Angle bisector surgical tool

Abstract

A device for indicating a centerline of a dual-component reference structure having first and second components includes a centerline guide, a first rotation arm including a first arm throughbore extending longitudinally therethrough for selectively accepting a first elongate wire, and a second rotation arm including a second arm throughbore extending longitudinally therethrough for selectively accepting a second elongate wire. When the first and second elongate wires are inserted through the respective first and second arm throughbores and concurrently extend tangent to both the first and second components, the first and second elongate wires cross, when viewed from the transverse direction, at a crossing location longitudinally between the device and the second component. When the angular positions of the first and second rotation arms with respect to the centerline guide are substantially the same, the centerline guide is selectively positioned substantially parallel to the centerline of the dual-component reference structure.

Description

ANGLE BISECTOR SURGICAL TOOLRelated Application

[0001] This application claims priority from U.S. Provisional Application No. 63 / 598,631 , filed 14 November 2023, the subject matter of which is incorporated herein by reference in its entirety.Technical Field

[0002] This disclosure relates to an apparatus and method for use of an angle bisector surgical tool and, more particularly, to a method for use and apparatus of an angle bisector surgical tool configured to aid k-wire insertion and rotation center detection.Background

[0003] The ankle syndesmosis is a joint just above the ankle where the tibia and the fibula meet. By definition, the syndesmosis is a joint and has characteristics of other joints in the body; however, it does not function like most joints, as there is very little motion between the two bones. Its main functions are, therefore, to provide stability to the ankle joint and allow motion of the joint.

[0004] Injuries to the syndesmosis are common and typically relate to an injury involving a twisting or rotation to the ankle, a broken ankle, or even a sprained ankle, resulting in stretched or torn ligaments supporting the syndesmosis. Certain severe injuries to the syndesmosis require surgical correction to properly align and stabilize the joint so the ligaments can heal in the correct position.

[0005] Typically, surgery involves an incision over the outside (lateral side) of the ankle . The fibula (bone) and syndesmosis are identified and exposed. Using direct vision and live X-ray techniques, the syndesmosis, based on learned skill and judgment of the surgeon, is placed into the correct position. The surgeon then “fixes” the syndesmosis in place with an implant such as screws, flexible fixation tools, or a combination of plates and screws. One of the most common methods involves one or two screws that go from the fibula bone into the tibia bone. The screws may be placed through a plate that sits on the fibula bone. Alternatively, a suture device or flexible fixation may be used instead of screws. Stress X-rays and / or CT scans maybe performed to confirm that the syndesmosis is stable. Stitches are placed to close the incision and the leg is then placed in a splint, cast or boot.

[0006] However, syndesmosis surgery is problematic. Medical literature commonly records difficulties with properly reducing and fixating a disruption of the syndesmosis. Improper reduction and fixation of the syndesmosis often arises with inaccurate placement of the syndesmosis implant. In cases where an implant is placed too anterior or posterior to the fibula or tibia (instead of being substantially centered), the fixation device can translate the fibula resulting in malreduction of the tibio-fibular joint.

[0007] Further, current techniques in syndesmosis surgery have additional limitations. Surgeons typically drill using solid drills to be able to insert the fixation implants such as screws and flexible fixations. This restricts the number of attempts a surgeon can make — in contrast with other joint repairs, in which a surgeon can use a K-wire to visually determine the proper trajectory, remove it and make corrections if needed, and then insert a cannulated screw over the guide wire once it is in the correct position. Therefore, surgeons often have limited numbers of attempts (sometimes only one, based on the quality of the bone) to drill and fix the syndesmotic joint. Also, the distance required to drill to depth is relatively large-the typical syndesmosis screw is around 40 mm, thus a small misalignment at the point of insertion can result in a significant malalignment further into the joint. Typically available operating room fluoroscopy is not sufficient to ensure that the drill is targeted at the center of the medial tibia before drilling. Finally, even after insertion of the implant, visual inspection for proper fixation is only practical through use of an expensive and cumbersome computed tomography (CT) scan process.Summary

[0008] In an aspect, alone or in combination with any other aspect, a device for indicating a centerline of a dual-component reference structure having a larger first component spaced apart from the device with a smaller second component interposed longitudinally therebetween is described. The device comprises a centerline guide having proximal and distal guide ends longitudinally separated by an elongate guide body. A first rotation arm has proximal and distal first arm ends longitudinally separated by an elongate first arm body. The first rotation arm includes a first arm throughbore extending longitudinally therethrough for selectivelyaccepting a first elongate wire. A second rotation arm has proximal and distal second arm ends longitudinally separated by an elongate second arm body. The second rotation arm includes a second arm throughbore extending longitudinally therethrough for selectively accepting a second elongate wire. An angular scale indicates, in a user-perceptible manner, an angular position of the first rotation arm and an angular position of the second rotation arm with respect to the centerline guide. The angular scale is affixed to the centerline guide. The distal first and second arm ends are pivotally attached to the distal guide end for pivotal movement substantially within a lateral-longitudinal plane into the respective angular positions. When the first and second elongate wires are inserted through the respective first and second arm throughbores and concurrently extend tangent to both the first and second components, the first and second elongate wires cross, when viewed from the transverse direction, at a crossing location longitudinally between the device and the second component. When the angular scale indicates that the angular positions of the first and second rotation arms with respect to the centerline guide are substantially the same, the centerline guide is selectively positioned substantially parallel to the centerline of the dual-component reference structure.

