Patent Description:
Bone fractures may be reduced and repaired with many different types of orthopedic internal fixation devices, systems, and methods. Two common types of orthopedic internal fixation devices include intramedullary rods and bone plates.

Intramedullary rods and bone plates each have their own particular advantages and disadvantages. For example, intramedullary rods typically require smaller incision sites and have less or no prominence in comparison to bone plates. Both of these characteristics may be desirable from a cosmetic perspective. Intramedullary rods usually cause fewer disturbances to surrounding soft tissues (e.g., less/no soft tissue stripping/irritation) in comparison to bone plates, reducing the risk of complications that may develop after surgery.

On the other hand, a bone plate may provide better structural integrity for certain types of bone fractures. In some instances, a bone plate surgical procedure may also be less difficult to perform in comparison to an intramedullary rod surgical procedure.

In any event, both intramedullary rods and bone plates can be associated with many risks, including, but not limited to breaking, bone screws that may loosen/pull-out over time, delayed healing/non-unions, infections, subsequent hardware removal issues (e.g., revision surgery) resulting in bone voids that can weaken the bone, etc..

Moreover, certain types of bone fractures may be subject to large tensile or traction forces that tend to "pull apart" a fractured bone, further complicating the bone healing process. Example bone fractures that can experience large tensile forces include, but are not limited to clavicle fractures, olecranon fractures, fibula fractures, patellar fractures, malleolar fractures, etc. In such cases, an intramedullary rod or bone plate alone may not provide an optimal solution for fixation strength and sustained fracture reduction during the bone healing process.

A tension band is another form of orthopedic internal fixation device that may be utilized to help resist tensile forces to increase fixation, reduce bone fractures, and help promote the bone healing process. However, a tension band alone may not provide optimal fixation strength, reduction characteristics, and/or bone healing in every scenario.

Accordingly, orthopedic fixation devices, systems, and methods that can provide improved fixation, reduction, and bone healing would be desirable. <CIT> discloses bone fixation device with an elongate body having a longitudinal axis and having a first state in which at least a portion of the body is flexible and a second state in which the body is generally rigid, an actuateable gripper disposed at a distal location on the elongated body, a hub located on a proximal end of the elongated body, and an actuator operably connected to the gripper to deploy the gripper from a retracted configuration to an expanded configuration. <CIT> discloses an implant for tubular bones. The implant is used to connect two parts of a tubular bine that has broken with a substantially smooth break. The implant is formed by a shaped piece that is intended to be inserted into the medullary cavity of a broken tubular bone. The shaped piece has at least one through-opening, which has a substantially constant internal diameter and extends substantially through the whole of the shaped piece and through which a cord can be pulled in order to stabilize the fracture. The shaped piece is made of resorbable material, and two anchor parts can be secured on the cord.

The various bone fixation devices and systems of the present disclosure have been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available bone fixation devices, systems, and methods. In some embodiments, the bone fixation devices and systems of the present disclosure may provide improved fixation, reduction, and healing between bone fragments.

The present invention relates to a bone fixation assembly as claimed hereafter. Preferred embodiments of the invention are set forth in the dependent claims. Associated methods are also described herein to aid understanding of the invention, but these do not form part of the claimed invention. References to "embodiments" throughout the description which are not under the scope of the appended claims merely represent possible exemplary executions and are therefore not part of the present invention.

The bone fixation assembly includes an elongate fixation member and a flexible tensioning element. The elongate fixation member may include a central longitudinal axis, a first portion couplable within a first intramedullary canal of a first bone fragment of a bone, a second portion couplable within a second intramedullary canal of a second bone fragment of the bone to provide fixation of the second bone fragment relative to the first bone fragment, a first transverse passageway formed through the first portion of the elongate fixation member, and a second transverse passageway formed through the second portion of the elongate fixation member. The flexible tensioning element is couplable to the first and second portions of the elongate fixation member to secure the elongate fixation member to the bone. The first transverse passageway may be configured to receive the flexible tensioning element therethrough from a first direction transverse to the central longitudinal axis of the elongate fixation member, and the second transverse passageway may be configured to receive the flexible tensioning element therethrough from a second direction transverse to the central longitudinal axis of the elongate fixation member. The flexible tensioning element is configured to span a bone fracture intermediate the first bone fragment and the second bone fragment to preload the bone fracture in compression to resist tensile force imparted across the bone fracture, thereby maintaining fixation of the first bone fragment relative to the second bone fragment.

In the bone fixation assembly, a first end of the flexible tensioning element is couplable with a second end of the flexible tensioning element to secure the elongate fixation member to the bone.

In some embodiments of the bone fixation assembly, the flexible tensioning element may include a first tension band couplable to the first portion of the elongate fixation member through the first transverse passageway, and a second tension band couplable to the second portion of the elongate fixation member through the second transverse passageway.

In the bone fixation assembly, the first and second tension bands are couplable to each other to secure the elongate fixation member to the bone.

In some embodiments of the bone fixation assembly, a first end of the first tension band may be couplable with a second end of the second tension band, and a second end of the first tension band may be couplable with a first end of the second tension band to form a crisscross pattern that spans the bone fracture and secures the elongate fixation member to the bone.

In some embodiments of the bone fixation assembly, a securing element may be couplable to the flexible tensioning element and configured to prevent loosening of the flexible tensioning element.

In some embodiments of the bone fixation assembly, a tensioner element may be couplable to the flexible tensioning element and configured to impart a tension force to the flexible tensioning element.

The bone fixation assembly includes an elongate fixation member and a flexible tensioning element. The elongate fixation member includes a central longitudinal axis, a distal portion couplable to a first bone fragment of a bone, and a proximal portion couplable to a second bone fragment of the bone to provide fixation of the second bone fragment relative to the first bone fragment. The flexible tensioning element is couplable to the proximal portion and the distal portion of the elongate fixation member to secure the elongate fixation member to the bone. The flexible tensioning element is configured to span a bone fracture intermediate the first bone fragment and the second bone fragment to preload the bone fracture in compression to resist tensile force imparted across the bone fracture, thereby maintaining fixation of the first bone fragment relative to the second bone fragment.

In some embodiments of the bone fixation assembly, a surface of the elongate fixation member may include one or more channels configured to receive the flexible tensioning element therein to secure the elongate fixation member to the bone.

In some embodiments of the bone fixation assembly, the flexible tensioning element may include a first tension band couplable to the distal portion of the elongate fixation member, and a second tension band couplable to the proximal portion of the elongate fixation member and to the first tension band to secure the elongate fixation member to the bone.

In some embodiments of the bone fixation assembly, the elongate fixation member may include a first transverse passageway formed through the distal portion of the elongate fixation member. The first transverse passageway may be configured to receive the first tension band therethrough from a first direction transverse to the central longitudinal axis of the elongate fixation member. The elongate fixation member may also include a second transverse passageway formed through the proximal portion of the elongate fixation member. The second transverse passageway may be configured to receive the second tension band therethrough from a second direction transverse to the central longitudinal axis of the elongate fixation member.

In some embodiments of the bone fixation assembly, the elongate fixation member may include a longitudinal passageway configured to receive the flexible tensioning element therethrough.

