Adjustable suture-button construct for ankle syndesmosis repair

Information

  • Patent Grant
  • 11701103
  • Patent Number
    11,701,103
  • Date Filed
    Thursday, November 12, 2020
    3 years ago
  • Date Issued
    Tuesday, July 18, 2023
    10 months ago
Abstract
An adjustable, knotless button/loop construct for fixation of ankle syndesmosis tibio-fibular diastasis and an associated method of ankle repair using the same. The knotless construct comprises a pair of buttons attached to a flexible, continuous, self-cinching, adjustable loop integrated with two splices that are interconnected. The knotless construct is passed through fibular and tibia tunnels and the buttons are secured on the cortical surfaces of tibia and fibula. One of the buttons (for example, an oblong button) is secured on the medial side of the tibia by passing the button and the flexible, adjustable loop though the fibular and tibia tunnels and then flipping and seating the button outside the tibia. The length of the flexible adjustable loop is adjusted so that the second button (for example, a round button) is appropriately secured on the lateral fibula.
Description
FIELD OF THE INVENTION

The present invention relates to the field of ankle surgery and, more particularly, to ankle syndesmosis repair techniques and associated fixation and reconstruction devices.


BACKGROUND OF THE INVENTION

Ankle injuries are among the most common of the bone and joint injuries. The ankle joint is formed of three bones coming together: the tibia which makes up the medial, or inside, anklebone; the fibula which parallels the tibia and makes up the lateral, or outside, anklebone; and the talus. The far ends of the tibia and fibula are known as the malleoli and together they form an arch that sits on top of the talus.


A fibrous membrane (the joint capsule) encases the joint architecture and is lined with a smoother layer called the synovium. The joint capsule contains the synovial fluid produced by the synovium. The synovial fluid allows for smooth movement of the joint surfaces. The ankle joint is stabilized by three groups of ligaments, which are fibers that hold these bones in place.


Surgery to fix an ankle fracture is indicated for patients who suffer a displaced ankle fracture involving the bone on the inside to the ankle (tibia), the bone on the outside of the ankle (fibula), or both. One injury that may occur in the ankle is a disruption of the syndesmosis. A syndesmotic injury is a disruption of the strong fibrous ligaments that hold the fibula and tibia together near the ankle joint. If the syndesmosis is disrupted, then the ankle joint will be unstable and surgery is usually indicated.


A suture-button construct for ankle syndesmosis repair is the subject matter of U.S. Pat. No. 7,235,091, the disclosure of which is incorporated by reference herein in its entirety. The construct and technique disclosed in this prior patent greatly facilitates ankle syndesmosis repair as compared to the prior art, but it requires the tying of knots to secure the second (round) button against the surface of the lateral fibular cortex. An ankle syndesmosis repair construct and technique is needed which provides the same fixation as disclosed in the aforementioned patent, but without the need for tying knots.


SUMMARY OF THE INVENTION

The present invention provides methods and reconstruction systems (an adjustable, self-locking knotless button/loop construct) for ankle syndesmosis with or without associated ankle fractures repair. One embodiment system of the present invention comprises an adjustable, knotless button/loop construct formed of a pair of fixation devices (for example, two buttons) connected by an adjustable, knotless flexible loop. Another embodiment system of the present invention comprises an adjustable, knotless button/loop construct interlocked with a non-adjustable loop each attached to a fixation device (for example, two buttons. The loop includes a flexible material (preferably suture or suture tape), for fracture fixation when a plate is disposed between the fractured bone and one fixation device.


The present invention also provides a method of assembling an adjustable self-locking, knotless button/loop construct by inter alia: (i) providing two fixation devices (i.e., an oblong button and a round button); (ii) threading a flexible strand through holes of the first and second button, to form a braid loop and an intertwining or interlinking “x” of the braid on the round button; (iii) forming two adjustable eyesplices on the braid loop and through the oblong button, so that the oblong button is centered between the two spliced sections; and (iv) threading the tails through the top holes of the round button.


The present invention also provides a method of ankle syndesmosis repair by inter alia: (i) providing an ankle repair system comprising an adjustable, self-locking knotless button/loop construct including two fixation devices (for example, a round button and an oblong button), and at least one flexible, adjustable loop attached to the fixation devices (i.e., the buttons); and (ii) securing the repair system to misaligned bones of the ankle.


The present invention also provides a method of ankle syndesmosis repair by inter alia: (i) providing an ankle repair system comprising an adjustable, self-locking knotless button/loop construct including two fixation devices (for example, a round button and an oblong button), and at least one flexible, adjustable loop attached to one fixation devices (i.e., the buttons) and a non-adjustable loop connected to the second fixation device; and (ii) securing the repair system to misaligned bones of the ankle.


The present invention also provides a fracture management system by inter alia: (i) providing an ankle repair system comprising an adjustable, self-locking knotless button/loop construct including two fixation devices (for example, a round button and an oblong button), and at least one flexible, adjustable loop attached to the fixation devices (i.e., the buttons); (ii) providing a fracture plate, and (iii) securing the repair system and plate to misaligned and fractured bones of the ankle.


These and other features and advantages of the present invention will become apparent from the following description of the invention that is provided in connection with the accompanying drawings and illustrated embodiments of the invention.





BRIEF DESCRIPTION OF THE DRAWINGS


FIGS. 1A and 1B illustrate a schematic top view of a round button and an oblong (elongated) button of an adjustable, self-locking knotless button/loop construct of the present invention.



FIG. 2 illustrates the braid strand passed through holes 1 and 2 of the round button of FIG. 1A.



FIG. 3 illustrates the braided strand passed through the eyelet holes of the oblong button of FIG. 1B.



FIG. 4 illustrates the strand passed through hole 3 of the round button.



FIG. 5 illustrates the braid loop connecting the round button and the oblong button.



