External Fixation Systems and Methods of Use

JP2025503225A5Pending Publication Date: 2026-01-28PARAGON 28 INC
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Patent Information

Application Number
JP2024544752
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-01-28
Filing Date
2023-01-26
Publication Date
2026-01-28

AI Technical Summary

Technical Problem

Current external fixing systems for orthopedic applications often fail to account for patient anatomy, leading to suboptimal results due to inadequate consideration of anatomical structures such as the foot and ankle.

Method used

An external fixing system comprising upper and lower fixing elements connected by pillar members with adjustable mechanisms, including coarse and fine tuning features, allowing for precise alignment and adjustment to accommodate individual patient anatomy.

Benefits of technology

Enables customized and effective fixation by allowing for precise alignment and adjustment to the patient's anatomy, enhancing the therapeutic outcomes of orthopedic treatments.

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Abstract

The external fixation system comprises an upper fixation element having a partial circle shape, and a middle fixation element having a circular shape and releasably coupled to the upper fixation element. The system further comprises a lower fixation element having a substantially U-shaped shape terminating at a first end point and a second end point and releasably coupled to the middle fixation element, and an anterior fixation element having a partial circle shape. The anterior fixation element is also fixedly coupled to the first end point and the second end point of the lower fixation element. The system also comprises at least one strut member releasably coupled to the middle fixation element and the lower fixation element. Also disclosed is a joint comprising a first component, a second component, and a middle component located between the first and second components to allow pivotable movement.
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Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 304,236, filed January 28, 2022, and entitled “EXTERNAL FIXATION SYSTEM AND METHOD OF USE,” the entire contents of which are incorporated herein by reference.

[0002] (Technical field) The present disclosure relates to fixation systems for orthopedic applications. Further, the present disclosure relates to external fixation systems used in the treatment of various acute and chronic orthopedic conditions. More specifically, but not exclusively, the present disclosure relates to external fixation systems used in orthopedic conditions of the foot and / or ankle. [Background technology]

[0003] Many of the currently available fixation systems and corresponding methods of use do not fully address the needs of patients, and furthermore, many of the currently available fixation systems and corresponding methods of use do not take into account the anatomical characteristics of the patient, such as the foot, ankle, and surrounding anatomical structures, and accordingly may not provide the most favorable outcome for that patient. Summary of the Invention

[0004] The present disclosure relates to surgical instruments, implants, and methods directed to joint arthroplasty.

[0005] A first aspect of the present disclosure includes an external fixation system comprising an upper fixation element having a partial circular shape, and a middle fixation element having a circular shape and releasably coupled to the upper fixation element. The system further comprises a lower fixation element having a substantially U-shaped shape terminating at first and second ends and releasably coupled to the middle fixation element, and a front fixation element having a partial circular shape and fixedly coupled to the first and second ends of the lower fixation element. The system also comprises at least one strut member releasably coupled to the middle fixation element and the lower fixation element.

[0006] According to one aspect of the present disclosure, in the external fixation system, the at least one strut member includes a pair of strut members.

[0007] According to one aspect of the disclosure, at least one support member has a first end having a first threaded portion to facilitate a threadable coupling, a second end having a second threaded portion to facilitate the threadable coupling, and a central portion located between the first and second ends.

[0008] According to one aspect of the disclosure, at least one strut member further includes a coarse adjustment mechanism disposed adjacent the second end and a central portion of the strut member, the coarse adjustment mechanism including a collar positioned radially about the threaded rod and a sleeve positioned radially outward from the collar and the threaded rod.

[0009] According to one aspect of the disclosure, a collar of at least one strut member is threadably engaged with a threaded portion of a threaded rod such that manipulation of the collar relative to the threaded portion causes the collar to translate along the threaded rod.

[0010] According to one aspect of the present disclosure, a sleeve of at least one strut member is translatable along the threaded rod.

[0011] According to one aspect of the present disclosure, the at least one strut member also includes a locking nut that is translatable along a length of the threaded rod and is located adjacent to the sleeve.

[0012] According to one aspect of the disclosure, the at least one strut member further comprises a tube, the threaded rod being translatable such that at least a portion of the threaded rod is disposed within the tube.

[0013] According to one aspect of the present disclosure, a tube of the at least one strut member has a plurality of markings on an outer surface of the tube that indicate a length of the at least one strut member based on a position of at least a portion of a threaded rod that is at least partially disposed within the tube.

[0014] According to one aspect of the present disclosure, at least one strut member further comprises a micro-adjustment mechanism actuable by rotating at least a portion of the micro-adjustment mechanism, the rotational action corresponding to a predetermined length adjustment to the strut member.

[0015] A second aspect of the present disclosure includes a joint of an external fixation system comprising a first component having a first longitudinal axis and a second component having a second longitudinal axis, the first and second components being maneuverable from a first position in which the first and second longitudinal axes are concentric to a second position in which the first and second longitudinal axes intersect and form an oblique angle with each other.

[0016] According to one aspect of the disclosure, a first component includes an elongate member having a first threaded portion on an outer surface extending from a terminal end to a central portion, and a body disposed opposite the terminal end of the elongate member.

[0017] According to one aspect of the present disclosure, the body has a substantially spherical shape with a lateral dimension greater than a diameter of the elongate member.

[0018] According to one aspect of the disclosure, the second component has a volume extending therethrough, the volume having a first thread disposed on at least a portion of an inner surface.

[0019] According to one aspect of the disclosure, the joint further includes an adapter having second threads disposed on an outer surface thereof and configured to engage the first threads of the volume of the second component.

[0020] According to one aspect of the present disclosure, the adapter includes a cannulated portion and a third threaded portion disposed on an inner surface of the cannulated portion, the third threaded portion configured to threadably engage complementary threads of an element of the external fixation system.

[0021] According to one aspect of the disclosure, the volume of the second component is configured to receive at least a portion of the body within the volume.

[0022] According to one aspect of the disclosure, the second component includes a shoulder adjacent the space configured to retain at least a portion of the body within the space.

[0023] According to one aspect of the present disclosure, the first component is releasably couplable with a ring member of the external fixation system and the second component is releasably couplable with a strut member of the external fixation system.

[0024] A third aspect of the present disclosure includes a joint for an external fixation system. The joint includes a first component having a first pair of projections defining a first space therebetween. Each of the first pair of projections has a first bore extending therethrough. The first bore is coaxial. The joint also includes a second component having a second pair of projections defining a second space therebetween. Each of the second pair of projections has a second bore extending therethrough. The second bore is coaxial. The joint also includes an intermediate component located at least partially within the first and second spaces. The intermediate component has a third bore aligned with the first bore and receiving a first fastener therein, thereby coupling the intermediate component to the first component. The intermediate component has a fourth bore aligned with the second bore and receiving a second fastener therein, thereby coupling the intermediate component to the second component. The first and second components are pivotable (rotatable) about the first and second fasteners, respectively.

