Ankle replacement system and method

Information

  • Patent Grant
  • 12064125
  • Patent Number
    12,064,125
  • Date Filed
    Thursday, August 12, 2021
    3 years ago
  • Date Issued
    Tuesday, August 20, 2024
    5 months ago
Abstract
A position adjustment device having a tool holder is locked to at least two pins projecting from respective anterior facing locations near a distal end of a tibia of a patient. The position adjustment device is adjusted. The position adjustment device is locked with the tool holder at first coordinates in the proximal-distal and medial-lateral directions. The distal end of the tibia is resectioned with a tool positioned on the tool holder, while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions. The tool is removed from the tool holder. A tibia trial is placed on the resectioned tibia using the tool holder, while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions. The tibia trial has a size and shape of a tibial tray of an ankle replacement system.
Description
BACKGROUND

The ankle is a joint that acts much like a hinge. The joint is formed by the union of three bones. The ankle bone is the talus. The top of the talus fits inside a socket that is formed by the lower end of the tibia, and the fibula, the small bone of the lower leg. Arthritis, bone degeneration and/or injury can cause ankle joint deterioration resulting in pain, reduced range of motion, and decreased quality of life. In many cases, physicians are recommending ankle replacement surgery with an implant as an option.


Available ankle replacement systems include, for example, the “INBONE”™ system sold by Wright Medical Technologies of Arlington, Tenn. The “INBONE” ™ system includes a talar tray component with stem, which fit into a resectioned distal end of the tibia. A poly insert having a concave distal surface is joined to the tibial tray. A talar dome and stem are implanted in a resectioned proximal end of the talus. The poly insert is configured to articulate with the talar dome.


Associated tools enable the physician to immobilize the foot, while the physician performs appropriate drilling and resectioning of the bones, and implants the prosthetic ankle. An example of such a tool is described in U.S. Pat. No. 7,534,246.


Improved devices and methods are desired.


SUMMARY

In some embodiments, a position adjustment device having a tool holder is locked to at least two pins projecting from respective anterior facing locations near a distal end of a tibia of a patient. The position adjustment device is adjusted. The position adjustment device is locked with the tool holder at first coordinates in the proximal-distal and medial-lateral directions. The distal end of the tibia is resectioned with a tool positioned on the tool holder, while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions. The tool is removed from the tool holder. A tibia trial is placed on the resectioned tibia using the tool holder, while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions. The tibia trial has a size and shape of a tibial tray of an ankle replacement system.





BRIEF DESCRIPTION OF THE DRAWINGS


FIG. 1 is an isometric view of a position adjustment device, or adjustment block suitable for sizing and trialing an implant.



FIG. 2 is an exploded view showing the adjustment block, tibial trial, poly trial insert, and floating trial.



FIG. 3 is an isometric view of the tibia trial of FIG. 2.



FIG. 4 is an anterior elevation view of the tibia trial of FIG. 3.



FIG. 5 is a lateral elevation view of the tibia trial of FIG. 3.



FIG. 6 is an isometric view of the floating trial of FIG. 2.



FIG. 7 is an isometric view of an adjustment block of FIG. 1, holding a drilling guide.



FIG. 8 is an isometric view of the adjustment block and drilling guide of FIG. 7, during the drilling operation.



FIG. 9 is an isometric view of the adjustment block of FIG. 1, holding a cut guide.



FIG. 10 is an isometric view showing the adjustment block and tibial trial during trial insertion.



FIG. 11 is a lateral side elevation view of the adjustment block and tibial trial during trial insertion.



FIG. 12 is an isometric view showing drilling using the tibia trial to locate peg holes in the distal surface of the tibia.



FIG. 13 shows the tibia and talus after resectioning.



FIG. 14 is an isometric view showing the adjustment block, tibial trial, poly trial insert, and floating trial inserted in the surgical window.



FIG. 15 is a lateral side elevation view of the adjustment block, tibial trial, poly trial insert, and floating trial inserted in the surgical window.



FIGS. 16 and 17 are isometric and lateral side elevation views showing the adjustment block, tibial trial, poly trial insert, and floating trial inserted while the floating trial is being pinned to the talus.



FIG. 18 is an isometric view of an embodiment of the adjustment block providing proximal-distal and medial-lateral adjustments.



FIG. 19 is an anterior top plan view of the adjustment block of FIG. 18, with a drill guide attached to its tool holder.





DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. In the description, relative terms such as “lower,” “upper,” “horizontal,” “vertical,”, “above,” “below,” “up,” “down,” “top” and “bottom” as well as derivative thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing under discussion. These relative terms are for convenience of description and do not require that the apparatus be constructed or operated in a particular orientation. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.



FIG. 1 is an isometric diagram of a position adjustment device 100 (also referred to below as an “adjustment block”) for positioning of drilling and cutting tools for tibia resectioning, and for tibia trial insertion. The adjustment block 100 provides a common reference location for locating tools and the tibia trial components throughout the sizing, resectioning and trial procedure. In some embodiments, the adjustment block 100 is small enough in profile to position a cut guide into the wound space close to the tibia bone without applying excess skin tension. The physician can use the adjustment block to position a drill guide and/or cut guide closer to the tibia bone, to make more accurate cuts with less chance of the blade or pins flexing.


The adjustment block 100 has three independently positionable frames 110, 120, and 130 for precisely positioning a tool holder 134 adjacent the joint to be replaced.


The first frame 110 is configured to be attached to two fixation pins 150 which have been inserted in the anterior surface of the tibia, near the distal end of the tibia. A locking screw 112 actuates a locking plate (not shown), which bears against the fixation pins 150 to secure the adjustment block 100 relative to the pins. The first frame has a proximal-distal adjustment knob 111 coaxially connected to a screw 113. The screw 113 can have an Acme thread, trapezoidal thread, square thread or other suitable thread for leadscrew use. The second frame 120 is fixedly attached or unitarily formed with a leadscrew nut (not shown), which the screw 113 drives. Rotation of the proximal-distal adjustment knob 111 rotates screw 113 to advance or retract the second frame 120 in the proximal-distal direction. When the second frame 120 is at the desired proximal-distal coordinate, the physician advances the locking screw 114 to lock the second frame 120 to the first frame 110 in place.