FIG. 6 illustrates the strand from hole 3 passing under the strand bridging holes 1 and 2.



FIGS. 7A and 7B illustrate the intertwined strands forming an “X” on the round button.



FIG. 8 illustrates the tail strands of each side of the round button pulled towards the oblong button.



FIG. 9 illustrates the tail strands exiting from holes adjacent to one another on the round button and strands forming a loop through the oblong button exiting from holes adjacent to one another on the round button.



FIG. 10 illustrates an enlarged view of the underside of the round button.



FIG. 11 illustrates an enlarged view of the 0.75″ splice (with the oblong button moved to the side to allow splicing near the center of the braided loop formed between the buttons).



FIG. 12 illustrates a splice on one side with tail passing through the oblong button.



FIG. 13 illustrates the formation of a second splice with the strand exiting at the end of the first splice.



FIG. 14 illustrates the strands passing through top holes 1 and 3 of the round button.



FIG. 15 illustrates the final construct (adjustable, self-locking knotless button/loop construct) of the present invention.



FIG. 16 is another, schematic view of the final, assembled, self-locking, knotless button/loop construct of the present invention (with a knotless, self-locking, loop attached to a round button and an oblong button, and with two splices through the oblong button, and intertwining/crossing strands on the round button).



FIGS. 17-20 illustrate subsequent steps of a method of ankle syndesmosis repair employing the self-locking, knotless button/loop construct of FIG. 16 and according to the present invention.



FIG. 21 illustrates a fracture fixation plate with self-locking, knotless button/loop construct of FIG. 16.



FIGS. 22-26 illustrate subsequent steps of a method of ankle syndesmosis repair and fracture fixation employing the self-locking, knotless button/loop construct of FIG. 16 and the fixation plate of FIG. 21.



FIG. 27 illustrates a buttress plate with self-locking, knotless button/loop construct of FIG. 16.



FIGS. 28-29 illustrate subsequent steps of a method of ankle syndesmosis repair employing the self-locking, knotless button/loop construct of FIG. 16 and the buttress plate of FIG. 27, of the present invention.



FIG. 30-32 respectively locking straight, tubular and hooking plates with self-locking, knotless button/loop construct of FIG. 16.



FIG. 33 schematically illustrates another adjustable loop construct in accordance with the present invention.



FIG. 34 schematically illustrates a further adjustable loop construct in accordance with the present invention.





DETAILED DESCRIPTION

The present invention provides assembling steps and reconstruction systems for the stabilization of ankle bones (for ankle syndesmosis repair) using an adjustable, knotless button/loop construct in a minimally invasive approach.


The stabilization system of the present invention comprises a knotless button/loop construct including two fixation devices (for example, two buttons) and at least one flexible, adjustable loop attached to the two fixation devices (i.e., the buttons). The knotless button/loop construct has an adjustable loop length and allows adjustment in one direction while preventing or locking the construct from loosening in the opposite direction, due to applied tensile forces.


The present invention also provides a method of ankle repair by inter alia: (i) providing a button/loop construct with two buttons and at least one flexible, adjustable loop (a four-point knotless fixation device) that is capable of adjusting tension (i.e., is provided with a loop having an adjustable perimeter and length) attached to the buttons; and (ii) securing the ankle bones in the proper position by advancing the button/loop construct through tunnels formed within the ankle bones.


Referring now to the drawings, where like elements are designated by like reference numerals, FIG. 1 illustrates top views of two fixation devices 10, 20 (button 10, 20) used for assembling the knotless, integrated, ankle repair system 100 (button/loop construct 100) of the present invention (shown in FIGS. 15 and 16). The knotless repair system 100 is an integrated system comprising two fixation devices 10, 20 attached to at least one flexible, adjustable loop formed of a flexible material 30.


The flexible material 30 forming the loop has an adjustable length and, as described below, is connected to two fixation devices (buttons) that are further secured on tibial cortex and fibular cortex, respectively. The flexible material is threaded through apertures/holes/eyelets of each of the first and second fixation devices 10, 20 and splices are created to form the knotless, integrated, self-cinching ankle repair system 100. In an exemplary only embodiment, and as detailed below, the flexible material 30 may be suture such as a suture braid with braided filaments having a hollow core (for example, strands of suture such as ultrahigh molecular weight polyethylene (UHMWPE) braided with strands of polyester, collagen, or other suture materials, such as PET, PEEK, silk nylon, and absorbable polymers, among many others).


In an alternative embodiment, the flexible material 30 may be suture such as FiberWire®, e.g., UHMWPE and polyester braided over a core of UHMWPE, such as #2 FiberWire®.


In an exemplary embodiment only, the first fixation device 10 is a round button provided with four circular holes having a round configuration, and the second fixation device 20 is an oblong button provided with two eyelets 5 and 6 having an oblong or elliptical configuration, or any other configuration including round, teardrop shape, or circular configuration. Although the embodiments below will be detailed with reference to particular configurations for the first and second fixation devices 10, 20 (i.e., a round button and an oblong, elongate button), the invention is not limited to this exemplary embodiment only and has applicability to fixation devices with other shapes and geometries, as long as the fixation devices are provided with apertures/holes/passages that allow a flexible material (a flexible strand) to pass therethrough (or be threaded therethrough) to form the flexible, adjustable, self-cinching, knotless loop of the invention.



FIGS. 2-14 illustrate exemplary steps of a method of assembling the reconstruction system 100 of FIGS. 15 and 16 (with the following starting materials which are only exemplary).


Starting Materials:


Braided high strength (UHMWPE) suture strand 30


Needle with nitinol loop 40


Round button 10


Oblong button 20


Assembly Instructions:


Step 1: A braided strand 30 is inserted through holes 1 and 2 of the round button 10. Fold braid 30 at midpoint to create two parallel equal length strands. FIG. 2 shows the braided strand 30 through holes 1 and 2 of the round button 10. In an exemplary embodiment, braided strand 30 is a braided UHMWPE strand.