[0025] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with the detailed description herein, serve to explain the principles of the present invention. It is emphasized that, in accordance with standard practice in the industry, various features may or may not be drawn to scale. In fact, the dimensions of various features may be arbitrarily increased or decreased for clarity of discussion. The drawings are for the purpose of illustrating embodiments of the present disclosure and are not to be construed as limiting the present invention. [Brief description of the drawings]

[0026] [Figure 1] FIG. 1 is a perspective view of an exemplary external fixation system according to the present disclosure. [Diagram 2] FIG. 2 is a front view of the exemplary external fixation system of FIG. 1 in accordance with the present disclosure. [Diagram 3] FIG. 2 is a top view of the exemplary external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 4] FIG. 2 is a rear view of the exemplary external fixation system of FIG. 1 in accordance with the present disclosure. [Diagram 5] FIG. 2 is a side view of the exemplary external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 6] FIG. 2 is a bottom view of the exemplary external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 7] FIG. 2 is a first side view of an exemplary strut member for use with the external fixation system of FIG. 1 in accordance with the present disclosure; [Figure 8] 8 is a second side view of the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 9] 8 is a first perspective view of the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 10] 8 is a second perspective view of the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 11] 8 is a side cross-sectional view of the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 12] FIG. 8 is a perspective view of the example strut member of FIG. 7 coupled with two joints in accordance with the present disclosure. [Figure 13] 13 is another perspective view of the example strut member of FIG. 12 connected with two joints in accordance with the present disclosure. [Figure 14] FIG. 8 is a perspective view of the exemplary strut member of FIG. 7 and a joint for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 15] 8 is another perspective view of the exemplary strut member of FIG. 7 and a joint for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 16] 15 is a side cross-sectional view of the joint of FIG. 14 used with the exemplary strut member of FIG. 7 and the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 17]13 is a side cross-sectional view of the exemplary strut member of FIG. 7 coupled with two joints of FIG. 12 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 18] 8 is a perspective view of an exemplary joint connectable with the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 19] 8 is a side view of an exemplary joint coupleable with the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 20] 8 is a perspective view of an exemplary joint connectable with the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 21] 8 is a side view of an exemplary joint coupleable with the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 22] 8 is a perspective view of an exemplary joint connectable with the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Diagram 23] 8 is a side view of an exemplary joint coupleable with the exemplary strut member of FIG. 7 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Figure 24] FIG. 2 is a perspective view of an exemplary foot plate connection system for use with the external fixation system of FIG. 1 in accordance with the present disclosure. [Diagram 25] FIG. 25 is another perspective view of the exemplary foot plate connection system of FIG. 24 for use with the external fixation system of FIG. 1 in accordance with the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] In this detailed description and in the claims that follow, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior, and inferior are defined by their standard usage to refer to specific sites or portions of a bone or implant, in accordance with terms that refer to the relative placement or orientation of natural bone. For example, "proximal" refers to the portion of the device or implant closest to the torso, and "distal" refers to the portion of the device or implant furthest from the torso. As directional terms, "anterior" refers to a direction toward the front of the body, "posterior" refers to a direction toward the back of the body, "medial" refers to a direction toward the midline of the body, "lateral" refers to a direction toward the side of the body or away from the midline of the body, "up" refers to a direction toward above another object or structure, and "down" refers to a direction toward below another object or structure. Furthermore, with respect to the foot specifically, "dorsal" refers to the top of the foot and "plantar" refers to the bottom of the foot.

[0028] Similarly, a location or direction may be used herein with reference to an anatomical structure or surface. For example, the systems, implants, devices, instruments, and methods are described herein with respect to use on the bones of the foot, and thus the bones of the foot, ankle, and lower leg may be used to describe the surface, location, direction, or orientation of the implants, devices, instruments, and methods. Furthermore, the systems, implants, devices, instruments, and methods disclosed herein, as well as their aspects, components, features, etc., are described with respect to one side of the body for the sake of brevity. However, since the human body is relatively symmetrical or mirror imaged with respect to a line of symmetry (the midline), it is expressly intended that the systems, implants, devices, instruments, and methods described and / or illustrated herein, as well as their aspects, components, features, etc., may be changed, altered, modified, reconfigured, or otherwise modified for use on or in association with the opposite side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, the systems, implants, devices, instruments, and methods, and aspects, components, features, etc., described herein with respect to the right foot may be reversed to function similarly with the left foot. Additionally, while the systems, implants, devices, instruments, and methods, and aspects, components, features, etc., disclosed herein are described with respect to the foot for brevity, it will be understood that the systems, implants, devices, instruments, and methods may also be used with other bones of the body having similar structures.

[0029] Referring to the drawings, like reference numerals are used throughout the several views to indicate like or similar components. With particular reference to FIGS. 1-6, an exemplary embodiment of an external fixation system 100 (hereinafter referred to as "system 100") is shown. System 100 may include various components, including but not limited to those shown and described herein. System 100 and its components may also be provided to a physician in an unassembled state so that the physician can select and use the desired components to provide external fixation to a patient using system 100. Furthermore, system 100 may include one or more of the components shown and described herein, and a physician may wish to use more than one of the one or more components, or may choose not to use one or more components, when selecting components to assemble system 100 to provide the best external fixation to a patient.

[0030] System 100 is shown to include upper portion 200 and lower portion 300. Upper portion 200 and lower portion 300 may be coupled (e.g., releasably, directly, indirectly, fixedly, etc.) to one another via various components, not limited to those shown and described herein. Upper portion 200 is shown to include first ring member 210 and second ring member 230. In some embodiments, system 100 may include both first ring member 210 and second ring member 230 as well as one or more of any other ring members shown and described herein. As shown, first ring member 210 has a semi-circular shape (e.g., less than a full circle). Furthermore, as shown, first ring member 210 has a substantially hemi-circular shape (e.g., about half of a circle). In some embodiments, first ring member 210 may have a full circular shape, a less than semi-circular shape, or other alternative shapes (e.g., U-shaped, etc.). The second ring member 230 is shown coupled (e.g., releasably, fixedly, screwably, pivotably, etc.) to the first ring member 210 at at least one coupling point. In some embodiments, the first ring member 210 may be coupled to the second ring member 230 such that each of the ring members are disposed about a common longitudinal axis. The first and second ring members 210, 230 may also be coupled to one another to allow movement (e.g., translation, pivoting, etc.) about one or more axes or coupling points.