The second frame 120 has at least one medial-lateral adjustment knob 121a, 121b coaxially connected to a screw 123. The screw 123 can have an Acme thread, trapezoidal thread, square thread or other suitable thread for leadscrew use. The screw 123 drives a leadscrew nut (not shown), to which the third frame 130 is fixedly attached or unitarily formed with. Rotation of the medial-lateral adjustment knob 121a or 121b rotates screw 123 to move the third frame 130 in the medial-lateral direction. When the third frame 130 is at the desired medial-lateral coordinate, the physician advances the locking screw 122 to lock the leadscrew 123 of the second frame 120 in place.


The third frame 130 has an anterior-posterior adjustment knob 131 coaxially connected to a screw 133. The screw 133 can have an Acme thread, trapezoidal thread, square thread or other suitable thread for leadscrew use. The screw 133 drives a leadscrew nut 136, to which a tool holder 134 is fixedly attached or with which tool holder 134 is unitarily formed. Rotation of the anterior-posterior adjustment knob 131 rotates screw 133 to move the tool holder 134 in the anterior-posterior direction. The tool holder 134 is adapted to hold a drilling tool, a cutting tool, or a tibia trial 210.



FIG. 2 is an exploded view showing the adjustment block 100, tibia trial 210, poly trial insert 230 and floating trial 250. FIG. 3 is an isometric view of the tibia trial 210. FIG. 4 is an anterior (rear) elevation view of the tibia trial 210. FIG. 5 is a sagittal (side) elevation view of the tibia trial 210.


The tibia trial 210 provides the profile of the tibia tray portion of an ankle replacement system. The tibia trial 210 comprises a plate 211 with a top surface adapted to fit against a distal surface 262 of the resectioned tibia 260. The plate 211 has a plurality of holes 212 to be used to locate peg holes 263 in the resectioned tibia 260. The plate 211 has a bottom surface 216 adapted to receive a trial insert, such as a poly trial insert 230. An anterior tibia reference member 218 extends from the plate 211. The anterior tibia reference member 218 has a posterior surface 219 adapted to contact an anterior surface 261 of the tibia 260 when the tibia trial 210 is properly positioned. The tibia trial 210 has an anterior mounting portion 213 sized and shaped to be mounted to the tool holder 134 of the adjustment block 100. In some embodiments, the tibia trial 210 has a notch 217 for aligning an anterior surface of the poly trial insert 230 with the tibia trial 210. Alignment (or misalignment is readily visible by checking whether the notch 217 is aligned with an edge of the poly trial insert 230. In some embodiments, the tibia trial 210 is formed of a strong, corrosion resistant material such as stainless steel or a titanium alloy.


The poly trial insert 230 is configured to provide the profile of the poly insert of an ankle replacement system. The poly trial insert 230 comprises a top surface 231 adapted to be detachably mounted to the bottom surface of the plate 216 of the tibia trial 210. The poly insert 230 has a concave bottom surface 232 with a size and shape of a prosthetic tibia joint surface of the ankle replacement system. The thickness of the poly trial insert 230 matches the poly insert of the ankle replacement system to which the poly trial insert 230 corresponds, allowing verification of the size and thickness of the poly insert using the poly trial insert 230. In some embodiments, the poly insert of the ankle replacement system has a locking tab to prevent release from the talar tray after surgery; but the poly trial insert 230 has a non-locking tab 233 with a ramped surface, to be detachably inserted in the tibia trial 210 and removed after sizing and resectioning is completed. The non-locking tab 233 fits in a corresponding recess (not shown) in the bottom surface 216 of the tibia trial 210. The posterior end of the poly trial insert 230 has an undercut 234, In some embodiments, the poly trial insert 230 is made from the same type of material used in the poly insert of an ankle replacement system. In some embodiments, the poly trial insert 230 is made of a chemical-resistant material such as polyphenylsulfone, which is also referred to as RadelR.



FIG. 6 is an isometric view of the floating trial 250. The floating trial 250 is configured to provide a contour that matches the contour of the talar dome of the ankle replacement system. The floating trial 250 is configured to be inserted beneath the poly trial insert 230 to contact the concave bottom surface 232 of insert 230. The floating trial 250 comprises a member 251 having at least one convex anterior surface with a size and shape of a prosthetic talar dome of the ankle replacement system, to permit articulation with the concave surface 232 of the insert. The posterior surface 255 of the member 251 is shaped to match the contour of the resectioned talus. In some embodiments, the floating trial 250 has two convex surfaces 251. The floating trial 250 further includes a handle portion 252 which is sized to project from the resection site, so the physician can easily optimize the position of the floating trial for smooth articulation with the poly trial insert 230. The handle 252 of the floating trial 250 has a plurality of pin holes 253 for receiving fixation pins to be used for locating a talar cut guide (not shown). Once the position is optimized, the pins are inserted through the pin holes 253 before completing the resectioning of the talus. In some embodiments, the floating trial 250 is formed of a strong, corrosion resistant material such as stainless steel or a titanium alloy. In some embodiments, the floating trial 250 also has one or more anterior chamfers 254 for reference and alignment.



FIGS. 7-17 show various stages of a method of resectioning and trialing, using the adjustment block 100, optional drill guide 280, optional cut guide 290, tibia trial 210, poly trial insert 230 and floating trial 250. This is one example of a use of the devices, but is not limiting.



FIG. 7 shows the adjustment block 100 fixed to the fixation pins 150 (e.g., 3.2 mm pins) which have been inserted in the anterior surface of the tibia 260 near the distal end 261 of the tibia. FIG. 7 also shows a drill guide 280 attached to the tool holder 134 of the adjustment block 100, with the first frame 110 slightly above the anterior surface of the tibia 260. In some embodiments, the tool holder 134 is stage with a pair of pins 135, and the drill guide 280 has a corresponding pair of mounting ears 283 with holes adapted to snap onto the pins 135. This tool holder design is just exemplary in nature, and other embodiments include other suitable mounting structures.


In the embodiment of FIG. 7, the drill guide 280 is a small profile device sized and shaped to be inserted beneath the retracted skin (not shown) in the ankle region. The drill guide 280 has at least two guide holes 281 to be used to drill pilot holes in the tibia 260. The drill guide also has pin holes 282 that can be used to pin the drill guide to the bone, for position fixation. In some embodiments, the drill guide 280 has sizing patterns 285 showing the size and location of one or more resectioning cuts corresponding to the holes to be drilled using the drill guide 280. In some embodiments, the drill guide 280 has one or more reference lines 286 that the physician can optionally use to position the drill guide 280 (by adjusting the proximal-distal knob 111, the medial-lateral knob 121a or 121b, and the anterior-posterior knob. In some embodiments, the lines 285, 286 are visible under a fluoroscope, so the physician can view the position and size of the lines 285, 286 in situ, relative to the patient's bones.


