Total Ankle Replacement Alignment Reference Wings and Sizing Guide

Abstract

A device comprising: a reference wing having a first end and a second end opposite the first end, each of the first end and second end of the reference wing including a plurality of through holes; an ablation profile configured to be removably coupled to the reference wing between the first end and the second end; and a lateral rod configured to be removably coupled to the reference wing via the plurality of through holes.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of priority to U.S. Provisional Application No. 63 / 301,840, entitled "Total Ankle Replacement Alignment Reference Wing and Sizing Guides," filed January 21, 2022, the contents of which are incorporated by reference herein in their entirety. [Background technology]

[0002] In total ankle replacement (TAR) arthroplasty, surgeons size and position tibial and talar implants in anterior-posterior (AP) and lateral views relative to both the natural bone anatomy and joint line. Additionally, surgeons need to be able to do this while ensuring they are seeing a true view of the bone anatomy. The present disclosure provides a system for sizing and positioning ankle implants. Summary of the Invention [Means for solving the problem]

[0003] The present disclosure includes tools to assist in sizing and positioning ankle implants.

[0004] Among other things, the present disclosure includes a system that assists in the alignment of the TAR External Adjustment Guide and the K-wire placement required to secure the bone resection block. Under fluoroscopy, the fiducial wings and associated attachments indicate the bone resection profile and overall implant placement location. When proper alignment is present, the fiducial wings and attachments will form a thin line profile that only indicates its thickness under fluoroscopy. A secondary alignment check is present when the horizontal lines of the resection profile and the vertical lines of the fiducial profile intersect to form a crosshair. The fiducial wings connect to the TAR External Adjustment Guide without the need to manually engage mechanical fasteners, allowing lateral guides and different sized implant outline guides to be attached to the wings without manually engaging mechanical fasteners. The quick connect feature is designed to be infinitely adjustable in the anterior-posterior direction while providing sufficient force to hold the mating attachments in place during the alignment technique.

[0005] The system described herein not only allows the surgeon to assess varus / valgus rotation in the anterior-posterior plane and flexion / extension rotation in the sagittal plane, it also allows the surgeon to determine implant size and position for both the tibia and talus individually, and also as linked cuts relative to the joint line.

[0006] In existing systems, reference alignment wings are used for both varus / valgus and coronal alignment. However, these existing systems do not provide bone resection lines or implant sizing reference lines to indicate implant placement as part of the alignment wings. Also, existing systems rely on mechanical attachment mechanisms that do not allow infinite adjustment in the anterior-posterior direction. Conventional alignment wings indicate only the superior tibial cut, whereas the presently disclosed system allows the surgeon to check the superior tibial cut along with the implant medial-lateral sizing in the anterior view, as well as the resection height for the tibial and talar resections in the lateral view.

[0007] Thus, in a first aspect, the device includes a reference wing having a first end and a second end opposite the first end. Each of the first and second ends of the reference wing includes a plurality of through holes. The device further includes an ablation profile configured to be removably coupled to the reference wing between the first and second ends. The device further includes a lateral rod configured to be removably coupled to the reference wing via the plurality of through holes.

[0008] In another aspect, the present disclosure provides a device including a gutter sword, the gutter sword including a flat portion configured to be positioned between a patient's tibia and talus, and an elongated rod extending from the flat portion. The device also includes a link, the link including a first through hole configured to receive the elongated rod of the gutter sword and a plurality of second through holes extending away from the first through hole. The device also includes a pin alignment guide including the rod, the rod configured to be positioned in one of the plurality of second through holes of the link. The pin alignment guide includes one or more through holes, the one or more through holes configured to receive one or more pins therethrough.

[0009] In another embodiment, the kit may comprise a device of the first embodiment and a device of the second embodiment.