Step 2: One end of the braided strand 30 is inserted through both eyelets 1 and 2 of the oblong button 20. FIG. 3 shows the braided strand 30 through the eyelets 5 and 6.


Step 3: The same strand 30 (that passed through oblong button 20) is threaded through hole 3 of the round button 10. This creates a loop 31 (FIG. 5) connecting both buttons 10, 20. FIG. 4 shows the strand 30 through hole 3 of the round button 10, and FIG. 5 shows the braid loop 31 connecting the round button 10 and the oblong button 20.


Step 4: The tail of the same strand 30 (that passed through hole 3) is passed under the strand looped through holes 1 and 2. FIG. 6 shows the strand from hole 3 passing under the strand in holes 5 and 6 of the round button 10. The tail of the same strand 30 is then passed over the strand looped through holes 1 and 2.


Step 5: The tail of same strand 30 is then threaded down through hole 4. This forms an intertwining or interlinking “X” 35 of the braid 30. The strand looped across holes 1 and 2 will be linked with the strand across holes 3 and 4. FIG. 7A and its schematic representation of FIG. 7B show the intertwined strands forming an “X” structure 35 on the round button 10.


Step 6: The following is confirmed:


a) The tails of each strand are pulled towards the oblong button 20 on each side of the round button 10 (as shown in FIG. 8).


b) Viewing the underside of the round button 10, the tail strands are exiting from holes adjacent to one another (as shown in FIGS. 9 and 10).


c) Viewing the underside of the round button 10, the strands forming the loop 31 through the oblong button 20 are adjacent to one another (as shown in FIGS. 9 and 10).



FIG. 8 shows the tail strands of each side of the round button 10 pulled towards the oblong button 20. FIG. 9 shows the tail strands exiting from holes adjacent to one another on the round button 10 and strands forming loop 31 through the oblong button 20 exiting from holes adjacent to one another on the round button 10. FIG. 10 shows the close up view of the underside of the round button 10.


Step 7: One tail strand is used to start a splice towards the midpoint of the braid loop 31 at oblong button 20. A splice 44a (FIG. 12) is created by passing the blunt tip needle 40 through the center of the braid 30 with the end of the strand 30 being carried through in the nitinol loop of the needle 40. The oblong button 20 may need to be moved to the side to allow splicing. The splice location should preferably be on the same side as the tail strand making the splice. FIG. 11 shows a close up of splice 44a. The oblong button 20 is moved to the side to allow splicing near center of braided loop 31 formed between buttons 10, 20.


Step 8: After the strand 30 is carried with needle 40 to create the splice 44a, the tail of the strand is threaded through both eyelet holes in the oblong button 20 (in from the bottom and out the top of the button 20). The oblong button 20 is slid so that it rests over spliced section. FIG. 12 shows the splice 44a on one side with the tail passing through the oblong button 20.


Step 9: Steps 7 and 8 (detailed above) are repeated to create another splice 44b with the opposing strand on the other side. The second splice 44b should be created such that the exiting aperture of the splice is as close as possible to the first splice 44a. The splice length may be about 17-19 mm. The tail of the strand is threaded through both eyelet holes of oblong button 20. FIG. 13 shows the formation of second splice 44b with the strand exiting at end of first splice 44a and as part of knotless, adjustable flexible loop 33.


Step 10: The oblong button 20 is slid to center between the two spliced sections 44a, 44b. The oblong button 20 sits approximately centered between the splices. The lower round button 10 sits approximately centered between intertwining/crossing “X” 35 of the strands.


Step 11: The tails of each strand are threaded through the top holes (holes 1 and 3) in the round button 10. Care should be taken to thread the tails through holes on same side of the button 10. Strands should not be crossed or twisted. The result is one overall adjustable knotless loop 33. FIG. 14 shows the strands passing through top holes 1 and 3 of the round button 10.


Step 12: After the button/loop construct 100 is constructed, the construct is stretched. The force to stretch the loop of the construct is applied such that it acts on the overall loop created between the two splices 44a, 44b rather than on individual splice loop.



FIGS. 15 and 16 show the final construct 100. As shown in FIGS. 15 and 16 and as detailed above, button/loop construct 100 (reconstruction system 100) is formed of a pair of buttons 10, 20 connected by a flexible, knotless, adjustable loop 33. Loop 33 includes a flexible material 30 with two adjustable eyesplices 44a, 44b.


In an exemplary and illustrative embodiment only, self-locking, knotless, adjustable button/loop construct 100 includes buttons 10, 20 and flexible material 30 with two adjustable eyesplices 44a, 44b that are interconnected to form one adjustable loop 33. By pulling on the free braid strands 30, the individual eyesplices constrict and, in turn, reduce the loop length of loop 33. Elongation of loop 33 is prevented because for loop 33 to elongate, a force must be applied interior to one or both of the eyesplices to elongate the individual loops.


Details regarding the formation/assembly of a self-locking adjustable construct with only one fixation device and two adjustable discrete splices, each splice (and which allows a graft to be fully inserted and seated in a bone tunnel) are provided in U.S. Patent Application Publication Nos. 2010/0256677 and 2010/0268273, the disclosures of which are incorporated by reference in their entirety herewith.


As described in the above-noted applications, a self-locking, adjustable, knotless construct includes a button and a flexible material with two adjustable eyesplices that are interconnected to form an adjustable continuous loop. By pulling on the free braid strands, the individual eyesplices constrict and, in turn, reduce the loop length L of loop. In order for the loop to elongate, a force needs to be applied interior to one or both of the eyesplices to elongate the individual loops.