The physician sizes the tibial tray component of the ankle replacement system by mounting a drill guide 280 on the tool holder and adjusting its position as described above. The position adjustment device (adjustment block) 100 is locked with the tool holder 134 at first coordinates in the proximal-distal and medial-lateral directions.


The physician views the X-ray of the tibia bone 260 and drill guide 280 and determines whether it is the optimum size and position for the patient. The position can be adjusted based on the X-ray, using knobs 111, 121, 131. If the size of the resectioning cut corresponding to the drill guide 280 is too large or too small, the physician removes the drill guide, selects a different size drill guide, and snaps the new drill guide onto the tool holder 134 of the adjustment block 100. The drill guide is then repositioned against the tibia, imaged by fluoroscope, and the size is again checked. To facilitate fluoroscopic X-ray imaging, the drill guide 280 can be made of plastic, while the circles surrounding holes 281 and the patterns 285, 286 can be made of metal. Thus, only the circles surrounding holes 281 and the patterns 285, 286 appear on the X-ray, superimposed against the tibia 260 and talus 265.


Although some embodiments use a single drill guide 280 for sizing, location of fixation pins by holes 282 and drilling corners 281, other embodiments (not shown) use a first guide (sizing guide) with holes 282 and patterns 285, 286 for sizing the tibia trial 210 and locating the fixation pins, and a second guide (drilling guide) with holes 281 and 282 for performing the drilling. Because the adjustment block 100 and the pins in holes 282 provide common references, the holes 281 can still be drilled with proper location relative to the pin holes 282 and patterns 285, 286.



FIG. 8 shows the tibia 260 with adjustment block 100 and drill guide 280. Soft tissue is omitted for ease of viewing. When the physician has verified that the optimum size of drill guide 280 has been selected, the physician pins the drill guide 280 to the tibia 260 using (e.g., 2.4 mm) fixation pins 287 inserted through the pin holes 282 and trimmed to extend slightly above the drill guide 280. Then the physician drills holes in the tibia 260 through the guides holes 281 using the drill guide 280 and drill 288. The holes thus drilled in the bone 260 define corners of a resectioning cut to be performed in the tibia. The physician then removes the drill guide 280, while leaving the pins 287 in place (in the distal portion of the tibia 260 to be removed by the resectioning). While removing the drill guide 280, the adjustment block can remain locked in the first coordinates with the first frame 110 adjusted to the same proximal-distal coordinate and the second frame 120 adjusted to the same medial-lateral coordinate.



FIG. 9 shows the adjustment block 100 still fixed to the fixation pins 150 in the same position, with a cut guide 290 mounted to the tool holder 134 of the adjustment block 100. The cut guide 290 has a plurality of slots 295, sized and located to connect the corner holes drilled with the drill guide 280. The cut guide 290 is sized and shaped to match the drill guide 280. Thus, the physician has a set of drill guides 280 and a corresponding set of cut guides 290. The selection of a drill guide size automatically selects the corresponding cut guide size to make cuts which are sized and located to connect the corner holes drilled with the drill guide 280, as described above. The cut guide 290 has a corresponding pair of mounting ears 293 with holes adapted to snap onto the pins 135. The cut guide 290 also has pin holes 292 which are sized and located to receive the fixation pins 287. This aligns the position of the cut guide 290 with the position previously occupied by the drill guide 280, to ensure alignment of the resectioning cuts with the previously drilled corner holes. In some embodiments, the cut guide 290 includes additional ears 296 with pin holes for receiving additional fixation pins 297.


To mount the cut guide 290, the physician slides the holes 292 of cut guide 290 over the fixation pins 287 and snaps the cut guide into place on the tool holder 134. For stability, the physician can then insert two more fixation pins 297 through the pin holes of ears 296 and into the talus bone 265. With the cut guide 290 and bones 260, 265 securely pinned, the physician performs the resectioning cuts through the guide slots 295, cutting the bone to connect the previously drilled holes. In some embodiments, as shown in FIG. 9, one cut guide 290 is used for both the tibia resection and the first cut of the talar resection. The cut guide 290 is then removed from the surgery site, and detached from the adjustment block 100. The sections of the tibia 260 and talus 265 that have been cut are removed, along with the fixation pins 287 and 297. In other embodiments (not shown), the tibia cut guide is only used to resection the tibia, and a separate cut guide is used to resection the talus after removal of the tibia cut guide.


The use of the adjustment block 100 permits the holes 281 to be drilled first with a first tool, and the cuts to be performed afterwards with a second tool, while maintaining accurate alignment between the holes and the cuts. Drilling the holes first avoids stress concentrations at the corners of the resectioned distal tibia.


Although some embodiments described herein use a drill guide 280 and a cut guide 290 commonly fixed using the adjustment block 100 and fixation pins 287, other embodiments attach different tools to the tool holder 134 for purpose of resectioning the tibia and talus. For example, some embodiments (not shown) include a cut guide without using a separate drill guide.


Following the initial resectioning, the physician inserts the tibia trial 210, poly trial insert 230 and floating trial 250, while the adjustment block 100 is still locked to the two fixation pins 150, and the tool holder 134 is in the first coordinates in the proximal-distal and medial-lateral directions. Should the physician choose to temporarily remove the adjustment block from the surgery site (e.g., for inspection, cleaning or suctioning), the physician returns the adjustment block to the same coordinates to locate the tool holder 134 at the same position to complete the procedure. Because the fixation pins 150 are excluded from the distal portion of the tibia removed by the resection, the fixation pins 150 are available throughout the procedure for use in adjusting or correcting the resection cuts.


The physician snaps the tibia trial 210 onto the tool holder 134. FIGS. 10 and 11 show the adjustment block in position with the tibia trial 210 attached. The adjustment block 100 is adjusted to position the tool holder in an anterior-posterior direction, while the tool holder is at the first coordinates in the proximal-distal and medial-lateral directions. The tibia trial 210 is repositioned in the posterior direction until a predetermined portion of the tibia trail contacts an anterior cortex of the tibia. In some embodiments, the position of the third frame 130 is adjusted until the posterior surface 219 of anterior tibia reference member 218 extending from the plate 211 contacts the anterior cortex of the tibia 260.