[0031] The first ring member 210 is shown having a plurality of holes 212 disposed therein. As shown, the holes 212 are disposed on a circumference or partial circumference of the first ring member 210 and are equally spaced from one another and from both the inner and outer circumferential edges of the first ring member 210. In some embodiments, the holes 212 may be disposed at other intervals (distances) (e.g., at various distances from one another, offset toward the outer or inner edges of the first ring member 210). Also, while the holes 212 are shown as being substantially circular and equally sized, in some embodiments, one or more of the holes 212 may have alternative sizes (e.g., larger or smaller diameters) and / or may have another shape (e.g., hexagonal, octagonal, etc.). In some embodiments, the inner surface of the holes 212 may have threads configured to receive a complementary component within / through the holes. As shown, the first ring member 210 is releasably coupled to the second ring member 230 via one or more structural members 218. The one or more structural members 218 are configured to be at least partially received within the bore 212 and within a plurality of holes 232 disposed in the second ring member 230. The holes 232 may be the same as and / or similar to the holes 212. The structural member 218 is shown as having a cylindrical shape with threads disposed on an exterior surface along its length. The threads may be at least partially received within the holes 212, 232. In some embodiments, the rod 218 may be releasably coupled to the first and second ring members 210, 230 via one or more other coupling components, such as various threaded nuts having threading complementary to the threading of the rod 218.

[0032] The first ring member 210 is further shown to include one or more coupling devices 214 releasably coupled to one or more of the holes 212. As shown, the coupling device 214 includes a linear member 216 (e.g., a rigid linear component) disposed at a lower portion thereof. The linear member 216 is configured to be received in the hole 212, thereby facilitating releasable coupling with the first ring member 210. The coupling device 214 has at least one cavity (e.g., a recess, void, hole, through-hole, opening, etc.) configured to receive the rod 222, thereby facilitating releasable coupling with the rod 222. The upper portion 200 and / or the system 100 may include one or more rods 222. The one or more rods 222 may be configured to releasably couple with the patient's anatomy (or other hardware components). The other hardware components include, but are not limited to, those shown and described herein. In some embodiments, the rod 222 has a substantially cylindrical shape and may further include a threaded portion disposed on at least a portion of its length. The cavity of coupling device 214 may be configured to facilitate translation of rod 222 while maintaining coupling with rod 222. In some embodiments, first ring member 210 may include an extension 220 configured to releasably couple with both hole 212 of first ring member 210 and coupling device 214 to space coupling device 214 from first ring member 210. For example, coupling device 214 may be vertically elevated from a surface of first ring member 210 such that rod 222, when coupled with coupling device 214, may be releasably coupled with at least one anatomical structure of the patient at an angle different from the angle that may be achieved in the absence of extension 220.

[0033] The second ring member 230 is shown to include one or more coupling devices 234 releasably coupled to one or more holes 232. As shown, the coupling device 234 may include an extension (e.g., a rigid linear member having the same and / or similar structure and / or function as the linear member 216) disposed at a lower portion thereof. The extension may be configured to be received by the hole 232 and thereby facilitate releasable coupling with the second ring member 230. The coupling device 234 has at least one cavity (e.g., a recess, void, hole, through-hole, opening, etc., which may be the same and / or similar to that of the coupling device 214) configured to receive at least a portion of and facilitate releasable coupling with one of the pins 236 (one of the one or more pins that the system 100 may include). The upper portion 200 and / or the system 100 may include one or more pins 236. The one or more pins 236 may be configured to releasably couple with the patient's anatomy (or other hardware component). Other hardware components include, but are not limited to, those shown and described herein. The pin 236 may have a similar length and / or shape as the rod 222 as shown with reference to the first ring member 210, but the pin 236 may have a smaller lateral dimension (width), may be unthreaded, or may have or lack various other structural components. The cavity of the coupling device 234 may be configured to facilitate translation of the pin 236 while maintaining coupling with the pin 236. In some embodiments, the second ring member 230 may include an extension similar to the extension 220 as shown with reference to the first ring member 210. Such an extension may be configured to releasably couple with both the hole 232 of the second ring member 230 and the coupling device 234 to space the coupling device 234 from the second ring member 230.For example, the connecting device 234 may be vertically elevated from the surface of the second ring member 230 such that the pin 236, when coupled with the connecting device 234, may be releasably coupled to at least one anatomical structure of the patient at an angle different from the angle that would be achieved in the absence of the extension.

[0034] The system 100 is shown to include at least one rod member 400. As shown in Figures 1-6, the system 100 includes one rod member 400 that releasably couples the first ring member 210 to the second ring member 230. As shown, the housing 430 of the rod member 400 is received by and extends through both the holes 212 and the holes 232 such that the rod member 400 is configured in a plane perpendicular to the upper or lower surfaces of the first and second ring members 210, 230. The system 100 also shows that the rod member 400 releasably couples the second ring member 230 of the upper portion 200 to a third ring member 610 of the ring system 600. The third ring member 610 is shown to have a substantially U-shape defined by a pair of terminal ends 614 located at the ends of two substantially parallel straight segments of the U-shape. The third ring member 610 has a plurality of holes 612 disposed therein. The size and shape of the holes 612 may be the same and / or similar to the size and shape of the holes 212, 232. In some embodiments, the third ring member 610 may have one or more rows or other configurations / patterns of holes 612 variously disposed relative to the third ring member 610.

[0035] The rod 400, which releasably connects the second ring member 230 and the third ring member 610, is shown having a first end 410 of the housing 430. The first end 410 is received by one of the holes 612 and is releasably connected to / through the holes 612. The housing 430 is also shown having a second end 440 opposite the first end 410 of the housing 430. The second end 440 includes a threaded rod 420 extending from the second end 440. The threaded rod 420 is shown received by one of the holes 232 and may be connected to the second ring member 230 via the holes 232 with one or more other connecting components (e.g., a threaded nut). The housing 430 may have a bore extending through the housing 430 from the first end 410 to the second end 430. At least some of the holes may have threads complementary to the threads of the threaded rod 420. In some embodiments, the housing 430 may be releasably coupled to one or more of the threaded rods 420 via the first and second ends 410, 440 (and / or threaded holes therein and therebetween), thereby allowing the housing 430 to provide a variety of height configurations (depending on the amount the rod member 420 is disposed within / extends from the housing 430) as well as facilitating alternative means of releasably coupling with various ring members or other components of the system 100.