[0009] In an aspect, alone or in combination with any other aspect, a bisection angle device for indicating a centerline of a syndesmotic joint is described. The syndesmotic joint includes a fibula defining a fibular perimeter shape in a laterallongitudinal plane and a tibia defining a tibial perimeter shape in the laterallongitudinal plane. The device comprises a centerline guide having proximal and distal guide ends longitudinally separated by an elongate guide body. A first rotation arm has proximal and distal first arm ends longitudinally separated by an elongate first arm body. The first rotation arm includes a first arm throughbore extending longitudinally therethrough for selectively accepting a first elongate wire. A second rotation arm has proximal and distal second arm ends longitudinally separated by an elongate second arm body. The second rotation arm includes a second arm throughbore extending longitudinally therethrough for selectively accepting a second elongate wire. An angular scale indicates, in a user-perceptible manner, an angular position of the first rotation arm and an angular position of the second rotation arm with respect to the centerline guide. The angular scale is affixed to the centerline guide. The distal first and second arm ends are pivotally attached to the distal guide end for pivotal movement substantially within a lateral-longitudinal plane into therespective angular positions. When the first and second elongate wires are inserted through the respective first and second arm throughbores and concurrently extend tangent to both the fibular and tibial perimeter shapes, the first and second elongate wires cross, when viewed from the transverse direction, at a crossing location longitudinally between the device and the fibula. When the angular scale indicates that the angular positions of the first and second rotation arms with respect to the centerline guide are substantially the same, the centerline guide is selectively positioned substantially parallel to the centerline of the syndesmotic joint.

[0010] In an aspect, alone or in combination with any other aspect, a method for indicating a centerline of a syndesmotic joint is described. The syndesmotic joint includes a fibula defining a fibular perimeter shape in a lateral-longitudinal plane and a tibia defining a tibial perimeter shape in the lateral-longitudinal plane. The method comprises providing a device for indicating a centerline of a syndesmotic joint. The device includes a centerline guide having proximal and distal guide ends longitudinally separated by an elongate guide body. A first rotation arm has proximal and distal first arm ends longitudinally separated by an elongate first arm body. The first rotation arm includes a first arm throughbore extending longitudinally therethrough. A second rotation arm has proximal and distal second arm ends longitudinally separated by an elongate second arm body. The second rotation arm includes a second arm throughbore extending longitudinally therethrough. The distal first and second arm ends are pivotally attached to the distal guide end for pivotal movement substantially within a lateral-longitudinal plane into the respective angular positions. The method includes pivoting the first and second rotation arms into predetermined trajectories with respect to the syndesmotic joint. A first elongate wire is extended distalward through the first arm throughbore and tangent to both the fibular and tibial perimeter shapes on a second lateral side thereof, including adjusting the pivot of the first rotation arm into a first insertion angle, with respect to the centerline guide, to facilitate location of the first elongate wire in a tangent relationship with the tibia and fibula. A second elongate wire is extended distalward through the second arm throughbore and tangent to both the fibular and tibial perimeter shapes on a first lateral side thereof, including adjusting the pivot of the second rotation arm into a second insertion angle, with respect to the centerline guide, to facilitate location of the second elongate wire in a tangent relationship with the tibia and fibula. The first and second elongate wires are crossed, when viewedalong the transverse direction, at a crossing location located longitudinally between the device and the fibula. With the first and second elongate wires held in the tangent relationships with the tibia and fibula, the first and second insertion angles are adjusted with respect to the centerline guide. With the angular positions of the first and second rotation arms, held at the first and second insertion angles with respect to the centerline guide, being substantially the same, the centerline guide is responsively positioned substantially parallel to the centerline of the syndesmotic joint.Brief Description of the Drawings

[0011] For a better understanding, reference may be made to the accompanying drawings, in which:

[0012] Fig. 1A is a schematic partial cross-sectional view of an example use environment for an aspect of the present invention;

[0013] Fig. 1 B is a schematic partial perspective view of the example use environment of Fig. 1 A;

[0014] Fig. 2 schematically depicts an example aspect of the present invention in the example use environment of Figs. 1 A-1 B;

[0015] Fig. 3 is a schematic top view of the aspect of Fig. 2;

[0016] Fig. 4 is a schematic bottom view of the aspect of Fig. 2;

[0017] Fig. 5 is a schematic perspective side view of the aspect of Fig. 2;

[0018] Fig. 6 is a schematic rear view of the aspect of Fig. 2; and

[0019] Figs. 7-8 schematically depict a top view of a use sequence of the aspect of Fig. 2.Description of Aspects of the Disclosure

[0020] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of ordinary skill in the art to which the present disclosure pertains.

[0021] As used herein, the term “subject” can be used interchangeably with the term “patient” and refer to any warm-blooded organism including, but not limited to, human beings, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, farm animals, livestock, etc.

