Methods, systems and apparatuses for the cutting of bone

Abstract

A system for preparing at least one of a tibia (308) and a talus (306) with a defect, the system optionally comprising: a cutting instrument (100) configured to receive a guide (204) at a tibiotalar joint space (314), wherein the cutting instrument is configured to resect at least one of the tibia and talus to prepare for an implant; and a shaft (204) configured to couple with the cutting instrument within the tibiotalar joint space.

Description

METHODS, SYSTEMS AND APPARATUSES FOR THE CUTTING OF BONECLAIM OF PRIORITY

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 591,298, filed on October 18, 2023, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to surgical instruments, systems and methods for preparing the tibia and / or talus bone to receive an implant or void filler. Specifically, the present disclosure relates to bone cutting instruments and techniques for preparing the tibia and / or the talus to receive an augment, bone substitute or other implant.BACKGROUND

[0003] Intramedullary implants are used in various contexts, including to repair fractures or to achieve joint fusion (z.e., arthrodesis). In the case of arthrodesis, it is frequently necessary to apply compression across one or more joints to bring the adjoining bones of the joint into apposition, and then fix the adjoining bones so that fusion can occur across the joint site. An intramedullary implant such as an intramedullary rod can be used to achieve fixation of the adjoining bones of the joint after compression and secure the bones in position to allow fusion to occur.

[0004] In some cases, bone augments can also be used with intramedullary implants to replace and / or augment a particular bone. This can be the case in instances where, for example, bone is diseased and / or some trauma has occurred to the bone and the bone needs to be replaced or augmented. When bone augments are used with intramedullary implants, it is desirable to ensure that the bone augment cooperates with the intramedullary device and also that proper bone ingrowth and / or fusion occurs when using the augment.

[0005] The present disclosure provides instruments, systems and methods that cut the tibia and / or talus to receive a bone augment, bone substitute or other implant to allow surgeons to conduct surgical repairs in a more effective manner, as described in more detail below.OVERVIEW

[0006] Various intramedullary implants and augments are known including those designed by the Applicant. Examples include, U.S. Patent Nos. 9,308,031, 10,869,701 and 10,716,603, the disclosures of each of which is incorporated herein by reference in its entirety. The present inventors have recognized, among other things, that problems to be solved in preparing the tibiotalar joint to receive an implant include difficulty assessing size of defect(s) and size of implant(s) needed to address such defect(s) and difficulty in preparing the bone properly to align the implant(s) relative to other anatomical features such as the intramedullary canal of the tibia. The present inventors recognize that some amount of healthy bone may be removed to accommodate the implant with typical techniques. Loss of healthy bone during a procedure is undesirable. Additionally, preparing the bone to receive the implant(s), and orienting the implant(s) properly adds to surgical complexity and procedure time.

[0007] The present subject matter can provide solutions to these and other problems, such as by providing a cutting instrument that can be coupled to a guide in vivo and actuated to remove bone at a desired orientation and to a desired controlled depth. The present inventors recognize, among other things, that it would be useful to have a selectively attachable and detachable bone cutting instrument such as a planer that couples to a guide positioned in a tibiotalar joint space. This guide can be positioned in a reamed intramedullary canal of the tibia and can access the tibiotalar joint having a defect (e.g., a void) through an incision (approach) at a sole of the foot. The bone cutting instrument can be actuated to cut the tibia and / or talus via a cannulated drive shaft that is inserted over the guide from the distal side of the foot.

[0008] The present inventors recognize that the instruments and techniques of the present application can have various benefits including preparing the bone in a controlled and guided manner so as to achieve a desired alignment for the implant with respect to the intramedullary canal, and hence, the mechanical axis of the tibia. Additionally, the present inventors recognize that such instruments and techniques can allow for a tighter clearance between the implant and the remaining bone so that the bone can grow into the implant more easily and rapidly. In particular, that cutting instrument can be shaped to substantially match a shape and / or size of the implant to be positioned at the tibiotalar joint space. Furthermore, by accessing the tibiotalar joint space by a reamed pathway, the present inventors contemplate that the present instruments and techniques can reduce incision size and reduce the amount of bone needed to be resected to access the joint. This can minimize bone loss and / or reduce discomfort to the patient.