Exemplary steps of a method of forming/assembling a self-locking adjustable knotless construct with only one fixation device (i.e., with only one button) and two splices/eyesplices are detailed in the above-noted applications, and include as starting materials a suture strand (for example, 50 inches of braided UHMWPE strand); a needle (for example, a blunt tip needle with nitinol loop) and a button (for example, a 3.5 mm titanium button). The suture strand is folded to create two equal length parallel braid strands. At this step, the braid is folded at the midpoint, 25 inches, to create two parallel equal length braid strands (Step 1). At Step 2, a first eyesplice is created on the first strand of braid by passing the blunt tip needle through the center of the braid with the end of the braid being carried through in the nitinol loop of the needle. The splice should travel for a distance of about 17-19 mm through the braid towards the braid midpoint created in Step 1.


Once the first eyesplice has been formed, at Step 3, the button is slid over the non-spliced strand passing the strand through both button holes. The button is slid so that it rests over the first spliced section. At Step 4, a second eyesplice is formed, similar to the first one, with the opposing strand. The strand should be looped through the first eyesplice loop resulting in two eyesplice loops that are interconnected. Again, the splice length should be between 17-19 mm. The splice should be created such that the exiting aperture of the splice is as close as possible to the first eyesplice.


Buttons 10, 20 of the construct 100 of the present invention may be formed, for example, of metal, PEEK or PLLA. As detailed above, the buttons are provided with openings (apertures, eyelets, holes) that allow the passage of the flexible material 30 to pass thereto.


The flexible material 30 is preferably a braided high strength suture material. The flexible material 30 may be provided with optional colored strands to assist surgeons in distinguishing between suture lengths with the trace and suture lengths without the trace. The flexible material 30 may be also provided in the form of a suture tape, or a combination of suture strand and suture tape, and as desired. The flexible material 30 may be suture such as a suture braid with braided filaments having a hollow core (for example, strands of suture such as ultrahigh molecular weight polyethylene (UHMWPE) braided with strands of polyester, collagen, or other suture materials, such as PET, PEEK, silk nylon, and absorbable polymers, among many others). The flexible material 30 may also contain a bioabsorbable material, such as PLLA, one of the other polylactides, or collagen, for example, and/or may be formed of twisted fibers having strands of a contrasting color added to the braided threads, to make the suture more visible during surgical procedures. In exemplary embodiments, flexible material 30 may be a braided suture cover containing strands of a high strength suture material, such as FiberWire® suture, sold by Arthrex, Inc. of Naples, Fla. The tail ends may preferably be coated (for example, tipped with Loctite or other adhesive).


The method of ankle syndesmosis repair using the suture-button construct of the present invention is similar to that disclosed in U.S. Pat. No. 7,235,091, except that, advantageously, no knot tying is required. Instead, the first (oblong) button of the construct is passed (with a suture passing instrument such as a needle) through drill holes passing through the fibula and tibia bones, flipped and secured against the medial tibial cortex, and the second (round) button is then tightened against the lateral fibular cortex simply by cinching the adjustable construct (instead of tying knots).



FIGS. 17-20 illustrate an ankle repair system 100 of the present invention employed in a method of ankle repair (fracture fixation and/or syndesmosis reduction) according to the present invention. A drill hole 88 is formed through tibia 90 and fibula 80. A long straight needle 85 with pull-through sutures 86 and optionally 87, are attached to the repair system 100 and passed through the drill hole 88, to advance the first, leading oblong button 20 substantially horizontally through the drill hole 88, as shown in FIGS. 18 and 19. Slight upward tension should be placed on the white pull-through suture, while placing downward tension on the green/white suture. The button should seat easily along the medial cortex. Once the first, oblong button 20 has exited the medial tibia 90, the angle of traction on the pull-through suture 86, 87 is changed and counter-traction is exerted on the loop 33, in order to flip (pivot) and engage the oblong button 20 against the medial tibial cortex (FIG. 20).


Once the oblong button 20 is anchored, the pull-through suture 88 can be cut and removed. The trailing or second, round button 10 is tightened down on the lateral side by further traction on the free ends of the suture 30 to tighten the adjustable, flexible loop 33 and adjust the tension between the two buttons 10, 20 (FIG. 20). This will further squeeze the syndesmosis but will not over-tighten it.



FIGS. 21, 27 and 30-32 illustrate fixation or buttress plates using the reconstruction system 100, whereas FIGS. 22-26 and 28-29 illustrate assembly steps for attaching reconstruction system 100, after a fracture plate 200, 400, 500, 600 or buttress plate 300 is affixed. FIGS. 22-26 illustrate, drilling all four cortices, 1.5 cm above the ankle joint, in the transmalleolar plane (30.degree. anterior to the coronal plane), using the 3.5 mm Drill Bit. The needle and pull-through sutures 86, 87 are passed along the drill hole and out the intact medial skin. The white 2-0 FiberWire pull-through suture advances the button 20, until it just exits the medial tibial cortex. A number 2.0 FiberWire suture may be added to facilitate placement of button 20. The pull-through sutures are cut where they connect to the needle after passage through the medial skin. The button 20 should seat easily along the medial.



FIGS. 28-29 illustrate attachment of construct 100 of the present invention may with a buttress plate 300 that features a four-hole plate. The contoured, titanium plate is preferably used as a “buttress” for ankle syndesmotic repairs with or without ankle fracture. The plate has two inner holes that custom fit the button 10, and two outer holes that accept two 3.5 mm.times.14 mm non-locking screws. The 3.5 mm screws are placed in the proximal and distal holes of the plate and the construct 100 is then placed in either the third hole (6), or both central holes (inset), if desired.



