A targeting device for inserting a screw into the distal end of the bone

Abstract

The present application provides a new and innovative device that aids in the insertion of a screw through a distal end of a nail inserted into a patient's bone (e.g., humerus). The distal end of the nail is spaced apart from the location of the nail's insertion into the bone. The targeting device includes a targeting body having an outer frame, a flexible member connected to the outer frame, a targeting block having a plurality of holes and connected to the flexible member such that the targeting block can translate toward the side of the outer frame due to the flexibility of the flexible member, and an adjustment assembly that adjusts and maintains the position of the targeting block relative to the side of the outer frame. The targeting device further includes a base plate removably coupled to the targeting body. The targeting device may be coupled to the nail at the base plate.

Description

[Technical field]

[0001] Claiming priority This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 164,272, filed March 22, 2021, which is incorporated by reference in its entirety herein. [Background technology]

[0002] A typical system and method for treating proximal humerus fractures, such as the Polarus 3 Solution surgical system marketed by Acumed®, involves inserting a treatment instrument into the humerus, which consists of a series of plates and nails that help compress the bone fragments together and promote healing. As part of inserting the nail into the humerus, a screw is inserted into the bone through a hole in the nail. This process involves targeting the screw so that it passes through the hole in the nail as it is driven into the humerus. Typically, screws inserted into the proximal end of the humerus (e.g., near the shoulder) are targeted using and inserted through a targeting instrument. Meanwhile, screws inserted into the distal end of the humerus (e.g., near the elbow) are typically targeted using a "freehand technique," which involves the surgeon using fluoroscopy to manually align a drill bit with the nail hole visible on the fluoroscopic image. The screw is then driven into the drill hole. Summary of the Invention [Problem to be solved by the invention]

[0003] The "freehand technique" may be challenging for some surgeons because it may be difficult to simultaneously view a fluoroscopic image showing the nail hole inserted into the bone and position the drill bit relative to the bone based on the fluoroscopic image as the drill bit moves through the nail hole. In other words, there are many variables, such as the surgeon's arm, the drill bit, and the C-arm, all of which must be stabilized to accurately target the drill bit, which may be difficult to do. Anatomical differences between patients may make the "freehand technique" more challenging to perform in some patients compared to others. Thus, there is a need for a device that helps address the above-mentioned shortcomings of typical systems and procedures for inserting nails and screws into the distal end of the humerus. [Means for solving the problem]

[0004] This application relates generally to fracture fixation. More specifically, this application provides a targeting guide / device that aids in the insertion of a screw through a distal end of a nail that is inserted into a bone, such as the humerus. When the nail is inserted into the bone, the proximal end of the nail is positioned near an insertion location where the nail is inserted into the bone, and the distal end of the nail is positioned away from the insertion location. For example, when the nail is inserted into the humerus, the proximal end of the nail is positioned near the patient's shoulder, and the distal end of the nail is positioned away from the shoulder.

[0005] In light of the technical features described herein, and without being limited thereto, in a first aspect of the disclosure of the present application, which may be combined with any other aspect unless otherwise specified, the targeting device comprises a targeting body having an outer frame, a flexible member connected to the outer frame, a targeting block having a plurality of holes and connected to the flexible member so that the targeting block can translate toward the side of the outer frame due to the flexibility of the flexible member, and an adjustment assembly for adjusting and maintaining the position of the targeting block relative to the side of the outer frame. The targeting device further comprises a base plate removably connected to the targeting body. The targeting device may be connected to the nail at the base plate.

[0006] 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 targeting device further comprises a curved connecting bow. The base plate is removably coupled to the targeting body via the curved connecting bow, such that a central plane of the curved connecting bow is substantially perpendicular to a central plane of the targeting body, and a central plane of the base plate is substantially perpendicular to a central plane of the curved connecting bow.

[0007] In a third aspect of the present disclosure, which may be combined with any other aspect (e.g., the first or second aspect) unless otherwise specified, the nail is substantially parallel to the targeting body when connected to the base plate.

[0008] 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 adjustment assembly includes a rod having a first threaded portion configured to engage with a second threaded portion to adjust the position of the targeting block by rotating the rod.

[0009] In a fifth aspect of the present disclosure, which may be combined with any other aspect (e.g., the fourth aspect) unless otherwise specified, the adjustment assembly further includes a component disposed in a first opening of the targeting block, the component having a second opening including a second threaded portion, and a rod disposed through a third opening of the targeting block and the second opening of the component.

[0010] In a sixth aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to fifth aspects) unless otherwise specified, the targeting device further comprises a removable targeting cannula configured to be positioned through a hole in the targeting body, the removable targeting cannula configured to guide a drill bit.

[0011] 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 specified, the targeting device further comprises a removable insert configured to be positioned relative to the targeting block such that the removable insert blocks access to some of the multiple holes in the targeting block while allowing access to the remaining unblocked holes.

[0012] 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 specified, the targeting device further comprises a magnet positioned adjacent to at least one of the plurality of holes.

[0013] In a ninth aspect of the present disclosure, which may be combined with any other aspect (eg, the eighth aspect) unless otherwise specified, the magnet is embedded within the targeting block.

[0014] In a tenth aspect of the present disclosure, which may be combined with any other aspect (eg, the first to ninth aspects) unless otherwise specified, the flexible member is a leaf spring.

[0015] In an eleventh aspect of the present disclosure, which may be combined with any other aspect (e.g., the first to ninth aspects) unless otherwise specified, the targeting device further comprises an X-ray opaque component embedded within the targeting block.

[0016] 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 radiopaque components include a first set of radiopaque components arranged in a first line, a second set of radiopaque components arranged in a second line parallel to the first line, and a third radiopaque component arranged parallel to the first and second lines.

[0017] 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 first and second sets of radiopaque components are arranged in a first plane, and the third radiopaque component is arranged in a second plane spaced apart from the first plane.

[0018] 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 specified, a system for inserting a screw through a distal end of a nail inserted into a patient's bone comprises a nail and a targeting device (e.g., the targeting device of the first aspect). The nail includes a screw hole at the distal end of the nail.

