within the substance of the tendon should promote tissue ingrowth and enhance the repair site. However, the large slits in the tendon ends might structurally damage the internal blood supply of the tendon and cause tissue degeneration.  
           [0014]    In the external splint technique, also known as the dorsal tendon splint technique, the surgeon aligns both tendon ends and places a two-strand Savage type core suture on the anterior surface of the tendon. The surgeon then places a rectangular Dacron® splint on the dorsal surface of the tendon across the laceration site and sutures it to both tendon ends. In this technique, and as mentioned earlier, the splint acts as a flexible tensile member that prevents the tendons from gapping and rupturing during early movement. As with the internal method, the knots are placed on the exterior surface of the tendons and the splint is actually on the outside surface. This will increase the risk of adhesions and consequently increase the work of flexion. The internal tendon splint may add too much bulk to the repair site, and the external tendon splint may interfere with tendon gliding. Preliminary work of flexion studies suggest both tendon splints increase the work of flexion by 16-19%.  
           [0015]    Another splint-type technique being used today is a Dacron® or Prolene® mesh sleeve that surrounds the tendons. The two ends of the lacerated tendons are placed in the proximal and distal openings of the sleeve. The tendon ends are butted together without any additional sutures, except that an epitendinous suture is placed thereby attaching the sleeve to the outside surfaces of the tendons. This is done on both ends of the sleeve. This technique is 117% stronger in tension than a conventional two-strand core stitch technique with an epitendinous suture on the external surface. Like the aforementioned splint techniques, these are tested in vitro (outside of the body) and do not take into account any of the in vivo (inside the body) problems that occur such as placing a significant amount of repair material external to the tendon and within the tendon sheath. Again, external repair material provides a potential source of fibrous adhesions and an increase in work of flexion.  
           [0016]    Implanted anchors have also been used to attach two ends of a severed tendon. This type of anchor is similar to a Dacron® splint in concept but is usually fabricated from stainless steel or titanium. The geometry of the anchor also differentiates the anchor from a splint. The anchor, which may measure 20 mm in length, 3 mm in width and 1 mm in thickness, has a symmetrical double barbed end configuration. The anchor is placed into the severed end of the tendon by making a small transverse incision. Once the anchor is in the correct depth the surgeon will place a suture through the tendon at the flat side of the barb and knot the suture into a loop thereby preventing the barb from being pulled out of the tendon. The tendon will be sutured at each flat on the barb, providing two suture loops per tendon end. The same suture technique is performed on both ends thereby re-attaching the severed tendon. This repair technique shows an increase in mean ultimate tensile strength of 49-240% over traditional two-strand and multi-strand suture techniques. This technique is relatively easy to perform but it does not address the in vivo problems caused by placing the suture knots on the outside of the tendon. Here, they become a potential source of fibrous adhesions and increase the work of flexion. This type of tendon anchor can limit motion or cause pain when positioned directly over a joint with the finger in maximal flexion since it is long and fairly rigid. Also, the surgeon must still bring the tendon ends together with a separate surgical tool and, in the process, risk damaging the tendon ends.  
           [0017]    Adhesives have been evaluated in the search for the ideal tendon repair. Studies have been conducted using adhesives of the cyanoacrylate group, more commonly known as super glues. These adhesives form a strong adhesive bond with most human tissue, particularly those containing a large amount of protein, such as skin and tendon tissue, because they polymerize in the presence of water and hydroxyl groups, both of which are abundantly present in tendon tissue, and they do not require a solvent. They are known to be biodegradable, although the time taken to degrade in tendons is unknown and only the long chain varieties are known to be minimally toxic to human tissue. The application of adhesives in tendon repair is in conjunction with two-strand or multi-strand core suture with an epitendinous suture. The adhesive is placed on the tendon ends after the sutures have been placed and approximated to allow for polymerization. The shortcomings that were discussed in connection with suture repair are experienced with adhesive techniques as well. Some problems with adhesives include their potential non-biodegradability within the tendon, their questionable effect on tendon healing, and their potential local and systemic toxicity. Currently, therefore, adhesives do not provide an adequate solution to tendon repair problems.  
           [0018]    Current and past tendon or ligament repair techniques concentrate on increasing the tensile strength of the repair by adding more structural components to the repair, e.g., sleeves, splints, additional suture strands, additional knots and adhesive. All of these techniques trade off between early tensile strength, increased work of flexion, and increased risk of adhesions or other problems. While the surgeon debates the clinical technique, the patient may suffer from a less than desirable outcome and discomfort over the life of the repair. Adhesions cause pain and limit motion of the affected joints. By increasing bulk to the tendon, motion may be further limited and this can result in a defect called “trigger finger.” 
           [0019]    None of these techniques have utilized the physiological makeup of the tendon to provide a stronger repair. The tensile strength of the tendon is provided by the lengthwise parallel collagen fibers, which give it the ability to withstand high tensile loads. The ground substance is made up primarily of water and cannot be used to provide strength to the repair. The tendon sheath is also too weak to provide meaningful assistance with holding the two tendon ends together.  
           [0020]    Similar problems arise when attaching tendons or ligaments to bone. That is, simply suturing the tendon or ligament to a bone anchor or using external tendon anchor members may not provide the necessary strength of repair. As further discussed above, these techniques also promote adhesion formation.  
           [0021]    Finally, tendon retrieval has also been a problematic portion of tendon repair surgery. Typically, the surgeon must use a small grasping tool with thin, movable jaws similar to needle-nose pliers to grasp a tendon end and pull and transfix it in an appropriate operating position. Unfortunately, gripping the tendon ends in this manner often damages them and makes the tissue less able to hold the epitendinous suture. The damaged tendon ends will also form scar tissue or adhesions which further adversely affect the repair.  
           [0022]    Therefore, there is a need for tendon repair techniques and apparatus that harness the intrinsic strength of the tendon fibers, but allow the tendon to flex while moving through the sheath. This repair apparatus should resist any gapping or rupture during immediate post-operative physical therapy, and reside in the interior of the tendon to reduce or possibly eliminate post-operative adhesions. The repair apparatus should also produce low work of flexion while gliding unhindered through the tendon sheaths. There is generally a need for tendon repair apparatus and methods that allow the patient to immediately begin active physical therapy without risking any tendon repair failure while minimizing or eliminating the need for sutures or other repair structure on the external surfaces of the tendon thereby reducing the occurrence of adhesions and friction between the tendon repair and the sheath pulley. There is a further need for tendon-to-bone repair techniques and apparatus with at least some of these attributes. Finally, there is a need for a tendon retrieval device which also harnesses the inherent strength of the tendon fibers and minimizes damage to the retrieved tendon end.  
         SUMMARY OF THE INVENTION  
         [0023]    The present invention generally provides apparatus for repairing damaged tendons or ligaments. The various repair apparatus according to the invention employ an elongate tensile member adapted to extend within the interior of the tendon or ligament and various types of anchor structures configured for insertion within the interior of the tendon or ligament. The anchor structures are both movable along and lockable to the elongate tensile member at a selected position. As some examples, these anchor structures may comprise helical anchors with separately connectable tendon fiber retaining members, unitary helical anchor/tendon fiber retaining member assemblies, compressible helical anchors, anchor bodies secured inside the tendon with sutures or projections such as barbs, and crimp-type anchor members that grip tendon fibers between two crimp portions or members, as well as other configurations. Various embodiments of repair apparatus are disclosed herein each serving to address the general needs and drawbacks presented by the prior art as discussed above.  
           [0024]    Among the various advantages and objectives of this invention, apparatus comprising at least one tendon or ligament anchor structure in combination with an elongate tensile member are provided and utilize the inherent strength of the bundles of parallel collagen fibers in tendons or ligaments. Repair techniques are provided that address the tensile component of the repair and eliminate the increase of bulk to the tendon or ligament. This is accomplished while reducing externally placed components that compromise the ability of the tendon to glide through the pulleys. Through an understanding and utilization of the inherent strength provided by the bundles of parallel collagen fibers, the inventors have developed anchor structures that grasp these high strength fibers without constricting the blood flow to the tendon, and without adding external bulk or additional knots. The anchor systems of this invention further allow the patient to begin immediate active motion physical therapy resulting in a quicker and stronger tendon repair with fewer adhesions. Also, the combined anchor structure and elongate tensile member of this invention provide a tendon or ligament repair that can withstand greater tensile loads than current and past repair techniques while retaining the repaired tendon or ligament ends in a viable repair position.  
           [0025]    Generally stated, the present invention comprises at least one anchor structure coupled for movement along the length of an elongate tensile member. The anchor structure is lockable at a desired location along the tensile member and generally includes first and second fiber gripping portions configured for insertion within the interior of a tendon or ligament. The gripping portions may be on two separate components of the anchor structure or may be portions of the same component. In several embodiments of the invention, at least one of the fiber gripping portions is movable with respect to the other to grip the fibers therebetween. Many different configurations of anchor structures are disclosed herein including single-piece anchor structures and multi-piece anchor structures. In the single-piece anchor structures, one portion of a member, such as a crimp member, is movable toward another portion of the member to grip tendon fibers therebetween. In other embodiments, separate pieces of the anchor structure are brought together and locked to grip, engage or compress the tendon fibers therebetween. In the most preferred embodiments, two anchor structures are each initially movable along the length of the elongate tensile member on opposite sides of a torn, lacerated or otherwise damaged portion of the tendon. The anchor structures may be locked to the fibers within the tendon and to the elongate tensile member itself when the tendon is at the proper repair position. Various more specific embodiments of the anchor structures and elongate tensile members of this invention are described hereinbelow.  
           [0026]    In one embodiment of the invention, an anchor body in the form of at least one helical anchor is configured for insertion within the interior of the tendon or ligament. At least one retaining member is coupled with the elongate tensile member and provides a securing structure to hold the helical anchor to the fibers extending within the interior of the tendon or ligament. In a preferred apparatus of this type, first and second helical anchors are provided with respective first and second retaining members each being couplable for movement along the elongate tensile member on opposite sides of a repair site. The retaining members may each include, for example, an axial hole to allow this movement. Optionally, a lengthwise slot may be provided in the retaining member. In this embodiment, and the other embodiments of the invention, the elongate tensile member may comprise a rigid, semi-rigid or flexible member, including flexible sutures formed from absorbable or non-absorbable materials, as well as tensile members formed from various biocompatible metals, plastics, ceramics, etc. The helical anchor preferably comprises a helically wound coil which may be of constant or variable diameter and may be formed of biocompatible metal. Optionally, the coil may be formed from absorbable material or other non-absorbable biocompatible materials. The retaining member is preferably configured to be received within a corresponding helical anchor for compressing the fibers between the retaining member and the helical anchor. When the helical anchor is rotated into the tendon or ligament, fibers of the tendon or ligament will be captured within the coils of the anchor. When the retaining member is then inserted and affixed within the helical anchor, the outer surface of the retaining member compresses the fibers against inner surfaces of the helical coils. Preferably, locking structure in the form of at least one locking member is used for holding the retaining member to the elongate tensile member at a desired position. This locking member may be a separate slidably adjustable member or an integral portion of the corresponding retaining member and may, for example, comprise a deformable or crimpable portion of the retaining member or a separate crimp member.  
           [0027]    The retaining member or members preferably have associated retaining structure either integrated therein or used as separate structure for gripping the tendon fibers against the helical anchor. For example, the retaining structure may comprise a discontinuous surface adapted to aid in holding the fibers between the retaining member and the helical anchor. As examples, this discontinuous surface may be an exterior serrated surface, a generally threaded surface, or another type of convoluted or discontinuous surface. This surface may also serve to prevent the retaining member from backing out of the helical anchor.  
           [0028]    As another feature, the elongate tensile member and the respective retaining member or members may include respective engageable portions, such as ratchet-like portions, for holding the retaining member at the desired position along the elongate tensile member.  
           [0029]    As still another feature, at least one of the elongate tensile member, the first helical anchor and the retaining member may be comprised of an absorbable material. During the absorption process, this will allow a gradual transfer of tensile load to the repair site to aid in healing. More generally stated, at least one component of the anchor system will be made from an absorbable material, such as polyglycolic acid or polyglyconate. This will allow for the tensile stress of the anchor system to be gradually transferred from the anchor system to the tendon during the healing of the tendon repair site. As revealed previously, the healing response of the tendon is directly proportional to the amount of tension being applied to the tendon. In other words, more tension on the tendon results in a stronger repair. However, the initial condition of the repaired tendon does not withstand any tensile load. Therefore, a timed release of the tension being applied to the tendon will result in a stronger repair. By making a key component or components from an absorbable material, the repair apparatus slowly transfers tension to the tendon until the component(s) completely degrade and releases all the tension to the tendon repair site.  
           [0030]    As an additional feature of the invention, the retaining members may include structure configured to directly engage the helical anchor to prevent the retaining members from backing out of the helical anchors after implantation. As one example, this may include ratchet-type structure on the retaining member adapted to engage the trailing end of the helical anchor.  
           [0031]    The retaining members of the various embodiments of this invention may also have various configurations. One configuration is a helical retaining member. In this case, the helical anchor will be either received within the helical retaining member or may receive the helical retaining member. Either construction forms inner and outer helical members. This is helpful because the helical members will compress tendon or ligament fibers therebetween in a generally sinusoidal pattern. At least one of the inner and outer helical members is collapsed or expanded toward the other to clamp or compress the tendon or ligament fibers therebetween. This may be accomplished, for example, through mechanical spring action of the helical members during insertion or through the use of electromagnetic impulse deformation. In the latter case, and as detailed further below, one helical member may be formed of a magnetic material while the other is not. Upon the application of one or more impulses of electromagnetic energy, the magnetic helical member will collapse onto the nonmagnetic helical member compressing the tendon fibers therebetween.  
