EP3823540A1

EP3823540A1 - Methods and kits of using an implant for tissue repair

Info

Publication number: EP3823540A1
Application number: EP19838907.4A
Authority: EP
Inventors: Chase THORNBUG
Original assignee: International Life Sciences D/b/a Artelon LLC
Current assignee: International Life Sciences D/b/a Artelon LLC
Priority date: 2018-07-19
Filing date: 2019-07-18
Publication date: 2021-05-26
Also published as: WO2020018751A9; EP3823540A4; WO2020018751A1

Abstract

Provided herein are systems, methods and kits of using an implant for tissue repair

Description

TITLE

METHODS AND KITS OF USING AN IMPLANT FOR TISSUE REPAIR BACKGROUND

[001] The present invention relates generally to medical implants, medical kits, medical implant components or medical instruments.

[002] Medical implants and instruments that are to be used in the human body and be in direct contact with the human tissues need to fulfill several requirements. Surgical treatment of injury to soft tissues of the muscular-skeletal system of mammals caused by trauma, sudden overload, fatigue, sickness or other degenerative medical condition may in some cases benefit from or even require structural support to start healing. An example of such a situation is injuries to structures that do not heal spontaneously such as the intraarticular crucial ligaments. A text book or review paper on sports medicine in general starts out with a phrase stating that“... anterior cruciate ligament (ACL) rupture is the most common chronically incapacitating injury...” stresses the importance to find a cure for this condition. The golden standard surgical therapy for ACL reconstruction is to put a biological graft where the native ACL used to be. Biological grafts can be either of auto or allogenic origin. Since grafts of allogenic origin poses a risk for disease transmission autograft is preferred instead. However, autografts also have inherent problems such as donor site morbidity. Furthermore, before the angiogenesis of the graft has proceeded far enough to regain proper nutrition the graft goes through a necrotic phase that compromises its mechanical properties (Weiler, A. et ah, Biomechanical properties and vascularity of an anterior cruciate ligament graft can be predicted by contrast-enhanced magnetic resonance imaging. A two-year study of sheep. Am J Sports Med 2001, 26(6): 751-761). This critical time of about 12 weeks restricts the intensity by which the rehabilitation program can proceed. Overload during this sensitive period can cause permanent elongation of the graft that inevitably ends up in a reconstruction failure. Hence, much effort has been put into development of alternative grafts of biological or synthetic origin.

[003] There is a consensus in both the medical device industry and the scientific community that the stronger a soft tissue reconstruction can be made the better. For instance Wright Medical highlights the superior strength of their augmentation patch“GraftJacket MaxForce Extreme”. Also suture branding follows the same path as exemplified by Arthrex Inc. that profiles their FiberWire as:“FiberWire has greater strength than comparable size standard polyester suture. Multiple independent scientific studies document significant increases in strength to failure, stiffness, knot strength and knot slippage with much less elongation” and MaxBraid by Arthrotek Inc (today Biomet Sports Medicine) is labeled as“the incredible strength suture”. Not only should the suture be as strong as possible, there are also numerous scientific papers that aim for the most rigid suture configuration possible (Hirpara, K.M., et ah, A biomechanical analysis of multistrand repairs with the Silfverskiold peripheral cross-stitch. J Bone Joint Surg Br 2007, 89(10): 1396-1401; Momose, T., et ah, Suture techniques with high breaking strength and low gliding resistance: experiments in the dog flexor digitorum profundus tendon. Acta Orthop Scand 2001, 72(6): 635-641), e.g. for Achilles tendon repair.

[004] The present invention attempts to solve these problems as well as others.

SUMMARY OF THU INVENTION

[005] Provided herein are systems, methods and kits of using an implant for tissue repair. In one embodiment, the present invention introduces implants into ligaments and tendons for repairing or otherwise treating the ligaments or tendons. In another embodiment, a medical kit comprises an implant, and one or more surgical tools or instruments configured for securing or implanting the implant at least one tendon or ligament or bone site.

[006] A surgical kit is disclosed including a plurality of instruments for the repair of a tissue, tendon, or ligament and comprises: a guidewire with a trocar tip, a cannulated drill bit, a drill bit, a punch tap, a drill guide, suture passing wire, needle, an inserter device, an a bone screw, wherein the guidewire with the trocar tip allows insertion of the guide wire without axial force and preventing displacement of small fragments during drilling; the cannulated drill bit is operably coupled with the drill guide as a stop and the cannulated drill bit permits drilling over the guide wire; wherein the drill bit is for drilling the hole in the bone without the use of a guidewire; wherein the punch tap allows for precise tapping near the bone to insert the bone screw; wherein the drill guide allows precise setting to a predetermined depth to prevent overdrilling and is operably coupled with the cannulated drill bit or drill bit; and the needles and suture passing wire are used to secure an implant; and wherein the inserter device is used to tension to the implant; and the bone screws are used to secure the implant and sutures to the bone.

[007] A method of repairing a tendon using the kit is disclosed and comprises: preparing the bone for insertion of at least two threaded bone anchors by drilling down to a laser line or to a shoulder stop when using the drill guide; creating at least two holes about 1 cm proximal to a distal insertion of the Achilles tendon and central to each half of the tendon; inserting the two threaded bone anchors loaded with the implant with or without a suture, into the proximal holes; placing an eyelet completely in a drill hole until an anchor body makes contact with the bone; holding the inserter steady and mallet a handle downward until the anchor body is flush with the bone; passing the needle attached to the implant or the suture through the Achilles tendon on each side; preparing a plurality of distal holes with the drill in the same manner as the proximal holes; retrieving both suture tails from each proximal anchor and preload them through a distal threaded anchor eyelet; adjusting tension of an implant suture and insert the threaded bone anchor into a prepared distal bone socket until the anchor body contacts bone and repeating for other distal threaded bone anchor.

[008] The methods, systems, and apparatuses are set forth in part in the description which follows, and in part will be obvious from the description, or can be learned by practice of the methods, apparatuses, and systems. The advantages of the methods, apparatuses, and systems will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the methods, apparatuses, and systems, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

[009] In the accompanying figures, like elements are identified by like reference numerals among the several preferred embodiments of the present invention.

[010] FIG. 1A is a perspective view of the implant according to one embodiment; and FIG. IB is perspective view of another embodiment of the implant.