[0036] The ring system 600 is shown to include a fourth ring member 630 having a partial circular (arc) shape (e.g., less than a full circle). Additionally, while the illustrated fourth ring member 630 has a substantially semicircular shape (e.g., approximately half a circle), in some embodiments, the ring member 630 may have a shape that is less than half a circle. In some embodiments, the fourth ring member 630 may have other alternative shapes (e.g., U-shaped, etc.). The fourth ring member 630 has a number of holes 632 disposed therein. The size and shape of the holes 632 may be the same and / or similar (similar) to the size and shape of the holes 212, 232, 612. The fourth ring member 630 is shown to be releasably coupled to the terminal end 614 of the third ring member 610 such that the surface adjacent the holes 632 lies in a plane substantially perpendicular to the surface adjacent the holes 612. In some embodiments, the fourth ring member 630 may be configured such that such plane is disposed at a substantially oblique angle. As shown, each of the coupling members (e.g., bolts or other coupling components) is received in one of the holes 632 (in the exemplary embodiment of FIGS. 1-6, the hole closest to the terminal end of the fourth ring member 630) and extends at least partially through the holes 632 such that the coupling components are at least partially received in a threaded hole disposed in the terminal end 614 of the third ring member 610. As shown in FIGS. 1-6, the fourth ring member 630 is coupled to the third ring member 610 such that the fourth ring member 630 cannot pivot or otherwise move relative to the third ring member 610 without decoupling (uncoupling) the pair of coupling components from the terminal end 614.

[0037] The fourth ring member 630 is also shown releasably coupled to the second ring member 230 via a rod 634, a first coupling device 636, and a second coupling device 638. The first coupling device 636 is shown releasably coupled to one of the holes 632. Such a releasable coupling may include using one or more common coupling components (e.g., bolts, nuts, etc.) and may further include the first coupling device 636 and / or at least a portion of said common coupling components being at least partially received within / through the hole 632. As shown, the first coupling device 636 is coupled to the hole 632 that is approximately equidistant from both ends of the fourth ring member 630 (e.g., both ends of the fourth ring member 630 are coupled to both ends 614 of the third ring member 610). The first connecting device 636 may include bearings or one or more other mechanisms configured to facilitate movement (e.g., rotation, pivoting, etc.) of at least a first portion of the first connecting device 636 relative to a second portion of the first connecting device 636 that is directly coupled to the fourth ring member 630. The first connecting device 636 is shown to be releasably coupled to a rod 634 (e.g., at least a portion of the rod 634 may be received by at least a portion of the first connecting device 636). The rod 634 has threads disposed at least partially along its length. In some embodiments, the rod 634 may be the same and / or similar to the structural member 218. The rod 634 is shown to be releasably coupled to a second connecting device 638, which is further coupled to the second ring member 230. In some embodiments, the first connecting device 636 and the second connecting device 638 may be the same or similar to one another.Further, like the first connecting device 636, the second connecting device 638 may include bearings or one or more other mechanisms configured to facilitate movement (e.g., rotation, pivoting, etc.) of at least a first portion of the second connecting device 638 relative to a second portion of the second connecting device 638 that is directly connected to the second ring member 230.

[0038] The lower portion 300 is further shown to include a grounding system 650 (e.g., "system 650") as shown in FIGS. 1-6. System 650 includes a pair of support members 652, each of which is configured to have an elongated, substantially rectangular shape. Support member 652 is shown to be releasably coupled to third ring member 610. As shown in the exemplary embodiment of FIGS. 1-6, third ring member 610 includes support member 652 releasably coupled to a leg of a U-shape of third ring member 610 such that support member 652 is disposed below third ring member 610. As shown, each of the support members is releasably coupled to third ring member 610 at two different connection points (e.g., one connection point adjacent terminal end 614 and another connection point at an opposite point of the leg of the U-shape). In some embodiments, the support member 652 may include one or more coupling elements that may extend vertically from the support member 652 and be configured to be at least partially received in and / or through the hole 612 of the third ring member 610, as shown in FIGS. 1-6. In some embodiments, the support member may have one or more holes on / in the support member that are configured to facilitate coupling between the support member 652 and other members of the system 100 (e.g., when used in combination with other common coupling components). The one or more holes in the support member may be the same as or similar to the holes 212, 232, 612, 632. In some embodiments, such coupling elements extending from the support member 652 may couple with the top of the support member 652 and may be common coupling elements the same as and / or similar to other elements (e.g., threaded rods, nuts, bolts, etc.) shown and described herein. Similarly, the coupling elements of the support member 652 may be releasably coupleable with the holes 612 of the third ring member 610 when used in combination with other common coupling elements (including but not limited to those previously described herein). In some embodiments, the support member 652 may be translatable (e.g., in the anterior-posterior direction) relative to the third ring member 610 without decoupling (uncoupling) from the third ring member 610.Although not shown, this translation or other adjustment (e.g., the height added to system 100 by adding support member 652) is accomplished by loosening and / or tightening one or more common coupling components that are releasably coupled to support member 652.

[0039] Each of the support members 652 is shown to include a ground contacting member 654 coupled (releasably or otherwise) to a bottom surface (e.g., lower, distal, etc.) of each of the support members 652. In some embodiments, each of the ground contacting members 654 is shown to be coupled to each of the support members 652 via a common coupling component used in combination with one or more holes disposed on or within the support members 652. The one or more holes of the support members 652 may be the same and / or similar to the holes 212, 232, 612, 632 shown herein and described above. The ground contacting members 654 may also be coupled to the support members 652 via an adhesive material applied to one or both of the support members 652 and / or the ground contacting members 654. Although not shown, the ground contacting members 654 may have a textured surface (e.g., a tread pattern) on their bottom surface configured to prevent patient slippage under weight bearing conditions. For example, such textures may include various ribs or other textures configured to increase friction with a contact surface (e.g., the ground when walking) and / or shed moisture or other potentially slippery materials from under the ground contact members 654 during a walking cycle. Additionally, such textures may include text such as "Paragon 28," "P28," "Monkey Sticks," "Monkey Rings," or other textual components. Similarly, the textures may include various logos, such as those used commercially by Paragon 28, Inc. The ground contact members 654 may also be configured to be replaceable. For example, if a patient wears the texture and / or the ground contact members, the patient or physician may separate a used pair of ground contact members 654 and replace them with a new set of ground contact members 654. In some embodiments, the system 100 may include various ground contact members 654 having various widths, heights, textured surfaces, or other characteristics.