           [0032]    As another option, the helical anchor of this invention may be formed from a flexible suture material. In this case, the retaining member is adapted to be inserted into the tendon or ligament and the flexible suture material is then wrapped generally helically about the retaining member to hold the tendon or ligament fibers therebetween. As the flexible suture material which is wrapped around the retaining member is not held in significant tension, it may be formed of material having lower tensile strength than the elongate tensile member.  
           [0033]    In another embodiment of the invention, the apparatus may comprise first and second helical anchors integrally formed from a wire with the elongate tensile member extending therebetween. In this embodiment, the anchors are helically wound in opposite directions such that rotation of the integral apparatus in a single direction, with the elongate tensile member disposed generally between the damaged or severed tendon ends, will cause rotation of each respective helical member into a respective tendon end. Retaining members in accordance with the invention may then be used to grip, compress or otherwise engage the tendon fibers to the helical anchors.  
           [0034]    In yet another embodiment of the invention, the apparatus may include a helically coiled, compressible anchor configured for insertion within the interior of the tendon or ligament and couplable with the elongate tensile member. This compressible anchor traps the fibers of the tendon or ligament between the coils as its coils are moved from their uncompressed state to their compressed state. As with the other embodiments of this invention, the apparatus preferably includes a second anchor structure in the form of another helically coiled, compressible anchor which is also couplable to the elongate tensile member. It should also be noted that the elongate tensile member of this invention may be formed by two or more separate tensile members, such as sutures, which are then tied or otherwise directly or indirectly affixed together during the repair procedure such that a unitary elongate tensile member is formed connecting at least two anchors together to hold the tendon or ligament in an approximated repair position. In other words, the elongate tensile member may be formed from a number of different segments or portions which are ultimately secured together and secured to the anchor structures. In the embodiment employing compressible anchors, these anchors are also preferably coupled for movement along the elongate tensile member and include respective locking members, preferably slidably coupled to the elongate tensile member, and adapted to hold the compressible anchors at desired locations on the elongate tensile member. The locking members may be, for example, formed as crimp members or other structures formed integrally or separately from the corresponding compressible anchor.  
           [0035]    The retaining members of this invention may also be slotted members. In a general sense, this allows the retaining member to be coupled to the elongate tensile member without necessarily using a sliding motion along the tensile member as with a retaining member that includes an axial hole. The slot or slots may further act as a collet structure configured to clamp onto the elongate tensile member upon insertion into the helical anchor or through the use of a separate tool. In another advantageous embodiment of a collet structure, the retaining member may be a two-piece slotted collet structure with an interior piece and an exterior piece. Upon insertion of the exterior piece into the helical anchor and the interior piece into the exterior piece, the interior piece is configured to clamp onto the elongate tensile member and the exterior piece is configured to expand within the helical anchor to compress the fibers against the helical anchor.  
           [0036]    In yet another embodiment, the elongate tensile member will be locked to the helical anchor by trapping the elongate tensile member between the internal retaining member and the helical anchor. This will eliminate the need to have a locking feature built into the internal retaining member in order to lock the elongate tensile member to the helical anchor.  
           [0037]    In yet another embodiment, the tendon repair apparatus has multiple helical anchors. In this embodiment, there is more than one helical anchor placed within the tendon. The helical anchors may be wound in opposite directions and/or intertwined together. This configuration is based on the aforementioned method of grasping parallel collagen fibers. An advantage to multiple anchors is that the amount of collagen fibers being trapped is directly proportional to the amount of coils on the helical anchor. Increasing the length and the number of coils of the helical anchor likewise increases the amount of trapped collagen fiber. Since there are limitations to the length of the anchor, an additional anchor of the same length is placed in the tendon.  
           [0038]    Another more specific anchor structure of this invention utilizes a crimp-type anchor member. In this embodiment, one of the fiber gripping portions further comprises at least one first deformable portion adapted to be crimped within the tendon or ligament to grip the fibers. In one specific embodiment, the crimp member will have opposed legs that may be deformed toward one another and onto the tendon fibers. The crimp member may further include a second deformable portion configured to be crimped onto the elongate tensile member to retain the crimp member at a desired location thereon. In a related embodiment, the anchor structure may further comprise first and second separate crimp members adapted to be crimped onto the fibers generally from opposite sides of the elongate tensile member. The first and second crimp members can each include a respective plurality of deformable legs configured to interlock after crimping to securely hold the first and second crimp members to the tendon fibers. The first and second crimp members can further include respective crimp portions configured to be crimped onto the elongate tensile member to retain the first and second crimp members at a desired location along the length of the tensile member. As one other alternative, a separate locking member may be used to retain the first and second crimp members at a desired position along the length of the elongate tensile member.  
           [0039]    In another aspect, the anchor structures further comprise first and second anchor bodies with respective first and second securing structures. These securing structures may, for example, comprise projections extending respectively from the first and second anchor bodies that retain the anchor bodies within the tendon or ligament. The anchor bodies may be tubular-shaped members or members having various other shapes configured for insertion within the tendon or ligament. As another alternative or additional securing structure, the anchor bodies may include portions for receiving sutures used to secure the first and second anchor bodies within the interior of the tendon or ligament. As with the previous embodiments, the locking structure can, for example, include a crimpable or swageable member or an integral portion of an anchor body operable to affix the anchor body onto the elongate tensile member. In many of the embodiments of this invention, two anchor bodies are each initially connected for movement along the elongate tensile member and first and second respective locking structures or members are used to lock each anchor body to the elongate tensile member with the tendon or ligament in a desired repair position.  
           [0040]    As a further aspect, the invention provides apparatus for affixing a tendon or ligament to a bone. In this embodiment, the apparatus includes an elongate tensile member, a tendon or ligament anchor structure constructed in accordance with any of the anchor structures of this invention, and a bone anchor. The elongate tensile member, for example, may be a flexible suture adapted to extend within the interior of the tendon or ligament. The bone anchor is coupled with the elongate tensile member and is configured to be retained within the bone. As a more specific feature of the preferred embodiment of this invention, the tendon or ligament anchor may be a helical anchor as generally described above and may be compressible. A retaining member is adapted to be retained at a selected position along the elongate tensile member to hold the bone anchor, elongate tensile member and helical anchor together with the tendon or ligament against the bone. The retaining member and the bone anchor may include cooperating locking portions for connecting the retaining member and bone anchor together with the helical anchor held generally therebetween. Alternatively, or in addition, the retaining member may be sized and configured to be received at least partially within the helical anchor and a locking member, such as a crimp, may be coupled with the elongate tensile member to hold the retaining member at a desired position. As with the other embodiments of this invention, the locking member may be, for example, a deformable and slidable crimp member either separately formed or integrally formed with the retaining member.  
           [0041]    In another aspect of the present invention, a tendon or ligament retrieval device is provided and operates to move a tendon or ligament end to a desired operating position. The device generally comprises an elongate body, a helical member coupled with the elongate body and at least one drive mechanism coupled with the helical member for effecting rotational movement of the helical member into the tendon or ligament and subsequent translational movement of the helical member to move the tendon or ligament to the desired operating position. To facilitate this function, the helical member is mounted for rotational and translational movement relative to the elongate body. The elongate body is adapted to be inserted into a tendon sheath, for example, and is preferably flexible to allow manipulation therein by the surgeon. The elongate body may also include a distal tip with anti-rotation structure for engaging the tendon or ligament end and preventing rotation thereof as the helical member rotates into the tendon or ligament end. As one optional anti-rotation feature, the helical member may further include first and second, counter-rotating helical grasping bodies each being connected for rotation and translation by the drive mechanism.  
           [0042]    Various methods are also contemplated in accordance with the invention relative to tendon or ligament repair. A representative method involves installing an elongate tensile member within the tendon or ligament and driving a first helical member into the tendon or ligament. The first helical anchor is secured to the elongate tensile member and a second helical anchor is driven into the tendon or ligament. The tendon or ligament is then moved to a repair position at least prior to securing the second helical anchor to the elongate tensile member whereupon the second helical anchor is then securely fastened to the elongate tensile member to hold the tendon or ligament in the repair position. The various tendon or ligament anchor structures disclosed herein may be used for carrying out the repair methods and additional repair methods will become more apparent upon review of the detailed description of this invention.  
           [0043]    In another embodiment of the invention, a helical anchor is coupled to a tendon fiber retaining member to form a unitary anchor assembly. The anchor and attached retaining member are driven into the tendon or ligament at one time. This aspect of the invention further includes an insertion tool for driving the assembly into the tendon or ligament preferably with a simultaneous rotating and translating movement. More specifically, the anchor assembly comprises a core portion or retaining member positioned inside of a helical anchor with the distal end of the anchor preferably being tapered or sharpened to ease insertion and also extending distally outward of a distal end of the retaining member. The distal end of the retaining member may also be tapered and the outer surface can include a helical groove or generally helically configured surface which generally corresponds with the helical anchor. At the proximal end of the retaining member, a slot is provided and the proximal end of the anchor resides in the slot and is secured in a suitable manner, such as through laser or resistence welding. The extreme proximal end of the core portion or retaining member includes tool engagement structure, such as a slot, which allows the insertion tool to be used to rotate and translate the assembly into the tendon or ligament. The core portion or retaining member includes a central bore through which the elongate tensile member extends and, in the preferred manner of making and using this embodiment, a separate crimp member is secured to the tensile member at the proximal end of the core portion or retaining member. However, integral crimp members or other types of locking members may be used instead. The seperate crimp member of this embodiment has an annular groove in its outer surface to reduce the force necessary to collapse the crimp on the elongate tensile member.  
           [0044]    A unique crimp tool is provided with a jaw configuration which both collapses the crimp, when desired, and which retains the crimp between the jaws prior to use, such as during packaging, shipping, and storage. For this latter purpose as well, a flexible or frangible bar is coupled between two handles of the crimp tool and aids in holding the jaws in a closed position to retain the crimp therein prior to use, but also prevent the jaws from moving together and prematurely collapsing the crimp until necessary during surgery. The bar or bars may be formed of a suitable material, such as plastic, which will bend or fracture during use. The jaws also include a projection on one jaw and a recess in an opposing jaw for receiving the crimp member. During use, the projection is forced against the crimp member to collapse the crimp member against the tensile member. The recess includes a ridge for registering in the annular groove of the crimp member and thereby assisting to hold the crimp member therein.  
           [0045]    The method of using the unitary anchor assembly generally corresponds to the broader aspects of the methods disclosed herein. In a more specific and preferred method of using the embodiment of this invention which comprises a unitary helical anchor and tendon fiber retaining member, an anchor assembly is driven into the tendon or ligament on each side of the damaged or lacerated area. An elongate tensile member having a needle at one end and a preset crimp member at an opposite end is then threaded through the proximal end of a first one of the anchor assemblies and into the space between the ends of the damaged tendon or ligament. A second capturing member, such as a vena-puncture or syringe needle is then inserted through the proximal end of the second anchor assembly and into the space between the damaged or lacerated tendon or ligament ends. The needle coupled to the elongate tensile member is then captured, such as by inserting its end into the syringe needle, and the elongate tensile member is pulled through the second anchor assembly. A crimp member is then threaded onto the elongate tensile member to a position abutting the proximal end of the second anchor assembly and the tendon or ligament ends are pulled together to the desired position. The crimp member is then deformed or collapsed onto the tensile member to fix the tensile member and two anchor assemblies at the desired length. The excess length of the tensile member is then cut at the proximal end of the second anchor assembly and any necessary additional closing procedures are performed by the surgeon.  
           [0046]    As one additional aspect of the invention, a removal tool is provided which is especially useful for the latter embodiment and comprises a rotatable tool having a pointed needle projecting from a tool driver head. The tool driver head is configured to engage the tool engagement structure on the proximal end of the unitary anchor assembly and, in the preferred embodiment, comprises a generally conventionally-shaped screwdriver projection complementary to a slot in the proximal end of the anchor assembly. It will be understood that many types of tool engagement structure may be used for this purpose.  