[Oil] FIG. 2 is a side view of the kit for the Lateral Ankle Anterior Talofibular Ligament (ATFL), according to one embodiment.

[012] FIGS. 3A-3F are side views of alternative embodiments of the Anterior Talofibular Ligament (ATFL) Techniques.

[013] FIG. 4 is a side view of the bone screw, according to one embodiment.

[014] FIG. 5A is a perspective view of the soft suture anchor; and FIG. 5B is a side view of the suture based anchor system, according to one embodiment. [015] FIG. 6 is a side view of the implant instalments in the kit for the Medial Collateral Ligament (MCL), according to one embodiment.

[016] FIG. 7 is a side view of the MCL procedure, according to one embodiment.

[017] FIG. 8 is a side view of the kit for plantar plate, according to one embodiment.

[018] FIG. 9A is a top view of the Hallux Varus procedure; and FIG. 9B is a side view of another plantar plate procedure, according to one embodiment.

[019] FIG. 10 is a side view of the kit for the Achilles tendon, according to one embodiment.

[020] FIGS. 11A-11F are side views of alternative embodiments for the Achilles tendon procedure.

[021] FIG. 12 is a side view of the peroneal tendon kit, according to one embodiment.

[022] FIGS. 13A-13B are side views of the peroneal tendon procedure, according some embodiments.

[023] FIG. 14 is a side view of the kit for the Medial Ankle Ligament (Spring Ligament).

[024] FIGS. 15A-15B are side views of the Spring Ligament implant procedure.

[025] FIG. 16 is a side view of the kit for the Medial Ankle Ligament (Deltoid Ligament).

[026] FIGS. 17A-17B are side views of the Deltoid Ligament implant procedure.

DETAILED DESCRIPTION OF TTTF INVENTION

[027] The foregoing and other features and advantages of the invention are apparent from the following detailed description of exemplary embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims and equivalents thereof.

[028] Embodiments of the invention will now be described with reference to the Figures, wherein like numerals reflect like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive way, simply because it is being utilized in conjunction with detailed description of certain specific embodiments of the invention. Furthermore, embodiments of the invention may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the invention described herein. The words proximal and distal are applied herein to denote specific ends of components of the instrument described herein. A proximal end refers to the end of an instrument nearer to an operator of the instrument when the instrument is being used. A distal end refers to the end of a component further from the operator and extending towards the surgical area of a patient and/or the implant.

[029] The use of the terms“a” and“an” and“the” and similar referents in the context of describing the invention are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. It will be further understood that the terms“comprises,”“comprising,”“includes,” and/or“including,” when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[030] Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. The word“about,” when accompanying a numerical value, is to be construed as indicating a deviation of up to and inclusive of 10% from the stated numerical value. The use of any and all examples, or exemplary language (“e.g” or“such as”) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any nonclaimed element as essential to the practice of the invention.

[031] References to“one embodiment,”“an embodiment,”“example embodiment,”“various embodiments,” etc., may indicate that the embodiment(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase“in one embodiment,” or“in an exemplary embodiment,” do not necessarily refer to the same embodiment, although they may.

[032] As used herein the term“method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

[033] It will be understood that when an element is referred to as being“on”,“attached” to, “connected” to, “coupled” with, “contacting”, etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example,“directly on”, “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.

[034] Generally speaking, the kits comprise an instrument, an implant, a suture, and a needle as referenced below and applied for a particular tissue, tendon, or ligament. In one embodiment, the medical implant can be used to treat a tendon or ligament repair. The instrument may include an implantation device to secure the implant into a bone or tissue, such as a bone screw, staple, and the like. The suture may further secure the implant to the ligament, tendon, or bone screw. The surgical kits may be produced containing elements necessary for treating and/or repairing tendons and ligaments with the implant. Such a kit may include various configurations of the implant. One or more surgical tools used in conventional tendon and/or ligament repair surgery are also advantageously provided in such kits. The surgical kits may treat the following tissue, ligaments, and tendons including, but are not limited to a Lateral Ankle Anterior Talofibular Ligament (ATFL); Medial Collateral Ligament (MCL), Plantar Plate, Achilles Tendon, Peroneal Tendon, Medial Ankle (Spring Ligament, Deltoid Ligament), Syndesmosis, Suture, Open Rotator Cuff, Acromioclavicular Joint Kit (AC Joint).

[035] In one embodiment, a ligament kit may heal tissue directed towards ATFL, CFL, Deltoid, Spring, ACL, MCL, Lisfranc, Plantar Plate. In another embodiment, a tendon kit may heal tissue directed towards Achilles, Peroneal, AT, PT, Quad Tendon, Patellar, Hamstring. Other kits may be directed towards healing Syndesmosis, Suture, Open Rotator Cuff, Acromioclavicular Joint Kit (AC Joint).

[036] The kits disclosed herein may also be used to heal the Shoulder for the following: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodeseis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. The kits disclosed herein may also be used to heal the Foot/ Ankle for the following: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. The kits disclosed herein may also be used to heal the Knee for the following: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis, and Secondary fixation of ACL/PCL reconstruction or repair. The kits disclosed herein may also be used to heal the Hand/Wri st for the following: Scapholunate Ligament Reconstruction, Ulnar or Radical Collateral Ligament Reconstruction. The kits disclosed herein may also be used to heal the Elbow for the following: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair. The kits disclosed herein may also be used to heal the Hip for the following: Capsular repair, acetabular labral repair.

[037] The present disclosure provides kits and methods for selectively treating defects or other conditions within or on ligaments and tendons. These procedures may relate to ligament and tendon surgeries, such as procedures on flexor or extensor tendons in for example the hand or antebrachium or brachium as well as shoulder, including but not limited to rotator cuff (supraspinatus, infraspinatus, teres minor and subscapularis) but also including biceps tendon, intraarticular and extraarticular, as well as the carpal ligaments in the wrist and at the distal radial ulnar joint and proximal radial ulnar joint. Also included are procedures on ligaments or tendons in and around the pelvis including the sacroiliac joint as well as the insertion at the anterior superior iliac spine of the sartorius, tensor fascia lata or at the anterior inferior iliac spine for the insertion of the rectus, or disruption of the symphysis pubis or at the ischium or the insertion of the biceps femoris and semitendinosus, semimembranosus or the adductor magnus. Moving distally, ligament and tendon repair or augmentation procedures around the hip can include procedures on attachments to the greater trochanter (piriformis, gluteus minimus, gluteus medius, gluteus maximus, obturator intemus and the superior and inferior gemelli as well as the obturator extemus). As for the lesser trochanter, procedures can be implemented on attachments including psoas major and adductor magnus iliacus. Moving more distally to the distal end of the femur on the medial epicondyle and supracondylar region, procedures can be implemented on attachments including the attachment of the gastroc and the tendon of the adductor magnus. On the lateral condyle, procedures can be implemented on attachments including the plantaris, lateral head of the gastrocnemius popliteus as well as the quadriceps muscle including rectus, vastus medialis, vastus intermedius, vastus lateralis and the insertions of the common tendon, as well as the continuation of that tendon into the patellar tendon, the anterior and posterior and lateral muscles of the leg and their tendinous insertions, and the ligaments and tendons of the ankle and foot ranging in size from small to relatively large (e.g., Achilles tendon).

