The present disclosure generally relates to interference anchors and, more generally, a tendon interference anchor inserted through impaction.
Traditional tendon interference anchors are torsionally installed into a desired fixation location (e.g., soft or hard tissue). Traditional installation methods impart increased torsion and tensile stresses on the material of the desired fixation location. Additionally, the constant sliding of the thread major of the anchor along a tendon and bone creates friction and further increases the probability of lacerating a tendon.
Based on the foregoing, a need exists for an effective anchor that will reduce the probability of anatomical damage. Thus, an interest exists for improved tendon interference anchors, and related methods of use. These and other inefficiencies and opportunities for improvement are addressed and/or overcome by the assemblies, systems and methods of the present disclosure.
The present disclosure provides an advantageous system for improved fixation with soft tissue (e.g., tendon) and/or hard tissue (e.g., bone). In particular, the present disclosure is directed to systems/methods that incorporate a tendon interference anchor with advantageous protrusions (e.g., splines, I-beams, barbs, knurls, threads, ribs, ridges, tines, teeth, wedges, fins, grooves, and any combination thereof) to affix soft tissue, medical implants (e.g., bone plates), and/or hard tissue to hard tissue. Even more particularly, exemplary systems/methods are disclosed that include an anchor system having an anchor body and protrusions for securing the anchor to the desired fixation location (e.g., desired bone location). The disclosed anchor system is configured to be advanced and fixed into a desired fixation location through impaction.
In exemplary embodiments, the present disclosure provides an advantageous anchor system for improved fixation between a variety of anatomical surfaces and/or structures (e.g., soft tissue, hard tissue, and/or medical implants). The disclosed anchor system includes an anchor body having a proximal end, a distal end, a longitudinal axis, an outer surface and at least one protrusion (e.g., one or more splines, I-beams, barbs, knurls, threads, ribs, ridges, tines, teeth, wedges, fins, grooves, and any combination thereof) for securing the anchor system relative to a desired fixation location. The outer surface of the anchor body may include the at least one protrusion extending outwardly therefrom in a direction non-parallel to the longitudinal axis of the anchor body. Further, the at least one protrusion may extend radially from the longitudinal axis.
The disclosed anchor system may be advantageously inserted into the desired fixation location through impaction. Depending on the protrusion style, a slight rotation of the anchor system may occur during the impaction. In some embodiments, the rotation assists the impaction to further secure the anchor relative to the surrounding anatomical surfaces and/or structures (e.g., soft and hard tissue). In those instances, it is understood that the impaction forces are the primary and substantial driver in inserting/advancing the anchor into the desired fixation location. In other embodiments, the impaction forces and the resultant rotational forces work in unison to insert/advance the anchor into the desired fixation location.
In an exemplary embodiment, an advantageous anchor system includes an anchor body having a proximal end, a distal end, a longitudinal axis, an outer surface and at least one helical spline associated, in whole or in part, with the outer surface of the disclosed anchor body. In exemplary embodiments, the disclosed anchor may include 5 or 6 external helical splines having a twist angle ranging from about 180 degrees to about 360 degrees. However, more or less external helical splines may be utilized without departing from the scope or spirit of this disclosure. The disclosed anchor system may further include an enlarged head to limit the depth that the anchor system may be impacted and/or travel relative to the desired fixation location. The disclosed anchor system may further include at least one (or both) of a cannulation hole and a cross hole. The disclosed hole(s) may enable an in situ settable polymer to enter and/or pass through the anchor body.
In another exemplary embodiment, an advantageous anchor system includes an anchor body having a proximal end, a distal end, a longitudinal axis, an outer surface and at least one helical spline associated, in whole or in part, with the outer surface of the disclosed anchor body. The disclosed anchor body may further include a plurality of protrusions extending, in whole or in part, from one or more of the disclosed splines. The disclosed anchor system may further include at least one (or both) of a cannulation hole and a cross hole. A four strand graft, previously secured to a femur, may be pulled through the cannulation hole. The strands may be separated and positioned within each quadrant of the disclosed anchor.