[0022] As used herein, the singular forms “a”, “an”, and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and / or “comprising”, as used herein, can specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0023] As used herein, the term “and / or” can include any and all combinations of one or more of the associated listed items.

[0024] It will be understood that when an element is referred to as being “on”, “attached” to, “connected” to, “coupled” with, “contacting”, “adjacent”, etc., another element, it can be directly on, attached to, connected to, coupled with, contacting, or adjacent the other element, or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on”, “directly attached” to, “directly connected” to, “directly coupled” with, “directly contacting”, or “directly adjacent” another element, there are no intervening elements present. It will also be appreciated by those of ordinary skill in the art that references to a structure or feature that is disposed “directly adjacent” another feature may have portions that overlap or underlie the adjacent feature, whereas a structure or feature that is disposed “adjacent” another feature might not have portions that overlap or underlie the adjacent feature.

[0025] Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description to describe one element or feature’s relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms can encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features.

[0026] As used herein, the phrase “at least one of X and Y” can be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element may, at a particular time, include X, Y, or a combination of X and Y, the selection of which could vary from time to time. In contrast, the phrase “at least one of X” can be interpreted to include one or more Xs.

[0027] It will be understood that, although the terms “first”, “second”, etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

[0028] The invention comprises, consists of, or consists essentially of the following features, in any combination.

[0029] Figs. 1 A-1 B depict a syndesmotic (A.K.A. “tibiofibular”) joint 100 of an ankle or lower leg area, with a tibia 102 and fibula 104 shown schematically. The fibula 104 defines a fibular perimeter shape FP in a lateral-longitudinal plane (coincident with the plane of the page, in the orientation of Fig. 1A, and labeled as “La-Lo” in the Figures) and the tibia 102 defines a tibial perimeter shape TP in the lateral-longitudinal plane. The “longitudinal” direction, as used herein, is shown schematically by arrow “Lo” in Fig. 1 A and extends along a centerline of the syndesmotic joint 100. The “lateral” direction, as used herein, is shown schematically by arrow “La” in Fig. 1 A and is substantially perpendicular to the longitudinal direction. In Fig. 1 A, lines have been drawn tangent to a first lateral side (toward the bottom / right, in the orientation of Fig. 1 A) of both the tibial and fibular perimeter shapes TP and FP, and tangent to a second lateral side (toward the top / left, in the orientation of Fig. 1 A) of both the tibial and fibular perimeter shapes TP and FP. An angle a is defined by these first and second lateral lines. When that angle a is bisected, or divided into two substantially equal halves (angles p, each having a value of 0.5a), then the resulting longitudinally extending bisection line BL has been found to lie substantially coincident with a centerline CL (A.K.A. centroidal axis) of the syndesmotic joint 100 as a whole. This quality is discussed in further detail in the articles “Cortices of Fibula and Tibia Can Provide Landmarks for Accurate Syndesmosis Fixation Angle: Computed Tomography Validation of Angle Bisector Method” (B. Karaismailoglu et al. I The Journal of Foot & Ankle Surgery 62 (2023) 788-791 , available at https: / / doi.Org / 10.1053 / j.jfas.2023.04.001 ) and “Angle bisector method to determine the accurate angle for tibiofibular syndesmotic fixation: A validation study with 3D-printed anatomical models” (B. Karaismailoglu, D.Yerlikaya, C. Ozdemir et al. I Foot and Ankle Surgery 29 (2023) 324-328, availableat https: / / doi.org / 10.1016 / j-fas.2023.04.008), both of which are incorporated by reference herein in their entirety, for all purposes.

[0030] Fig. 1 B shows a three-dimensional representation of the Fig. 1 A arrangement, with K-wires serving as the lines drawn tangent to the first and second lateral sides of both the tibial and fibular perimeter shapes TP and FP. (It should be noted that, though the tibial and fibular perimeter shapes TP and FP are labeled at the “cut planes” of the tibia 102 and fibula 104 in Fig. 1 B, the tibial and fibular perimeter shapes TP and FP can be considered as “cross-sections” of the tibia 102 and fibula 104 taken at any suitable transverse location along the syndesmotic joint 100. The “transverse” direction, as used herein, is substantially parallel to the long axes of the tibia 102 and fibula 104 and is perpendicular to both the lateral and longitudinal directions.

[0031] As would be understood by one of ordinary skill in the art, it may be useful to find the centerline CL of the syndesmotic joint 100 and pass a hardware component along that centerline CL in certain types of orthopedic surgery. For example, because surgical malreduction of a syndesmotic joint 100 can cause patient discomfort or other complications, it may be useful for a surgeon to be able to readily identify the centerline CL of the syndesmotic joint 100, drill therealong, and insert a fastener into the syndesmotic joint 100 along that centerline CL. This can be done with an intraoperative radiograph or other imaging, but using such a visual guidance aid can result in unwanted cost, time, radiation exposure, complexity, and other undesirable complications during the surgical procedure.