[038] Particular implementations, according to certain aspects of the present disclosure, can include repair in connection with the major ligament reconstructions that are being performed on a daily basis in orthopedics/sports medicine disciplines, including treatments of the anterior cruciate ligament (ACL), the posterior cruciate ligament (PCL), the medial and lateral collateral ligaments, the medial and lateral meniscus, the rotator cuff and biceps tendon musculature, as well as smaller ligaments such as the medial and lateral collateral ligaments of the elbow, the triangular fibrocartilage complex (TFCC) and other ligaments of the wrist and distal radial ulnar joint, as well as the ankle ligaments including but not limited to the anterior talofibular ligament, calcaneofibular ligament, posterior talofibular ligament, and deltoid ligament.

[039] Included within the scope are additional ligaments that support the spine and the motion segments. The methods of the present disclosure can thus be applied to, for example, ligaments including the anterior longitudinal ligament, posterior longitudinal ligament, facet joint capsules and capsular ligaments, supraspinous ligament, and intraspinous ligament, which may give rise to additional structural stability to the spine and motion segments that may be involved in conjunction with disc degeneration, pars defects, anterior listhesis or retrolisthesis or laterallisthesis or rotatory scoliosis.

[040] The aforementioned group of applications, including treatments of ligaments related to the joints of the upper and lower limbs, as well as the pelvis, is only a partial list. In one or more of the above contexts, application of a tissue-generating or collagen-promoting implant according to the present invention can provide structural support in the healing of ligaments and tendons, whether the defect, injury or area of interest is at (i) any location of the ligament or adjacent tissues including the origin and insertion thereof, or (ii) any location of the tendon or adjacent tissues such as the musculotendinous junction or anywhere in the tendonous region or at the insertion of the tendon insertion. The scope and field of the present disclosure for orthopedic tendons and ligament reconstruction, however, is vast and is intended to include any of the major or minor joints with ligaments or tendons that may be injured or otherwise determined to be in need of or likely to benefit from an intervention or treatment using implants.

[041] Implant [042] Generally speaking, the implant may include the configuration and properties as described in U.S. patent no. 9,427,494 and U.S. patent application serial no. US 2011-0015735, herein incorporated by reference in their entries. The implant may be referred to as the Artelon flexband, according to one embodiment.

[043] In this application the terms“implant” and“graft” have the same meaning and designate implants and grafts prior to implantation and as well as in an implanted state. In this application “stiffness” refers to“tensile stiffness”. In this application“pre-stretched” and corresponding terms refer to the stretching of an implant or an implant material or portion during implantation and to fixate the implant in a stretched condition. In this application“shrinking”,“heat-set” and corresponding terms refers to thermally effected shrinkage of porous implant polymer matrices or scaffolds, in particular of warp knitted synthetic fiber fabrics such as poly(urethane urea) fiber fabrics and implants manufactured from them.

[044] The implant of the invention and the material(s) of which it is made is preferably biocompatible and biodegradable; if biodegradable, its degradation rate is slow, such as that it offers substantial mechanical support after one year from implantation and even two years or more from implantation.“Substantial mechanical support” is a mechanical support of from 20 % to 50% or more of the mechanical support at the time of implantation. By selection of a proper material the biodegradation rate can be advantageously adapted to the expected healing rate of the tissue to be reconstructed.

[045] According to the present invention is disclosed an implant for reconstructing soft tissues of the musculo-skeletal apparatus, in particular tendon, fascia, periosteum, ligament, muscle but excluding bone and articular cartilage having an initial tensile stiffness that is significantly lower than that of the tissue to be reconstructed. In this application“initial stiffness” is the tensile stiffness at the time of implantation. The implant of the invention has a porosity and texture capable of accommodating matrix producing cells to form a functional tissue. Furthermore, the implant material of the invention is capable of resisting long term stress relaxation and creep thereby avoiding plastic deformation of the implant. Stress relaxation that rapidly levels off (within, for instance, one minute) is acceptable while plastic deformation (elongation) is not. Plastic deformation or creep ruins the implant's ability to template the healing tissue to its desired dimensions ensuring correct kinematics. The ability to support an applied load with an initial stress relaxation that rapidly levels off asymptotically to a finite value is beneficial to the implant for two reasons. Firstly, the residual load generated from the prestretch procedure can reapproximate retracted tissues, a clinical condition often seen, for instance, in tendon injuries such as rotator cuff tears or in avulsion injuries. Secondly, the residual pre-stretch force of a pre- stretched implant used in joint surgery provides active joint stabilization. This kind of active joint stabilization is important for intra-articular ligament reconstruction according to the invention. The nature of stress relaxation of fabrics is two-fold. There are contributions both from the textile design and from the material itself. Depending on fiber interlocking the fibers slide in respect of each other; with an elastic material this sliding will be gradual and appear as a rapid stress relaxation. The material's resistance to stress relaxation is strongly dependent on inherent limitation of molecular mobility by cross-links that may be chemical or physical. Chemical cross-links are found in e.g. rubbers while physical cross-links of permanent character are found in e.g. poly(urethane urea). The limited molecular mobility also offers the ability to orient the molecular network by simply stretching the implant and thereby modulate its stiffness. The molecules orient along the direction of the applied pre-stretch. Thereby the implant is stiffened in the pre-stretch direction.