FIG. 12 shows the tibia 260 and talus 265 with the adjustment block and tibia trial 210 in position. The tibia peg drill (not shown) is placed in the head of a tibia peg drill guide 299, and is inserted in the holes 212 (FIG. 3) of the tibia trial 210. The physician drills a plurality (e.g., 3) peg holes 263 in the distal surface 262 of the resectioned tibia 260 using the tibia peg drill 299. The holes 212 (FIG. 3) of the tibia trial 210 are used to locate these holes 263. FIG. 13 shows the distal end 261 of the tibia 260 at the completion of the peg drilling, with the three peg holes 263 in the resectioned surface 262 of the tibia.


The tibia trial 210 is used to verify size and shape of the resectioning using the tibia trial, prior to implanting the ankle replacement system. Advantageously, the steps of attaching the tibia trial 210 to the tool holder 134, adjusting the position adjustment device 100 to position the tool holder 134 in an anterior-posterior direction, and placing the tibia trial 210 on the resectioned tibia 260 using the tool holder 134, can be formed without inserting any additional location fixing pins into the tibia, while the tool holder is locked in the first coordinates in the proximal-distal and medial-lateral directions.



FIGS. 14 and 15 show the adjustment block 100 and tibia trial 210, after installing the poly trial insert 230 into the tibia trial 210 and positioning the floating trial 250 between the talus 265 and the poly insert trial 230, to permit articulation with the concave surface 232 of the poly insert trial 230 while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions. The physician can now assess the fit of the ankle replacement system, including size, anterior-posterior position, and whether the tibia has been sized, drilled and cut optimally. If any adjustments are deemed appropriate to the tibia resectioning, the physician can reapply the cut guide with the adjustment block set to the same proximal-distal and medial-lateral coordinates used before.


Referring to FIGS. 16 and 17, the physician now performs a trial reduction to ensure the correct poly insert height and talus dome position. The talar implant anterior-posterior coordinate is determined by moving the floating trial 250 to the location where it best articulates with the concave surface 232 of the poly trial insert 230. Two additional fixation pins 298 are inserted through the pin holes 253 of the floating trial 250 using 2 mm K-wire, for example. Additional resection guides (not shown) can be positioned by sliding pin holes in the resection guide(s) over the fixation pins 298. The remaining two talar cuts are then performed, to match the geometry of the talar dome implant of the ankle replacement system.


A position adjustment device (adjustment block) 100 as described above provides a fixed point of reference that facilitates the AP position of the tibial and talar implants of an ankle replacement system. The adjustment block 100 is capable of fixing a tibial trial 210 via a modular connection 134 to avoid insertion of additional pins in the distal tibia. The tibial trial 210, while attached to the adjustment block 100, allows the user to set the tibial implant anterior-posterior position by abutting the anterior post 218 against the tibial bone. The tibial trial 210 also serves as a drill guide to prepare the tibial pegs on the tibial implant.


The tibial trial 210 while rigidly fixed to the adjustment block 100 then translates the anterior-posterior position to the talar trial 250 by using the poly trial insert 230 to articulate with the talar (dome) trial 250. The talar trial 250 also has chamfer indicators 254 to help the user determine the optimal talar anterior-posterior position.


Advantageously, the system and method described above uses the adjustment block 100 as a fixed reference to associate all other instruments used for trial sizing and trials related to tibial side of the ankle replacement. Thus, a tibial sizer (e.g., drill guide 280), tibial resection guide (e.g., cut guide 290), and tibial trial 210 can all be anchored at the same position defined by the adjustment block 100. This method preserves the distal layer of the tibia to avoid excess pin holes from fixation pins and devices.


The compact size of the adjustment block allows the tools to be fixed and placed close to the surgery site, for more accurate cuts, with reduced chance of components flexing. Sizing guides (e.g., drill guide 280) and resection guides (e.g. cut guide 290) can all be placed in the surgical window. The position of the tools and trials can be accurately adjusted by turning the adjustment knobs 111, 121, 131 in a small area.



FIGS. 18 and 19 show another embodiment of the adjustment block 300. The adjustment block 300 has two independently positionable frames 110, 120 for precisely positioning a tool holder 330 in the proximal-distal and medial-lateral directions, adjacent the joint to be replaced.


The first frame 110 is configured to be attached to two fixation pins 150 which have been inserted in the anterior surface of the tibia, near the distal end of the tibia. A locking screw 112 actuates a locking plate (not shown), which bears against the fixation pins 150 to secure the adjustment block 100 relative to the pins. The first frame has a proximal-distal adjustment knob 111 coaxially connected to a screw 113. The screw 113 can have an Acme thread, trapezoidal thread, square thread or other suitable thread for leadscrew use. The second frame 120 is fixedly attached or unitarily formed with a leadscrew nut (not shown), which the screw 113 drives. Rotation of the proximal-distal adjustment knob 111 rotates screw 113 to advance or retract the second frame 120 in the proximal-distal direction. When the second frame 120 is at the desired proximal-distal coordinate, the physician advances the locking screw 114 to lock the second frame 120 to the first frame 110 in place.


The second frame 120 has at least one medial-lateral adjustment knob 121a, 121b coaxially connected to a screw 123. The screw 123 can have an Acme thread, trapezoidal thread, square thread or other suitable thread for leadscrew use. The screw 123 drives a leadscrew nut (not shown), to which the tool holder 330 is fixedly attached or unitarily formed with. Rotation of the medial-lateral adjustment knob 121a or 121b rotates screw 123 to move the tool holder 330 in the medial-lateral direction. When the tool holder 330 is at the desired medial-lateral coordinate, the physician advances the locking screw 122 to lock the leadscrew 123 of the second frame 120 in place.


The position of the tool holder 330 in the anterior-posterior direction is determined by location of the first frame 110 relative to the pins 150.


The tool holder 330 can have any of a variety of configurations for easily attaching a tool or trial. FIGS. 18 and 19 show a non-limiting example in which the tool or trial is attached to the adjustment block 300 by a dovetail joint 332. FIG. 19 shows an example of a drill guide 380 adapted for mounting to the dovetail joint 332 of tool holder 330. The drill guide 380 has corner holes 381 and fixation holes 382, 383 and sizing patterns 385. Other tools (e.g., a cut guide) and trials (e.g., tibia trial) can be adapted to fit the tool holder 330.


Although the subject matter has been described in terms of exemplary embodiments, it is not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments, which may be made by those skilled in the art.