[0032] In order to facilitate the identification of the centerline CL for a particular patient and the insertion of a surgical hardware component along the centerline CL, optionally without the use of intraoperative imaging, Figs. 2-8 schematically depict a goniometric tool or jig, referenced herein as a bisection angle device 106 for indicating a centerline CL of a syndesmotic joint 100. While the device 106 can be used for indicating a centerline of any dual-component reference structure having a larger first component spaced apart from the device 106 with a smaller second component interposed longitudinally between the first component and the device 106, the remainder of this description will reference an example use environment having a syndesmotic joint 100 having a fibula 104 interposed longitudinally between a tibia 102 and the device 106 for ease of description. This is the situation shown schematically in Fig. 2.

[0033] Referring now to at least Figs. 3-6, the device 106 includes a centerline guide 108 having proximal and distal guide ends 110 and 112, respectively, longitudinally separated by an elongate guide body 114. With reference to Figs. 5-6, the centerline guide 108 may include a centerline bore 116 extending through the guide body 114, longitudinally between the proximal and distal guide ends 110 and 112. When present, the centerline bore 116 may selectively accept at least one of a surgical material-removal tool (e.g., the drill bit shown schematically at 118 in Fig. 2), a fastener, and a marker device longitudinally therethrough. The centerline bore 116 is selectively positioned substantially parallel to the centerline CL of the syndesmotic joint 100 during use of the device 106, as will be described below.

[0034] A first rotation arm 120 has proximal and distal first arm ends 122 and 124, respectively, longitudinally separated by an elongate first arm body 126. The first rotation arm 120 includes a first arm throughbore 128 (shown in at least Figs. 5-6) extending longitudinally therethrough for selectively accepting a first elongate wire 130. Fig. 1 B shows the first elongate wire 130 (as if it were extending through the first arm throughbore 128) concurrently held tangent to at least a portion of the outer perimeters of the tibia 102 and fibula.

[0035] A second rotation arm 132 has proximal and distal second arm ends 134 and 136, respectively, longitudinally separated by an elongate second arm body 138. The second rotation arm 132 includes a second arm throughbore 140 (shown in at least Figs. 5-6) extending longitudinally therethrough for selectively accepting a second elongate wire 142. Fig. 1 B shows the second elongate wire 142 (as if it were extending through the second arm throughbore 140) concurrently held tangent to at least a portion of the outer perimeters of the tibia 102 and fibula. As can be seen in at least Fig. 1 B, the first and second elongate wires 130 and 142 form an angle a therebetween, which can be bisected to indicate the centerline CL of the syndesmotic joint 100.

[0036] An angular scale 144 indicates, in a user-perceptible manner, an angular position of the first rotation arm 120 and an angular position of the second rotation arm 132 with respect to the centerline guide 108. The angular scale 144 is affixed to the centerline guide 108. For example, and as shown in at least Figs. 3-6, the angular scale 144 may include a plurality of incised lines showing angular measurements from a “zero” line which is coincident with a longitudinal axis of the centerline guide 108.

[0037] It is contemplated that angle measurement values, sequential symbols, or some other user-perceptible signifier could be used on the angular scale 144 to indicate “pairs” or incised lines symmetrically around the ’’zero” line. (E.g., incised lines could be provided + / - 30, 40, 50, 60, etc. degrees positive or negative-right or left— of the “zero” line.) One of ordinary skill in the art will recognize that formation of angle a and the subsequent bisection will provide the syndesmotic joint 100 centerline CL location-responsive to the first and second elongate wires 130 and 142 being positioned as in Fig. 1 B and extending through the first and second arm throughbores 128 and 140-when the angular position of the first rotation arm 120 with respect to the centerline guide 108 is arranged to be substantially equal to the angular position of the second rotation arm 132 with respect to the (same) centerline guide 108. The angular scale 144 is configured to assist the user with adjusting the device 106 to this position, as will be discussed in more detail below.

[0038] The distal first and second arm ends 124 and 136 are pivotally attached to the distal guide end 112 for pivotal movement substantially within a laterallongitudinal plane. This attachment may be direct or indirect. The pivotal movement of the first and second rotation arms 120 and 132 with respect to the centerline guide 108 facilitates placement of the first and second rotation arms 120 and 132 into the respective angular positions from which the angle a can be determined and used for the bisection scheme which is helpful in identifying the centerline CL of the syndesmotic joint 100.

[0039] An arc rail 146 may be provided to support at least one of the first and second arm bodies 126 and 138 during pivotal motion of the distal first and second arm ends 124 and 136 respective to the distal guide end 112. This support could be provided by the arc rail 146, or a related or component structure thereof, exerting (directly or indirectly) a transversely directed force to prevent the first and / or second arm bodies 126 and 138 from undesirable motion in the transverse direction during the pivotal motion, due to gravity, transmitted forces from the first and / or second elongate wires 130 and 142, user hand motions, or any other source.

[0040] The arc rail 146 may include one or more user-perceptible signifier of the angular position(s) of the first and second rotation arms 120 and 132 with respect to the centerline guide 108, such as the incised lines shown in the Figures. Like those of the angular scale 144, the signifier(s) of the arc rail 146 can be used to help theuser to “center” the centerline guide 108 symmetrically in a bisection orientation to angle a.