[0010] In yet another aspect, a method of preparing a tibia for an implant can include the steps of positioning a pin in a patient's tibia; positioning an external adjustment guide over the pin; removably coupling a reference wing to the external adjustment guide; removably coupling a resection profile to the reference wing; adjusting a position of the resection profile relative to the tibia via the external adjustment guide; and resecting a portion of the tibia using the resection profile as a guide. [Brief description of the drawings]

[0011] [Figure 1] FIG. 1 is a perspective view of an exemplary device. [Diagram 2] FIG. 2 is an exploded view of the exemplary device of FIG. 1. [Diagram 3] 2 is a perspective view of a reference wing of the exemplary device of FIG. 1. [Figure 4] 2 is a top cross-sectional view of a reference wing of the exemplary device of FIG. 1. [Diagram 5]2 is a perspective view of an ablation profile of the exemplary device of FIG. 1. [Figure 6] 2 is a front view of an ablation profile of the exemplary device of FIG. 1. [Figure 7] 2 is a side view of an ablation profile of the exemplary device of FIG. 1. [Figure 8] FIG. 13 is a front view of a plastic block of another exemplary cut profile. [Figure 9] FIG. 9 is a perspective view of a plastic block of the ablation profile of FIG. 8. [Figure 10] FIG. 9 is a front view of the metal insert of the cut profile of FIG. 8. [Figure 11] 11 is a front view of the assembled ablation profile with the metal insert of FIG. 10 positioned within the plastic block of FIG. 8. FIG. [Figure 12] 2 is a side view of a reference wing of the example device of FIG. 1 illustrating vertical alignment lines. [Figure 13] 2 is a side view of an ablation profile of the exemplary device of FIG. 1 illustrating the horizontal reference line. [Figure 14] 2 is a side view of an ablation profile placed on the reference wing of the exemplary device of FIG. 1, illustrating that the vertical alignment line of the reference wing and the horizontal reference line of the ablation profile form a crosshair. [Figure 15] FIG. 2 is a biplane perspective view of a lateral rod of the exemplary device of FIG. 1. [Figure 16] FIG. 16 is a perspective view of the biplane of FIG. 15 being positioned through a reference wing of the exemplary device of FIG. 1 prior to coupling with a lateral blade. [Figure 17] 2 is a perspective view of a lateral blade of a lateral rod of the exemplary device of FIG. 1. FIG. [Figure 18] FIG. 18 is a side cross-sectional view of the lateral blade of FIG. 17. [Figure 19] 2 is an anterior-posterior view of a block configured to be removably coupled to a lateral rod of the exemplary device of FIG. 1. [Figure 20] FIG. 20 is a sagittal view of the block of FIG. 19. [Figure 21] 20 is an anterior-posterior view of the block of FIG. 19 coupled to the device of FIG. 1 and positioned adjacent the ankle anatomy. [Figure 22] FIG. 20 is a sagittal view of the block of FIG. 19 coupled to the device of FIG. 1 and positioned adjacent to the ankle anatomical structure. [Figure 23] FIG. 1 illustrates a device for initial pin alignment being positioned adjacent to the ankle anatomical structure. [Figure 24] FIG. 1 illustrates another device for initial pin alignment. [Diagram 25] FIG. 1 illustrates an alignment system including an external adjustment guide and reference wings positioned adjacent the ankle anatomical structure. [Figure 26] FIG. 26 illustrates a knee clamp of the alignment system of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 1-2 show a device 100. The device 100 includes a reference wing 102, an ablation profile 104, and a lateral rod 106. The lateral rod 106 includes a biplane 108 that is removably coupled to a lateral blade 110. As shown in FIGS. 1-2, the reference wing 102 is made from a semicircular blade with a plurality of through holes 112 at each of a first end 111 and a second end 113 of the reference wing 102 to mate with the lateral rod 106.

[0013] 4 illustrates the reference wing 102 including a first cannulated rod 114 and a second cannulated rod 115 positioned between the first end 111 and the second end 113 of the reference wing, respectively. The ablation profile 104 includes a first rod 120 and a second rod 121 configured to fit within the first cannulated rod 114 and the second cannulated rod 115 of the reference wing 102, thereby removably coupling the ablation profile 104 to the reference wing 102. In one example, the first cannulated rod 114 and the second cannulated rod 115 each include a canted coil spring 116. The reference wings 102 are connected to the ablation profile 104 without the need to manually engage mechanical fasteners, allowing a variety of ablation profiles to be attached to the reference wings 102 without manually engaging mechanical fasteners. The quick connect feature is designed to be infinitely adjustable in the anterior-posterior direction while providing sufficient force to hold the ablation profile 104 in place during alignment techniques. As shown in Figures 5-7, the ablation profile 104 is created by a thin wall 118 that outlines the area of ​​the anatomy to be resected. The ablation profile 104 includes a first rod 120 and a second rod 121 that mate with a canted coil spring 116 on the reference wings 102.