[0009] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others:

[0010] Example 1 is a system for preparing at least one of a tibia and a talus with a defect, optionally comprising: a cutting instrument configured to receive a guide at a tibiotalar joint space, wherein the cutting instrument is configured to resect at least one of the tibia and talus to prepare for an implant; and a shaft configured to couple with the cutting instrument within the tibiotalar joint space.

[0011] In Example 2, the subject matter of Example 1 optionally includes, a reamer configured to access a tibiotalar joint space through an incision at a distal side of a foot and create a reamed intramedullary canal in the tibia; and the guide configured to be insertable into the tibiotalar joint space from the distal side of the foot and insertable along a passage formed by the reamer into the reamed intramedullary canal in the tibia; wherein the shaft is insertable into the tibiotalar joint space from the distal side of the foot, and wherein the shaft is cannulated to be configured to receive at least a portion of the guide.

[0012] In Example 3, the subject matter of Example 2 optionally includes, wherein at least one of the shaft and the reamer is flexible.

[0013] In Example 4, the subject matter of Examples 2-3 optionally includes, wherein the guide has an enlarged head configured to center in the guide with respect to the reamed intramedullary canal and fixate the guide within the reamed intramedullary canal.

[0014] In Example 5, the subject matter of Examples 1-4 optionally includes, wherein the shaft includes visualization indicia to indicate a depth of resection to the at least one of the tibia and talus.

[0015] In Example 6, the subject matter of Examples 1-5 optionally includes, wherein the shaft is configured to actuate rotation and proximal-distal translation of the cutting instrument about the guide.

[0016] In Example 7, the subject matter of Examples 1-6 optionally includes, wherein the cutting instrument is shaped and sized to substantially match a shape and a size of the implant.

[0017] In Example 8, the subject matter of Examples 1-7 optionally includes, wherein the cutting instrument has two opposing cutting surfaces and is configured to form resection planes in both the tibia and talus.

[0018] In Example 9, the subject matter of Examples 1-8 optionally includes, wherein the cutting instrument includes a thru hole passing from a proximal side to a distal side thereof, wherein the cutting instrument includes a slotted opening communicating with the thru hole, and wherein the slotted opening is configured to receive the guide and allow for passage of the guide to the thru hole.

[0019] Example 10 is a method of preparing at least one of a tibia and a talus for an implant, optionally comprising: exposing a tibiotalar joint space from one of a medial access location or lateral access location; reaming a passage in a calcaneus and the talus from a distal side of a foot; passing a cutting instrument into the tibiotalar joint space from one of the medial access location or the lateral access location; inserting a shaft into the tibiotalar joint space from the distal side of the foot; coupling the shaft to the cutting instrument in the tibiotalar joint space; and resecting the at least one of the tibia and the talus with the cutting instrument.

[0020] In Example 11, the subject matter of Example 10 optionally includes, reaming an intramedullary canal of the tibia; placing a guide in the intramedullary canal of the tibia; coupling the cutting instrument to the guide in the tibiotalar joint space; and inserting the shaft over the guide from the distal side of the foot.

[0021] In Example 12, the subject matter of Example 11 optionally includes, wherein the placing the guide in the intramedullary canal of the tibia includes fixating and centering the guide within the intramedullary canal.

[0022] In Example 13, the subject matter of Examples 11-12 optionally includes, wherein the coupling the cutting instrument to the guide includes passing the guide through a slotted side opening and into a thru hole of the cutting instrument.

[0023] In Example 14, the subject matter of Examples 10-13 optionally includes, wherein the resecting the at least one of the tibia and the talus includes cutting both the tibia and the talus with opposing cutting surfaces of the cutting instrument.

[0024] In Example 15, the subject matter of Examples 10-14 optionally includes, wherein the resecting the at least one of the tibia and the talus includes translating the shaft and the cutting instrument proximal and distal within the tibiotalar joint space.

[0025] In Example 16, the subject matter of Examples 10-15 optionally includes, measuring a depth of resection with indicia of the shaft or with one or more trials.

[0026] In Example 17, the subject matter of Examples 10-16 optionally includes, wherein the coupling the shaft to the cutting instrument includes one of: threading a threaded proximal end of the shaft into mating thread of the cutting instrument, snapping the shaft in to a first corresponding feature of the cutting instrument, or quick connecting the shaft with a second corresponding feature of the cutting instrument.