FIGS. 33 and 34 schematically illustrate alternative attachment construct embodiments where loop 31 of construct 100 interlocked with a non-adjustable loop 131 of flexible material. The construct embodiment of FIG. 33 is deployed in a manner similar to that illustrated in FIGS. 17-20 when a plate is not needed or used, and FIGS. 22-29 when a plate is used as detailed above. In the construct embodiment of FIG. 34, a 4-hole button 120 is used and the suture, after passing from eyesplices 44a and 44b is threaded through the holes in button 20 and though the 3rd and 4th holes in button 120.


While the present invention is described herein with reference to illustrative embodiments for particular applications, it should be understood that the invention is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments and substitution of equivalents all fall within the scope of the invention. Accordingly, the invention is not to be considered as limited by the foregoing description.

Claims
  • 1. A bone repair system, comprising: a first fixation device adapted for insertion through a bone hole in a first configuration and for fixation relative to a first bone in a second configuration;a second fixation device adapted for fixation relative to a second bone; anda flexible suture construct connected to the first fixation device and the second fixation device,wherein the flexible suture construct includes at least one spliced section having a strand of the flexible suture construct threaded through itself,wherein a free end of the strand is tensionable to shorten a length of the flexible suture construct between the first fixation device and the second fixation device,wherein the free end of the flexible suture construct is received through an aperture of the second fixation device,wherein the flexible suture construct includes a first loop portion that interlinks with a second loop portion at a location between the first fixation device and the second fixation device,wherein the location is closer to the first fixation device than to the second fixation device.
  • 2. The system as recited in claim 1, wherein the second fixation device is shaped differently from the first fixation device.
  • 3. The system as recited in claim 1, comprising a bone plate that includes a first opening and a second opening.
  • 4. The system as recited in claim 3, wherein the second fixation device is configured to be positioned within the first opening, and further comprising a bone screw configured to be positioned within the second opening.
  • 5. The system as recited in claim 1, wherein the flexible suture construct is arranged to include at least three suture strands positioned between the first fixation device and the second fixation device.
  • 6. The system as recited in claim 1, wherein one of the first loop portion and the second loop portion is smaller than the other of the first loop portion and the second loop portion.
  • 7. The system as recited in claim 1, wherein the free end of the strand of the flexible suture construct is received through the aperture of a round portion of the second fixation device.
  • 8. The system as recited in claim 1, wherein the flexible suture construct is the sole structure extending between the first fixation device and the second fixation device.
  • 9. A bone repair system, comprising: a first fixation device adapted for insertion through a bone hole in a first configuration and for positioning relative to a first bone in a second configuration;a second fixation device adapted for positioning relative to a second bone; anda flexible suture construct connected to the first fixation device and the second fixation device,wherein the flexible suture construct includes at least one spliced section having a strand of the flexible suture construct threaded through itself,wherein a free end of the strand is tensionable to shorten a length of the flexible suture construct between the first fixation device and the second fixation device,wherein the free end of the flexible suture construct is received through an aperture of the second fixation device,wherein the flexible suture construct includes a first loop portion that interlinks with a second loop portion at a location between the first fixation device and the second fixation device,wherein the location is closer to the first fixation device than to the second fixation device,wherein one of the first loop portion or the second loop portion is a non-adjustable portion and the other of the first loop portion or the second loop portion is an adjustable portion.
  • 10. The system as recited in claim 9, wherein the first fixation device is an elongated device and the second fixation device includes a round portion, and further wherein the first fixation device is attached to the non-adjustable portion and the second fixation device is attached to the adjustable portion.
  • 11. A bone repair system, comprising: a first fixation device adapted for insertion through a bone hole in a first configuration and for positioning relative to a first bone in a second configuration;a second fixation device adapted for positioning relative to a second bone; anda flexible suture construct connected to the first fixation device and the second fixation device,wherein the flexible suture construct includes at least one spliced section having a strand of the flexible suture construct threaded through itself,wherein a free end of the strand is tensionable to shorten a length of the flexible suture construct between the first fixation device and the second fixation device,wherein the free end of the flexible suture construct is received through an aperture of the second fixation device,wherein the flexible suture construct includes a first loop portion that interlinks with a second loop portion at a location between the first fixation device and the second fixation device,wherein the location is closer to the first fixation device than to the second fixation device,a passing instrument; anda suture connecting the passing instrument to the first fixation device.
  • 12. The system as recited in claim 11, wherein the passing instrument is an elongated device that includes an eyelet.
  • 13. The system as recited in claim 12, wherein the suture is received through the eyelet.
CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional of U.S. patent application Ser. No. 16/794,542, filed Feb. 19, 2020, which is a continuation of U.S. patent application Ser. No. 15/483,279, filed Apr. 10, 2017, which is a continuation of U.S. patent application Ser. No. 14/883,890, filed Oct. 15, 2015, now U.S. Pat. No. 10,251,686, which is a continuation of U.S. patent application Ser. No. 13/298,863, filed Nov. 17, 2011, now U.S. Pat. No. 9,179,950, which claims the benefit of U.S. Provisional Application No. 61/414,706, filed Nov. 17, 2010. The entire disclosures of all of the above priority applications are incorporated herein by reference.