[0014] The device 100 may further include an external adjustment guide 103 configured to be removably coupled to the reference wing 102 between the first end 111 and the second end 113 of the reference wing 102. The external adjustment guide 103 is configured to be positioned on a first side of the reference wing 102, and the ablation profile 104 is configured to be positioned on a second side of the reference wing 102, as shown in FIGS. 1-2. As described above, the reference wing 102 may include a first cannulated rod 114 and a second cannulated rod 115 positioned between the first end 111 and the second end 113 of the reference wing 102, respectively. The external adjustment guide 103 can include a first hole 117 and a second hole 119 that are configured to receive the first cannulated rod 114 and the second cannulated rod 115 of the reference wing 102, thereby removably connecting the external adjustment guide 103 to the reference wing 102. In one example, the first hole 117 and the second hole 119 each include a canted coil spring. As such, the reference wing 102 is connected to the external adjustment guide 103 without the need to manually engage mechanical fasteners, allowing lateral guides and different sized implant outline guides to be attached to the reference wing 102 without manually engaging mechanical fasteners. The quick connect feature is designed to be infinitely adjustable in the anterior-posterior direction while providing sufficient force to hold the external adjustment guide 103 in place during alignment techniques.

[0015] Another variation of the above resection profile 104 is shown in Figures 8-11. In particular, Figures 8-11 illustrate a two-piece assembly attached by threaded fasteners. The first piece is a plastic block 122 capable of receiving a metal insert 124 that is the shape profile of the TAR bone cut. The metal insert 124 can show the tibial cut, the talar cut, and even the joint line in the AP view. The metal insert 124 may or may not include fluoroscopic alignment features. Additionally, the metal insert 124 may or may not include on-axis and off-axis k-wire holes for pinning the plastic block 122 to the bone. Additionally, the plastic block 122 can include attachment features (not shown) that allow it to connect to the fiducial wing 102. The metal insert 124 is not pressed into the plastic block 122. Instead, the metal insert 124 is placed on top of the plastic block 122 and secured by a fastener. By fastening the metal insert 124 to the plastic block 122 via fasteners, residual stresses from press-fit pins or from metal expansion contacts during sterilization can be avoided.

[0016] FIG 12 is a side view of a portion of reference wing 102 illustrating vertical alignment line 126. FIG 13 is a side view of ablation profile 104 illustrating horizontal alignment line 128. FIG 14 is a side view of ablation profile 104 placed on reference wing 102 illustrating that vertical alignment line 126 of reference wing 102 and horizontal alignment line 128 of the ablation profile form crosshairs 130. As shown in FIG 4, when ablation profile 104 is placed on reference wing 102, crosshairs 130 allow a user to visualize a true forward view of device 100.

[0017] As explained above, the lateral rod 106 can be split into two components (the biplane 108 and the lateral blade 110) that mate together with the reference wing 102. As shown in Fig. 15, the biplane 108 can include two horizontal blades 132, 134 and a vertical blade 136. The two horizontal blades 132, 134 represent the superior talar resection and the natural joint line, respectively.

[0018] 16 is a perspective view of the biplane 108 being positioned through the reference wing 102 prior to coupling with the lateral blade 110. As shown in FIG. 16, the biplane 108 can include a feature that matches the holes 112 on the reference wing 102 and further matches the mating hole 138 of the lateral blade 110. The feature can prevent rotation of the biplane 108 relative to the reference wing 102 when the feature is positioned through one of the holes 112.

[0019] Figure 17 is a perspective view of the lateral blade 110 of the lateral rod 106, and Figure 18 is a side cross-sectional view of the lateral blade 110. As shown in Figure 18, the mating hole 138 of the lateral blade 110 can include a canted coil spring 140 that will hold the biplane 108 in place over the reference wing 102. The lateral blade 110 has a narrow blade profile that aligns with the tibial axis in use.