Claims
  • 1. System for providing a common reference location for surgical tools comprising: a tool holder;at least two pins projecting from respective anterior facing locations near a distal end of a tibia of a patient;a first frame and a second frame arranged and configured for lockably adjusting a position of the tool holder in the proximal-distal and medial-lateral directions relative to at least one of the at least two pins, wherein a first tool is mounted to the tool holder, the first tool configured for sizing a tibia implant and a second tool mounted to the tool holder, the second tool configured for removing a portion of a tibia bone for acceptance of a tibia implant;wherein the first frame is coupled to the at least two pins such that a locking screw urges a portion of the frame to bear against the at least two pins so as to secure the tool holder relative to the pins.
  • 2. The system of claim 1, wherein the first frame includes a proximal-distal adjustment knob coaxially connected to a screw.
  • 3. The system of claim 2, wherein rotation of the proximal-distal adjustment knob rotates a screw so as to move the second frame in the proximal-distal direction.
  • 4. The system of claim 3, wherein when the second frame is at a desired proximal-distal coordinate, the second frame is secured with respect to the first frame.
  • 5. The system of claim 1, wherein the second frame includes at least one medial-lateral adjustment knob coaxially connected to a screw.
  • 6. The system of claim 5, comprising a third frame such that rotation of the medial-lateral adjustment knob rotates the screw so as to move the third frame in the medial-lateral direction.
  • 7. The system of claim 6 wherein when the third frame is at the desired medial-lateral coordinate, the third frame is secured with respect to the second frame.
  • 8. The system of claim 7 wherein the third frame includes an anterior-posterior adjustment knob coaxially connected to a screw such that rotation of the anterior-posterior adjustment knob moves the tool holder in a anterior-posterior direction.
  • 9. The surgical system of claim 1 comprising a trial configured to be received within a resected first bone, the trial including a plate having a bottom surface defining a channel and a spacer having a body with an extension located at one end, the body being sized and configured to be received within a channel defined by the trial, the extension defining at least first and second holes that are configured to each receive one of the at least two pins.
  • 10. The surgical system of claim 9, further comprising a cutting guide including a front face defining a plurality of holes and a slot, wherein a first subset of the plurality of holes is configured to each receive one of the at least two pins such that cutting guide is positioned in a first position with respect to a first bone, and wherein a second subset of the plurality of holes is configured to each receive one of the at least two pins such that the cutting guide is positioned in a second position with respect to the first bone that is different from the first position.
  • 11. The surgical system of claim 10, wherein one of the plurality of holes is a hole that is at least partially threaded for receiving a threaded rod to assist in removing the spacer from the channel defined by the channel.
  • 12. The surgical system of claim 11, wherein the spacer is formed from a radiolucent material.
  • 13. The surgical system of claim 12, wherein the first bone is a tibia and the second bone is a talus.
  • 14. A method comprising: (a) providing a tool holder and at least two pins projecting from respective anterior facing locations near a distal end of a tibia of a patient with a first frame and a second frame arranged and configured for adjusting a position of the tool holder in the proximal-distal and medial-lateral directions relative to at least one of the at least two pins, wherein a first tool is mounted to the tool holder, the first tool configured for sizing a tibia implant and a second tool mounted to the tool holder, the second tool configured for removing a portion of a tibia bone for acceptance of a tibia implant, wherein the first frame is coupled to the at least two pins such that a locking screw;(b) urging a portion of the frame to bear against the at least two pins so as to secure the tool holder relative to the pins;(c) locking the tool holder to one of the at least two pins;(d) adjusting the position of the tool holder in the proximal-distal and medial-lateral directions;(e) locking the position of the tool holder at a first selected coordinates in the proximal-distal and medial-lateral directions;(f) resectioning the distal end of the tibia with a tool positioned on the tool holder, while the tool holder is in the first selected coordinates in the proximal-distal and medial-lateral directions;(g) removing the tool from the tool holder;(h) placing a tibia trial on the resectioned tibia using the tool holder while the tool holder is in the first selected coordinates in the proximal-distal and medial-lateral directions, the tibia trial having a size and shape of a tibial tray of an ankle replacement system; and(i) translating the tibia trial in a posterior direction until a predetermined portion of the tibia trial contacts an anterior cortex of the tibia.
  • 15. The method of claim 14, further comprising verifying size and shape of the resectioning using the tibia trial, prior to implanting the ankle replacement system.
  • 16. The method of claim 15, further comprising, before step (g): (i) attaching the tibia trial to the tool holder; and(ii) adjusting the position adjustment device to position the tool holder in an anterior-posterior direction, while the tool holder is at the first coordinates in the proximal-distal and medial-lateral directions.
  • 17. The method of claim 14, wherein steps (g) and (h) are performed in the absence of additional location fixing pins located in the tibia.
  • 18. The method of claim 14, further comprising: (i) positioning a drill using the tibia trial; and(j) drilling at least one peg hole in a distal surface of the resectioned tibia, through at least one hole in the tibia trial.
  • 19. The method of claim 14, further comprising: installing an insert into the tibia trial while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions, the insert having a concave surface with a size and shape of a prosthetic tibia joint surface; andpositioning a floating trial adjacent the concave surface of the insert trial while the tool holder is in the first coordinates in the proximal-distal and medial-lateral directions, the floating trial having a convex surface with a size and shape of a prosthetic talar dome.
  • 20. The method of claim 14, further comprising pinning the floating trial to a talus of the patient, while the floating trial is positioned to permit articulation with the concave surface of the insert trial.
  • 21. The method of claim 20, wherein the pinning step includes inserting pins through holes in the floating trial, the K-wires being suitable for positioning a guide for resectioning the talus.
  • 22. The method of claim 14, wherein step (d) includes adjusting at least one adjustment screw to position a connection block in at least one of proximal-distal, medial-lateral and anterior-posterior directions, the connection block adapted to hold the tool or the tibia trial.
  • 23. The method of claim 14, wherein step (f) includes: mounting a drill guide on the tool holder;drilling holes using the drill guide to define corners of a resectioning cut to be performed in the tibia.
  • 24. The method of claim 14, wherein step (f) further includes: mounting a cut guide to the tool holder; andcutting the bone to connect the drilled holes.
  • 25. The method of claim 14, wherein the tibia trial comprises: a plate having a top surface adapted to fit against a distal surface of the resectioned tibia, the plate having a plurality of holes to be used to locate peg holes in the resectioned tibia, the plate having a bottom surface adapted to receive an insert;an anterior tibia reference member extending from the plate, adapted to contact an anterior surface of the tibia when the tibia trial is properly positioned; andan anterior mounting portion sized and shaped to be mounted to the tool holder.
  • 26. The method of claim 25, wherein the insert comprises: a top surface adapted to be detachably mounted to the bottom surface of the plate of the tibia trial;a concave bottom surface with a size and shape of a prosthetic tibia joint surface of the ankle replacement system.
  • 27. The method of claim 26, a floating trial is inserted to contact the insert, the floating trial comprising: a member having at least one convex surface with a size and shape of a prosthetic talar dome of the ankle replacement system, to permit articulation with the concave surface of the insert,the member having a handle for manual positioning of the floating trial,the handle having a plurality of holes for inserting pins for locating a talar cut guide.
FIELD