[0041] It is also contemplated that the arc rail 146 may be configured to guide the pivotal motion of at least one of the first and second arm bodies 126 and 138, in any suitable manner. For example, the arc rail 146 could include a groove and each of the first and second arm bodies 126 and 138 could include a protrusion configured to ride along the groove of the arc rail 146. One of ordinary skill in the art can readily provide a suitable mechanism to facilitate guiding of the pivotal motion of at least one of the first and second arm bodies 126 and 138 via the arc rail 146.

[0042] Similarly, one example of a suitable mechanical pivoting connection is provided and will now be described with reference to Figs. 4-6, though one of ordinary skill in the art will readily be able to attach the various components described herein together in order to achieve the functions of the device 106, without restriction by the present specification.

[0043] As shown in Figs. 4-6, a transversely extending pivot rod 148, defining a pivot axis PA, is operative to pivotally attach the distal first and second arm ends 124 and 126 (directly or indirectly) to the distal guide end 112. The arc rail 146, when present, may be attached to the pivot rod 148 as a convenient attachment point for affixation to the centerline guide 108. The pivot rod 148 shown in the Figures is threaded, to facilitate assembly and / or operation of the device 106, but could instead be at least partially smooth-surfaced.

[0044] Optionally, and also as shown in Figs. 4-6, the first and second rotation arms 120 and 132 may each be fixedly attached to a transversely oriented arm bushing 150. Each arm bushing 150, when present, may be interposed laterally between a corresponding one of the first and second rotation arms 120 and 132 and an other one of the first and second rotation arms 120 and 132. (That is, each of the first and second rotation arms 120 and 132 has an arm bushing on a side thereof laterally “facing” the other of the first and second rotation arms 120 and 132.) Each arm bushing 150, when present, pivotally attaches the corresponding first or second rotation arm 120 or 132 to the centerline guide 108 via the transversely extending pivot rod 148, defining the pivot axis PA. However, it is contemplated that the first and second rotation arms 120 and 132 could themselves be attached to the pivot rod 148 or any other suitable mechanism could be provided to facilitate pivotal motion ofthe first and second rotation arms 120 and 132 with respect to the centerline guide 108.

[0045] It should be noted that Fig. 2 includes a schematic depiction (at CoR) of the center of rotation of the device 106. This CoR location corresponds to the angular center defined by the device 106 as a whole, taking into account the pivot point (e.g., pivot axis PA) about which the first and second rotations arms 120 and 132 pivotally rotate. For many potential use environments, having the CoR located longitudinally between the tibia 102 and fibula 104 and along the centerline CL may be helpful in achieving a predetermined placement of the device 106, and thus of any orthopedic tool, hardware, and or fastener inserted with the aid of the device into the syndesmotic joint 100.

[0046] It can be seen in Figs. 5-6 that the first and second arm throughbores 128 and 140 may be mutually transversely offset, such as by being placed off-center within the first and second arm bodies 126 and 138. This asymmetry of the first and second arm throughbores 128 and 140 may be helpful, for example, in avoiding unwanted contact between the first and second elongate wires 130 and 142 as they cross one another upon extending distally from the device 106 (as shown in Figs. 1 B and 7-8) Another way this transverse offset of the throughbores 128 and 140 could be provided, for example, would be for the first and second rotation arms 120 and 132 to be transversely spaced from one another (even if only slightly) along the pivot rod 148--e.g., the pivot rod 148 could be sequentially passed through a transversely extending aperture (not shown) in each of the first and second rotation arms 120 and 132, thus “stringing” or “threading” the first and second rotation arms 120 and 132 directly onto the pivot rod 148. One of ordinary skill in the art could readily provide a device 106 having transversely offset throughbores 128 and 140 in any desired manner.

[0047] It is contemplated that a bisection mechanism (shown schematically at 152 in Fig. 4) may be provided to impose symmetrical pivotal movement, with respect to the centerline guide 108, upon a selected one of the first and second rotation arms 120 and 132 when an other one of the first and second rotation arms 120 and 132 is moved pivotally with respect to the centerline guide 108. That is, a rack-and-pinion, four-bar mechanism, pneumatic cylinder, or any other desired mechanism could be used to symmetrically rotate, e.g., the second rotation arm 132 outward or inward with respect to the centerline guide 108 a same angular amount responsive to, e.g.,the first rotation arm 120 being manually pivoted by a user. The symmetrical motion imposed by any such bisection mechanism may be helpful in quickly arranging the guide 106 into place with the centerline guide 108 being coincident with the centerline CL of the syndesmotic joint 100.

[0048] Finally, it is contemplated that any suitable lock (shown schematically at 154 in Fig. 3) could be provided to maintain the first and second rotation arms 120 and 132 in place, once angle a has been established, to prevent angle a from shifting position or angular value as the user manipulates the guide 106 through, e.g., insertion of an orthopedic tool (such as, but not limited to, a drill bit 118) through the centerline bore 116. At least one set screw, spring-biased jaw, cotter pin, magnetic link, expanding bushing, or any other desired mechanical component could be provided as a lock 154 in a particular use environment of the device 106.