[0020] 19-22 illustrate another exemplary component that may be removably coupled to the lateral blade 110 in place of the biplane 108. As shown in FIGS. 19-22, a block 142 is shown with k-wire holes 144. The block 142 is attached to the reference wing 102 in a similar manner as the biplane 108 (e.g., via the canted coil spring 116 of the lateral blade 110). The k-wire holes 144 are located such that they reference the joint lines and talus cuts of multiple sizes of implants. In one example, the tibial cuts can be referenced by the block 142. In another example, the tibial cuts are indicated by the reference wing 102. The block 142 can be made of a material that is transparent under fluoroscopy (i.e., radel, etc.) and can be used to identify different sizes of talus flat cuts, chamfer cuts, or both.

[0021] Figure 19 illustrates an anterior-posterior view of block 142. Figure 20 illustrates a sagittal view of block 142. Figure 21 illustrates an anterior-posterior view of block 142 coupled to lateral blade 110 and positioned adjacent the ankle anatomy. Figure 22 illustrates a sagittal view of the block of Figure 19 coupled to lateral blade 110 and positioned adjacent the ankle anatomy.

[0022] FIG. 23 illustrates a device 150 for initial pin alignment positioned adjacent ankle anatomical structures. As shown in FIG. 23, the device 150 includes a gutter sword 152 including a flat portion 154 configured to be positioned between a patient's tibia 156 and talus 158 and an elongated rod 160 extending from the flat portion 154. The device 150 further includes a link 162 including a first through hole 164 configured to receive the elongated rod 160 of the gutter sword 152 and a plurality of second through holes 166 extending away from the first through hole 164 at various distances. The device 150 further includes a pin alignment guide 168 including a rod 170 configured to be positioned within one of the plurality of second through holes 166 of the link 162. The pin alignment guide 168 includes one or more through holes 172 configured to receive one or more pins therethrough. Figure 24 illustrates another variation of a device 150 for initial pin alignment.

[0023] FIG. 25 illustrates an alignment system 200 including an external adjustment guide 103 and a reference wing 102 positioned adjacent to the ankle anatomy. As shown in FIG. 25, the alignment system 200 further includes a rod 202 extending from the external adjustment guide 103 to a knee clamp 204. As shown in FIG. 26, the knee clamp 204 can include a first arm 206 and a second arm 208 that can open to various diameters based on the patient's anatomy. As further shown in FIG. 26, the first arm 206 can include a first portion 207 and a second portion 209 that are rotatably coupled to one another via a first pin joint 210, and the second arm 208 can include a first portion 211 and a second portion 213 that are rotatably coupled to one another via a second pin joint 212.

[0024] Also disclosed is a kit for resecting a tibia, the kit including device 100 and device 150 as described herein.

[0025] The methods disclosed herein can be used with any of the device 100, device 150, and kit embodiments as described herein.

[0026] A method of preparing the tibia for an implant includes the steps of positioning a pin in the patient's tibia, positioning an external adjustment guide over the pin, removably connecting a reference wing 102 to the external adjustment guide 103, removably connecting a resection profile 104 to the reference wing 102, adjusting a position of the resection profile 104 relative to the tibia via the external adjustment guide 103, and resecting a portion of the tibia using the resection profile 104 as a guide.

[0027] It should be understood that the arrangements described herein are for illustrative purposes only. As such, those skilled in the art will recognize that other arrangements and other elements (e.g., machines, interfaces, functions, orders, and groupings of functions) can be used instead, and some elements can be omitted entirely depending on the desired results. Furthermore, many of the described elements are functional entities that can be implemented in any suitable combination and location, as discrete or distributed components, or in conjunction with other components, or other structural elements described as separate structures can be combined.

[0028] Although various aspects and examples have been disclosed herein, other aspects and examples will be apparent to those skilled in the art. The various aspects and examples disclosed herein are for illustrative purposes only and are not intended to be limiting, with the true scope being set forth in the following claims, along with the full scope of equivalents to which such claims are entitled. It should also be understood that the terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting.