[0040] System 100 is also shown to include a strut 500. Strut 500 is shown in combination with other components of system 100 in FIGS. 1-6 and separately from system 100 in FIGS. 7-11. In some embodiments, system 100 may include one or more struts 500, and system 100 may be assembled by a physician with one or more struts 500. As shown in FIGS. 1-6, strut 500 is releasably coupled to second ring member 230 and third ring member 610. However, in alternative embodiments (or assembled configurations at the discretion of the physician), strut 500 may be coupled to one or more alternative components of system 100. Although the strut 500 is shown as being releasably coupleable with one of the holes 232 of the second ring member 230 and one of the holes 612 of the third ring member 610, the strut 500 may also be coupleable with other similar holes (or other coupling devices, including but not limited to other coupling devices shown and described herein). Once a user couples the strut 500 with, for example, the second ring member 230 and the third ring member 610, the strut 500 may be manipulated (e.g., actuated, adjusted, etc.) to change the distance between the second ring member 230 and the third ring member 610.

[0041] The strut 500 is shown having a first end 510, a second end 520, and a central portion 530. The first end 510 is opposite the second end 520 of the strut 500, and the central portion 530 is disposed between the first end 510 and the second end 520. The strut 500 is releasably connectable to one or more other components of the system 100 (or, in some embodiments, other external fixation systems / components), such as the second ring member 230 and the third ring member 610 as previously shown and described herein. The first end 510 and the second end 520 have a first threaded portion 511 and a second threaded portion 521, respectively. Both threaded portions 511, 521 are shown to have a substantially cylindrical shape. Threaded portions 511, 521 may have one or more other characteristics similar to other linear structural components (eg, structural member 218) of system 100 shown and described herein.

[0042] The second end 520 of the post 500 includes a gross adjustment mechanism located at or near the central portion 530. This gross adjustment mechanism will likely be operated prior to the fine adjustment mechanism shown and described later herein when the post 500 is used by a physician. The central portion 530 of the post 500 is shown to include a sleeve 532 located radially outward from a collar 534 located on the outer surface of the rod 518. In some embodiments, the inner surface of the collar 534 (the surface that abuts the outer surface / threading of the rod 518) may have complementary threads, teeth, or other texture or engagement means to facilitate engagement between the collar 534 and the rod 518. The collar 534 may be translatable relative to the length of the rod 518 or at least a portion thereof. The sleeve 532 may also be movable (e.g., translatable) relative to the collar 534 and / or the rod 518. This may allow sleeve 532 to be manipulated so that all, a portion, or none of collar 534 is positioned radially between rod 518 and sleeve 532. In some embodiments, sleeve 532 may be open at one or more ends and may have a substantially cylindrical shape. Additionally, in some embodiments, sleeve 532 may have threads or other texture on its outer surface.

[0043] The central portion 530 is further shown to have a nut 536 configured to at least partially abut (e.g., adjacent to, contacting, engaging, disposed within, etc.) the collar 534. As shown in FIG. 11, the nut 536 is radial to the rod 518 and disposed within the sleeve 532. Additionally, the nut 536 engages (e.g., contacts) the collar 534 and the rod 518. The central portion 530 of the strut 500 is also shown to have a locking nut 538 and a tube 540. To facilitate gripping and / or manipulating the locking nut 538, the locking nut 538 may have grooves or texture on its outer surface. In some embodiments, the tube 540 may be integral with the second threaded portion. The tube 540 is disposed to receive at least a portion of the rod 518 at its inner portion (the tube 540 has a substantially cylindrical shape at least in part thereof and further has a bore extending at least partially within the cylindrical shape). As shown, the tube 540 has markings of various lengths on its outer surface. The markings are located adjacent to an elongated window. The elongated window provides fluid communication between the bore of the tube 540 and the outer surface of the tube 540. A locking nut 538 is disposed adjacent the sleeve 532 (e.g., radially of at least a portion of the rod 518) and has threads on an inner surface. The threads are configured to engage complementary threads disposed on at least a portion of the outer surface of the tube 540. The tube 540 is shown to include a restricting element 542. At least a portion of the restricting element 542 has a substantially circular / cylindrical shape that is the same and / or similar to (e.g., complementary to, configured to contact, configured to be received, or configured to be disposed within) the bore of the rod 518 and / or the tube 540.

[0044] The strut 500 may be adjusted in a coarse manner (e.g., in larger increments than the fine adjustment mechanisms / methods shown and described later herein) by a user or physician to make relatively large adjustments to the length of the strut 500. To adjust the length of the strut 500, and referring to FIG. 11, a user may manipulate the locking nut 538 from right to left by rotating (e.g., screwing) the locking nut 536 about a threaded portion located on the exterior portion of the tube 540 that the locking nut engages. Such movement of the locking nut 536 releases the sleeve 532 from contact with the locking nut 536, thereby allowing the sleeve 532 to slide in the same direction as the locking nut 536 (e.g., right to left as shown) when the locking nut 536 is manipulated. Such movement of the sleeve 532 disengages the inner surface of the sleeve (which may have a protrusion / projection configured to contact the nut 536) from the outer surface of the nut 536 (which was biased by the sleeve 532 to mechanically engage at least a portion of the rod 518). Disengagement of the nut 536 from the rod 518 allows the rod 518 to move relative to the tube 540 (e.g., translate in / along its longitudinal axis). This rod movement is limited by a limiting element 542 disposed within the tube 540. Once the strut 500 is at the desired length, the aforementioned components may be replaced in a reverse order to that described above to allow for coarse adjustment of the strut 500. For example, nut 536 is re-engaged to the threads on rod 518, sleeve 532 is manipulated so that at least a portion of the inner surface of sleeve 532 contacts at least a portion of the outer surface of nut 536, and locking nut 538 is manipulated along the outer threads of tube 540 until locking nut 538 abuts sleeve 532, thus mechanically holding strut 500 at the desired length.

[0045] The limiting element 542 is configured to prevent over-adjustment (e.g., over-extension) of the strut 500, for example, by manipulating the rod 518 to the right in FIG. 11. The limiting element 542 has a lateral dimension (width dimension) larger than the opening of the bore of the tube 540, thereby mechanically limiting the length of the strut 500, as translation of the rod 518 to lengthen the strut 500 is ultimately mechanically limited at the point where the limiting element 542 (connected to the end of the rod 518) cannot be pulled out of the bore of the tube 540. Adjusting the strut 500 to be shorter can be accomplished by following the same steps outlined herein, except that the shortening of the strut 500 is mechanically limited by translating the rod 518 until it contacts the end of the bore of the tube 540. During adjustment of strut 500 using the coarse adjustment mechanism, at least a portion of rod 518 may be visible within the elongated opening of tube 540 such that the end of rod 518 lies adjacent a length marking on the outer surface of tube 540. The length marking that the end of rod 518 is adjacent corresponds to the length of strut 500 at the current adjustment.

