Rotatable handle for orthopedic intramedullary nail targeting guide

Abstract

A drill guide assembly for use with an intramedullary ("IM") nail can include a barrel configured to be coupled to an end of an IM nail and a handle coupled to the barrel. The handle is movable to each of a plurality of angular positions relative to the barrel. The handle can include a targeter coupling interface substantially opposing the barrel coupling portion and configured to couple the handle to a targeter having one or more openings formed therein for targeting one or more openings formed in the IM nail.

Description

Attorney Docket No.: 8178.6170WOROTATABLE HANDLE FOR ORTHOPEDIC INTRAMEDULLARY NAIL TARGETING GUIDECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a non-provisional of, and claims the benefit of the filing date of, U.S. provisional patent application number 63 / 755,509, filed February 7, 2025, entitled “Rotatable Handle for Orthopedic Intramedullary Nail Targeting Guide,” the entirety of which application is incorporated by reference herein.FIELD OF THE DISCLOSURE

[0002] The present disclosure is directed to orthopedic implants, and more specifically to a targeting system for targeting an opening formed in an intramedullary (“IM”) nail system.BACKGROUND

[0003] Orthopedic implants may be used, for example, to stabilize an injury, to support a bone fracture, to fuse a joint, and / or to correct a deformity. Orthopedic implants may be attached permanently or temporarily, and they may be attached to the bone at various locations, including implanted within an intramedullary canal or other cavity of the bone, implanted beneath soft tissue and attached to an exterior surface of the bone, or disposed externally and attached by fasteners such as screws, pins, and / or wires. Some orthopedic implants allow the position and / or orientation of two or more bones, bone pieces, or bone fragments (terms used interchangeably herein without the intent to limit or distinguish) toAttorney Docket No.: 8178.6170WObe adjusted relative to one another. Orthopedic implants are generally machined or molded from isotropic materials, such as metals including, for example, titanium, titanium alloys, stainless steel, cobalt-chromium alloys, tantalum, etc.

[0004] An intramedullary (“IM”) nail is one type of orthopedic implant. The primary function of the IM nail is to stabilize the fractured bone fragments and thereby enable load transfer across the fracture site while maintaining anatomical alignment of the bone. When implanting an IM nail, a drill guide is attached to the implant and used to control the nail depth and orientation, serve as an impaction surface, and ultimately facilitate the percutaneous, non-radiographic targeting of certain interlocking holes within the nail. In some cases, however, these drill guides can be obtrusive, cumbersome, and sometimes obstructive to the use of reductive aids like clamps, peri-prosthetic implants, and supporting / enabling instrumentation, and / or adjacent soft tissue structures in certain patients.

[0005] Thus, there remains a need for a drill guide that satisfies the requirements listed above without having the drill guide obstruct x-ray imaging, reduction clamps, peri-prosthetic plate implantation, or the like. The present disclosure satisfies this need and provides other benefits and advantages in a novel and unobvious manner.BRIEF SUMMARY

[0006] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is notAttorney Docket No.: 8178.6170WOintended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0007] A drill guide assembly for use with an intramedullary (“IM”) nail is disclosed. In some examples, the drill guide assembly may be used in an IM nail-bone plate system, which can incorporate an optional bone plate, which may be coupled to the IM nail. In some examples, the drill guide assembly includes a barrel configured to be coupled to an end of an IM nail and a handle that is rotatably coupled to the barrel. The coupling of the handle to the barrel is configured such that the handle is selectively movable to each of a plurality of angular positions relative to the barrel. In some examples, the handle includes a targeter substantially opposing the barrel coupling portion, the targeter having one or more openings formed therein for targeting one or more openings formed in the IM nail.

[0008] An intramedullary (“IM”) nail system is also disclosed. In some examples, the IM nail-bone plate system includes an IM nail arranged and configured to be inserted into an intramedullary canal of a patient’s bone. In some examples, an optional bone plate may also be used, the bone plate being arranged and configured to be positioned against the patient’s bone. A drill guide assembly is also included, the drill guide assembly including a barrel configured to be coupled to an end of the IM nail and a handle comprising a barrel coupling portion rotatably coupled to the barrel. In some examples, the system includes a targeter coupled to the handle, the targeter having one or more openings formed therein for targeting one or more openings in the IM nail and / or the bone plate, if utilized. One or more bone screws can be arranged and configured to be inserted into the one or more openings.Attorney Docket No.: 8178.6170WOIn some examples, the handle is selectively movable to each of a plurality of angular positions relative to the barrel.