A method not claimed method of fixing a first bone fragment of a bone relative to a second bone fragment of the bone may include forming one or more first bone tunnels in the first bone fragment and forming one or more second bone tunnels in the second bone fragment. The method may also include coupling a first portion of an elongate fixation member to the first bone fragment and coupling a second portion of the elongate fixation member to the second bone fragment to provide fixation of the second bone fragment relative to the first bone fragment. The method may additionally include passing a flexible tensioning element through the one or more first bone tunnels and the one or more second bone tunnels, coupling the flexible tensioning element to the first portion of the elongate fixation member and the second portion of the elongate fixation member to secure the elongate fixation member to the bone, and spanning a bone fracture intermediate the first bone fragment and the second bone fragment with the flexible tensioning element to preload the bone fracture in compression to resist tensile force imparted across the bone fracture, thereby maintaining fixation of the first bone fragment relative to the second bone fragment.

In some examples not claimed of the method, forming the one or more first bone tunnels in the first bone fragment may include at least one of: forming a first transverse bone tunnel in the first bone fragment, and forming a first longitudinal bone tunnel in a first intramedullary canal of the first bone fragment. Likewise, forming the one or more second bone tunnels in the second bone fragment comprises at least one of: forming a second transverse bone tunnel in the second bone fragment, and forming a second longitudinal bone tunnel in a second intramedullary canal of the second bone fragment.

In some examples not claimed of the method, coupling the first portion of the elongate fixation member to the first bone fragment may include coupling the first portion of the elongate fixation member within the first intramedullary canal of the first bone fragment. Likewise, coupling the second portion of the elongate fixation member to the second bone fragment may include coupling the second portion of the elongate fixation member within the second intramedullary canal of the second bone fragment.

In some examples not claimed of the method, coupling the first portion of the elongate fixation member to the first bone fragment may include coupling the first portion of the elongate fixation member to a first surface of the first bone fragment. Likewise, coupling the second portion of the elongate fixation member to the second bone fragment may include coupling the second portion of the elongate fixation member to a second surface of the second bone fragment.

The not claimed method may also include coupling a first end of the flexible tensioning element with a second end of the flexible tensioning element to secure the elongate fixation member to the bone.

These and other features and advantages of the present disclosure will become more fully apparent from the following description and appended claims.

Exemplary embodiments of the disclosure will become more fully apparent from the following description taken in conjunction with the accompanying drawings. Understanding that these drawings depict only exemplary embodiments and are, therefore, not to be considered limiting of the scope of the present disclosure, the exemplary embodiments of the present disclosure will be described with additional specificity and detail through use of the accompanying drawings in which:.

It is to be understood that the drawings are for purposes of illustrating the concepts of the disclosure and may not be drawn to scale. Furthermore, the drawings illustrate exemplary embodiments and do not represent limitations to the scope of the present disclosure.

Exemplary embodiments of the present disclosure will be best understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood that the components of the present disclosure, as generally described and illustrated in the drawings, could be arranged, and designed in a wide variety of different configurations. Thus, the following more detailed description of the embodiments of the devices and systems as represented in the drawings, is not intended to limit the scope of the present disclosure but is merely representative of exemplary embodiments of the present disclosure.

While the various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless specifically indicated.

The terms "coupled" and "couplable" can include components that are coupled to each other, or that are capable of being coupled to each other, via integral formation, as well as components that are removably and/or non-removably coupled/couplable with each other. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term "abutting" refers to components that may be in direct physical contact with each other, although the components may not necessarily be attached together.

As defined herein, the terms "flexible tensioning element" and "tension band" can comprise any tensioning element that may be utilized to preload a bone fracture in compression to resist tensile or distraction forces imparted across the bone fracture and maintain fixation/reduction of the bone fracture. Any flexible tensioning element or tension band described herein may include, but is not limited to a wire, a suture, a fabric, a strap, a strip, etc. Moreover, any flexible tensioning element or tension band described herein can comprise any flexible, semi-flexible, semi-rigid, or rigid material, or any combination thereof suitable for preloading a bone fracture in compression. Additionally, any flexible tensioning element or tension band described herein may include, but is not limited to a metal, an alloy, a plastic, a fiber (or group of fibers braided/woven together such as Dacron, etc.), a polymer, an elastomeric material, a flexible laminate, a resin, a film, an adhesive, etc..

Any of the devices, features, instruments, method steps, etc., that are described herein with respect to any particular bone fixation assembly or procedure may also be utilized in conjunction with (or omitted from) any other bone fixation assembly or that is described or contemplated herein in any combination.

<FIG> illustrate example devices, instruments, and not claimed method steps for a bone fixation assembly.

<FIG> illustrates a bone <NUM> comprising a first bone fragment <NUM> and a second bone fragment <NUM> separated by a bone fracture <NUM>. In some embodiments, the bone <NUM> may comprise a clavicle bone. However, it will be understood that the various devices, instruments, and method steps described herein can be utilized in any combination with each other and for any type of bone fracture including, but not limited to olecranon fractures, fibula fractures, patellar fractures, malleolar fractures, etc..

<FIG> illustrates a first step of the procedure, in which the intramedullary canals of the first and second bone fragments <NUM>, <NUM> may be prepared with a drill bit or reamer <NUM>. The intramedullary canals of the first and second bone fragments <NUM>, <NUM> may be drilled and/or reamed with any diameter drill bit or reamer to any desired depth within the intramedullary canal in order to form a prepared intramedullary canal. <FIG> illustrates the first and second bone fragments <NUM>, <NUM> with prepared intramedullary canals including a first longitudinal bone tunnel or first intramedullary canal <NUM>, and a second longitudinal bone tunnel or second intramedullary canal <NUM>.

In some non-limiting examples of the procedure, a <NUM> diameter drill bit may be utilized and each intramedullary canal of the first and second bone fragments <NUM>, <NUM> may be drilled and/or reamed to a depth of about <NUM>. However, it will be understood that in other examples any diameter size and/or any depth may be utilized, as desired.

Moreover, it will also be understood that in some examples of the procedure the intramedullary canals of the bone fragments may not require preparation, such as drilling, reaming, etc. For example, in some embodiments a suitable intramedullary rod may be press-fit and/or tamped into an unprepared intramedullary canal of a bone fragment.

<FIG> illustrates a second step of the procedure, in which a drill guide <NUM> may be utilized to place one or more transverse bone tunnels through a cortical surface <NUM> of the bone <NUM> and down into the prepared intramedullary canals of the bone fragments with a suitable drill bit (not shown).

In some examples; the drill guide <NUM> may be configured to utilize the reamer <NUM> as a reference to place a drill guide barrel <NUM> at a correct location along the cortical surface <NUM> of the bone <NUM>, as shown in <FIG>. In this manner, the drill guide <NUM> may utilize the morphology and/or depth of the prepared intramedullary canals to guide the placement of the one or more transverse bone tunnels via the drill guide barrel <NUM>. <FIG> illustrates the first and second bone fragments <NUM>, <NUM> with prepared transverse bone tunnels including one or more first transverse bone tunnels <NUM> and one or more second transverse bone tunnels <NUM>.

