Nail-based bone fixation devices and systems

Abstract

The present disclosure provides a clamp comprised of four distinct parts. Compared to conventional two-piece clamps, the ability to disassemble the provided clamp into four components can significantly facilitate cleaning and sterilization. The provided clamp may include a first arm, a second arm, a cannula block, and a rotating cannula. In some cases, the provided clamp may include a locking feature for locking and unlocking the rotating cannula to the cannula block. The present disclosure also provides a clamp with a scale for determining bone dimensions, a clamp with a scale for determining how much compressive force is applied to the bone between the jaws of the clamp, a bushing and set screw system, where the set screw is self-locking, and a drill component system for creating an opening in the bone for a fixation component.

Description

[Technical Field]

[0001] Priority claims This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 089,337, filed October 8, 2020, which is incorporated herein by reference in its entirety.

[0002] This application relates generally to nail-based bone fixation. More specifically, this application provides a clamping device, a bushing and set screw system, and a drill component that assist in locking the nail shank to the bone. [Background technology]

[0003] Intramedullary (IM) nails are internal fixation devices that can be placed along the medullary canal of a fractured bone. The nail acts as a splint inside the bone, holding the bone segments in alignment as they heal. A standard double-locking nail defines multiple openings near its opposing ends to receive screws that lock both ends of the nail to the bone. However, some bones, such as the fibula and ulna, may be too thin to receive a standard nail without excessive reaming. For such bones, an elongated single-locking nail may instead be installed. A single-locking nail has a head that defines openings for the screws and a shank that is too thin to receive the screws. Thus, one end of the nail (the head) is locked to the bone, while the other end (the shank) remains unlocked. If the bone is broken across the shank, the nail may allow the bone segments to move relative to each other. In these types of fractures, the bone can be more effectively stabilized if the surgeon has the option to also lock the shank to the bone.

[0004] U.S. Patent No. 7,785,326 proposes a nail-based fixation system in which the nail extends through and is locked to a fastener. More specifically, this system uses a mounting jig that requires the nail to travel a linear path as it enters the bone until the tip of the nail enters the fastener hole. However, this system is inadequate for locking a nonlinear and / or flexible nail shank to bone at a significant distance from the site where the nail enters the bone.

[0005] U.S. Patent No. 10,758,280 proposes a nail-based fixation system that specifically aims to overcome this drawback of conventional nail-based fixation systems. The present disclosure aims to improve various aspects of the nail-based fixation system provided in U.S. Patent No. 10,758,280. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 7,785,326 [Patent Document 2] U.S. Patent No. 10,758,280 Summary of the Invention

[0007] The present disclosure provides new and innovative systems and methods for nail-based bone fixation. In one aspect, the present disclosure provides a clamp comprised of four distinct parts. Compared to conventional two-piece clamps, the ability of the provided clamp to be disassembled into four components may allow for greater ease of cleaning and sterilization. The provided four-piece clamp allows surgeons and other medical personnel to use only the cannula block in some cases. The four-piece clamp may include two separate arms, a cannula block, and a rotating cannula. In some cases, the provided clamp may include a locking feature for locking and unlocking the rotating cannula to the cannula block.

[0008] In another aspect, the present disclosure provides a clamp with a scale for determining bone sizing. In another aspect, the present disclosure provides a clamp with a scale for determining how much compressive force is being applied to the bone between the jaws of the clamp. In another aspect, the present disclosure provides a system including a bushing and a set screw. The bushing and set screw can lock the nail to the bushing as part of a nail-based bone fixation system. In another aspect, the present disclosure provides a drill component system for creating an opening in the bone for a fixation component, such as a screw or a bushing (e.g., a bushing disclosed herein).

[0009] In view of the technical features described in this disclosure, a first aspect of the present disclosure, which can be combined with any other aspect unless otherwise stated, provides a clamping device for use in bone fixation procedures, including, but not limited to, a first arm, a second arm, a cannula block, and a rotatable cannula. The first arm includes a handle at an end opposite the clamping end and a first slot between the two ends. The second arm includes a handle at an end opposite the clamping end and a second slot between the two ends. The cannula block includes a body portion having a channel, a post extending from the body portion, and a cap at the end of the post. The rotatable cannula includes a body portion having a cannula insertion portion along its longitudinal axis. The rotatable cannula is configured to be placed through the channel in the cannula block. The first arm, the second arm, the cannula block, and the rotatable cannula are each separate and distinct components configured to allow the clamping device to be repeatedly assembled and disassembled into separate and distinct components. In the operating configuration, the post of the cannula block is disposed within the first and second slots such that the first and second arms can rotate about the post.

[0010] In a second aspect of the present disclosure, which may be combined with any other aspect (e.g., the first aspect) unless otherwise specified, the first arm, the second arm, and the cannula block are configured such that, in an operative configuration, the first arm and the second arm prevent the post of the cannula block from exiting the first slot and the second slot.

[0011] In a third aspect of the present disclosure, which may be combined with any other aspect (e.g., the first and second aspects) unless otherwise specified, the first arm, the second arm, and the cannula block are configured such that disassembly of the clamping device includes manipulating the first arm and the second arm to align the first slot with the second slot so that the post of the cannula block can translate out of the first slot and the second slot.

[0012] In a fourth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to third aspects) unless otherwise specified, the cap is configured such that, in an assembled configuration, the cap prevents the first arm or the second arm from moving parallel to the axial direction of the post.

[0013] In a fifth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to fourth aspects) unless otherwise stated, the first arm and the second arm are connected such that the connection limits openings of the first arm and the second arm.

[0014] In a sixth aspect of the present disclosure, which may be combined with any other aspect (e.g., the fifth aspect) unless otherwise stated, the first arm and the second arm are connected by a ratchet connection including a ratchet member and a ratchet receiver.

[0015] In a seventh aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to sixth aspects) unless otherwise stated, the length of the post is approximately equal to the sum of the first thickness of the first arm in the first slot and the second thickness of the second arm in the second slot.

[0016] In an eighth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to seventh aspects) unless otherwise stated, the first arm or the second arm includes a branch having a rod, and the other of the first arm or the second arm includes a branch having an opening, and the rod is configured to fit well into the opening.

[0017] In a ninth aspect of the present disclosure, which may be combined with any other aspect (e.g., the eighth aspect) unless otherwise stated, the cannula block includes an elongated opening, and in an assembled configuration, is configured to have a rod positioned within the elongated opening.

[0018] In a tenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to ninth aspects) unless otherwise stated, the cannula block includes a plurality of fixation device openings.

[0019] In an eleventh aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to tenth aspects) unless otherwise stated, the body portion of the cannula block includes a tab within the channel, and the body portion of the rotating cannula includes a flat surface and a groove extending around the body portion of the rotating cannula and terminating at the flat surface, and the tab is configured to be able to move parallel within the groove.

[0020] In a twelfth aspect of the present disclosure, which may be combined with any other aspect (e.g., the eleventh aspect) unless otherwise specified, the cannula block and the rotating cannula are configured such that when the tab is oriented toward a flat surface, the rotating cannula can translate only axially through the channel in the cannula block.

[0021] In a thirteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the twelfth aspect) unless otherwise specified, the cannula block and the rotating cannula are configured such that the rotating cannula is locked to the cannula block, such that when the rotating cannula is rotated so that the tab is positioned within the groove, the rotating cannula is prevented from moving in translation along the longitudinal axis of the body portion of the rotating cannula.

[0022] In a fourteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to thirteenth aspects) unless otherwise stated, the clamping device further comprises an indicator or numerical scale corresponding to the distance between the clamping ends of the first arm and the second arm.

[0023] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to fourteenth aspects) unless otherwise stated, the clamping device further comprises an indicator or numerical scale corresponding to the amount of compressive force applied between the clamping ends of the first arm and the second arm.

[0024] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the second to fifteenth aspects) unless otherwise stated, a clamping device used in a bone fixation procedure comprises a first arm, a second arm, a cannula block, and a rotatable cannula. The first arm and the second arm are configured to rotate relative to each other about a shared axis. The cannula block comprises a body portion having a channel and a tab extending within the channel. The rotatable cannula comprises a body portion having a cannula insertion portion along its longitudinal axis. The body portion of the rotatable cannula further comprises a flat surface and a groove extending around the body portion of the rotatable cannula and terminating at the flat surface. The groove is configured to allow the rotatable cannula to rotate together with the tab disposed within the groove. The cannula block and the rotatable cannula are configured such that when the tab is directed toward the flat surface, the rotatable cannula is translated only axially through the channel of the cannula block. Rotating the rotatable cannula so that the tabs are positioned within the grooves locks the rotatable cannula to the cannula block against translation along the longitudinal axis of the body portion of the rotatable cannula.