[0009] A method of repairing a fractured bone is also disclosed. In some examples, the method includes inserting an intramedullary (“IM”) nail into an intramedullary canal of the fractured bone, optionally positioning a bone plate against the fractured bone, and coupling a drill guide assembly to the IM nail, the drill guide assembly including a barrel configured to be coupled to an end of the IM nail, a handle comprising a barrel coupling portion rotatably coupled to the barrel, and a targeter coupled to the handle, the targeter having one or more openings formed therein for targeting one or more openings in the IM nail. In some examples, the method further includes adjusting an angular position of the handle relative to the barrel. In some examples, the method further includes inserting one or more guide sleeves into the one or more openings formed in the targeter. In some examples, the method further includes inserting one or more provisional fixation pins through the one or more guide sleeves and through the one or more openings in the IM nail and / or the bone plate, if utilized.

[0010] In any preceding or subsequent example, one of the barrel or the barrel coupling portion of the handle can include an arrangement of grooves formed on a surface thereof, and an other of the barrel coupling portion of the handle or the barrel can include a protrusion arranged on a surface thereof and configured to slide along the arrangement of grooves among a plurality of engagement positions. In some examples, the arrangement of grooves includes one or more coupling recess configured to receive the protrusion therein, and the handle is movable to each of a plurality of angular positions relative to the barrelAttorney Docket No.: 8178.6170WOcorresponding to the protrusion being received in an associated one of the one or more coupling recess. In some examples, a biasing element is provided in communication with the barrel and the barrel coupling portion of the handle, and the biasing element is configured to provide a directional force that biases the handle axially towards a position in which the protrusion is engaged with a nearest one of the one or more coupling recess. In some examples, the arrangement of grooves includes at least one engagement channel along which the protrusion is movable to selectively engage or disengage the barrel with the handle.

[0011] In any preceding or subsequent example, the handle can include a coupling release actuator or a quick disconnect actuator that is configured to selectively engage or disengage the handle from the barrel.

[0012] In any preceding or subsequent example, the handle can include a coupling lock configured to selectively prevent the barrel from moving relative to the handle.

[0013] In any preceding or subsequent example, the handle can include a targeter coupling interface substantially opposing the barrel coupling portion, the targeter coupling interface being configured to selectively couple or decouple the handle to the targeter. The targeter coupling interface can include a targeter release actuator that is operable to selectively decouple the handle from the targeter. Alternatively, in some examples, the targeter can be integrally connected to the handle.

[0014] Examples of the present disclosure provide numerous advantages. For example, in accordance with one or more features of the present disclosure, the design of the drillAttorney Docket No.: 8178.6170WOguide assembly affords dramatically reduced obstruction in the operative field, removing limitations from the surgeon to fix complex fractures.

[0015] Further features and advantages of at least some of the examples of the present disclosure, as well as the structure and operation of various examples of the present disclosure, are described in detail below with reference to the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] By way of example, specific examples of the disclosed device will now be described, with reference to the accompanying drawings, in which:

[0017] FIG. 1 is a perspective view of an example of IM nail-bone plate combo system including associated instrumentation in accordance with various features of the present disclosure, the IM nail-bone plate combo system shown implanted within a patient’s bone;

[0018] FIG. 2 is a perspective view of a drill guide assembly for use with the IM nail shown in FIG. 1;

[0019] FIG. 3A is a partially exploded perspective view of elements of the drill guide assembly shown in FIG. 2;

[0020] FIG. 3B is a side view of a barrel of the drill guide assembly shown in FIG. 2;

[0021] FIG. 3C is a side view of a portion of a handle of the drill guide assembly shown in FIG. 2;

[0022] FIG. 4 is a side perspective view of a system for marking the relative rotational position of a handle relative to a barrel of a drill guide assembly in accordance with one or more features of the present disclosure.Attorney Docket No.: 8178.6170WO

[0023] FIGS. 5A-9 are alternative configurations for a drill guide assembly for use with the IM nail shown in FIG. 1.

[0024] It should be understood that the drawings are not necessarily to scale and that the disclosed examples are sometimes illustrated diagrammatically and in partial views. In certain instances, details which are not necessary for an understanding of the disclosed methods and devices or which render other details difficult to perceive may have been omitted. It should be further understood that this disclosure is not limited to the particular examples illustrated herein. In the drawings, like numbers refer to like elements throughout unless otherwise noted.DETAILED DESCRIPTION

[0025] Various features or the like of an orthopedic intramedullary (“IM”) nail targeting guide, supporting / enabling instrumentation, and / or method of use will now be described more fully hereinafter with reference to the accompanying drawings, in which one or more features of the orthopedic IM nail targeting guide, instrumentation, and / or method of use will be shown and described. It should be appreciated that the various features may be used independently of, or in combination, with each other. It will be appreciated that the orthopedic IM nail targeting guide, instrumentation, and / or method of use as disclosed herein may be embodied in many different forms and should not be construed as being limited to the specific examples set forth herein. Rather, these examples are provided so that this disclosure will convey certain features to those skilled in the art.Attorney Docket No.: 8178.6170WO