<FIG> illustrates a third step of the procedure, in which one or more retrieval wires <NUM> may be placed through the first and second transverse bone tunnels <NUM>, <NUM> and out the first and second intramedullary canals <NUM>, <NUM>. This step (and/or other similar steps described herein) may be facilitated with any suitable tool. In some examples, a magnetic wire retriever (not shown) with one or more magnets located on a tip of the magnetic wire retriever may be utilized. The magnetic wire retriever may be inserted into a bone tunnel to magnetically capture a wire and retrieve the wire from the bone tunnel. However, it will be understood that any other tool (or not tool at all) may be utilized to help facilitate the step of threading a flexible tensioning element through a bone tunnel.

<FIG> illustrates an elongate fixation member <NUM>, according to an embodiment of the present disclosure. The elongate fixation member <NUM> may generally include a distal portion or first portion <NUM>, a proximal portion or second portion <NUM>, and a central longitudinal axis <NUM>.

In some embodiments, the elongate fixation member <NUM> may be configured to couple with at least one flexible tensioning element to secure the elongate fixation member to the bone <NUM>.

In some embodiments, a first end of the flexible tensioning element may be couplable with a second end of the flexible tensioning element to secure the elongate fixation member <NUM> to the bone <NUM>.

In some embodiments, the flexible tensioning element may comprise a first tension band or a first flexible tensioning element <NUM>, as well as a second tension band or a second flexible tensioning element <NUM> in order to secure the elongate fixation member <NUM> to the bone <NUM>.

In some embodiments, the elongate fixation member <NUM> may include a first transverse passageway <NUM> configured to receive the first flexible tensioning element <NUM> therethrough from a first direction transverse to the central longitudinal axis <NUM> of the elongate fixation member <NUM>. The elongate fixation member <NUM> may also include a second transverse passageway <NUM> configured to receive the second flexible tensioning element <NUM> therethrough from a second direction transverse to the central longitudinal axis <NUM> of the elongate fixation member <NUM>.

In some embodiments, the first direction and the second direction may be similar to each other.

In some embodiments, the first direction and the second direction may be opposite from each other.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may be couplable to each other in order to secure the elongate fixation member <NUM> to the bone <NUM>.

With reference to <FIG>, in some embodiments a first end <NUM> of the first flexible tensioning element <NUM> may be couplable with a second end <NUM> of the second flexible tensioning element <NUM>, and a second end <NUM> of the first flexible tensioning element <NUM> may be couplable with a first end <NUM> of the second flexible tensioning element <NUM> to form a crisscross pattern that spans the bone fracture <NUM> and secures the elongate fixation member <NUM> to the bone <NUM>.

In some embodiments, the flexible tensioning elements may be configured to span the bone fracture <NUM> intermediate the first bone fragment <NUM> and the second bone fragment <NUM> to preload the bone fracture <NUM> in compression to resist tensile force imparted across the bone fracture <NUM>, thereby maintaining fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>.

In some embodiments, the elongate fixation member <NUM> may comprise an intramedullary rod.

In some embodiments, the elongate fixation member <NUM> may include a generally cylindrical shape.

In some embodiments, the elongate fixation member <NUM> may be solid or substantially solid. However, it will also be understood that in some embodiments the elongate fixation member <NUM> may comprise an at least partially hollow interior.

In some embodiments, the elongate fixation member <NUM> may comprise a rigid material to provide rigid fixation of the first and second bone fragments <NUM>, <NUM> relative to each other.

<FIG> illustrates a fourth step of the procedure, in which the one or more retrieval wires <NUM> shown in <FIG> may be utilized to couple with and retrieve the first and second flexible tensioning elements <NUM>, <NUM> in order to pull the first and second flexible tensioning elements <NUM>, <NUM> through the intramedullary canals and back through the transverse bone tunnels formed in the bone fragments.

<FIG> illustrate a fifth and sixth step of the procedure, in which the elongate fixation member <NUM> may be inserted into the prepared intramedullary canals of the first and second bone fragments <NUM>, <NUM>. Specifically, <FIG> illustrates the elongate fixation member <NUM> inserted into the second bone fragment <NUM> in a fifth step, and <FIG> illustrates the elongate fixation member <NUM> inserted into both the first and second bone fragments <NUM>, <NUM> in a sixth step with the bone fracture <NUM> reduced.

Thus, in some embodiments the first portion <NUM> of the elongate fixation member <NUM> may be couplable within the first intramedullary canal <NUM> of the first bone fragment <NUM> of the bone <NUM>, and the second portion <NUM> of the elongate fixation member <NUM> may be couplable within the second intramedullary canal <NUM> of the second bone fragment <NUM> of the bone <NUM> to provide fixation of the second bone fragment <NUM> relative to the first bone fragment <NUM>.

In some examples, steps four through six discussed above can be performed together in a partial stepwise manner in order to ensure the flexible tensioning elements remain threaded through the transverse bone tunnels during the procedure. In this manner, initial reduction and/or initial fixation of the bone fracture <NUM> may be achieved through either or both of: (<NUM>) inserting the elongate fixation member <NUM> into the intramedullary canals of the bone fragments via a press fit; and/or (<NUM>) tensioning the flexible tensioning elements in order to draw the bone fragments together to achieve initial reduction and/or initial fixation of the bone fracture <NUM>.

<FIG> illustrates a seventh step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be woven around the bone fracture <NUM> and secured together. The first and second flexible tensioning elements <NUM>, <NUM> may be configured to span the bone fracture <NUM> and preload the bone fracture <NUM> in compression to resist tensile and/or distraction forces imparted across the bone fracture <NUM>, thereby maintaining fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>. In this manner, the bone fracture <NUM> may receive improved fixation and reduction strength by combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM>.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may be woven around the bone fracture <NUM> such that they form a crisscross pattern that spans the bone fracture <NUM> on a side of the bone <NUM>.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may be woven around the bone fracture <NUM> such that they form a crisscross pattern that spans the bone fracture <NUM> on a superior side of the bone <NUM>. However, it will also be understood that in other embodiments the flexible tensioning elements may be woven around the bone fracture <NUM> to form any suitable pattern and on any side of the bone <NUM> to achieve a desired resistance to tensile and/or distraction force that may be imparted across the bone fracture <NUM>.

<FIG> illustrate an eighth step of the procedure, in which a clamp or securing element may be applied to the flexible tensioning elements to secure flexible tensioning elements in place and prevent the flexible tensioning elements from loosening over time.

<FIG> illustrates a top view of a first securing element <NUM>, as one non-limiting example of the present disclosure, that may be utilized to secure the first and second flexible tensioning elements <NUM>, <NUM> in place and prevent the first and second flexible tensioning elements <NUM>, <NUM> from loosening over time. The first securing element <NUM> may include one or more attachment features <NUM> that may be configured to couple with the bone <NUM> and/or the first and second flexible tensioning elements <NUM>, <NUM> to prevent loosening of the first and second flexible tensioning elements <NUM>, <NUM> over time.