US Referenced Citations (216)
Number Name Date Kind
2765787 Pellet Oct 1956 A
3176316 Bodell Apr 1965 A
3762418 Wasson Oct 1973 A
4187558 Dahlen et al. Feb 1980 A
4301551 Dore et al. Nov 1981 A
4400833 Kurland Aug 1983 A
4776851 Bruchman et al. Oct 1988 A
4790850 Dunn et al. Dec 1988 A
4792336 Hlavacek et al. Dec 1988 A
4851005 Hunt et al. Jul 1989 A
4863471 Mansat Sep 1989 A
4917700 Aikins Apr 1990 A
4932972 Dunn et al. Jun 1990 A
4988351 Paulos et al. Jan 1991 A
5024669 Peterson et al. Jun 1991 A
5026398 May et al. Jun 1991 A
5129902 Goble et al. Jul 1992 A
5171274 Fluckiger et al. Dec 1992 A
5211647 Schmieding May 1993 A
5217495 Kaplan et al. Jun 1993 A
5219359 McQuilkin et al. Jun 1993 A
5263984 Li et al. Nov 1993 A
5266075 Clark et al. Nov 1993 A
5306290 Martins et al. Apr 1994 A
5306301 Graf et al. Apr 1994 A
5320626 Schmieding Jun 1994 A
5397357 Schmieding et al. Mar 1995 A
5409490 Ethridge et al. Apr 1995 A
5562669 McGuire Oct 1996 A
5575819 Amis et al. Nov 1996 A
5628756 Barker et al. May 1997 A
5643266 Li et al. Jul 1997 A
5645588 Graf et al. Jul 1997 A
5830234 Wojciechowicz et al. Nov 1998 A
5921986 Bonutti et al. Jul 1999 A
5931869 Boucher et al. Aug 1999 A
5961520 Beck, Jr. et al. Oct 1999 A
5964764 West et al. Oct 1999 A
6056752 Roger May 2000 A
6099530 Simonian et al. Aug 2000 A
6099568 Simonian et al. Aug 2000 A
6110207 Eichhorn et al. Aug 2000 A
6117160 Bonutti Sep 2000 A
6159234 Bonutti et al. Dec 2000 A
6193754 Seedhom Feb 2001 B1
6203572 Johnson et al. Mar 2001 B1
6238395 Bonutti May 2001 B1
6283996 Chervitz et al. Sep 2001 B1
6296659 Foerster Oct 2001 B1
6325804 Wenstrom, Jr. et al. Dec 2001 B1
6517578 Hein Feb 2003 B2
6533802 Bojarski et al. Mar 2003 B2
6635073 Bonutti Oct 2003 B2
6641596 Lizardi et al. Nov 2003 B1
6716234 Grafton et al. Apr 2004 B2
7097654 Freedland Aug 2006 B1
7235091 Thornes Jun 2007 B2
7494506 Brulez et al. Feb 2009 B2
7686838 Wolf et al. Mar 2010 B2
7749250 Stone et al. Jul 2010 B2
7776039 Bernstein et al. Aug 2010 B2
7819898 Stone et al. Oct 2010 B2
7828855 Ellis et al. Nov 2010 B2
7875057 Cook et al. Jan 2011 B2
7875058 Holmes, Jr. Jan 2011 B2
7905903 Stone et al. Mar 2011 B2
7914539 Stone et al. Mar 2011 B2
8109965 Stone et al. Feb 2012 B2
8118836 Denham et al. Feb 2012 B2
8162997 Struhl Apr 2012 B2
8206446 Montgomery Jun 2012 B1
8231654 Kaiser et al. Jul 2012 B2
8388655 Fallin et al. Mar 2013 B2
8439918 Gelfand May 2013 B2
8512376 Thornes Aug 2013 B2
8821551 Zeetser et al. Sep 2014 B2
9179950 Zajac et al. Nov 2015 B2
9259217 Fritzinger et al. Feb 2016 B2
9498204 Denham et al. Nov 2016 B2
9833230 Stone Dec 2017 B2
11129654 Zajac et al. Sep 2021 B2
20010041938 Hein Nov 2001 A1
20020019634 Bonutti Feb 2002 A1
20020161439 Strobel et al. Oct 2002 A1
20020198527 Muckter Dec 2002 A1
20030114929 Knudsen et al. Jun 2003 A1
20030130694 Bojarski et al. Jul 2003 A1
20030236555 Thornes Dec 2003 A1
20040015171 Bojarski et al. Jan 2004 A1
20040059415 Schmieding Mar 2004 A1
20040073306 Eichhorn et al. Apr 2004 A1
20040116963 Lattouf Jun 2004 A1
20040236373 Anspach, III Nov 2004 A1
20040243235 Goh et al. Dec 2004 A1
20040267360 Huber Dec 2004 A1
20050004670 Gebhardt et al. Jan 2005 A1
20050033363 Bojarski et al. Feb 2005 A1
20050065533 Magen et al. Mar 2005 A1
20050070906 Clark et al. Mar 2005 A1
20050137704 Steenlage Jun 2005 A1
20050149187 Clark et al. Jul 2005 A1
20050171603 Justin et al. Aug 2005 A1
20050203623 Steiner et al. Sep 2005 A1
20050261766 Chervitz et al. Nov 2005 A1
20060067971 Story et al. Mar 2006 A1
20060095130 Caborn et al. May 2006 A1
20060142769 Collette Jun 2006 A1
20060190041 Fallin et al. Aug 2006 A1
20060264944 Cole Nov 2006 A1
20060265064 Re et al. Nov 2006 A1
20060276896 Fallin et al. Dec 2006 A1
20060293709 Bojarski et al. Dec 2006 A1
20070021839 Lowe Jan 2007 A1
20070083236 Sikora et al. Apr 2007 A1
20070118217 Brulez May 2007 A1
20070162123 Whittaker et al. Jul 2007 A1
20070162125 LeBeau et al. Jul 2007 A1
20070179531 Thornes Aug 2007 A1
20070225805 Schmieding Sep 2007 A1
20070239209 Fallman Oct 2007 A1
20070239275 Willobee Oct 2007 A1
20070250163 Cassani Oct 2007 A1
20070270857 Lombardo et al. Nov 2007 A1
20080046009 Albertorio et al. Feb 2008 A1
20080082128 Stone Apr 2008 A1
20080177302 Shumas Jul 2008 A1
20080188935 Saylor et al. Aug 2008 A1
20080188936 Ball et al. Aug 2008 A1
20080195148 Cook et al. Aug 2008 A1
20080208252 Holmes Aug 2008 A1