In yet another embodiment, an advantageous anchor system includes an anchor body having a proximal end, a distal end, a longitudinal axis, an outer surface and at least one spline associated, in whole or in part, with the outer surface of the disclosed anchor body. The disclosed spline(s) may function, inter alia, to vary the amount of potential engagement with the disclosed fixation location, such that at one position along the anchor body the disclosed spline(s) may engage with the opposing hard/soft tissue more than at another position along the anchor body. The disclosed anchor may further include a plurality of protrusions at least partially positioned along one or more splines. The disclosed anchor system may further include at least one (or both) of a cannulation hole and a cross hole. In some instances, a four strand graft, already secured to a femur, may be pulled through the cannulation hole. The strands are separated and positioned within each quadrant of the depicted anchor body.
Any combination or permutation of features, functions and/or embodiments as disclosed herein is envisioned. Additional advantageous features, functions and applications of the disclosed systems, methods and assemblies of the present disclosure will be apparent from the description which follows, particularly when read in conjunction with the appended figures. All references listed in this disclosure are hereby incorporated by reference in their entireties.
Features and aspects of embodiments are described below with reference to the accompanying drawings, in which elements are not necessarily depicted to scale.
Exemplary embodiments of the present disclosure are further described with reference to the appended figures. It is to be noted that the various features, steps and combinations of features/steps described below and illustrated in the figures can be arranged and organized differently to result in embodiments which are still within the scope of the present disclosure.
To assist those of ordinary skill in the art in making and using the disclosed assemblies, systems and methods, reference is made to the appended figures, wherein:
The exemplary embodiments disclosed herein are illustrative of advantageous systems for improved fixation with soft tissue (e.g., tendon) and/or hard tissue (e.g., bone). It should be understood, however, that the disclosed embodiments are merely illustrative of the present disclosure, which may be embodied in various forms. Therefore, details disclosed herein with reference to exemplary assemblies/fabrication methods and associated processes/techniques of assembly and use are not to be interpreted as limiting, but merely as the basis for teaching one skilled in the art how to make and use the advantageous assemblies/systems of the present disclosure.
The present disclosure provides an advantageous system/method of an exemplary tendon interference anchor with improved protrusions to affix soft tissue, medical implants (e.g., bone plates), and/or hard tissue to hard tissue. Even more particularly, exemplary systems/methods are disclosed which include an anchor system having an anchor body and protrusions for securing the anchor to the desired bone location. The disclosed anchor system is configured to be substantially impacted into the desired bone location. Particularly, where the primary form of insertion is impaction. As used herein, tendon interference anchor may be referred to as “interference anchor,” “anchor system,” or “anchor”.
The disclosed tendon interference anchor may include an anchor body and at least one protrusion (e.g., splines, I-beams, barbs, knurls, threads, ribs, ridges, tines, teeth, wedges, fins, grooves, and any combination thereof). At least one protrusion is at least partially associated with the outer surface of anchor body. Anchor body and at least one protrusion may be fabricated as a single component or may be two separate components that are assembled together to give the appearance/functionality of a single component. The present disclosure is not intended to be limiting and the use of “anchor body” and “protrusion” are merely explanatory, therefore, both fabrication variations are anticipated, unless expressly stated otherwise.
The disclosed anchor has a proximal end, a distal end, and a longitudinal axis. Distal end may include at least one element to assist with the insertion of anchor into the desired fixation location. For example, anchor may include a substantially conical distal tip. However, distal tip may be fabricated into a variety of shapes, including, cylindrical, spherical, and/or with a loop, which is adapted for retention of at least one suture or cable. The disclosed anchor may have an anchor body with a cross-section that is substantially circular. However, the disclosed anchor body is not limited to the disclosed cross-section and a variety of shapes may be utilized (e.g., an oval, an ellipse, a quadrilateral, a triangle, or a combination thereof).