<FIG> illustrates a top view of a second securing element <NUM>, as another non-limiting example of the present disclosure, that may be utilized to secure the first and second flexible tensioning elements <NUM>, <NUM> in place and prevent the first and second flexible tensioning elements <NUM>, <NUM> from loosening over time. IL illustrates the second securing element <NUM> of <FIG> coupled to the first and second flexible tensioning elements <NUM>, <NUM> of the bone fixation assembly from <FIG>.

In some embodiments, the second securing element <NUM> may be configured to receive and/or couple with the crisscross pattern formed by the first and second flexible tensioning elements <NUM>, <NUM> to prevent the first and second flexible tensioning elements <NUM>, <NUM> from loosening over time.

In some embodiments, the second securing element <NUM> may include one or more holes or channels (not shown) configured to receive the first and second flexible tensioning elements <NUM>, <NUM> therein.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may be threaded into/through the second securing element <NUM> via the holes/channels in order to secure the flexible tensioning elements in place and prevent the flexible tensioning elements from loosening over time.

In some embodiments, the second securing element <NUM> may include a fastener <NUM> (e.g., such as a set screw, a screw cap, etc.) and a fastener aperture <NUM> configured to receive the fastener <NUM> therein. In these embodiments, the fastener <NUM> may removably couple with the second securing element <NUM> (e.g., via threading or by some other means) and may be configured to apply a compression force to the first and second flexible tensioning elements <NUM>, <NUM> to prevent the first and second flexible tensioning elements <NUM>, <NUM> from loosening over time.

In some embodiments, the fastener <NUM> may also be configured to apply a tension force to the first and second flexible tensioning elements <NUM>, <NUM> in order to preload the bone fracture in compression to further resist tensile/distraction forces that may be imparted across the bone fracture <NUM> and provide additional fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>. For example, the fastener <NUM> may include one or more prongs (not shown) that may engage with the first and second flexible tensioning elements <NUM>, <NUM> as the fastener <NUM> rotates into the fastener aperture <NUM> via threading or by some other means. In this manner, the one or more prongs may also engage with and rotate the first and second flexible tensioning elements <NUM>, <NUM> to tighten them up and impart a tension force to the first and second flexible tensioning elements <NUM>, <NUM> to preload the bone fracture <NUM> in compression.

In some embodiments, the flexible tensioning elements may cross each other on top of the second securing element <NUM>. However, it will also be understood that in other embodiments the flexible tensioning elements may cross each other within the second securing element <NUM> and/or under the second securing element <NUM>.

In some embodiments, one or more bone fasteners <NUM> may also be utilized to provide additional tension and/or fixation to the first and second flexible tensioning elements <NUM>, <NUM> in order to preload the bone fracture <NUM> in compression and/or to prevent the first and second flexible tensioning elements <NUM>, <NUM> from loosening over time, as shown in <FIG>. In these embodiments, the one or more bone fasteners <NUM> may be configured to hold the ends of the first and second flexible tensioning elements <NUM>, <NUM> in place with respect to the first and second bone fragments <NUM>, <NUM>.

In some embodiments, the one or more bone fasteners <NUM> may comprise bone screws configured to couple with the bone <NUM>. The bone screws may include bone screw heads configured to capture and/or hold the first and second flexible tensioning elements <NUM>, <NUM> in order to preload the bone fracture <NUM> in compression and/or to prevent the first and second flexible tensioning elements <NUM>, <NUM> from loosening over time.

<FIG> illustrate example devices, instruments, and not claimed method steps for a bone fixation assembly , according to another embodiment of the present disclosure.

In some examples the bone <NUM> may comprise a distal or proximal end of a bone, such as a fractured olecranon process of the ulna, as one non-limiting example. However, it will be understood that the various devices, instruments, and method steps described herein can be utilized in any combination with each other and for any type of bone fracture including, but not limited to clavicle fractures, fibula fractures, patellar fractures, malleolar fractures, olecranon process fractures, etc..

<FIG> illustrates a first step of the procedure, in which the intramedullary canals of the first and second bone fragments <NUM>, <NUM> may be prepared with the reamer <NUM>. The intramedullary canals of the first and second bone fragments <NUM>, <NUM> may be drilled and/or reamed with any diameter drill bit or reamer to any desired depth within the intramedullary canals. <FIG> illustrates the first and second bone fragments <NUM>, <NUM> with prepared first and second intramedullary canals <NUM>, <NUM>.

<FIG> illustrates a side view of an elongate fixation member <NUM>, according to another embodiment of the present disclosure. The elongate fixation member <NUM> may generally include the distal or first portion <NUM>, the proximal or second portion <NUM>, and the central longitudinal axis <NUM>.

In some embodiments, the elongate fixation member <NUM> may be configured to couple with at least one flexible tensioning element to secure the elongate fixation member <NUM> to the bone <NUM>.

In some embodiments, the elongate fixation member <NUM> may comprise a longitudinal passageway <NUM> formed through the elongate fixation member <NUM> and configured to receive the at least one flexible tensioning element therethrough.

In some embodiments, a first end of the at least one flexible tensioning element may be couplable with a second end of the at least one flexible tensioning element to secure the elongate fixation member <NUM> to the bone <NUM>.

In some embodiments, the at least one flexible tensioning element may comprise the first flexible tensioning element <NUM> and the second flexible tensioning element <NUM> to secure the elongate fixation member <NUM> to the bone <NUM>.

In some embodiments, the first end <NUM> of the first flexible tensioning element <NUM> may be couplable with the second end <NUM> of the first flexible tensioning element <NUM>, and the first end <NUM> of the second flexible tensioning element <NUM> may be couplable with the second end <NUM> of the second flexible tensioning element <NUM> such that the first and second flexible tensioning elements <NUM>, <NUM> span the bone fracture <NUM> and secure the elongate fixation member <NUM> to the bone <NUM>, as shown in <FIG>.

In a second step of the procedure, one or more first transverse bone tunnels <NUM> may be formed in the first bone fragment <NUM>, as can be seen in <FIG>. The one or more first transverse bone tunnels <NUM> may intersect the first intramedullary canal <NUM>, as previously described herein. In some examples, one or more second transverse bone tunnels (not shown) may also be formed in the second bone fragment <NUM> that may intersect the second intramedullary canal <NUM>. The one or more second transverse bone tunnels may be slightly spread apart from each other in the tip of the fractured olecranon process on either side of the second intramedullary canal <NUM>. This will create more distance between the first and second flexible tensioning elements <NUM>, <NUM> which can provide more rotational control of the fracture and/or allow the first and second flexible tensioning elements <NUM>, <NUM> to be buried underneath soft tissues with a lower profile to avoid prominent and/or painful protrusion of the first and second flexible tensioning elements <NUM>, <NUM> (e.g., under the skin, muscles, soft tissues, etc.).

<FIG> illustrates a third step of the procedure, in which one or more retrieval wires <NUM> may be placed through the first transverse bone tunnels <NUM> and the first and second intramedullary canals <NUM>, <NUM> to retrieve the first and second flexible tensioning elements <NUM>, <NUM>, as previously described herein. <FIG> shows the first and second flexible tensioning elements <NUM>, <NUM> pulled through the first transverse bone tunnels <NUM>.