[0029] Exemplary methods and systems are described herein. It should be understood that the words "example," "exemplary," and "illustrative" are used herein to mean "serving as an example, instance, or illustration." Any example or feature described herein as being "example," "exemplary," or "for illustrative purposes" is not necessarily to be construed as preferred or advantageous over other examples or features. The examples described herein are not meant to be limiting. It will be readily understood that aspects of the present disclosure, as generally described herein and as illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are expressly contemplated herein.

[0030] Moreover, the particular arrangements shown in the figures should not be seen as limiting. It should be understood that other examples can include more or less of each element shown in a given figure. Further, some of the elements shown may be combined or omitted. Furthermore, examples can include elements not shown in the figures.

[0031] In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which may be practiced without some or all of these details. In other instances, details of well-known devices and / or processes have been omitted to avoid unnecessarily obscuring the present disclosure. While some concepts will be described in conjunction with specific examples, it will be understood that these examples are not intended to be limiting.

[0032] As used herein, "coupled" means directly associated and indirectly associated. For example, member A can be directly associated with member B or indirectly associated thereto, for example, through another member C. It will be understood that not all relationships between the various disclosed elements are necessarily represented.

[0033] Unless otherwise indicated, terms such as "first," "second," and the like are used herein merely as labels and are not intended to impose any sequential, positional, or hierarchical requirements on the items to which they refer. Moreover, a reference to, for example, a "second" item does not require or preclude the presence of, for example, a "first" or lower-numbered item, and / or, for example, a "third" or higher-numbered item.

[0034] Reference herein to "one embodiment" or "one example" means that one or more features, structures, or characteristics described in connection with the example are included in at least one implementation. The phrases "one embodiment" or "one example" in various places throughout this specification may or may not be referring to the same example.

[0035] As used herein, a system, apparatus, structure, article, element, component, or hardware that is "configured to" perform a particular function is in fact capable of performing the particular function without modification, rather than merely having the potential to perform the particular function after further modification. In other words, a system, apparatus, structure, article, element, component, or hardware that is "configured to" perform a particular function is specifically selected, generated, implemented, utilized, programmed, and / or designed for the purpose of performing the particular function. As used herein, "configured to" refers to an existing attribute of a system, apparatus, structure, article, element, component, or hardware that enables the system, apparatus, structure, article, element, component, or hardware to perform a particular function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware that is described as "configured to" perform a particular function can additionally or alternatively be described as "adapted to" perform that function and / or as "operable to" perform that function.

[0036] The following claim limitations are not written in means-plus-function form and are not intended to be interpreted under 35 U.S.C. 112(f), unless such claim limitation expressly uses the phrase "means for" followed by a statement of function devoid of further structure.

[0037] The terms "about," "approximately," or "substantially" with respect to amounts or measurements described herein mean that the stated characteristic, parameter, or value need not be exactly achieved, but rather that deviations or variations (including, for example, tolerances, measurement errors, limits of measurement precision, and other factors known to those of skill in the art) may occur in an amount that does not interfere with the effect that the characteristic is intended to provide. For example, in one embodiment, the term "about" can refer to ±5% of a given value.

[0038] For illustrative purposes, non-exhaustive examples of subject matter in accordance with the present disclosure (which may or may not be claimed) are provided below. [Explanation of symbols]

[0039] 100 devices 102 Reference Wing 103 External Adjustment Guide 104 Ablation Profile 106 Lateral Rod 108 Biplane 110 Lateral Blade 111 First end 112 Through hole 113 Second End 114 First cannulated rod 115 Second cannulated rod 116 Canted coil spring 117 First Hole 119 Second Hole 118 Thin Wall 120 First Rod 121 Second Rod 122 Plastic Block 124 Metal Insert 126 Vertical Alignment Lines 128 Horizontal Alignment Lines 130 Crosshairs 132 Horizontal Blade 134 Horizontal Blade 136 Vertical Blade 138 Fitting hole 140 Canted coil spring 142 blocks 144 k-wire hole 150 devices 152 Gutter Sword 154 Flat area 156 Tibia 158 Talus 160 Rod 162 Links 164 First Through Hole 166 Second Through Hole 168 Pin Alignment Guide 170 Rod 172 Through hole 200 Alignment System 202 Rod 204 Knee Clamp 206 First Arm 207 First Part 208 Second Arm 209 Second Part 210 First Pin Joint 211 First Part 212 Second Pin Joint 213 Second Part

Claims

1. a reference wing having a first end and a second end opposite the first end, each of the first end and the second end of the reference wing including a plurality of through holes; an ablation profile configured to be removably coupled to the reference wing between the first end and the second end; a lateral rod configured to be removably coupled to the reference wing through the plurality of through holes; Including, the device.