[0049] As has been alluded to above, the device 106 can be used in conjunction with a method for indicating a centerline CL of a syndesmotic joint 100. As previously noted, the syndesmotic joint 100 includes a fibula 104 defining a fibular perimeter shape FP in a lateral-longitudinal plane and a tibia 102 defining a tibial perimeter shape TP in the lateral-longitudinal plane. In order to use the device 106 to indicate the centerline, the first and second rotation arms 120 and 132 are pivoted into predetermined trajectories with respect to the syndesmotic joint 100. This pivotal motion is shown in the sequence of Figs. 7-8.

[0050] The pivoting of the first and second rotation arms 120 and 132 into predetermined trajectories with respect to the syndesmotic joint 100 may include imposing symmetrical pivotal movement, with respect to the centerline guide 106, upon a selected one of the first and second rotation arms 120 and 132 when an other one of the first and second rotation arms 120 and 132 is moved pivotally with respect to the centerline guide. As previously discussed, this can be accomplished with the aid of a bisection mechanism, when present.

[0051] The first elongate wire 130 is extended distalward through the first arm throughbore 128 (as shown schematically in Fig. 8) and tangent to both the fibular and tibial perimeter shapes FP and TP on a second lateral side thereof (the lower left side of the syndesmotic joint 100, or approximately 6 to 9 o’clock), in the orientation of Fig. 8). This extension can include adjusting the pivot of the first rotation arm 120 into a first insertion angle, with respect to the centerline guide 108, to facilitatelocation of the first elongate wire 130 in a tangent relationship concurrently with both the tibia 102 and fibula 104.

[0052] Likewise, the second elongate wire 142 is extended distalward through the second arm throughbore 140 (as shown schematically in Fig. 8) and tangent to both the fibular and tibial perimeter shapes FP and TP on a first lateral side thereof (the lower right side of the syndesmotic joint 100, or approximately 3 to 6 o’clock, in the orientation of Fig. 8). This extension can include adjusting the pivot of the second rotation arm 132 into a second insertion angle, with respect to the centerline guide 108, to facilitate location of the second elongate wire 142 in a tangent relationship with the tibia 102 and fibula 104.

[0053] As a result of this extension of the first and second elongate wires 130 and 142 into the described tangential relationships, the first and second elongate wires 130 and 142 will cross, when viewed along the transverse direction, at a crossing location (“X”) located longitudinally between the device 106 and the fibula 104. Depending upon the specific structure of the device 106, the first and second elongate wires 130 and 142 might not actually touch one another, but instead will appear to intersect when viewed from above / below (i.e., along a tangent direction).

[0054] It should be noted that, responsive to various characteristics of the patient, the user, the device 106, the first and second elongate wires 130 and 142, or any other components of the system or actions thereof, the first and second insertion angles might not be symmetrical to one another when the first and second elongate wires 130 and 142 are first placed through the first and second throughbores 128 and 140. As a result, the centerline guide 108 may initially be canted or “crooked”, with respect to the centerline CL of the syndesmotic joint 100.

[0055] Accordingly, with the first and second elongate wires 130 and 142 held in the tangent relationships with the tibia 102 and fibula 104, the first and second insertion angles may be adjusted with respect to the centerline guide 108, as desired by a user. This may be accomplished with the aid of an angular scale 133, markings on an arc rail 146, a separately provided protractor or goniometer, a bisection mechanism 152, and / or in any other desired manner. Regardless of the adjustment mechanism, the device 106 then achieves the positioning shown in Fig. 8, with each of the first and second insertion angles being the same (i.e., angle P) with respect to the centerline guide 108.

[0056] With the angular positions of the first and second rotation arms 120 and 132, held at the first and second insertion angles with respect to the centerline guide (and extending tangent to both the tibial and fibular perimeter shapes TP and FP), being substantially the same (i.e., angle P), the centerline guide 108 responsively can be found to have achieved a position substantially parallel to the centerline CL of the syndesmotic joint 100.

[0057] In other words, when the first and second elongate wires 130 and 142 are inserted through the respective first and second arm throughbores 128 and 140 and concurrently extend tangent to both the fibular and tibial perimeter shapes FP and TP, then the first and second elongate wires 130 and 142 cross, when viewed from the transverse direction, at a crossing location X longitudinally between the device 106 and the fibula 104.

[0058] Once such a physical arrangement has been achieved, and once the angular scale 144 indicates that the angular positions of the first and second rotation arms 120 and 132 with respect to the centerline guide 108 are substantially the same, the centerline guide 108 will be selectively positioned substantially parallel to- and even colinear with-the centerline CL of the syndesmotic joint 100. The angles, bone shapes, and other characteristics of the syndesmotic joint 100 and the device 106 may be very different from one patient to another, but through use of the device 106 as a tool or jig, a “patient-specific” routing for the centerline guide 108 to indicate the centerline CL of the syndesmotic joint 100 in a rapid, simple, and repeatable manner without the use of expensive and inconvenient intra-operative imaging.

[0059] Once the device 106 has achieved the arrangement shown in Fig. 8, with the centerline guide 108 indicating, in a colinear or coaxial manner, the centerline CL of the syndesmotic joint 100 at that transverse position along the tibia 102 and fibula 104, then the user can selectively extend at least one of a surgical material-removal tool, a fastener, and a marker device longitudinally into, and at least partially through, the centerline bore 116.