[046] A property of importance of the implant of the invention is that it should be made of a material or comprise a material of a relaxation behaviour such that its relaxation upon tensioning quickly approaches asymptotically a finite value. A preferred material of this kind is polyurethane, in particular poly(urethane urea).

[047] The textile material of the invention is preferably a warp-knitted fabric. By this textile design the implant can be made particularly resistant to frying. Resistance to frying is a crucial factor in fixation of an implant to connective tissue when penetrating fixation elements such as sutures are being utilized. Except for articular cartilage, the soft tissues of the musculo-skeletal apparatus addressed by this implant may be connected to bone at one or both implant ends. For the implant to transfer load to and from tissue it is essential that it can be securely and conveniently attached to the tissue. Attachment to soft tissue is normally accomplished by suturing whereas fixation to bone is a more delicate task. Fixation to bone hinders movement at the bone-implant interface. Penetrating, holding or squeezing fixation elements may be considered, for instance, for bone-implant attachment. Examples of fixation elements for these kinds of fixation, i.e. penetrating, holding or squeezing fixation, are sutures and screws, button with a sling such as EndoButton™ and ACL/PCL interference screws that both may be metallic or bioresorbable.

[048] The design of the implant governs how it can be applied and interfaced with host tissue. A square or rectangular fabric that permits bed side trimming in all directions enables adaptation to optimize fitting and attachment to its host structure by penetrating fixation devices. For a design with a high aspect ratio, such as a substantially linear implant in form of a rope or thin strip, intended to transfer a load in a direction of the implant's longitudinal extension, the implant is normally attached near its both ends by penetrating or squeezing fixation elements. In this application“aspect ratio” denotes a length to width ratio. The ability of an implant to transfer a load across the implant-fixation element interface depends on its stress distribution properties. Extreme stress concentrations need to be leveled or avoided.

[049] One fixation mode that distributes stresses efficiently is by a linear implant being folded over a holding fixation element, such as an integrated fibrous sling over a button element, a cross- pin or directly over a button or pin. Clinically utilized brands comprising such elements include EndoButton™, RetroButton™, ToggleLoc™, CrossPin™ and EndoButton Direct™.

[050] As mentioned in the foregoing healing of native tissue by a target tissue is a slow process, extending over months and even years. In view of this the implant of the invention shall be made of a biocompatible material with a corresponding in vivo endurance, in particular one that ensures that at least half of the stiffness persists for at least one year, preferably at least two years upon implantation. Furthermore, it is preferred that the implant material of the invention be more adapted to deformation than the target tissue so as to ensure matrix continuity even if the healing target tissue is overstretched, causing partial or total laceration. In such case the healing of a damaged target tissue will restart and continue to be supported by the implant without the need for repeated surgery.

[051] The can be implanted or secured into a ligament or tendon, such as a partial or complete ligament or tendon defect, to thereby facilitate or augment a repair of the ligament or tendon defect. A partial ligament or tendon defect may comprise a ligament or tendon which is not entirely severed. A complete ligament or tendon defect may include for example a ligament which has been completely severed or detached and which, by means known to those skilled in the art, such as, for example, anastomosis using sutures, has been or will be reattached or mended. In examples involving ligament or tendon anastomosis procedures, proximal and/or distal ends of the ligaments or tendons can be perforated, as described below. The perforations can be formed at the anastomosis site to extend up to the origin and insertion point of the ligament in question. Generally, the tissue treatments (e.g., perforations) as described herein may be formed in directions parallel to lengths of the ligaments or tendons, along directions perpendicular to lengths of the ligaments or tendons, and/or along any directions or combinations of directions therebetween. The directions and/or lengths of the perforations may vary along similar or different paths or axes, and the cross-sectional areas or diameters of the perforations may vary per unit length along individual perforations and/or between perforations, as a result of, for example, varying types, sizes and shapes of perforating instruments being used and varying perforating techniques.

[052] The implant made of the material of the invention manufactured into a porous matrix, a template, an added synthetic extracellular matrix, but most often referred to as a scaffold. The implant has a tensile stiffness significantly lower than that of the native tissue it is intended to reconstruct, for instance lower by at least 50 % or at least 80 % or 85 % and even as much as 90 % or more. The material of the invention has elastomeric characteristics, which ensures that the implant can be deformed without permanent elongation. The implant may be manufactured by processes with inherent ability to accomplish porosity such as foaming, porogen extraction from molded block, textile confection or non-woven structures made out of fibers. It is also possible to manufacture it from combinations of these processes such as a porous matrix reinforced by fibers or a fabric.

[053] As shown in FIGS. 1A-1B, the implant may be a variety of shapes and sizes. The implant 10 may include a generally square shape, as shown in FIG. 1A. The implant 12 may include a generally rectangular shape, as shown in FIG. IB. Alternative sizes and configurations may be employed depending upon the particular tissue, tendon, or ligament to be repaired. The dimensions of the implant 10 may be about 3 cm x about 4 cm, about 4 cm x about 6 cm, and about 6 cm x about 9 cm. The dimensions of the implant 12 may be about 0.3 cm x about 8.0 cm, about 0.3 cm x about 16 cm, about 0.5 cm x about 8.0 cm, about 0.5 cm x about 16 cm, about 0.7 cm x about 8 cm, about 0.7 cm x about 16 cm, about 0.7 cm x about 32 cm, about 0.5 cm x about 32 cm, and about 0.3 cm x about 32 cm. The implants may have a tubular configuration. The implants 10, 12 may have thickness between about 0.5 mm and about 1.5 mm. The implant may have a modulus of elasticity between about 12 Mpa and about 16 Mpa, alternatively between about 12 Mpa and 116 Mpa. The modulus of elasticity may be selected according to the particular tissue, tendon, or ligament being treated.

[054] Alternatively, the implant may have a Y- configuration or be the Artelon FlexBand.

[055] Anterior Talofibular Ligament (ATFL)

[056] In one embodiment, the kit 100 for the ATFL comprises a plurality of instruments including a guidewire with trocar tip 122, a cannulated drill bit 124, a drill bit 126, a punch tap 128, a drill guide 130, suture passing wire 132, needle 134, a inserter device 136, an a bone screw 138, as shown in FIG. 2. The guidewire with trocar tip 122 allows insertion of guide wire without axial force and preventing displacement of small fragments. The cannulated drill bit 124 works with the drill guide 130 as a stop and cannulation permits drilling over the guide wire. The drill bit 126 is for drilling the hole in the bone without the use of a guidewire. The punch tap 128 allows for precise tapping near the bone to insert the bone screw. The drill guide 130 allows precise setting to a predetermined depth to prevent overdrilling and is operably coupled with the drill sleeves or the cannulated drill bit 124 or drill bit 126. The needles and suture passing wire are used to pass and secure the implant. The inserter device is used to secure and the inserter device is used to tension the Artelon implant. And the bone screws are used to secure the implant and sutures if necessary.