<FIG> illustrates a fourth step of the procedure, in which the elongate fixation member <NUM> may be inserted into the prepared first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM>.

<FIG> also illustrates a fifth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be coupled to each other, woven around the bone fracture <NUM>, and secured together.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may be additionally secured in place and/or tensioned via any of the securing element and/or tensioning element designs described or contemplated herein.

Thus, the first and second flexible tensioning elements <NUM>, <NUM> may be configured to span the bone fracture <NUM> and preload the bone fracture in compression to resist tensile and/or distraction forces imparted across the bone fracture <NUM>, thereby maintaining fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>. In this manner, the bone fracture <NUM> may receive improved fixation and reduction strength by combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM>.

As previously discussed, the devices and procedures described herein can be utilized for bone fractures in other various locations throughout the body. For example, the procedure for an olecranon process fracture could be slightly modified for a different type of bone fracture, such as a fractured fibula. In this example, the technique would be similar to the olecranon process, except the surgeon would drill up initially from the tip of the fibula along the lateral ankle, then drill holes past the fracture into the fibulae shaft proximal to the fracture. Then, the surgeon would pull the device from the tip of the lateral malleolus, through the fracture site, and then secure the flexible tensioning element as previously discussed.

<FIG> illustrate an example bone fixation assembly that utilizes an elongate fixation member <NUM> comprising a bone plate in combination with a flexible tensioning element <NUM>, according to another embodiment of the present disclosure.

In some embodiments, the bone fracture <NUM> may be provisionally reduced and the elongate fixation member <NUM> may be secured to cortical surfaces <NUM> of the first and second bone fragments <NUM>, <NUM> (e.g., via bone screws, not shown) in order to provide initial fixation for the bone fracture <NUM>. In some embodiments, the elongate fixation member <NUM> may be located superiorly on the bone <NUM>. However, in other embodiments the elongate fixation member <NUM> may be placed along any side of the bone <NUM>, and/or multiple bone plates may be utilized to stabilize the bone fracture <NUM> on any side of the bone <NUM>.

In some embodiments, first and second transverse bone tunnels <NUM>, <NUM> may be drilled through the first and second bone fragments <NUM>, <NUM>. In some embodiments, the first and second transverse bone tunnels <NUM>, <NUM> may be drilled through the first and second bone fragments <NUM>, <NUM> in an anterior to posterior direction (e.g., for a clavicle bone). In some embodiments, the first and second transverse bone tunnels <NUM>, <NUM> may be drilled through the first and second bone fragments <NUM>, <NUM> at locations that are past the proximal and distal portions <NUM>, <NUM> of the elongate fixation member <NUM>. However, it will be understood that in other embodiments the first and second transverse bone tunnels <NUM>, <NUM> may not be drilled through the first and second bone fragments <NUM>, <NUM> in any particular direction, or at any location past the proximal and distal portions <NUM>, <NUM> of the elongate fixation member <NUM>.

In some embodiments, the flexible tensioning element <NUM> may be threaded through the first and second transverse bone tunnels <NUM>, <NUM> and woven around or cinched over the bone fracture <NUM> such that the flexible tensioning element <NUM> forms one or more crisscross patterns on top of, within, and/or below the elongate fixation member <NUM>. However, it will also be understood that in other embodiments the flexible tensioning element <NUM> may be woven around the bone fracture <NUM> to form any suitable pattern on any side of the bone <NUM> and/or any side of the elongate fixation member <NUM> to preload the bone fracture <NUM> in compression and resist tensile/distraction forces imparted across the bone fracture <NUM>.

In some embodiments, the flexible tensioning element <NUM> may comprise a single flexible tensioning element.

In some embodiments, the flexible tensioning element <NUM> may comprise one or more flexible tensioning elements that may be couplable to each other, such as the first and second flexible tensioning elements <NUM>, <NUM> previously described herein.

In some embodiments, the elongate fixation member <NUM> may comprise one or more grooves (not shown) located on top of, within, or on the bottom of the elongate fixation member <NUM> that may be configured to receive the flexible tensioning element <NUM> therein to achieve a lower overall profile and reduce the risk of prominence and/or complications due to soft tissue disturbances.

In some embodiments, the flexible tensioning element <NUM> may be threaded through one or more sleeves (not shown) to prevent the flexible tensioning element <NUM> from cutting through the bone <NUM> over time. The one or more sleeves may be made of any biocompatible material including, but not limited to metals, plastics, PEEK, rubber, silicone, etc..

In some embodiments, the flexible tensioning element <NUM> may also be secured in place and/or tensioned via one or more third securing elements <NUM> (see <FIG>), which may include any of the securing element designs and/or tensioning element designs described or contemplated herein.

<FIG> illustrate example devices and instruments for a bone fixation assembly and not claimed surgical procedure that may be performed from a lateral approach.

In some examples, the bone <NUM> illustrated in <FIG> may comprise a clavicle bone. However, it will be understood that the various devices, instruments, and method steps described herein may be utilized in any combination with each other and for any type of bone fracture including, but not limited to olecranon fractures, fibula fractures, patellar fractures, malleolar fractures, etc..

<FIG> illustrate a first step of the procedure, in which the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> may be prepared with a drill bit or reamer <NUM>.

In some embodiments, the reamer <NUM> may be guided through a reamer passageway <NUM> that is formed through a reamer guide <NUM>.

In some embodiments, the reamer guide <NUM> may also include a reference member <NUM> projecting from the reamer guide <NUM>.

In some embodiments, the reference member <NUM> may be configured to abut a cortical surface <NUM> of the first and/or second bone fragments <NUM>, <NUM> to orient the reamer passageway <NUM> with respect to the cortical surfaces <NUM> of the first and/or second bone fragments <NUM>, <NUM>.

As previously discussed, the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> may be drilled and/or reamed with any diameter drill bit or reamer to any desired depth within the intramedullary canal in order to form prepared intramedullary canals. Moreover, it will also be understood that in some embodiments of the procedure the intramedullary canals of the bone fragments may not require preparation, such as drilling, reaming, etc. For example, in some embodiments a suitable elongate fixation member may be press-fit and/or tamped into an unprepared intramedullary canal of a bone fragment.

<FIG> illustrate a second step of the procedure, in which a drill guide <NUM> and drill bit <NUM> may be utilized to place one or more first transverse bone tunnels <NUM> through the cortical surface <NUM> of the first bone fragment <NUM> down into the prepared first intramedullary canal <NUM>.

In some embodiments, the drill guide <NUM> may include one or more drill guide barrels <NUM>, an insert member <NUM>, and a handle <NUM>.

In some embodiments, the insert member <NUM> may be inserted into the prepared first intramedullary canal <NUM> to orient the one or more drill guide barrels <NUM> with respect to the prepared first intramedullary canal <NUM> of the first bone fragment <NUM>.

<FIG> illustrate a third step of the procedure, in which a retrieval wire <NUM> may be placed through the second intramedullary canal <NUM> of the second bone fragment <NUM> in order to capture and pull the first flexible tensioning elements <NUM> through the second intramedullary canal <NUM> of the second bone fragment <NUM>, as shown in <FIG>.