This application is a continuation of U.S. patent application Ser. No. 16/405,212, filed May 7, 2019, which is a continuation of U.S. patent application Ser. No. 15/335,949, filed Oct. 27, 2016 (now U.S. Pat. No. 10,321,922) which is a division of U.S. patent application Ser. No. 14/100,799, filed Dec. 9, 2013 (now U.S. Pat. No. 9,480,571), which is a non-provisional of U.S. Patent Application No. 61/746,393, which was filed Dec. 27, 2012, all of which are incorporated herein by reference in their entireties. This disclosure relates to prosthetics generally, and more specifically to systems and methods for total ankle replacement.

US Referenced Citations (228)
Number Name Date Kind
3839742 Link Oct 1974 A
3872519 Giannestras et al. Mar 1975 A
3886599 Schlein Jun 1975 A
3889300 Smith Jun 1975 A
3896502 Lennox Jul 1975 A
3896503 Freeman et al. Jul 1975 A
3975778 Newton, III Aug 1976 A
3987500 Schlein Oct 1976 A
4021864 Waugh May 1977 A
4069518 Groth, Jr. et al. Jan 1978 A
4156944 Schreiber et al. Jun 1979 A
4166292 Bokros Sep 1979 A
4204284 Koeneman May 1980 A
4232404 Samuelson et al. Nov 1980 A
4309778 Buechel et al. Jan 1982 A
4470158 Pappas et al. Sep 1984 A
4661069 Weissman Apr 1987 A
4755185 Tarr Jul 1988 A
4913144 Del Medico Apr 1990 A
4968316 Hergenroeder Nov 1990 A
5041139 Brånemark Aug 1991 A
5190544 Chapman et al. Mar 1993 A
5312412 Whipple May 1994 A
5326365 Alvine Jul 1994 A
5342368 Petersen Aug 1994 A
5354300 Goble et al. Oct 1994 A
5364402 Mumme et al. Nov 1994 A
5423825 Levine Jun 1995 A
5476466 Barrette et al. Dec 1995 A
5601563 Burke et al. Feb 1997 A
5634927 Houston et al. Jun 1997 A
5667511 Vendrely et al. Sep 1997 A
5674223 Cipolletti et al. Oct 1997 A
5678996 Dawson Oct 1997 A
5683470 Johnson et al. Nov 1997 A
5688279 McNulty et al. Nov 1997 A
5735904 Pappas Apr 1998 A
5766259 Sammarco Jun 1998 A
5776200 Johnson et al. Jul 1998 A
5817097 Howard et al. Oct 1998 A
5824106 Fournal Oct 1998 A
5879389 Koshino Mar 1999 A
5885299 Winslow et al. Mar 1999 A
5888203 Goldberg Mar 1999 A
5897559 Masini Apr 1999 A
5935132 Bettuchi et al. Aug 1999 A
6002859 DiGioia, III et al. Dec 1999 A
6033405 Winslow et al. Mar 2000 A
6102952 Koshino Aug 2000 A
6183519 Bonnin et al. Feb 2001 B1
6245109 Mendes et al. Jun 2001 B1
6342056 Mac-Thiong et al. Jan 2002 B1
6409767 Pericéet al. Jun 2002 B1
6436146 Hassler et al. Aug 2002 B1
6478800 Fraser et al. Nov 2002 B1
6520964 Tallarida et al. Feb 2003 B2
6530930 Marino et al. Mar 2003 B1
6610067 Tallarida et al. Aug 2003 B2
6610095 Pope et al. Aug 2003 B1
6620168 Lombardo et al. Sep 2003 B1
6645215 McGovern et al. Nov 2003 B1
6663669 Reiley Dec 2003 B1
6673116 Reiley Jan 2004 B2
6679917 Ek Jan 2004 B2
6719799 Kropf Apr 2004 B1
6824567 Tornier et al. Nov 2004 B2
6852130 Keller et al. Feb 2005 B2
6860902 Reiley Mar 2005 B2
6863691 Short et al. Mar 2005 B2
6875222 Long et al. Apr 2005 B2
6875236 Reiley Apr 2005 B2
6926739 O'Connor et al. Aug 2005 B1
6939380 Guzman Sep 2005 B2
6942670 Heldreth et al. Sep 2005 B2
7001394 Gundlapalli et al. Feb 2006 B2
7011687 Deffenbaugh et al. Mar 2006 B2
7025790 Parks et al. Apr 2006 B2
7163541 Ek Jan 2007 B2
7238190 Schon et al. Jul 2007 B2
7252684 Dearnaley Aug 2007 B2
7314488 Reiley Jan 2008 B2
7323012 Stone et al. Jan 2008 B1
7476227 Tornier et al. Jan 2009 B2
7481814 Metzger Jan 2009 B1
7485147 Papps et al. Feb 2009 B2
7534246 Reiley et al. May 2009 B2
7618421 Axelson, Jr. et al. Nov 2009 B2
7625409 Saltzman et al. Dec 2009 B2
7641697 Reiley Jan 2010 B2
7648508 Lutz et al. Jan 2010 B2
7678151 Ek Mar 2010 B2
7713305 Ek May 2010 B2
7717920 Reiley May 2010 B2
7744601 Rosa et al. Jun 2010 B2
7763027 Irving Jul 2010 B2
7763080 Southworth Jul 2010 B2
7803158 Hayden Sep 2010 B2
7850698 Straszheim-Morley et al. Dec 2010 B2
7896883 Ek et al. Mar 2011 B2
7896885 Miniaci et al. Mar 2011 B2
7909882 Stinnette Mar 2011 B2
7963996 Saltzman et al. Jun 2011 B2
8002841 Hasselman Aug 2011 B2
8012217 Strzepa et al. Sep 2011 B2
8034114 Reiley Oct 2011 B2
8034115 Reiley Oct 2011 B2
8048164 Reiley Nov 2011 B2
8110006 Reiley Feb 2012 B2
8114091 Ratron et al. Feb 2012 B2
8167888 Steffensmeier May 2012 B2
8172850 McMinn May 2012 B2
8177841 Ek May 2012 B2
8268007 Barsoum et al. Sep 2012 B2
8303667 Younger Nov 2012 B2
8313492 Wong et al. Nov 2012 B2
8323346 Tepic Dec 2012 B2
8337503 Lian Dec 2012 B2
8361159 Ek Jan 2013 B2
8475463 Lian Jul 2013 B2
8491596 Long et al. Jul 2013 B2
8652180 Federspiel et al. Feb 2014 B2
8808303 Stemniski et al. Aug 2014 B2
9186154 Li Nov 2015 B2
9326780 Wong et al. May 2016 B2
9675471 Bojarski et al. Jun 2017 B2
9775639 Hanson et al. Oct 2017 B2