[0019] In a fifteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the fourteenth aspect) unless otherwise specified, the system further comprises a linear component, and the targeting device is configured to couple the linear component to the targeting device.

[0020] In a sixteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the fifteenth aspect) unless otherwise specified, the targeting device further comprises a removable insert configured to be partially inserted into at least one of the multiple holes of the targeting block, the removable insert being configured to couple the linear component to the removable insert.

[0021] In a seventeenth aspect of the disclosure of the present application, which may be combined with any other aspect (e.g., the first to sixteenth aspects) unless otherwise specified, a method of inserting a screw through a distal end of a nail inserted into a bone of a patient includes inserting a nail into a bone of a patient, the nail including a screw hole at a distal end of the nail. A targeting device (e.g., the targeting device of the first aspect) may be coupled to a proximal end of the nail. The coupled targeting device may be aligned using X-ray fluoroscopy such that one of the holes of the targeting block is targeted to the screw hole at the distal end of the nail. A bone hole may be drilled in the bone to align the drilled bone hole with the screw hole at the distal end of the nail. A screw may then be inserted into the screw hole.

[0022] In an eighteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the seventeenth aspect) unless otherwise specified, aligning the targeting device includes inserting the targeting marker into one of the holes in the targeting block to bring an end of the targeting marker adjacent to the bone. The end of the targeting marker is radiopaque.

[0023] In a nineteenth aspect of the present disclosure, which may be combined with any other aspect (e.g., the seventeenth aspect or the eighteenth aspect) unless otherwise specified, the method further includes connecting a linear radiopaque component to the targeting device, and aligning the targeting device includes adjusting the targeting device until the connected linear radiopaque component and the inserted nail are substantially parallel on the fluoroscopic image.

[0024] In a twentieth aspect of the present disclosure, which may be combined with any other aspect (e.g., the seventeenth to nineteenth aspects) unless otherwise specified, the targeting block includes a first row of radiopaque components, a second row of radiopaque components parallel to the first row, and a third radiopaque component arranged parallel to the first and second rows, and aligning the targeting device includes adjusting the targeting device until the third radiopaque component is equidistantly spaced from the first and second rows of radiopaque components on the fluoroscopic image.

[0025] Further 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 many additional features and advantages will be apparent to those skilled in the art in light of the figures and descriptions. Furthermore, it should be noted that the language used in this specification has been chosen primarily for purposes of readability and explanation, and not to limit the scope of the inventive subject matter. [Brief description of the drawings]

[0026] [Figure 1A] 1 shows a perspective view of a targeting device that assists a surgeon in targeting bone screws to the medial / lateral aspects at the distal end of a nail inserted into the humerus, according to one aspect of the present disclosure.

[0027] [Figure 1B]FIG. 1B is a perspective view showing the targeting device of FIG. 1A assisting a surgeon in targeting a bone screw to the anterior / proximal surface at the distal end of a nail inserted into the humerus, according to one embodiment of the present disclosure.

[0028] [Diagram 2] FIG. 1C is a perspective view showing a targeting body of the targeting device of FIGS. 1A and 1B according to one embodiment of the present disclosure.

[0029] [Figure 3A] FIG. 3 is a perspective view showing an adjustment assembly of the targeting body of FIG. 2 according to one embodiment of the present disclosure.

[0030] [Figure 3B] FIG. 3B is a perspective view showing components of the adjustment assembly of FIG. 3A according to one embodiment of the present disclosure.

[0031] [Figure 4] FIG. 3 is a perspective view showing a targeting block of the targeting body of FIG. 2 according to one embodiment of the present disclosure.

[0032] [Diagram 5] FIG. 1C is a perspective view showing components of the targeting device of FIGS. 1A and 1B according to one embodiment of the present disclosure.

[0033] [Figure 6] FIG. 1 is a perspective view of an exemplary removable insert according to one aspect of the present disclosure.

[0034] [Figure 7A] 1C is a perspective view illustrating an exemplary magnet arrangement that assists in retaining a targeting cannula within the cannula bore of the targeting block of FIGS. 1A and 1B, according to one embodiment of the present disclosure. FIG. [Figure 7B] 1C is a perspective view illustrating an exemplary magnet arrangement that assists in retaining a targeting cannula within the cannula bore of the targeting block of FIGS. 1A and 1B, according to one embodiment of the present disclosure. FIG. [Figure 7C] 1C is a perspective view illustrating an exemplary magnet arrangement that assists in retaining a targeting cannula within the cannula bore of the targeting block of FIGS. 1A and 1B, according to one embodiment of the present disclosure. FIG. [Figure 7D] 1C is a perspective view illustrating an exemplary magnet arrangement that assists in retaining a targeting cannula within the cannula bore of the targeting block of FIGS. 1A and 1B, according to one embodiment of the present disclosure. FIG.

[0035] [Figure 8] FIG. 1 illustrates a perspective view of an exemplary removable insert including a body having a plurality of slots according to one aspect of the present disclosure.

[0036] [Figure 9] 9 is a perspective view showing a removable insert being used with the targeting block of FIG. 2 while k-wires are snapped into respective slots of the removable insert of FIG. 8 according to one embodiment of the present disclosure. FIG.

[0037] [Figure 10] FIG. 13 is a perspective view showing a k-wire snapped into a slot of an exemplary removable insert and exemplary markings to assist in aligning the k-wire on a fluoroscopic image, according to one embodiment of the present disclosure.

[0038] [Figure 11] 3 is a perspective view of the targeting body of FIG. 2 in a transparent form, showing radiopaque spheres and radiopaque rods embedded within the targeting block, according to one embodiment of the present disclosure. FIG.

[0039] [Figure 12] FIG. 1 is a perspective view of a targeting marker according to one aspect of the present disclosure.

[0040] [Figure 13]FIG. 1B is a perspective view showing the targeting device of FIG. 1A positioned relative to a patient for targeting a screw, according to one embodiment of the present disclosure.

[0041] [Figure 14] FIG. 1C is a perspective view showing the targeting device of FIG. 1B positioned relative to a patient for targeting a screw, according to one embodiment of the present disclosure.