           [0047]    Various additional features, advantages and objectives of the invention will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description of the preferred embodiments, taken in conjunction with the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0048]    [0048]FIG. 1 is a perspective sectional view of the bone repair device according to the present invention;  
         [0049]    [0049]FIG. 2 is a side view of the suture to be used with the bone repair device according to the present invention;  
         [0050]    [0050]FIG. 3 is a sectional view of the suture in place in a bone to be repaired in accordance with the present invention;  
         [0051]    [0051]FIG. 4 is a sectional view of a fractured bone repaired with the bone repair device according to the present invention;  
         [0052]    [0052]FIG. 5 is a sectional view of a first embodiment of a button to be used with the bone repair device of the present invention;  
         [0053]    [0053]FIG. 6 is a sectional view of a second embodiment of a button to be used with the bone repair device of the present invention;  
         [0054]    [0054]FIG. 7 is a top view of a third embodiment of a button to be used with the bone repair device of the present invention;  
         [0055]    [0055]FIG. 8 is a side view of a third embodiment of a button to be used with the bone repair device of the present invention;  
         [0056]    [0056]FIG. 9 is a sectional view of the third embodiment of a button to be used with the bone repair device of the present invention being attached to a suture;  
         [0057]    [0057]FIG. 10 is a sectional view of a fourth embodiment of a button to be used with the bone repair device of the present invention being attached to a suture;  
         [0058]    [0058]FIG. 11 is a perspective view of the bone repair device of the present invention being used to repair a torn or fractured meniscus;  
         [0059]    [0059]FIG. 12 is a top view of the incisions made in a hand in the prior art to repair a torn tendon;  
         [0060]    [0060]FIG. 13 is a top view of the incisions made in accordance with the present invention to repair a torn tendon;  
         [0061]    [0061]FIG. 14 is a sectional view of a tendon being repaired in accordance with the present invention;  
         [0062]    [0062]FIG. 15 is a sectional view of a tendon being repaired using a first embodiment of a button;  
         [0063]    [0063]FIG. 15A is a cross-sectional view of a first embodiment of a button as shown in FIG. 15;  
         [0064]    [0064]FIG. 15B is a cross-sectional view of a second embodiment of a button as shown in FIG. 15;  
         [0065]    [0065]FIG. 15C is a cross-sectional view of a third embodiment of a button as shown in FIG. 15;  
         [0066]    [0066]FIG. 15D is a cross-sectional view of a Fourth embodiment of a button as shown in FIG. 15;  
         [0067]    [0067]FIG. 16 is a sectional view of a repaired tendon using a first embodiment of a button in accordance with the present invention;  
         [0068]    [0068]FIG. 16A is a sectional view of a revised stitching procedure in accordance with the invention of FIG. 15;  
         [0069]    [0069]FIG. 17 is a sectional view of a repaired tendon using a second embodiment of a button in accordance with the present invention;  
         [0070]    [0070]FIG. 17A is a sectional view of a second embodiment of a button in accordance with the present invention being swaged to a suture;  
         [0071]    [0071]FIG. 17B is a top view of a second embodiment of a button in accordance with the present invention;  
         [0072]    [0072]FIG. 18A is a sectional view of a step in repair of a tendon using a second embodiment of a suture in connection with the second embodiment of the button;  
         [0073]    [0073]FIG. 18B is a sectional view of a step in repair of a tendon using a second embodiment of a suture in connection with the second embodiment of the button;  
         [0074]    [0074]FIG. 18C is a sectional view of a step in repair of a tendon using a second embodiment of a suture in connection with the second embodiment of the button;  
         [0075]    [0075]FIG. 18D is a sectional view of a step in repair of a tendon using a second embodiment of a suture in connection with the second embodiment of the present invention;  
         [0076]    [0076]FIG. 19 is a sectional view of a repaired tendon using a third embodiment of the present invention;  
         [0077]    [0077]FIG. 19A is a sectional view of the button of FIG. 19;  
         [0078]    [0078]FIG. 20A is a sectional view of a step in the repair of a tendon using a fourth embodiment of the present invention;  
         [0079]    [0079]FIG. 20B is a sectional view of a repaired tendon using the fourth embodiment of the present invention;  
         [0080]    [0080]FIG. 21 is a sectional view of a tendon repair device in accordance with the present invention used in connection with a bone anchor;  
         [0081]    [0081]FIG. 22 is a sectional view of a second tendon repair device in accordance with the present invention used in connection with a bone anchor;  
         [0082]    [0082]FIG. 23A is a sectional view illustrating an alternative embodiment of a tendon-to-bone repair apparatus in exploded form;  
         [0083]    [0083]FIG. 23B is a sectional view similar to FIG. 23A, but showing the apparatus in assembled form attaching the tendon to the bone;  
         [0084]    [0084]FIG. 23C is an enlarged sectional view of the apparatus as shown in FIG. 23B, specifically illustrating the compression of tendon fibers within a helical anchor of the present invention;  
         [0085]    [0085]FIG. 24A is a sectional view of another alternative tendon-to-bone repair apparatus shown in exploded form;  
         [0086]    [0086]FIG. 24B is a sectional view similar to FIG. 24A, but showing the apparatus in assembled form;  
         [0087]    [0087]FIG. 24C is an enlarged sectional view of the apparatus shown in FIG. 24B;  
         [0088]    [0088]FIG. 25A is a perspective view showing another alternative tendon-to-bone repair apparatus in exploded form;  
         [0089]    [0089]FIG. 25B is a sectional view of another tendon-to-bone repair apparatus;  
         [0090]    [0090]FIG. 26 is a sectional view illustrating yet another alternative tendon-to-bone repair apparatus also including a helical anchor system according to the invention;  
         [0091]    [0091]FIG. 27 is a top view showing incisions made in a finger to access a tendon in accordance with additional aspects of the invention;  
         [0092]    [0092]FIG. 28 is a top view similar to FIG. 27, but isolating the finger to be repaired and showing transfixation of the tendon segments;  
         [0093]    [0093]FIG. 29 is a perspective, schematic view showing initial steps in a tendon repair procedure in accordance with the invention;  
         [0094]    [0094]FIG. 30 is an enlarged perspective view of the distal end of the tool shown in FIG. 29, illustrating the attachment of a helical anchor in accordance with the invention;  
         [0095]    [0095]FIG. 31 is a perspective view showing the insertion of the helical anchor within a tendon segment;  
         [0096]    [0096]FIG. 31A is a partially cross sectioned, perspective view illustrating a modified form of the anchor insertion tool shown in FIGS.  29 - 31 ;  
         [0097]    [0097]FIG. 32 is a perspective view similar to FIG. 31, but showing the subsequent insertion of a retaining member into the tendon segment;  
         [0098]    [0098]FIG. 33 is a partially fragmented sectional view similar to FIG. 32, but showing the locking of the retaining member to the elongate tensile member;  
         [0099]    [0099]FIG. 34 is a sectional view taken along line  34 - 34  of FIG. 33;  
         [0100]    [0100]FIG. 34A is a sectional view similar to FIG. 34, but illustrating the locking portion of the retaining member in a crimped or deformed condition;  
         [0101]    [0101]FIG. 35 is a perspective view of the tendon repaired in accordance with the invention;  
         [0102]    [0102]FIG. 36 is an enlarged sectional view schematically illustrating the attachment of a tendon repair apparatus of this invention to the tendon fibers;  
         [0103]    [0103]FIG. 37 is a plan view of an elongate tensile member, helical anchor, and retaining member in accordance with another embodiment of the invention;  
         [0104]    [0104]FIG. 37A is a perspective view of another embodiment of a helical anchor constructed in accordance with the invention;  
         [0105]    [0105]FIG. 37B is an elevational view of repair apparatus including the helical anchor of FIG. 37A and a retaining member shown affixed to an elongate tensile member within a tendon in accordance with the invention;  
         [0106]    [0106]FIG. 38 is a partially sectioned plan view showing another embodiment of a helical anchor system;  
         [0107]    [0107]FIG. 39 is an enlarged partially sectioned view similar to FIG. 38, but illustrating the partial absorption of the retaining member in accordance with this embodiment;  
         [0108]    [0108]FIG. 40 is a schematic, sectional view showing an alternative configuration of a helical anchor;  
         [0109]    [0109]FIG. 41 is a schematic, sectional view of another alternative helical anchor;  
         [0110]    [0110]FIG. 42 is a schematic, sectional view of another alternative helical anchor;  
         [0111]    [0111]FIG. 43 is a partially sectioned view of another alternative repair apparatus connected within a tendon;  
         [0112]    [0112]FIG. 44A is a partially sectioned view of another alternative repair apparatus in accordance with the invention;  
         [0113]    [0113]FIG. 44B is a partially sectioned view similar to FIG. 44A, but showing the partial absorption of the retaining member of this embodiment;  
         [0114]    [0114]FIG. 45A is a partially sectioned view showing another alternative embodiment of a repair apparatus in accordance with the invention;  
         [0115]    [0115]FIG. 45B is a partially sectioned view similar to FIG. 45A, but showing partial absorption of the various components of the apparatus;  
         [0116]    [0116]FIG. 45C is a partially sectioned view similar to FIG. 45B, but illustrating full absorption of the helical anchor and internal retaining member and partial absorption of the elongate tensile member;  
         [0117]    [0117]FIG. 46 is a perspective view showing the partially assembled condition of another alternative repair apparatus employing a compressible helical anchor;  
         [0118]    [0118]FIG. 47A is a perspective view of an alternative apparatus employing a compressible helical anchor with an integrated locking member;  
         [0119]    [0119]FIG. 47B is a perspective view illustrating the embodiment of FIG. 47A in a compressed and locked condition within a tendon;  
         [0120]    [0120]FIG. 48A is a partially sectioned view of an alternative embodiment for a locking member used to retain a helical anchor at a selected position along the elongate tensile member and showing the locking member in an adjustable condition;  
         [0121]    [0121]FIG. 48B is a partially sectioned view similar to FIG. 48A, but showing the locking member in a locked condition;  
         [0122]    [0122]FIG. 49A is a perspective view showing another alternative tendon repair apparatus employing compressible, helical anchors in accordance with the invention;  
         [0123]    [0123]FIG. 49B is a perspective view similar to FIG. 49A, but showing the apparatus fully implanted to repair the tendon;  
         [0124]    [0124]FIG. 50 is a perspective view of another alternative embodiment employing compressible, helical anchors in accordance with the invention;  
         [0125]    [0125]FIG. 51A is a partially sectioned view of another alternative tendon repair apparatus employing electromagnetic impulse energy to collapse one helical member onto another and showing the uncollapsed condition;  
         [0126]    [0126]FIG. 51B is a partially sectioned view similar to FIG. 51A, but showing the collapsed condition of the outer helical member and the attachment of a locking member within a tendon;  
         [0127]    [0127]FIG. 51C is a partially sectioned view similar to FIG. 51B, but illustrating an alternative embodiment having a solid or non-helical inner retaining member;  
         [0128]    [0128]FIG. 52 is a schematic, perspective view showing a magnetic impulse generator operatively connected to a patient&#39;s finger for generating the required electromagnetic impulse in the embodiments of FIGS. 51A and 51B;  
         [0129]    [0129]FIG. 53A is a schematic, perspective view showing another alternative embodiment of a tendon repair apparatus employing a collapsible helical member;  
         [0130]    [0130]FIG. 53B is a schematic perspective view showing an intermediate step in the application of the collapsible helical member within the tendon;  
         [0131]    [0131]FIG. 53C is a schematic perspective view similar to FIG. 53B, but showing a subsequent step with the collapsible helical member being collapsed onto another helical member to compress tendon fibers therebetween;  
         [0132]    [0132]FIG. 54 is another alternative embodiment similar to the embodiment of FIGS.  53 A- 53 C, but schematically illustrating an expandable helical member for trapping tendon fibers with another helical member;  
         [0133]    [0133]FIG. 55 is a fragmented plan view showing another tendon repair apparatus employing a collet structure in accordance with the invention;  
         [0134]    [0134]FIG. 56 is a perspective view of another collet-type anchor structure shown in exploded form;  
         [0135]    [0135]FIG. 57 is a partially sectioned view of the embodiment shown in FIG. 56, but illustrating the assembled condition of this embodiment within a tendon;  
         [0136]    [0136]FIG. 58 is a perspective view of another alternative helical anchor and internal retaining member showing a ratchet structure for preventing counter-rotation of the retaining member;  
         [0137]    [0137]FIG. 59 is a perspective view of another embodiment employing two helical members with interlocking or intermeshing coils;  
         [0138]    [0138]FIG. 60 is a perspective view of another alternative anchor structure employing a flexible helical anchor wrapped around a retaining member;  
         [0139]    [0139]FIG. 61 is a graph illustrating a force/displacement curve comparing a helical anchor repair apparatus of the invention against a conventional Kessler repair technique;  
         [0140]    [0140]FIG. 62 is a perspective view of another alternative embodiment of the invention employing two helical anchors integrated with an elongate tensile member;  
         [0141]    [0141]FIG. 63 is a partially sectioned view of a tendon retrieval device constructed in accordance with the invention;  
         [0142]    [0142]FIG. 64 is a perspective view showing use of the retrieval device of FIG. 63;  
         [0143]    [0143]FIG. 65 is a perspective view illustrating an alternative double helix embodiment useful in the tendon retrieval device of this invention;  
         [0144]    [0144]FIG. 66 is an end view taken along line  66 - 66  of FIG. 65;  
         [0145]    [0145]FIG. 67 is a perspective view illustrating another alternative anchor structure employing two crimpable anchor members, and an elongate tensile member;  
         [0146]    [0146]FIG. 68 is a perspective view of a portion of a tool used to apply the anchor structure shown in FIG. 67;  
         [0147]    [0147]FIG. 69 is a partially sectioned view illustrating the use of the tool to crimp the anchor members onto a tendon and the elongate tensile member;  
         [0148]    [0148]FIG. 70 is a sectional view taken generally along line  70 - 70  of FIG. 67, but illustrating the crimped or deformed condition of the crimp members on the tendon tissue;  
         [0149]    [0149]FIG. 71 is a sectional view taken generally along line  71 - 71  of FIG. 67, but illustrating the crimped or deformed condition of the crimp members locked onto the elongate tensile member;  
         [0150]    [0150]FIG. 72 is a plan view illustrating an alternative crimp-type anchor structure employing a single crimp member and elongate tensile member;  
         [0151]    [0151]FIG. 73 is a sectional view taken generally along line  73 - 73  of FIG. 72, but illustrating the crimped or deformed condition of the crimp member onto the tendon tissue and around the elongate tensile member;  
         [0152]    [0152]FIG. 74 is a sectional view taken generally along line  74 - 74  of FIG. 72, but illustrating the crimped or deformed condition of the crimp member onto the elongate tensile member;  
         [0153]    [0153]FIG. 75 is a perspective view of a unitary anchor assembly comprised of a helical anchor coupled for insertion with a core portion or tendon fiber retaining member;  
         [0154]    [0154]FIG. 76 is a plan view showing the unitary anchor assembly of FIG. 75 carried on an elongate tensile member and including a crimp member at a proximal end thereof;  
         [0155]    [0155]FIG. 77 is a perspective view showing an insertion tool for inserting the assembly of FIG. 75 into a tendon or ligament;  
         [0156]    [0156]FIG. 78 is a cross sectional view generally taken along the longitudinal axis of the insertion tool shown in FIG. 77;  
         [0157]    [0157]FIG. 78A is an enlarged view, partially cross sectioned, of the distal end of the tool shown in FIG. 78;  
         [0158]    [0158]FIG. 79 is an enlarged cross sectional view of the tool being used to drive the unitary anchor assembly into a tendon or ligament;  
         [0159]    [0159]FIG. 80 is a side elevational view schematically showing an alternative pistol grip assembly for the insertion tool of FIG. 77 allowing one-handed operation by a surgeon;  
         [0160]    [0160]FIG. 80A is a fragmented end view of the pistol grip assembly of FIG. 80 schematically illustrating the interaction between the rack and pinion drive;  
         [0161]    FIGS.  81 - 87  are perspective views illustrating a tendon or ligament repair method utilizing two unitary anchor assemblies and an elongate, flexible tensile member;  
         [0162]    [0162]FIG. 88 is an enlarged perspective view showing the jaw portion of a crimp tool and a crimp member each constructed in accordance with additional aspects of the invention.  