The disclosed anchor system may further include at least one of a cannulation hole and a cross hole. In some instances, a four strand graft, already secured to a femur, may be pulled through the cannulation hole. The strands may be separated and positioned within each quadrant of the depicted anchor. The disclosed anchor system may further include an element located in relation to the proximal end that is at least partially larger than the cross-section of the anchor system (e.g., the head of a nail). However, in other instances, the element may not exceed the cross-section of the anchor system in all directions. The disclosed anchor system may be fabricated into any desired length, as will be appreciated by one skilled in the art based on the anticipated use.
The disclosed anchor may be introduced into a desired fixation location (e.g., soft tissue and/or hard tissue). As used herein, the desired fixation location may be a desired position, located in close proximity to an anatomical surface, or may be at least a partial hole wherein the disclosed anchor may be introduced. In one embodiment, the desired fixation location includes a hole having a diameter that is substantially similar to the diameter of the disclosed anchor body. As previously stated, the disclosed anchor may be introduced into the desired fixation location through impaction. Depending on the desired protrusion style and orientation, the disclosed anchor may rotate during impaction. However, in terms of the primary insertion of the anchor, rotation is ancillary to impaction. Rotation, as a secondary form of insertion, helps to secure the disclosed anchor to the desired fixation location, without the disclosed pitfalls of torsional insertion.
In operation, an impactive force may be applied directly/indirectly to the proximal end of the disclosed anchor. In an exemplary embodiment, where the disclosed anchor includes helical protrusions, the disclosed anchor may slightly rotate during impaction into the desired fixation location. However, in another exemplary embodiment, where the disclosed anchor includes non-helical protrusions, the disclosed anchor may be impactively inserted into the desired fixation location without ancillary rotation. The desirable method depends on the application.
The disclosed anchor may be at least partially fabricated from a biodegradable citrate-based composite. The disclosed anchor may be bioabsorbable. The disclosed anchor system may be at least partially formed from the polycondensation product of citric acid and/or citrate with at least one C2 to C20 alkane diol. More particularly, the disclosed anchor system may be at least partially formed from the polycondensation product of citric acid and/or citrate with at least one C4 to C12 alkane diol. In certain embodiments, the citrate-based (co)polyester may be poly(1,8-octanediol citrate). In certain embodiments, the disclosed anchor may at least in part be formed from a composite comprising a citrate-based polymer and a bioceramic. In certain embodiments, the bioceramic is selected from the group including hydroxyapatite and beta-tricalcium phosphate. The citrate-based polymer(s) and the bioceramic(s) may be present in the composite in any suitable weight ratio relative to each other.
Examples of the tendon interference anchors and anchor systems/methods according to the present disclosure are illustrated in
With reference to
In an exemplary embodiment, at least one protrusion 18, 102 may be a spline. More particularly, the disclosed spline 18, 102 may be helical having a twist angle ranging from about 180 degrees to about 360 degrees. The disclosed helical splines 18, 102 may begin in close proximity to proximal end 14 and end in close proximity to distal end 16. In some examples, the disclosed helical splines 18, 102 may twist from about proximal end 14 to about distal end 16. Spline 18, 102 may extend outwardly from the outer surface of anchor body 12 in a direction non-parallel to the longitudinal axis of anchor body 12. As illustrated in
The design of spline 18, 102 may be substantially symmetrical (e.g., similar to the cross-section of a V-shaped thread, a rounded V-shaped thread, a square thread, an acme thread, a knuckle thread, among others), such that bearing surface (i.e., engaging surface) 106 and opposing thread surface 108 have a substantially similar angle (i.e., spline/thread angle) in relation to the longitudinal axis of anchor body 12. (See, e.g.,
Alternatively, the design of spline 18, 102 may be biased (e.g., biased in a downward direction) so as to limit movement of the engaged anatomical surface(s) (e.g., tendon). (See, e.g.,
In the present examples, helical splines 18, 102 are described having a right-handed configuration. However, a left-handed configuration is possible. In such instance, bearing surface 24, 106 and opposing thread surface 26, 108 would be switched. The depth of spline 18, 102, which is defined as the distance between outer surface 22, 104 of spline 18, 102 and the outer surface of anchor body 12, may at least partially affect the level of engagement between anchor 10, 100 and the desired fixation location. Much like the spline angle, the spline depth may be altered depending on the application and desired fixation location.