[0042] [Figure 15A] 10 illustrates a portion of a method for aligning the k-wire of FIG. 9 with the inserted nail on a fluoroscopic image, according to one embodiment of the present disclosure. [Figure 15B] 10 illustrates a portion of a method for aligning the k-wire of FIG. 9 with the inserted nail on a fluoroscopic image, according to one embodiment of the present disclosure.

[0043] [Figure 16A] 12A-12C illustrate a portion of a method for aligning the radiopaque rod of FIG. 11 with the radiopaque sphere of FIG. 11 according to one embodiment of the present disclosure. [Figure 16B] 12A-12C illustrate a portion of a method for aligning the radiopaque rod of FIG. 11 with the radiopaque sphere of FIG. 11 according to one embodiment of the present disclosure.

[0044] [Figure 17A] 1C illustrates a portion of a method for aligning the cannula holes of FIG. 4 with the screw holes of the nail of FIG. 1B according to one embodiment of the present disclosure. [Figure 17B] 1C illustrates a portion of a method for aligning the cannula holes of FIG. 4 with the screw holes of the nail of FIG. 1B according to one embodiment of the present disclosure.

[0045] [Figure 18] FIG. 13 is a perspective view showing the targeting marker of FIG. 12 positioned adjacent the humerus, according to one embodiment of the present disclosure.

[0046] [Figure 19]FIG. 13 shows an X-ray fluoroscopic image displaying the radiopaque rods and radiopaque rings of the targeting marker of FIG. 12 according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] The present application provides a new and innovative device and method to assist a surgeon in targeting a screw through a hole in a nail inserted into a bone at the distal end of the bone (e.g., humerus). The surgeon may first insert the nail into the patient's bone. A provided targeting device may then be coupled to the proximal end of the inserted nail. From this point on, the surgeon can align the coupled targeting device with the inserted nail, which allows the surgeon to use the targeting device as a guide to drill a bone hole concentric with the screw-receiving hole located at the distal end of the inserted nail. For example, the provided targeting device comprises a block having a plurality of holes, each configured to receive a cannula that guides a drill bit. The surgeon can adjust the orientation of the targeting device such that at least one hole in the block, and thus the cannula that guides the received drill bit, is targeted to the screw-receiving hole of the inserted nail. In this manner, as the surgeon advances the drill bit through the cannula to reach into the bone, the drill bit creates a bone hole that leads to the screw-receiving hole in the distal end of the inserted nail.

[0048] The provided targeting device may include any combination of the various features described herein that aid the surgeon in accurately and reliably targeting the screw. In one example, the screw is typically inserted into the distal end of the nail with both the medial / lateral and anterior / posterior surfaces inserted. To aid the surgeon in avoiding potential errors with respect to the surface, such as mistaking the medial / lateral surface for the anterior / posterior surface, the provided targeting device may include a removable insert that indicates to the surgeon which surface the surgeon is targeting.

[0049] In another example, the provided targeting device may have components that improve the circular approach. The surgeon usually uses a circular approach when aligning the targeting tool with the radiopaque marker, which requires the C-arm (e.g., fluoroscope) to move through six axes in 3D space, which can be difficult and time-consuming. In one embodiment, the provided targeting device and method allow the surgeon to align the inserted nail with one or more straight lines on the fluoroscopic image, thereby eliminating two free axes for accurate C-arm alignment. In another embodiment, the provided targeting device and method allow the surgeon to align the radiopaque components embedded in the targeting device, which contributes to more accurate C-arm alignment. In some embodiments, the targeting marker with a radiopaque portion may be used during alignment with the provided targeting device to contribute to reducing the parallax effect inherent to the C-arm. Further advantages will become clear from the following description of the figures. Additionally, although the following drawing descriptions are made in relation to the humerus, this description is by way of example only, and the targeting devices provided may be used to target screws through nails inserted into any suitable bone (e.g., long bones).

[0050] 1A and 1B are perspective views showing an exemplary targeting device 100 that can be used by a surgeon to align a drill bit with a screw hole at the distal end of a nail inserted into a bone (e.g., the humerus) and thereby target a bone screw to be inserted into the screw hole of the nail. The bone screws inserted into the distal end of the nail inserted into the humerus are usually inserted into two different planes that are perpendicular to each other: the anterior / posterior plane and the medial / lateral plane. FIG. 1A is a perspective view showing an exemplary arrangement of the targeting device 100 that assists the surgeon in targeting a bone screw in the medial / lateral plane, and FIG. 1B is a perspective view showing an exemplary arrangement of the targeting device 100 that assists the surgeon in targeting a bone screw in the anterior / posterior plane.

[0051] In FIG. 1A, the exemplary targeting device 100 comprises a targeting body 102. A base plate 104 may be removably coupled to the targeting body 102. For example, a body 506 (FIG. 5) of the base plate 104 may be coupled to the targeting body 102 via a threaded knob 120A and a bolt (not shown) at a connecting hole 206 (FIG. 2) of the targeting body 102. The base plate 104 may be coupled to the targeting body 102 at any of the connecting holes 206 to adjust different nail lengths. In various embodiments, the base plate 104 may include a connecting tube 114 that removably couples the nail to the base plate 104. In at least some embodiments, the targeting device 100 may comprise a removable insert, such as an insert 110A and / or an insert 110B (FIG. 1B). Insert 110A and / or insert 110B can correspond to whether targeting device 100 is being used to target a screw on the medial / lateral surface (e.g., insert 110A) or the anterior / posterior surface (e.g., insert 110B), as described in more detail below.

[0052] In at least some embodiments, targeting device 100 may include one or more removable targeting cannulas 112A, 112B. The targeting cannulae 112A, 112B may be positioned through cannula holes 400-406 (FIG. 4) in targeting body 102, and possibly through inserts 110A or 110B. When so positioned, the targeting cannulae 112A, 112B assist in guiding the drill bit once targeting device 100 is aligned in a desired location.