[0046] The first end 510 of the strut 500 includes an actuator 512 disposed adjacent the first threaded portion 511. The actuator 512 is configured to facilitate fine adjustment of the length of the strut 500 and is further configured to be rotatable relative to (about) the rod 518. The rod 518 includes threads disposed along at least a portion of its length and is at least partially received within a bore 514 of the actuator (the bore 514 may have threads). In some embodiments, the actuator 512 may be configured such that a predetermined amount of rotation (e.g., degrees or rotations) of the actuator 512 about the rod 518 corresponds to a linear length adjustment (e.g., millimeters). For example, one full rotation of the actuator 512 about the rod 518 may correspond to a one millimeter increase or decrease in the length of the strut 500 depending on the direction the actuator 512 is rotated. In some embodiments, such calibration may be indicated by one or more markings on an exterior surface of the actuator 512. As shown, actuator 512 includes a double-ended arrow with the arrows at each end indicating a direction of rotation. Additionally, actuator 512 is shown to include one or more incremental indicia (e.g., dots) configured to guide a user in rotating actuator 512 to increase or decrease the length of strut 500 by rotating in one of the directions indicated by the double-ended arrow. Actuator 512 may have one or more flats or other surfaces on its outer portion configured to facilitate gripping and rotating actuator 512 about rod 518.

[0047] The actuator 512 is further configured to include a biasing element 516 configured to provide feedback to a physician or other user in response to rotation of the actuator 512. The feedback provided by the biasing element 516 may include audible feedback (e.g., a clicking sound) as well as tactile feedback (e.g., the physician may feel an increasing number of clicking sounds while holding and actuating the actuator 512). As shown in the exemplary embodiment of FIG. 11, the biasing element 516 includes a spring 517 and a ball member 519. The spring 517 may be compressed when the actuator 512 is rotated about the rod 518 and may further compress and expand in response to the rotation of the actuator 512 to provide one or both of tactile and / or audible feedback to the user. The ball member 519 may be configured to facilitate rotation of the actuator 512 about the rod 518 in a manner similar to the function of a ball bearing, for example, to contact one or more components and facilitate movement of one or both of the components. In some embodiments, the aforementioned incremental indication may also provide visual feedback to the user indicating either an increase or decrease in the length of the strut 500 depending on the direction of rotation as the actuator 512 is rotated about the rod 518. In some embodiments, the spring 517 may be replaced with an alternative elastic member and / or the ball member 519 may be replaced with an alternative substantially spherical (cylindrical) member having similar mechanical and kinematic properties. When using the system 100 and one or more struts 500 in combination with the system 100, the physician may perform coarse adjustments of the strut 500 prior to fine adjustments of the strut 500. That is, fine adjustments of the strut 500 via the actuator 512 and its components may be performed to determine or achieve a final desired length of the strut 500.

[0048] 12-17, a modular ball joint 700 (hereinafter referred to as "joint 700") is shown in accordance with an exemplary embodiment. The joint 700 is connectable to one or both ends of the strut 500 as shown in FIGS. 12-13 and 17. Alternatively, the joint 700 may be connectable to other struts and / or components of the system 100 shown in FIG. 1. One or more of the joints 700 may be used in various ways within the system 100, such as connecting to one or both ends of the strut 500 or connecting to one or both ends of other rigid components of the system 100. The joint 700 is shown to be modular in that it has multiple pieces / components and is connectable to another piece / component to form the joint 700.

[0049] The joint 700 is shown having a first portion 710 having a first end. The first portion 710 is disposed substantially opposite a second portion 720 having a second end at the joint 700. The first portion 710 and the second portion 720 are manipulable (e.g., actuatable) relative to one another such that the respective longitudinal axes of the first and second portions 710, 720 may be coaxial or such that the axes are at an oblique angle to one another. The first portion 710, as shown, comprises an elongated member 712. The elongated member 712 has a substantially cylindrical shape and has a threaded portion 714 disposed on an outer surface thereof. The elongated member 712 comprises a body 718 configured opposite the first end of the elongated member 712. The body is shown in FIGS. 16-17 as being spherical in shape. The body is also shown to have a lateral dimension that is greater than a lateral dimension of the elongated member 712. However, it should be understood that in some aspects, the body 718 may have alternative shapes in other embodiments, for example, an ellipsoidal shape. The second portion 720 is shown having a volume (or space) 722 extending longitudinally along the length of the second portion 720 from an opening adjacent said second end. As shown, the volume 722 has a substantially cylindrical shape and has threads 724 disposed on at least a portion of its inner surface. Additionally, the second portion 720 is shown to include an adaptor 726. The adaptor 726 is threadably coupled to the threads 724 via the threads of the adaptor 726 such that the adaptor 726 is disposed within the volume 722. The adaptor 726 has a cylindrical cannula shape and has threads on its inner surface in addition to threads on its outer surface that engage with the threads 724. The adaptor 726 may be configured to enhance compatibility with various posts and their connecting components (e.g., posts the same as or similar to post 500), for example, to receive within the cannulated portion of the adaptor 726 a screwable connecting portion of post 500 that is smaller in size and therefore would not be able to engage with the threaded portion 724 of the second portion 720.In some embodiments, an adapter 726 may not be required to couple the second portion 720 with a corresponding coupling feature on the post (or other component of the system 100).

[0050] The second part 720 includes a first housing portion 728. The first housing portion 728 is located on a side of the second part 720 substantially opposite an opening of the volume 722 configured to receive a connecting portion of a post or other component. As shown, the first housing portion 728 is located to abut the second housing portion 740 of the first part 710 and retain at least a portion of the body 718 within the volume 722. The first housing portion 728 has a shoulder 730 extending circumferentially relative to an end of the volume 722 to facilitate retaining at least a portion of the body 718 within the volume 722. The second housing portion 740 is shown to have a threaded portion 742 disposed on at least a portion of its inner surface. The threaded portion 742 is configured to engage with the threaded portion 714 of the elongated member 712. The second housing portion 740 also has a volume (or space) 744, which in the exemplary embodiment of FIG. 16 is shown as a recess. The first housing portion 728 is configured to have a smaller lateral dimension than the volume 744 such that manipulation of the first housing portion 728 relative to the second housing portion 740 (e.g., moving the longitudinal axes of the first and second portions 710, 720 at an oblique angle) can bias at least a portion of the first housing portion 728 into the volume 744 of the second housing portion 740. When applied to the system 100, a pair of joints 700 may be coupled to opposite ends of the strut 500 to facilitate a non-linear (e.g., off-axis) coupling of the strut 500 to one or more of the ring members or other structures. For example, when viewed from above, the strut 500 may be connected to a lower annular ring member and an upper annular ring member (e.g., component 230 in FIG. 1) via a pair of joints 700, with a first joint 700 connecting the strut 500 at the 9 o'clock position of the lower annular ring member and a second joint 700 connecting the strut 500 at the 6 o'clock position of the upper annular ring member. Such a configuration is an example of a non-linear, "off-axis" configuration of the strut 500, and may also be classified as a strut 500 used in system 100 (or other similar systems) in a position such that the strut 500 forms an oblique angle with respect to the horizontal and vertical planes.