[057] In one embodiment, a l.35mm Guidewire w/ Trocar Tip 122, a 4.0mm Cannulated Drill Bit 124, 4.0mm Drill Bit 126, , a 4.0mm threaded Anchor 138 may be used. In one embodiment, the anchor screws are made of Polyether ether ketone (PEEK), titanium alloy, alternatively TLAMV ELI. Other sized guidewires, drill bits, and threaded anchors may be utilized depending on the particulars of the procedure.

[058] The implant for the AFTL may include a modulus of elasticity between about 12.00 Mpa and about 116.00 Mpa. The modulus of elasticity may be varied depending upon the severity of the AFTL injury, size and weight of the subject, and the like. The AFTL includes a modulus of elasticity between about 48.36 N/mm² to about 436.80 N/mm².

[059] Anterior Talofibular Ligament (ATFL) - procedures

[060] As shown in FIG. 3A, the Chrisman Snook Procedure 160 comprising an implant 10 for the ATFL operably coupled a first bone screw 144 and a second bone screw 142; and a second implant leg 12 for the Calcaneofibular Ligament (CFL) operably coupled to the first bone screw 144 and a third bone screw 146. The first bone screw is located in the fibula bone, the second bone screw is located in the talus, and the third bone screw is disposed in the calcaneus bone. The flexible implant legs are secured by the kit 100 using a 4.0 mm suture length and the first, second, and third bone screws 144, 142, 146.

[061] As shown in FIG. 3B, the ATFL procedure 162 comprises an implant patch 20 operably coupled at least four bone screws 148 disposed on the distal comers of the implant patch 20. At two of the bone screws are disposed in the fibula and at least two bone screws are secured in the talus bone. The bone screws may be l5mm in length. The bone screw 148 includes a threaded design that locks securely within the bone, as shown in FIG. 4. The bone lock is set prior to suture lock, minimizing the possibility of gap formation.

[062] As shown in FIG. 3C, the ATFL procedure 164 comprising a first implant 10 operably attached to a first bone screw 144 and disposed through a fibular tunnel 2. A second implant leg 10 is operably attached to the interference screw 142 and secured in the calcareus. The implant 10 may be tensioned through the talar tunnel and secured by the interference screw 142. A third interference screw 150 may be inserted into the fibular tunnel 2 to secure the implant.

[063] As shown in FIG. 3D, the ATFL procedure 166 comprises a first threaded anchor 152 operably attached to a first implant 10 and the first implant 10 operably attached to a second threaded anchor 154. The implant 10 is tensioned by the fibular bone tunnel under tension from the second threaded anchor 154 into the fibula.

[064] As shown in FIG. 3E, the ATFL procedure 168 comprises a first soft suture anchor 156 operably attached to a first implant 10 and the first implant 10 operably attached to a second soft suture anchor 158, as shown in FIG. 5A. The implant 10 may be passed percutaneously through two small incisions 170 and the soft suture anchors may be implanted with a suture based anchor system 190, as shown in FIG. 5B.

[065] As shown in FIG. 3F, the ATFL procedure 169 comprises a first threaded anchor 143 with a distal eyelet operably attached to a first implant 10. The first anchor 143 is malleted into a drilled hole in the Talus. The implant 10 is operably attached to a second threaded anchor 145. Slight tension is placed on the implant 10 and the second threaded anchor 145 is aligned with a drilled hole in the fibula. The second anchor 145 is then malleted into the fibular securing the implant 10 and tensioning at the same time.

[066] Medial Collateral Ligament

[067] In one embodiment, the kit 200 for the Medial Collateral Ligament (MCL) comprises a plurality of instruments including anchor instruments, staple instruments, and the implant. As shown in FIG. 3F, the same procedure as the ATFL kit as shown in FIG. 3 A. The method comprises drilling one hole, implanting the anchor and stretching over the second hole and implanting anchor and tensioning out at the same time.

[068] As shown in FIG. 6B, the staple instruments include a sizing guide 230, an insertion tool 232, a drill guide 234, a drill bit 236, a slap hammer 238, a tamp 240, and a staple 242. The sizing guide 230 determines the size of the staple and is inserted by the insertion tool 232.vThe drill guide 234 allows precise setting to a predetermined depth to prevent overdrilling and is operably coupled with the drill sleeves or the drill bit 236. The drill bit 236 works with the drill guide 234 as a stop. The drill bit 236 is for drilling the hole in the bone without the use of a guidewire. The slap hammer 238 is used to remove the staple if necessary. The cannula includes a longitudinal slot on a top of the cannula to allow oversized instruments to be introduced over the implant, in one embodiment.

[069] In one embodiment, a l.35mm x 8” Guide Pin 210, a 4.0mm Cannulated Drill Bit, a 4.00mm Punch/Tap, and a 4.00mm x l7mm bone Anchor is used. Other sized guide pins, drill bits, punch taps, and bone anchors may be utilized depending on the particulars of the procedure.

[070] In one embodiment, the implant may include a modulus of elasticity of between about 12.00 Mpa and about 116.00 Mpa as to accommodate the MCL. The modulus of elasticity may be varied depending upon the severity of the MCL injury, size and weight of the subject, and the like. The MCL may include a modulus of elasticity between about 273.90 N/mm² and about 559 N/mm². In one embodiment, the staples 242 may include a material of titanium, stainless steel, or nitinol.

[071] Medial Collateral Ligament (MCL) - Techniques

[072] In one embodiment, the MCL procedure 260 comprises applying the implant 10 slightly proximal and posterior to the medial epicondyle, as shown in FIG. 7. The implant 10 is attached to the adductor tubercle by way of the staple instrument and staples 242. The tibial attachment of the implant 10 is applied just proximal to the pes anserine and 3 mm anterior to the posteromedial crest of the tibia. The implant is secured to the metaphysis of tibia by way of the staple instrument and staples 242.