[0026] With reference to FIG. 1, in accordance with one or more features of the present disclosure, an IM nail 20 is configured to be implanted in a patient’s bone to stabilize fractured bone fragments. In some examples, the IM nail 20 can be implanted as a component of an IM nail-bone plate system 10. As illustrated, the IM nail-bone plate system 10 includes the IM nail 20 and an optional bone plate 30, which can be arranged such that one or more bone screw can be inserted through openings formed in the bone plate 30 and / or the IM nail 20 to fasten the bone plate 30 to the patient’s bone B. While an example of an IM nail 20 and optional bone plate 30 are illustrated herein, it should be appreciated that any configuration of IM nail now known or hereafter developed may be utilized. In addition, in use, a bone plate may also be used, in which instance, one or more bone screws can be inserted through linking openings formed in the bone plate and IM nail. In use, any bone plate now known or hereafter developed may be utilized. As will be appreciated by one of ordinary skill in the art, the configuration of IM nail may be partly determined by the area of the patient’s body being fixated such as, for example, the femur, tibia, humerus, etc. As such, the present disclosure should not be limited to any particular configuration of IM nail except as specifically claimed.

[0027] In use, the IM nail 20 is implanted within the intramedullary canal of the patient’s bone B. If a bone plate 30 is utilized, the bone plate 30 may be positioned against the patient’s bone B, with these components being aligned such that the one or more openings formed in the bone plate 30 and / or the IM nail 20 may be targeted. With reference to FIGS. 1 and 2, a drill guide assembly, generally designated 100, can be used for precisely targeting the one or more openings formed in the IM nail 20 and / or in the optionalAttorney Docket No.: 8178.6170WObone plate 30. As illustrated, the drill guide assembly 100 includes a barrel 110 that is configured to be coupled to the implanted IM nail 20. For example, the barrel 110 may include a first end 112 and a second end 114. In use, the second end 114 may be coupled to a proximal end portion of the body of the IM nail 20. In some examples, the barrel 110 is rigidly secured to the IM nail 20 using a guide bolt.

[0028] As illustrated, the drill guide assembly 100 further includes a guide handle 120 that is configured to be selectively coupled to the barrel 110. In accordance with one or more features of the present disclosure, in use, the guide handle 120 is arranged and configured to swivel relative to a longitudinal axis 111 of the barrel 110 and correspondingly the implanted IM nail 20. That is, in use, the guide handle 120 may be arranged and configured to rotate about the longitudinal axis 111 to any of a variety of positions relative to the barrel 110 and thus relative to the implanted IM nail 20. Thus arranged, the guide handle 120 can be moved among the various positions as needed to accommodate the steps of installing the IM nail 20 and / or optional bone plate 30.

[0029] Referring again to FIG. 1, the drill guide assembly 100 may also include a drop or targeter 200 that is configured to be coupled to the guide handle 120. As shown in FIG.2, in some examples, the handle 120 includes a targeter coupling interface 127 that is configured to selectively engage the targeter 200 in a desired orientation with respect to the barrel 110 to provide a desired alignment with the IM nail 20 and / or optional bone plate 30 to be targeted. In some examples, the handle 120 further includes a targeter release actuator 128 that can be selectively operated to move a retaining element that is arranged at or near the targeter coupling interface 127 and allow the coupling or decoupling of theAttorney Docket No.: 8178.6170WOtargeter 200 with the targeter coupling interface 127. Alternatively, in some examples, the targeter 200 is integrally connected to the handle 120.

[0030] In use, the targeter 200 includes one or more openings 202 formed therein for targeting the one or more openings formed in the IM nail 20 and / or optional bone plate 30, if utilized. In some examples, one or more guide sleeves 210 may be inserted into the one or more openings 202 formed in the targeter 200 In some examples, one or more provisional fixation pins 220 may be inserted through the guide sleeves 210 and into the one or more openings formed in the IM nail 20 and / or optional bone plate 30, if utilized. Thus arranged, the bone plate 30 and the IM nail 20 may be provisionally coupled to each other via the provisional fixation pins 220 while enabling the surgeon to still adjust the position of the bone plate 30 and / or IM nail 20 (i.e., the bone plate 30 and the IM nail 20 can be provisionally coupled to each other while still enabling the final position of the IM nail 20 and / or bone plate 30 to be adjusted).