[0051] 18-19, a universal joint 800 (hereinafter referred to as "joint 800") is shown. Similar to joint 700, joint 800 may be releasably (e.g., threadably) coupled to one or both ends of a strut 500 (or similar) or other rigid linear component of system 100 or other similar systems. Joint 800 may be configured to facilitate use of system 100 or similar with strut 500 or other components in an "off-axis" configuration. An "off-axis" configuration includes, for example, the "off-axis" configurations discussed above with reference to strut 500 and joint 700. Joint 800 is shown to include first and second components 802 and 804 configured to oppose one another. In some embodiments, first and second components 802, 804 may be substantially similar and / or identical components. Each of first and second components 802, 804 is shown to have a pair of projections extending therefrom parallel to one another. Each of the protrusions has a hole extending therethrough that is coaxial with the hole of the opposing protrusion. The joint 800 further comprises an intermediate component 806. The intermediate component 806 is configured to have a lateral dimension that is less than a width between the inner surfaces of the pair of protrusions of each of the first and second components 802, 804. As shown, the intermediate component 806 has a substantially rectangularuloid (e.g., a rectangular prism with a rectangular base) shape, but may have alternative shapes in some embodiments. In some aspects, the intermediate component 806 may be solid or at least partially hollow.

[0052] The intermediate component 806 is shown having a pair of holes extending therethrough at opposite ends of the intermediate component 806, with the longitudinal axes of the pair of holes lying in mutually perpendicular planes. The intermediate component 806 is shown positioned such that at least a portion of the intermediate component 806 is disposed in the space between the pair of projections of both the first and second components 802, 804. Additionally, a first fastener 808 is configured to couple the intermediate component 806 to the first component 802 and hold the intermediate component 806 in said position at least partially within the space between the pair of projections of the first component 802. The first fastener 808 is configured to be received in and extend through the hole in the first projection of the first component 802, the hole in the intermediate component 806, and the hole in the second projection of the first component 802, thereby holding the intermediate component 806 in the aforementioned position. Similarly, the second fastener 810 is configured to couple the intermediate component 806 to the second component 804 and hold the intermediate component 806 in the position at least partially within the space between the pair of projections of the second component 804. The second fastener 810 is configured to be received and extend through the hole in the first projection of the second component 804, the hole in the intermediate component 806, and the hole in the second projection of the second component 804, thereby holding the intermediate component 806 in the position described above (similar to the first component 802). As shown, the first and second components 802, 804 are positioned approximately 90 degrees out of phase with each other when in an engaged orientation with the intermediate component 806. Thus, the first and second components 802, 804 can pivot about their respective first and second fasteners 808, 810, which facilitates movement, manipulation, and various positioning of the joint 800.

[0053] 20-21, a universal joint 900 (hereinafter referred to as "joint 900") is shown. Similar to joints 700, 800, joint 900 may be releasably (e.g., screwably, etc.) coupled to one or both ends of a strut 500 (or similar) or other rigid linear component of system 100 or other similar systems. Joint 900 may be configured to facilitate use of system 100 or similar with strut 500 or other components in an "off-axis" configuration. An "off-axis" configuration includes, for example, the "off-axis" configuration described above with reference to strut 500 and joint 700. Joint 900 is shown to include a first component 902 and a second component 904 configured to oppose one another. In some embodiments, the first and second components 902, 904 may be substantially similar and / or identical components. Each of the first and second components 902, 904 is shown having a pair of protrusions extending therefrom parallel to one another, with each of the protrusions having a hole extending therethrough and coaxial with the hole of the opposing protrusion. The joint 900 further comprises an intermediate component 906. The intermediate component 906 is configured to have a lateral dimension less than the width between the inner surfaces of the pair of protrusions of each of the first and second components 902, 904. As shown, the intermediate component 906 has a substantially rectangular parallelepiped (e.g., prism with a rectangular base) shape, but may have alternative shapes in some embodiments. In some aspects, the intermediate component 906 may be solid or at least partially hollow.

[0054] The intermediate component 906 is shown having a pair of holes extending therethrough at both ends of the intermediate component 906. The longitudinal axes of the pair of holes lie in mutually orthogonal planes. The intermediate component 906 is shown positioned such that at least a portion of the intermediate component 906 is disposed in the space between the pair of projections of both the first and second components 902, 904. Additionally, a first fastener 908 is configured to couple the intermediate component 906 with the first component 902 and hold the intermediate component 906 in said position at least partially within the space between the pair of projections of the first component 902. The first fastener 908 is configured to be received in and extend through the hole in the first projection of the first component 902, the hole in the intermediate component 906, and the hole in the second projection of the first component 902, thereby holding the intermediate component 906 in the aforementioned position. Similarly, the second fastener 910 is configured to couple the intermediate component 906 to the second component 904 and hold the intermediate component 906 in said position at least partially within the space between the pair of projections of the second component 904. The second fastener 910 is configured to be received and extend through the hole in the first projection of the second component 904, the hole in the intermediate component 906, and the hole in the second projection of the second component 904, thereby holding the intermediate component 906 in the position described above (similar to the first component 902). As shown, the first and second components 902, 904 are positioned approximately 90 degrees out of phase with each other when in an engaged orientation with the intermediate component 906. Thus, the first and second components 902, 904 can pivot about their respective first and second fasteners 908, 910, which facilitates movement, manipulation, and various positioning of the joint 900.

[0055] 22-23, a hinge joint 1000 (hereinafter referred to as "joint 1000") is shown. Similar to joints 700, 800, 900, joint 1000 may be releasably (e.g., screwably, etc.) coupled to one or both ends of a post 500 (or similar) or other rigid linear component of system 100 or other similar systems. Joint 1000 may be configured to facilitate use of system 100 or similar with a post 500 or other component in an "off-axis" configuration. An "off-axis" configuration includes, for example, the "off-axis" configuration described above with reference to post 500 and joint 700. Joint 1000 is shown to include a first component 1002 and a second component 1004 configured inversely to one another. In some embodiments, the first and second components 1002, 1004 may be substantially similar and / or identical components. Each of the first and second components 1002, 1004 is shown having a protrusion extending outwardly (parallel to its longitudinal axis) from an end thereof and having a hole disposed in a central portion of the protrusion. A fastener 1006 is shown to be received through each of the holes (when the first and second components 1002, 1004 are positioned such that the protrusions abut one another) to facilitate pivotal movement of one or both of the first and second components 1002, 1004 about the fastener 1006.

[0056] 24-25, the foot plate system 1100 is shown in an exemplary configuration with the third ring member 610 as initially shown as a component of the system 100. It should be understood that the foot plate system 1100 may be used with the third ring member 610 (as well as other components) as an element of the system 100. The foot plate system 1100 includes a pair of coupling mechanisms 1110 configured to releasably couple the foot plate 1102 to the third ring member 610 (e.g., at least partially adjacent the terminal end 614 of the third ring member). As shown, the coupling mechanisms 1110 are translatable within a cavity disposed in the foot plate 1102 along the length of the cavity. This facilitates coupling any point along the length of the cavity of the foot plate 1102 with any portion of the third ring member 610. For example, as shown in FIG. 24, the coupling mechanisms 1110 are located at both ends of the cavity of the foot plate 1102. 25, the linkages 1110 are located adjacent to each other in a central portion of the cavity of the foot plate 1102. As such, the linkages 1102 may be positioned and coupled to the third ring member 610 to optimize various factors affecting patient comfort and safety, such as weight distribution, stability, and foot plate position relative to the patient's normal gait.

[0057] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. The terms "comprise," "have," "include," "comprises," "comprising," "have," "have," "include ... Similarly, a method step or apparatus element that "comprises," "has," "includes," or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, an apparatus or structure that is configured in a particular way is configured in at least that way, but may also be configured in ways not recited.

[0058] The present disclosure has been described with reference to preferred embodiments. It will be understood that the structural and operational embodiments described herein are illustrative of multiple possible configurations for providing the same general features, characteristics and general system operation. Modifications and alterations will occur to others upon reading and understanding the foregoing detailed description. It is intended that the present disclosure be construed as including all such modifications and alterations.

Claims

1. an upper fixation element having a part-circular shape; an intermediate fixation element having a circular shape and releasably coupled to the upper fixation element; a lower fixation element having a substantially U-shaped configuration terminating at a first end point and a second end point, the lower fixation element being releasably coupled to the intermediate fixation element; a front fixation element having a partial circular shape and fixedly connected to the first end point and the second end point of the lower fixation element; at least one strut member releasably coupled to the intermediate fixation element and the lower fixation element; 1. An external fixation system comprising:

2. The external fixation system of claim 1 , wherein the at least one strut member comprises a pair of strut members.

3. The at least one support member is a first end having first threads to facilitate a threadable connection; a second end having second threads to facilitate a threadable connection; 10. The external fixation system of claim 1, further comprising a central portion located between the first end and the second end.

4. the at least one support member further comprising a coarse adjustment mechanism disposed adjacent the second end and the central portion of the at least one support member; The coarse adjustment mechanism a collar positioned radially about the threaded rod; 4. The external fixation system of claim 3, comprising a sleeve positioned radially outward from the collar and the threaded rod.

5. 5. The external fixation system of claim 4, wherein the collar is in threaded engagement with the threaded portion of the threaded rod such that manipulation of the collar relative to the threaded portion causes the collar to translate along the threaded rod.

6. The external fixation system of claim 5 , wherein the sleeve is translatable along the threaded rod.

7. The external fixation system of claim 6 , further comprising a locking nut translatable along the length of the threaded rod and positioned adjacent the sleeve.

8. Further comprising a tube; The external fixation system of claim 7 , wherein the threaded rod is translatable such that at least a portion of the threaded rod is disposed within the tube.

9. 9. The external fixation system of claim 8, wherein the tube has a plurality of markings on an outer surface of the tube that indicate a length of the at least one strut member based on a position of at least a portion of the threaded rod that is at least partially disposed within the tube.

10. the at least one strut member further comprises a fine adjustment mechanism; the fine adjustment mechanism is actuable by rotating at least a portion of the fine adjustment mechanism; The external fixation system of claim 4 , wherein a rotational manipulation corresponds to a predetermined length adjustment for the strut members.

11. 1. A joint of an external fixation system, comprising: a first component having a first longitudinal axis; a second component having a second longitudinal axis; a joint, wherein the first component and the second component are operable from a first position in which the first longitudinal axis and the second longitudinal axis are concentric to a second position in which the first longitudinal axis and the second longitudinal axis intersect and form an oblique angle with each other.

12. The first component is an elongated member having a first threaded portion on an outer surface thereof extending from a terminal end to a central portion; 12. The joint of claim 11, further comprising: a body disposed opposite the terminal end of the elongate member.

13. The joint of claim 12 , wherein the body has a substantially spherical shape with a lateral dimension greater than a diameter of the elongated member.

14. the second component has a volume extending therethrough; The joint of claim 13 , wherein the volume has a first thread disposed on at least a portion of an inner surface thereof.

15. further comprising an adapter; The joint of claim 14 , wherein the adapter has second threads disposed on an outer surface thereof and configured to engage the first threads of the volume of the second component.

16. the adapter includes a cannula portion and a third threaded portion disposed on an inner surface of the cannula portion; 16. The joint of claim 15, wherein the third threaded portion is configured to threadably engage complementary threads of an external fixation system element.

17. The joint of claim 14 , wherein the volume of the second component is configured to receive at least a portion of the body within the volume.

18. The joint of claim 17 , wherein the second component comprises a shoulder adjacent the volume configured to retain at least a portion of the body within the volume.

19. The joint of claim 11 , wherein the first component is releasably coupleable to a ring member of an external fixation system and the second component is releasably coupleable to a strut member of an external fixation system.

20. 1. A joint of an external fixation system, comprising: A first component; A second component; and an intermediate component; the first component has a first pair of protrusions defining a first space therebetween, each of the first pair of protrusions having a first bore extending therethrough, the first bores being coaxial; the second component has a second pair of projections defining a second space therebetween, each of the second pair of projections having a second bore extending therethrough, the second bores being coaxial; the intermediate component is at least partially located within the first space and the second space; The intermediate component is a third bore aligned with the first bore and adapted to receive a first fastener therethrough to couple the intermediate component to the first component; a fourth bore aligned with the second bore and adapted to receive a second fastener therethrough to couple the intermediate component to the second component; The first and second components are pivotable about the first and second fasteners, respectively.