[073] Plantar Plate [074] In one embodiment, the kit 300 for plantar plate comprises a guide wire 310, a drill bit 312, , a suture passing wire 318, a inserter device 320, a bone screw 322, , a suture with needle 328, shown in FIG. 8. The guide wire, the drill bit, the suture passing wire, the insertion device, the bone screw, and the suture with needle are operably coupled to the implant to repair a tissue, tendon, or ligament.

[075] In one embodiment, a l.35mm Guide Wire, a 2.7mm x 8mm bone screw is used. Other sized guide wires and bone screws may be utilized depending on the particulars of the procedure. In one embodiment, the bone screw is made from PEEK.

[076] In one embodiment, the implant may include a modulus of elasticity of between about 12.00 Mpa and about 116.00 Mpa as to accommodate the Plantar Plate. The modulus of elasticity may be varied depending upon the severity of the Plantar Plate injury, size and weight of the subject, and the like. In one embodiment, the implant may be the Artel on Flexband as previously described.

[077] Plantar Plate - Techniques

[078] In one embodiment, the Hallux Varus procedure 360 is shown in FIG. 9A. A Guidewire is placed into the medial metatarsal in the metadiaphyseal junction at midline and is advanced laterally, exiting just proximal to the articular cartilage. A second Guidewire is placed into the proximal phalanx, exiting just distal to the articular cartilage. The lst metatarsal Guidewire is over drilled with the cannulated Drill Bit. Next, the proximal phalanx Guidewire is over drilled next with the 2.5 mm Drill bit. The Suture passing wire is used to shuttle the Suture from lateral to medial. An Artelon flexband with or without a suture is inserted laterally into the Nitinol Suture Passing Wire and is pulled medially through the lst metatarsal drill hole. Suture passing wire may be utilized to shuttle the Suture from lateral to medial. The distal end of the Artelon flexband with or without a suture is pulled through the proximal phalanx drill hole from lateral to medial using the Suture Passing Wire. While holding tension on the Artelon Flexband, a 2.7 x 8 mm bone Screw 322 is inserted into the bone tunnel at the proximal phalanx. The toe is placed into the corrected position. The Artelon flexband is tensioned and the second bone Screw is placed into the metatarsal head bone tunnel.

[079] In one embodiment, the plantar plate procedure 362 is shown in FIG. 9B with the implant 12 secured with two bone screws 322.

[080] Achilles Tendon Kit [081] In one embodiment, the kit 400 for the Achilles tendon is shown in FIG. 10 and comprises a drill bit 410, a drill guide 414, an inserter device 416, a threaded bone anchor 418, an Artelon flexband with or without a suture 422. The guide wire, the drill bit, the suture passing wire, the inserter device, the bone screw, the Artelon implant, the and the suture operably couple to implant the implant to repair the tissue, tendon, or ligament.

[082] In one embodiment, a 4.0mm Drill Bit, a 4.0mm threaded bone anchor is used. Other sized drill bits, and threaded bone anchors may be utilized depending on the particulars of the procedure. The threaded bone anchor may be a biocompatible material such as PEEK. The method comprises implanting at least two parallel implants sandwiching the Achilles tendon.

[083] In one embodiment, the implant may include a modulus of elasticity of between about 12.00 Mpa and about 116.00 Mpa as to accommodate the Achilles Tendon. The modulus of elasticity may be varied depending upon the severity of the Achilles Tendon injury, size and weight of the subject, and the like. The Achilles tendon may include a modulus of elasticity between about 598 N/mm² and about 1610 N/mm².

[084] Achilles Tendon - Techniques

[085] As shown in FIG. 11 A, an Achilles procedure 460 comprises the following: Preparing the bone for insertion of the two (2) 4.00 mm threaded bone anchors 418 by drilling down to the laser line or to the shoulder stop when using the drill guide; Creating 2 holes about 1 cm proximal to the distal insertion of the Achilles tendon and central to each half of the tendon; the tap will prepare the holes for the 4.00 mm threaded bone anchors 418; inserting the two (2) 4.00 mm threaded bone anchors 418 loaded with Artelon flexband with or without a suture, into the proximal holes; placing the eyelet completely in the drill hole until the anchor body makes contact with the bone; ho holding the driver handle mallet downwards until the anchor body is flush with the bone; passing the suture attached to the Artelon flexband or the Artelon Flexband through the Achilles tendon on each side; preparing the distal holes with the 4.0 mm drill in the same manner as the proximal holes; taping the distal holes in preparation for the 4.00 mm threaded bone anchor 418; retrieving the suture tails from the proximal anchor and preload them through the distal threaded anchor eyelet; adjust tension of the Artelon flexband suture by inserting the 4.00 mm threaded bone anchor 418 into the prepared distal bone socket until the anchor body contacts bone and repeat for other distal threaded bone anchor 418.

[086] As shown in FIG. 11B, another embodiment of the Achilles procedure 462 includes two bone screws 418 the implant acting as tension strips through bone tunnels.

[087] As shown in FIG. 11C, another embodiment of the Achilles procedure 464 includes a V-Y plasty and the Artel on Flexband 10 on the sides of the V-Y plasty.

[088] As shown in FIG. 11D, another embodiment of the Achilles procedure 466 includes two parallel Artel on Flexbands 10 sandwiching the Achilles tendon.

[089] As shown in FIG. HE, another embodiment of the Achilles procedure 468 includes an Artel on Flexband 10 inlay with re-tubularized Achilles tendon 90 and the implant inlay wraps around the re-tubularized Achilles tendon.

[090] As shown in FIG. 11F, another embodiment of the Achilles procedure 470 includes an Artel on Flexband 10 weaved around the repair site in a spaghetti strand configuration.

[091] Peroneal Tendon

[092] As shown in FIG. 12, the peroneal tendon kit 500 includes a plurality of instruments including, but not limited to: a loop suture with needle 512, an Artelon Flexband 10, and a needle. The loop suture with needle, and needle are all operably coupled to implant the Artelon Flexband to repair the tissue, tendon, or ligament.

[093] In one embodiment, the implant may include a modulus of elasticity of between about 12.00 Mpa and about 116.00 Mpa as to accommodate the Peroneal Tendon. The modulus of elasticity may be varied depending upon the severity of the Peroneal Tendon injury, size and weight of the subject, and the like. In one embodiment, the implant may be the Artelon Flexband.