<FIG> illustrates a fourth step of the procedure, in which one of the first flexible tensioning elements <NUM> may be passed through the first transverse passageway <NUM> of the elongate fixation member <NUM> and then coupled to the other one of the first flexible tensioning elements <NUM>, as can be seen in <FIG>. The elongate fixation member <NUM> will be discussed in more detail below with respect to <FIG>.

<FIG> illustrates a fifth step of the procedure, in which the elongate fixation member <NUM> may be inserted into the prepared first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> from a lateral approach. This may be accomplished by pulling the first flexible tensioning elements <NUM> through the first transverse bone tunnels <NUM>, and/or by impacting the distal end of the elongate fixation member <NUM> with an impact driver (not shown).

<FIG> illustrates a sixth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be woven around the bone fracture <NUM> and secured together, as previously described herein. The first and second flexible tensioning elements <NUM>, <NUM> may be configured to span the bone fracture <NUM> and preload the bone fracture <NUM> in compression to resist tensile and/or distraction forces imparted across the bone fracture <NUM>, thereby maintaining fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>. In this manner, the bone fracture <NUM> may receive improved fixation and reduction strength by combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM>.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may also be secured in place and/or tensioned via one or more fourth securing elements <NUM> (see <FIG>), which may include any of the securing element designs and/or tensioning element designs described or contemplated herein.

<FIG> illustrate example devices and instruments for a bone fixation assembly and surgical procedure that may be performed from a lateral approach.

In some examples, the first and second bone fragments <NUM>, <NUM> may be prepared in a similar manner to the first bone fragment <NUM> shown in <FIG> in a first step and a second step. However, the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> may also be tapped with a tap tool <NUM> in a third step to form internal bone threads <NUM> within the first and second intramedullary canals <NUM>, <NUM> (e.g., see <FIG>).

<FIG> illustrate a fourth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be pulled through the bone tunnels of the first bone fragment <NUM>, the longitudinal passageway <NUM> of the elongate fixation member <NUM>, and the second intramedullary canal <NUM> of the second bone fragment <NUM> via a retrieval wire (not shown) in <FIG>.

The elongate fixation member <NUM> may generally include a distal or first portion <NUM>, a proximal or second portion <NUM>, a central longitudinal axis <NUM>, a longitudinal passageway <NUM>, a first thread <NUM>, a second thread <NUM>, an intermediate portion <NUM>, and a torque reception feature <NUM>.

In some embodiments, the elongate fixation member <NUM> may comprise a compression screw design.

In some embodiments, the first thread <NUM> may comprise a first pitch, and the second thread <NUM> may comprise a second pitch that is different from the first pitch of the first thread <NUM>. In these embodiments, the first and second bone fragments <NUM>, <NUM> may be drawn toward each other in compression as the elongate fixation member <NUM> is inserted into the first and second intramedullary canals <NUM>, <NUM>, due to the differential thread pitches between the first and second threads <NUM>, <NUM>.

In some embodiments, the elongate fixation member <NUM> (and/or any other elongate fixation member described or contemplated herein) may comprise a resorbable material (such as PEEK, hydroxyapatite, etc.), and/or any other biocompatible material such as titanium, stainless steel, polymer, etc..

<FIG> illustrate a fifth step of the procedure, in which the elongate fixation member <NUM> may be inserted into the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> from a lateral approach.

<FIG> illustrate a driver <NUM> that may be utilized to couple the elongate fixation member <NUM> to the first and second bone fragments <NUM>, <NUM>. In some examples the driver <NUM> may include a torque transmission feature <NUM> that may be configured to mate with a complementary shaped torque reception feature <NUM> formed within the longitudinal passageway <NUM> of the elongate fixation member <NUM> to drive the elongate fixation member <NUM> into the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM>. <FIG> shows the elongate fixation member <NUM> after it has been fully inserted into the first and second intramedullary canals <NUM>, <NUM> and the bone fracture <NUM> has been reduced in compression by the compression screw design of the elongate fixation member <NUM>.

<FIG> also illustrates a sixth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be pulled through the second transverse bone tunnels <NUM> of the second bone fragment <NUM> after the driver <NUM> is removed. This may be accomplished with one or more retrieval wires, as previously discussed.

<FIG> illustrate a seventh step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be coupled to each other and woven around the bone fracture <NUM> to further preload the bone fracture <NUM> in compression to resist tensile/distraction forces that may be imparted across the bone fracture <NUM>, as previously described. Thus, combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM> provides additional fixation, stabilization, and reduction of the bone fracture <NUM> over an elongate fixation member or flexible tensioning element alone.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may also be secured in place and/or tensioned via one or more fourth securing elements <NUM>, which may include any of the securing element designs and/or tensioning element designs described or contemplated herein.

<FIG> illustrate example devices and instruments for a bone fixation assembly and surgical procedure that may be performed from both a medial and lateral approach.

In some embodiments, the first and second bone fragments <NUM>, <NUM> may be prepared in a similar manner to the first bone fragment <NUM> shown in <FIG> in a first step and a second step. However, the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> may also be tapped with the tap tool <NUM> shown in <FIG> in a third step to form internal bone threads <NUM> within the first and second intramedullary canals <NUM>, <NUM>.

<FIG> illustrate a fourth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be pulled through a first driver <NUM>, the second intramedullary canal <NUM> of the second bone fragment <NUM>, the elongate fixation member <NUM>, and a second driver <NUM>. This may be accomplished with one or more retrieval wires, as previously discussed.

<FIG> illustrates a fifth step of the procedure, in which the second driver <NUM> may be utilized to drive the elongate fixation member <NUM> into the second intramedullary canal <NUM> of the second bone fragment <NUM> from a medial direction.

<FIG> illustrates a sixth step of the procedure, in which the first bone fragment <NUM> may be positioned adjacent the second bone fragment <NUM> and the first driver <NUM> may be utilized to drive the elongate fixation member <NUM> into the first intramedullary canal <NUM> of the first bone fragment <NUM> from a lateral direction in order to couple the elongate fixation member <NUM> to the first and second bone fragments <NUM>, <NUM>.

<FIG> illustrates a seventh step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be pulled through the first and second transverse bone tunnels <NUM>, <NUM> of the bone fragments after the first and second drivers <NUM>, <NUM> have been removed. This may be accomplished with one or more retrieval wires, as previously discussed.

<FIG> illustrates an eighth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be coupled to each other and woven around the bone fracture <NUM> to preload the bone fracture <NUM> in compression to further resist tensile/distraction forces that may be imparted across the bone fracture <NUM>, as previously described. Thus, combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM> provides additional fixation, stabilization, and reduction of the bone fracture <NUM> over an elongate fixation member or flexible tensioning element alone.

In some embodiments, the first and second flexible tensioning elements <NUM>, <NUM> may also be secured in place and/or tensioned via one or more securing elements (not shown), which may include any of the securing element designs and/or tensioning element designs described or contemplated herein.

<FIG> illustrate example devices and instruments for a bone fixation assembly and not claimed surgical procedure.

In some embodiments, the first and second bone fragments <NUM>, <NUM> may be prepared in a similar manner to the first and second bone fragments <NUM>, <NUM> shown in <FIG> in a first step and a second step.