[0060] With the centerline bore 1 16, the surgical material-removal tool, fastener, and / or marker device is guided along the centerline CL of the syndesmotic joint 100 responsive to the centerline guide 108 being positioned substantially parallel to the centerline CL of the syndesmotic joint 100. For example, a drill bit 118 could be inserted into the centerline bore 1 16 and guided thereby to create a drillhole in the syndesmotic joint 100, with the user having confidence that the drillhole is coincidentwith the centerline CL of the syndesmotic joint 100. The device 106 and / or the first and second elongate wires 130 and 142 can be removed from the surgical field, and a fastener inserted into the drillhole with confidence that the fastener is being installed along the centerline CL of the syndesmotic joint 100.

[0061] It is contemplated that, in certain use environments, the first and second elongate wires 130 and 142 could be inserted into the syndesmotic joint 100, in the tangent relationships shown in Figs. 1 A-1 B, before the first and second elongate wires 130 and 142 come to extend through the first and second throughbores 128 and 140. That is, the device 106 could be “threaded / passed onto” the first and second elongate wires 130 and 142 (already inserted into the positions shown in Figs. 1A-1 B). One of ordinary skill in the art will understand how the device 106 could be used to indicate the centerline CL of the syndesmotic joint 100 regardless of the order in which the steps disclosed herein have been carried out.

[0062] While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means / options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and / or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to thatcomponent, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status. The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified-a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.

[0063] Other aspects, objects, and advantages can be obtained from a study of the drawings, the disclosure, and the appended claims.

Claims

We claim:1 . A device for indicating a centerline of a dual-component reference structure having a larger first component spaced apart from the device with a smaller second component interposed longitudinally therebetween, the device comprising: a centerline guide having proximal and distal guide ends longitudinally separated by an elongate guide body; a first rotation arm having proximal and distal first arm ends longitudinally separated by an elongate first arm body, the first rotation arm including a first arm throughbore extending longitudinally therethrough for selectively accepting a first elongate wire; a second rotation arm having proximal and distal second arm ends longitudinally separated by an elongate second arm body, the second rotation arm including a second arm throughbore extending longitudinally therethrough for selectively accepting a second elongate wire; and an angular scale indicating, in a user-perceptible manner, an angular position of the first rotation arm and an angular position of the second rotation arm with respect to the centerline guide, the angular scale being affixed to the centerline guide; wherein the distal first and second arm ends are pivotally attached to the distal guide end for pivotal movement substantially within a lateral-longitudinal plane into the respective angular positions; and wherein, when the first and second elongate wires are inserted through the respective first and second arm throughbores and concurrently extend tangent to both the first and second components, the first and second elongate wires crossing, when viewed from the transverse direction, at a crossing location longitudinally between the device and the second component, and when the angular scale indicates that the angular positions of the first and second rotation arms with respect to the centerline guide are substantially the same, the centerline guide is selectively positioned substantially parallel to the centerline of the dual-component reference structure.

2. The device of claim 1 , wherein the centerline guide includes a centerline bore extending longitudinally between the proximal and distal guide ends, the centerline bore selectively accepting at least one of a surgical material-removal tool, a fastener, and a marker device longitudinally therethrough, the centerline bore being selectively positioned substantially parallel to the centerline of the dualcomponent reference structure.

3. The device of claim 1 , including a pivot rod, defining a pivot axis, operative to pivotally attach the distal first and second arm ends to the distal guide end.

4. The device of claim 1 , including an arc rail supporting at least one of the first and second arm bodies during pivotal motion of the distal first and second arm ends respective to the distal guide end.

5. The device of claim 3, including an arc rail transversely supporting at least one of the first and second arm bodies during pivotal motion of the distal first and second arm ends respective to the distal guide end, the arc rail being attached to the pivot rod.

6. The device of claim 5, wherein the arc rail guides the pivotal motion of at least one of the first and second arm bodies.

7. The device of claim 1 , wherein the first and second arm throughbores are mutually transversely offset.

8. The device of claim 1 , wherein the first and second rotation arms are each fixedly attached to a transversely oriented arm bushing, each arm bushing being interposed laterally between a corresponding one of the first and second rotation arms and an other one of the first and second rotation arms, with each arm bushing pivotally attaching the corresponding first or second rotation arm to the centerline guide via a transversely extending pivot rod, defining a pivot axis.

9. The device of claim 1 , including a bisection mechanism imposing symmetrical pivotal movement, with respect to the centerline guide, upon a selected one of the first and second rotation arms when an other one of the first and second rotation arms is moved pivotally with respect to the centerline guide.