[094] Peroneal Tendon - Techniques

[095] As shown in FIG. 13A, the peroneal tendon procedure 560 comprises an implant strip 12 in laid with the peroneal tendon and the peroneal tendon is tubularized around the implant strip 12

[096] As shown in FIG. 13B, the peroneal tendon procedure 562 comprises an implant strip 12 inlaid into the peroneal tendon ends.

[097] Medial Ankle Ligaments (Spring Ligament!

[098] As shown in FIG. 14, the guidewire, the cannulated drill bit, the drill bit, the drill guide, the needle, the suture passing wire, the inserter device, the threaded bone anchor, and the suture are all operably coupled to implant the implant to repair the tissue, tendon, and ligament. [099] In one embodiment, a l.35mm Guidewire, a 4.0mm Cannulated Drill Bit, a 4.0mm Drill Bit, and a 4.0mm threaded bone anchor may be used. Other sized guidewires, drill bits, punch taps, and threaded bone anchors may be utilized depending on the particulars of the procedure.

[0100] In one embodiment, the implant may include a modulus of elasticity of between about 12.00 Mpa and about 116.00 Mpa as to accommodate the Medial Ankle ligament. The modulus of elasticity may be varied depending upon the severity of the Medial Ankle ligament injury, size and weight of the subject, and the like. Various types of sutures may be used.

[0101] Spring Ligament - Techniques

[0102] As shown in FIG. 15A, the spring ligament technique 660 comprises two bone anchors 626 and the implant in a Y-configuration 14 is implanted with the kit 600 for the Medial Ankle Ligament.

[0103] As shown in FIG. 15B, the spring ligament technique 662 comprises two bone anchors 626 and the implant 12 is implanted using the kit 600 for the Medial Ankle Ligament.

[0104] Medial Ankle Ligaments (Deltoid Ligament)

[0105] As shown in FIG. 16,

[0106] In one embodiment, a l.35mm Guidewire, a 4.0mm Cannulated Drill Bit, a 4.0mm Drill Bit, a Drill Guide, a 4.0mm threaded bone anchor may be used. Other sized guidewires, drill bits, and threaded bone anchors may be utilized depending on the particulars of the procedure.

[0107] In one embodiment, the implant may include a modulus of elasticity of between about 12.00 Mpa and about 116.00 Mpa as to accommodate the Deltoid ligament. The modulus of elasticity may be varied depending upon the severity of the Deltoid ligament injury, size and weight of the subject, and the like.

[0108] Deltoid Ligament - Techniques

[0109] As shown in FIG. 17A, the deltoid ligament technique 760 comprises three bone anchors 726 and the implant in a Y-configuration 14 is implanted using the kit 700 for the Deltoid Ligament.

[0110] As shown in FIG. 17B, the deltoid ligament technique 762 comprises two bone anchors 726 and the implant 12 is implanted using the kit 700 for the Deltoid Ankle Ligament.

[0111] It should be appreciated that all of the described embodiments may be custom sized, molded and/or fitted for any clinician based on implant size or anatomy. All of the described embodiments may be configured for tissue, tendon, or ligament to be repaired. Moreover, all of the described instruments may be formed from any conformable, flexible, rigid, or semi-rigid material, e.g., rubber, metal, metal alloy, plastic, polymer, or the like. Any of the embodiments described herein may be used separately from and/or in combination with each other, where practical.

[0112] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

[0113] While the invention has been described in connection with various embodiments, it will be understood that the invention is capable of further modifications. This application is intended to cover any variations, uses or adaptations of the invention following, in general, the principles of the invention, and including such departures from the present disclosure as, within the known and customary practice within the art to which the invention pertains.

Claims

CLAIMS What is claimed is:

1. A surgical kit including a plurality of instruments for the repair of a tissue, tendon, or ligament comprising:

a guidewire with a trocar tip, a cannulated drill bit, a drill bit, a punch tap, a drill guide, suture passing wire, needle, an inserter device, an a bone screw,

wherein the guidewire with the trocar tip allows insertion of the guide wire without axial force and preventing displacement of small fragments during drilling;

the cannulated drill bit is operably coupled with the drill guide as a stop and the cannulated drill bit permits drilling over the guide wire;

wherein the drill bit is for drilling the hole in the bone without the use of a guidewire;

wherein the punch tap allows for precise tapping near the bone to insert the bone screw;

wherein the drill guide allows precise setting to a predetermined depth to prevent overdrilling and is operably coupled with the cannulated drill bit or drill bit;

and the needles and suture passing wire are used to secure an implant; and wherein the inserter device is used to tension to the implant; and the bone screws are used to secure the implant and sutures to the bone.

2. The kit of Claim 1, wherein the implant includes a modulus of elasticity between about 48.00 Mpa and about 112.00 Mpa.

3. The kit of Claim 2, wherein the tissue, tendon, or ligament is selected from the group consisting of: Lateral Ankle Anterior Talofibular Ligament (ATFL); Medial Collateral Ligament (MCL), Plantar Plate, Achilles Tendon, Peroneal Tendon, Medial Ankle (Spring Ligament, Deltoid Ligament), Syndesmosis, Open Rotator Cuff, and

Acromioclavicular Joint Kit (AC Joint).

4. The kit of Claim 3, further comprising a first implant for the ATFL operably coupled a first bone screw and a second bone screw; and a second implant for the Calcaneofibular Ligament (CFL) operably coupled to the second bone screw and a third bone screw; wherein the first bone screw is located in the talus bone, the second bone screw is located in the fibula, and the third bone screw is disposed in the calcaneus bone; and the first, second, and third bone screws, bone tunnels.

5. The kit of Claim 2, further comprising an implant patch operably coupled to at least four bone screws disposed on a distal corner of the implant patch; wherein at least two of the bone screws are disposed in the fibula and at least two bone screws are secured in the talus bone.

6. The kit of Claim 2, further comprising a first implant operably attached to a first bone screw and disposed through a fibular tunnel and to an interference screw; and a second implant is operably attached to the interference screw and a second bone screw or suture anchors; wherein the first implant is tensioned by the talar tunnel.

7. The kit of Claim 2, further comprising a first threaded anchor operably attached to a first implant and the first implant operably attached to a second threaded anchor; wherein the implant is tensioned by the fibular bone tunnel under tension from the second threaded anchor into the fibula.