<FIG> illustrates a third step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be passed through a centrally located transverse passageway <NUM> of an elongate fixation member <NUM>, through the first and second intramedullary canals <NUM>, <NUM>, and out of the first and second transverse bone tunnels <NUM>, <NUM>. This may be accomplished with one or more retrieval wires, as previously discussed.

In some embodiments, the elongate fixation member <NUM> may include one or more grooves <NUM> formed in opposing sides of the elongate fixation member <NUM>. The one or more grooves <NUM> may be configured to receive the first and second flexible tensioning elements <NUM>, <NUM> therein to facilitate insertion of the elongate fixation member <NUM> into the first and second intramedullary canals <NUM>, <NUM> by preventing frictional binding of the first and second flexible tensioning elements <NUM>, <NUM> against the walls of the first and second intramedullary canals <NUM>, <NUM>.

<FIG> and <FIG> illustrate a fourth step of the procedure, in which the elongate fixation member <NUM> may be inserted into the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> reducing the bone fracture <NUM>.

<FIG> illustrates a fifth step of the procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be coupled to each other and woven around the bone fracture <NUM> to preload the bone fracture <NUM> in compression to further resist tensile/distraction forces that may be imparted across the bone fracture <NUM>, as previously described. Thus, combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM> provides additional fixation, stabilization, and reduction of the bone fracture <NUM> over an elongate fixation member or flexible tensioning element alone.

<FIG> illustrate example devices and instruments for a bone fixation assembly and one or more simplified not claimed surgical procedures.

<FIG> illustrate a first step of a simplified procedure, in which a drill bit <NUM> may be utilized to create pilot holes through the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM>.

<FIG> and <FIG> illustrate a second step of the simplified procedure, in which the first and second bone fragments <NUM>, <NUM> may be aligned with each other to reduce the bone fracture <NUM> and a reamer <NUM> may then be utilized to enlarge or ream out the pilot holes of <FIG> in order to create prepared first and second intramedullary canals <NUM>, <NUM> that are aligned with each other. In some examples, the reamer <NUM> may be utilized from a lateral direction. However, it will be understood that in other examples the reamer <NUM> may be utilized from a medial direction.

<FIG> illustrates an elongate fixation member <NUM>, according to another embodiment of the present disclosure. The elongate fixation member <NUM> may generally include a distal portion or first portion <NUM>, a proximal portion or second portion <NUM>, and a central longitudinal axis <NUM>.

In some embodiments, the proximal and/or distal portions <NUM>, <NUM> may comprise tapered ends <NUM> to facilitate insertion of the elongate fixation member <NUM> into bone.

In some embodiments, the elongate fixation member <NUM> may include a first transverse passageway <NUM> configured to receive a first flexible tensioning element <NUM> therethrough from a first direction that may be transverse to the central longitudinal axis <NUM> of the elongate fixation member <NUM>. The elongate fixation member <NUM> may also include a second transverse passageway <NUM> configured to receive a second flexible tensioning element <NUM> therethrough from a second direction that may be transverse to the central longitudinal axis <NUM> of the elongate fixation member <NUM>.

In some embodiments, the first direction and the second direction may be the same, or similar to each other.

<FIG> illustrate a third step of the simplified procedure, in which the elongate fixation member <NUM> may be inserted into the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM>. <FIG> shows the first flexible tensioning element <NUM> passing through the first and second intramedullary canals <NUM>, <NUM>. This may be accomplished with one or more retrieval wires, as previously discussed. <FIG> shows the elongate fixation member <NUM> being forced into the first and second intramedullary canals <NUM>, <NUM> with an impact driver tool <NUM>, and <FIG> shows the elongate fixation member <NUM> placed within the first and second intramedullary canals <NUM>, <NUM>.

<FIG> illustrates a fourth step of the simplified procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be woven around the bone fracture <NUM> and secured together. The first and second flexible tensioning elements <NUM>, <NUM> may be configured to span the bone fracture <NUM> and preload the bone fracture <NUM> in compression to resist tensile and/or distraction forces imparted across the bone fracture <NUM>, thereby maintaining fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>. In this manner, the bone fracture <NUM> may receive improved fixation and reduction strength by combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM>.

<FIG> illustrate example devices and instruments for a bone fixation assembly and an alternative simplified surgical procedure.

In some examples, the first and second bone fragments <NUM>, <NUM> may be prepared in a similar manner to the first and second bone fragments <NUM>, <NUM> shown in <FIG> in a first step and a second step.

<FIG> illustrates a third step of the alternative simplified procedure, in which the elongate fixation member <NUM> may be inserted into the first and second intramedullary canals <NUM>, <NUM> of the first and second bone fragments <NUM>, <NUM> without the first and second flexible tensioning elements <NUM>, <NUM> being coupled to the elongate fixation member <NUM>.

<FIG> illustrate a fourth step of the alternative simplified procedure, in which the first and second transverse bone tunnels <NUM>, <NUM> may be formed through the first and second bone fragments <NUM>, <NUM> with a drill bit <NUM>.

In some embodiments, the first and second transverse passageways <NUM>, <NUM> of the elongate fixation member <NUM> may be utilized to guide the drill bit <NUM> through the first and second bone fragments <NUM>, <NUM> to quickly form the first and second transverse bone tunnels <NUM>, <NUM> therethrough.

<FIG> illustrates a fifth step of the alternative simplified procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be inserted through the first and second transverse bone tunnels <NUM>, <NUM> and through the first and second transverse passageways <NUM>, <NUM> of the elongate fixation member <NUM>.

<FIG> illustrates a sixth step of the alternative simplified procedure, in which the first and second flexible tensioning elements <NUM>, <NUM> may be woven around the bone fracture <NUM> and secured together. The first and second flexible tensioning elements <NUM>, <NUM> may be configured to span the bone fracture <NUM> and preload the bone fracture <NUM> in compression to resist tensile and/or distraction forces imparted across the bone fracture <NUM>, thereby maintaining fixation of the first bone fragment <NUM> relative to the second bone fragment <NUM>. In this manner, the bone fracture <NUM> may receive improved fixation and reduction strength by combining the elongate fixation member <NUM> with the first and second flexible tensioning elements <NUM>, <NUM>.

<FIG> illustrate example devices and instruments for a bone fixation assembly and procedure.

<FIG> illustrates an elongate fixation member <NUM> couplable with a tensioner element.

The elongate fixation member <NUM> may include a distal or first portion <NUM>, a proximal or second portion <NUM>, an eyelet <NUM> at the distal portion, one or more attachment features <NUM>, and a recess <NUM> formed in the proximal portion of the elongate fixation member <NUM>.

The tensioner element <NUM> may include an attachment member <NUM>, a resilient member <NUM>, and an opening <NUM> formed in the resilient member <NUM>.

In some embodiments, the resilient member <NUM> may be slightly angled with respect to the attachment member <NUM> in a free state.

In some embodiments, the tensioner element <NUM> may comprise a super elastic material (e.g., such as nitinol, etc.) that may be configured to provide a tensioning force to the flexible tensioning element <NUM>, as shown in <FIG>.