         [0163]    [0163]FIG. 89 is a perspective view of an anchor assembly removal tool in accordance with another aspect of the invention; and  
         [0164]    [0164]FIG. 90 is an enlarged perspective view of the distal end of the removal tool and the unitary anchor assembly of this invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0165]    Bone and Meniscus Repair Device  
         [0166]    As shown in FIGS.  1 - 10 , a novel device  10  for repairing a fractured bone  12  is shown. The fractured bone repair device  10  has three primary parts, a flexible or rigid suture or filament  14 , a first button  16 , and a second button  18 . First button  16  is ideally identical to second button  18 . The suture or filament may be rigid or flexible, monofilament or multifilament.  
         [0167]    As shown most particularly in FIG. 2, suture  14  has a first end  20  and a second end  22 . First end  20  of suture  22  is made rigid so as to allow the suture to be drilled through a fractured bone  12 , as shown in FIG. 1. The rigid segment  20  is placed in a standard driver (not shown) which is well-known to one of ordinary skill in the art, most preferably a MicroAire Wire Driver. The rigid segment  20  ideally has a sharp point  24  to allow for easier drilling.  
         [0168]    A sheath  26  may also be provided for the filament  14  during the drilling procedure and forms a part of this invention. The sheath  26  would serve as an extension from the collet  28  of any of the well-known drilling tools. Two forms are contemplated. The first would use a collapsing sheath (not shown), such as an accordion pleat such that the sheath will buckle as the tool moves towards the bone  12 . alternatively, a concentric spring  30  may be made of any of a variety of materials. The material must be strong enough to withstand any punctures from small bone fragments which may be displaced through the drilling procedure. However, it must be thin enough to allow its collapse as drilling progresses. The material must also have sufficient heat resistance or a sufficiently high melting point that it is unaffected by the heat generated by the drill. The sheath  16  will extend the full length of the drilling tool from the collet  28  to fully protect surrounding tissues.  
         [0169]    Optionally a short pin is located on the second end  22  of the suture  14 . This pin  32  may be used for hand drilling the bone  12 . whether the bone  12  must be hand-drilled or may be drilled by machine is based on a number of factors, all of which are well-known by these of ordinary skill in the art. The filament may alternately be passed through a pre-drilled hole in the bone  12 .  
         [0170]    Regardless of how the bone  12  is drilled, the method of operation of the bone repair device  10  is the same. The rigid second end  22  is drilled from a first side  34  of a fracture  36  to a second side  38  of fracture  36 . The rigid second end  22  is then pulled such that the suture portion  14  is within the bone  12 . The purpose of the suture  14  being optionally flexible is that many bones which are fractured are small in size and are not easily aligned. In order to properly repair a bone, most particularly a small bone, using prior art technology, a practitioner must spend a large amount of time precisely aligning the first side  34  and second side  38  of fracture  36 . If the suture used is flexible, the first side  34  and second side  38  need not be precisely aligned, since the flexible suture  14  can bend at any point. While it is desirable that first side  34  and second side  38  be somewhat aligned, it is not necessary to have as great a precision and much time can be saved.  
         [0171]    The suture  14  is preferably a monofilament or multifilament wire or flexible polymer. The thickness of suture  14  depends on the size and location of the bone but, for small bones such as are in the hand, will fall within the range of 0.02 to 0.06 inches in diameter. The differing tensile strengths which will be needed for various bones and the tensile strengths of various thicknesses are well-known to one of ordinary skill in the art.  
         [0172]    Once the suture  14  has been drilled through bone  12 , or passed through a pre-drilled hole, it extends completely through bone  12  from the first side  34  of fracture  36  to the second side  38  of fracture  36 . The suture  14  must then be secured in order to hold the first side  34  and second side  38  together until fracture  36  is healed. The suture is secured on each side  34 ,  36  by a button  16 ,  18 . Because each button  16 ,  18  is selected from the same group of possible designs, the designs are described only in reference to first button  16 . However, it will be understood that second button  18  may have a similar design.  
         [0173]    As is most clearly shown in FIGS. 5 and 6, two types of buttons  16  are preferred. FIG. 5 shows a button  16  which includes a flange  40  which extends to or beneath the surface  44  of bone  12 . FIG. 6 shows a button  16  which includes a flange  42  resting on the surface  44  of bone  12 . Flanges  40 ,  42  serve to aid in distributing the tension load from the suture  14 . Each button  16  has an inner surface  46 ,  48  which slidably contacts and circumscribes suture  14 . On the inner surfaces  46 ,  48  of the buttons  16  is one or more notches  50 ,  52 . Notch  50  is formed such that it is an extension of flange  40 , whereas notch  52  is formed separately of flange  42 . Because suture  14  is flexible and somewhat soft, compared to buttons  16 , a crimping tool (not shown) may be used to press inwardly on or crimp button  16  such that notches  50 ,  52  penetrate suture  14  and become secured to suture  14 . In this way, the buttons  16 ,  18  may become attached to suture  14 .  
         [0174]    An alternative button  16  is shown in FIGS.  7 - 10 . This button  16  is a locking spring washer. With such a button  16 , the tension on the suture  14  may be increased, but not decreased. This type of button  16  locks by itself with no crimping tool required. The suture  14  ideally includes notches or grooves  54  to aid in the attachment of button  16  to suture  14 .  
         [0175]    This method if ideally designed for use with bones in the hands or feet which are smaller and more delicate. However, the same invention may be used in connection with larger bones and may be particularly useful if a larger bone is broken into many smaller pieces. The diameter of the rigid segment, filament, and pin must be adjusted to effectively join the bone and fragment, especially if the bone and fragment are large.  
         [0176]    Turning to FIG. 11, the same invention may also be used to repair a torn meniscus  56 . The suture  14  (shown in dashed lines) is threaded through the meniscus  56  from a first side  58  to a second side  60  of fracture or gear  62 . While a meniscus  56  is typically referred to as being torn rather than fractured, the word “fracture” and all forms thereof should be understood to refer to both bones and to menisci in the context of this invention for ease of understanding and vocabulary and to avoid confusion with the invention (described below) which relates to the repair of torn tendons. A first button  16  is attached to and circumscribes suture  14  on a first side  58  of the fracture  62  and a second button  18  is attached to and circumscribes suture  14  on a second side  60  of fracture  62 . Buttons  16 ,  18  may have the same configuration as those described above or may resemble the tabs  144  as described in tendon repair, FIG. 17B.  
         [0177]    Tendon Repair Device and Method  
         [0178]    The method described may be used with any of the relevant buttons in the present invention. The prior art method for repairing a torn tendon is shown in FIG. 12, and involves making a single long incision over the location of the torn tendon. The present invention (shown in FIG. 13) uses a device and method for repairing a torn tendon through one or more skin incisions and two or more smaller incisions in the sheath, minimizing trauma to critical tissues. This invention may be used to repair either a tendon or a ligament. The term “tendon” as used in the application should be understood to also encompass ligaments.  
         [0179]    As shown in FIGS. 13 and 14, a surgeon makes a first incision  100  in the skin  102  above the location of the tear  104  in the tendon  106 . It is noted that the skin above the tendon tear  104  may have already been incised as in a laceration. If such is the case, only a small neatening of the incision may be relevant. The surgeon then makes a second incision  108  on the first side  110  of the first incision  100 . The surgeon also makes a third incision  112  on the second side  114  of the first incision. These incisions  100 ,  108 ,  112  preferably involve several transverse incisions or short “T” or “L” incisions. Additional small “window” incisions may be necessary to gain access for retrieval of the tendon end. The incisions  100 ,  108 ,  112  may also involve rolling the tendon or ligament sheath down a distance of about 3 mm. A needle  116  (FIG. 14) is then threaded with a core suture or elongate tensile member  118 . The needle  1167  is preferably a swaged, large radius, non-cutting needle, which allows the needle  116  to penetrate the filamentous tendon  106  without weakening it. For flexor tendons in the hand, the suture  118  is preferably USP size No. 1 or No. 2 and is preferably made of a monofilament of polyester, stainless steel, or polyglactin  910 , or other high strength material. The needle  116  and attached suture  118  are then inserted into the tendon at the first side  112  of the tear  104 . The needle  116  and the suture  118  travel down the center  120  of the tendon  106 , exiting at the second incisions  108 . The surgeon then inserts needle  116  and attached suture  118  at approximately the same center  120  of the second side  124  of tear  104 . The needle  116  and attached suture  118  exit the tendon  104  through the third incision  112  on the second side  114  of the tear  104 . The suture  118  is then tightened such that the first side  122  of the tear  104  is drawn into abutting relationship to the second side  124  of the tear  104 , shown most clearly in FIG. 13. A second suture  118  may also need to be inserted in a similar fashion, as will become clear from the following description. Once the suture  118  has been properly placed, it must be secured in order to maintain the abutting relationship between first side  122  and second side  124  of tear  104 .  
         [0180]    A first way of securing the suture is with a variety of buttons. A first embodiment is shown in FIG. 15 which shows the use of a sliding anchor button or body  126 . A surgeon makes a stab or slit wound  128  in the tendon  106  in an area generally under the second incision  108  made on the first side  110  of the first incision  100 . The sliding anchor button or body  126  slips onto the suture  118  and into the stab wound  128  under the exterior surface  129  of tendon  106 . The sliding anchor button  126  has burrs  130  which serve to assist in holding sliding anchor button  126  in place in tendon  106  once it reaches the desired location. The burrs  130  are directed such that they are facing towards the tear  104  and generally outwardly from the suture  118  and serve to reduce the possible motion of sliding anchor button  126  and to distribute the axial load. In order to properly place the sliding anchor button  126 , a tool  132  should be used which is capable of keeping the exterior surface of sliding anchor button  126  from coming into contact with tendon  106  prior to its correct placement. The tool  132  is important, since otherwise, the burrs  130  can tear or otherwise damage the tendon  106 . Once the sliding anchor button  126  is in place, the tool  132  is retracted and sliding anchor button  126  is swaged to the suture  118  such that sliding anchor button  126  is attached to and at least partially circumscribes suture  118 . FIGS.  15 A- 15 D show a variety of possible forms for the sliding anchor button  126  in cross section. Each of these sliding anchor buttons  126  has a width W. Preferably width W is about 2 mm. As can be seen in these Figs., the sliding anchor button  126  can be configured such that it slides onto suture  118  by being threaded, as in FIGS.  15 B- 15 D, or through a side slot as in FIG. 15A. Note also that in these embodiments, the burrs  130  are directed radially outwardly from the suture. Once the sliding anchor button  126  has been placed and swaged onto suture  118 , the stab wound  128  is closed, preferably using a continuous microsuture. As can be seen in FIG. 16A, the stitches used to close the stab wound  128  may also penetrate to sliding anchor button  126  and to optional holes  133 . Once one sliding anchor button  126  has been placed, a surgeon can insert a second sliding anchor button in the same way on the second side  114  of the first incision  100  below the third incision  112 . During the installation of the second button  126 , the abutting relationship between first side  122  and second side  124  of tear  104  is assured by pre-tensioning the core suture  118  as the second button  126  is attached. Tension may be applied by a special aspect of tool  132  or by manual means. The remainder of the procedure is the same as that mentioned above. Once a button has been inserted on each of first side  110  and second side  114 , the tendon appears as is shown in FIG. 16. The incisions  100 ,  108 ,  112  may then be closed in any fashion known in the art.  