20080215150 Koob et al. Sep 2008 A1
20080228271 Stone et al. Sep 2008 A1
20080234819 Schmieding et al. Sep 2008 A1
20080243248 Stone et al. Oct 2008 A1
20080275553 Wolf et al. Nov 2008 A1
20080275554 Iannarone et al. Nov 2008 A1
20080300683 Altman et al. Dec 2008 A1
20080312689 Denham et al. Dec 2008 A1
20090018654 Schmieding et al. Jan 2009 A1
20090030516 Imbert Jan 2009 A1
20090036893 Kartalian et al. Feb 2009 A1
20090054928 Denham et al. Feb 2009 A1
20090054982 Cimino Feb 2009 A1
20090062854 Kaiser et al. Mar 2009 A1
20090082805 Kaiser et al. Mar 2009 A1
20090187244 Dross Jul 2009 A1
20090216326 Hirpara et al. Aug 2009 A1
20090228017 Collins Sep 2009 A1
20090234451 Manderson Sep 2009 A1
20090265003 Re et al. Oct 2009 A1
20090275950 Sterrett et al. Nov 2009 A1
20090287215 Fisher et al. Nov 2009 A1
20090306776 Murray Dec 2009 A1
20090306784 Blum Dec 2009 A1
20090312776 Kaiser et al. Dec 2009 A1
20100049258 Dougherty Feb 2010 A1
20100049319 Dougherty Feb 2010 A1
20100100182 Barnes et al. Apr 2010 A1
20100145384 Stone et al. Jun 2010 A1
20100145448 Montes De Oca Balderas et al. Jun 2010 A1
20100211075 Stone Aug 2010 A1
20100211173 Bardos et al. Aug 2010 A1
20100249930 Myers Sep 2010 A1
20100256677 Albertorio et al. Oct 2010 A1
20100268273 Albertorio et al. Oct 2010 A1
20100268275 Stone et al. Oct 2010 A1
20100274355 McGuire et al. Oct 2010 A1
20100274356 Fening et al. Oct 2010 A1
20100292792 Stone et al. Nov 2010 A1
20100305709 Metzger et al. Dec 2010 A1
20100312341 Kaiser et al. Dec 2010 A1
20100318188 Linares Dec 2010 A1
20100324676 Albertorio et al. Dec 2010 A1
20100331975 Nissan et al. Dec 2010 A1
20110040380 Schmieding et al. Feb 2011 A1
20110046734 Tobis et al. Feb 2011 A1
20110054609 Cook et al. Mar 2011 A1
20110071573 Sixto et al. Mar 2011 A1
20110087284 Stone et al. Apr 2011 A1
20110098727 Kaiser et al. Apr 2011 A1
20110106153 Stone May 2011 A1
20110112640 Amis et al. May 2011 A1
20110112641 Justin et al. May 2011 A1
20110118838 Delli-Santi et al. May 2011 A1
20110137416 Myers Jun 2011 A1
20110184227 Altman et al. Jul 2011 A1
20110196432 Griffis, III Aug 2011 A1
20110196490 Gadikota et al. Aug 2011 A1
20110218625 Berelsman et al. Sep 2011 A1
20110224729 Baker et al. Sep 2011 A1
20110238179 Laurencin et al. Sep 2011 A1
20110270278 Overes et al. Nov 2011 A1
20110276137 Seedhom et al. Nov 2011 A1
20110282350 Kowarsch et al. Nov 2011 A1
20110288635 Miller et al. Nov 2011 A1
20110301707 Buskirk et al. Dec 2011 A1
20110301708 Stone et al. Dec 2011 A1
20120046746 Konicek Feb 2012 A1
20120046747 Justin et al. Feb 2012 A1
20120053630 Denham et al. Mar 2012 A1
20120065731 Justin et al. Mar 2012 A1
20120065732 Roller et al. Mar 2012 A1
20120089143 Martin et al. Apr 2012 A1
20120109194 Miller et al. May 2012 A1
20120109299 Li et al. May 2012 A1
20120123474 Zajac et al. May 2012 A1
20120123541 Albertorio et al. May 2012 A1
20120150297 Denham et al. Jun 2012 A1
20120165938 Denham et al. Jun 2012 A1
20120197271 Astorino et al. Aug 2012 A1
20120296345 Wack et al. Nov 2012 A1
20130023928 Dreyfuss Jan 2013 A1
20130023929 Sullivan et al. Jan 2013 A1
20130123841 Lyon May 2013 A1
20130331886 Thornes Dec 2013 A1
20170209140 Thornes Jul 2017 A1
Foreign Referenced Citations (8)
Number Date Country
29910202 Sep 1999 DE
20101791 Jun 2001 DE
0440991 Aug 1991 EP
1108401 Jun 2001 EP
1707127 Oct 2006 EP
2238944 Oct 2010 EP
2007002561 Jan 2007 WO
2008091690 Jul 2008 WO
Non-Patent Literature Citations (29)
Entry
E.P. Su, et al., “Using Suture Anchors for Coracoclavicular Fixation in Treatment of Complete Acromioclavicular Separation,” The American Journal of Orthopedics, May 2004, pp. 256-257.
US District Court, Middle District of Florida, Fort Myers Division, Case No. 2:22-CV-0019-JLB-NPM Arthrex, Inc. v. Parcus Medical LLC and Anika Therapeutics, Inc. Defendants Parcus Medical, LLC's and Anika Therapeutics, Inc.'s Disclosure of Non-Infringement and Invalidity Contentions Dated May 6, 2022, 58 pages.
Exhibit A-1—Non-Infringement Contentions for Alleged Infringement of U.S. Pat. No. 10,251,686 by Anika and Parcus Synd-EZ Titanium Kit and Synd-EZ SS Kit, Including at least part Nos. 11223 (Synd-EZ Titanium Kit); 11224 (Synd-EZ SS Kit), nine pages.
Exhibit A-2—Non-Infringement Contentions for Alleged Infringement of U.S. Pat. No. 10,864,028 by Anika and Parcus Synd-EZ Titanium Kit and Synd-EZ SS Kit, Including at least part Nos. 11223 (Synd-EZ Titanium Kit); 11224 (Synd-EZ SS Kit), eight pages.