[0031] In some examples, one configuration of the targeter 200 can be removed and another coupled to the handle 120 to accommodate different steps of installing the IM nail 20. In some examples, multiple configurations for the targeter 200 can be configured for use with a given supported implant. For instance, a “left” configuration for a targeter 200 and a “right” configuration for a targeter 200 can be selectively connected to the handle 120 for separately interacting with the left or right side of the IM nail 20, respectively. In some examples, a “standard” configuration for the targeter 200 can be configured to target the majority of holes in an implant (e.g., holes 1-3 in an implant with 5 holes), and a comparatively more complex configuration for the targeter 200 can be configured to targetAttorney Docket No.: 8178.6170WOthe remaining holes. Alternatively or in addition, in some examples, the targeter 200 can be configured such that, when attached to the handle 120, the targeter 200 provides a radiographic “reference” from which a surgeon might derive a hand / drill position prior to drilling rather than directly targeting a hole (e.g., using a guide sleeve 210 to directly guide the a drill and or screw).

[0032] Alternatively, in configurations in which the targeter 200 is integrally mounted to the handle 120, changes to the configuration of the targeter 200 can be achieved by selectively removing the entire assembly of the guide handle 120 with an integral targeter 200 from the barrel 110. Then, a different configuration of the guide handle 120 and targeter 200 can be coupled to the barrel 110.

[0033] In an example configuration of the drill guide assembly 100 shown in FIGS.3A-3C, the barrel 110 can be configured to be inserted through an opening 122 in a barrel coupling portion 121 of the handle 120 and selectively fixed to the handle 120 such that the handle 120 may be movable relative to the barrel 110 by manipulation of one or more elements of the drill guide assembly 100. In particular, in some examples, the handle 120 is configured to be swiveled about the longitudinal axis 111 of the barrel 110. In some examples, the handle 120 is constrained to the barrel 110 by the interaction of a series of grooves 115 provided on the barrel 110 (See, e.g., FIG. 3B) and a pin or other protrusion 125 positioned on a corresponding interior surface of the barrel coupling portion 121 of the handle 120 within the opening 122 (See, e.g., FIG. 3C). In this configuration, the handle 120 may be movable relative to the barrel 110 by sliding the protrusion 125 along the grooves 115 to any of a variety of engagement positions. Although the exampleAttorney Docket No.: 8178.6170WOconfigurations shown and described with reference to FIGS. 3A-3C include the series of grooves 115 on the barrel 110 and the corresponding protrusion 125 positioned within the opening 122 in the barrel coupling portion 121 of the handle 120, those having ordinary skill in the art will appreciate that a converse configuration can also be implemented in which the interior surface of the opening 122 in the barrel coupling portion 121 of the handle 120 includes a series of grooves that are configured to interact with a protrusion formed on an opposing surface of the barrel 110. (See, e.g., FIG. 5B and 6B)

[0034] In some examples, the arrangement of grooves 115 can include one or more coupling recess 116 into which the protrusion 125 can be positioned, wherein the handle 120 is movable to each of a plurality of angular positions relative to the barrel 110 corresponding to the protrusion 125 being received in an associated one of the one or more coupling recess 116. Further in this regard, in some examples, the angular positions to which the handle 120 is movable relative to the barrel 110 can correspond to positions at which the targeter 200 is aligned with the one or more openings formed in the IM nail 20 and / or optional bone plate 30, if utilized, and / or to positions at which the targeter 200 is moved out of the way to provide additional space for the surgeon during the surgical procedure such as, for example, access space for a C-arm, provisional clamps, inserting additional bone screws through the bone plate, etc.

[0035] For example, the guide handle 120 may include a first position for targeting the one or more openings formed in the IM nail 20 and / or optional bone plate 30, if utilized (FIG. 1). Thereafter, the guide handle 120 may be configured to swivel ± 90-degrees, although this is but one configuration and the guide handle 120 may include more or lessAttorney Docket No.: 8178.6170WOdiscrete positions or may be continuously rotatable. In some examples, the barrel coupling portion 121 includes one or more alignment holes that provide visibility of the barrel 110 within the opening 122 to allow observation of the positions of the one or more coupling recess 116 as reference. In some other examples, the barrel 110 can include one or more first alignment marking 113, and the barrel coupling portion 121 can include one or more second alignment marking 133, such as is shown in FIG. 4. In this configuration, the alignment of the one or more first alignment marking 113 with the one or more second alignment marking 133 can correspond to an alignment of the guide handle 120 with respect to the barrel 110 at an associated rotation position. In some examples, the rotation positions at which the alignment markings are aligned with one another correspond to positions at which the protrusion 125 is in registry with one of the one or more coupling recess 116. In some examples, the handle 120 can be movable relative to the barrel 110 to at least three discrete angular positions, such as two opposing medial-lateral positions and one anterior-posterior position therebetween. In other examples, the handle 120 can be movable relative to the barrel 110 to more or fewer discrete angular positions. In some examples, the number and / or position of the discrete angular positions available can correspond to the configuration of the targeter 200 and / or the requirements of the procedure with which the drill guide assembly 100 is to be used.