[0025] In a seventeenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to sixteenth aspects) unless otherwise specified, the cannula block and the rotating cannula are configured such that when the rotating cannula is positioned within the cannula block, the cannula block channel and the cannula insertion portion of the rotating cannula are not coaxial.

[0026] In an 18th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 17th aspect) unless otherwise specified, the cannula block further includes a plunger, which is configured to extend into the channel in a relaxed state and to be pushed into the body portion of the cannula block when force is applied to the plunger.

[0027] In a 19th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 18th aspect) unless otherwise stated, the body portion of the rotating cannula includes a plurality of detents configured to receive the tip of the plunger.

[0028] In a twentieth aspect of the present disclosure, which may be combined with any other aspect (e.g., the nineteenth aspect) unless otherwise stated, at least some of the detents are arranged in the body portion of the rotating cannula so as to correspond to respective individual offset amounts of the longitudinal axis of the cannula insertion portion of the rotating cannula relative to the longitudinal axis of the channel of the cannula block.

[0029] In a twenty-first aspect of the present disclosure, which can be combined with any other aspect (for example), unless otherwise stated, a clamping device used in a bone fixation procedure comprises a first arm, a second arm, a member, a member receiver, and an indicator or numerical scale. The first arm and the second arm are configured to rotate relative to each other about a shared axis. The first arm and the second arm each include a clamping end. The member is connected to or integral with the first arm or the second arm. The member receiver is connected to or integral with the other of the first arm or the second arm that is not connected to or integral with the member. The indicator or numerical scale corresponds to the distance between the clamping ends of the first arm and the second arm. The member and the member receiver are configured to form a connection between the first arm and the second arm, which connection maintains the relative positions of the first arm and the second arm when no force is applied to the first arm and the second arm.

[0030] In a twenty-second aspect of the present disclosure, which may be combined with any other aspect (e.g., the twenty-first aspect) unless otherwise stated, the member comprises an indicator or a numerical scale.

[0031] In a 23rd aspect of the present disclosure, which may be combined with any other aspect (e.g., the 21st aspect) unless otherwise stated, the member is a first member, the clamping device further comprises a second member, and the second member comprises an indicator or a numerical scale.

[0032] In a 24th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 21st to 24th aspects) unless otherwise stated, the first arm or the second arm having the member receiver includes an indication or marking arranged to align with the scale indication or number.

[0033] In a 25th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 22nd to 24th aspects) unless otherwise stated, a clamping device used in a bone fixation procedure comprises a first arm, a second arm, a member, a member receiver, and an indicator or numerical scale. The first arm and the second arm are configured to rotate relative to each other about a shared axis. The first arm and the second arm each include a clamping end. The first arm and the second arm are each made of a material having elastic properties. The member is connected to or integral with the first arm or the second arm. The member receiver is connected to or integral with the other of the first arm or the second arm that is not connected to or integral with the member. The indicator or numerical scale corresponds to the amount of compressive force applied between the clamping ends of the first arm and the second arm. The member and member receiver are configured to form a connection between the first arm and the second arm, which connection maintains the positions of the first arm and the second arm relative to each other when no force is applied to the first arm and the second arm.

[0034] In a twenty-sixth aspect of the present disclosure, which may be combined with any other aspect unless otherwise specified, a system includes a set screw and a bushing. The set screw has a plurality of external threads. The bushing has a body portion, an opening through the body portion, and a nipple extending from the body portion. The body portion includes a plurality of external threads and an interior. The interior consists of one of: (i) a first portion having a fully formed internal thread, a second portion having a partially formed internal thread, and a third portion without internal threads; (ii) a fourth portion having a fully formed internal thread and a fifth portion having a partially formed internal thread; (iii) a sixth portion having a partially formed internal thread and a seventh portion without internal threads; (iv) an eighth portion having a fully formed internal thread and a ninth portion without internal threads; (v) a partially formed internal thread; and (vi) a surface without internal threads. The set screw is configured to be advanced into the interior of the bushing.

[0035] In a 27th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 26th aspect) unless otherwise stated, the interior of the main body portion consists of (i), and the second portion is between the first portion and the third portion.

[0036] In a 28th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 26th or 27th aspect) unless otherwise stated, the interior of the body portion comprises (i), and the second portion is longer than the first portion relative to the length of the bushing.

[0037] In a 29th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 26th to 28th aspects) unless otherwise stated, the set screw includes multiple external threads along its entire length excluding the non-threaded end.

[0038] In a thirtieth aspect of the present disclosure, which may be combined with any other aspect (e.g., the twenty-ninth aspect) unless otherwise stated, the set screw includes a tapered end.

[0039] In a thirty-first aspect of the present disclosure, which may be combined with any other aspect (e.g., the twenty-sixth aspect) unless otherwise stated, the system further includes a nail.

[0040] In a thirty-second aspect of the present disclosure, which may be combined with any other aspect (e.g., the thirty-fifth aspect) unless otherwise stated, the nail is placed through an opening in the body portion of the bushing, and the set screw and bushing apply a compressive force to the nail.

[0041] In a thirty-third aspect of the present disclosure, which may be combined with any other aspect unless otherwise specified, a system includes at least one fixation component, a first drill component, and a second drill component. The first drill component includes a first shaft having a first cutting end configured to cut into bone when the first drill component is driven by a driving instrument. The first shaft further includes a portion having a larger diameter than the remainder of the first shaft, which prevents the first drill component from being inserted through a cannula past the larger diameter portion. The larger diameter portion is positioned along the first shaft to prevent the first cutting end from reaching the distal cortex of the bone when the first drill component is used to drill a hole in the bone. The size of the first cutting end corresponds to the size of at least a portion of the at least one fixation component. The second drill component includes a second shaft having a second cutting end configured to cut into bone when the second drill component is driven by a driving instrument. The second cutting end includes a sharp tip extending from a blunt portion, the size of the sharp tip corresponding to the size of at least a portion of the at least one fixation component, and the size of the blunt portion corresponding to the size and shape of at least a portion of the at least one fixation component.

[0042] In a thirty-fourth aspect of the present disclosure, which may be combined with any other aspect (e.g., the thirty-third aspect) unless otherwise specified, at least one fixing component is a bushing or one or more screws.

[0043] In a thirty-fifth aspect of the present disclosure, which may be combined with any other aspect (e.g., the thirty-third aspect) unless otherwise specified, the fixing component is a bushing including an externally threaded body portion and a nipple extending from the body portion. The size of the first cutting end in this aspect corresponds to the size of the externally threaded body portion of the bushing. The size of the sharp tip in this aspect corresponds to the size of the nipple of the bushing. The size of the blunt portion in this aspect corresponds to the size and shape of the externally threaded body portion of the bushing.

[0044] In a 36th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 33rd to 35th aspects) unless otherwise specified, the first drill part or the second drill part is configured to be removably coupled to a driving tool.

[0045] In a 37th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 33rd to 35th aspects) unless otherwise specified, the first drill part or the second drill part is configured to be connected to a driving tool.

[0046] In a 38th aspect of the present disclosure, which may be combined with any other aspect (e.g., the 33rd to 37th aspects) unless otherwise specified, the set screw is made of a first material having a higher hardness than a second material from which the bushing is made.

[0047] In a thirty-ninth aspect of the present disclosure, which may be combined with any other aspect (e.g., the thirty-third to thirty-eighth aspects) unless otherwise specified, a method for preparing bone for nail-based fixation includes selecting at least one fixation component having a size. The first drill component is selected corresponding to the selected size of the at least one fixation component. The first drill component includes a first shaft having a first cutting end configured to cut into the bone when the first drill component is driven by a driving instrument. The first shaft further includes a portion having a larger diameter than the remainder of the first shaft, which prevents the first drill component from being inserted through a cannula past the larger diameter portion. The larger diameter portion is positioned along the first shaft to prevent the first cutting end from reaching the distal cortex of the bone when the first drill component is used to drill a bone. The size of the first cutting end corresponds to the size of at least a portion of the at least one fixation component. The second drill component is selected according to the selected size of the at least one fixation component. The second drill element includes a second shaft having a second cutting end configured to cut into bone when the second drill element is driven by the driving instrument. The second cutting end includes a sharp tip extending from a blunt portion. The size of the sharp tip corresponds to the size of at least a portion of the at least one fixation component. The size of the blunt portion corresponds to the size of at least a portion of the at least one fixation component. The selected first drill element is inserted through the cannula in contact with the bone. A first bone hole is formed by drilling a proximal cortical portion of the bone with the drill element and the first drill element. The selected first drill element may then be removed from the cannula. The selected second drill element is inserted through the cannula in contact with the bone. A second bone hole is formed by drilling a distal cortical portion of the bone with the drill element and the second drill element through the first bone hole created by the first drill element. The selected second drill element may then be removed from the cannula.