9907561 Luna et al. Mar 2018 B2
10034678 Park et al. Jul 2018 B2
10039558 Park et al. Aug 2018 B2
10206588 Park et al. Feb 2019 B2
10888336 McGinley et al. Jan 2021 B2
20020082607 Heldreth et al. Jun 2002 A1
20020133164 Williamson Sep 2002 A1
20020173853 Corl et al. Nov 2002 A1
20030208280 Tohidi Nov 2003 A1
20030236522 Long et al. Dec 2003 A1
20040030399 Asencio Feb 2004 A1
20040039394 Conti et al. Feb 2004 A1
20040068322 Ferree Apr 2004 A1
20040167631 Luchesi et al. Aug 2004 A1
20040186585 Feiwell Sep 2004 A1
20040216259 Ponziani Nov 2004 A1
20040236431 Sekel Nov 2004 A1
20050004676 Schon et al. Jan 2005 A1
20050075643 Schwab et al. Apr 2005 A1
20050165408 Puno et al. Jul 2005 A1
20050192674 Ferree Sep 2005 A1
20050216008 Zwirnmann Sep 2005 A1
20060009857 Gibbs et al. Jan 2006 A1
20060020345 O'Connor et al. Jan 2006 A1
20060036237 Steffensmeier Feb 2006 A1
20060116679 Lutz et al. Jun 2006 A1
20060142870 Robinson et al. Jun 2006 A1
20060235541 Hodorek Oct 2006 A1
20060247788 Ross Nov 2006 A1
20070038303 Myerson et al. Feb 2007 A1
20070100346 Wyss et al. May 2007 A1
20070112431 Kofoed May 2007 A1
20070162025 Tornier et al. Jul 2007 A1
20070173944 Keller et al. Jul 2007 A1
20070173947 Ratron et al. Jul 2007 A1
20070213830 Ammann et al. Sep 2007 A1
20070233129 Bertagnoli et al. Oct 2007 A1
20070276400 Moore et al. Nov 2007 A1
20080015602 Axelson Jan 2008 A1
20080097617 Fellinger et al. Apr 2008 A1
20080103603 Hintermann May 2008 A1
20080109081 Bao et al. May 2008 A1
20080195233 Ferrari et al. Aug 2008 A1
20080215156 Duggal et al. Sep 2008 A1
20080287954 Kunz et al. Nov 2008 A1
20080312745 Keller et al. Dec 2008 A1
20090043310 Rasmussen Feb 2009 A1
20090054992 Landes et al. Feb 2009 A1
20090082875 Long Mar 2009 A1
20090105767 Reiley Apr 2009 A1
20090105840 Reiley Apr 2009 A1
20090182433 Reiley et al. Jul 2009 A1
20090198341 Choi et al. Aug 2009 A1
20090234360 Alexander Sep 2009 A1
20090276052 Regala et al. Nov 2009 A1
20100010493 Dower Jan 2010 A1
20100023066 Long et al. Jan 2010 A1
20100023126 Grotz Jan 2010 A1
20100057216 Gannoe et al. Mar 2010 A1
20100069910 Hasselman Mar 2010 A1
20100198355 Kofoed et al. Aug 2010 A1
20100241237 Pappas Sep 2010 A1
20100262150 Lian Oct 2010 A1
20100305572 Saltzman et al. Dec 2010 A1
20100331984 Barsoum et al. Dec 2010 A1
20110015636 Katrana et al. Jan 2011 A1
20110029090 Zannis et al. Feb 2011 A1
20110035018 Deffenbaugh et al. Feb 2011 A1
20110035019 Goswami et al. Feb 2011 A1
20110106268 Deffenbaugh et al. May 2011 A1
20110125200 Hanson et al. May 2011 A1
20110125275 Lipman et al. May 2011 A1
20110125284 Gabbrielli et al. May 2011 A1
20110152868 Kourtis et al. Jun 2011 A1
20110152869 Ek et al. Jun 2011 A1
20110166608 Duggal et al. Jul 2011 A1
20110190829 Duggal et al. Aug 2011 A1
20110218542 Lian Sep 2011 A1
20110253151 Tochigi et al. Oct 2011 A1
20110276052 Hasselman Nov 2011 A1
20110295380 Long Dec 2011 A1
20120010718 Still Jan 2012 A1
20120046753 Cook et al. Feb 2012 A1
20120053644 Landry et al. Mar 2012 A1
20120071802 Reiley et al. Mar 2012 A1
20120083789 Blakemore et al. Apr 2012 A1
20120109131 Vasarhelyi et al. May 2012 A1
20120109326 Perler May 2012 A1
20120130376 Loring et al. May 2012 A1
20120136443 Wenzel May 2012 A1
20120185057 Abidi et al. Jul 2012 A1
20120191210 Ratron et al. Jul 2012 A1
20120239045 Li Sep 2012 A1
20120245645 Hanson et al. Sep 2012 A1
20120245701 Zak et al. Sep 2012 A1
20120271430 Arnett et al. Oct 2012 A1
20120277745 Lizee Nov 2012 A1
20130041473 Rouyer et al. Feb 2013 A1
20130046313 Lian Feb 2013 A1
20130116797 Coulange et al. May 2013 A1
20130316562 Nagasaka Nov 2013 A1
20160135815 Loring et al. May 2016 A1
Foreign Referenced Citations (23)
Number Date Country
2967697 Apr 2018 EP
H11500035 Jan 1999 JP
2006150055 Jun 2006 JP
2007-518453 Jul 2007 JP
2007-519477 Jul 2007 JP
2011526189 Oct 2011 JP
2012518517 Aug 2012 JP
2013500810 Jan 2013 JP
2013511358 Apr 2013 JP
2014-131738 Jul 2014 JP
2007536011 Dec 2017 JP
WO 0166021 Sep 2001 WO
WO 2005011523 Feb 2005 WO
WO 2006023824 Mar 2006 WO
WO 2006099270 Sep 2006 WO
WO 2007084846 Jul 2007 WO
WO 2009158522 Dec 2009 WO
WO 2010099142 Sep 2010 WO
WO 2011015863 Feb 2011 WO
2011072249 Jun 2011 WO
WO 2011151657 Dec 2011 WO
WO 2012088036 Jun 2012 WO
WO 2012116089 Aug 2012 WO
Non-Patent Literature Citations (37)
Entry
Laurence W. McKeen, Handbook of Polymer Applications in Medicine and Medical Devices (2014), 38 pages.
Bonasia, D. E. et al., Total ankle replacement: Why, When and How?, The Iowa Orthopaedic J., 30, (2010), 12 pages.
Clare, Michael P. et al., Preoperative Considerations in Ankle Replacement Surgery, Foot and Ankle Clinic, vol. 7 (2002), 12 pages.