As previously discussed, five helical spline anchors and six helical spline anchors may each have a twist angle ranging from about 180 degrees to about 360 degrees. As previously illustrated, and reproduced as
In another exemplary embodiment, as illustrated in
Proximal end 204 may include mounting element (e.g., head) 212, configured and adapted to ensure at least a portion of anchor 200 remains in close proximity to the opening of the desired fixation location. More particularly, element 212 may ensure at least a portion of anchor 200 is external to, flush with, or slightly recessed to (e.g., countersink or counterbore) the opening of the desired fixation location. Element 212 may have a cross-section that is at least partially larger than the combined cross-section of at least one protrusion 208 and anchor body 202. Even more particularly, in an example where anchor 200 is joining two or more bone sections, discussed in more detail below with reference to
In one example, as depicted in
In another exemplary embodiment, as illustrated in
Anchor 300 may include at least one hole (e.g., cannulation hole and cross hole). In an exemplary embodiment, anchor 300 may include at least one cross hole 314 and at least one cannulation hole 316. Cross hole 314 may extend at least partially through anchor body 302 at a desired non-parallel angle in relation to the longitudinal axis of anchor 300. For example, cross hole 314 may be substantially perpendicular to the longitudinal axis of anchor 300, as depicted in
In an exemplary embodiment, cannulation hole 316 extends from proximal end of anchor 300 at least partially through anchor body 302 along the longitudinal axis of anchor 300. At least two cross holes 314 may intersect cannulation hole 316. Cross holes 314 may be substantially perpendicular to cannulation hole 316 and may be substantially perpendicular to each other. Cross hole(s) 314 and cannulation hole 316 may facilitate interdigitation between an in situ polymer material (e.g., low viscosity) and the surrounding anatomy. In one example, anchor 300 may be inserted into the desired fixation location, as described above. Once inserted, an in situ polymer material may be introduced through cannulation hole 316. The in situ polymer material flows through cannulation hole 316 and out at least one cross hole 314, thereby interdigitating with the surrounding anatomy within desired fixation location. In another example, prior to insertion of anchor 300, the in situ polymer material may be introduced into the desired fixation location. During installation, anchor 300 compresses the in situ polymer material within the desired fixation location such that the in situ polymer material interdigitates the desired fixation location and anchor 300 (e.g., at least partially through cross hole 314 and/or cannulation hole 316).
In another example, anchor 300 may further include mounting element 312 (e.g., head), configured and adapted to ensure at least a portion of anchor 300 remains in close proximity to the opening of the desired fixation location. Element 312 may be associated with proximal end 304. More particularly, element 312 may ensure at least a portion of anchor 300 is external to, flush with, or slightly recessed to (e.g., countersink or counterbore) the opening of the desired fixation location. Element 312 may have a cross-section that is at least partially larger than the combined cross-section of at least one protrusion 308 and anchor body 302. Even more particularly, in an example where anchor 300 is joining two or more bone sections, element 312 may ensure at least a portion of anchor 300 is external to, flush with, or slightly recessed to (e.g., countersink or counterbore) one of the bone sections. (See, e.g.,
In another exemplary embodiment, as illustrated in
Anchor 400 may further include at least one notch 410 that at least partially surrounds anchor body 402. Notch 410 may be designed such that removal of anchor 400 from the desired fixation location is more difficult than during insertion of anchor 400. Notch 410 may include a section that is angled with reference to the longitudinal axis of anchor 400. Particularly, notch 410 includes a section that is substantially perpendicular to the longitudinal axis of anchor 400. In an exemplary embodiment, anchor includes 4 notches 410 that at least partially surround anchor body 402. Notch 410 may facilitate interdigitation between an in situ polymer material (e.g., low viscosity) and the surrounding anatomy. In one example, prior to insertion of anchor 400 into the desired fixation location, the in situ polymer material may be introduced into the desired fixation location. During installation of anchor 400, anchor 400 compresses the in situ polymer material within the desired fixation location such that the in situ polymer material interdigitates the desired fixation location and anchor 400 (e.g., at least partially in relation to notch 410).