2. The device of claim 1 , wherein the reference wing is semicircular.

3. 3. The device of claim 1 or 2, wherein the lateral rod comprises a biplane that is removably connected to a lateral blade.

4. the biplane includes a first horizontal blade, a second horizontal blade, and a vertical blade; The device of claim 3 , wherein the first horizontal blade and the second horizontal blade represent a superior talar resection and a natural joint line, respectively.

5. 5. The device of claim 3 or 4, wherein the biplane includes a geometric feature that matches the plurality of through holes on the reference wing and further matches a mating hole in the lateral blade, the geometric feature preventing rotation of the biplane relative to the reference wing when the geometric feature is positioned through one of the plurality of through holes in the lateral blade.

6. 6. The device of claim 5, wherein the mating hole in the lateral blade includes a canted coil spring for removably connecting the lateral blade to the biplane.

7. 7. The device of claim 1, wherein the reference wing includes a first cannulated rod and a second cannulated rod positioned between the first end and the second end of the reference wing, respectively, and the ablation profile includes a first rod and a second rod configured to fit within the first cannulated rod and the second cannulated rod of the reference wing, thereby removably coupling the ablation profile to the reference wing.

8. 8. The device of claim 7, wherein the first cannulated rod and the second cannulated rod each include a canted coil spring.

9. 9. The device of claim 1, further comprising an external adjustment guide configured to be removably coupled to the reference wing between the first end and the second end, the external adjustment guide configured to be positioned on a first side of the reference wing, and the ablation profile configured to be positioned on a second side of the reference wing.

10. 10. The device of claim 9, wherein the reference wing includes a first cannulated rod and a second cannulated rod positioned between the first end and the second end of the reference wing, respectively, and the external adjustment guide includes a first hole and a second hole configured to receive the first cannulated rod and the second cannulated rod of the reference wing, thereby removably coupling the external adjustment guide to the reference wing.

11. 11. The device of claim 10, wherein the first bore and the second bore each include a canted coil spring.

12. The ablation profile comprises: With plastic blocks; a metal insert configured to be positioned within the plastic block, the metal insert being coupled to the plastic block via one or more fasteners; 12. The device according to claim 1 , comprising:

13. The device of claim 12 , wherein the metal insert includes one or more radioscopic alignment features.

14. 14. The device of claim 1, wherein the reference wing includes a vertical alignment line and the ablation profile includes a horizontal alignment line, the vertical alignment line and the horizontal alignment line together forming a crosshair when the ablation profile is removably coupled to the reference wing, thereby visualizing a true anterior view of the device.

15. 15. The device of any one of claims 1 to 14, wherein the lateral rod includes a lateral blade removably coupled to a block, the block including joint lines corresponding to multiple sizes of implants and multiple k-wire holes corresponding to multiple talar cuts.

16. a gutter sword including a flat portion configured to be positioned between a patient's tibia and talus and an elongated rod extending from the flat portion; a link including a first through hole configured to receive the elongated rod of the gutter sword and a plurality of second through holes extending away from the first through hole at various distances; a pin alignment guide including a rod, the rod configured to be positioned within one of the plurality of second through holes of the link, the pin alignment guide including one or more through holes configured to receive one or more pins therethrough; Including, the device.

17. A device according to any one of claims 1 to 15; A device according to claim 16. Including the kit.

18. 1. A method of preparing a tibia for an implant, the method comprising: positioning a pin in the tibia of the patient; positioning an external adjustment guide over the pin; removably connecting a reference wing to the external adjustment guide; removably coupling an ablation profile to the reference wing; adjusting a position of the resection profile relative to the tibia via the external adjustment guide; resecting a portion of the tibia using the resection profile as a guide; A method comprising:

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