Cenni, Francesco et al., Position of the Prosthesis Components in Total Ankle Replacement and the Effect on Motion at the Replaced Joint, Int'l Orthopaedics, vol. 36(3) (2012), 8 pages.
Steeves, Mark et al., How Pilot-Hole Size Affects Bone-Screw Pullout Strength in Human Cadaveric Cancellous Bone, Canadian J.of Surgery, vol. 48(3) (2005), 6 pages.
Howell, Joel D., Early Clinical Use of the X-Ray, Transactions of the Am. Clinical and Climatological Ass'n, vol. 127 (2016), 10 pages.
Hofstetter, R. et al., Fluoroscopy as an Imaging Means for Computer-Assisted Surgical Navigation, Computer Aided Surgery, vol. 4 (1999), 14 pages.
Jennings, John D. et al., Intraoperative Fluoroscopy Improves Component Position During Anterior Hip Arthroplasty, Slack Inc., vol. 38(11) (2015), 6 pages.
Roberts, Timothy T. et al., History of the Orthopedic Screw, Orthopedics, vol. 36(1) (2013), 4 pages.
Definition of “Fluoroscopy”, U.S. Food and Drug Admin.,https://www.fda.gov/radiation-emitting-products/medical-x-ray-imaging/fluoroscopy, 10 pages.
Definition of “Dovetail Joint”, https://en.wikipedia.org/wiki/Dovetail_joint, 6 pages.
Non-Final Office Action issued in connection with U.S. Appl. No. 16/047,425, filed Apr. 24, 2020, 8 pages.
Response to Non-Final Office Action filed in connection with U.S. Appl. No. 16/047,425, filed Sep. 8, 2020, 19 pages.
Notice of Allowance issued in connection with U.S. Appl. No. 16/047,425, filed Oct. 20, 2020, 8 pages.
Non-Final Office Action issued in connection with U.S. Appl. No. 14/446,921, filed Jun. 16, 2017, 20 pages.
Response to Non-Final Office Action filed in connection with U.S. Appl. No. 14/446,921, filed Sep. 15, 2017, 14 pages.
Notice of Allowance issued in connection with U.S. Appl. No. 14/446,921, filed Oct. 25, 2017, 6 pages.
Petition for Inter Partes Review issued in connection with U.S. Pat. No. 10,888,336, 88 pages, Oct. 4, 2022.
Petition for Inter Partes Review issued in connection with U.S. Pat. No. 9,907,561, 86 pages, Oct. 4, 2022.
Declaration of Bruce Weber in connection with U.S. Pat. No. 10,888,336, _pages, Date.
Declaration of Bruce Weber in connection with U.S. Pat. No. 9,907,461, _pages, Date.
First Examination Report issued in connection with Australian Patent Application No. 202106853, 3 pages, Jul. 13, 2022.
Search report issued for European U.S. Appl. No. 13/198,280 dated Feb. 5, 2014. *cited in parent.
International Search Report for International patent application No. PCT/US2014/027448 dated Jul. 7, 2014. *cited in parent.
International Preliminary Report on Patentability issued for International patent application No. PCT/US2014/027448, Sep. 15, 2015, 8 pages. *cited in parent.
Partial European Search Report issued in connection with European patent application No. 14768333.8, Oct. 26, 2016, 6 pages. *cited in parent.
Patent Examination Report No. 1 issued in connection with Australian patent application No. 2015202080, Jul. 5, 2016, 4 pages. *cited in parent.
First Office Action issued for Japanese patent application No. 2016-117842, Sep. 12, 2017, 5 pages. *cited in parent.
Extended European Sean Report and Opinion in connection with European Patent Application No. 14768333.8, Jan. 30, 2017, 10 pages *cited in parent.
Final Office Action issued in connection with corresponding Japanese Patent Application No. 2016-502443, May 15, 2018, 3 pages.
European Search Report issued in connection with European Patent Application No. 18160378.8, Jun. 29, 2018.
Examination Report No. 1 issued in connection with corresponding Australian Patent Application No. 20182000073, Dec. 24, 2018, 3 pages.
First Office Action issued in connection with corresponding Japanese Patent Application No. 2018-092289, Mar. 5, 2019, 2 pages.
First Office Action issued in connection with corresponding Japanese Patent Application No. 2018-178853, Sep. 3, 2018, 3 pages.
Office Action in corresponding Canadian Patent Application No. 2,904,652, Jun. 2, 2020, 6 pages.
First Examination Report issued in corresponding Australian Patent Application No. 2019213412, Sep. 3, 2020, 5 pages.
First Office Action issued in connection with corresponding Japanese Patent Application No. 2020-016447, Apr. 6, 2021, 4 pages.
Related Publications (1)
Number Date Country
20210369288 A1 Dec 2021 US
Provisional Applications (1)
Number Date Country
61746393 Dec 2012 US
Divisions (1)
Number Date Country
Parent 14100799 Dec 2013 US
Child 15335949 US
Continuations (2)
Number Date Country
Parent 16405212 May 2019 US
Child 17400620 US
Parent 15335949 Oct 2016 US
Child 16405212 US