         [0181]    A second embodiment of securing buttons is shown in FIG. 17. In FIG. 17, two sutures  118  are used to hold first side  122  and second side  124  in abutting relationship, as was mentioned above. In such a case, a first suture  118  must be placed to one side of the center  120  of tendon  106  and a second suture  118  must be placed to another side of the center  120  of tendon  106 . If this embodiment is used, no stab wound need be made in the tendon  106 . In this embodiment, once the suture is placed, the tab buttons  136  slide onto suture  118  until they reach the exterior surface  129 . The suture  118  may be placed under greater tension by pushing tab buttons  136  such that they place some pressure on the exterior surface  138  of tendon  106 . Once the tab buttons  136  have been appropriately placed, they are swaged or crimped to suture  118  such that they are attached to and circumscribe at least a part of suture  118 , as shown most clearly in FIG. 17A, by a swaging tool  140 . Preferably, as shown in FIG. 17B, the tab button  136  has a circular shape, and includes a central portion  142  and a circular flange  144 . The central portion  142  and flange  144  include a slot  146  which allows tab button  136  to be easily placed on suture  118 . When tab button  136  is in place, the flange  144  extends radially outwardly of the suture  118 , shown most clearly in FIG. 17. The tab button  136  may include burrs  148  which extend generally outwardly from the suture  118  and serve to keep the tab buttons  136  in place and distribute the axial load. Once the first tab button  136  has been placed, a second, third, and fourth tab button  136  may be similarly placed using a similar method for each suture  118 .  
         [0182]    The tab button  136  may also be used with a different embodiment of the suture, as shown in FIGS.  18 A- 18 D. In this embodiment, a split and monofilament  150  is used. The split end suture  150  is inserted in the center  120  of first side  122  of tendon  106 , as shown by the direction of the arrow in FIG. 18A. The split end suture  150  has a first end  152 . The first end  152  of split end suture  150  is divided into a first part  154  and a second part  156 . When split end suture  150  is inserted into tendon  106 , the first part  154  and second part  156  are contained within a cap  158  to retain first part  154  and second part  156  together. Cap  158  has a sharp end  160  to allow cap  158  to penetrate tendon  106 . After the split end suture  150  and cap  158  reach an appropriate depth, the split end suture  150  is withdrawn in the direction of the arrow shown in FIG. 18B. The split end suture  150  is withdrawn only to just beyond the cap  158 . The split end suture  150  is then pushed in an inward direction as noted by the arrow in FIG. 18C. When the split end suture  150  is pushed, the first part  154  and second part  156  split apart and eventually break the exterior surface  138  of tendon  106 . A fifth and sixth tab button  136  are then attached to the first part  154  and second part  156 , respectively, such that fifth and sixth tab buttons  136  are attached to and at least partially circumscribe the first part  154  and second part  156 , respectively. The same operation would apply on the second end (not shown) of the split end suture  150 , which is substantially the same as the first end  152  of split end suture  150 . The second end would simply be inserted into the second side  124  of tear  104 . Other considerations which would be relevant are that the split end suture  150  should ideally be inserted such that half of it extends into each of first side  122  and second side  124 , and the first side  122  and second side  124  must be held in an abutting relationship, so that the entire length of the split end suture  150  should be within the tendon  106 . The tab buttons  136  used with the split end suture  150  are the same as those mentioned earlier and may include flanges  144  or burrs  148 .  
         [0183]    Turning now to FIG. 19, a third embodiment of buttons is shown. The transverse button  162  is again used in conjunction with two sutures  118 , inserted as described above. The transverse button  162 , as shown in FIG. 19A, is attached to an partially circumscribes a first suture  118  and is swaged or crimped onto the first suture  118  with a swaging tool, such as tool  140 . Another transverse button  162  is attached to and partially circumscribes a second suture  118  and is swaged or crimped onto the second suture  118  with a swaging tool, such as tool  140 . In this embodiment, the transverse buttons  162  are attached to each other by a telescoping mating pin  164 . Attached to one of the transverse buttons  162  is the male portion  166  of the pin  164 , and attached to the other transverse button  162  is the female portion  168  of the pin  164 . The male portion  166  and the female portion  168  are pushed towards each other through tendon  106 . When male portion  166  and female portion  168  reach each other, they ratchet and lock, thereby causing one of the transverse buttons  162  to be attached to the other transverse button  162 .  
         [0184]    The second method of securing the suture, instead of using buttons, is by using the suture itself. Turning to FIGS. 20A and 20B, the suture  170  includes barbs  172 , which serve to secure the suture  170  and distribute the axial load. When the barbed sutures  170  are inserted into tendon  106  as described above, the sutures must be completely surrounded by a cannula  174  or other protective device which serves to keep barbs  172  from become attached to tendon  106  prior to proper placement. Once suture  170  is properly placed, as shown in FIG. 20A, cannula  174  is removed in any standard way. The barbs  172  will then keep the suture  170  in place and keep first side  122  and second side  124  of tear  104  in abutting relationship.  
         [0185]    An alternative installation process may be used in this invention where a single suture has a needle on each end. In which case the needles enter the central wound opening and each penetrates the severed end of the tendon; the two needles moving in opposite directions to exit at one of the window openings spaced from the wound. After each needle exits the suture is tightened and the tendon ends are drawn together by the structure and procedural steps described above.  
         [0186]    Device for Securing a Torn Tendon to a Bone  
         [0187]    This invention relates to the use of a button as described above in connection with a known bone anchor in order to secure a tendon to a bone. Turning first to FIG. 21, a system is shown for attaching a bone  200  and a tendon or ligament  202 . A bone anchor  204  is installed in a hole  205  in the bone  200 . Any of the standard bone anchors known in the art are suitable, as long as they are capable of being attached to a flexible suture  206 . As shown in FIG. 21, a sliding anchor button  208  is attached to the flexible suture  206  and at least partially circumscribes the flexible suture  206 . The sliding anchor button shown in connection with the bone anchor  204  is inserted as was described earlier in connection with the tendon repair device under the surface  210  of the tendon  202 .  
         [0188]    Turning now to FIG. 22, a second embodiment of the tendon-bone anchor is disclosed. This embodiment is most preferably used when the tendon has a relatively thin cross-section, such as for exterior tendons and most ligaments. Again, bone anchor  204  is installed in a hole  205  in the bone  200 . Any of the standard bone anchors known in the art are suitable, as long as they are capable of being attached to a flexible suture  206 . Also attached to the flexible suture  206  is a tab button  212 , which includes barbs  214  extending generally parallel with flexible suture  206  and radially outward on flange  211 . Tab button  212  is attached to suture  206  as was described above such that tab button  212  is attached to and at least partially circumscribes suture  206 .  
         [0189]    Another embodiment of a tendon to bone repair apparatus  250  is shown in FIGS.  23 A- 23 C. In this embodiment, apparatus  250  includes an elongate tensile member  252  connected at one end with a bone anchor  254 , such as by a knot or other stop member  252 a. Bone anchor  254  may be a conventional bone anchor configured for retainment within a bone  256 . Apparatus  250  further includes a helical, compressible anchor  258  which has been rotated into a tendon or ligament  260 . A retaining member  262 , which may simply comprise a small button in this embodiment, receives elongate tensile member  252 , which may be a strong suture, and slides down onto tendon  260  as shown in FIG. 23B. A locking member, which may be a crimp member  264  receives elongate tensile member  252  and slides down on top of retaining member  262  where upon it is deformed or crimped and locked onto elongate tensile member  252  to hold apparatus  250  together with a portion of tendon  260  held firmly against bone anchor  254 . As further detailed in FIG. 23C, the compressible, helical anchor  258 , which may have the tapered configuration as shown or other configurations as detailed herein, traps fiber  266  of tendon  260  in a generally sinusoid pattern between respective coils of anchor  258 .  
         [0190]    Another embodiment of a tendon to bone repair apparatus  270  is shown in FIGS.  24 A- 24 C. Apparatus  270  also comprises an elongate tensile member  272  connected with a bone anchor  274  again by way of a suitable stop, knot or other method. Bone anchor  274  is fixedly secured within a bone  276 . A helical anchor  278  is rotated into a tendon or ligament  280  and is compressible. Unlike the previous embodiment, however, anchor  278  is inserted generally with its axis in line with the length of tendon or ligament  280  and anchor  278  is compressible generally along its length, as shown in FIG. 24B. When a retaining member  282  is received on elongate tensile member  272  and compressed onto tendon  280 , against bone anchor  274 , this will compress helical anchor  278  in a sideward manner as shown. A locking member  284 , which again may be a crimp member integral or separate from retaining member  282 , is then slid down elongate tensile member against retaining member  282  to hold  20  apparatus  270  in the position shown in FIG. 24B. As shown in FIG. 24C, elongate tensile member  272  extends through the center of helical anchor  278  generally along the lengthwise axis thereof and from one end to the other, although the helical anchor may intertwine with the coils of anchor  274  in other manners as well. Fibers  286  of tendon  280  will extend between the coils of anchor  274  in a generally sinusoidal pattern thus firmly trapping anchor  274  within tendon or ligament  280 .  
         [0191]    Another embodiment  290  is shown in FIG. 25A. Apparatus  290  comprises an elongate tensile member  292  suitable connected to a bone anchor  294  by way of a knot or stop member  292   a  or another method. Apparatus  290  further includes a helical anchor  298 , which again is preferably compressible, and received on elongate tensile member  292 . A retaining member  302  is also received on elongate tensile member  292  as shown in FIG. 25A. Locking members, in the form of projections  294   a ,  294   b ,  294   c , are disposed on bone anchor  294  and register in receiving slots  302   a ,  302   b ,  302   c  within retaining member  302 . Apparatus  290  is used in a manner similar to apparatus  250  shown in FIGS.  23 A- 23 C, except that after helical anchor  298  has been rotated into a tendon, retaining member  302  is pushed or rotated simultaneously with helical anchor  298  if anchor  298  is attached to retaining member  302 , and locked onto bone anchor  294  through the receipt of projections  294 ,  294   b ,  294   c  within the respective slots  302   a ,  302   b ,  302   c . The insertion and retainment of helical anchor  298  within a tendon or ligament may advantageously occur in a single surgical step if helical anchor  298  is connected for rotation with retaining member  302 . In this case, for example, rotation of retaining member  302  can simultaneously rotate helical anchor  298  into a tendon or ligament and lock the assembly onto bone anchor  294 .  
         [0192]    Another embodiment of a tendon to bone repair apparatus  310  is shown in FIG. 25B. In apparatus  310 , an elongate tensile member  312  is again connected with a bone anchor  314  by a suitable method, such as a knot  312   a . Bone anchor  314  is securely affixed, such as by a threading action within a bone  316 . A helical anchor  318  is received on elongate tensile member  312  and is adapted to be rotated into a tendon  320 . Helical anchor  318  is connected to a retaining member  322  in this embodiment either through a mechanical or integral connection. A locking member  324 , which again may comprise a crimp member, is integrally formed with retaining member  322  in this alternative embodiment. In its attached configuration, apparatus  310  is very similar to apparatus  250  shown in FIGS.  23 A- 23 C with helical anchor  318  being trapped within tendon  320  and fibers thereof being generally sinusoidally trapped between the coils of anchor  318 .  
         [0193]    Another alternative tendon bone repair apparatus  330  is shown in FIG. 26. Apparatus  330  includes an elongate tensile member  332  connected in a suitable rigid manner to bone anchor  334  such that it may be placed into tension. Bone anchor  334  is again affixed securely within a bone  336 . A helical anchor  338  is rotated into a tendon or ligament  340  in a manner similar to the embodiment, for example, of FIGS.  23 A- 23 C. In this embodiment, however, a retaining member  322  is provided for at least partial insertion within anchor  338  as shown in the assembled condition of FIG. 26. This traps fibers between retaining member  342  and the coils of anchor  338 . Once retaining member  342  is securely received within anchor  338 , a locking member  344 , which may be integral to or separate from retaining member  342 , is slid onto elongate tensile member  332  against retaining member  342  and crimped onto tensile member  332 . It should be appreciated that, although the elongate tensile members of the embodiments shown in FIGS.  23 A- 26  are flexible sutures, these may also be more rigid tensile members, such as members made of biocompatible metals or they may alternatively be formed of absorbable materials. One or more of the other elements of these tendon to bone repair apparatus may also be formed of absorbable materials.  
         [0194]    Alternative Tendon Repair Apparatus  
         [0195]    The invention contemplates further embodiments of tendon-to-tendon or ligament-to-ligament repair apparatus. For simplicity, only the term “tendon” is used herein at various points. A review of the general procedure is appropriate with reference first to FIGS. 27 and 28. When faced with repairing a severed or otherwise damaged tendon, the surgeon must make an incision to repair the severed or damaged tendon. FIG. 27 shows the actual laceration site  350  of a finger  351  and the augmented incision  352  made by the surgeon to gain access. After the incision has been made the skin flaps  354  are reflected back for full visualization of the damage. The surgeon will retrieve the proximal tendon segment  356  of the damaged tendon through a triangular window access incision  358  made in the tendon sheath  360 . The triangular incision  358  helps prevent the end of the proximal tendon segment  356  from catching on window incision  358  as it is retrieved. The distal segment  362  of the damaged tendon will also be retrieved in the same manner. Once the tendons ends have been retrieved as shown in FIG. 28, they are held in place temporarily with transfixation needles  364 . The function of these needles is to hold the tendon segments  356 ,  362  together without damaging the tips of the tendon which must be kept as trauma free as possible to promote a good repair.  
         [0196]    [0196]FIG. 29 shows the transfixed tendon ends  370 ,  372  without the surrounding anatomy and transfixation needles  364 . In accordance with the invention, access incisions  374  of about 0.5 cm in length is made approximately 2-3 cm from the lacerated ends  370 ,  372  of the tendon. Preferably, a No. 2 suture  376  is placed in through the access incision  374  of the proximal tendon segment  356  out through the lacerated end  372  of the proximal segment  356  into the lacerated end  370  of the distal tendon segment  362  and out through the access incision  374  of the distal tendon segment  362 . Once the suture  376  is placed lengthwise through the tendon with a needle  378 , the surgeon places an anchor system of this invention into the tendon body.  