8. The kit of Claim 2, further comprising a first soft suture anchor operably attached to a first implant and the first implant operably attached to a second soft suture anchor, and the soft suture anchors are implanted with a suture based anchor system.

9. A kit including a plurality of instruments for tissue, tendon, or ligament repair comprising: a plurality of anchor instruments, a plurality of staple instruments, and an implant; wherein the anchor instruments comprise a guide pin, a cannulated drill bit, a cannula, a punch tap, a suture passing wire, and an inserter device; wherein the cannula includes a longitudinal slot on a top of the cannula to allow oversized instruments to be introduced over the implant; wherein the staple instruments include a sizing guide, an insertion tool, a drill guide, a drill bit, a slap hammer, a tamp, and a staple; wherein the plurality of anchor instruments operably couple with the plurality of staple instruments to implant the implant to repair the tissue, tendon, or ligament.

10. The kit of Claim 9, wherein the implant includes a modulus of elasticity between about 12.00 Mpa and about 116.00 Mpa.

11. The kit of Claim 10, wherein the tissue, tendon, or ligament is selected from the group consisting of: Lateral Ankle Anterior Talofibular Ligament (ATFL); Medial Collateral Ligament (MCL), Plantar Plate, Achilles Tendon, Peroneal Tendon, Medial Ankle (Spring Ligament, Deltoid Ligament), Syndesmosis, Open Rotator Cuff, and Acromioclavicular Joint Kit (AC Joint).

12. The kit of Claim 10, wherein the kit secures the implant slightly proximal and posterior to the medial epicondyle; the implant is attached to the adductor tubercle by the staple instrument and a plurality of staples; the tibial attachment of the implant is applied just proximal to the pes anserine and 3 mm anterior to the posteromedial crest of the tibia; and the implant is secured to the metaphysis of tibia by the staple instrument and staples.

13. A kit including a plurality of instruments for tissue, tendon, or ligament repair, comprising: a guide wire, a drill bit, a suture passing wire, an inserter device, a bone screw, an implant, a suture with needle; wherein the guide wire, the drill bit the suture passing wire, the inserter device, the bone screw, and the suture with needle are operably coupled to implant the implant to repair a tissue, tendon, or ligament.

14. The kit of Claim 13, wherein the kit places the guide wire into the medial metatarsal in the metadiaphyseal junction at midline and is advanced laterally, exiting just proximal to the articular cartilage; and the kit places a second guidewire into the proximal phalanx, exiting just distal to the articular cartilage; a lst metatarsal Guidewire is drilled with a cannulated Drill Bit; a proximal phalanx Guidewire is drilled next with the Drill bit; a shuttle the Suture Passing Wire from lateral to medial; the implant with or without a suture is inserted laterally into a Nitinol Suture Passing Wire and is pulled medially through a lst metatarsal drill hole; a distal end of the implant with or without a suture is pulled through a proximal phalanx drill hole from lateral to medial using the Suture Passing Wire; the bone screws are inserted into a bone tunnel at the proximal phalanx while holding tension on the implant; the toe is placed into a corrected position; the implant is tensioned and a second bone Screw is placed into a metatarsal head bone tunnel.

15. The kit of Claim 14, further comprising two bone screws securing the implant.

16. A kit including a plurality of instruments for tissue, tendon, or ligament repair comprising a drill bit, a drill guide, an inserter device, a threaded bone anchor, an implant with or without a suture with needle; wherein a guide wire, the drill bit, the suture passing wire, an inserter device, a bone screw, the implant, and the suture with needle operably couple to implant the implant to repair the tissue, tendon, or ligament.

17. A method of repairing an Achilles tendon using the kit of Claim 16 comprising: preparing the bone for insertion of at least two threaded bone anchors by drilling down to a laser line or to a shoulder stop when using the drill guide; creating at least two holes about 1 cm proximal to a distal insertion of the Achilles tendon and central to each half of the tendon; inserting the two threaded bone anchors loaded with the implant with or without a suture, into the proximal holes; placing an eyelet completely in a drill hole until an anchor body makes contact with the bone; holding the inserter steady and mallet a handle downward until the anchor body is flush with the bone; passing the needle attached to the implant or the suture through the Achilles tendon on each side; preparing a plurality of distal holes with the drill in the same manner as the proximal holes; retrieving both suture tails from each proximal anchor and preload them through a distal threaded anchor eyelet; adjusting tension of an implant suture and insert the threaded bone anchor into a prepared distal bone socket until the anchor body contacts bone and repeating for other distal threaded bone anchor.

18. The method of Claim 17, further comprising using at least two bone screws the implant acting as tension strips through bone tunnels.

19. The method of Claim 17, further comprising a V-Y plasty and the implant on the sides of the V-Y plasty.

20. The method of Claim 17, further comprising implanting at least two parallel implants sandwiching the Achilles tendon.

21. The method of Claim 17, further comprising an implant inlay with re-tubularized

Achilles tendon and an implant inlay wraps around the re-tubularized Achilles tendon.

22. The method of the Achilles procedure of Claim 17, further comprising an implant weaved around a repair site in a spaghetti strand configuration.

23. A kit including a plurality of instruments for tissue, tendon, or ligament repair comprising a guidewire, a cannulated drill bit, a drill bit, a drill guide, a needle, a suture passing wire, an inserter device, an implant, a threaded bone anchor, and a suture; wherein the guidewire, the cannulated drill bit, the drill bit, a punch tap, the drill guide, the needle, the suture passing wire, the inserter device, the threaded bone anchor, and the suture are all operably coupled to implant the implant to repair the tissue, tendon, or ligament.

24. A method of repairing a spring ligament using the kit of Claim 23, comprising implanting two bone anchors and the implant in a Y-configuration.

25. A method of repairing a spring ligament using the kit of Claim 23 comprising implanting two bone anchors and implanting the implant for the Medial Ankle Ligament.

26. A kit including a plurality of instruments for tissue, tendon, or ligament repair comprising a guidewire, a cannulated drill bit, a drill bit, a drill guide, a needle, a suture passing wire, an inserter device, an implant, a threaded bone anchor, and a suture; wherein the guidewire, the cannulated drill bit, the drill bit, the drill guide, the needle, the suture passing wire, the inserter device, the threaded bone anchor, and the suture are all operably coupled to implant the implant to repair the tissue, tendon, and ligament.