Anchor body 402 may further include hole 416 that at least partially extends from proximal end 404 towards distal end 406. In an exemplary embodiment, hole 416 extends from proximal end 404 through distal end 406 such that hole 416 is a through hole. Hole 416 may at least partially extend from proximal end 404 towards distal end 406 along the longitudinal axis of anchor 400. In one embodiment, hole 416 may facilitate interdigitation between an in situ polymer material and the surrounding anatomy, as discussed above. In another embodiment, hole 416 may at least partially engage with a graft (not shown). Particularly, in an instance where the graft (e.g., four strand graft) is already secured to the desired fixation location (e.g., femur), the graft may be pulled through hole 416. The strands of the graft may be separated and laid within a respective groove 409. Anchor 400 is inserted into the desired fixation location (e.g., through impaction) while pulling the graft to ensure proper tension.
Proximal end 404 may include a mounting element (e.g., head), configured and adapted to ensure at least a portion of anchor 400 remains in close proximity to the opening of the desired fixation location. More particularly, the mounting element may ensure at least a portion of anchor 400 is external to, flush with, or slightly recessed to (e.g., countersink or counterbore) the opening of the desired fixation location. The element may have a cross-section that is at least partially larger than the combined cross-section of at least one protrusion 408 and anchor body 402. Even more particularly, in an example where anchor 400 is joining two or more bone sections, the element may ensure at least a portion of anchor 400 is external to, flush with, or slightly recessed to (e.g., countersink or counterbore) one of the bone sections. Distal end 406 may include at least one element to assist with the insertion of anchor 400 into the desired fixation location. For example, anchor may include substantially conical distal tip 412. Conical distal tip 412 may further include surface 414, which may facilitate the separation of at least one strand from a graft (e.g., four strand graft). In a particular instance, surface 414 may be partially angled and slightly concaved. In one embodiment, surface 414 may separate two strands may from a four strand graft. The separated strands may be laid within a respective groove 409 of protrusion 408, 452, as mentioned above. Anchor body 402 may have a cross-section that is substantially circular.
In another exemplary embodiment, as specifically depicted in
In yet another exemplary embodiment, as depicted in
Anchor 500 may further include groove 512, which is defined by side walls 514, 516. Anchor body 502 may further define at least a portion of the depth of groove 512. Groove 512 may be positioned in close proximity to distal end 506. At least a portion of side walls 514, 516 and/or anchor body 502 may be radiused. Groove 512 may be dimensioned to accept at least one graft (e.g., four strand graft). Particularly, the graft (not shown) may be placed in close proximity to groove 512 while anchor 500 is inserted into the desired fixation location (e.g., through impaction). Anchor 500 may be inserted into the desired fixation location through only impaction. Protrusions 508, 510 at least partially secure anchor 500 to the desired fixation location and groove 512 may provide a resting location for the graft (not shown).
Although the present disclosure has been described with reference to exemplary implementations, the present disclosure is not limited by or to such exemplary implementations. Rather, various modifications, refinements and/or alternative implementations may be adopted without departing from the spirit or scope of the present disclosure.
The present application claims priority benefit to a U.S. provisional patent application entitled “Tendon Interference Anchor,” which was filed on Aug. 31, 2018, and assigned Ser. No. 62/725,831. The content of the foregoing provisional application is incorporated herein by reference.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/048313 | 8/27/2019 | WO | 00 |
Number | Date | Country | |
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62725831 | Aug 2018 | US |