         [0197]    [0197]FIG. 31A illustrates an alternative tool  392 ′ for rotating helical anchor  390  into the tendon. Tool  392 ′ includes a flexible, hollow shaft  396 ′, however, in this embodiment shaft  396 ′ is contained within a hollow sheath  397  which is also flexible. Anti-rotation structure  399  is disposed within sheath  397  and may be actuated between a retracted position within sheath and an extended position as shown in FIG. 31A. In the illustrative example shown, structure  399  comprises spikes that flare outwardly into tendon segment  356  to prevent rotation of tendon segment  356  as flexible shaft  396 ′ is rotated, while sheath  397  remains stationary. This prevents the tendency of the tendon from rotating with the anchor as the anchor is rotated into place.  
         [0198]    Referring now to FIGS.  29 - 31 , a first alternative helical anchor repair apparatus is shown being inserted into tendon segments  356 ,  362 . This includes a first helical anchor  390  being applied with a tool  392  having a handle  394  and a flexible shaft  396 . It will be appreciated that many different tool configurations may be used in place of tool  392 . A distal end of tool  392  includes an anchor mounting portion  398  having a blunt tip. A trailing end  400  of helical anchor  390  includes a drive portion received in an aperture  402  associated with a hub  404  of end portion  398 . Anchor  390  further includes a leading end  406  which may be formed as either a sharpened or blunt tip. Anchor mounting portion  398  further includes a suitable aperture (not shown) along its length such that elongate tensile member or suture  376  may be threaded therethrough as shown in FIG. 29. Thus, anchor  390  is releasably attached to end portion  398  and elongate tensile member  376  extends through the center of helical anchor  390 .  
         [0199]    Tool  392  is used to rotate helical anchor  390  like a screw into tendon segment  356  through access incision  374  and rotated into place as shown in FIG. 31. At this point, the surgeon pulls back on tool  392  thereby releasing mounting end portion  398  from helical anchor  390 . At this point, and as shown in FIG. 32, a retaining member  410  is installed at least partially within helical anchor  390 . An installation tool  412  is used to grasp retaining member  410 , which is slidably received on elongate tensile member  376 . The surgeon slides retaining member  410  along elongate tensile member or suture  376  until reaching the position shown in FIG. 33. This traps and compresses the collagen fibers of the tendon between retaining member  410  and helical anchor  390  in a manner to be discussed further below. When retaining member is firmly situated within helical anchor  390 , the surgeon can deform a rear crimpable portion  414  as depicted in FIGS. 33, 34 and  34 A. In this regard, FIG. 34 shows rear crimpable portion  414  in an uncrimped state, while FIG. 34A shows crimpable portion  414  in a crimped position securely affixed to elongate tensile member  376 . This fixes the anchor structure, comprising anchor  390  and retaining member  410  securely to the fibers within tendon segment  356  and also affixes the anchor structure to the desired location on elongate tensile member suture  376 . Upon completion of this step, the surgeon moves on to tendon segment  362  and applies a similar procedure to affix a second helical anchor  420  and retaining member  422  to the suture  376  through access incision  374 . Prior to crimping retaining member  422  onto suture  376 , the surgeon may adjust the distance between tendon ends  370 ,  372  by sliding the anchor structure  420 ,  422  along suture  376  while applying a force, such as with tool  412 , to move the assembly  420 ,  422  along with tendon segment  362  toward the opposite segment  356 . When the desired repair position is reached, for example, with tendon ends  370 ,  372  approximately 1-2 mm apart, the surgeon crimps retaining member  422  to suture  376  in a manner similar to FIG. 34A.  
         [0200]    It will be understood that other manners of locking a retaining member, such as members  410  and  422 , in place may be used instead of crimp members or deformable portions of the retaining members. As shown in FIG. 35, opposite ends of suture  376  are cut at locations close to the respective retaining members  410 ,  422  and access incisions are closed, such as by using sutures  424 ,  426  or another acceptable method. Finally, a running suture  428  is placed at the junction of tendon ends  370 ,  372  or, again, another acceptable connection method may be used.  
         [0201]    [0201]FIG. 36 illustrates an alternative helical anchor  440  and retaining member  442  connected to elongate tensile member or suture  376  and held within tendon segment  356 . FIG. 36 further illustrates the benefits of the invention in more detail. In this regard, fibers  244 , which extend lengthwise within tendon segment  356  have been engaged within coils  446  of anchor  440  as anchor  440  was rotated into place as previously described. This engagement will occur generally in a sinusoidal pattern as shown, although the number and density of fibers  444  has been drastically reduced in the figure for clarity. Retaining member  442  may also have a discontinuous outer surface  448 , as shown, such as a serrated surface as shown in cross section in this view. This will further help retain the tendon fibers  444  between retaining member  442  and helical anchor  440  and prevent retaining member  442  from backing out of helical anchor  440 . An integral crimp member  450  is disposed on a trailing end of retaining member  442 . A separate crimp member or other locking structure may be used in its place.  
         [0202]    [0202]FIG. 37 discloses another alternative embodiment including a helical anchor  460  and a retaining member  462  adapted to be fixed into place on elongate tensile member  376  in a manner generally similar to the previous helical anchor embodiments. In this embodiment, retaining member  462  includes a discontinuous outer surface in the form of a threaded surface  464  which provides an anti-backout function and will allow gripping of the tendon fibers as retaining member  462  is rotated into helical anchor  460 . A crimp, member  466  may be provided to fix retaining member  462  in place as previously described. Also, suitable flats  468  may be provided for tool engagement allowing rotation of retaining member  462 .  
         [0203]    [0203]FIGS. 37A and 37B respectively illustrate another alternative embodiment of a helical anchor  460 ′ and an anchor structure comprising a helical anchor and retaining member  460 ′,  462 ′. Helical anchor  460 ′ has opposite, tapering but blunt ends  460   a ′,  460   b ′ to allow insertion into a tendon at either end  460   a ′ and  460   b ′. The blunt ends  460   a ′,  460   b ′ will spread the tendon tissue during entry as opposed to tearing, slicing or otherwise damaging the tissue. Other sharpened or blunt end configurations may be used as well. Retaining member  462 ′ includes a slot  462   a ′ at a trailing end for engagement with a rotating tool, and a tapered leading end  462   b ′ for entry into helical anchor  460 ′. An outer surface  462   c ′ is discontinuous in a convoluted, generally helical manner to generally register with the coils of helical anchor  460 ′. Thus, fibers  444  will be retained during use in a generally sinusoidal manner between the coils of helical anchor  460 ′ and the convoluted outer surface  462   c ′ of retaining member  462 ′. Finally, retaining member  462 ′ includes a central aperture  463  along its longitudinal axis for receiving an elongate tensile member such as the previously described suture  376 .  
         [0204]    [0204]FIGS. 38 and 39 illustrate another alternative embodiment utilizing a modified elongate tensile member  376 ′ having barb or ratchet structure  470 . Ratchet structure  470  is engageable with an internal portion  472  of a retaining member  474 . Therefore, as retaining member  474  is moved into helical anchor  460 , the interaction of structures  470  and  472  will prevent retaining member  474  from backing out. This therefore provides an alternative locking structure for holding retaining member  474  against anchor  460  with tendon fibers trapped and compressed therebetween. As further shown in FIG. 39, retaining member  474  may be formed from absorbable material, such as polyglycolic acid or polyglyconate. As retaining member  474  is absorbed, more tensile force will be experienced at the repair site as retaining member  474  will tend to move slightly further into helical anchor  460 . This gradual increase in tensile stress at the repair site will promote faster and stronger healing.  
         [0205]    FIGS.  40 - 42  illustrate three potential alternative embodiments of helical anchors, namely, anchors  480 ,  482  and  484 . As currently contemplated, the anchors will be tapered from a larger diameter at a trailing end to a smaller diameter at a leading end to assist in threading the anchor into the tendon tissue. However, it will be understood that many other configurations are possible as well with a few of the possibilities illustrated in FIGS.  40 - 42 . In FIG. 40, helical anchor  480 , shown in cross section, has a varying diameter along its length and an axis  486  which is not parallel to elongate tensile member  376  during use. Also, tensile member  376  travels partially within the coils of anchor  480  and partially outside of the coils. In FIG. 41, a similar configuration is shown, except that tensile member  376  is contained entirely within helical anchor  482  and anchor  482  has coils of approximately equal diameter along its length. FIG. 42 illustrates an anchor  484  that converges in diameter centrally from each end.  
         [0206]    [0206]FIG. 43 illustrates another embodiment of the invention wherein the elongate tensile member  376  is retained by a wedging action between a retaining member  490  and a helical anchor  492 . Retaining member  490  may have a serrated or otherwise discontinuous outer surface  494  for assisting in wedging and retaining elongate tensile member  376  against tendon fibers  496  and helical anchor  492 . Again, the number and density of fibers  496  is drastically reduced in FIG. 43 for clarity.  
         [0207]    Another embodiment of the invention is shown in FIGS. 44A and 44B. This embodiment is similar to the embodiment shown in FIG. 36 but illustrates the effect of forming retaining member  442 ′ from absorbable materials. The effect is similar to the effect described above in connection with FIGS. 38 and 39. That is, as retaining member  442 ′ absorbs into the tendon, the repair site will experience a greater amount of tensile force during physical therapy or other motion of the tendon. Again, this will speed the healing process and result in strengthening the repair site.  
         [0208]    FIGS.  45 A- 45 C illustrate a further use of absorbable materials for helical anchor  440 ′, retaining member  442 ′ and elongate tensile member  376 ″. In this embodiment, each of the elements will gradually absorb as shown progressively in the figures such that the function of transferring more tensile stress to the repair site is accomplished and such that the repair apparatus as a whole will fully or substantially absorb into the tendon after it has fulfilled its repair function. In this embodiment, the absorption rates of the different components may be varied by using different materials. For example, retaining member  442 ′ may be formed to absorb faster than elongate tensile member  376 ” or anchor  440 ′ such that tension is, at first, gradually transferred to the repair site. Then, after full healing has taken place, the remaining components can absorb into the tendon, removing all tensile reinforcement from the repair.  
         [0209]    [0209]FIG. 46 illustrates an alternative embodiment of the invention comprising a compressible, helical anchor  500  receiving elongate tensile member  376  and adapted to be retained in place within a tendon through a compressing action brought about by a suitable structure on elongate tensile member  376 , such as a separate crimp member  502  or an integral or attached crimp member associated with helical anchor  500  as shown in FIGS. 47A and 47B. It will be understood that many other potential locking structure may be substituted for crimp members  502  and  504  as long as the ultimate function of compressing helical anchor  500  is accomplished. As shown in FIG. 47B, when crimp member  502  or  504  is fixed onto elongate tensile member  376 , an elongate tensile member  376  is pulled in the direction of arrow  506 , toward the repair site, the coils of helical anchor  500  will compress and securely engage the tendon fibers therein. In this manner, helical anchor  500  will be locked onto tendon fibers  508  and the tendon segments may be pulled together at the repair site in the manner described above.  
         [0210]    An alternative crimp member is shown in FIGS. 48A and 48B. In this embodiment, crimp member  520  comprises first and second movable portions  522 ,  524  connected at a central portion  526 . Crimp member  520  may be received on and slid along elongate tensile member  376  in abutting relation to a trailing end portion  500 a of helical anchor  500  and crimped against elongate tensile member  376  by squeezing ends  528 ,  530  together as shown in FIG. 48B. A nub  532  and opposing recess  534  may be provided to help retain crimp member  520  fixed against elongate tensile member  376 . Opposite ends  536 ,  538  may bear against trailing end portion  500   a . In this manner, the assembly may be used, for example, in the manner described with respect to FIG. 47B.  
         [0211]    An alternative embodiment of a repair apparatus  550  incorporating an elongate tensile member  552  and a pair of compressible, helical anchors  554 ,  556  is shown in FIGS. 49A and 49B. In this embodiment, elongate tensile member  552  is initially comprised of two suture segments  552   a ,  552   b . As with the other embodiments this may be USP No. 2 suture. As in the previous embodiments, a crimp member  558 ,  560  may be associated with each compressible, helical anchor  554 ,  556  or the respective tensile member segments  552   a ,  552   b  may be connected with anchors  554 ,  556  in another suitable manner. The two tensile member segments  552   a ,  552   b  are threaded through a central crimp member  562  after being introduced through respective tendon segments  564 ,  566  preferably through respective proximal and distal windows in the tendon as described above. Tensile member segments  552   a ,  552   b  are pulled taut through central crimp member  562 . This simultaneously compresses helical anchors  554 ,  556  and pulls tendon segments  564 ,  566  together to a repair position as shown in FIG. 49B. At this time, a conventional running suture  568 , or optionally an adhesive or other acceptable method, may be used to connect tendon segments  564 ,  566  together at the repair site.  
         [0212]    Another embodiment of a tendon repair apparatus  570  is shown in FIG. 50. Apparatus  570  utilizes an elongate tensile member  572 , such as a suture comprised of one suture segment looped through a plurality of, for example, four compressible, helical anchors  574 ,  576 ,  578 ,  580 . In this embodiment, separate crimp members at each helical anchor may be eliminated as the suture itself will pull each of the helical anchors  574 ,  576 ,  578 ,  580  to a compressed position as the two suture ends  572   a,    572   b  are pulled through central crimp member  582 . As in the embodiment of FIG. 49A and 49B, pulling the two ends  572   a ,  572   b  through central crimp member  582  will simultaneously compress each helical anchor  574 ,  576 ,  578 ,  580  and bring tendon segments  584 ,  586  together to a repair position at which points ends  572   a ,  572   b  may be cut and a running suture or other final attachment method may be employed by the surgeon to complete the repair.  