[0036] Alternatively, in some examples, the drill guide assembly 100 is configured to change a position of the handle 120 along the longitudinal axis 111 of the barrel 110. In some such examples, the handle 120 can be movable to at a first index position (e.g., at the 90 degree mark) at which the handle 120 is positioned relatively closer to the barrel / nailAttorney Docket No.: 8178.6170WOinterface and to a second index position (e.g., at the 45 degree mark) at which the handle 120 is relatively more distant (e.g., about 5 mm farther) from the interface. Alternatively, in some examples, the handle 120 can be movable relative to the barrel 110 to multiple linear positions while at the same rotational angle.

[0037] In use, with the IM nail 20 implanted within the bone B via the provisional fixation pins 220, the surgeon can remove the guide sleeves 210 and swivel the targeter 200 out of the way. In some examples, the surgeon may further optionally proceed to couple the bone plate 30 to the patient’s bone B using the remaining screw openings (e.g., by inserting bone screws through the bone plate 30 into the patient’s bone B while avoiding the implanted IM nail 20). Then, with the bone plate 30 coupled to the patient’s bone B, the targeter 200 can be returned to its first position, the provisional fixation pins 220 can be removed and one or more screws can be inserted into the one or more openings formed in the IM nail 20 and / or optional bone plate 30, if utilized, using the guide sleeves 210. Thereafter, as needed or desired, the guide handle 120, and hence the targeter 200, can be swiveled out of the way again and any remaining screws can be inserted into bone plate 30 and into the patient’s bone B.

[0038] In some examples, a spring or other biasing element 118 can be positioned between the barrel 110 and the handle 120 to provide a directional force that biases the handle 120 axially towards a position in which the protrusion 125 is engaged with a nearest one of the one or more coupling recess 116. In this configuration, the handle 120 can be configured to effectively “snap” into one of the predetermined angular positions relative to the barrel 110. In the configuration shown and described with reference to FIGS. 3A-3C,Attorney Docket No.: 8178.6170WOthe biasing element 118 is arranged to produce a biasing force that urges the handle 120 to move towards the second end 114 of the barrel 110 (i.e., towards the IM nail 20) such that adjustment of the position of the handle 120 can require that the handle be pulled towards the first end 112 of the barrel 110 (i.e., away from the IM nail 20) to disengage the protrusion 125 from a respective one of the one or more coupling recess 116 before the handle 120 can be rotated relative to the barrel 110. Alternatively, in other examples, the drill guide assembly 100 can be configured such that the biasing element 118 is arranged to produce a biasing force that urges the handle 120 to move towards the first end 112 of the barrel 110 (i.e., away from the IM nail 20) such that adjustment of the position of the handle 120 can require that the handle be pushed towards the second end 114 of the barrel 110 (i.e., towards the IM nail 20) to allow the handle 120 can be rotated relative to the barrel 110.

[0039] Further, in some examples, the arrangement of grooves 115 can include at least one engagement channel 117 along which the protrusion 125 is movable to selectively engage or disengage the barrel 110 with the handle 120. In this configuration, engagement of the barrel 110 with the handle 120 can involve aligning the protrusion 125 with the engagement channel 117, sliding the barrel 110 axially into the opening 122 in the barrel coupling portion 121 of the handle 120, and rotating the handle 120 relative to the barrel 110 to a desired relative angular position. Disengagement of the barrel 110 from the handle 120 can conversely be achieved by rotating the handle 120 relative to the barrel 110 to a position at which the protrusion 125 is aligned with the engagement channel 117 and sliding the barrel 110 axially out of the opening 122 in the barrel coupling portion 121 ofAttorney Docket No.: 8178.6170WOthe handle 120. In some examples, this selective disengagement of the handle 120 from the barrel 110 can be advantageous to enable access for cleaning of the various surfaces of the moving mechanism between uses. Alternatively, in some examples, the handle 120 may be affixed permanently to the barrel 110.

[0040] In some examples, the handle 120 can include one or more feature that is selectively operable to switch between a “disengaged” configuration in which the handle 120 is movable relative to the barrel 110 and an “engaged” configuration in which the position of the handle 120 is substantially fixed with respect to the barrel 110. In the configuration illustrated in FIGS. 3A-3C, for example, the handle 120 further includes a coupling lock 123 that is movable to selectively prevent the barrel 110 from moving axially. In some examples, the coupling lock 123 can be configured to selectively engage a locking groove 119 provided in the barrel 110. In some examples, the locking groove 119 is positioned such that a position of the barrel 110 at which the coupling lock 123 engages the locking groove 119 corresponds to an axial position at which the protrusion 125 is engaged with one of the one or more coupling recess 116. In this configuration, the coupling lock 123 can be configured to retain the barrel 110 in a position in which the protrusion 125 is engaged with a selected one of the one or more coupling recess 116.

[0041] In some examples, the coupling lock 123 is selectively movable by operating a trigger or other actuator 124 arranged on the handle 120. In this way, the handle 120 can be configured to only be swiveled about the barrel 110 while the trigger 124 is actuated. Absent this actuation, the orientation of the handle 120 with regard to the barrel 110 can be effectively “locked.” In some examples, the trigger 124 is positioned and / or otherwiseAttorney Docket No.: 8178.6170WOconfigured such that a user can easily actuate the trigger 124 while holding the handle 120.In the configuration illustrated in FIG. 2, for example, a user can depress the trigger 124 with their palm while gripping the handle 120. In this way, the position of the handle 120 relative to the barrel 110 can be adjusted by a single hand of the user. In some examples, the handle 120 further includes a trigger lock 126 that is selectively operable to block the operation of the trigger 124. In this arrangement, the trigger lock 126 is configured to provide a “lockout” feature that prevents the actuation of the handle 120 and / or its rotation about the barrel 110.

[0042] Although an example configuration for the drill guide assembly 100 is shown and described with reference to FIGS. 2-3C, those having ordinary skill in the art will recognize that other configurations for the drill guide assembly 100 can likewise provide selective engagement of a handle 120 with a barrel 110. In some examples, the relative configurations of the barrel 110 and the handle 120 can be designed such that the first end 112 of the barrel 110 is inserted into the opening 122 of the barrel coupling portion 121 to engage the barrel 110 with the handle 120. In this arrangement, in some examples, the spring or other biasing element 118 can be positioned between the barrel 110 and the handle 120 to produce a biasing force that urges the handle 120 to move towards the first end 112 of the barrel 110 (i.e., away from the IM nail 20) such that adjustment of the position of the handle 120 can require that the handle be pushed towards the second end 114 of the barrel 110 (i.e., towards the IM nail 20) to allow the handle 120 can be rotated relative to the barrel 110. One advantage of this configuration can be that the handle 120 can be selectively attached to and / or detached from the barrel 110 while the barrel 110 is coupledAttorney Docket No.: 8178.6170WOto the implanted IM nail 20. This in situ separability can be desirable in situations in which visibility and / or access to the IM nail-bone plate system 10 could otherwise be obstructed by the handle 120.

[0043] In some examples, attachment and / or detachment can be achieved by rotating the handle 120 relative to the barrel 110 to a position at which the components are configured to slide with respect to one another, such as to a position at which the protrusion 125 is aligned with the engagement channel 117 as discussed above. Alternatively or in addition, the configurations shown in FIGS. 5A-6B illustrate additional features that can be included in the drill guide assembly 100 to facilitate the selective coupling of the handle 120 and the barrel 110. In some examples, a coupling release actuator 131 can be provided on the handle 120 as shown in FIGS. 5A and 5B, which can be used for decoupling the handle 120 from the barrel 110. In the configuration illustrated FIGS. 5A and 5B, the coupling release actuator 131 can be provided as a rotatable port that is configured for receiving a tool that can then be rotated to actuate the mechanism and selectively disengage the handle 120 from the barrel 110. In this configuration, the mechanism that is operable to allow rotation of the handle 120 relative to the barrel 110 (i.e., the trigger 124) is distinct from the mechanism that decouples the handle 120 from the barrel 110 (i.e., coupling release actuator 131). Alternatively or in addition, the example configurations shown in FIGS. 5B and 6A further include a configuration for a quick disconnect actuator 132 that is configured to quickly decouple the handle 120 from the barrel 110 without the need for a separate tool.Attorney Docket No.: 8178.6170WO

[0044] Some further examples are shown in FIGS. 7-9 having other combinations of features. In the example configurations shown in FIGS. 2 and 8, the biasing element 118 is coupled to the barrel 110, whereas the configurations shown in FIGS. 5B-7 and 9 can be configured such that the biasing element 118 is instead a component of the handle 120.The example configuration shown in FIG. 9 further includes an alternative configuration for the quick disconnect actuator 132 that is configured to quickly decouple the handle 120 from the barrel 110.

[0045] The orthopedic implants including, for example, the IM nail, the bone plate, the bone screws, the nail screws, etc. may be manufactured from any suitable material now known or hereafter developed, including, for example, metals, polymers, plastics, ceramics, resorbable, non-resorbable, composite materials, etc. Suitable materials may include, for example, titanium, stainless steel, cobalt chrome, polyetheretherketone (PEEK), polyethylene, ultra-high molecular weight polyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolic acid (PGA), combinations or alloys of such materials or any other appropriate material that has sufficient strength to be secured to and hold bone, while also having sufficient biocompatibility to be implanted into a patient’s body. In some examples, the bone screws may be manufactured from the same material as the implant. In other examples, the bone screws may be manufactured from a different material as compared to the implant.

[0046] The bone screws can be any type of fastener now known or hereafter developed. For example, the bone screws may include any type of external thread including standard or non-standard threads. For example, the external threads can be arranged as a continuousAttorney Docket No.: 8178.6170WOridge or a non-continuous ridge. The external threads can form a portion of a revolution, one complete revolution, multiple revolutions, a single lead, multiple leads, or any other threads known in the art. Additionally, and / or alternatively, in the case of locking screws, the head portion of the bone screw can include any surface that will engage with and seat within the opening. For example, the head portion can include threads. Alternatively, the head portion can include a series of dimples, ridges, bumps, textured areas, or any other surface that can secure the bone screw.

[0047] The bone screw may be any typical bone screw, made out of any appropriate material. The bone screws may include a bore for receiving a driver in order to drive the bone screw through the bone plate and into the patient’s bone. The bore may be any size and shape, for example, it may have a hexagonal configuration to receive a corresponding hexagonal driver, a Phillips screw head, a flat-head, a star configuration, Torx, or any other appropriate configuration that can cooperate with a driver to drive the bone screw through the bone plate and into the patient’s bone.

[0048] The shaft of the bone screws may be fully threaded, partially threaded, or a helical blade, and / or may include one or more tacks, deployable talons, expandable elements, or any feature that allows the shaft to engage the patient’s bone. The end of the shaft may be a self-tapping or self-drilling tip.

[0049] The foregoing description has broad application. Accordingly, the discussion of any example is meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples. In other words, while illustrative examples of the disclosure have been described in detail herein, it is to beAttorney Docket No.: 8178.6170WOunderstood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art.

[0050] The term "a" or "an" entity, as used herein, refers to one or more of that entity. As such, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. The use of "including," "comprising," or "having" and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Accordingly, the terms "including," "comprising," or "having" and variations thereof are open-ended expressions and can be used interchangeably herein. The phrases "at least one", "one or more", and "and / or", as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation.

[0051] All directional references (e.g., proximal, distal, upper, underside, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, second, third, fourth, etc.) are not intended to connote importance or priority but are usedAttorney Docket No.: 8178.6170WOto distinguish one feature from another. The drawings are for purposes of illustration only and the dimensions, positions, order, and relative sizes reflected in the drawings attached hereto may vary.

Claims

Attorney Docket No.: 8178.6170WOCLAIMSWhat is claimed is:

1. A drill guide assembly for use with an intramedullary (“IM”) nail comprising: a barrel configured to be coupled to an end of an IM nail implanted within an intramedullary canal of a patient’s bone; anda handle comprising a barrel coupling portion rotatably coupled to the barrel; wherein the handle comprises a targeter substantially opposing the barrel coupling portion, the targeter having one or more openings formed therein for targeting one or more openings formed in the IM nail; andwherein the handle is selectively movable to each of a plurality of angular positions relative to the barrel.

2. The drill guide assembly of claim 1, wherein one of the barrel or the barrel coupling portion of the handle comprises an arrangement of grooves formed on a surface thereof; andwherein an other of the barrel coupling portion of the handle or the barrel comprises a protrusion arranged on a surface thereof and configured to slide along the arrangement of grooves among a plurality of engagement positions.

3. The drill guide assembly of claim 2, wherein the arrangement of grooves includes one or more coupling recess configured to receive the protrusion therein;wherein the handle is movable to each of a plurality of angular positions relative to the barrel corresponding to the protrusion being received in an associated one of the one or more coupling recess.

4. The drill guide assembly of claim 3, comprising a biasing element in communication with the barrel and the barrel coupling portion of the handle;Attorney Docket No.: 8178.6170WOwherein the biasing element is configured to provide a directional force that biases the handle axially towards a position in which the protrusion is engaged with a nearest one of the one or more coupling recess.

5. The drill guide assembly of claim 2, wherein the arrangement of grooves includes at least one engagement channel along which the protrusion is movable to selectively engage or disengage the barrel with the handle.

6. The drill guide assembly of claim 1, wherein the handle comprises a coupling release actuator or a quick disconnect actuator that is configured to selectively engage or disengage the handle from the barrel.

7. The drill guide assembly of claim 1, wherein the handle comprises a coupling lock configured to selectively prevent the barrel from moving relative to the handle.

8. The drill guide assembly of claim 1, wherein the handle comprises a targeter coupling interface substantially opposing the barrel coupling portion, the targeter coupling interface being configured to selectively couple or decouple the handle to the targeter; and wherein the targeter coupling interface comprises a targeter release actuator that is operable to selectively decouple the handle from the targeter.

9. An intramedullary (“IM”) nail system comprising:an IM nail arranged and configured to be inserted into an intramedullary canal of a patient’s bone;a drill guide assembly comprising:a barrel configured to be coupled to an end of the IM nail; and a handle comprising a barrel coupling portion rotatably coupled to the barrel;Attorney Docket No.: 8178.6170WOa targeter coupled to the handle, the targeter having one or more openings formed therein for targeting one or more openings in the IM nail;one or more bone screws arranged and configured to be inserted into the one or more openings; andwherein the handle is selectively movable to each of a plurality of angular positions relative to the barrel.

10. The system of claim 9, wherein one of the barrel or the barrel coupling portion of the handle comprises an arrangement of grooves formed on a surface thereof; and wherein an other of the barrel coupling portion of the handle or the barrel comprises a protrusion arranged on a surface thereof and configured to slide along the arrangement of grooves among a plurality of engagement positions.

11. The system of claim 10, wherein the arrangement of grooves includes one or more coupling recess configured to receive the protrusion therein;wherein the handle is movable to each of a plurality of angular positions relative to the barrel corresponding to the protrusion being received in an associated one of the one or more coupling recess.

12. The system of claim 11, comprising a biasing element in communication with the barrel and the barrel coupling portion of the handle;wherein the biasing element is configured to provide a directional force that biases the handle axially towards a position in which the protrusion is engaged with a nearest one of the one or more coupling recess.

13. The system of claim 10, wherein the arrangement of grooves includes at least one engagement channel along which the protrusion is movable to selectively engage or disengage the barrel with the handle.Attorney Docket No.: 8178.6170WO14. The system of claim 9, wherein the handle comprises a coupling release actuator or a quick disconnect actuator that is configured to selectively engage or disengage the handle from the barrel.

15. The system of claim 9, wherein the handle comprises a coupling lock configured to selectively prevent the barrel from moving relative to the handle.

16. The system of claim 9, wherein the handle comprises a targeter coupling interface substantially opposing the barrel coupling portion, the targeter coupling interface being configured to selectively couple or decouple the handle to the targeter; andwherein the targeter coupling interface comprises a targeter release actuator that is operable to selectively decouple the handle from the targeter.

17. The system of claim 9, wherein the targeter is integrally connected to the handle.

18. The system of claim 9, comprising a bone plate arranged and configured to be positioned against the patient’s bone;wherein the one or more openings formed in the targeter are configured for targeting one or more openings in the bone plate.

19. A method of repairing a fractured bone, the method comprising:inserting an intramedullary (“IM”) nail into an intramedullary canal of the fractured bone;coupling a drill guide assembly to the IM nail, the drill guide assembly including:a barrel configured to be coupled to an end of the IM nail;a handle comprising a barrel coupling portion rotatably coupled to the barrel; anda targeter coupled to the handle, the targeter having one or more openings formed therein for targeting one or more openings in the IM nail;Attorney Docket No.: 8178.6170WOadjusting an angular position of the handle relative to the barrel;inserting one or more guide sleeves into the one or more openings formed in the targeter; andinserting one or more provisional fixation pins through the one or more guide sleeves and through the one or more openings in the IM nail.

20. The method of claim 19, wherein the handle comprises a targeter coupling interface substantially opposing the barrel coupling portion; andwherein coupling the drill guide assembly to the IM nail comprises coupling the targeter to the handle at the targeter coupling interface.

21. The method of claim 19, wherein adjusting the angular position of the handle relative to the barrel comprises moving the handle such that a protrusion arranged on a surface of one of the barrel coupling portion of the handle or the barrel slides along an arrangement of grooves formed on a surface of an other of the barrel or the barrel coupling portion of the handle among a plurality of engagement positions.

22. The method of claim 21, wherein adjusting the angular position of the handle relative to the barrel comprises moving the handle to one of a plurality of angular positions relative to the barrel corresponding to the protrusion being received in an associated one of one or more coupling recess provided in the arrangement of grooves.

23. The method of claim 19, further comprising:removing the one or more guide sleeves; androtating the targeter relative to the IM nail to provide increased access space to a surgeon.

24. The method of claim 23, further comprising inserting one or more bone screw through the one or more openings formed in the IM nail.

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