[0048] In a fortieth aspect of the present disclosure, which may be combined with any other aspect (e.g., the twenty-sixth to thirty-ninth aspects) unless otherwise specified, at least one fixing component is a bushing including an externally threaded body portion and a nipple extending from the body portion. The size of the first cutting end in this aspect corresponds to the size of the externally threaded body portion of the bushing. The size of the sharp tip in this aspect corresponds to the size of the nipple of the bushing. The blunt reamer portion in this aspect corresponds to the size of the externally threaded body portion of the bushing.

[0049] Additional features and advantages of the disclosed method and apparatus will be described in, and will be apparent from, the following detailed description and figures. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will be apparent to those skilled in the art in view of the figures and description. Furthermore, it should be noted that the language used herein has been chosen primarily for ease of reading and for explanatory purposes, and not to limit the scope of the inventive subject matter. [Brief explanation of the drawings]

[0050] [Figure 1] FIG. 1 is a perspective view of a clamp according to one aspect of the present disclosure.

[0051] [Figure 2] FIG. 2 is a top view of the clamp of FIG. 1 according to one embodiment of the present disclosure.

[0052] [Figure 3] FIG. 3 is an exploded view of the clamp of FIGS. 1 and 2 according to one embodiment of the present disclosure.

[0053] [Figure 4A] FIG. 1 is a top view of an exemplary first arm, according to one embodiment of the present disclosure.

[0054] [Figure 4B] FIG. 1B is a top view of an exemplary second arm, according to one embodiment of the present disclosure.

[0055] [Figure 4C] FIG. 1 is a side view of an exemplary cannula block according to one aspect of the present disclosure.

[0056] [Figure 4D] FIG. 1 is a perspective view of an exemplary rotating cannula according to one aspect of the present disclosure.

[0057] [Figure 5A] FIG. 1B is a bottom view of the first and second arms in an assembled / disassembled position, according to one embodiment of the present disclosure.

[0058] [Figure 5B] FIG. 10 is a bottom view of the first and second arms in operating positions according to one embodiment of the present disclosure.

[0059] [Figure 6] FIG. 10 is an enlarged perspective view of a channel of a cannula block according to one aspect of the present disclosure.

[0060] [Figure 7A] FIG. 12 is a perspective view of the insertion / removal position of a rotating cannula according to one aspect of the present disclosure.

[0061] [Figure 7B] FIG. 12 is a perspective view of a docking position of a rotating cannula according to one aspect of the present disclosure.

[0062] [Figure 8] FIG. 1 is a perspective view of a clamp having a bone size scale for determining the size of a bone disposed between a first jaw and a second jaw of the clamp, according to one embodiment of the present disclosure.

[0063] [Figure 9] FIG. 1 is a perspective view of a clamp having a compression force scale for determining the amount of force applied by the first and second jaws of the clamp, according to one embodiment of the present disclosure.

[0064] [Figure 10] FIG. 1 is a perspective view of a system including a bushing, a set screw, and a nail according to one aspect of the present disclosure.

[0065] [Figure 11] FIG. 11 is a front view of the system of FIG. 10 according to one embodiment of the present disclosure.

[0066] [Figure 12] FIG. 10 is a perspective view, partially in section, of a bushing showing the internal threads of the bushing, according to one aspect of the present disclosure.

[0067] [Figure 13] FIG. 1 is a perspective view of a bushing and set screw having a non-threaded portion and a tapered end according to one aspect of the present disclosure.

[0068] [Figure 14] FIG. 1 illustrates a perspective view of a juxtacortical drill element at maximum drill depth according to one aspect of the present disclosure.

[0069] [Figure 15] 1 illustrates a perspective view of a juxtacortical drill piece according to one aspect of the present disclosure.

[0070] [Figure 16] 1 shows an enlarged perspective view of a tip of a juxtacortical drill element according to one aspect of the present disclosure. FIG.

[0071] [Figure 17] 1 illustrates a perspective view of a distal cortical drill component according to one aspect of the present disclosure. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0072] The present disclosure provides devices and systems for nail-based bone fixation. In at least some embodiments, the provided devices and systems are intended to improve upon various aspects of the devices and systems disclosed in U.S. Patent No. 10,758,280 ("'280 Devices and Systems"). For example, in various embodiments, the provided devices and systems are intended to improve the accuracy, reliability, and / or user comfort of utilizing the '280 devices and systems to lock the tips of nails to help stabilize fractures.

[0073] In one aspect, the present disclosure provides a clamp comprised of four distinct parts. Compared to conventional two-piece clamps, the ability to disassemble the provided clamp into four components can significantly facilitate cleaning and sterilization. For example, compared to two-piece clamps that may include connection points that are difficult to reach with a cleaning or sterilizing agent, this can facilitate the penetration of cleaning or sterilizing media into all parts of each clamp's components and connections. In at least some aspects, the provided clamp includes a first arm, a second arm, a cannula block, and a rotatable cannula. In various cases, the first arm and the second arm are configured to lock the cannula block to the first arm and the second arm. In some cases, a ratchet connection including a ratchet member and a ratchet receiver can connect the first arm and the second arm. The first arm may include the ratchet member, and the second arm may include the ratchet receiver, or vice versa. In other cases, the first arm and the second arm may be connected by another suitable connection. The cannula block includes an opening through which a rotating cannula may be placed.

[0074] In some embodiments, the cannula block may include one or more holes for one or more fixation devices. For example, the holes in the cannula block may be sized for translation through a k-wire. In such embodiments, the provided four-piece clamp allows a surgeon or other medical professional to use only the cannula block in some cases. For example, in some cases, a surgeon may want to limit the size of an incision during a procedure. Inserting the jaws of the clamp requires a larger incision than inserting only the cannula block, and therefore, the option of using only the cannula block may be desirable for the surgeon. In such cases, the cannula block may be secured to the bone by one or more fixation devices (e.g., k-wires) placed through one or more holes in the cannula block.

[0075] In some cases, the provided clamp may include a locking feature for locking and unlocking the rotatable cannula to the cannula block. The locking feature may include a groove in the rotatable cannula and a tab on the cannula block. In such a case, the groove in the rotatable cannula may terminate in a flat on the rotatable cannula. The rotatable cannula may be inserted into the opening in the cannula block with the flat on the rotatable cannula oriented so that the tab on the cannula block slides along the flat until it aligns with the groove. The rotatable cannula may then be rotated so that the tab enters the groove. Once the tab enters the groove, the rotatable cannula is locked to the cannula block in the axial direction of the rotatable cannula.

[0076] In another aspect, the present disclosure provides a clamp including a bone sizing scale. The bone sizing scale may be included in the provided four-part clamp or may be provided on any other suitable clamp. For example, a surgeon or other medical professional may clamp a bone with each jaw of the provided clamp and take a reading from the bone sizing scale to determine the size of the bone between the jaws. Knowing the bone size can help the surgeon or other medical professional select the size of an implant (e.g., screw, bushing, rod, nail, arthroplasty) or determine whether the bone is too small for a particular surgical procedure. In some aspects, the bone sizing scale may be located on a ratchet member of one of the arms. In some cases, the arm opposite the ratchet receiver may include an indicator that aligns with a portion of the scale to indicate the measurement.

[0077] In another aspect, the present disclosure provides clamps with a scale for determining how much compressive force is being applied to the bone between the jaws of the clamp. The scale for determining compressive force may be included in the provided four-part clamp or may be provided on any other suitable clamp. In some cases, the first arm or second arm of the provided clamp having the compressive force scale may include an indicator arm that aligns with a portion of the compressive force scale to indicate the measurement.

[0078] In another aspect, the present disclosure provides a system including a bushing and a set screw. The bushing and set screw can lock the nail to the bushing as part of a nail-based bone fixation system. The set screw can be inserted into the bushing and press the nail against the bushing to lock the nail to the bushing. In combination with the internal threads of the bushing, the set screw can be self-locking to the bushing, which helps prevent the set screw from loosening to maintain a desired position of the bushing relative to the nail. In some cases, the set screw can include a non-threaded tip. In some cases, the set screw can include a tapered tip. The non-threaded and / or tapered tip can help guide the set screw into the internal threads of the bushing to help prevent cross-threading and / or tilting during initial insertion. In various aspects, the bushing can include a threaded body portion and a nipple extending from the threaded body portion. In at least one embodiment, when the bushing is used in a bone fixation procedure, the threaded body portion engages the proximal cortex and the nipple engages the distal cortex.

[0079] In another aspect, the present disclosure provides a drill element system for preparing an opening in bone for a fixation element, such as a screw or a bushing (e.g., a bushing disclosed herein). The drill element system helps ensure that a surgeon or other medical professional does not accidentally over-drill, either near or at the distal cortex. Such over-drilling weakens the fixation element's engagement with the bone, dramatically reducing its holding strength. In various instances, the drill element system may include a near-cortical drill element and a distal-cortical drill element. In at least some aspects, a surgeon or other medical professional may place the near-cortical drill element or the distal-cortical drill element through a cannula (e.g., a rotating cannula of a provided clamp) to drill the bone.

[0080] In at least some embodiments, the juxtacortical drill element comprises a shaft having a shoulder. The shoulder is sized to prevent passage through a cannula, thus limiting the depth to which the juxtacortical drill element can drill. The shoulder is positioned on the shaft to prevent the entry of the juxtacortical drill element's drill hole from reaching or drilling into the distal cortex. After the juxtacortical drill element drills a hole in the bone, a distal cortical drill element may be advanced through the drilled hole. In at least some embodiments, the distal cortical drill element comprises a shaft having a blunt reamer portion and a sharp trocar tip extending from the blunt reamer portion. In at least some embodiments, the shaft has a larger diameter than the sharp trocar tip. The sharp trocar tip can create a hole in or through the distal cortex.

[0081] The blunt reamer portion is configured to prevent penetration of the distal cortex, thereby preventing the shaft of the distal cortical drill component from penetrating the distal cortex, and limiting the depth to which the sharp trocar tip penetrates the distal cortex. For example, the sharp trocar tip can have a certain length and not penetrate any further than that. In one example, the sharp trocar tip is configured so that the hole it creates in the distal cortex corresponds to the nipple of a provided bushing, thereby creating a good fit with the nipple of the provided bushing and thus maintaining its position or fixation within the bone once installed. In this example, the blunt reamer portion is configured to contour the inside of the bone canal to accommodate the shape of the body portion of the provided bushing.

[0082] In various instances, the systems of the present disclosure may include one or more of the provided clamps, bushings, set screws, juxtacortical drill components, and distal cortical drill components. For example, the systems may include all of these components. In another example, the systems may include the provided bushings, set screws, juxtacortical drill components, and distal cortical drill components. In another example, the systems may include the provided clamps, juxtacortical drill components, and distal cortical drill components. Further advantages of the present disclosure will become apparent from the following description of the figures.

[0083] 1, 2, and 3 illustrate a perspective view, a top view, and an exploded view, respectively, of an exemplary clamp 100. In at least some embodiments, clamp 100 comprises a first arm 102, a second arm 104, a cannula block 106, and a rotatable cannula 108. First arm 102, second arm 104, cannula block 106, and rotatable cannula 108 are each separate and distinct parts in their own right (see, e.g., the exploded view in FIG. 3). Stated differently, clamp 100 can be disassembled into four parts: first arm 102, second arm 104, cannula block 106, and rotatable cannula 108. Compared to conventional two-piece clamps, the ability to disassemble clamp 100 into four components can enable greater ease of cleaning and sterilization of the parts.

[0084] In various embodiments, first arm 102, second arm 104, and cannula block 106 rotate about a shared axis. First arm 102 and second arm 104 can rotate in a closing direction, such that arm 406 of first arm 102 and arm 426 of second arm 104 move toward each other, or in an opening direction, such that arm 406 and arm 426 move away from each other. The structure of clamp 100 that provides this shared axis of rotation is described in more detail below in connection with FIGS. 5A and 5B . In various instances, first arm 102 and second arm 104 can include handles 404 and 424, respectively. A surgeon or other medical professional can place their fingers through handles 404 and 424 to control the opening and closing of arms 406 and 426.

[0085] In various embodiments, the first arm 102, the second arm 104, and the cannula block 106 may be connected to control a maximum closing distance between the arms 406 and 426 and a maximum opening distance between the arms 406 and 426. For example, the first arm 102 may include a branch 412 including a rod 414. For example, the second arm 104 may include a branch 432 including an opening 434 ( FIG. 4B ). In other examples, the branches 412 and 432 may be reversed between the arms 102 and 104. The cannula block 106 may include an elongated opening 302. The opening 434 may be positioned above the rod 414 such that the branch 412 is connected to the branch 432. Connecting the branch 412 to the branch 432 may help maintain the first arm 102 and the second arm 104 in an assembled configuration. Elongated opening 302 may be positioned above rod 414 at the top of branch 432. In this configuration, as arms 102 and 104 move in an opening or closing direction, rod 414 translates within elongated opening 302. When rod 414 contacts one of the ends of elongated opening 302, arms 102 and 104 are prevented from opening or closing further. Limiting arm 406 of arm 102 and arm 426 of arm 104 from fully opening or closing, respectively, can help maintain the ratcheting connection between arms 102 and 104.

[0086] In at least some embodiments, the first arm 102 and the second arm 104 are connected such that the positions of the first arm 102 and the second arm 104 are maintained when no force is applied. For example, the first arm 102 and the second arm 104 may be connected by a ratchet connection including a ratchet member 436 and a ratchet receiver 416. In the illustrated example, the first arm 102 includes the ratchet receiver 416 and the second arm 104 includes the ratchet member 436, although in other examples this may be reversed. In various cases, the ratchet member 436 and / or the ratchet receiver 416 may be connected to or integral with their respective arms 102 and 104. The ratchet member 436 and the ratchet receiver 416 may each include teeth that engage with each other. In various embodiments, engagement of ratchet member 436 with ratchet receiver 416 allows first arm 102 and second arm 104 to move in a closing direction (e.g., jaw 406 moves toward jaw 426), but prevents movement in the opposite direction until the tooth and pawl sets disengage from one another. In other examples, first arm 102 and second arm 104 may be connected in a suitable manner other than a ratchet connection (e.g., a quick-lock connection) that allows the positions of first arm 102 and second arm 104 to be maintained when no force is applied.

[0087] In various embodiments, the cannula block 106 includes a cannulation section or channel 304 through which the rotating cannula 108 may be partially disposed. In at least some embodiments, the long axis of the channel 304 may be offset from the long axis of the channel 464 of the rotating cannula 108, as described in more detail with respect to FIGS. 7A and 7B . A plane 320 may extend through the long axis of the channel 304 of the cannula block 106. In some embodiments, the cannula block 106 includes one or more channels 306A and 306B for one or more fixation devices, such as k-wires. The k-wires may be advanced through the one or more channels 306A and 306B to secure the cannula block 106 to bone. In some cases, clamp 100 can be disassembled so that cannula block 106 is itself a separate piece and cannula block 106 is secured to bone with one or more fasteners, allowing a surgeon or other medical professional to use cannula block 106 alone, without the other parts of clamp 100. For example, in some cases, a surgeon may wish to limit the size of an incision during a procedure. Inserting jaws 406 and 426 of clamp 100 requires a larger incision than inserting cannula block 106 alone, and therefore, the option of using cannula block 106 alone may be desirable for a surgeon.

[0088] FIG. 4A is a top view of an exemplary first arm 102. The first arm 102 includes a body portion 402. In various embodiments, at one end, the body portion 402 may include a handle 404. The handle 404 may have any suitable shape that allows a surgeon or medical professional to control the clamp 100 with their hand or fingers. At the opposite end, or clamp end, the body portion 402 may include a jaw portion 406. In various instances, the jaw portion 406 may include teeth 418. The teeth 418 can help increase the pulling force of the jaw portion 406 against the bone, thereby keeping the clamp 100 in place during a surgical procedure. In at least some embodiments, the body portion 402 may include a concave surface 408. The concave surface 408 may be configured to allow a portion of the second arm 104 to be positioned in the concave surface 408, allowing the first arm 102 and the second arm 104 to rotate relative to each other. In at least some embodiments, body portion 402 includes a slot 410 .

[0089] As mentioned above, in at least some embodiments, a branch 412 may extend from body portion 402. In some cases, branch 412 may include a rod 414. In at least some embodiments, body portion 402 may include a ratchet receiver 416. In various cases, ratchet receiver 416 may be connected to or integral with body portion 402. Ratchet receiver 416 may include a set of teeth.

[0090] FIG. 4B is a top view of an exemplary second arm 104. The second arm 104 includes a body portion 422. In various embodiments, at one end, the body portion 422 may include a handle 424. The handle 424 may have any suitable shape that allows a surgeon or medical professional to control the clamp 100 with their hand or fingers. At the opposite end, or clamp end, the body portion 422 may include a jaw 426. In various instances, the jaw 426 may include teeth 438. The teeth 438 can help increase the pulling force of the jaw 426 against the bone, thereby keeping the clamp 100 in place during a surgical procedure. In at least some embodiments, the body portion 422 may include a concave surface 428. The concave surface 428 may be configured to allow a portion of the cannula block 106 to be positioned in the concave surface 428, allowing the arm 104 to rotate relative to the cannula block 106. In at least some embodiments, body portion 422 includes slot 430 .

[0091] As described above, in at least some embodiments, a branch 432 may extend from body portion 422. In some cases, branch 432 may include an opening 434. In at least some embodiments, body portion 422 may include a ratchet member 436. In various cases, ratchet member 436 may be connected to or integral with body portion 422. Ratchet member 436 may include a set of teeth 502 ( FIGS. 5A and 5B ) configured to engage a set of teeth on ratchet receiver 416.

[0092] FIG. 4C is a side view of an exemplary cannula block 106. Cannula block 106 includes a body portion 442. In some embodiments, body portion 442 may include an extension 450 at one end thereof. In some embodiments, body portion 442 may alternatively or additionally include a block 452 at the same end. Extension 450 may connect to ratchet member 436 of second arm 104 and may help prevent cannula block 106 from translating, as further described with respect to FIGS. 5A and 5B. Block 452 may also help a surgeon or other medical personnel disassemble clamp 100, as also described with respect to FIGS. 5A and 5B.

[0093] In at least some embodiments, body portion 442 may include a support post 448 at its opposite end. In various cases, body portion 442 may additionally or alternatively include channel 304 at the opposite end. Support post 448 acts as a support for maintaining alignment of rotatable cannula 108 when rotatable cannula 108 is positioned through channel 304. In at least some embodiments, post 444 extends from body portion 442. Post 444 may be configured to be positionable within slot 410 of first arm 102 and slot 430 of second arm 104. Post 444 serves as a rotation axis for clamp 100. In various examples, cap 446 may be attached to or integral with post 444.

[0094] 4D shows a perspective view of an exemplary rotating cannula 108. The rotating cannula 108 includes a body portion 462. A cannula or channel 464 extends the entire length of the body portion 462. In at least some embodiments, the body portion 462 may include a groove 466. In various cases, the groove 466 may extend around a portion of the body portion 462 and terminate at a flat surface 708 ( FIG. 7A ) of the body portion 462, as described in more detail in connection with FIGS. 7A and 7B .

[0095] In some embodiments, the body portion 462 may include a ribbed surface 470 at one end thereof. The ribbed surface 470 may make it easier for a surgeon or other medical professional to rotate the rotatable cannula 108 compared to a smooth surface. In some embodiments, a handle 468 may extend from the body portion 462, e.g., from the ribbed surface 470. The handle 468 may make it easier for a surgeon or other medical professional to rotate the rotatable cannula 108. The position of the handle 468 relative to the rest of the clamp 100 may indicate the position in which the rotatable cannula 108 is inserted (insertion / removal position, operating position, etc.). In some examples, the body portion 462 may include a set of markings 474 that visually indicate the position in which the rotatable cannula 108 is inserted. In some embodiments, the body portion 462 may include multiple detents 472. In such embodiments, the multiple detents 472 may interface with a ball plunger to position the rotatable cannula 108 at specific intervals.

[0096] 5A and 5B show bottom views of the coupling mechanism of the exemplary clamp 100 that allows the first arm 102, the second arm 104, and the cannula block 106 to be assembled. The first arm 102, the second arm 104, and the post 444 of the cannula block 106 are shown solely for clarity in the figures. FIG. 5A shows the assembled / disassembled position of the clamp 100. In the assembled / disassembled position, the slot 410 of the first arm 102 and the slot 430 of the second arm 104 are aligned with one another (e.g., their openings are parallel). In this position, the post 444 of the cannula block 106 can slide out of the slots 410 and 430.

[0097] As mentioned above, in some cases, cannula block 106 may include extension 450 that connects with ratchet member 436. In such cases, extension 450 may prevent cannula block 106 from translating in a direction that would allow post 444 to exit slots 410 and 430. By preventing this translation, extension 450 may help prevent cannula block 106 from disengaging from slots 410 and 430 when disassembly is not desired. For example, a surgeon or other medical professional may adjust first arm 102 and second arm 104 while using clamp 100 during a surgical procedure so that slots 410 and 430 are aligned, an adjustment that occurs when the surgeon or other medical professional is using clamp 100 and does not want to disassemble it. To disassemble clamp 100, the surgeon or other medical professional may lift extension 450 so that it no longer contacts ratchet member 436, and then translate cannula block 106 when slots 410 and 430 are aligned to release post 444 from slots 410 and 430. For example, the surgeon or other medical professional may grasp and lift block 452, thereby lifting extension 450 and translating block 452 to release cannula block 106 from slots 410 and 430.

[0098] 5B shows an exemplary operating position of clamp 100. In the operating position, first arm 102 and second arm 104 are rotated relative to each other so that their respective slots 410 and 430 are not aligned (e.g., the openings are not parallel). Because slots 410 and 430 are not aligned (e.g., the openings are not parallel), post 444 cannot translate out of slots 410 and 430 but is instead prevented from doing so (e.g., trapped) by the respective body portions 402 and 422 of first arm 102 and second arm 104. Additionally, the connection between branch 412 of first arm 102 and branch 432 of second arm 104 can help maintain first arm 102 and second arm 104 in an assembled configuration by preventing post 444 from sliding out of first arm 102 and second arm 104. In at least some embodiments, cap 446 of cannula block 106 prevents first arm 102 and second arm 104 from moving relative to cannula block 106 along the axis of post 444. In such embodiments, post 444 may have a length equal to the thickness of first arm 102 and second arm 104 to minimize or eliminate axial movement.

[0099] In the operating position, first arm 102, second arm 104, and cannula block 106 are coupled to one another while allowing first arm 102 and second arm 104 to partially rotate about post 444. The described coupling mechanism that allows assembly (and disassembly) of clamp 100 allows clamp 100 to be securely coupled to bone, with cannula block 106 securely connected to first arm 102 and second arm 104 to provide a stable and precise position for rotatable cannula 108. The stable and precise position of rotatable cannula 108 assists a surgeon or other medical professional in drilling a precise bone hole for a surgical procedure.

[0100] 6 is an enlarged perspective view of channel 304 of cannula block 106. In at least some embodiments, body portion 442 of cannula block 106 includes a tab 602 within channel 304. Tab 602 extends into channel 304 and may have any suitable shape. In at least some embodiments, cannula block 106 may include a ball plunger 604. In such embodiments, ball plunger 604 may be, for example, any suitable ball and spring plunger. Ball plunger 604 may extend into channel 304 and may be forced into body portion 442 when force is applied to ball plunger 604.

[0101] 7A and 7B illustrate the locking feature of the exemplary clamp 100 for coupling and uncoupling the rotatable cannula 108 to the cannula block 106. The cannula block 106 is shown in cross section for illustrative purposes. The ability to separate the rotatable cannula 108 from the cannula block 106 allows the rotatable cannula 108 to be properly cleaned and sterilized between surgeries. The ability to separate the rotatable cannula 108 from the cannula block 106 also helps reduce the storage footprint of the clamp 100 compared to at least some conventional clamps, making it easier to store on a surgical tray.

[0102] 7A shows the insertion / removal position 700 of the rotatable cannula 108. In the insertion / removal position 700, a flat surface 708 on the body portion 462 of the rotatable cannula 108 aligns with a tab 702 on the cannula block 106. The tab 702 can slide along the flat surface 708 to allow the rotatable cannula 108 to be inserted into and removed from the channel 304 of the cannula block 106. In other words, in the insertion / removal position 700, the tab 702 is not within the groove 704. Instead, the groove 704 begins on the opposite side of the flat surface 708. As shown, in various embodiments, a set of markings 474 on the rotatable cannula 108 may indicate that the rotatable cannula 108 is in the insertion / removal position 700. Additionally or alternatively, the orientation of the handle 468 may indicate that the rotatable cannula 108 is in the insertion / removal position 700. Optionally, when the rotating cannula 108 is in the insertion / removal position 700 , the ball plunger 604 may be disposed within the detent 472 .

[0103] 7B illustrates the docking position 710 of the rotatable cannula 108. In the docking position 710, the tabs 702 of the cannula block 106 are positioned within the grooves 704 of the rotatable cannula 108. The tabs 702 prevent the rotatable cannula 108 from translating in and out of the channel 304 of the cannula block 106. Once the exemplary clamp 100 is introduced into the surgical site, the surgeon or other medical professional pushes the clamp 100 through the soft tissue and down to the bone until the rotatable cannula 108 is flush with the near-cortex of the bone (e.g., FIG. 14 ). The configuration of the tabs 702 within the grooves 704 allows the surgeon or other medical professional to apply an axial force to the rotatable cannula 108 to push the rotatable cannula 108 through the soft tissue without forcing the rotatable cannula 108 out of the cannula block 106. To transition from the insertion / removal position 700 to the docking position 710, a surgeon or other medical professional may rotate the rotatable cannula 108. In one example, the docking position 710 is where the rotatable cannula 108 is rotated 180 degrees from the insertion / removal position 700.

[0104] In at least some embodiments, when the rotatable cannula 108 is disposed through the channel 304 of the cannula block 106, the longitudinal axis of the channel 464 of the rotatable cannula 108 is offset from the longitudinal axis of the channel 304 of the cannula block 106. Stated another way, in some embodiments, when the rotatable cannula 108 is disposed within the channel 304 of the cannula block 106, the channel 464 and the channel 304 are not coaxial. This offset configuration creates a camming effect in which the channel 464 translates relative to the plane 320 extending through the longitudinal axis of the channel 304 when the rotatable cannula 108 is rotated while disposed within the cannula block 106.

[0105] For example, the long axis of channel 464 may initially be neutrally positioned so that it intersects plane 320, and may similarly become neutrally positioned if rotatable cannula 108 is rotated a half turn (180 degrees). However, if rotatable cannula 108 is rotated less than a half turn (e.g., greater than 0 degrees but not more than 180 degrees) or more than a half turn (e.g., greater than 180 degrees but not more than 360 degrees), the long axis of channel 464 translates away from plane 320. The maximum translation of the long axis of channel 464 away from plane 320 may be achieved by rotating cannula 108 a quarter turn (90 degrees or 270 degrees) from its starting position. The amount of offset of the long axis of channel 464 relative to the long axis of channel 304 when rotatable cannula 108 is inserted through channel 304 determines the amount that the long axis of channel 464 translates relative to plane 320 when rotatable cannula 108 is rotated. In one example, the offset may be 2 millimeters, allowing up to 2 millimeters of translation relative to the long axis of rotatable cannula 108 from plane 320 extending through the long axis of channel 304.

[0106] In such embodiments including this offset configuration, clamp 100 may include multiple different engagement positions 710. For example, rotatable cannula 108 may include multiple detents 472, each representing a different engagement position 710 (in addition to detent 472 corresponding to insertion / removal position 700). When ball plunger 604 is within detent 472, ball plunger 604 provides additional resistance to rotation of rotatable cannula 108 to help maintain the correct rotational position until a change in rotational position is desired. In one example, detent 472 may be positioned such that ball plunger 604 engages detent 472 when the long axis of rotatable cannula 108 is oriented at its maximum translation (e.g., 2 mm) from plane 320. In some cases, rotatable cannula 108 may include two additional detents 472, each designating a maximum translation of the long axis of rotatable cannula 108. In some cases, the rotating cannula 108 may include one or more detents 472 that designate when the long axis of the rotating cannula 108 has translated less than the maximum translation (e.g., 1 mm). As shown, in various embodiments, a set of markings 474 may indicate when the rotating cannula 108 is in a binding position 710, and in some cases, which binding position 710. Additionally or alternatively, the orientation of the handle 468 may indicate when the rotating cannula 108 is in a binding position 710, and in some cases, which particular binding position 710 it is in.

[0107] In various embodiments of the present disclosure, each of the components of the exemplary clamp 100 may be constructed from a suitable medical-grade material. For example, suitable medical-grade materials may include carbon fiber reinforced PEEK, stainless steel, titanium, cobalt chrome, or other suitable plastics. In some cases, suitable plastics have the advantage of being radiotransparent. In some cases, the components of the clamp 100 may all be constructed from the same material. In other embodiments, one or more components of the clamp 100 may be constructed from a different material than the other components. In at least some embodiments, the first arm 102 and the second arm 104 may each be constructed from a material that is sufficiently strong while also having elastic properties. For example, the first arm 102 and the second arm 104 may be constructed from titanium, carbon fiber reinforced plastic, stainless steel, or cobalt chrome.

[0108] The present disclosure further provides a new and innovative bone size scale for use with surgical clamps. In some cases, this can help surgeons and other medical professionals determine the size of the bone they are clamping. Knowing the bone size (e.g., the width between the teeth 418 of the first jaw 406 and the teeth 438 of the second jaw 426) can be useful to help surgeons and other medical professionals select the size of an implant (e.g., a screw, bushing, rod, nail, or arthroplasty). Knowing the bone size can also be useful in determining whether the bone is too small for a particular procedure. FIG. 8 shows an exemplary clamp 800 having a bone size scale 802 disposed between the first arm 102 and the second arm 104 for determining bone size. In some cases, the bone size scale 802 may be included in the clamp 100, and therefore this description will refer to components of the clamp 100. In other cases, the provided bone size scale 802 may be included in any other suitable clamp.

[0109] In at least some embodiments, the bone dimension scale 802 may be disposed on the ratchet member 436. The bone dimension scale 802 may include multiple indicators (line markings, indentations, etc.) and / or values ​​corresponding to particular bone dimensions. In various instances, as the first arm 102 and the second arm 104 rotate relative to one another, the position of the ratchet member 436 changes relative to the first arm 102, thereby changing the reading on the bone dimension scale 802. In other embodiments, the clamp 800 may include an arm separate from the ratchet member 436 that includes the bone dimension scale 802. The separate arm may be connected to or integral with the second arm 104 (e.g., the same arm as the ratchet member 436). In some embodiments, the separate arm may slide along the first arm 102 (e.g., the arm opposite to the one to which the separate arm is connected) as the first arm 102 and the second arm 104 rotate relative to one another.

[0110] Once the first arm 102 and the second arm 104 are in a desired position (e.g., in contact with the bone but before clamping), the surgeon or other medical professional can determine the bone dimension based on where a particular marking (e.g., an edge of the first arm 102) aligns with the bone dimension scale 802. Because clamping can deform the first arm 102 and the second arm 104, leading to erroneous bone dimension determinations, it may be beneficial for the surgeon or other medical professional to determine the bone dimension while the first jaw 406 and the second jaw 426 are in contact with the bone but before clamping the bone. In at least some examples, the first arm 102 may include an indicator 804, such as a line marking or indentation, as the particular marking. In such examples, the indicator and / or value on the bone dimension scale 802 that aligns with the indicator 804 is considered the measured bone dimension.

[0111] The present disclosure further provides a new and innovative compression force scale for use in surgical clamps. In some cases, this can help surgeons and other medical professionals determine how much force they are applying to bone when clamping. For example, it may be important for surgeons and other medical professionals to limit the amount of force they apply to osteoporotic bone so as not to fracture the bone by clamping. FIG. 9 shows an exemplary clamp 900 having a compression force scale 906 for determining the amount of force applied by a first jaw 914 of a first arm 902 and a second jaw 916 of a second arm 904, according to one embodiment of the present disclosure. In some cases, the exemplary clamp 900 may be similar to clamp 100 with the addition of the compression force scale 906. In other cases, the clamp 900 may have any other clamp configuration suitable for implementing the compression force scale 906. For example, in some examples, the first arm 902 may be coupled to the second arm 904 at a revolute joint 912.

[0112] In some embodiments, the compression force scale 906 is disposed on a member 910 connected to or integral with the second arm 904. In some examples, the member 910 is a ratchet member. In other examples, the member 910 may be another suitable connecting member (e.g., part of a quick-lock connection) between the first arm 902 and the second arm 904. In some embodiments, the compression force scale 906 may be disposed on a second member separate from the connecting member. The second separate member may extend from the second arm 904 (e.g., the same arm as the connecting member). In some embodiments, as the first jaw 902 and the second jaw 904 rotate relative to one another, a separate arm may slide above or below the first jaw 902 (e.g., the jaw opposite to the one to which the separate arm is connected). In some cases, the compression force scale 906 may include multiple indicators (line markings, indentations, etc.) and / or values ​​corresponding to specific amounts of force. In some cases, the compression force scale 906 may include multiple indicators (line markings, indentations, etc.) corresponding to levels or ranges of clamping force (eg, high, medium, low).

[0113] In at least some embodiments, the first arm 902 and the second arm 904 may be constructed of a material having elastic properties. In such embodiments, the first arm 902 and the second arm 904 may deform while clamping the bone. The resulting deformation may cause the indicator arm 908 to move relative to the compression force scale 906. The elastic first arm 902 and the second arm 904 are calibrated relative to the compression force scale 906 based on the elastic properties and shape of the first arm 902 and the second arm 904. In at least some embodiments, the indicator arm 908 may be connected to or integral with the second arm 904. Once the first arm 902 and the second arm 904 are in the position to be measured (e.g., clamping a bone), the surgeon or other medical professional can determine where the indicator arm 908 aligns on the compression force scale 906 to determine the compression force being applied to the bone between the first arm 902 and the second arm 904.

[0114] The present disclosure further provides a system including a bushing and a set screw. The provided bushing and set screw can lock a nail to the bushing as part of a nail-based bone fixation system. FIGS. 10 and 11 show perspective and side views, respectively, of an exemplary system 1000 including an exemplary bushing 1002 and an exemplary set screw 1006. In some cases, the exemplary system 1000 may include a nail 1004. The set screw 1006 may be inserted into the bushing 1002 to press the nail 1004 against the bushing 1002 (against the inner surface of the bushing, as shown) to lock the nail 1004 to the bushing 1002. The nail 1004 is shown locked to the bushing 1002 by the set screw 1006.

[0115] In at least some embodiments, the bushing 1002 comprises a plurality of external threads 1101 on a body portion 1100. The body portion 1100 may comprise an opening 1110 extending through the body portion 1100. In at least some embodiments, the bushing 1002 comprises a nipple 1102 extending from the body portion 1100. In some examples, the nipple 1102 may be blunt or smooth. In other examples, the nipple 1102 may include a sharp end. In some examples, the nipple 1102 may comprise external threads.

[0116] In some examples, the interior of body portion 1100 may be smooth or may have no internal threads. In other examples, body portion 1100 may include multiple internal threads, as shown in FIG. 12 . In at least some embodiments, as shown in FIG. 12 , the internal threads of bushing 1002 may include a fully threaded portion 1202 and a partially threaded portion 1204. In some cases, the internal threads may gradually taper from the fully threaded threads at portion 1202 to the partially threaded threads at portion 1204. In various cases, the interior of bushing 1002 includes an unthreaded portion 1206. In some cases, the internal threads may gradually taper from the partially threaded threads at portion 1204 to the completely unthreaded portion at portion 1206. In various embodiments, portions 1202, 1204, and 1206 may have any suitable lengths relative to one another.

[0117] In some embodiments, the internal threads of the bushing 1002 may include only partially formed threads. Stated another way, the partially formed thread portion 1204 may extend the entire length of the interior of the body portion 1100. In some embodiments, the internal threads of the bushing 1002 may include only fully formed threads and only partially formed threads. For example, the interior of the body portion 1100 may include one or more fully formed thread portions 1202 and one or more partially formed thread portions 1204. In such an example, the interior of the body portion 1100 may be divided into fully formed thread portions 1202 and partially formed thread portions 1204, or the fully formed portions and partially formed portions may alternate (e.g., portion 1202, portion 1204, portion 1202 along the length of the interior of the body portion 1100). In some embodiments, the internal threads of the bushing 1002 may include only one or more fully formed thread portions 1202 and one or more portions 1206 without internal threads. In some embodiments, the internal threads of the bushing 1002 may include only one or more partially threaded portions 1204 and one or more portions 1206 without internal threads.

[0118] Returning to FIG. 11 , in at least some embodiments, the set screw 1006 includes a plurality of threads 1106. The threads 1106 of the set screw 1006 may be fully formed. In at least some embodiments, the set screw 1006 is constructed of a material (e.g., cobalt chrome or stainless steel) that is harder than the material (e.g., titanium, stainless steel, or a suitable plastic) from which the bushing 1002 is constructed. In at least some examples, when the set screw 1006 having the fully formed plurality of threads 1106 is driven or advanced into the bushing 1002, the partially formed internally threaded portion 1204 and the unthreaded portion 1206 interfere with the plurality of threads 1106. This interference causes the plurality of threads 1106 of the set screw 1006 to apply an outward force (e.g., in the opposite direction of arrows 1108A and 1108B) to the sidewall of the body portion 1100 of the bushing 1002, pushing the sidewall outward. For example, the set screw 1006 may be constructed of a harder material than the bushing 1002 so that the threads 1106 of the set screw 1006 are not forced into the bushing 1002 and vice versa.

[0119] Once the set screw 1006 is fully inserted, the set screw 1006 applies a compressive force to the nail 1004 in the direction of arrow 1104, which helps lock the nail 1004 in place. The compressive force creates a tension force in the bushing 1002 in the direction of arrow 1104. At the same time, the engagement of the threads 1106 with the internal threads of the bushing 1002 creates an opposing tension force in the bushing 1002 in the direction of arrow 1106. The opposing tension forces in the directions of arrows 1104 and 1106 tend to pull the bushing 1002 apart and also act against each other on the side walls of the body portion 1100 in the directions of arrows 1108A and 1108B. The forces created in the directions of arrows 1108A and 1108B oppose the outward force (e.g., in the opposite direction of arrows 1108A and 1108B) created by the interference and applied by the set screw 1006. The repulsive forces create friction between the set screw 1006 and the bushing 1002, preventing loosening of the set screw 1006. In this manner, the bushing 1002 and the set screw 1006 provide a self-locking structure.

[0120] In at least some embodiments of the present disclosure, as shown in FIG. 13 , the set screw 1006 may include an unthreaded portion 1304 at its tip. The unthreaded portion 1304 may be a smooth portion lacking external threads. In some embodiments, the tip, including the unthreaded portion 1304, may be cylindrical. In some embodiments, the unthreaded portion 1304 may include a tapered tip 1306. During a surgical procedure, the set screw 1006 is inserted using a long driver through a long cannula (e.g., a cannula inserted into the rotating cannula 108), which makes it difficult to properly guide the set screw 1006 into the bushing 1002 while avoiding tilt and cross-threading during initial insertion. The unthreaded portion 1304 helps the set screw 1006 automatically orient itself relative to the bushing 1002 during insertion. For example, the unthreaded portion 1304 may be coaxially aligned with the internal threads of the bushing 1002 (e.g., portion 1202) to help ensure that the set screw 1006 is coaxially aligned with the bushing 1002 prior to threaded engagement between the set screw 1006 and the bushing 1002. Ensuring that the set screw 1006 and the bushing 1002 are coaxially aligned prior to threaded engagement helps prevent canting of the set screw 1006 during initial insertion and helps prevent cross-threading.

[0121] The present disclosure further provides a drill component system for preparing a fixation component for insertion into bone. The fixation component may be, for example, a bushing (e.g., bushing 1002), a screw or fastener, or another suitable fixation component. In one example, when bushing 1002 is used in a bone fixation procedure, the plurality of external threads 1101 of threaded body portion 1100 engages the proximal cortex of the bone and nipple 1102 engages the distal cortex of the bone. In such an example, a provided drill component system can prepare bushing 1002 including such features for insertion into bone. In various embodiments, a provided drill component system may include a juxtacortical drill component 1404 ( FIGS. 14 , 15 , and 16 ) for preparing the proximal cortex. A provided drill component system may additionally or alternatively include a distal cortical drill component (e.g., FIG. 17 ) for preparing the distal cortex. A provided drill component system helps ensure that surgeons and other medical personnel do not accidentally over-drill the proximal or distal cortex. Such over-drilling may weaken the potential retention force of the fixation component. For example, such over-drilling may weaken the engagement of the bushing 1002 with the bone, thereby dramatically reducing the retention force provided by the bushing 1002 and the set screw 1006. The juxtacortical drill component and the distal cortical drill component may each be coupled to a driving instrument, such as a drill.

[0122] 14 and 15 illustrate an exemplary juxtacortical drill element 1404. The juxtacortical drill element 1404 includes a shaft 1502. A tip 1506 of the shaft 1502 is configured to cut into bone when driven by a driving instrument. In some embodiments, a rear end 1504 of the shaft 1502 may be configured to couple to the driving instrument. For example, the rear end 1504 may be configured as an AO connector. In other embodiments, the juxtacortical drill element 1404 may be connected to the driving instrument rather than being configured to couple to the driving instrument.

[0123] In at least some embodiments, the shaft 1502 of the juxtacortical drill element 1404 includes a shoulder 1406. The shoulder 1406 extends outward from the shaft 1502 such that the juxtacortical drill element 1404 has a larger outer diameter at the shoulder 1406 than elsewhere on the shaft 1502. In various embodiments, the shoulder 1406 is configured so that when the juxtacortical drill element 1404 is inserted through a surgical cannula, the shoulder 1406 cannot pass through the cannula, thereby limiting the depth to which a surgeon or other medical practitioner can drill using the juxtacortical drill element 1404. The shoulder 1406 is specifically positioned on the shaft 1502 to help prevent a surgeon or other medical practitioner from reaching or drilling into the distal cortex with the juxtacortical drill element 1404. For example, FIG. 14 shows the clamp 100 in position for performing a drilling operation on a bone 1402. The juxtacortical drill element 1404 is placed through the rotating cannula 108 at a maximum insertion depth where the shoulder 1406 contacts the rotating cannula 108 .

[0124] 16 shows a close-up view of the tip 1506 of the juxtacortical drill element 1404. In at least some embodiments, the tip 1506 includes a sharp cutting portion 1602 that cuts into bone when the juxtacortical drill element 1404 is driven by a driving instrument. The sharp cutting portion 1602 is configured so that the bone hole it creates has a diameter smaller than the outer diameter of the fixation element into which it is drilled. In various embodiments, the fixation element may be a bushing (e.g., bushing 1002), a screw or fastener, or another suitable fixation element. The smaller diameter of the bone hole than the outer diameter of the fixation element allows the fixation element (e.g., its screw) to be driven into the bone to create a fixation effect.

[0125] 17 shows a side view of an exemplary cortical distal drill element 1700. The cortical distal drill element 1700 includes a shaft 1702. In some embodiments, a trailing end 1704 of the shaft 1702 may be configured to couple to a driving instrument. For example, the trailing end 1704 may be configured as an AO connector. In other embodiments, the cortical distal drill element 1700 may be connected to a driving instrument rather than being configured to couple to a driving instrument. A tip 1706 of the cortical distal drill element 1700 is configured to cut into bone when the cortical distal drill element 1700 is driven by the driving instrument. In at least some instances, a surgeon or other medical professional may use the cortical distal drill element 1700 after drilling a hole near the cortex of a bone using the juxtacortical drill element 1404.

[0126] In at least some embodiments, the tip 1706 of the distal cortical drill element 1700 includes a blunt reamer portion 1710. A sharp trocar tip 1708 may extend from the blunt reamer portion 1710. The blunt reamer portion 1710 may have a larger diameter than the sharp trocar tip. When a surgeon or other medical professional impacts the distal cortical drill element 1700 into bone, the sharp trocar tip 1708 can create a hole at the distal cortex. The hole created at the distal cortex has a smaller diameter than the hole created in the bone by the proximal cortical drill element 1404. In at least some embodiments, the blunt reamer portion 1710 is configured not to penetrate or penetrate into the bone. In such an embodiment, the blunt reamer portion 1710 prevents the shaft 1702 of the distal cortical drill element 1700 from penetrating the distal cortex and also limits the depth to which the sharp trocar tip 1708 can penetrate or pass through the distal cortex because the sharp trocar tip 1708 has a certain length and cannot penetrate further than a certain length.

[0127] In at least some embodiments, the sharp trocar tip 1708 is configured such that the hole it creates corresponds to at least a portion of the fixation component used in the procedure. For example, the hole may correspond to the diameter of a screw. In another example, the sharp trocar tip 1708 may be configured such that the hole it creates distal to the cortex corresponds to the nipple 1102 of the bushing 1002. In such an example, the bushing 1002 maintains its position or fixation within the bone once installed because the hole created by the sharp trocar tip 1708 can provide a good fit for the nipple 1102. In at least some embodiments, the blunt reamer portion 1710 may be configured with a shape to contour the inside of the bone canal to correspond to the shape of at least a portion of the fixation component used in the procedure. For example, the blunt reamer portion 1710 may contour the inside of the bone canal to correspond to the body portion 1100 of the bushing 1002. In such an example, once the bone canal is contoured by the blunt reamer portion 1710, the multiple external threads 1101 of the bushing 1002 can penetrate evenly into the bone wall to maximize engagement of the multiple external threads 1101 and help stabilize the bushing 1002.

[0128] An exemplary method for preparing a bone for nail-based fixation is also provided. A surgeon may select at least one fixation component (e.g., bushing 1002) having a specific size. Next, the surgeon may select a first drill component (e.g., juxtacortical drill component 1404) corresponding to the selected size of bushing 1002. A second drill component (e.g., distal cortical drill component 1700) corresponding to the selected size of bushing 1002 may further be selected. The surgeon may insert the juxtacortical drill component 1404 through a cannula (e.g., rotatable cannula 108 of clamp 100) in contact with the bone. The juxtacortical drill component 1404 may be coupled or connected to a power drilling instrument. Once the juxtacortical drill component 1404 is inserted through the rotatable cannula 108, the surgeon can drill a juxtacortical portion of the bone to form a juxtacortical bone hole. The juxtacortical drill component 1404 may then be removed from the rotatable cannula 108.

[0129] The surgeon may then insert the cortical distal drill element 1700 through the rotating cannula 108. The cortical distal drill element 1700 may be coupled or connected to a power drill instrument. Once the cortical distal drill element 1700 is inserted through the rotating cannula 108, the surgeon drills the distal cortex of the bone through the bone hole created by the juxtacortical drill element 1404, thereby forming a second bone hole in the distal cortex. The cortical distal drill element 1700 may then be removed from the rotating cannula 108. Using the bone holes drilled in the juxtacortical and distal cortical regions, the surgeon can attach the bushing 1002 to the drilled bone hole. In at least some embodiments of this example, the surgeon may attach a nail (e.g., nail 1004) through an opening (e.g., opening 1110) in the bushing 1002. With the nail 1004 installed through the opening 1110 , the surgeon can install a set screw (e.g., set screw 1006 ) within the bushing 1002 so that the set screw 1006 locks the nail 1004 to the bushing 1002 .

[0130] The examples and embodiments disclosed herein should be construed as merely illustrative and in no way limit the scope of the present disclosure. It will be apparent to those skilled in the art that changes can be made to the details of the above-described examples without departing from the basic principles described. In other words, various modifications and improvements of the examples specifically disclosed in the above description are within the scope of the appended claims. For example, any suitable combination of features of the various examples described is contemplated.

Claims

1. A clamping device for use in a bone fixation procedure, comprising: a first arm including a handle at one end opposite a clamping end and an elongated first slot between opposite ends of the first arm, the first slot extending through the first arm in an elongated direction and opening toward the clamping end of the first arm; a second arm including a handle at one end opposite the clamping end and an elongated second slot between opposite ends of the second arm, the second slot extending through the second arm in an elongated direction and opening toward the clamping end of the second arm; a cannula block including a body portion having a channel, a post extending from the body portion, and a cap on one end of the post, the post connecting the first arm, the second arm, and the cannula block; a rotating cannula including a body portion having a cannula insert along a longitudinal axis thereof, the rotating cannula configured to be disposed through the channel of the cannula block; Equipped with the first arm, the second arm, the cannula block, and the rotating cannula are different, separate components configured to allow the clamping device to be repeatedly assembled and disassembled into different, separate components; In an operative configuration, the post of the cannula block is disposed within the first slot and the second slot such that the first arm and the second arm can rotate about the post.

2. 2. The clamping apparatus of claim 1, wherein the first arm, the second arm, and the cannula block are configured such that in the operating configuration, the first arm and the second arm prevent the post of the cannula block from exiting the first slot and the second slot.

3. 2. The clamping device of claim 1, wherein the first arm, the second arm, and the cannula block are configured such that disassembling the clamping device includes manipulating the first arm and the second arm to align the first slot with the second slot and allow the post of the cannula block to translate out of the first slot and the second slot.

4. The clamping apparatus of claim 1 , wherein the cap is configured such that, in an assembled configuration, the cap prevents the first arm or the second arm from axially translating along the post.

5. The clamping apparatus of claim 1 , wherein the first arm and the second arm are connected such that the connection limits openings of the first arm and the second arm.

6. The clamping apparatus of claim 5 , wherein the first arm and the second arm are connected by a ratchet connection including a ratchet member and a ratchet receiver.

7. 2. The clamping apparatus of claim 1, wherein the length of the post is approximately equal to the sum of a first thickness of the first arm in the first slot and a second thickness of the second arm in the second slot.

8. 2. The clamping apparatus of claim 1, wherein the first arm or the second arm includes a branch having a rod, and the other of the first arm or the second arm includes a branch having an opening, the rod configured to fit snugly through the opening.

9. The clamping apparatus of claim 8 , wherein the cannula block includes an elongated opening, and in the assembled configuration, the rod is configured to be disposed within the elongated opening.

10. The clamping apparatus of claim 1 , wherein the cannula block includes a plurality of fastener openings.

11. 2. The clamping device of claim 1, wherein the body portion of the cannula block includes a tab protruding into the channel, and the body portion of the rotating cannula includes a flat surface located forward of the channel in a direction of insertion of the rotating cannula, and a groove extending around the body portion of the rotating cannula and terminating at the flat surface, the tab being configured to be able to move parallel to the groove, and a bottom of the groove being continuous with the flat surface.

12. 12. The clamping apparatus of claim 11, wherein the cannula block and the rotating cannula are configured such that when the tab is oriented toward the flat surface, the rotating cannula can translate only axially through the channel in the cannula block.

13. 13. The clamping apparatus of claim 12, wherein the cannula block and the rotatable cannula are configured such that the rotatable cannula is locked to the cannula block such that rotating the rotatable cannula so that the tabs are disposed within the grooves prevents the rotatable cannula from translating along the longitudinal axis of the rotatable cannula body portion.

14. The clamping apparatus of claim 1 , further comprising an indicator or numerical scale corresponding to the distance between the clamping ends of the first arm and the second arm.

15. The clamping apparatus of claim 1 , further comprising an indicator or numerical scale corresponding to an amount of compressive force applied between the clamping ends of the first and second arms.

Images