         [0213]    [0213]FIGS. 51A, 51B and  52  illustrate an alternative manner of employing helical anchors to connect a repair apparatus to tendons and ligaments. Specifically, this system employs first and second helical members  590 ,  592  with at least one of the helical members  590 ,  592  being movable toward the other to trap and compress tendon or ligament fibers  594  of the tendon or ligament  596  therebetween. As with other embodiments of the invention, a suitable locking member, such as a crimp member  600 , may be used to connect elongate tensile member  598  for movement with anchor members  590 ,  592  such that tendon segment  596  may be pulled and placed under tension with elongate tensile member  598 . In the specific embodiment shown in FIGS. 51A, 51B and  52 , a magnetic impulse generator  602  is connected with a magnetic impulse supply unit  604  disposed around the patient&#39;s finger  606 . Analogous systems are available from Maxwell Magneform® in San Diego, Calif. When a magnetic impulse or impulses are supplied with generator  602  this will collapse first helical member  590  onto second helical member  592 . To accomplish this, for example, first helical member or outer helical member  590  may be formed from a magnetic metal material, while second helical member or inner member  592  is formed from a non-magnetic material and, therefore, does not deform through the application of an electromagnetic impulse. As with several other embodiments of this invention, this again employs the general technique of providing two portions of a tendon or ligament anchor structure with at least one portion being movable toward the other portion to trap and compress tendon or ligament fibers therebetween. Furthermore, prior to crimping of member  600 , crimp member  600  may be moved along elongate tensile member  598 , after collapsing outer helical member  590  such that tendon segment  596  is moved to the appropriate repair position at which point the surgeon may crimp member  600  to retain tendon segment  596  at the repair position.  
         [0214]    [0214]FIG. 51C illustrates another alternative embodiment similar in concept to the embodiment of FIGS. 51A and 51B. In this embodiment, however, an inner retaining member  462 ′ can comprise a solid core member, as opposed to a helical member. Retaining member  462 ′ can be formed of absorbable or non-absorbable materials. Retaining member  462 ′ is preferably threaded over elongate tensile member  598  after insertion of outer helical member  590  within tendon  596 . Initially, outer helical member  590  is in an uncollapsed or expanded state, as shown in phantom lines, and receives both elongate tensile member  598  and retaining member  462 ′. After insertion of retaining member  462 ′, one or more electromagnetic impulses are applied to collapse outer helical member  590  generally to the position shown in solid lines thereby compressing tendon fibers  594  between outer helical member  590  and inner retaining member  462 ′. As further shown, retaining member  462 ′ may include an outer discontinuous surface, such as a convoluted or threaded surface  462   c ′ to help retain, grip or otherwise engage fibers  594 . As necessary, a locking member  600 ′ may be crimped or otherwise locked onto elongate tensile member  598  and against retaining member  462 ′ to lock the anchor structure, comprising retaining member  462 ′ and helical member  590 , to elongate tensile member. It will be appreciated that locking member  600 ′ may not be necessary in any given application of the inventive concepts.  
         [0215]    FIGS.  53 A- 53 C illustrate another alternative embodiment of a repair apparatus  610  employing generally similar concepts to the embodiment of FIGS. 51A and 51B. Specifically, in FIG. 53A, apparatus  610  is employed in a tendon segment  612  and again includes an elongate tensile member  614  connected with a first helical member  616  by a suitable connector  618 . A second helical member  620  is initially contained in a hollow, helical carrier  622 . Carrier  622  has a diameter “D” which is greater than the diameter “d” of second helical member  620 . Thus, as second helical member  620  is rotated into carrier  622 , member  620  elastically expands to the shape of carrier  622  and is therefore initially disposed or carried at a diameter “D′. As further shown in FIG. 53B, as carrier  622  and second helical member  620  are rotated into tendon segment  612  through an access incision  624 , carrier  622  is rotated over first helical member  616 . As further shown in FIG. 53C, as carrier  622  is counter-rotated or rotated in a reverse direction, second helical member  620  is left behind and resiliently contracts or compresses around first helical member  616  thereby trapping tendon fibers (not shown) between member  616  and member  620 . It may be necessary for the surgeon to hold second helical member  620  stationary while counter-rotating carrier  622  as shown in FIG. 53C. Upon removal of carrier  622 , elongate tensile member  614  will be effectively connected to tendon segment  612  and may be placed under tension while, for example, pulling tendon segment  612  to a repair position as previously described.  
         [0216]    [0216]FIG. 54 illustrates an alternative embodiment of an apparatus  630  essentially employing a reverse technique as compared to the embodiment of FIGS.  53 A- 53 C. In this embodiment, a hollow, helical carrier  632  has a smaller outer diameter “d”, than the respective diameters “D” associated with first and second helical members  634 ,  636 . Elongate tensile member  614  may be suitably connected to first helical member  634 , such as through the use of a suture knot  614   a . In this embodiment, first helical member  634  is rotated into tendon segment  612  in one of the previously described manners and, similarly, carrier  632 , which contains second helical member  636  in a resiliently compressed state is rotated into the center of first helical member  634 . With second helical member  636  held stationary, helical carrier  632  is counter-rotated, as shown in FIG. 54, leaving second helical member  636  to resiliently expand to its normal diameter “D” thereby trapping tendon fibers (not shown) between first and second helical members  634 ,  636 . With carrier  632  removed, and helical members  634 ,  636  securely affixed to the tendon fibers, elongate tensile member  614  may be placed under tension and used to pull tendon segment  612  to a repair position as previously described. It should be appreciated that the respective diameters of helical members  616 ,  620  and  634 ,  636  may vary within the same anchor system. That is, helical anchor  616  may be slightly smaller or larger than helical anchor  620  and helical anchor  634  may be slightly smaller or larger than helical anchor  636  while retaining the ability to trap tendon fibers therebetween. Again, each of these anchor structures employ at least one moveable anchor portion to trap fibers between itself and another anchor member.  
         [0217]    [0217]FIG. 55 illustrates another alternative apparatus  640  comprised of a helical anchor  642  and elongate tensile member  644  and a retaining member  646 . These three elements operate together similar to previous embodiments in that helical anchor  642  and retaining members  646  are each initially slidable along elongate tensile member  644 . Elongate tensile member  644  may again be a flexible suture, semi-flexible or rigid tensile member. In this embodiment, retaining member  646  acts as a collet structure and includes one or more slots  648  extending from a leading end  646   a.  Also, retaining member  646  may include a discontinuous outer surface  650 , such as a surface having a generally threaded configuration. It will be appreciated that, as retaining member  646  is rotated into helical anchor  642 , tendon or ligament fibers (not shown) will be trapped between surface  650  of retaining member  646  and the inner surfaces of helical anchor  642 . At the same time, the collet structure at the leading end of retaining member  646  will compress due to the slot or slots  648  and will clamp against elongate tensile member  644  to retain the assembly fixed on elongate tensile member  644 . Retaining member  646  may be formed of a material that allows the leading end to plastically deform and clamp onto elongate tensile member  644 .  
         [0218]    A related embodiment utilizing collet-like structure is shown in FIGS. 56 and 57. In this embodiment, an apparatus  660  generally includes a helical anchor  662  and a two-piece retaining member structure comprised of inner and outer retaining elements  664 ,  666 . Anchor  662  and retaining elements  664 ,  666  are initially slidable-along an elongate tensile member  668 . One or more slots  670  are formed at a leading end of inner retaining element  664  and one or more slots  672  are formed at a trailing end of outer retaining element  666 . Again, an outer surface  674  may be discontinuous to help trap tendon fiber between outer retaining element  666  and helical anchor  662  as described below. A review of FIG. 57 will indicate the function of various elements shown in FIG. 56. More particularly, after helical anchor  662  has been rotated into a tendon segment  676 , the surgeon slides inner retaining element  664  into helical anchor  662  to trap tendon fiber  678  between outer surface  674  and helical anchor  662 . To lock the assembly into place and to expand outer retaining element  664  to further lock the tendon fiber  678 , the surgeon slides inner retaining element  664  or, alternatively, rotates inner retaining element  664  into outer retaining element  666 . This simultaneously expands outer retaining element  666  through the action of slots  672  and contracts the leading end of inner retaining element  664  through the action of slots  670  and a tapered inner surface  680  of outer retaining element  666 . Thus, in the position shown in FIG. 57, apparatus  660  is ready for use in accordance with the inventive concepts to repair the tendon by placing tendon segment  676  into tension using elongate tensile member  668 .  
         [0219]    [0219]FIG. 58 illustrates an alternative apparatus  690  again employing a helical anchor member  692  and a retaining member  694  each connected for sliding movement along an elongate tensile member  696 . Retaining member  694  may again include a drive portion  698  for allowing retaining member  694  to be rotated into helical anchor  692 . This embodiment illustrates a manner of preventing counter-rotation or backout of retaining member  694  after installation within a tendon. In this regard, a ratchet structure  700  is disposed at a trailing end portion of retaining member  694  for engaging a trailing end  692   a  of helical anchor  692 . As retaining member  694  is rotated into helical anchor  692 , ratchet structure  700  will engage trailing end  692   a  to prevent counter-rotation of retaining member  694 .  
         [0220]    [0220]FIG. 59 illustrates two helical anchors  702 ,  704  in which the helical coils are interlocked or intertwined. This may be used in the various embodiments of this invention to better interlock the helical anchor structure with the tendon fibers. For example, while one helical anchor  702  may be initially rotated into the tendon and, subsequently, the second helical anchor  704  may be rotated in an interlocking fashion with the first helical anchor  702 . The assembly is then used in accordance with the invention, and with one or more elongate tensile members or tensile member segments to place a tendon under tension during a repair as generally described herein. Alternatively, the coils of anchor  702 ,  704  may interlock in a lateral direction as shown in FIG. 59 without actually having the coils of one anchor rotate into the coils of the other anchor.  
         [0221]    [0221]FIG. 60 illustrates an alternative apparatus  710  in which a flexible helical anchor  712  is wrapped around an internal retaining member  714 . Helical anchor  712  may be formed from suture material, for example, that is one in the same with an elongate tensile member  716  used in accordance with the inventive concepts or which is separate from an elongate tensile member which may extend through a central longitudinal aperture (not shown) within retaining member  714 . Leading and trailing hook members  718 ,  720  may be provided for guiding helical anchor  712  at the ends of retaining member  714 .  
         [0222]    [0222]FIG. 61 illustrates force vs. displacement curves for helical anchor apparatus of the present invention as compared to conventional Kessler repair techniques. The helical anchor repair apparatus represented in FIG. 61 corresponds with the embodiment of FIG. 37B. The Kessler stitch techniques were performed with 3-0 Vicryl sutures and each repair was placed in porcine tendon of approximately 5 mm diameter. The graph demonstrates that the Kessler stitches allow displacement or gapping between the tendon segments at low levels of tensile force as compared to the helical anchor structures and elongate tensile member of the present invention. In other words, the helical anchors of the present invention will sustain much higher levels of tensile force without significant amounts of gapping occurring between the tendon ends as compared to the Kessler stitch technique. For this reason, a patient who has undergone a repair using the present invention can undergo more immediately and vigorous physical therapy than a patient having a Kessler stitch repair. Ultimately, the patient will experience a quicker recovery time and more mobility proximate the repair site using the present invention.  
         [0223]    [0223]FIG. 62 illustrates an alternative embodiment of the invention wherein an integral apparatus  730  comprises a tensile member  732  and opposite helical anchors  734 ,  736 . Anchors  734 ,  736  are coiled in opposite directions such that rotation of apparatus  730  in a single direction will cause helical portions  734 ,  736  to each rotate into respective opposed tendon segments  738 ,  740 . Apparatus  730  may be formed with various degrees of rigidity or flexibility suitable for the repair site. Retaining members (not shown) in accordance with the invention may be used to hold anchors  734 ,  736  securely to the tendon tissue.  
         [0224]    The concepts employed in the helical anchor based repair apparatus of the present invention may also be employed in a tendon retrieval device  750  as, for example, shown in FIGS. 63 and 64. Retrieval device  750  may be inserted into a tendon sheath through a window  752 , which may be triangular-shaped as previously described. Retrieval device  750  more specifically comprises a rotatable shaft or rod  754  having a helical retrieving member  756  at one end and a rotatable knob  758  connected at an opposite end. Shaft or rod  754  is contained within a hollow inner core  760  which, in turn, is contained within an outer core  762 . Anti-rotation members  764 ,  766  are preferably provided within hollow outer core  762  and may be actuated from non-operative positions to the operative positions shown in FIG. 63. This is accomplished by reciprocating a knob  768  back and forth. When knob  768  is moved to the left, as viewed in FIG. 63, this extends anti-rotation members  764 ,  766  into the tendon sheath  770  to prevent rotation thereof as rotatable knob  758  is subsequently rotated and moved inwardly to rotate helical member  756  into tendon end  772 . Once helical member  756  is fully rotated into tendon end  772 , knob  758  may be pulled to the right, as viewed in FIG. 63, to retrieve tendon end  772 .  
         [0225]    It will be appreciated that retrieval device  750  may be modified in many different manners consistent with the concepts disclosed herein. As one example, device  750  may further include an internal retaining member which may be inserted into helical member  756  to retain tendon fibers therebetween as previously discussed above with respect to tendon-to-bone and tendon-to-tendon repair apparatus. Another potential alternative is shown in FIGS. 65 and 66 in which inner and outer helical retrieving members  776 ,  778  are employed to counter-rotate into tendon end  772 . Suitable actuation structure (not shown) will be employed to counter-rotate helical members  776 ,  778 , thereby eliminating tendon rotation while the retrieval device is attaching to the tendon end  772 .  