[0053] As shown in FIG. 1B, when using the exemplary targeting device 100 to target bone screws on the anterior / posterior surface, the base plate 104 may be coupled to the targeting body 102 via the curved connecting bow 106. For example, one end 508 (FIG. 5) of the body 500 (FIG. 5) of the connecting bow 106 may be removably coupled to the targeting body 102, and a second end 510 of the body 500 of the connecting bow 106 may be removably coupled to the base plate 104. In one example, the end 508 of the connecting bow 106 may be coupled to the targeting body 102 via a threaded knob 120A at the connecting hole 206 (FIG. 2) of the targeting body 102. The connecting bow 106 may be coupled to the targeting body 102 at any of the connecting holes 206 to adjust for different nail lengths. In one example, the end 510 of the connecting bow 106 may be coupled to the base plate 104 via a threaded knob 120B and a bolt (not shown). In the illustrated example of FIG. 1B, the targeting device 100 is configured to target bone screws to the anterior / posterior aspects of the patient's right humerus (e.g., FIG. 14). In another example, the targeting device 100 may target bone screws to the anterior / posterior aspects of the patient's left humerus by positioning the connecting bow 106 and base plate 104 in a mirror image position as shown in FIG. 1B.

[0054] For illustrative purposes, Figure 1B further shows nail 108 coupled to connecting tube 114 of base plate 104. In at least some embodiments, nail 108 may be coupled to connecting tube 114 via lug bolt 122. For example, lug bolt 122 may be disposed through connecting tube 114, and a threaded end 512 (Figure 5) of lug bolt 122 may be coupled to internal threads of nail 108. Nail 108 may be similarly coupled to connecting tube 114 of targeting device 100 shown in Figure 1A.

[0055] In at least some embodiments, the distal end of the nail 108 includes screw holes 124A and 124B. The screw holes 124A and 124B may be positioned on the nail 108 such that the screw holes 124A and 124B are on the medial / lateral sides when the nail 108 is inserted into the humerus. In at least some embodiments, the distal end of the nail 108 includes screw holes 126A and 126B. The screw holes 126A and 126B may be positioned on the nail 108 such that the screw holes 126A and 126B are on the anterior / posterior sides when the nail 108 is inserted into the humerus. As shown, the medial / lateral screw holes 124A, 124B and the anterior / posterior screw holes 126A, 126B are offset from one another along the length of the nail 108 so that screws may be inserted through each of the screw holes 124A, 124B and 126A, 126B simultaneously as needed. In some embodiments as shown, the medial / lateral screw holes 124A, 124B may be interleaved with the anterior / posterior screw holes 126A, 126B. In other words, the screw hole 126A is between the screw holes 124A and 124B along the length of the nail 108, and the screw hole 124B is between the screw holes 126A and 126B along the length of the nail 108. In other embodiments, the medial / lateral screw holes 124A, 124B may be grouped together and the anterior / posterior screw holes 126A, 126B may be grouped together so that the screw holes are not staggered.

[0056] FIG. 5 illustrates various components of the targeting device 100. An exemplary base plate 104 is shown having a body 506 with a connecting tube 114 and a tip 507. The tip 507 of the base plate 104 may be coupled to the targeting body 102 (e.g., FIG. 1A) or the connecting bow 106 (e.g., FIG. 1B). An exemplary connecting bow 106 is shown having a body 500 with a first end 508 and a second end 510. The body 500 of the connecting bow 106 may be curved. In some embodiments, the body 500 of the connecting bow 106 may include multiple cross bars 509 that contribute to maintaining the structural integrity of the body 500 while reducing the material used of the body 500. In other embodiments, the body 500 may have another suitable curved structure. FIG. 5 further illustrates an exemplary targeting cannula 112A having a tube 502 and a head 504. The head 504 of the targeting cannula 112A has a larger cross-sectional width / diameter than each of the cannula holes 400-406 of the targeting body 102 such that the head 504 does not translate through the respective cannula holes 400-406. The targeting cannula 112B may be identical to the targeting cannula 112A. Also shown is an exemplary lug bolt 122 having a shaft with a threaded end 512 and a head 514. Additionally, an exemplary threaded knob 120A is shown having a shaft with a threaded end 516 and a head 518. The threaded knob 120B may be identical to the threaded knob 120A.

[0057] FIG. 2 is a perspective view showing the targeting body 102 of the exemplary targeting device 100. The targeting body 102 includes an outer frame 200 having a first end 202 opposite a second end 204 and a first side 206 opposite a second side 208. The targeting body 102 includes a plurality of connection holes 206 adjacent the first end 202. For clarity of illustration only, only one connection hole 206 is indicated by a reference number in the figures, and it should be understood that the description of the connection hole 206 applies equally to each of the illustrated connection holes 206. In at least some embodiments, each connection hole 206 corresponds to an option for making a nail 108 of a different length that may be used with the targeting device 100. For example, the connection holes 206 proximate the first end 202 may correspond to an option for making the nail 108 longer in length than the connection holes remote from the first end 202.

[0058] The exemplary targeting body 102 further includes a targeting block 210. In at least some embodiments, the targeting block 210 is connected to the outer frame 200 by a flexible member 212. In one example, the flexible member 212 may be a leaf spring, while in other examples, the flexible member 212 may be another suitable flexible component. The flexible member 212 allows the targeting block 210 to translate toward either the first side 206 or the second side 208 of the outer frame 200 in an arc motion indicated by a double arrow 216. In at least some embodiments, the targeting body 102 may include an adjustment assembly (e.g., adjustment assembly 300 of FIGS. 3A and 3B ) that adjusts and maintains the position of the targeting block 210 relative to the first side 206 and the second side 208 of the outer frame 200. The targeting block 210 may include an opening 214 that can accommodate a portion of the adjustment assembly. Targeting block 210 may include multiple cannula holes, which are described in more detail in connection with FIG. 4 below.

[0059] FIG. 3A illustrates an exemplary adjustment assembly 300 of the targeting body 102, and FIG. 3B illustrates components of the exemplary adjustment assembly 300 in more detail. In some embodiments, the adjustment assembly 300 includes a connector 306 disposed within the opening 214 of the targeting block 210. The connector 306 may include an opening 316 having internal threads. The drive rod 304 may be disposed through the opening 316, the opening of the targeting block 210, and the openings in the sides 206 and 208 of the outer frame 200, all of which are coaxial with the opening 316. The drive rod 304 includes a first end 310 opposite a second end 312 and a threaded portion 314. The threaded portion 314 may engage with the internal threads of the opening 316. The rotation knobs 302A and 302B may be permanently or removably attached to each of the first and second ends 310 and 312, respectively, of the drive rod 304. In some embodiments, the targeting block 210 itself may include internal threads that engage with the threads 314 of the drive rod 304 rather than a separate connector 306.

[0060] When the rotation knob 302A and / or the rotation knob 302B are rotated in one direction, the engagement between the threads 314 of the drive rod 304 and the internal threads of the opening 316 of the connector 306 drives the targeting block 210 towards either the first side 206 or the second side 208. The rotation knob 302A and / or the rotation knob 302B may be rotated in the opposite direction to drive the targeting block 210 towards the other of the first side 206 and the second side 208. Additionally, the engagement between the threads 314 of the drive rod 304 and the internal threads of the opening 316 of the connector 306 maintains the position of the targeting block 210 when the rotation knob 302A and / or the rotation knob 302B are not rotated.

[0061] 4 is a perspective view illustrating the targeting block 210 showing the cannula holes 400-406 of the targeting block 210. The cannula holes 400-406 may be sized such that the targeting cannula 112A or 112B is disposed through the cannula holes 400-406, respectively. Additionally, each cannula hole 400-406 may be positioned on the targeting block 210 such that each cannula hole 400-406 corresponds to a particular screw hole 124A, 124B, 126A, or 126B of the nail 108 coupled to the targeting device 100. For example, as discussed above, the screw holes 124A and 124B and the screw holes 126A and 126B may be offset from one another along the length of the nail 108. In one example, cannula hole 400 may correspond to screw hole 124A, cannula hole 402 may correspond to screw hole 126A, cannula hole 404 may correspond to screw hole 124B, and cannula hole 406 may correspond to screw hole 126B. In other words, in this example, cannula holes 400 and 404 may be used when targeting screws on the medial / lateral surfaces, respectively, and cannula holes 402 and 406 may be used when targeting screws on the anterior / posterior surfaces, respectively.

[0062] The surgeon may sometimes forget which cannula holes 400-406 should be used when inserting bone screws on the medial / lateral side and the anterior / posterior side. To avoid confusion for the surgeon and to help increase confidence in correct targeting, in some embodiments, the exemplary targeting device 100 may include one or more removable inserts that, when used with the targeting block 210, provide access to only the cannula holes 400-406 required for the side in which the bone screw is being inserted. For example, the removable inserts may provide access to only the cannula holes 400 and 404 (e.g., for the medial / lateral side) or only the cannula holes 402 and 406 (e.g., for the anterior / posterior side). The removable inserts may have a variety of suitable shapes and sizes, examples of which are described herein. In some embodiments, the targeting block 210 may include a slot 410. The slot 410 may have a variety of suitable purposes as described herein. For example, slots 410 may be utilized to help maintain a removable insert in contact with targeting block 210, to help retain targeting cannulas 112A, 112B within cannula holes 400-406, or for any other suitable purpose.

[0063] FIG. 6 illustrates an exemplary insert 110B and an exemplary insert 600. The exemplary insert 600 may be an alternative version of the insert 110A illustrated in FIG. 1A. The insert 110B is configured for anterior / posterior screw targeting. For example, the insert 110B includes a body 610 having an opening 606 and an opening 608. Extending from the body 610 are legs 602 and 604, respectively. When the insert 110B is used with the targeting block 210 as illustrated in FIG. 6, the legs 602 are positioned within the cannula bore 400 and the legs 604 are positioned within the cannula bore 404 to prevent the targeting cannulas 112A, 112B from entering the cannula bores 400 and 404. Conversely, openings 606 and 608 allow access to cannula holes 402 and 406 by targeting cannulas 112A, 112B, respectively.

[0064] The insert 600 is configured to target a screw on the medial / lateral surface. For example, the insert 600 includes a body 620 having an opening 616 and an opening 618. Extending from the body 620 are legs 612 and 614, respectively. When the insert 600 is used with the targeting block 210, the legs 612 are positioned within the cannula bore 402 and the legs 614 are positioned within the cannula bore 406 to prevent the targeting cannulas 112A, 112B from entering the cannula bores 402 and 406, respectively. Conversely, the openings 616 and 618 allow the targeting cannulas 112A, 112B to enter the cannula bores 400 and 404, respectively. Thus, the surgeon can ensure that targeting cannulas 112A, 112B are inserted into the appropriate cannula holes 400-406 by using insert 110B when targeting bone screws on the anterior / posterior surfaces and insert 600 when targeting bone screws on the medial / lateral surfaces.

[0065] One potential problem that may arise during surgery is if the targeting cannula 112A, 112B falls out of the targeting block 210 and onto the floor. In some embodiments, to help avoid this potential problem, the targeting device 100 may include one or more magnets disposed to assist in retaining the targeting cannula 112A, 112B within the respective cannula bores 400-406. For example, the one or more magnets may be disposed within the targeting block 210 and / or the removable insert. The magnetic force of the one or more magnets may attract the targeting cannula 112A, 112B disposed within the respective cannula bores 400-406 toward the one or more magnets, thereby increasing friction between the targeting cannula 112A, 112B and the respective cannula bores 400-406 and assisting in retaining the targeting cannula 112A, 112B within the respective cannula bores 400-406.

[0066] 7A-7D show example arrangements of one or more magnets. In the example of FIG. 7A, magnets 702, 704, and 706 are embedded directly into targeting block 210. In another example, magnets may be embedded or built into a removable insert of the present disclosure. FIG. 7B shows an example removable insert 710 having magnets 712 and 714 embedded into legs 716 of the removable insert 710. Legs 716 may be inserted into slots 410 of targeting block 210. FIG. 7C shows an example removable insert 720 having one or more pockets 722 (e.g., example removable insert 720 is shown with two pockets 722). A magnet 724, or a component 726 including magnet 724, may be inserted into pocket 722. 7D, a cassette 730 including multiple magnets 732-740 may be inserted into slot 410 of targeting block 210. The multiple magnets 732-740 may be positioned in cassette 730 such that when cassette 730 is inserted into slot 410, each magnet 732-740 is aligned with a respective cannula hole 400-406.

[0067] In at least some embodiments, the provided targeting device 100 may include features that aid the surgeon in accurately aligning the targeting device 100 when targeting the drill bit to drill the nail hole. The surgeon typically uses a circular approach when aligning a typical targeting instrument, which has a radiopaque marker aligned concentrically and over the nail hole visible on an X-ray image. This circular approach requires the surgeon to align the typical targeting instrument attached to the nail located inside the intramedullary canal with a fluoroscope. The surgeon must move the C-arm (e.g., fluoroscope) in 3D space using all six axes to properly align the C-arm. This alignment can be difficult and may take time (e.g., several minutes), especially for an inexperienced surgeon. Moreover, once the correct position is found, the C-arm typically needs to be held in place by hand while the surgeon uses his free hand to drill into the bone, preferably through the nail hole.

[0068] To aid the operator in aligning the exemplary targeting device 100, in some embodiments, the targeting device 100 may include a component or components that allow the operator to align the inserted nail with one or more straight lines on the fluoroscopic image, so that the nail is equidistant to the one or more straight lines. In one embodiment, the component that creates the one or more straight lines may be a radiopaque guidewire (e.g., a k-wire) that is visible on the fluoroscopic image. The k-wire may be integral with or attached to the exemplary targeting device 100. For example, FIG. 8 illustrates an exemplary removable insert 800 that includes a body 802 having a plurality of slots 804, 806. In this example, the removable insert 800 is shown to include five slots 804, 806 on either side of the openings 808 and 810, but may include other suitable numbers of slots 804, 806 in other examples. The k-wire may be inserted (e.g., snapped into) either of the slots 804, 806 of the removable insert 800. For example, the surgeon may select the slot 804, 806 into which the k-wire should be inserted to best determine equidistant alignment between the k-wire and the inserted nail on the fluoroscopic image. FIG. 9 shows the removable insert 800 being used with the targeting block 210 while the k-wire 900 is snapped into the slot 804 and the k-wire 902 is snapped into the slot 806 of the removable insert 800. In other examples, the targeting body 102 or the targeting block 210 may include one or more slots such that a k-wire or other suitable straight component may be directly coupled to the targeting body 102 or the targeting block 210 rather than to the removable insert.

[0069] FIG. 10 shows the k-wire 900 snapped into slots 1002 and 1004 of the exemplary removable insert 1000. The slots 1002 and 1004 do not extend the length of the exemplary removable insert 1000 as compared to the slots 804 and 806 of the removable insert 800. FIG. 10 further shows a set of marks 1010 on the outer frame 200 and the targeting block 210 of the targeting body 102. For example, the set of marks 1010 may include a single mark on the targeting block 210 and multiple marks on the outer frame 200. Aligning the single mark on the targeting block 210 with the multiple marks on the outer frame 200 can assist the surgeon in adjusting the targeting block 210 (e.g., via the adjustment assembly 300) so that the k-wire 900 is equidistant along its length to the inserted nail on a fluoroscopic image. The process of aligning the k-wire with the inserted nail on the fluoroscopic image is described in more detail in connection with FIG. 15 below.

[0070] In other embodiments, to aid the operator in aligning the exemplary targeting device 100, the targeting device 100 may include radiopaque marker(s) embedded within the targeting device 100. For example, as shown in FIG. 11, a plurality of radiopaque spheres 1104 and radiopaque rods 1102 may be embedded within the targeting block 210. In other examples, the radiopaque markers may have suitable shapes other than spheres and rods. The plurality of radiopaque spheres 1104 are at a different height (e.g., on a different plane) than the radiopaque rods 1102 within the targeting block 210. For example, FIG. 11 shows a plane 1106 of the radiopaque rods 1102 and a plane 1108 of the radiopaque spheres 1104. The plurality of radiopaque spheres 1104 may be arranged in two separate columns 1110 and 1120. The radiopaque rod 1102 is parallel to an imaginary line extending through each of the radiopaque spheres 1104 in column 1110 and parallel to an imaginary line extending through each of the radiopaque spheres 1104 in column 1120. When viewed from the top side (e.g., looking down an axis perpendicular to the top surface of the targeting block 210), the radiopaque rod 1102 is between columns 1110 and 1120 and is equidistant from an imaginary line extending through each of the radiopaque spheres 1104 in column 1110 and an imaginary line extending through each of the radiopaque spheres 1104 in column 1120 (see, e.g., FIG. 16B). The placement of the radiopaque sphere 1104 and the radiopaque rod 1102 assists the surgeon in vertically aligning a C-arm (e.g., a fluoroscope) with respect to the targeting device 100, as will be described in more detail in connection with Figures 16A and 16B below.

[0071] One of the difficulties that the surgeon faces when aligning the drill bit with the target screw with the C-arm is the inherent parallax effect of the C-arm, which may produce distorted fluoroscopic images. Due to the design of the C-arm, the distance of the imaged objects relative to the X-ray source and collimator affects how those objects appear on the fluoroscopic image. In addition, the further an object (e.g., a radiopaque marker) is from the object (e.g., a bone), the greater the distortion on the fluoroscopic image due to the parallax effect. Because the targeting body 102 of the targeting device 100 is outside the patient during imaging while the nail 108 is inserted into the patient's humerus, the magnified image of the targeting body 102 relative to the nail 108 may appear distorted on the fluoroscopic image. For example, certain indicators on a fluoroscopic image (e.g., k-wire 902 and nail 108, or radiopaque rod 1102 and radiopaque sphere 1104) may appear misaligned when the physical objects corresponding to those indicators are actually aligned.

[0072] In some embodiments, to help reduce parallax effects and aid the operator in aligning the exemplary targeting device 100, the targeting device 100 may include one or more removable targeting markers 1200, as shown in FIG. 12. The targeting marker 1200 may include a radiolucent body 1202 and a radiopaque core 1204 extending outside the radiolucent body 1202. The radiopaque core 1204 may extend the entire length of the radiolucent body 1202 or only a portion thereof. The radiopaque core 1204 may extend outside the radiolucent body 1202 to any suitable extent. The targeting marker 1200 may be placed through the cannula holes 400-406 of the targeting device 100 during alignment. When the targeting marker 1200 is so positioned, the tip of the radiopaque core 1204 is near or in contact with the patient's humerus. Thus, the distance between the tip of the radiopaque core 1204 and the humerus is minimized, which in turn minimizes the parallax effect on the fluoroscopic image of the tip of the radiopaque core 1204 and the humerus. In this manner, the targeting marker 1200 can facilitate the surgeon in determining whether the targeting device 100 is properly aligned with the screw holes 124A, 124B, 126A, 126B of the nail 108.

[0073] In some embodiments, the tip of the radiopaque core 1204 may be blunt. In other embodiments, the tip of the radiopaque core 1204 may be sharp so that the surgeon can score the bone. Scorching the bone after final adjustment can aid in subsequent drilling while preventing bone stripping. In some embodiments, the targeting marker 1200 may include a radiopaque ring 1206 at the rear end of the radiolucent body 1202. The radiopaque ring 1206 can assist in identifying the individual ends of the targeting marker 1200 on a fluoroscopic image, which can assist the surgeon in identifying which end on a fluoroscopic image is the tip of the radiopaque core 1204 that is near or in contact with the humerus. The use of the targeting marker 1200 during the alignment procedure is further discussed below in connection with FIGS. 18 and 19.

[0074] A method of targeting a screw using the exemplary targeting device 100 will now be described. The surgeon may first insert a nail (e.g., nail 108) into the patient's humerus, which may include drilling a hole in the humerus in preparation for inserting the nail 108. The targeting device 100 may be coupled to the inserted nail 108, for example, via a lug bolt 122. As discussed above, screws are typically targeted on both the medial / lateral and anterior / posterior surfaces. FIG. 13 is a perspective view of the targeting device 100 configured and positioned relative to the patient 1300 to target a screw on the medial / lateral surface. FIG. 14 is a perspective view of the targeting device 100 configured and positioned relative to the patient 1300 to target a screw on the anterior / posterior surface. The targeting device 100 in either the position of FIG. 13 or FIG. 14 is coupled to the inserted nail 108 (not shown) in the humerus of the patient 1300. In this example, the surgeon targets the screws on the medial / lateral surface first, but in other examples, the surgeon may target the screws on the anterior / posterior surface first.

[0075] In some embodiments, the surgeon may select and insert a removable insert that corresponds to the surface on which he or she is targeting the screw. Whether or not a removable insert is used, the surgeon may then align targeting device 100 using fluoroscopy so that cannula holes 400 and 404 are aligned with screw holes 124A and 124B of the inserted nail 108.

[0076] In some embodiments, aligning the targeting device 100 includes aligning a k-wire (e.g., k-wire 904) with the inserted nail 108 on a fluoroscopic image such that the k-wire 108 is equidistant along its length to the nail 108. FIG. 15A shows the k-wire 904 misaligned with the nail 108. The surgeon may then adjust the position of the targeting device 100. For example, the surgeon may rotate the rotation knob 302A and / or the rotation knob 302B of the adjustment assembly 300 to adjust the positioning of the targeting block 210 coupled to the k-wire 904. FIG. 15B shows the k-wire 904 properly aligned with the nail 108 after adjustment. In such embodiments, when the k-wire 904 is properly aligned with the nail 108, the targeting block 210 is aligned with the screw holes 124A and 124B of the nail 108. This technique of aligning the straight k-wire 904 with the straight edge of the nail 108 eliminates the need to precisely align the C-arm (e.g., fluoroscope) with the targeting device 100, thereby eliminating two axes of freedom.

[0077] In other embodiments, aligning the targeting device 100 includes adjusting the targeting device 100 so that the radiopaque markers (e.g., the radiopaque rod 1102 and the radiopaque sphere 1104) are aligned on the fluoroscopic image. The radiopaque markers may be embedded in the targeting device 100 as described above. FIG. 16A shows the radiopaque rod 1102 misaligned with the radiopaque sphere 1104. Thus, the operator may move and rotate the C-arm, or the arm of the patient 1300, with the targeting device 100 until the radiopaque rod 1102 is equidistantly positioned between the two columns 1110 and 1120 of the sphere 1104. FIG. 16B shows the radiopaque rod 1102 properly aligned with the two columns 1110 and 1120 of the sphere 1104. At this point, the C-arm is aligned vertically to the targeting device 100.

[0078] In at least some instances, the cannula holes 400 and 404 may not be aligned with the screw holes 124A and 124B, as shown in the depiction illustrated in FIG. 17A. In such cases, the surgeon may adjust the targeting block 210 so that the cannula holes 400 and 404 are aligned with the screw holes 124A and 124B. For example, the surgeon may rotate the rotation knobs 302A and / or the rotation knobs 302B of the adjustment assembly 300 to adjust the positioning of the targeting block 210 so that the cannula holes 400 and 404 are concentric with the screw holes 124A and 124B. This method is similar to the circular approach described above. FIG. 17B shows the cannula holes 400 and 404 properly aligned with the screw holes 124A and 124B. In embodiments in which radiopaque markers are used for alignment, when the radiopaque rod 1102 and radiopaque sphere 1104 are properly aligned and the cannula holes 400 and 404 are properly aligned, the targeting block 210 is aligned with the screw holes 124A and 124B of the nail 108.

[0079] In some embodiments, aligning the targeting device 100 includes using a targeting marker(s) (e.g., one or more targeting markers 1200) when adjusting the targeting device 100. The surgeon may insert the targeting marker 1200 into one or both of the cannula holes 400 and 404. FIG. 18 shows the targeting marker 1200 inserted into the cannula hole 400 of the targeting device 100 with the tip of the radiopaque core 1204 near the humerus 1800. FIG. 19 shows a fluoroscopic image displaying the radiopaque core 1204 and the radiopaque ring 1206 of the targeting marker 1200. The surgeon can use the radiopaque ring 1206 on the fluoroscopic image to know which end of the radiopaque core 1204 is where. In such an embodiment using one or more targeting markers 1200, once the targeting block 210 is aligned with the screw holes 124A and 124B of the nail 108, the one or more targeting markers 1200 can be removed from the targeting block 210 and the targeting cannulas 112A and 112B can be inserted for drilling.