10. A bisection angle device for indicating a centerline of a syndesmotic joint, the syndesmotic joint including a fibula defining a fibular perimeter shape in a lateral-longitudinal plane and a tibia defining a tibial perimeter shape in the laterallongitudinal plane, the device comprising: a centerline guide having proximal and distal guide ends longitudinally separated by an elongate guide body; a first rotation arm having proximal and distal first arm ends longitudinally separated by an elongate first arm body, the first rotation arm including a first arm throughbore extending longitudinally therethrough for selectively accepting a first elongate wire; a second rotation arm having proximal and distal second arm ends longitudinally separated by an elongate second arm body, the second rotation arm including a second arm throughbore extending longitudinally therethrough for selectively accepting a second elongate wire; and an angular scale indicating, in a user-perceptible manner, an angular position of the first rotation arm and an angular position of the second rotation arm with respect to the centerline guide, the angular scale being affixed to the centerline guide; wherein the distal first and second arm ends are pivotally attached to the distal guide end for pivotal movement substantially within a lateral-longitudinal plane into the respective angular positions; and wherein, when the first and second elongate wires are inserted through the respective first and second arm throughbores and concurrently extend tangent to both the fibular and tibial perimeter shapes, the first and second elongate wires crossing, when viewed from the transverse direction, at a crossing location longitudinally between the device and the fibula, and when the angular scale indicates that the angular positions of the first and second rotation arms with respect to the centerline guide are substantially the same, the centerline guide is selectively positioned substantially parallel to the centerline of the syndesmotic joint.1 1 . The device of claim 10, wherein the centerline guide includes a centerline bore extending longitudinally between the proximal and distal guide ends, the centerline bore selectively accepting at least one of a surgical material-removal tool, a fastener, and a marker device longitudinally therethrough, the centerline bore being selectively positioned substantially parallel to the centerline of the syndesmotic joint.

12. The device of claim 10, wherein the first and second arm throughbores are mutually transversely offset to facilitate crossing of the first and second elongate wires when views in the transverse direction while avoiding contact between the first and second elongate wires at the crossing location.

13. The device of claim 1 , including a bisection mechanism imposing symmetrical pivotal movement, with respect to the centerline guide, upon a selected one of the first and second rotation arms when an other one of the first and second rotation arms is moved pivotally with respect to the centerline guide.

14. A method for indicating a centerline of a syndesmotic joint, the syndesmotic joint including a fibula defining a fibular perimeter shape in a laterallongitudinal plane and a tibia defining a tibial perimeter shape in the laterallongitudinal plane, the method comprising: providing a device for indicating a centerline of a syndesmotic joint, the device including: a centerline guide having proximal and distal guide ends longitudinally separated by an elongate guide body, a first rotation arm having proximal and distal first arm ends longitudinally separated by an elongate first arm body, the first rotation arm including a first arm throughbore extending longitudinally therethrough, and a second rotation arm having proximal and distal second arm ends longitudinally separated by an elongate second arm body, the second rotation arm including a second arm throughbore extending longitudinally therethrough,the distal first and second arm ends being pivotally attached to the distal guide end for pivotal movement substantially within a lateral-longitudinal plane into the respective angular positions; pivoting the first and second rotation arms into predetermined trajectories with respect to the syndesmotic joint; extending a first elongate wire distalward through the first arm throughbore and tangent to both the fibular and tibial perimeter shapes on a second lateral side thereof, including adjusting the pivot of the first rotation arm into a first insertion angle, with respect to the centerline guide, to facilitate location of the first elongate wire in a tangent relationship with the tibia and fibula; extending a second elongate wire distalward through the second arm throughbore and tangent to both the fibular and tibial perimeter shapes on a first lateral side thereof, including adjusting the pivot of the second rotation arm into a second insertion angle, with respect to the centerline guide, to facilitate location of the second elongate wire in a tangent relationship with the tibia and fibula; crossing the first and second elongate wires, when viewed along the transverse direction, at a crossing location located longitudinally between the device and the fibula; with the first and second elongate wires held in the tangent relationships with the tibia and fibula, adjusting the first and second insertion angles with respect to the centerline guide; and with the angular positions of the first and second rotation arms, held at the first and second insertion angles with respect to the centerline guide, being substantially the same, responsively positioning the centerline guide substantially parallel to the centerline of the syndesmotic joint.

15. The method of claim 14, including providing the centerline guide with a centerline bore extending longitudinally between the proximal and distal guide ends, selectively extending at least one of a surgical material-removal tool, a fastener, and a marker device longitudinally through the centerline bore, and with the centerline bore, guiding the at least one of the surgical materialremoval tool, the fastener, and the marker device along the centerline of thesyndesmotic joint responsive to the centerline guide being positioned substantially parallel to the centerline of the syndesmotic joint.

16. The method of claim 14, wherein pivoting the first and second rotation arms into predetermined trajectories with respect to the syndesmotic joint includes imposing symmetrical pivotal movement, with respect to the centerline guide, upon a selected one of the first and second rotation arms when an other one of the first and second rotation arms is moved pivotally with respect to the centerline guide.

17. The method of claim 14, including providing the device with an angular scale affixed to the centerline guide, the angular scale indicating, in a user- perceptible manner, an angular position of the first rotation arm and an angular position of the second rotation arm with respect to the centerline guide, the method including with the angular scale indicating that the angular positions of the first and second rotation arms, held at the first and second insertion angles with respect to the centerline guide, are substantially the same, responsively positioning the centerline guide substantially parallel to the centerline of the syndesmotic joint.

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