         [0226]    FIGS.  67 - 71  illustrate another alternative embodiment of the present invention employing analogous concepts to previous embodiments wherein at least one portion of an anchor structure moves with respect to another to a position at which tendon fibers are trapped between the portions and the anchor structure is affixed to an elongate tensile member. In particular, an apparatus  800  is shown and comprises a pair of anchor members  802 ,  804  which may be crimped together and simultaneously crimped within a tendon  806  and securely against an elongate tensile member  808 , such as a suture or other tensile member as described above. Each anchor member  802 ,  804  includes respective long legs  810  and respective short legs  812  that register together in alternating fashion when in opposed relation as shown in FIG. 67 and as shown being applied through opposite access incisions  814 ,  816  in FIG. 69.  
         [0227]    [0227]FIGS. 68 and 69 illustrate a tool  820  having a pair of movable jaws  822 ,  824  used to apply anchor members  802 ,  804  to tendon  806 . Jaws  822 ,  824  include respective grippers  826 ,  828  for holding anchor members  802 ,  804  in opposed relation as shown in FIG. 69. As further detailed in FIG. 68, each jaw  822 ,  824  includes pockets  830  that align with the ends of the legs  810 ,  812  of the opposed anchor member  802  or  804 . A clip  832 , or other structure, may be provided to retain anchor member  802  and  804  in place until the crimping operation is complete. As shown in FIGS. 70 and 71, as jaws  822 ,  824  and grippers  826 ,  828  are brought together from the position shown in FIG. 69 to the position shown in FIGS. 70 and 71, legs  810 ,  812  will be deformed or crimped permanently into the position shown by respective pockets  830 . At the locations proximate longer legs  810 , this will lock anchor members  802 ,  804  to the tendon tissue  834  and, more specifically, to the tendon fibers comprising tissue  834 . At the area of proximate short legs  812 , anchor members  802 ,  804  will be crimped more directly onto elongate tensile member  808 . This action is brought about by the tapered angle of grippers  826 ,  828  as illustrated in FIG. 68 and by comparing FIGS. 70 and 71 which show the grippers in the same actuated position.  
         [0228]    In this embodiment, tool  820  may be actuated to a first position sufficient to grip tendon fibers  834 , but still allow sliding motion along elongate tensile member  808 . Using tool  820 , or another method, tendon  806  may then be pulled to a repair position by sliding anchor members  802 ,  804  along elongate tensile member  808 . At the appropriate repair position, the crimp may be finished by further actuating tool  820  to the position shown in FIGS. 70 and 71. In a tendon-to-tendon repair, as with the previous embodiments, one pair of anchor members  802 ,  804  may be rigidly affixed to tendon  806  in the manner illustrated in FIGS. 70 and 71, on one side of a tear, and the sliding adjustment may be accomplished in the opposite side of the tear followed by a final crimping action on a second set of anchor members  802 ,  804  as described above.  
         [0229]    FIGS.  72 - 74  illustrate another apparatus similar to FIGS.  67 - 71 , but employing a single anchor member  840  having respective long and short legs  842 ,  844 . The operation of this embodiment is similar to the previous embodiment, except that only one of the opposed jaws would require an anvil surface, such as one comprised of recesses or pockets, in order to bend legs  842  into a position suitable for tightly gripping tendon tissue  834  against elongate tensile member  808  and also tightly deforming legs  844  substantially directly against elongate tensile member  808  as shown in FIG. 74. Again, this embodiment comprises an anchor structure having an anchor member  844  with at least one portion movable with respect to another for gripping and compressing tendon tissue therebetween. Furthermore, before the final crimping action takes place, anchor member  840  can initially grip tissue  834  and move along elongate tensile member  808  to a suitable repair position where upon the surgeon may finally crimp anchor member  840  securely against elongate tensile member  808  as shown in FIG. 74. As further shown in FIG. 74, each access incision  814 ,  816  is then closed using stitches  846 ,  848  or another suitable method.  
         [0230]    Referring now to FIGS. 75 and 76, another embodiment of the invention is described in connection with tendon-to-tendon or ligament-to-ligament repair, however, it will be appreciated that this embodiment will also be useful for other procedures. In this embodiment, an anchor assembly  850  is comprised of a helical anchor  852  and a core portion or tendon fiber retaining member  854 . Helical anchor  852  has proximal and distal ends  856 ,  858  and retaining member likewise has proximal and distal ends  860 ,  862 . The distal end  858  of helical anchor  852  extends distally beyond the distal end  862  of retaining member  854  and is sharpened to a point  864  to aid in insertion. In addition, retaining member  854  is tapered at its distal end  862  creating a space  866  between coils  852   a  of the helical anchor  852  and the outside surface  868  of the retaining member  854  for receiving and retaining tendon or ligament fibers  870  therein at least at a location near distal ends  858 ,  862 . The proximal end  856  of helical anchor  852  is fixed to a proximal end portion  872  of retaining member  854 . This may be accomplished in various ways, however, in the preferred embodiment, the proximal end  856  is retained in a slot  874  and is welded such as through a laser or resistence welding operation. The proximal end  860  of retaining member  854  includes a slot  876  for receiving an insertion tool and, if necessary, a removal tool to be described below. Slots  874 ,  876  may communicate with each other as shown. Retaining member  854  includes a central longitudinal bore  878  for receiving an elongate, preferably flexible, tensile member  880 . Finally, a crimp member  882  is provided and may be a separate member with a central bore  884  for receipt on elongate flexible tensile member  880  or, as previously described, it may be integral with retaining member  854  or a different type of locking member may be used instead.  
         [0231]    [0231]FIGS. 77, 78 and  78 A illustrate an anchor assembly insertion tool  890  for inserting the anchor assembly  850  of FIG. 75 within a tendon or ligament  892 . Insertion tool  890  comprises an elongate body portion  894  having a rotatable knob  896  at a proximal end  898  and having a needle-shaped drive portion  900  at a distal end  902 . A flexible cable or shaft  904  is coupled between knob  896  and needle-shaped drive portion  900  and, in the preferred embodiment, this cable  904  is both rotated and translated as knob  896  is rotated in the direction of arrows  906 . A threaded coupling  908  within the elongate body portion  894  allows the simultaneous rotation and translation around and along axis  912  as knob  896  is rotated. Needle-shaped drive portion  900  is rigidly affixed to flexible cable  904  as shown in FIG. 78A through the use of a coupling member  914  and, preferably, an anchor assembly  850  as shown in FIG. 75 is retained within a curved, tubular housing  916  which does not rotate but retains rotatable cable  904  therein. Needle-shaped drive portion  900  includes a needle  918  which extends through anchor assembly  850  and further includes a projecting portion  920  which is complimentary to the tool engaging slot portion  876  of anchor assembly  850  and fits therein to allows rotation and translation of assembly  850  as the needle  918  is both rotated and translated into the tendon or ligament in the direction of arrow shown in FIG. 78A. As more specifically shown in FIG. 79, anchor assembly  850  is rotated and translated, or moved axially, into a tendon or ligament  892  and fibers  870  are captured during this insertion process between the coils  852   a  of anchor  852  and the outside surface  868  of retaining member  854 . During the insertion process, the coils  852 a expand slightly outward away from the outer surface  868  of retaining member  854  due to their inherent spring action and, also due to their spring action, spring back to apply a force against the tendon or ligament fibers  870  and against the outer surface  868  of the retaining member  854 . This forcefully traps fibers  870  and strengthens the connection between anchor assembly  850  and the tendon or ligament fibers  870 .  
         [0232]    [0232]FIGS. 80 and 80A illustrate a pistol grip device  940  for driving the shaft  904  of the tool  890  as generally shown in FIGS. 77 and 78. Device  940  replaces knob  896  to allow one-handed operation by a surgeon. In this embodiment, a firing lever  942  may be actuated toward a handle  944  with a single hand of the surgeon to rotate the firing lever  942  about a pivot  946  and thereby drive a rack gear  948  upwardly, via a connecting pin  948   a,  to rotate a pinion gear  950  coupled for rotation with flexible shaft  904 . In this embodiment, shaft  904  includes an externally threaded portion  904   a  and an internally threaded nut  952  is rigidly affixed, so as not to rotate, within device  940 . Threaded portion  904 a engages the internal threads of nut  952  and as shaft  904  rotates through the interaction of rack and pinion  948 ,  950 , shaft  904  also translates to the left, as viewed in FIG. 80, to move drive portion  900  and anchor assembly  850  (FIG. 78A) into tendon or ligament  892 . Alternatively, if a translation mechanism were not provided, the surgeon could translate the anchor assembly  850  manually into the tendon or ligament  892  by simultaneously pushing the pistol grip handle assembly  940  while actuating the firing lever  942 . Other forms of pistol grip or other one-handed actuators may be used and configured in any number of ways by those of ordinary skill to simultaneously rotate and, optionally, translate shaft  904 .  
         [0233]    FIGS.  81 - 87  illustrate one preferred method out of many possible methods for utilizing anchor assembly  850  of FIG. 75. In this regard, two anchor assemblies  850  are respectively driven into tendon or ligament segments  892   a,    892   b  as shown in FIG. 81 and in a manner such as described above. An assembly  960  comprised of a distal needle  962  coupled with a flexible elongate tensile member  880 , such as a multi-filament suture, and a preset crimp member  964  crimped onto a proximal end  966  of elongate tensile member  880  is threaded through a first one of the anchor assemblies  850  using a tool  968  until needle  962  is positioned between tendon or ligament segments  892   a,    892   b  as shown in FIG. 81. From the opposite side, a second tool  970  is used to thread a capturing member, which may be a conventional syringe or vena-puncture needle  972 , through the second anchor assembly  850  and into the space  974  between tendon or ligament segments  892   a,    892   b.  The first needle  962  is then captured by inserting its end into the hollow interior of the syringe needle  972  and the connected assembly is then withdrawn through the second anchor assembly  850  as shown in FIGS. 82 and 83. Alternatively, elongate tensile member  880  may be pushed through the second anchor assembly  850  without first being captured in space  974 .  
         [0234]    Tendon or ligament segments  892   a,    892   b  are then drawn together using the well-secured anchor assemblies  850  as shown in FIGS. 84 and 85. Anchor assembly  850  in ligament segment  892   a  is pulled by preset crimp member  964  as anchor assembly  850  in ligament segment  892   b  is pushed using crimp member  882  and a crimp tool  980 . Crimp tool  980  is used to collapse crimp member  882  onto the flexible elongate tensile member  880  to retain the second anchor assembly  850  in position within segment  892   b.  The first anchor assembly  850  is retained in position by the preset crimp member  964  as previously described. Thus, the tendon or ligament segments  892   a,    892   b  are held at the desired positions relative to each other as determined by the surgeon. The excess length of the elongate tensile member  880  is then cut with a cutting tool  982  at a location adjacent the proximal end of the crimp member  882  as generally shown in FIG. 86 and, as shown in FIG. 87, the access incisions are closed, such as by suturing, and a running suture, or other means, may be used to secure the ends of the tendon or ligament segments  892   a ,  892   b.    
         [0235]    [0235]FIG. 88 shows the jaws  990 ,  992  of crimp tool  980  in more detail. One jaw  990  includes a projection  990   a  for collapsing crimp member  882  against a recess  992   a  formed in the jaw  992 . The recess  992   a  in the opposite jaw includes a ridge  994  which helps retain crimp member  882  in place within the jaws  990 ,  992 , such as during shipping and during use by the surgeon. As also shown in FIGS. 84 and 85, one or more flexible bars  996   a,    996   b  are provided between opposing handles  998   a,    998   b  of crimp tool  980 . These bars  996   a,    996   b  retain the jaws  990 ,  992  at predetermined positions which hold the crimp member  882  in place during packaging, shipping and storage, but prevent jaws  990 ,  992  from coming together during application of relatively light loads to prematurely collapse the crimp member  882 . During use by the surgeon, however, the flexible bar or bars  996   a,    996   b  do not prevent manual actuation of the handles  998   a,    998   b  to bring the jaws  990 ,  992  together and collapse the crimp member  882  as shown in FIG. 85.  
         [0236]    [0236]FIGS. 89 and 90 illustrate a removal tool  1000  which, in certain cases, may be necessary to remove an anchor assembly  850 . Specifically, removal tool  1000  is in the general form of a rotatable hand tool generally similar to a screwdriver. However, as shown in FIG. 90, tool  1000  includes a head portion  1002  having a needle  1004  extending from a drive portion  1006 . Needle  1004  extends through the central bore  878  of anchor assembly  850  and drive portion  1006  engages slot  876  of anchor assembly in a manner similar to a screwdriver to allow rotation of anchor assembly  850 . In the configuration shown, counterclockwise rotation of tool  1000  and anchor assembly  850  will back the anchor assembly  850  out of the tendon or ligament  892 , for example, if the anchor assembly  850  is malpositioned.  
         [0237]    While the present invention has been illustrated by a description of the preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. The present disclosure has been illustrative of many features which may be modified, and configured in many different sizes depending on the intended use. The various embodiments and features of the invention may be used singularly or in various combinations not to be limited by the detail provided herein. Additional advantages and modifications will readily appear to those skilled in the art. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. Various aspects of this invention may be used alone or in different combinations. The scope of the invention itself should only be defined by the appended claims, wherein we claim: