Implant Guide, Device, System, and Method of Use

Abstract

Implant guides, devices, systems and methods for implants to correct bone deformities and fractures in the lower limb are disclosed. In particular, implant guides, devices, systems and methods for use with implants to correct bone deformities and / or fractures in the foot and ankle are disclosed.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 899,520, filed on September 12, 2019, entitled "Implant Guides, Devices, Systems, and Methods of Use", and U.S. Provisional Patent Application No. 62 / 961,896, filed on January 16, 2020, entitled "Implant Guides, Devices, Systems, and Methods of Use". The entire disclosure of each of the prior applications is hereby incorporated by reference in its entirety.

[0002] The present invention generally relates to implants for general surgery, podiatry, and orthopedics used to correct bone deformities. More particularly, but not exclusively, the present invention relates to implant guides, devices, systems, and methods for implants for correcting bone deformities.

Background Art

[0003] Generally, due to pathology, trauma, or a failed previous surgery, fusion of the tibial - talar - calcaneal (TTC) complex is required. Options currently available for fusing the three bones include intramedullary (IM) nails, cross - screws, or plating. Currently available implants cross two joints, namely, the tibio - talar or ankle joint and the talo - calcaneal or subtalar joint. During the use of currently available implants, an absorption period occurs that causes gap formation between the joint surfaces. This gap formation can lead to failed fusion (non - union) and ultimately device failure. Thus, new implant guides, devices, systems, and implant methods are needed to ensure that gap formation is prevented or minimized and bone opposition is maintained during the healing process.

Summary of the Invention

Means for Solving the Problems

[0004] Aspects of the present invention provide an implant guide, device, system, and method for correcting bone deformities of the foot and ankle.

[0005] In one aspect, provided herein is an implant guide device. The implant guide device includes a base, a first arm coupled to a first end of the base, a second arm coupled to a second end of the base, and a sighting arm hinge-coupled to at least one of the first arm and the second arm.

[0006] In another aspect, provided herein is an implant guide system. The implant guide system includes an implant guide device. The implant guide device of the implant guide system includes a base, a first arm coupled to a first end of the base, a second arm coupled to a second end of the base, and a sighting arm hinge-coupled to at least one of the first arm and the second arm. Further, the implant guide system includes a mount system that traverses an opening of the base. Further, the implant guide system includes an implant coupled to the mount system.

[0007] Also provided herein is a surgical method. The surgical method includes selecting an implant guide system, coupling an implant to a mount system of the implant guide system, positioning the implant guide device of the implant guide system in a desired implant orientation, inserting the implant into a patient's lower limb using the implant guide system, inserting at least one fastener into the patient's lower limb via the implant using the implant guide system, releasing the implant within the patient's lower limb by removing the implant guide device and attachment system, and closing the patient's incision.

[0008] These and other objects, features, and advantages of the present disclosure will become apparent from the following detailed description of various aspects of the present disclosure in connection with the accompanying drawings.

Brief Description of the Drawings

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description of the present disclosure, serve to explain the principles of the present disclosure. It is emphasized that various features are not drawn to scale in accordance with standard practice in the industry. In fact, for clarity of discussion, the dimensions of various features may be arbitrarily increased or decreased. The foregoing and other objects, features, and advantages of the present invention will be apparent from the following detailed description in connection with the accompanying drawings.

[0010]

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DETAILED DESCRIPTION OF THE INVENTION

[0011] Briefly described, what is disclosed herein is an implant guide, device, and system for use in inserting an implant into a patient, where the implant is configured to correct bone deformities. Further, methods of using the implant guide, device, and system are also discussed.

[0012] In this detailed description and the following claims, the terms: proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by standard usage to denote particular parts or portions of a patient's body, bone, device, or implant, according to terms of reference of relative alignment or orientation of the patient. For example, "proximal" means the particular part or portion of the patient's limb, bone, device or implant that is closest to the torso, while "distal" indicates the part of the patient's limb, bone, device or implant that is furthest from the torso. With respect to directional terms, "anterior" is the direction towards the front side of the body, bone, device or implant, "posterior" means the direction towards the rear side of the body, bone, device or implant, "medial" means towards the midline of the body, "lateral" is the direction away from the midline of the body towards the side, "superior" means upwards, and "inferior" means downwards relative to another object or structure. Further with respect to the foot, the term "dorsal" refers to the top of the foot and the term "plantar" refers to the bottom of the foot.

[0013] Similarly, position or orientation can be used here with reference to anatomical structures or surfaces. For example, since the current devices, systems, apparatuses, and methods are described herein with reference to use with the ankle bones, the bones of the foot, ankle, and lower leg can be used to describe the surface, position, orientation, or alignment of the devices, systems, apparatuses, and methods. Further, the devices, systems, apparatuses, and methods disclosed herein, as well as their aspects, components, mechanisms, etc., are described herein with reference to one side of the body for the sake of brevity. However, since the human body is relatively symmetric or mirror-imaged about the line of symmetry (midline), the devices, systems, apparatuses, and methods, as well as their aspects, components, mechanisms, etc., described and / or illustrated herein can be varied, changed, modified, reconfigured, or otherwise altered for use with or in relation to the other side of the body for the same or similar purposes without departing from the spirit and scope of the present disclosure. For example, the devices, systems, apparatuses, and methods, as well as their aspects, components, mechanisms, etc., described herein with respect to the right foot may be mirrored to function similarly with the left foot. Further, while the devices, systems, apparatuses, and methods, as well as their aspects, components, mechanisms, etc., disclosed and described herein are described with respect to the leg for the sake of brevity, it should be understood that the devices, systems, apparatuses, and methods can be used with other bones of the body having similar structures.

[0014] Due to pathology, trauma, or a failed prior surgery, fusion of the tibial-talar-calcaneal (TTC) complex may involve the insertion of an implant (i.e., an intramedullary (IM) nail), and one or more bone screws or bone fasteners, where the fasteners referred to herein are to include screws, pins, fixation members, etc. The IM nail may be configured, for example, to provide continuous compression across both the tibio-talar or ankle joint and the talo-calcaneal or subtalar joint. By providing continuous compression at the ankle or subtalar joint, it can be ensured that bone apposition is maintained throughout the fusion process. According to one embodiment, the IM nail can tolerate different compression loads for each of the individual joints. The IM nail may include an internal spring for providing compression to the subtalar joint and an external spring for providing compression to the ankle joint. By providing independent compression for each of the individual joints, joint space formation can be prevented during the fusion process. For example, the internal spring of the IM nail can be configured or sized and shaped to provide optimal compression between the talus and the calcaneus, and the external spring can be configured or sized and shaped to provide optimal compression between the talus and the tibia. The compression may be dynamic to allow continuous compression of the joint surface during bone resorption or bone remodeling.

[0015] Aspects of the present disclosure provide implant guides, devices, systems, and methods for use in inserting an implant for fusion of the TTC complex. For example, an implant guide system configured to provide optimal positioning of an implant during a surgical procedure is described herein. In particular, disclosed herein are implant guides, devices, systems, and methods that are advantageous for reducing surgical time, reducing the number of operators or assistants required during surgery, streamlining the surgical technique, providing predictability and reliability when inserting bone screws or bone fasteners into a patient, reducing the potential for setup errors, and reducing the potential for misplacement of implants and bone screws, thereby facilitating a more rigid configuration of the inserted implant.

[0016] Referring now to FIG. 1, an embodiment of an implant guide system 400 is shown. The implant guide system 400 includes an implant guide device 402. The implant guide device 402 includes a base 404, a first arm 406 coupled to a first end 408 of the base 404, and a second arm 410 coupled to a second end 412 of the base 404. The implant guide device 402 also includes a sighting arm 414 hinge-coupled to at least one of the first arm 406 and the second arm 410. The implant guide system 400 also includes a mount system 500 that traverses an aperture 448 in the base 4041. Further, the implant guide system 400 includes an implant 300 coupled to the mount system 500. The aperture 448 may be sized and shaped, for example, to receive the implant 300 and further to receive a portion of the mount system 500. The implant 300 may be of the type described in detail in U.S. Provisional Application No. 62 / 812,247, entitled "Implant, System, and Method of Use" (Attorney Docket No. 3645.146P), the contents of which are hereby incorporated by reference in their entirety.

[0017] FIG. 2 is a perspective view of the implant guide system of FIG. 1, and in accordance with one aspect of the present disclosure, the implant 300 is inserted into a patient's lower limb 600. For insertion of the implant 300, the base 404 of the implant guide device 402 can be positioned, for example, below the plantar portion of the foot 602 of the patient's lower limb 600, the first arm 406 of the implant guide device 402 is positioned medial to the patient's lower limb 600, and the second arm 410 of the implant guide device 402 is positioned lateral to the patient's lower limb 600. Further, the sighting arm 414 may be positioned toward the rear of the patient's foot 602.

[0018] Referring now to FIGS. 3-7, a mounting system 500 of an implant 300 and an implant guide system 400 is shown. The implant 300 may include, according to various embodiments, a nail system or an IM nail (e.g., a double spring dynamic nail). The implant 300 includes a first end or proximal end 302 and a second end or distal end 304, and the second end 304 is configured to couple to the mounting system 500.

[0019] Continuing to refer to FIGS. 3-7, the implant 300 can include a first member or outer sheath 310 and a connecting member 130 at the first end or proximal end 302. The connecting member 130 can include a rotation prevention pin opening 132 for maintaining the configuration of the connecting member 130. The first member or outer sheath 310 may include a body portion 112.

[0020] Continuing to refer to FIGS. 3-7, the body portion 112 may include a first portion or proximal portion 316 connected to a first deformable member 120 (e.g., an external spring) and a second portion or distal portion 318 connected to the distal end portion 320 of the outer sheath 310. The body portion 112 may include a rotation prevention pin opening 312 for assisting in maintaining the configuration of the implant 300. The body portion 112 may further include one or more holes 114, 116 that traverse the implant 300 and are perpendicular to the longitudinal axis of the body portion 112 of the implant 300. At least one of the one or more holes 114, 116, e.g., hole 114, may be disposed in the first portion or proximal portion 316 of the body portion 112, and at least one of the one or more holes 114, 116, e.g., hole 116, may be disposed in the second portion or distal portion 318 of the body portion 112. The one or more holes 114, 116 may have a size and shape, or be configured, to receive a bone screw or bone fastener that is inserted into the patient's tibia, for example.

[0021] Also, as shown in FIGS. 3-7, the distal end 320 of the first member or outer sheath 310 may further include one or more holes 322, 326 that cross the implant 300 and are perpendicular to the longitudinal axis of the implant 300. The one or more holes 322, 326 in the distal end 320 may have a size and shape to receive, for example, bone screws or bone fasteners inserted into the patient's talus or calcaneus. For example, when the implant 300 is inserted into the patient's lower limb, the first hole 326 can be configured to extend from the front portion of the implant 300 to the rear portion of the implant 300, while the second hole 322 can be configured to extend from the lateral portion of the implant 300 to the inner portion of the implant 300. The one or more holes 114, 116, 322, 326 may be, for example, elongated, round, circular, oval, etc.

[0022] As shown in FIGS. 3-7, the mount system 500 can include an implant engagement portion 190 configured or sized and shaped to couple to the second end 304 of the implant 300, a mount screw spacer 502, and a strike plate 504. The implant engagement portion 190 may include a body portion 192 with at least one groove 194 that is inserted into the outer surface of the body portion 192. The implant engagement portion 190 may also include a connection protrusion 196 that extends away from the first end 184 of the body portion 192. The connection protrusion 196 may include a threaded portion 200 that surrounds the outer surface of the connection protrusion 196 for insertion into the distal end 304 of the outer sheath 310. The implant engagement portion 190 may also include a through hole 202 with a tool engagement opening or drive opening 204 for receiving a tool to remove preload compression from the implant 300. The implant engagement portion 190 may be configured or sized and shaped to compress and hold, for example, the first deformable member 120 of the implant 300. By compressing and positioning the implant 300, the implant 300 can be inserted into the patient in a "preloaded" position. The "preloaded" position includes compression of the first deformable member 120.

[0023] Continuing to refer to FIGS. 3 - 7, the mount system 500 can facilitate the alignment of the implant 300 with respect to the implant guide device 402, for example, as shown in FIG. 1. For example, by engaging one or more accessories using the implant guide device 402, as shown in FIG. 11, the insertion of one or more bone screws 308 through the fastener holes 114, 116, 322 and into the patient's lower limb 600 as shown in FIG. 2 is facilitated. By appropriately aligning the implant 300 with respect to the implant guide device 402 using the mount system 500, inserting one or more bone screws 308 through the implant guide device 402 ensures predictable engagement with the fastener holes 114, 116, 322 while simultaneously avoiding striking and / or damaging the implant 300 during the insertion of the one or more bone screws 308. The insertion of the one or more bone screws 308, once inserted into the patient's lower limb 600 as shown in FIG. 2, can provide additional fixation and stability to the implant 300.

[0024] Still referring to FIGS. 3 - 7, the mount screw spacer 502 of the mount system 500 may include an insertion portion 506, a screw spacing portion 508, a base engagement portion 510, and a strike plate attachment portion 512. As shown in FIG. 1, the base engagement portion 510 may be configured to traverse the opening 448 of the base 404 of the implant guide device 402. The strike plate attachment portion 512 may include a threaded portion surrounding the outer surface of the strike plate attachment portion 512.

[0025] Further referring to FIGS. 3-7, the strike plate 504 of the mount system 500 can include a striking portion 516, a mounting portion 518, a first threaded cavity 520, a second threaded cavity 536, and a strike plate opening 522 that traverses both the first threaded cavity 520 and the second threaded cavity 536. The first threaded cavity 520 can be installed inside the striking portion 516 of the strike plate 504, and the second threaded cavity 536 can be installed inside the mounting portion 518 of the strike plate 504. The first threaded cavity 520 can include threads for engaging an attachment. For example, the first threaded cavity 520 can engage a sledgehammer attachment for lowering the implant 300 distally based on the implant 300 being inserted excessively into the patient's lower limb. For example, by lowering the implant 300 distally, the position of the implant 300 can be easily controlled without colliding with the mount system 500 (e.g., without colliding with the mounting system 500 using a mallet to lower the implant 300). The second threaded cavity 536 includes threads for engaging the strike plate mounting portion 512 of the mount screw spacer 502. The second threaded cavity 536 is configured such that the strike plate 504 can be removed (e.g., during a surgical procedure) while the remainder of the mount system 500 and the implant 300 are engaged with the patient's lower limb and / or the implant guide device 402, as shown in FIGS. 1-2, or it may have a size and shape. The strike plate 504 may include a configuration that is enlarged, for example, to provide a large surface area that is struck using a mallet during insertion of the implant 300. For example, the removable strike plate 504 enables replacement of the strike plate without the need to disassemble or break other mechanisms or aspects of the mount system 500 (e.g., based on the strike plate being damaged and / or broken due to one or more large strikes using a mallet during insertion).

[0026] Continuing to refer to FIGS. 3-7, the mount system 500 may include a mount screw 524 that includes a threaded portion 526, a shaft 528, and a head 530. Further, the mount screw spacer 502 may include a through hole 514 into which the mount screw 524 is insertable. For example, the mount screw 524 can be inserted through the strike plate opening 522 of the strike plate 504, the through hole 514 of the mount screw spacer 502, and the through hole 202 of the implant engagement portion 190, such that the shaft 528 of the mount screw 524 traverses the strike plate 504 and the screw spacer 502 of the mount system 500. The threaded portion 526 of the mount screw 524 can be configured to be inserted into the second or distal end 304 of the implant 300, or may have a size and shape. Once the mount screw 524 is inserted, the head 530 of the mount screw 524 may be placed, for example, inside the first screw cavity 520 of the strike plate 504.

[0027] Referring now to FIG. 8, there is shown a mount screw spacer 502 of the mount system 500. As shown in FIGS. 3-7, the insertion portion 506 of the mount screw spacer 502 can include one or more alignment tabs 532, 534 for engaging the insertion portion 506 with the tool engagement opening 204 of the implant engagement portion. For example, the first alignment tab 532 can be configured to dovetail with a corresponding recess of the tool engagement opening 204, or can have a size and shape, and the second alignment tab 534 can be configured to interlock with a corresponding notch of a separate tool engagement opening 204 that corresponds to the first alignment tab 532. For example, one or more alignment tabs 532, 534 can be disposed at the first end 538 of the insertion portion 506, and the second end 540 of the insertion portion 506 is connected to the screw spacing portion 508 of the mount screw spacer 502. Each of the one or more alignment tabs 532, 534 can include one or more engagement portions of varying size, shape, positioning or angle. For example, as shown in FIG. 10, the first alignment tab 532 can be a narrow protrusion that extends outwardly along the longitudinal axis of the mount screw spacer 502, while the second alignment tab 534 can include a relatively wide protrusion that extends outwardly along the longitudinal axis of the mount screw spacer 502. Further, the first alignment tab 532 can include, for example, a convex engagement surface, while the second alignment tab 534 can include, for example, a concave engagement surface. The one or more alignment tabs 532, 534 can be configured to prevent rotation of the mount system 500 relative to the implant 300 while simultaneously aligning the mount screw spacer 502 within the tool engagement opening 204 of the implant engagement portion, or can have a size and shape. The one or more alignment tabs 532, 534 can facilitate mounting the mount system 500 to multiple implant designs (e.g., single spring dynamic nail, double spring dynamic nail, etc.) according to various embodiments, so that, as shown in FIGS. 1-2, the implant guide device 402 can facilitate inserting multiple implant designs into the patient's lower limb 600.

[0028] Referring now to FIGS. 9-10, as shown in FIGS. 3-7, an implant 300 and an implant engagement portion 190 of the mount system are shown. The implant 300 can include a through hole 306 that extends through a first member 310 along a longitudinal axis. The implant 300 can also include a second member or inner rod 330, where the connecting member 130 is configured or sized and shaped to secure the first member or outer sheath 310 to the second member or inner rod 330 at the proximal end 302. Further, the implant engagement portion 190 can be configured or sized and shaped to secure the first member or outer sheath 310 to the second member or inner rod 330 at the distal end 304.

[0029] Further, as shown in FIGS. 9-10, the second member or inner rod 330 includes a shaft or body portion 332 having an inner rod clip 340 connected to and extending from a first end of the second member 330. The body portion 332 of the second member 330 may include a first through hole or proximity through hole or fastener hole 334 for receiving a bone screw or bone fastener that is inserted into the bone of the patient's lower limb. The through hole 334 may be positioned, for example, near the inner rod clip 340. The through hole 334 can be positioned to align with the through hole 114 of the first member 310 during assembly. The second member 330 may further include at least one fastener hole 336 that is positioned near a second deformable member (i.e., an internal spring) 350. The at least one fastener hole 336 can be positioned to align with at least one hole 116 of the first member 310 during assembly.

[0030] Continuing to refer to FIGS. 9-10, the distal end 320 of the first member or outer sheath 310 may also include an anti-rotation pin opening 324 to assist in maintaining the configuration of the implant 300. The second member 330 may also be positioned to align with the anti-rotation pin opening 312 of the first member 310 and include at least one anti-rotation pin opening 338 through which an anti-rotation pin 106 can be inserted through the pin opening 312 and the pin opening 338 to fix the first member 310 to the second member 330. The second member or inner rod 330 may also include an anti-rotation pin opening 344 that extends through the inner rod clip 3401. The second member 330 may further include an anti-rotation pin opening 356 to assist in maintaining the configuration of the second deformable member 350. Each of the anti-rotation pin openings 312, 324, 338, 344, 356 may have a size and shape, for example, to receive the anti-rotation pin 106.

[0031] Still referring to FIGS. 9-10, the inner rod clip 340 of the second member 330 may include a base portion 342 that is connected to and extends from the body portion 322. During assembly, the base portion 342 is positioned inside the through-hole 306 of the first member 310 and surrounded by the deformable member 120. The second deformable member 350 may include, for example, a helically machined spring. The spring 350 may include a first through-hole or fastener hole 352 that extends from one side to the other through the spring 350 and a second through-hole or fastener hole 354 that extends from one side to the other through the spring 350. The spring 350 may further include a connection portion 358 that is positioned at the distal end of the second member 330. The connection portion 358 may include an opening 360 with an internal thread for receiving the threaded portion 526 of the mount screw 524. According to various embodiments, the connection portion 358 may include one or more alignment recesses for engaging corresponding alignment protrusions at the implant engagement portion 190. The connection portion 358 may also include an external thread surrounding the connection portion 358 for insertion into the internal thread portion 198 of the implant engagement portion 190.

[0032] FIG. 11 shows an implant 300 inserted into the lower limb 600 of a patient. The implant 300 is configured or sized and shaped to traverse the longitudinal axis of the patient's tibia 604 and the patient's talus 606 and calcaneus 608. The implant 300 can be fixed to each bone 604, 606, 608 of the patient's lower limb 600 using a plurality of bone screws 308 inserted into one or more through-holes 114, 116, 322, 326, 334, 336, 352, 354 of the implant 300. For example, one or more bone screws 308 may be inserted perpendicular to the longitudinal axes of both the patient's tibia 604 and the implant 300. Further, one or more bone screws 308 can be configured or sized and shaped to traverse a portion of the patient's talus 606 and one or more through-holes 114, 116, 322, 326, 334, 336, 352, 354. As shown in FIG. 11, the implant 300 can be fixed to the calcaneus 608 using a bone screw 308 that extends through the posterior portion of the calcaneus 608 and through a through-hole of the implant 300.

[0033] FIGS. 12-13 show an implant guide system 400 coupled to the lower limb 600 of a patient. As shown in FIG. 12, the aiming arm 414 of the implant guide device 402 may be hingedly coupled to at least one of the first arm 406 and the second arm 408 as shown in FIGS. 1-2. The aiming arm 414 may be coupled to the first arm 406, for example, via an aiming arm lock 416. The aiming arm lock 416 may include a hinged lever for fixing the position of the aiming arm 414.

[0034] Continuing to refer to FIGS. 12-13, the aiming arm 414 can be positioned at an angle of approximately 90° with respect to the longitudinal axis of the first arm 406, for example, to insert the bone screw 308 into the posterior portion of the calcaneus 608. To obtain a more optimal angle for inserting the bone screw into the posterior portion of the calcaneus 608, it may be desirable to vary the trajectory of the bone screw 308 (e.g., ±5° in both directions) to provide an optimal entry point for the bone screw 308. The aiming arm lock 416 can be loosened, for example, by extending a hinged lever away from the first arm 406 of the implant guide device 402. This loosening operation allows the aiming arm 414 to be repositioned to change the entry point of the bone screw 308. Once the aiming arm 414 is positioned at the desired angle with respect to the longitudinal axis of the first arm 406, the aiming arm lock 416 can be retracted toward the first arm 406 of the implant guide device 402. The aiming arm 414 can change the entry point of the bone screw 308 into the calcaneus 608 by adjusting the trajectory of the bone screw 308 by ±5° in both directions, but the bone screw 308 can be configured, or have a size and shape, such that it can be inserted through the hole 326 in the distal end 320 of the implant 300. Conveniently, by varying the trajectory of the bone screw 308 (e.g., at an angle of ±5° in both directions) for insertion into the posterior portion of the calcaneus 608, a plurality of bone screws 30 can be inserted into the calcaneus 608 (e.g., parallel screws can be inserted / inserted into the calcaneus 608).

[0035] Referring further to FIGS. 12-13, the aiming arm 414 can include one or more inlays 418 (e.g., metal rods) embedded in a gap within the side support portion 420 of the aiming arm 414. The one or more inlays 418 can be configured to provide a visual for aligning the bone screw 308 that is inserted into the calcaneus 608, or can have a size and shape. For example, the one or more inlays 418 can be longitudinally positioned within the side support portion 420 to correspond to the trajectory of an accessory that is inserted into the patient's calcaneus 608. For example, the one or more inlays 418 can be configured, or sized and shaped, such that the insertion of the screw 308 through the screw guide 424 allows the screw 308 to align parallel to the one or more inlays 418, and as a result, provides a visual representation of the insertion point of the screw 308 into the calcaneus 608 through the screw guide 424. As shown, each side support portion 420 can include, for example, an inlay 418. For example, based on an implant guide device 402 that includes an aiming arm 414 having two side support portions 420, one side support portion 420 coupled to the first arm 406, and the other side support portion 420 coupled to the second arm 410. Each side support portion 420 can include, for example, an inlay 418 for providing a visual trajectory of the accessory to be inserted. The inlay 418 of the side support portion 420 coupled to the first arm 406 can be configured, or sized and shaped, to provide, for example, a side view of the trajectory of the accessory to be inserted, while the inlay 418 of the side support portion 420 coupled to the second arm 410 can be configured, or sized and shaped, to provide, for example, an inside view of the trajectory of the accessory to be inserted. In the absence of one or more inlays 418, fluoroscopy can show the entry points into the calcaneus 608 and / or the fastener holes 326 of the implant 300, but typically the surgeon needs to visualize in their head the alignment and / or trajectory of the accessory to be inserted. Advantageously, the one or more inlays 418 can assist the surgeon by facilitating visualization of the trajectory of the accessory to be inserted.

[0036] Further referring to FIGS. 12 - 13, the aiming arm 414 may also include an accessory engagement portion 422 connected to the side support portion 420 via, for example, one or more stabilization pins 426. The accessory engagement portion 422 may be configured to engage with a screw guide 424 for insertion of a bone screw into the calcaneus 608, or may have a size and shape. For example, the screw guide 424 may traverse a hollow conduit of the accessory engagement portion 422. The screw guide 424 may be configured to engage with a drill guide 434 used, for example, to facilitate drilling a bone screw 308 into a patient's bone, or may have a size and shape.

[0037] Further referring to FIGS. 12 - 13, the aiming arm 414 may also be configured to provide an elevation support to the patient's lower limb 600, or may have a size and shape. As shown in FIG. 13, the patient's lower limb 600 is positioned in a supine position using a first arm 406 of an implant guide device 402 parallel to the patient's tibia 604 when the foot 602 is facing upward. Further, the aiming arm 414 is positioned perpendicular and downward with respect to the first arm 406 of the implant guide device 402 and the patient's tibia 604 while being placed on a horizontal plane (e.g., an operating table), such that the patient's foot 602 rises above the horizontal plane. Based on the aiming arm 414 being positioned as shown in FIG. 13, the aiming arm 414 can, for example, independently support the implant guide device 402 and the patient's lower limb 600 during surgery. Advantageously, by using the aiming arm 414 to support the patient's lower limb 600 and the implant guide device 402 above the horizontal plane (i.e., providing a kickstand function), for example, during insertion of the bone screw 308, the need for an assistant to support or hold the patient's lower limb 600 above the operating table can be eliminated, facilitating access to the patient's lower limb 600 during a surgical procedure.

[0038] Figure 14 shows a part of the implant guide device 402 of the implant guide system 400. The implant guide device 402 may include, for example, one or more side support orientation markings 428 on a side support portion 420 of the aiming arm 414 of the implant guide device 402. Further, the implant guide device 402 may include one or more arm orientation markings 430 for aligning the aiming arm with at least one of the first arm 406 and the second arm 410. The one or more side support orientation markings 428 may also be disposed at other positions on the side support portion 420 of the aiming arm 414, so that the aiming arm 414 is observable when viewed, for example, from an inner perspective, a side perspective, a front perspective, a rear perspective, or other viewing trajectories. The one or more side support orientation markings 428 can facilitate aligning the aiming arm 414 at any desired angle (e.g., a nominal calcaneal angle) with respect to at least one of the first arm 406 and the second arm 410.

[0039] Also shown in FIG. 14 is a pivot (swivel) hole 432 into which a pin for connecting the aiming arm 414 to at least one of the first arm 406 and the second arm 410 can be inserted. By pivoting the aiming arm 414 around the pivot hole 432, it becomes easy to adjust the trajectory of the insertion accessory.

[0040] Referring to FIGS. 15-22, an implant guide system 400 is shown. The implant guide device 402 can be configured to engage a plurality of accessories or may have a size and shape. For example, the first arm 406 and the second arm 410 can be configured to secure one or more screw guides 424 for inserting the bone screw 308 into the patient's lower limb or may have a size and shape. For example, the implant guide device 402 may include a plurality of through holes 436, and each screw guide 424 can be configured to be inserted therethrough or may have a size and shape. The through holes 436 can be configured to align with, for example, the fastener holes 116 of the implant 300 or may have a size and shape, facilitating the insertion of the bone screw 308 into the fastener holes 116 of the implant 300 and into the patient's lower limb. In particular, one or more through holes 436 can be positioned at the proximal portion of at least one of the first arm 406 and the second arm 410 of the implant guide device 402 and can align with the fastener holes 116 for inserting the bone screw 308 into the patient's tibia. Further, one or more through holes 436 can be positioned at the distal portion of at least one of the first arm 406 and the second arm 410 and can align with the fastener holes 322 for inserting the bone screw 308 into the patient's talus.

[0041] Continuing to refer to FIGS. 15-22, the through-hole 436 can also be configured to engage one or more locks 438 (e.g., cam locks) for securing a plurality of accessories, or may have a size and shape. For example, one or more locks 438 may be hingedly coupled to at least one of the first arm 406 and the second arm 410. The lock 438 can engage the through-hole 436 by pivoting one or more locks 438 away from at least one of the first arm 406 and the second arm 410. The pivoting of the lock 438 traverses the through-hole 436, or loosens an accessory that pivots one or more locks 438 and retracts it toward at least one of the first arm 406 and the second arm 410, fastening the accessory traversing the through-hole 436 in a desired position. The aiming arm 414 may also include an aiming arm through-hole 444 configured to engage an aiming arm lock 440 (e.g., cam lock) for securing an accessory, or having a size and shape. For example, the aiming arm lock 440 can be hingedly coupled to the aiming arm 414, such that by extending the aiming arm lock 440 away from the aiming arm 414, an accessory traversing the through-hole 444 can be loosened. Further, by retracting the aiming arm lock 440 toward the aiming arm 414, an accessory traversing the aiming arm through-hole 444 is secured. The implant guide device 402 may include a plurality of fasteners 446 for fastening the lock 438 to at least one of the first arm 406 and the second arm 410 and for fastening the aiming arm lock 440 to the aiming arm 414.

[0042] Referring further to FIGS. 15 - 22, the implant guide device 402 may include one or more aiming arm support pins 442 about which the aiming arm 414 can pivot relative to at least one of the first arm 406 and the second arm 410. The aiming arm 414 can be configured to pivot relative to at least one of the first arm 406 and the second arm 410 to align the screw guide 424 for inserting the bone screw 308 into the patient's lower limb, or it may have a size and shape. The one or more aiming arm support pins 442 can be configured to cross or may have a size and shape to cross at least one pivot hole 432 of the first arm 406 and the second arm 410. For example, as shown in FIG. 15, the one or more side support orientation markings 428 and the one or more arm orientation markings 430 can be configured to be visible when observing the implant guide device 402 from a front - side view to facilitate alignment of the aiming arm 414, or they may have a size and shape.

[0043] FIG. 23 shows the implant guide system 400 with the implant guide device 402 removed from the implant 300 and the accessories. The accessories may include, for example, one or more screw guides 424. Each screw guide 424 can be configured to engage with the drill guide 434 when inserting the bone screw 308 into the patient, or it may have a size and shape.

[0044] Referring now to FIGS. 24 - 31, the implant guide system 400 is shown in relation to a patient's lower limb 600. The bone screw 308 can be dropped or inserted into the patient's lower limb 600 from the inside and / or distal side of the implant guide device 402. Based on the aiming arm 414 being hingedly coupled to at least one of the first arm 406 and the second arm 410, the aiming arm 414 can be positioned on the front side and / or the rear side of the implant guide device 402.

[0045] Conveniently, based on the aiming arm 414 being hinge-coupled to at least one of the first arm 406 and the second arm 410, the implant guide device 402 is reversible, so that whether the first arm 406 or the second arm 410 is positioned medially with respect to the patient's lower limb 600, or whether the first arm 406 or the second arm 410 is positioned laterally with respect to the patient's lower limb 600, the implant guide device 402 maintains functionality. The reversible aspect of the implant guide device 402 enables, in part, the implant guide device 402 to be ambidextrous.

[0046] Referring now to FIG. 32, the implant guide device 402 of the implant guide system is shown. The implant guide device 402 can be configured to be substantially symmetric, or have a size and shape, to facilitate use of the implant guide device 402 on a patient's left lower limb and a patient's right lower limb.

[0047] Referring now to FIGS. 33 - 40, an exploded view of the implant guide device 402 is shown. One or more locks 438 of the implant guide device 402 can be coupled to at least one of the first arm 406 and the second arm 410 via a lock pin 450, a lock pin support 452, and a plurality of fasteners 446. For example, one or more locks 438 can be configured to pivot around the lock pin 450, or have a size and shape, when loosening and / or securing an accessory within the through-hole 436. Similarly, the aiming arm lock 440 can be configured to engage the lock pin 450 and the lock pin support 452, or have a size and shape, when loosening and / or securing an accessory through the aiming arm through-hole 444.

[0048] Continuing to refer to FIGS. 33 - 40, the implant guide device 402 can include a plurality of stabilization pin holes 454 for receiving the stabilization pins 426 during assembly. For example, the first arm 406 can be connected to the base 404 by inserting a portion of the first arm 406 that includes the stabilization pin holes 454 into the first end 408 of the base 404 and fixing the first arm 406 to the base 404 by embedding the stabilization pins 426 into each of the stabilization pin holes 454.

[0049] Still referring to FIGS. 33 - 40, the implant guide device 402 may include a hinge pin 456 for engaging the hinge pin conduit 462 of the side support portion 420. For example, the hinge pin 456 can be partially inserted into the interior of the first arm 406 of the implant guide device 402 and can be partially inserted into the hinge pin conduit 462 of the side support portion 420 of the implant guide device 402. The hinge pin 456 can be configured to limit the rotation of the aiming arm 414, or can have a size and shape. For example, the aiming arm 414 may pivot by a distance corresponding to the range within which the hinge pin 456 can move within the hinge pin conduit 462. In particular, the aiming arm 414 can be configured to limit the rotation of the aiming arm 4142, or can have a size and shape such that, based on the engagement of the hinge pin 456 with the hinge pin conduit 462, it pivots only between 90 - 180° with respect to at least one of the first arm 406 and the second arm 410.

[0050] Referring further to FIGS. 33 - 40, the implant guide device 402 may also include a aiming arm lock pin 458 configured to engage, or sized and shaped to engage, the aiming arm lock 416. For example, when loosening the aiming arm 414 or fixing the aiming arm 414 in a desired position, it may be configured to pivot around the aiming arm lock pin 458, or sized and shaped to do so. The aiming arm lock pin 458 may also be configured to engage, or sized and shaped to engage, the threaded portion of the aiming arm support pin 442. Further, the aiming arm support pin 442 can engage a spring 460 when rotating the aiming arm 414. Further, the spring 460 and the aiming arm support pin 442 may be configured to cross, or sized and shaped to cross, the pivot hole 432 of the first arm 406 of the implant guide device 402.

[0051] Referring now to FIG. 41, an implant guide system 400 is shown, for example, including an external compression attachment 700. The external compression attachment 700 can be configured to provide external compression outside and independent of the implant 300, or sized and shaped to do so. In particular, the external compression attachment 700 can extend from at least one of the first arm 406 and the second arm 410 to provide compression at the proximal portion of the patient's lower limb 600 relative to the implant guide device 402. The external compression attachment 700 can be configured to engage, or sized and shaped to engage, one or more through holes of at least one of the first arm 406 and the second arm 410 to secure the external compression device 700 to the implant guide device 402.

[0052] Referring further to FIG. 41, the external compression attachment 700 can include one or more outer support rods 702 and one or more inner support rods 704 for supporting the compression portion 710 of the external compression attachment 700. The external compression attachment 700 can also be configured to include a threaded rod 706, or can have a size and shape that is configured to engage, or can have a size and shape, with the compression portion 710 to adjust the location of the compression portion along one or more outer support rods 702 and one or more inner support rods 704. The external compression attachment 700 can also be configured to include, or can have a size and shape, an attachment portion 708 for engaging one or more through-holes of at least one of the first arm 406 and the second arm 410 of the implant guide device 402. The compression portion 710 may include a compression applicator 712 for applying compression to the patient's lower limb 600.

[0053] Referring now to FIG. 42, an implant guide system 400 is shown that includes a single - arm aiming accessory 800 and an extension accessory 900. The single - arm aiming accessory 800 can be coupled to at least one of, for example, a first arm 406 and a second arm 410 of an implant guide device 402. For example, as shown in FIG. 42, the single - arm aiming accessory 800 may be coupled to the second arm 410. The single - arm aiming accessory 800 can be coupled using a lock 438 and at least a portion of the single - arm aiming accessory 800 can be fixed inside a through - hole 436 of the second arm 410. The single - arm aiming accessory 800 can be configured to facilitate inserting a bone screw 308 into a posterior portion of a patient's lower limb and may have a size and shape. For example, the single - arm aiming accessory 800 can include an aiming accessory through - hole 802 for inserting an accessory (e.g., a screw guide 424 and / or a drill guide 434). In particular, the single - arm aiming accessory 800 can be configured to facilitate inserting a talocalcaneal bone screw or may have a size and shape. For example, when using the single - arm aiming accessory 800, the aiming arm 414 can pivot to its lowest position (i.e., the most distal position), creating a room for the single - arm aiming accessory 800 behind the calcaneus 608.

[0054] Continuing to refer to FIG. 42, the implant guide system 400 may also include an extension accessory 900. The extension accessory 900 can be configured, for example, to extend at least one of the first arm 406 and the second arm 410 of the implant guide device 402, or may have a size and shape. The extension accessory 900 can be coupled, for example, using a lock 438, to at least one of the first arm 406 and the second arm 410 of the implant guide device 402, and fix at least a part of the extension accessory 900 inside the through hole 436. The extension accessory 900 can include, for example, an extension accessory fastener 902 for engaging the accessory. For example, the extension accessory fastener 902 can be configured, or may have a size and shape, to fix the screw guide 424 and the drill guide 434 for inserting a bone screw into the proximal portion of the patient's lower limb 600.

[0055] FIGS. 43A-43B show other embodiments of the implant guide system 400. The implant guide system 400 includes, for example, an implant guide device 461. Some or all aspects of the implant guide device 461 may be the same as or similar to the implant guide device 402 described above. In one embodiment, the implant guide device 461 includes a base 464, a first arm 466 coupled to the first end 468 of the base 464, and a second arm 470 coupled to the second end 472 of the base 464. The implant guide device 461 also includes a sighting arm 474 hinge-coupled to at least one of the first arm 466 and the second arm 470. The implant guide system 400 also includes a mount system 500 that traverses the opening 476 of the base 464. Further, the implant guide system 400 includes an implant 300 coupled to the mount system 500.

[0056] Referring further to FIGS. 43A - 43B, the aiming arm 474 of the implant guide device 461 may include one or more side support portions 478 and an accessory engagement portion 480. The accessory engagement portion 480 may be configured to engage a screw guide 484 or may include an aiming arm through - hole 482 having a size and shape. Depending on the shape of the shaft 486 of the desired screw guide 484 (e.g., circular, elliptical, etc.), the aiming arm through - hole 482 can have various dimensions, for example. For a screw guide 484 including a wider shaft 486, the accessory engagement portion 480 can include one or more protrusions 488 that accommodate an aiming arm through - hole 482 having a larger dimension. Various other embodiments of the aiming arm 474 are also contemplated herein.

[0057] Referring now to FIGS. 78 - 82, an alternative embodiment of an implant guide system 400 including an implant guide device 1502 is shown. In some aspects, the implant guide device 1502 can include one or more components that are the same as and / or similar to the implant guide device 402 described and illustrated above. Further, the implant guide device 1502 can be implemented with the components of the implant guide system 400 and with other implant guide systems. For example, the implant guide device 1502 may be configured to facilitate the implantation of the implant 300 as described and illustrated above and / or may be configured to facilitate the implantation of other implants (some of which may be the same as and / or similar to the implant 300).

[0058] Continuing to refer to FIGS. 78-82, the implant guide device 1502 includes a base 1504, a first arm 1506 coupled to the first end 1508 of the base 1504, and a second arm 1510 coupled to the second end 1512 of the base 1504. The implant guide device 1502 is further illustrated with one or more through holes 1536 disposed in both the first arm 1506 and the second arm 1508. In some embodiments, the through holes 1536 can be disposed laterally (e.g., providing fluid communication through the first arm 1506 / second arm 1510 in the inner lateral direction). Further, the first arm 1506 and the second arm 1510 can include one or more retention mechanisms 1538 configured to hold and / or releasably couple a drill guide (e.g., drill guide 434), a screw guide (e.g., screw guide 424), or other components housed within the through holes 1536. In some embodiments, the retention mechanism 1538 can be integral with the first arm 1506 and the second arm 1510. However, in some embodiments, the retention mechanism 1538 can be coupled to the first arm 1506 and the second arm 1508 to form an assembly.

[0059] The holding mechanism 1538 shown in FIGS. 78-82 may be disposed inside the first arm 1506 and the second arm 1510 of the implant guide device 1502 (e.g., housed inside the first arm 1506 and the second arm 1510). The holding mechanism 1538 can hold and / or releasably connect the components received in the through-hole 1536 by various means. In some embodiments, the holding mechanism 1538 may include one or more elastic members (e.g., springs, compression springs, coil springs, etc.) configured to apply one or more forces to a component at least partially received and positioned inside the through-hole 1536. For example, a coil spring may be configured to apply a force to a component at least partially positioned inside the through-hole 1536 to frictionally hold the component at a desired position inside the through-hole 1536. In some embodiments, the holding mechanism 1538 may be provided adjacent thereto (e.g., around the circumferential direction, etc.) for each of the through-holes 1536 of both the first arm 1506 and the second arm 1510. In some embodiments, a single holding mechanism 1538 may be configured to hold components in a plurality of through-holes 1536 (e.g., a single coil spring is circumferentially arranged around two or more through-holes 1536). Further, it should be noted that the holding mechanism 1538 is configured to provide increased radiopacity. For example, the holding mechanism 1538 (e.g., a spring, a coil spring, etc.) enables increased visibility during surgery when imaging is performed if the holding mechanism 1538 has a minimized radiopaque footprint (while other larger holding mechanisms may have a larger radiopaque footprint when observed by various medical imaging techniques and may interfere with anatomical structures).

[0060] Referring now to FIGS. 44A-44B, mount system 500 may be at least partially fixed to base 464 of implant guide device 461 before implant 300 is coupled to mount system 500. For example, mount system 500 may include a mount screw spacer 542 coupled to a first surface 490 (i.e., proximal surface) of base 464 and a strike plate 544 coupled to a second surface 492 (i.e., distal surface) of base 464, where first surface 490 and second surface 492 are surfaces positioned opposite one another. Mount screw 546 may be inserted, for example, through strike plate 544, and implant 300 may be coupled to mount screw spacer 542 via at least one tab 550, 552. At least one tab 550, 552 of mount screw spacer 542 may be dovetailed, for example, with at least one corresponding recess 314 of implant 300. Further, implant 300 may include a first end 346 and a second end 348, where second end 348 includes at least one recess 314 into which at least one tab 550, 552 of mount screw spacer 542 may be dovetailed. Advantageously, by having mount screw spacer 542 and strike plate 544 coupled to base 464, striking strike plate 544 upon insertion of implant 300 can provide proper positioning of implant guide device 461, for example, as shown in FIG. 11, for later insertion of one or more bone fasteners 308, as shown in FIG. 11, into patient's lower limb 600.

[0061] As shown in FIGS. 45-46, at least one of the tabs 550, 552 of the mount system 500 can include, for example, a plurality of tabs 550, 552. In one embodiment, the plurality of tabs 550, 552 can include, for example, a tab 550 having a greater width than the other tab 552 among the plurality of tabs 548. The tab 550 with the greater width can, for example, facilitate proper alignment of the implant 300 with respect to the mount system 500 (see FIGS. 44A-44B), such that the implant 300 can be aligned in only one pre-specified orientation. The mount screw spacer 542 can include, for example, one or more laser markings 558 that can provide a visual indicator for aligning the mount system 500 and can provide proper positioning of the implant 300 (see FIGS. 44A-44B). Further, the mount screw spacer 542 may include a threaded portion 554 for attaching the mount screw spacer 542 to the first surface 490 of the base 464 (see FIGS. 44A-44B). According to one embodiment, the mount screw spacer 542 may be separate from the strike plate 544 of the mount system 500. For example, the threaded portion 544 may be attached, for example, to the first surface 490 of the base 464 (see FIGS. 44A-44B). The strike plate 544 may include a threaded portion 556 for attaching to the second surface 492 of the base 464 (see FIGS. 44A-44B). Thus, the threaded portion 554 of the strike plate 544 may be separate and distinct from the threaded portion 544 of the mount screw spacer 5442. Various other attachment mechanisms are also envisioned here.

[0062] Referring now to FIGS. 47A - 48B, in accordance with one embodiment, the aiming arm 474 of the implant guide device 461 can rotate around at least one of the first arm 466 and the second arm 470. For example, the aiming arm 474 can rotate between approximately 90° and 215°. For example, the aiming arm 474 can be positioned at approximately 108°, as shown in FIGS. 47A and 47B. An aiming arm lock 494 can be attached to the first arm 466, and the aiming arm lock 494 can facilitate rotation of the aiming arm 474 by functioning as a hinged lever for locking the position of the aiming arm 474. For example, by pressing the aiming arm lock 494 against the first arm 466, the aiming arm 474 can be locked in place. Further, as shown in FIG. 48A, by lifting the aiming arm lock 494, movement of the aiming arm 474 with respect to the first arm 466 and the second arm 470 can be permitted. As shown in FIGS. 48A and 48B, the aiming arm 474 rotates from the approximately 108° position shown in FIGS. 47A and 47B to an approximately 180° position. Further, in accordance with one embodiment, the implant guide device 461 can include one or more locks 496 positioned on at least one of the first arm 466 and the second arm 470 for locking an accessory (e.g., screw guide, external compression attachment, extension accessory, etc., described in more detail above and not re - described here for brevity) to a location where it is attached to at least one of the first arm 466 and the second arm 470. The aiming arm lock 494 and the one or more locks 496 can rotate around a lock pin or an aiming arm lock pin (see, e.g., FIGS. 33 - 40). For example, the aiming arm lock 494 and the one or more locks 496 can rotate between 0° and 200° around an axis, for example. For example, the aiming arm lock 494 and the one or more locks 496 can be in a locked state when positioned at approximately 0°, as shown in FIG. 48B. Conversely, the aiming arm lock 494 and the one or more locks 496 can be opened when rotated approximately 180° - 200°, as shown in FIG. 48A, for example.

[0063] Referring now to FIGS. 49A - 50, other positions of the aiming arm 474 are possible to provide support to the implant guide device 461 and / or to facilitate the insertion of one or more screws at a desired angle into the patient's bone. For example, as shown in FIG. 49A, the 90° positioning of the aiming arm 474 allows the implant guide device 461 to be levered during surgery to provide good access to the plantar part of the patient's foot for inserting, for example, a nail implant as shown in FIG. 50. The 108° positioning of the aiming arm 474 can be used, for example, when inserting a calcaneal screw into the posterior part of the patient's calcaneus bone as shown in FIG. 49B. The 180° positioning of the aiming arm 474 may be desirable to move the aiming arm 474 away from the surgical area to provide better access, for example, for the insertion of a subtalar screw as shown in FIG. 49C. Other positionings of the aiming arm 474, such as the 215° shown in FIG. 49D, are also possible.

[0064] Referring now to FIG. 51, the aiming arm 474 of the implant guide device 461 can be used, for example, to insert a calcaneal screw 1002 (see FIG. 55) into the posterior part of the patient's calcaneus bone 608 (see FIG. 52). For example, in order to insert the calcaneal screw 1002 (see FIG. 55), the aiming arm 474 may desirably be positioned at approximately 108°. The calcaneal screw guide 1000 can be inserted through the aiming arm through - hole 482 (see FIG. 1) of the accessory engagement portion 480 of the aiming arm 474. The drill guide 1014 can be inserted through the drill guide opening 1008 (see FIG. 54) of the calcaneal screw guide 1000 when preparing to insert the calcaneal screw 1002 (see FIG. 55).

[0065] Referring now to FIGS. 52-53B, once the implant 300 has been inserted into the patient's lower limb 600, the implant guide device 461 can be positioned for insertion of the calcaneal screw 1002 (see FIG. 55). According to one embodiment, by using fluoroscopy to observe the patient's lower limb 600, the alignment of the aiming arm 474 can be facilitated for the desired positioning of the calcaneal screw 1002 (see FIG. 55). For example, as shown in FIGS. 53A-53B, by observing the implant guide device 461 using fluoroscopy, it is easy to observe the first inlay 479A of one side support portion 478A of the aiming arm 474 and the second inlay 479B of the other side support portion 478B of the implant guide device 461, and the first inlay 479A and the second inlay 479B function as fluoroscopic markers. FIG. 53A shows, for example, a side view of the patient's lower limb 600 in which the first inlay 479A and the second inlay 479B are not aligned. To obtain an accurate trajectory representation for inserting the calcaneal screw 1002 (see FIG. 55), a medical professional can position the first inlay 479A and the second inlay 479B to be aligned, as shown, for example, in FIG. 53B.

[0066] Once the aiming arm 474 is properly aligned, a medical professional can insert, for example, a pin 1010 into the posterior portion of the patient's calcaneus to provide drill stabilization for drilling through the patient's bone, and the pin 1010 passes through the pin opening 1012 of the calcaneal screw guide 1000, as shown, for example, in FIG. 54. Once the aiming arm 474 is aligned and stabilized, a medical professional can drill through the posterior portion of the patient's calcaneus 608, for example, before inserting the calcaneal screw 1002 (see FIG. 55). Various methods can be used to determine the depth of the drilled portion of the patient's calcaneus 608. For example, lateral fluoroscopy of the patient's lower limb 600 can provide a visual depiction of the depth. Further, the depth can be measured using markings on a depth gauge 1006 that can be inserted through the drill guide opening 1008 of the calcaneal screw guide 1000, as shown, for example, in FIG. 54.

[0067] Referring now to FIGS. 55-57D, once inserted, the calcaneal screw 1002 traverses the fastener hole 326 of the implant 300 (i.e., the IM nail), as shown, for example, in FIG. 55. To ensure alignment of the calcaneal screw 1002 with the fastener hole 326, the calcaneal screw 1002 can be inserted through the drill guide opening 1008 of the calcaneal screw guide 1000. The calcaneal screw guide 1000 can be held in position inside the aiming arm through hole 482 by a spring 483 inserted into the cavity 481 of the accessory engagement portion 480 of the aiming arm 474, as shown in FIG. 57C. Further, the alignment channel 1004 (FIGS. 51-52) of the calcaneal screw guide 1000 can engage a protrusion 498 in the aiming arm through hole 482.

[0068] As shown in FIG. 55, the first arm 466 and the second arm 470 may include various through holes 467A, 467B, 469A, 469B, 471A, 471B, 473A, 473B that traverse at least one of the first arm 466 and the second arm 470 from the inside laterally. The most distal tibial through holes 467A, 467B can be configured to receive a screw guide 424 (see FIG. 54) or may have a size and shape to facilitate insertion of a screw 308 (see FIG. 54) through the implant 300 into the patient's tibia 604 (see FIG. 54) to secure the implant 300. The through-holes 469A, 469B can provide proper screw positioning inside the implant 300 and the patient's tibia 604 (see FIG. 54), and provide weight bearing post-operative compression, known as dynamization. Alternatively, if post-operative dynamization is not desirable, the through-holes 471A, 471B can provide proper screw positioning inside the implant 300 and the patient's tibia 604 (see FIG. 54). In particular, the through-holes 471A, 471B can provide a relatively static support for the implant 300. The through-holes 473A, 473B can enable the insertion of one or more accessories (i.e., a single-arm alignment accessory 800 (see FIGS. 58A - 64)). Optionally, the through-holes 467A, 467B, 471A, 471B can be configured to receive, for example, an extension accessory 900 (see FIGS. 65A, 65B), or may have a size and shape.

[0069] Referring now to FIGS. 58A-60, once the calcaneal screw 1002 has been inserted into the patient's calcaneus 608, according to one embodiment, the subtalar screw 806 can be inserted using the implant guide device 461. The single arm aiming accessory 800 can be attached, for example, to the second arm 470 of the implant guide device 461 by an aiming arm lock 494. According to one embodiment, the single arm aiming accessory 800 can include a side support portion 808 and an accessory engagement portion 810. Further, a drill guide 812 can be inserted into the subtalar screw guide 814 and through an aiming accessory through hole 802 of the accessory engagement portion 810 of the single arm aiming accessory 800. The single arm aiming accessory 800 can be positioned, for example, at approximately 30° below the transverse plane (i.e., approximately 120°), providing proper placement of the subtalar screw 806 such that once inserted, the subtalar screw 806 is angled from a lower position to a higher position (e.g., 19-35°). Further, the through hole 802 is angled such that the subtalar screw 806 is angled, for example, along the sagittal plane from left to right (e.g., 16.4°), which will angle the subtalar screw from a lateral posterior to a medial anterior position (e.g., 11°-25°).

[0070] According to other embodiments, as shown in FIGS. 61-64, the single-arm aiming accessory 800 can be used, for example, to insert one or more wires 816 into the patient's lower limb 600. For example, if inserting the subtalar screw 806 through the implant 300 does not contribute to the patient's anatomical structure, the subtalar screw 806 can be positioned to avoid interference with the implant 300 and the calcaneal screw 1002. In particular, the wire 816 can, for example, facilitate the positioning of the subtalar screw 806 as shown in FIG. 2. For example, the single-arm aiming accessory 800 may include one or more slots 818 that traverse the accessory engagement portion 810 of the single-arm aiming accessory 800. The slot 818 may be, for example, a groove that traverses the surface 820 of the accessory engagement portion 810, or a through-hole that traverses the accessory engagement portion 810. A wire guide 822 can be inserted into the slot 818 of the single-arm aiming accessory 800, and the wire 816 can be inserted through the wire guide 822. Further, a drill can be positioned over the wire 816, and a portion of the patient's bone can be removed before inserting the subtalar screw 806. The wire 816 can also be used for other purposes, for example, positioned medially or laterally with respect to the implant 300 as shown in FIG. 63.

[0071] Referring now to FIGS. 65A-65B, the implant guide device 461, as described above and not described again here for the sake of simplicity, can be configured to extend at least one of the first arm 466 and the second arm 470 of the implant guide device 461, or may include an extension accessory 900 having a size and shape. The extension accessory 900 can facilitate fixing a screw guide 424 for inserting a bone screw 904, for example, into the patient's tibia 604. The screw guide 424 can hold its positioning within an opening (not shown) of the extension accessory 900, for example, by a spring (not shown) inserted within the extension accessory 900.

[0072] In FIGS. 66-73B, the implant guide system 400, which was referred to in more detail above, can include an aiming guide assembly 1100 that facilitates the placement of drill pins 1180 (see FIG. 69) at the plantar portion of the patient's calcaneus 608 according to one embodiment. The aiming guide assembly 1100 can be of a type described in detail, for example, in U.S. Provisional Application No. 62 / 805,777, entitled "Threaded Aiming Devices, Systems and Methods of Use" (Attorney Docket No. 3645.148P), or of a type described in detail in U.S. Provisional Application No. 62 / 464,051, entitled "Aiming Devices, Systems and Methods of Use" (Attorney Docket No. 3645.127P), the entire contents of both of which are hereby incorporated by reference in their entirety. The aiming guide assembly 1100 can include, according to one embodiment, a guide arm 1101, a drill guide tube 1120, a guide pin 1122, an alignment fin 1160, and a drill pin 1180.

[0073] As shown in FIGS. 66-70B, the guide arm 1101 includes a body or elongated body 1112 that connects a first end 1114 and a second end 1116. The first end 1114 includes, for example, a first portion 1102 with one or more gaps 1104. A second portion 1106 can include an arcuate side that attaches the first portion 1102 to the body 1112, and the first portion 1102 is in a direction substantially perpendicular to the body 112. The first portion 1102 can also include a connecting portion 1108 with a through hole 1110 configured or sized and shaped to receive the drill guide tube 1120. The through hole 1110 can be larger or smaller, for example, than that shown in FIGS. 66-70B. The through hole 1110 can extend along the first portion 1102 parallel to the body 1112, allowing the drill guide tube 1120 to extend parallel to the body 1112 of the guide arm 1101.

[0074] Continuing to refer to FIGS. 66 to 73B, the second end portion 1116 can include, for example, an inclined portion 1118. The inclined portion 1118 extends in a downwardly inclined direction from the body 1112 to the second end portion 1116. A housing element 1124 can be positioned at the second end portion 1116 and configured to receive the guide pin 1122, or may have a size and shape. The housing element 1124 may include a first arm portion 1130 and a second arm portion 1132 separated by a channel 1136. The channel 1136 may extend from the outer surface of the housing element 1124 into the housing element 1124 and into the inclined portion 1118. The housing element 1124 may include an upper opening 1126 and a bottom opening 1128 that forms an inner surface or cavity 1134 extending between the upper opening 1126 and the bottom opening 1128.

[0075] Continuing to refer to FIGS. 66 - 73B, the upper opening 1126 may be sized to allow insertion of the spherical member 1156 of the guide pin 1122 into the housing element 1124. The housing element 1124 may also include, for example, a first protrusion or ear 1140 and a second protrusion or ear 1144 as shown in FIG. 66. The first protrusion 1140 may extend from the first arm portion 1130 on the side opposite the channel 1136. The first protrusion 1140 may have a through - hole 1142. The through - hole 1142 may extend through the first arm 1130 and at an angle, for example, with respect to the outer surface of the first protrusion 1140. The second protrusion 1144 may include a through - hole 1146, and the through - hole 1146 may extend through the second arm 1132 and at an angle, for example, with respect to the outer surface of the second protrusion 1144. The trajectories of the first through - hole 1142 and the second through - hole 1146 may be positioned, for example, for guide wires that are inserted into the through - holes 1142, 1146 and converge without intersecting. Further, a first groove 1139 may be positioned between the first arm portion 1130 and the first protrusion 1140 and configured or sized and shaped to engage the first prong (branch) 1166 of the alignment fin 1160, and a second groove 1138 may be positioned between the second arm portion 132 and the second protrusion 1144 and configured or sized and shaped to engage the second prong 1168 of the alignment fin 1160. The bottom opening 1128 may be slightly smaller than the upper opening 1126, for example, and can capture or hold the guide pin 1122 inside the inner cavity 1134 of the housing element 1124. Further, the inner cavity 1134 may intersect the channel 1136. The inner surface 1134 may be configured or sized and shaped, for example, to allow the guide pin 1122 to pivot, rotate, or move in multiple planes.

[0076] Continuing to refer to FIGS. 66-73B, the alignment fin 1160 can slide over the guide pin 1122 and engage the housing element 1124. By attaching the alignment fin 1160, for example, the movement of the guide pin 1122 relative to the housing element 1124 can be reduced, and the first arm portion 1130 and the second arm portion 1132 can be locked to prevent them from widening the opening, thereby preventing the guide pin 1122 from disengaging from the guide arm 1101.

[0077] Continuing to refer to FIGS. 66-73b, the guide pin or target pin 1122 can include a shaft 1154, a spherical member 1156, a first end 1148, a second end 1150 opposite the first end 1148, and a cylindrical protrusion 1158. The spherical member or sphere 1156 can be positioned between the first end 1148 and the second end 1150. The guide pin 1122 can have, for example, a smooth outer surface with a tip, dot, or sharp portion 1152 at the first end 1148. The first end 1148 may be threaded, but it is also envisioned that the first end 1148 may have a smooth outer surface to facilitate insertion. The tip 1152 can be configured such that a user can insert the guide pin 1122 directly or through the skin into the target bone, or it may have a size and shape. The sphere 1156 can be configured to be inserted into the housing element 1124, or it may have a size and shape, and the sphere 1156 can allow for a full range of rotational movement, which can be fixed in place, for example, by the alignment fin 1160. The cylindrical protrusion 1158 may be positioned adjacent to the sphere 1156, and more particularly, may be positioned between the sphere 1156 and the first end 1148. As shown in FIGS. 66-67B, the guide pin 1122 can be positioned in a proximal to distal direction, for example, via the inner cavity 1134 of the housing element 1124. Once inserted into the target bone, the guide pin 1122 can be fixed to establish a target location on the plantar portion of the patient's calcaneus 608.

[0078] Next, as shown in FIG. 69, the drill guide tube 1120 and the drill pin 1180 can be inserted through the through hole 1110 of the connecting portion 1108, and a target location can be further established on the plantar portion of the patient's calcaneus (see FIG. 68). The drill pin 1180 can include, for example, a first end or tip 1182 for insertion into the patient, and a second end 1184 opposite the first end 1182. The drill pin 1180 can be, for example, a guide wire, a K-wire, a pin, or an elongated pin-shaped structure or member for insertion into the patient's bone. In the illustrated embodiment, the drill pin 1180 has a smooth outer surface with a pointed or sharp tip 1182. The drill pin 1180 can be inserted in a distal-to-proximal direction via the cannula opening of the drill guide tube 1120, which can enable the establishment of a target location at the surgical site.

[0079] As shown in FIGS. 67A, 67B, and 70A - 73B, once the guide pin 1122 is inserted into the patient's bone, such as the patient's tibia 604, the alignment fin 1160 can be inserted over the guide pin 1122, so that the through hole 1162 of the alignment fin 1160 receives the guide pin 1122. Further, the fin body 1164 can be inserted into the channel 1136 of the housing element 1124, and the first prong 1166 and the second prong 1168 of the pin engagement portion 1170 of the alignment fin 1160 can be fastened to the outer surfaces of the first arm 1130 and the second arm 1132 of the housing element 1124 of the guide arm 1101, as shown in FIG. 72. By fixing the first prong 1166 and the second prong 1168 of the alignment fin 1160 around the first arm 1130 and the second arm 1132 of the housing element 1124, for example, the guide pin 1122 can be locked in place, so that, as shown in FIGS. 73A and 73B, the sphere 1156 does not rotate inside the inner cavity 1134 of the housing element 1124.

[0080] Referring now to FIGS. 74A-74H, the alignment fin 1160 may include a pin engagement portion 1170 and a fin body 1164. The pin engagement portion 1170 may include a pentagonal shape having a relatively planar first surface 1172 according to one embodiment. The pin engagement portion 1170 may include, for example, a second surface 1191 and a third surface 1192 that are perpendicular relative to the first surface 1172. Further, the pin engagement portion 1170 may include a first inclined surface 1193 and a second inclined surface 1194, and the first inclined surface 1193 and the second inclined surface 1194 converge at the fin body 1164. A channel 1196 is positioned between the first surface 1200 of the fin body 1164 and the first inclined surface 1193, and a channel 1195 is positioned between the second surface 1202 of the fin body 1164 and the second inclined surface 1194.

[0081] Continuing with FIGS. 74A-74H, the pin engagement portion 1170 may include a first end 1174 having a head 1173 with a through hole 1162 extending from the first end 1174 to the second end 1176 of the alignment fin 1160. Towards the second end 1176 of the pin engagement portion 1170, the through hole 1162 may include a rim 1163 surrounding the through hole 1162. The pin engagement portion 1170 may also include a conduit 1178 positioned between a first prong 1166 and a second prong (11168), and the conduit may be configured or sized and shaped to engage a housing element 1124 of the guide arm 1101. The first prong 1166 may include an inclined edge 1189 extending from the first wall 1185 of the conduit 1178 to the end 1181 of the first prong 1166 as shown in FIGS. 74C-74D. Further, the second prong 1168 may include an inclined edge 1199 extending from the second wall 1187 of the conduit 1178 to the end 1183 of the second prong 1168 as shown in FIGS. 74C-74D.

[0082] Continuing with FIGS. 74A - 74H, and more particularly as shown in FIGS. 74A - 74B, the first inclined surface 1193 can include a ledge 1197 having a surface 1198 that is inclined in the longitudinal direction extending from the first prong 1166 to the recess 1190 towards the second end 1176 of the first inclined surface 1193 of the alignment fin 1160. The second inclined surface 1194 may include a ledge 1186 having a surface 1188 that is inclined in the longitudinal direction extending from the second prong 1168 to the recess 1190 (see FIG. 74d). The recess 1190 may include a first arcuate surface 1204 adjacent to the ledge 1197 and the ledge 1186, and the first arcuate surface 1204 converges to a second arcuate surface 1206 adjacent to the inner surface 1210 of the fin body 1164.

[0083] Continuing with FIGS. 74A - 74H, the fin body 1164 may include a first face 1200 that extends longitudinally from the first end 1174 to the second end 1176 of the alignment fin 1160, and a second face 1202 that faces the first face 1200, and the second face 1202 also extends longitudinally from the first end 1174 to the second end 1176. The alignment fin 1160 may also include a spine 1212 that extends longitudinally from the first end 1174 to the second end 1176 and connects the first face 1200 and the second face 1202. The head 1173 of the pin engagement portion 1170 may be adjacent to a ridge 1214 that extends from the flat first surface 1172 to the spine 1212 of the fin body 1164, and the spine 1212 may be perpendicular to the ridge 1214. Along the first face 1200 and the second face 1202, there may be one or more furrow or recess 1216 parallel to the ridge 1214 that cross and extend across the surfaces of the first face 1200 and the second face. Each of the furrow 1216 may extend from the spine 1212 to the inner lip 1218. The fin body 1164 may include an inclined portion 1220 that extends longitudinally from the spine 1212 to a protrusion 1222, and the protrusion 1222 is adjacent to the inner surface 1210 of the fin body. The protrusion 1222 can be configured to engage or may have a size and shape to engage the channel 1136 of the housing element 1124 of the guide arm 1101.

[0084] Referring now to FIGS. 83 - 84, an alternative embodiment of the aiming guide assembly 1100 and its components are shown. The aiming guide assembly 1100 shown in FIGS. 83 - 84 can include one or more components that are the same as and / or similar to those shown in FIGS. 66 and 68 - 70B. The aiming guide assembly 1100 of FIGS. 83 - 84 is illustrated as including alignment fins 1660 configured to be received by a housing element 1124 in a manner similar to or the same as alignment fins 1160. For example, alignment fins 1660 are illustrated as including a first prong and a second prong that are the same as or similar to the first prong 1166 and the second prong 1168 of alignment fins 1160, and the first prong and the second prong are configured to engage with a first groove 1139 and a second groove 1138 of the housing element 1124. Alignment fins 1660 are illustrated as including an opening (e.g., a hole, a recess, etc.) 1662 disposed in the first prong 1166, and the opening 1662 extends laterally through the first prong 1166, thus providing fluid communication therethrough. In some aspects, the opening 1662 and the protrusion 1664 can collectively form a retaining mechanism (e.g., the alignment fins 1660 are releasably coupled to and retained by the housing element 1124). In some aspects, the opening 1662 can be configured to accommodate a protrusion 1664 disposed on the housing element 1124 and installed within the first groove 1139. In some aspects, the opening 1662 and the protrusion 1664 collectively form a retaining mechanism (e.g., the alignment fins 1660 are releasably coupled to and retained by the housing element 1124). For example, when the alignment fins 1660 engage with the housing element 1124 (e.g., the first prong 1166 and the second prong 1168 engage with the first groove 1139 and the second groove 1138), the opening 1662 receives the protrusion 1664 to facilitate retention and / or enable releasable coupling between the housing element 1124 and the alignment fins 1660.In some embodiments, the aperture 1662 may be disposed in the second prong 1168 along with a protrusion disposed within the second groove 1138. Further, in some embodiments, the housing element 1124 may include a plurality of protrusions (e.g., protrusions disposed within both the first groove 1139 and the second groove 1138), and the alignment fin 1660 may include a plurality of apertures (e.g., apertures disposed in both the first prong 1166 and the second prong 1168). In some embodiments, one or more of the protrusions 1664 may have a substantially hemispherical geometry with one or more apertures 1662 having a complementary cylindrical shape (e.g., forming a ball detent (detent)). In some embodiments, one or more of the protrusions 1664 may have other geometries, such as square, rectangular, semi-elliptical, etc., with one or more apertures 1662 having a corresponding geometry. Further, in some embodiments, one or more of the apertures 1662 may have a geometry complementary to one or more of the protrusions 1664. For example, if one or more of the protrusions 1664 are hemispherical, one or more of the apertures 1662 may likewise be hemispherical and may not extend through the first prong 1164 (and / or the second prong 1668). Additionally, it should be noted that the alignment fin 1160 and / or the alignment fin 1660 may include a combination of the features illustrated and described herein (e.g., one or more apertures 1662, one or more protrusions 1664, etc.).

[0085] Referring now to FIGS. 75-76, a surgical method 1300 is shown. The surgical method 1300 can be performed, for example, to assist in a TTC fusion of an ankle complex. The surgical method 1300 may include selecting an implant guide system 1302. The method also includes connecting the implant to a mounting system 1304. The method further includes positioning an implant guide device of the implant guide system in a desired implant orientation 1306 in addition to inserting the implant into the patient's lower limb using the implant guide system 1308. Further, the method includes inserting at least one screw into the patient's lower limb using the implant guide system 1310 and passing through the implant. The method also includes releasing the implant within the patient's lower limb by removing the implant guide device and the mounting system 1312. Further, the method includes closing the patient's incision 1314.

[0086] The surgical method 1300 may also include, for example, positioning the patient's lower limb in a supine or lateral position on an operating table (e.g., radiolucent) 1350. The patient's lower limb (including the entire foot and lower limb) is prepared such that the patient is covered with a drape above the patient's knee, presenting visualization of the knee and lower limb and allowing assessment of lower limb alignment. For example, the distal extremity may extend about 5 cm to 50 cm, more particularly 20 cm, onto the operating room table, providing optimal access to the lower limb. Further, a C-arm can be positioned over the surgical site from the opposite side of the patient's lower limb.

[0087] Referring further to the surgical method 1300, the tibiotalar joint can be exposed. For example, the exposure of the tibiotalar joint may include forming a longitudinal midline incision in the patient's anterior ankle, and the longitudinal midline incision may start proximally to the ankle joint portion, for example, about 8 cm to 12 cm, more specifically 10 cm, and terminate distally to the talonavicular joint. Further, the incision may start transversely to the tibial apex and immediately lateral to the anterior tibial tendon, for example, 0.5 cm to 1.5 cm, more specifically 1 cm, although alternative measurements are also contemplated and will be known or understood by those skilled in the art. The initial incision should penetrate only the skin, but direct tension should not be placed on the skin edges until a full-thickness flap is possible. Further, the superficial peroneal nerve should be identified and retracted laterally. Further, the extensor hallucis longus (EHL) should be identified under the retinaculum, and the retinaculum should be longitudinally divided over the extensor hallucis longus tendon. Optimally, the sheath of the tibialis anterior (TA) tendon should remain intact.

[0088] Further, the exposure of the tibiotalar joint may include retracting the EHL tendon laterally and retracting the TA tendon medially. Also, the neurovascular bundle should be identified and retracted laterally with the EHL tendon. The exposure should continue until the anterior capsule is visualized. The anterior capsulotomy should be performed through a longitudinal incision. The capsule and periosteum should be elevated over the anterior tibia and talus to expose the anterior ankle joint, the tibial plafond, the medial and lateral gutters, and the anterior and dorsal talus. All bony spurs on the tibia and talus should be removed to allow exposure to the ankle joint and to facilitate entry of instruments for cartilage removal.

[0089] Surgical method 1300 may also include exposure of the subtalar joint 1354. For example, an incision can be formed over the subtalar joint by starting at the distal surface of the lateral malleolus extending towards the fourth midfoot bone base and stopping at the calcaneocuboid joint. Further exposure may continue through the subcutaneous tissue, carefully identifying and retracting the anterior branch of the sural nerve. Also, the extensor hallucis brevis may be reflected distally to expose the sinus tarsi and posterior surface of the subtalar joint. The exposure of the subtalar joint 1354 may also include an incision of the fat pad from the sinus tarsi, along with reflection of the dorsal tissues.

[0090] Surgical method 1300 may also include preparation of the ankle joint (1356). Preparation of the joint (1356) may include removing cartilage from the ankle joint as needed. For example, removal of cartilage from the ankle joint may include removing cartilage from the posterior, middle, and anterior aspects of the subtalar joint, based on the surgeon's preference.

[0091] In surgical method 1300, the ankle may be temporarily fixed (1360). Temporary fixation 1358 may include, for example, alignment of the ankle and subtalar joint. The foot and ankle should be positioned such that the ankle is neutral with respect to dorsiflexion and plantarflexion. Further, the foot can be externally rotated 5 - 10° and the hindfoot valgus 5°. Additionally, with the subtalar joint and ankle joint held in this alignment, guide wires, K-wires, etc. can be used to temporarily fix the tibial joint and subtalar joint in a preferred alignment. The wire crossing the tibial joint should pass from the anterolateral tibia to the lateral talus, thereby avoiding the expected path of the implant.

[0092] Surgical method 1300 may also include reaming to form a canal in the patient's lower limb 1360. For example, the plantar incision can be determined using fluoroscopy with lateral and axial views. Also, the desired starting point can be marked, the incision can be formed over the starting point, and care can be taken to bluntly incise the plantar surface of the calcaneus. Further, a drill may be used to establish an entry point in the calcaneus. For example, the drill can be used to perforate beyond the distal epiphyseal line of the tibia. Further, an X-ray template can be utilized to determine the length of the implant, and a guide wire with a ball tip, a K-wire, etc. can be inserted from the plantar calcaneus to the distal tibia. The position and length can be confirmed using fluoroscopy. Further, a reamer can be used to ream the K-wire with a ball tip to a desired depth. For example, the reamer can be used to gradually ream in 0.5 mm increments, which increases in size until the desired implant diameter is obtained. And after the desired reaming size is obtained, the K-wire with a ball tip and the reamer can be removed.

[0093] {0202} The surgical method 1300 may also include the insertion of an implant (1362). For example, an implant of the measured size (e.g., an IM nail) can be retrieved. Once retrieved, the implant engagement portion of the mounting system can be coupled to the distal surface of the implant. The implant can further be coupled to the implant guide device by the insertion of the mounting system and the implant into a portion of the implant guide device. The mounting system can be coupled to the implant by screwing the mounting system clockwise until it fits snugly while being connected to the implant. The connection between the implant engagement portion and the mounting system can be configured to provide the proper orientation of the implant with respect to the implant guide device or may have a size and shape. Further, the implant mounted on the implant guide device can be inserted into the reamed tube. For example, a mallet can be used to gently tap the implant guide device and the mounting system coupled to the implant to insert the implant into the reamed tube. The mallet can be used to gently tap the mounting system until the implant is fully seated or embedded at a desired distance within the patient's lower limb. The size and placement of the implant can be confirmed using fluoroscopy. The position of the implant guide device can be rotated and / or adjusted as needed to provide the desired implant orientation.

[0094] Surgical method 1300 may also include the insertion of tibial screws (1364). For example, a 3.8 mm drill guide can be inserted into the through-hole of at least one of the first arm and the second arm of the implant guide device. The through-hole into which the drill guide is inserted can be positioned to align with the tibia of the patient's lower limb. Once the drill guide is inserted, a 3.8 mm drill can be used to drill through the tibia through the drill guide. Drilling the tibia may include measuring the depth of the drill using laser markings associated with the drill guide. Based on the tibia being drilled, a screw can be inserted into the tibia using a driver, and the insertion of the screw includes rotating the driver in a clockwise direction until the screw is flush with the surface of the tibia. If necessary, this same process can be used to insert additional screws into the tibia.

[0095] Surgical method 1300 may also include the insertion of calcaneal screws (1366). For example, the aiming arm of the implant guide device can be rotated to its highest position (most proximal) with respect to at least one of the first arm and the second arm. Further, a drill guide (e.g., a 4.6 mm drill guide) can be inserted into, for example, the aiming arm. Further, a drill (e.g., a 4.6 mm drill) can be used to drill through the calcaneus while measuring the depth of the drill using laser markings. Once the calcaneus is drilled, a calcaneal screw can be inserted using a driver that engages a screw guide.

[0096] Surgical method 1300 may also include the insertion of a talocalcaneal screw (1368). To facilitate the insertion of the talocalcaneal screw, the aiming arm of the implant guide device can be pivoted to its most distal position. A single-arm aiming accessory can be inserted into the through-hole of the implant guide device and locked in place using the lock of the implant guide device. Further, a drill guide (e.g., a 4.6 mm drill guide) can be inserted into the aiming accessory through-hole of the single-arm aiming accessory and locked in place using an aiming accessory fastener. A drill (e.g., a 4.6 mm drill) can be used to engage the drill guide and the drill into the calcaneus and talus while measuring the depth using laser marking. Further, a driver can be used to insert the talocalcaneal screw into the patient's talus and calcaneus.

[0097] Surgical method 1300 may also include the removal of the implant guide device. For example, the removal of the implant guide device may include removing the implant guide device by turning the mount system in a counterclockwise direction. Further, using a driver, by turning the driver in a counterclockwise direction, the implant engagement portion can be removed from the implant.

[0098] Surgical method 1300 may also include the insertion of a tension screw (1370). For example, by inserting the tension screw into the plantar portion of the implant, the tibio-talar joint can be transected and compression can be applied. For example, a driver can be used to insert the tension screw into the implant and tightened to a predetermined position by rotating the driver in a clockwise direction. By transecting the tibio-talar joint and applying compression, proper alignment of the tibio-talar joint is facilitated, which can be verified using fluoroscopy.

[0099] Referring now to FIG. 77, a surgical method 1400 is shown, which can be applied, for example, to correct existing deformities. The surgical method 1400 may include positioning the patient (1402). The patient can be positioned based on the preferences of various medical specialists (1402) and may depend on the pathology and / or previous surgical approach for a particular patient. Patient positioning options may include a lateral bump, a lateral step, or a supine position with a prone position. The medical specialist can obtain, for example, a radiolucent table. The medical specialist can prepare the patient's lower limbs and feet such that the patient is covered with a cloth above the knees, presenting visualization of the knees and lower limbs and enabling evaluation of lower limb alignment. The distal extremities of the limbs may extend slightly beyond the edge of the operating table. A large C-arm is available for entry from the opposite side to the surgical side.

[0100] Continuing with method 1400, the method 1400 may include preparing the talocrural joint and the anterior, middle, and posterior surfaces of the talocrural joint for temporary arthrodesis according to the preferred techniques and approaches of the medical specialist (1404). For example, this preparation 1304 may include removing cartilage and penetrating the subchondral plate, for example, with a subchondral drill, burr, and / or an osteotome for bone windowing to promote healing. Optionally, one approach may include aligning the ankle and subtalar joints such that the ankle is neutral with respect to dorsiflexion and plantarflexion. The foot can be, for example, set at 5° of rearfoot valgus and 0 - 5° of calcaneal external rotation equal to the opposite side. The subtalar joint and ankle joint are held in this alignment and can be temporarily fixed in a suitable alignment using one or more wires such as K-wires for the talocrural joint and subtalar joint. The wire crossing the talocrural joint can pass, for example, from the anterolateral tibia to the lateral talus, which can avoid the expected path of the IM nail implant.

[0101] Continuing with method 1400, the implant size can be determined (1406) using an implant sizing device. For example, utilizing a true lateral fluoroscopic view, the sizing device can be positioned along the subtalar and ankle joints along the side of the patient's leg most suitable for positioning. The distal holes of the implant sizing device can be aligned within the body of the talus. Additionally, the plantar calcaneal window can indicate the intended calcaneal screw trajectory, and the plantar notch can indicate the end point of the nail. The appropriate nail length can be determined by measuring the conduit length within the tibia through the measurement notch of the implant sizing device. In addition to determining the nail length, the nail diameter can be estimated using the diameter holes on the proximal side of the sizing device. The holes can be positioned at the protruding end point of the nail, and the approximate nail diameter can be determined by determining which template hole best fills the tibial canal without disturbing the cortex.

[0102] Method 1400 may also include establishing an entry point incision (1408). For example, the aiming guidance assembly can facilitate establishing an entry point for the incision. According to one embodiment, a plantar incision can be formed slightly laterally to the midline just distal to the plantar fat pad, and a straight incision can be made down to the plantar calcaneus to avoid disruption of the nearby neurovascular bundle. For example, a guide arm and a guide pin can be obtained. The foot end of the guide arm can be positioned, for example, about one finger width plantar to the heel fat pad, and the proximal end is positioned along the medial tibial apex. The entry point of the guide pin is obtained along the medial tibial apex. The entry point of the guide pin can be marked, and a small stab incision can be formed in the area of the intended guide pin placement. Further, the guide pin can be positioned perpendicular to the tibial apex and parallel to the foot. The guide pin can be driven, for example, until the cylindrical protrusion contacts the bone. It can be placed and confirmed using fluoroscopy to ensure that the tip of the guide pin is centered within the medullary canal. In particular, an oblique fluoroscopic view can be taken under the center of the wire to ensure that the guide pin is centered on the anterior edge apex of the tibia. Further, the drill pin trajectory terminates at the tip of the guide pin, and the tip needs to be adjusted according to the patient's anatomical structure. Further, the guide arm can be snap-fitted to the guide pin or attached in other ways. The alignment fin can be inserted above the guide pin and engaged with the guide arm, so that the hole of the alignment fin receives the guide pin and the fin body portion is inserted into the elliptical channel or recess of the guide arm near the guide pin, whereby the first prong and the second prong can grip the guide pin.

[0103] Continuing with method 1400, a drill pin can be inserted (1410). For example, a drill pin tube or a drill guide tube can be positioned through the plantar surface of the guide arm. The intended drill pin starting point can be confirmed by lateral fluoroscopy as described in more detail above. The drill pin can be searched for and, based on establishing the correct starting point, the drill pin is driven into the calcaneus, talus, and tibia using anteroposterior (AP), lateral, and calcaneal axis fluoroscopic views during and after the process to ensure that the drill pin is centered in the calcaneus, tibia, and talus and terminates in the medullary canal of the tibia just proximal to the metaphyseal flare. Then the alignment fin is removed from the guide wire, the guide arm is removed from the guide wire, the guide arm is removed from the guide wire, and by sliding the guide arm over the drill pin, the drill pin guide is removed from the surgical field. Further, the guide wire can be removed from the tibia. According to one embodiment, the drill pin can be inserted without a guide arm, the tip of the drill pin is positioned relative to the plantar calcaneus, and a lateral fluoroscopic image can be taken to ensure correct placement from distal to proximal of the calcaneus. Further, once the correct starting point is established, the drill pin can be driven into the calcaneus, talus, and tibia using AP, lateral, and calcaneal axis fluoroscopic views during and after the process to ensure that the drill pin is centered in the calcaneus, talus, and tibia and terminates in the medullary canal of the tibia just proximal to the metaphyseal flare. If the angle of the drill pin is appropriate but the position of the drill pin is anterior, posterior, medial, or lateral, a parallel offset guide can be used. For example, the central hole of the parallel offset guide can slide over the initial wire. Further, a second wire can be placed in any of the adjacent holes such that the second wire is arranged parallel to the first wire and offset, for example, about 4 mm (center to center) in the desired direction.

[0104] Continuing with method 1400, the method may include perforating the tibia through the plantar surface of the calcaneus (1412). For example, perforation 1412 may optionally include extending the plantar incision, which measures, for example, about 3 - 4 cm. And the plantar surface of the calcaneus can be incised directly. And the entry tissue protector can be placed over the drill pin and positioned within the incision site against the calcaneal cortex. Further, an entry drill may be inserted over the drill pin, and the drill may be advanced proximally. The drill path trajectory can be confirmed by fluoroscopy at each joint. Perforation 1412 may continue, for example, through the distal metaphyseal line within the tibia. And the entry drill and the entry tissue protector can be removed while maintaining the position of the drill pin.

[0105] Continuing with method 1400, a stepped reamer and tissue protector can be retrieved and inserted over the drill pin. Method 1400 may include reaming to increase the diameter of the portion of the patient's perforated bone 1414. For example, the healthcare professional can ream proximally until the laser mark on the stepped drill reaches the tissue protector. If resistance is felt when reaming the large - diameter portion of the stepped reamer through the ankle joint, the reamer can be removed from the foot and bone fragments can be removed from the cutting grooves of the reamer. Lateral fluoroscopy can be used to ensure that a larger diameter contacts the diaphyseal bone of the tibia and that the proximal portion of the drill aligns with the intended socket hole of the nail. When reaming is complete, the drill pin can be removed. And a ball - tipped guide rod can be placed through the bone reamed from the plantar calcaneus into the distal tibia. If not already removed, the temporary fixation pins can be removed at this point or after nail placement. And a hammer or mallet can be used to fully seat the guide rod within the tube. The position and length of the ball - tipped guide rod can be confirmed using fluoroscopy. Furthermore, a flexible reamer shaft may be retrieved and a desired reamer head attached. It is desirable to start with the smallest diameter reamer head. Further, a reamer assembly may be used to allow a medical professional to ream over a guide rod to a distal laser marking on the flexible shaft. The size of the reamer head may be increased if appropriate resistance is felt during reaming. The medical professional may ream gradually in increments of increasing size until the desired resistance is reached, which can be confirmed using fluoroscopy. Removing the reamer assembly during incremental reaming can inadvertently cause partial withdrawal of the guide rod, and a hammer may be used to prevent withdrawal of the guide rod. It is desirable to decrease the nail diameter following the desired resistance felt during the reaming process. And the guide rod may then be removed from the tibial canal.

[0106] Method 1400 may include preparing an implant guide for the insertion of a nail implant (1416). For example, the measured nail size can be retrieved, and if internal compression is desired, internal compression screws can be retrieved. The internal compression screws may be attached to a driver and a handle. The internal compression screws can be inserted into the foot end of the nail and turned clockwise until the screw is just visible through the heel bone window of the nail. The aiming arm lock can be opened to access the bottom end of the aiming arm. Once positioned, the aiming arm lock is locked and a mounting screw or bolt can be inserted through the bottom end of the mounting system. A mounting driver can be retrieved. Further, at least one tab of the mounting system may be aligned with a corresponding recess in the nail implant. The nail can be attached by positioning corresponding front and rear laser markings at a desired location. The mounting system can be fixed to the nail by placing a mounting driver through the bottom surface of the mounting system and turning it in a clockwise direction. Further, preparing the implant guide 1416 may include inserting a tibial drill guide into the tibial screw guide and turning it in a clockwise direction. Further, the locks along the first and second arms may be opened. The implant guide device may include labels for the holes in the first and second arms, which can be used to facilitate the identification of dynamic or static slots (e.g., slots near the base of the implant guide device) that can be aligned with the most distal tibial slots. If immediate postoperative dynamization is desired, the screw / drill guide can be inserted into the dynamic hole. If immediate postoperative dynamization is not desired, the screw / drill guide may be inserted into the static hole. Each tibial screw guide may be inserted into an applicable tibial outrigger hole based on determining whether it has a dynamic or static tibial screw arrangement. The lock can be closed to lock the tibial screw guide in place. Also, the calcaneal drill guide may be inserted into the calcaneal screw guide, for example, in a clockwise direction to tighten the calcaneal drill guide in place.The calcaneal drill / screw guide may be inserted into the aiming arm through-hole. Further, the protrusion ensures that the pin opening is properly positioned such that it is in the proximal position of the calcaneal screw guide. To ensure that the implant guide is operable, the medical professional inserts the drill into each screw / drill guide assembly, which is attached to the first and second arms, ensuring that the drill passes through the individual holes of the nail. Further, the drill is inserted into the calcaneal drill / screw guide assembly to ensure that the drill passes through the nail at the desired location. Further, a single-arm aiming accessory, particularly the subtalar arm, can be retrieved, unlocked, and the subtalar arm can be positioned within the appropriate through-hole of the first or second arm. Then, the lock is closed to lock the subtalar arm in place and ensure that the drill is inserted into the subtalar arm and the trajectory of the subtalar screw is appropriate. Then, when the implant guide is prepared, all drills can be removed.

[0107] Method 1400 may also include inserting a nail implant into the patient (1418). The nail can be attached to the mounting system and implant guide device and inserted into the reaming tube. For example, the placement of the nail can be, for example, 5 mm through the plantar cortex of the calcaneus, taking into account compression. The inlay of the aiming arm can function as a fluoroscopic marker to indicate 5 mm proximal to the end of the nail. Further, proper positioning can include ensuring that the fluoroscopic marker is flush with the plantar surface of the calcaneus. A hammer can be used to strike the striking plate of the mounting system until the nail is fully seated. Verification that the selected nail size is appropriate and that the nail is properly placed can be provided using fluoroscopy.

[0108] Continuing with method 1400, the inlays of the aiming arm can provide a visual trajectory using fluoroscopy. For example, the inlays of one side support can be aligned with the inlays of the other side support so that they appear as if a single line shows a true lateral view by fluoroscopy. The position of the calcaneal screw can be evaluated using the inlays as markers. The calcaneal aiming arm may be pivoted to an advantageous position, and the specific angle of the aiming arm may be based on the patient's anatomical structure and the screw trajectory preference of the medical professional. The position of the calcaneal drill / screw guide assembly may be observed relative to the orientation of the calcaneus. For example, the medical professional can palpate the medial edge of the calcaneus and ensure that the calcaneal screw guide is lateral to the medial edge of the calcaneus while not being too far from the center, allowing for the future placement of the subtalar screw.

[0109] Continuing with this method 1400, once the nail and the mounted mounting system are inserted into the reamed tube and fully seated, a pin (e.g., a K-wire) can be inserted into the upper hole of the calcaneal screw guide. The axial position of the projected screw path can be confirmed by taking a fluoroscopic axial view of the calcaneus. Also, the height, size, and placement of the nail can be confirmed using a lateral fluoroscopic image. Once the appropriate calcaneal screw placement is determined, the healthcare professional can lightly press the calcaneal drill guide against the skin to mark the starting point of the drill. Then, an incision (e.g., a 1 cm incision) can be made, and a direct incision into the bone can be performed. The healthcare professional can drill through the calcaneus using a drill and ensure an appropriate stopping point using lateral fluoroscopy during an intermediate check. For example, the intended end point may be the distal surface of the calcaneus and may be centrally located from top to bottom. Alternatively, the depth can be measured using the drill markings on the screw guide. Then, the drill guide can be removed from the screw guide by rotating it counterclockwise, for example, to disengage it. A depth gauge can be inserted into the screw guide to measure the screw length. If a cannulated drilling technique for calcaneal screw insertion is preferred, a K-wire guide can be inserted into the calcaneal drill guide, and a K-wire can be inserted into the pin opening of the calcaneal screw guide. Then, positioning can be confirmed using fluoroscopy, and the K-wire length can be measured using a cannulated depth gauge. A driver can be used to insert a calcaneal screw peg or a calcaneal screw. Then, the length and placement of the calcaneal screw can be verified using fluoroscopy.

[0110] Method 1400 may include inserting one or more tibial screws into a patient (1420). This process 1420 may include placing the most proximal screw / drill guide and gently indenting the skin with the screw guide assembly to indicate where a small stab incision is to be made. And then, a direct incision into the bone can be made. A medical professional can drill through the drill guide laterally from the inside. The depth may be measured using a drill or a solid depth gauge. And then, the drill guide can be removed and an appropriately sized screw can be inserted through the screw guide into the nail using a driver, for example, by turning the handle connected to the driver in a clockwise direction until the laser mark on the driver aligns with the end of the screw guide or until the head of the screw fits snugly against the tibia. The length and placement of the screw can be confirmed using fluoroscopy. This process 1420 may be repeated to place additional screws into the tibia. For example, if the nail is, for example, longer than 250 mm, a third tibial screw peg hole is included and an additional tibial screw may be inserted using a proximal arm guide or an extension accessory. To attach the extension accessory, the arm of the extension accessory may be inserted into the most proximal through-hole of either the first arm or the second arm. The extension accessory can be fixed using an extension accessory fastener. The tibial screw insertion process 1420 may be repeated through the through-hole of the extension accessory.

[0111] Continuing with method 1400, it may be desirable to apply internal compression to the nail. To compress the nail via an internal compression screw, a driver can be inserted into the plantar portion of the nail via a mount system. The driver can be turned, for example, counterclockwise until the desired compression is achieved. The internal compression screw can be translated proximally and threaded into the calcaneal compression slot. According to one embodiment, for example, 0.5 mm of compression is possible per turn and the compression screw may have the ability to progress, for example, 8 mm or about 16 turns.

[0112] Method 1400 may also include inserting a subtalar screw into the patient (1422). Insertion 1422 may include releasing the lock of either the first arm or the second arm and moving the aiming arm downward to align with the lower surface or base of the implant guide device. The subtalar arm or single-arm aiming accessory may be retrieved and positioned within the appropriate right or left through-hole of the first arm or the second arm. The individual locks may be closed around the first arm or the second arm to fix the subtalar arm in place. A drill guide may be screwed into the subtalar screw guide and inserted into the subtalar arm. Using the screw guide, an indentation can be formed on the skin for the incision. An incision, e.g., a stab incision, can be made, and a direct incision into the bone can be performed. A medical professional can drill into the calcaneus and talus using a drill, and the subtalar screw length can be measured, for example, using laser markings on the drill. The drill guide can be removed, and an appropriately sized subtalar screw can be inserted through the bone and nail using an appropriate driver and handle using the techniques described above for the calcaneal screw. The length and position of the screw can be confirmed by fluoroscopy.

[0113] Continuing with Method 1400, if the trajectory of the subtalar screw through the nail does not contribute to the patient's anatomy, a hindfoot screw can be inserted through another single-arm aiming accessory (i.e., an alternative subtalar screw arm) to avoid interference with the nail and the calcaneal screw. The alternative subtalar screw arm can be attached to the through-hole of the first arm or the second arm and locked in place using a lock. A pin or K-wire guide can be inserted into the desired hole of the alternative subtalar screw arm. Further, according to one embodiment, a countersunk hole with a head can be searched for the subtalar screw. The countersunk hole can be rotated clockwise, for example, over a wire (e.g., a K-wire) to remove the appropriate bone and seat the screw head. The screw length can be measured using a cannula-inserted depth gauge. When a medical professional uses a headless screw, the screw length can be measured using a cannula-inserted depth gauge before using a headless countersunk hole for the headless screw. Further, a medical professional can drill on a wire (e.g., a K-wire) using a drill for a headless subtalar screw. The headless subtalar screw can be inserted using a driver, and the length and placement of the screw can be confirmed using fluoroscopy.

[0114] Method 1400 may include removing the implant guide (1424). Once the placement of the nail and screw is confirmed (e.g., using a fluoroscopic image), the bolt driver attachment can be rotated, for example, counterclockwise until the mount system and the implant guide device are released from the nail. Then, the implant guide device can be removed from the surgical field.

[0115] Method 1400 may also include placing an end cap (1426). For example, an optimal end cap can be searched for and fixed to the rear end of the nail using a driver. A long end cap can be selected for a nail countersunk into the calcaneus.

[0116] Finally, Method 1400 may include closing the patient's incision (1428).

[0117] Removal of the implant and / or change of the surgical method may be necessary once the implant has been inserted into the patient's lower limb. For example, one or more bone screws inserted into the tibia can be positioned using fluoroscopy. Further, a small incision can be formed in the patient's lower limb, and a driver can be used to turn the head of the bone screw in a counterclockwise direction until the bone screw is removed. This process may be repeated to remove one or more other bone screws previously inserted into the patient's lower limb. Also, confirmation that all bone screws have been removed can be performed using fluoroscopy. Further, this confirmation should be performed prior to attempting to remove the implant. Using fluoroscopy, the plantar insertion point of the implant can be positioned, a small incision can be formed, and a driver can be attached to the tension screw connected to the plantar insertion point of the implant. Using the driver, the tension screw can be turned in a counterclockwise direction until it is removed. A slide hammer can be used to engage the implant by inserting and rotating the hammer clockwise on the plantar portion of the implant until the slide hammer is securely connected to the implant. Then, the slide hammer can be pulled distally on the plantar portion of the foot, thereby removing the implant as the slide hammer extends away from the plantar portion of the foot. And a change of the surgical method can be performed.

[0118] As will be appreciated by those skilled in the art based on the teachings herein, numerous changes and modifications can be made to the above-described and other embodiments of the present disclosure without departing from the scope of the present disclosure. The components of the devices, guides, implants, plates and / or systems as disclosed herein, including the appended abstract and drawings, may be replaced by alternative components or mechanisms such as those disclosed in other embodiments, which function for the same, equivalent or similar purposes as those known to those skilled in the art, and achieve the same, equivalent or similar results by such alternative components or mechanisms and provide similar functions for the intended purposes. Further, the devices, guides, implants, plates and / or systems may include more or fewer components or mechanisms than the embodiments described and illustrated herein. For example, the components and mechanisms of FIGS. 1 to 74H can be used interchangeably in alternative combinations as may be modified or changed by those skilled in the art. Further, the steps of the surgical methods associated with the systems of FIGS. 75 to 77 can be used interchangeably in alternative combinations as may be modified or changed by those skilled in the art. Accordingly, the detailed description of the presently preferred embodiments should be construed as exemplary rather than limiting of the present disclosure.

[0119] Aspects of the invention are described herein with reference to flowchart illustrations and / or block diagrams of methods. The flowchart illustrations and / or block diagrams illustrate the functionality and operation of possible implementations of devices, systems and methods according to various embodiments of the invention. In this regard, each block of the flowchart illustrations may represent a step, segment, or portion of a process. In some alternative implementations, the functions noted in the blocks may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality required.

[0120] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. As used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprise", "comprises", "comprising", etc., "have", "has", "having", etc., "include", "includes", "including", etc., "contain", "contains", "containing", etc. are to be understood as open-ended correlative verbs. As a result, a method or device that comprises, has, includes, or contains one or more steps or elements owns these one or more steps or elements, but is not limited to owning only these one or more steps or elements. Similarly, a step of a method or an element of a device that comprises, has, includes, or contains one or more features owns these one or more features, but is not limited to owning only these one or more features. Further, a device or structure configured in a particular way is at least configured in that way, but may also be configured in ways not enumerated.

[0121] The invention has been described with reference to preferred embodiments. It will be understood that the operational embodiments described herein are illustrative of a number of possible configurations for providing the same general features, characteristics, and general system operation. Modifications and changes will occur to others upon reading and understanding the foregoing detailed description. It is intended that the invention be construed to include all such modifications and changes.

Claims

1. A base, a first arm connected to the first end of the base, a second arm connected to the second end of the base, and a sighting arm hinge - connected to at least one of the first arm and the second arm, comprising: The sighting arm includes two side support portions, the first side support portion is hinge - connected to the first arm, and the second side support portion is hinge - connected to the second arm. An implant guide device.

2. The base is provided with an opening configured to receive an implant, The implant includes a nail system inserted into the patient's lower limb. The implant guide device according to claim 1.

3. The opening is further configured to receive a part of a mounting system connected to the implant. The implant guide device according to claim 2.

4. The first arm includes a locking or retaining mechanism and one or more through - holes associated with the locking or retaining mechanism, Each of the one or more through - holes is configured to engage with an accessory, The accessory facilitates inserting a fastener into the patient's lower limb. The implant guide device according to claim 1.

5. The sighting arm is provided with a sighting arm lock configured to fix the position of the sighting arm. The implant guide device according to claim 1.

6. The sighting arm is provided with one or more inlays configured to provide a visual track for an accessory inserted into the implant guide device, The one or more inlays are embedded in the gaps of the side supports of the sighting arm. The implant guide device according to claim 1.

7. The sighting arm is configured to provide an elevation support for the patient's lower limb. The implant guide device according to claim 1.

8. The sighting arm is provided with one or more orientation markings, The one or more orientation markings are configured to align with one or more corresponding side - support orientation markings, The side - support orientation markings are installed on at least one of the first arm and the second arm. The implant guide device according to claim 1.

9. A base, a first arm connected to the first end of the base, a second arm connected to the second end of the base, and a sighting arm hingedly connected to at least one of the first arm and the second arm, the sighting arm including two side support portions, the first side support portion being hingedly connected to the first arm and the second side support portion being hingedly connected to the second arm, an implant guide device; A mounting system that traverses an opening in the base; An implant connected to the mounting system, an implant guide system.

10. The base includes an opening configured to receive an implant; The implant includes a nail system inserted into a patient's lower limb, the implant guide system according to claim 9.

11. The opening is further configured to receive a part of a mounting system connected to the implant, the implant guide system according to claim 10.

12. The first arm includes a locking or retaining mechanism and one or more through holes associated with the locking or retaining mechanism; Each of the one or more through holes is configured to engage with an accessory; The accessory facilitates inserting a fastener into a patient's lower limb, the implant guide system according to claim 9.

13. The sighting arm includes a sighting arm lock configured to fix the position of the sighting arm; One or more inlays configured to provide a visual trajectory of an accessory inserted into the implant guide device; The one or more inlays are embedded in a gap of a side support of the sighting arm, the implant guide system according to claim 9.

14. The sighting arm is configured to provide a lifting support to a patient's lower limb, the implant guide system according to claim 9.

15. The sighting arm includes one or more orientation markings; The one or more orientation markings are configured to align with one or more corresponding side support orientation markings; The side support orientation markings are provided on at least one of the first arm and the second arm, the implant guide system according to claim 9.

16. Further comprising a sighting guide assembly that facilitates the placement of drill pins at the plantar portion of a patient's calcaneus; The sighting guide assembly is A guide arm having a first end and a second end, A drill guide tube configured to engage the first end of the guide arm, A guide pin configured to engage the second end of the guide arm, An alignment fin that slides on the guide pin and is configured to engage the second end of the guide arm, The drill pin configured for insertion through the drill guide tube, comprising the implant guide system according to claim 9.

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