[0080] Regardless of the alignment method used, provided that targeting block 210 is properly aligned, the surgeon may insert targeting cannulas 112A and 112B into cannula holes 400 and 404, if they are not already inserted. In some cases, the surgeon may insert targeting cannulas 112A and 112B before targeting block 210 is finally aligned. The surgeon may then drill bone holes in the humerus of patient 1300 through targeting cannula 112A or 112B. Each drilled bone hole is coaxial or substantially coaxial with a corresponding screw hole 124A or 124B.

[0081] In some embodiments, once the bone holes are created for the medial / lateral surfaces, the surgeon can insert bone screws into the created bone holes and the corresponding screw holes 124A and 124B of the inserted nail 108. In other embodiments, the surgeon may create the bone holes for the anterior / posterior surfaces before inserting any bone screws. To create the bone holes for the anterior / posterior surfaces, the surgeon can adjust the targeting device 100. For example, in some embodiments, the surgeon can detach the targeting device 100 from the inserted nail 108 (e.g., by removing the lug bolts 122). With the targeting device 100 detached, the surgeon can add the connecting bow 106. For example, the surgeon can detach the base plate 104 from the targeting body 102, couple the connecting bow 106 to the targeting body 102, and couple the base plate 104 to the connecting bow 106. The surgeon can then re-couple the targeting device 100 to the inserted nail 108.

[0082] With the targeting device 100 in position to create bone holes in the anterior / posterior surfaces, the surgeon may align the targeting device 100 in a manner similar to that described above for the medial / lateral surfaces and drill bone holes in the humerus of the patient 1300 that are coaxial with the screw holes 126A and 126B, respectively. At this point, the surgeon may insert bone screws into each of the created bone holes in the medial / lateral and anterior / posterior surfaces, or only in the anterior / posterior surfaces. Once the nail 108 is inserted with a bone screw through each of the nail screw holes 124A, 124B, 126A, and 126B, the surgeon may complete any final steps to complete the procedure (e.g., closing the incision on the patient).

[0083] Without further elaboration, it is believed that those skilled in the art can use the preceding description to make the most of the claimed invention. 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 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. 1. A targeting device for assisting in the insertion of a screw through a distal end of a nail inserted into a patient's bone, the proximal end of the nail being positioned near an insertion location where the nail is inserted into the bone and the distal end of the nail being positioned away from the insertion location; The targeting device: Outer frame, a flexible member connected to the outer frame; a targeting block connected to the flexible member, the flexibility of the flexible member allowing the targeting block to translate toward a first side of the outer frame and toward a second side of the outer frame, the first side facing the second side, the targeting block including a plurality of holes; and an adjustment assembly configured to adjust and maintain a position of the targeting block relative to the first side and the second side of the outer frame; A targeting body including: a base plate removably coupled to the targeting body; Equipped with The targeting device is configured such that the base plate can be coupled to the nail. Targeting device.

2. Further comprising a curved connecting bow; 2. The targeting device of claim 1, wherein the base plate is removably coupled to the targeting body via the curved connecting bow such that a central plane of the curved connecting bow is substantially perpendicular to a central plane of the targeting body and a central plane of the base plate is substantially perpendicular to the central plane of the curved connecting bow.

3. The targeting device of claim 1 , wherein the nail is substantially parallel to the targeting body when coupled to the base plate.

4. 2. The targeting device of claim 1, wherein the adjustment assembly includes a rod having a first threaded portion configured to engage a second threaded portion to adjust a position of the targeting block by rotation of the rod.

5. The adjustment assembly includes: a component disposed in the first opening of the targeting block and having a second opening including the second threaded portion. Further comprising: The targeting device of claim 4 , wherein the rod is disposed through a third opening of the targeting block and the second opening of the component.

6. a removable targeting cannula configured to be disposed through a bore of the targeting body, the removable targeting cannula configured to guide a drill bit; The targeting device of claim 1 , further comprising:

7. a removable insert configured to be positioned relative to the targeting block such that the removable insert blocks access to some of the plurality of holes in the targeting block while allowing access to remaining unblocked holes; The targeting device of claim 1 , further comprising:

8. a magnet disposed adjacent to at least one of the plurality of holes; The targeting device of claim 1 , further comprising:

9. The targeting device of claim 8 , wherein the magnet is embedded within the targeting block.

10. The targeting device of claim 1 , wherein the flexible member is a leaf spring.

11. A radiopaque component embedded within the targeting block. The targeting device of claim 1 , further comprising:

12. The radiopaque component comprises: a first set of radiopaque components arranged in a first line; a second set of radiopaque components arranged in a second line parallel to the first line; a third radiopaque component disposed parallel to the first line and the second line; and The targeting device of claim 11 , comprising:

13. 13. The targeting device of claim 12, wherein the first and second sets of radiopaque components are disposed in a first plane and the third radiopaque component is disposed in a second plane spaced apart from the first plane.

14. 1. A system for inserting a screw through a distal end of a nail that is inserted into a patient's bone, the proximal end of the nail being positioned near an insertion location where the nail is inserted into the bone and the distal end of the nail being positioned away from the insertion location; The system is a nail including a screw hole at the distal end of the nail; a targeting device including a targeting body; a base plate removably coupled to the targeting body; Equipped with The targeting body comprises: The outer frame and a flexible member connected to the outer frame; a targeting block connected to the flexible member, the flexibility of the flexible member allowing the targeting block to translate toward a first side of the outer frame and a second side of the outer frame, the first side facing the second side, the targeting block including a plurality of holes; an adjustment assembly configured to adjust and maintain a position of the targeting block relative to the first side and the second side of the outer frame; Including, The targeting device is configured such that the base plate can be coupled to the nail. system.

15. Further comprising a straight line component, The system of claim 14 , wherein the targeting device is configured to couple the linear component to the targeting device.

16. the targeting device further comprising a removable insert configured to be inserted partially within at least one of the plurality of holes of the targeting block; The system of claim 15 , wherein the removable insert is configured to couple the linear component to the removable insert.

Images