Exhibit B-1—Invalidity Contentions for U.S. Pat. No. 10,251,686, 31 pages.
Exhibit B-2—Invalidity Contentions for U.S. Pat. No. 10,864,028, 30 pages.
ToggleLoc Femoral Fixation Device, Femoral Fixation for ACL Reconstruction, Surgical Protocol by Mark Gittins, D.O. Biomet Sports Medicine, 12 pages (NPL-1).
J Chris Coetzee, et al, Treatment of syndesmoses disruptions, SA Orthopaedic Journal, Autumn 2009, Clinical Article, six pages (NPL-2).
Hugh J.S. Pel, et al, Tightrope stabilisation of proximal and distal tibiofibular syndesmosis rupture: The floating fibula—A case report, Elsevier, Injury Extra 40 (2009) 16-18 (NPL-3).
Lyndon W. Mason, et al, Tibiofibular Synostosis following Syndesmosis Fixation: A case report, Open Access Publication, The Foot and Ankle Online Journal 3 (3): 3 (NPL-4).
Brian Thomes, et al; Suture-Button Syndesmosis Fixation, Accelerated Rehabilitation and Improved Outcomes, Clinical Orthopaedics and Related Research, No. 431, pp. 207-212 (NPL-5).
Brian Thomes, et al, Suture-Endobutton Fixation of Ankle Tibio-Fibular Diastasis: A Cadaver Study, Article in Foot & Ankle International, Feb. 2003, 147 pages (NPL-6).
Brian Thomes, et al, Ankle Syndesmosis Injuries Treated with the TightRope™ Suture-Button Kit, Techniques in Foot and Ankle Surgery 5(1):45-53, 2006, 9 pages (NPL-7).
Michael J. DiRaimo Jr., et al, Distal Biceps Tendon Repair Using the Toggle Loc With Zip Loop, tips & techniques, Spotlight on upper extremity, Dec. 2008, vol. 31, No. 12, pp. 1201-1204 (NPL-8).
James Fleischli, et al, Ulnar Collateral Ligament Reconstruction Using theToggleLoc With ZipLoop for Ulnar Side Fixation, Orthopedics, May 2010, six pages (NPL-9).
Chad S. Conner, et al, Three Femoral Fixation Devices for Anterior Cruciate Ligament Reconstruction: Comparison of Fixation on the Lateral Cortex Versus the Anterior Cortex, Arthroscopy: The Journal of Arthroscopic and Related Surgery, vol. 26, No. 6 (June), 2010: pp. 796-807 (NPL-10).
Vivek Agrawal, Arthroscopic Coracoclavicular Ligament Reconstruction Utilizing a Semitendinosis Graft and Titanium Flip Button Tension Band Construct, Indiana Orthopaedic Journal, vol. 4—2010, six pages (NPL-11).
Biomet 501(k) Summary, ToggleLoc™ System, Dec. 16, 2008, five pages (NPL-12).
Biomet Sports Medicine 501 (k) Summary, Sleeve with ZipLoop™ Fixation Devices, Jun. 23, 2010, five pages (NPL-13).
Kevin Forsythe, et al, Comparison of a Novel FiberWire-Button Construct versus Metallic Screw Fixation in a Syndesmotic Injury Model, Foot & Ankle International, Copyright 2008 by the American Orthopaedic Foot & Ankile Society, 49 pages (NPL-14).
Wes Jackson, et al, Update on the treatment of chronic ankle instability and syndesmotic injuries, 2006 Lippincott Williams & Wilkins, six pages (NPL-15).
Jatros, Unfallchirurgie & Sporttraumatologie, Universimed Publishing GmbH, ISSN 1991-8399, Jahrgang 5, Mar. 2010, 56 pages (NPL-16).
ZipTight TM Ankle Syndesmosis, Surgical Technique, Zimmer Biomet, 12 pages (NPL-17).
Cyclic Displacement of the RetroButton and ToggleLoc with ZipLoop, Arthrex Research and Development, 2009, Arthrex Inc., one page (NPL-18).
Nam Su Cho, et al, Clinical Results of Arthroscopic Bankart Repiar With Knot-Typing and Knotless Suture Anchors, Arthroscope:The Journal of Arthroscopic and Related Surgery, vol. 22, No. 12 (December), 2006; pp. 1276-1282 (NPL-19).
ZipLoop™ Technology, A smart option for every body. Zimmer Biomet, two pages (NPL-20).
ZipTight™ Fixation Device with ZipLoop™ Technology for Chronic Anatomic AC Joint Reconstruction, Surgical Technique, Surgical Protocols by Eric McCarty, M.D., 2013 Biomet Sports Medicine, 20 pages (NPL-21).
ZipTight™Fixation System featuring ZipLoop™ Technology, Ankle Syndesmosis, Surgical Protocal by Timothy Charlton, M.D., Biomet Sports Medicine, eight pages (NPL-22).
ZipTight™ Ankle Syndesmosis, Surgical Technique, Zimmer Biomet, 12 pages (NPL-23).
Related Publications (1)
Number Date Country
20210059729 A1 Mar 2021 US
Provisional Applications (1)
Number Date Country
61414706 Nov 2010 US
Divisions (1)
Number Date Country
Parent 16794542 Feb 2020 US
Child 17095975 US
Continuations (3)
Number Date Country
Parent 15483279 Apr 2017 US
Child 16794542 US
Parent 14883890 Oct 2015 US
Child 15483279 US
Parent 13298863 Nov 2011 US
Child 14883890 US