In some embodiments, the attachment member <NUM> may be received within the recess <NUM> formed in the proximal portion of the elongate fixation member <NUM> to removably couple the tensioner element <NUM> with the elongate fixation member <NUM>.

In some embodiments, the tensioner element <NUM> may be integrally formed with, or otherwise permanently attached to, the elongate fixation member <NUM>.

In some embodiments, the elongate fixation member <NUM> may comprise a resorbable material (such as PEEK, hydroxyapatite, etc.) and/or any other biocompatible material such as titanium, stainless steel, polymer, etc..

<FIG> illustrate the elongate fixation member <NUM> of <FIG> in conjunction with an actuation tool <NUM>, according to an embodiment of the present disclosure.

In some embodiments, the actuation tool <NUM> may include an actuator <NUM> coupled with a handle <NUM>.

In some embodiments, the actuation tool <NUM> may also include one or more attachment features (not shown) which may be configured to engage with the one or more attachment features <NUM> of the elongate fixation member <NUM> to removably couple the actuation tool <NUM> with the elongate fixation member <NUM>, as shown in <FIG> and <FIG>.

In some embodiments, the actuator <NUM> may comprise a threaded thumb screw which may be advanced toward the resilient member <NUM> via rotation in a first direction to bend the resilient member <NUM> forward, as shown in <FIG> and <FIG>.

In some embodiments, the resilient member <NUM> of the tensioner element <NUM> may be bent to about <NUM> degrees when fully loaded by the actuator <NUM>.

In some embodiments, the actuator <NUM> may be retracted from the resilient member <NUM> via rotation in a second direction to release the resilient member <NUM> and/or remove the actuation tool <NUM> from the elongate fixation member <NUM>, as shown in <FIG> and <FIG>.

<FIG> illustrates the elongate fixation member <NUM> inserted into a bone <NUM> and a flexible tensioning element <NUM> passing through the opening <NUM> in the resilient member <NUM> with the actuation tool <NUM> attached to the elongate fixation member <NUM> and applying a bending force to the resilient member <NUM>. In this manner, the surgeon can couple the flexible tensioning element <NUM> to the resilient member <NUM> as tight as possible while the resilient member <NUM> is bent forward by the actuator <NUM>.

<FIG> illustrates the bone fixation assembly of <FIG> with the actuation tool <NUM> removed from the elongate fixation member <NUM>, thus allowing the resilient member <NUM> to pull the flexible tensioning element <NUM> even tighter and further preload the bone fracture <NUM> in compression to resist tensile/distraction forces that may be imparted across the bone fracture <NUM>, as previously described.

<FIG> illustrate various alternative devices for tensioning a flexible tensioning element, according to embodiments of the present disclosure.

<FIG> illustrates an elongate fixation member <NUM> with an angled cap <NUM> attached thereto at an angle with respect to the elongate fixation member <NUM>. In this embodiment, a bottom surface <NUM> of the angled cap <NUM> may act to press downward on a flexible tensioning element (not shown) that may be coupled to the bottom surface <NUM> of the angled cap <NUM>. This may further tension the flexible tensioning element and preload a bone fracture in compression to resist tensile/distraction forces that may be imparted across the bone fracture, as previously described herein.

<FIG> illustrates an elongate fixation member <NUM> with an angled fastener <NUM> attached thereto at an angle with respect to the elongate fixation member <NUM>. In this embodiment, a bottom surface <NUM> of the angled fastener <NUM> may likewise act to press downward on a flexible tensioning element (not shown) that may be coupled to the bottom surface <NUM> of the angled fastener <NUM>. This may further tension the flexible tensioning element and preload a bone fracture in compression to resist tensile/distraction forces that may be imparted across the bone fracture, as previously described herein. <FIG> illustrates the elongate fixation member <NUM> and the angled fastener <NUM> inserted into a bone <NUM>.

<FIG> illustrates a flared fastener <NUM> comprising a flared portion <NUM> near the head of the flared fastener <NUM>. In this manner, the flared fastener <NUM> may be coupled with an elongate fixation member (not shown) without the need of angling the flared fastener <NUM> with respect to the elongate fixation member, due to the inherent angle already created by the flared portion <NUM>. In this embodiment, the flared portion <NUM> may act to press on a flexible tensioning element (not shown) as the flared fastener <NUM> couples with an elongate fixation member. This may further tension the flexible tensioning element and preload a bone fracture in compression to resist tensile/distraction forces that may be imparted across the bone fracture, as previously described herein.

<FIG> illustrates a flared cap <NUM> comprising a flared portion <NUM> near the head of the flared cap <NUM>. In this manner, the flared cap <NUM> may likewise be coupled with an elongate fixation member (not shown) without the need of angling the flared cap <NUM> with respect to the elongate fixation member, due to the inherent angle already created by the flared portion <NUM>. In this embodiment, the flared portion <NUM> may likewise act to press on a flexible tensioning element (not shown) as the flared cap <NUM> couples with an elongate fixation member. This may further tension the flexible tensioning element and preload a bone fracture in compression to resist tensile/distraction forces that may be imparted across the bone fracture, as previously described herein.

Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, drawing, or description thereof for the purpose of streamlining the present disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any embodiment requires more features than those expressly recited in that embodiment. Rather, inventive aspects lie in a combination of fewer than all features of any single embodiment disclosed herein.

The phrases "connected to," "coupled to," and "in communication with" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. The phrase "fluid communication" refers to two or more features that are connected such that a fluid within one feature is able to pass into another feature. Moreover, as defined herein the term "substantially" means within +/- <NUM>% of a target value, measurement, or desired characteristic.

Claim 1:
A bone fixation assembly comprising:
an elongate fixation member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprising:
a central longitudinal axis (<NUM>);
a first portion (<NUM>) configured to be coupled within a first intramedullary canal (<NUM>) of a first bone fragment (<NUM>) of a bone (<NUM>);
a second portion (<NUM>) configured to be coupled within a second intramedullary canal (<NUM>) of a second bone fragment (<NUM>) of the bone (<NUM>) to provide fixation of the second bone (<NUM>) fragment relative to the first bone fragment (<NUM>); and
a flexible tensioning element (<NUM>, <NUM>) couplable to the first (<NUM>) and second (<NUM>) portions of the elongate fixation member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to secure the elongate fixation member to the bone (<NUM>),
wherein:
a first end (<NUM>, <NUM>) of the flexible tensioning element (<NUM>, <NUM>) is couplable with a second end (<NUM>, <NUM>) of the flexible tensioning element (<NUM>, <NUM>) to secure the elongate fixation member (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) to the bone (<NUM>); and
when the first end (<NUM>, <NUM>) of the flexible tensioning element (<NUM>, <NUM>) is coupled to the second end (<NUM>, <NUM>) of the flexible tensioning element, the flexible tensioning element is configured to span a bone fracture (<NUM>) intermediate the first bone fragment (<NUM>) and the second bone fragment (<NUM>) to preload the bone fracture (<NUM>) in compression to resist tensile force imparted across the bone fracture (<NUM>), thereby maintaining fixation of the first bone fragment (<NUM>) relative to the second bone fragment (<NUM>).