[0027] Example 18 is a cutting instrument for preparing at least one of a tibia and a talus for an implant, optionally comprising: a main body having a thru hole passing from a proximal side to a distal side; a first cutting surface configured to resect the at least one of the tibia and the talus, wherein the first cutting surface forms one of the proximal side or the distal side of the main body; and a coupling feature positioned along the main body for coupling with a shaft.

[0028] In Example 19, the subject matter of Example 18 optionally includes, wherein the main body and cutting surface are shaped and sized to substantially match a shape and a size of the implant.

[0029] In Example 20, the subject matter of Examples 18-19 optionally includes, a second cutting surface configured to resect one of the tibia and the talus, wherein the second cutting surface is on an opposing side of the main body from the first cutting surface.

[0030] In Example 21, the subject matter of Example 20 optionally includes, wherein the main body has a first disk shaped feature at the proximal side that forms the first cutting surface and a second disk shaped feature at the distal side that forms the second cutting surface.

[0031] In Example 22, the subject matter of Examples 18-21 optionally includes, wherein the first cutting surface has one of a substantially planar, hemispherical, conical or frustoconical shape.

[0032] In Example 23, the subject matter of Examples 18-22 optionally includes, wherein the main body forms a slotted opening that communicates with the thru hole.

[0033] Example 24 is at least one machine-readable medium including instructions that, when executed by processing circuitry, cause the processing circuitry to perform operations to implement of any of Examples 1-23.

[0034] Example 25 is an apparatus comprising means to implement of any of Examples 1-23.

[0035] Example 26 is a system to implement of any of Examples 1-23.

[0036] Example 27 is a method to implement of any of Examples 1-23.

[0037] Example 28, is the apparatuses, machine-readable medium, system or method of any one or any combination of Examples 1 - 27 can optionally be configured such that all elements or options recited are available to use or select from.BRIEF DESCRIPTION OF THE FIGURES

[0038] In the drawings, like numerals can be used to describe similar elements throughout the several views. Like numerals having different letter suffixes can be used to represent different views or features of similar elements. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0039] Fig. 1 is a perspective view of a cutting instrument according to an example of the present application.

[0040] Fig. 2 is an example of a first guide and a second guide configured for insertion into a reamed intramedullary canal of a tibia, the second guide can have an enlarged head according to an example of the present application.

[0041] Fig. 3 is a perspective view of a reamer being inserted from a position on a distal side of the foot, the reamer can be configured to create a passage to a tibiotalar joint space and can ream the intramedullary canal of the tibia according to an example of the present application.

[0042] Fig. 4 is a side view of the tibia, a talus and a calcaneus with the first guide of FIG. 2 inserted therein along the passage created by the reamer of FIG. 3.

[0043] Fig. 5 is a side view of the tibia, the talus and the calcaneus with the first guide and the second guide of FIG. 2 inserted therein along the guide of FIG. 4.

[0044] FIG. 6 is a perspective view of the foot with the cutting instrument of FIG. 1 being inserted into and removed from the tibiotalar joint space from an access location to a medial or lateral side of the tibiotalar joint space according to an example of the present application.

[0045] FIG. 7 is a perspective view of the cutting instrument of FIG. 1 receiving the second guide of FIG. 2 in the tibiotalar joint space according to an example of the present application.

[0046] FIG. 8 shows a cannulated shaft being inserted from the distal side of the foot through the passage and along the second guide of FIG. 2 toward the tibiotalar joint space according to an example of the present application.

[0047] FIG. 9 illustrates a proximal end portion of the cannulated shaft of FIG. 8 being coupled with the cutting instrument of FIG. 1 within the tibiotalar joint space according to an example of the present application.

[0048] FIGS. 10A-10C illustrate the cannulated shaft of FIGS. 8 and 9 resecting the tibia and talus in the tibiotalar joint space according to three different examples of the present application.

[0049] FIG. 11 is a flowchart of a method of preparing at least one of a tibia and a talus for an implant according to an example of the present application.

[0050] FIG. 12 is a perspective view of a cutting instrument according to another example of the present application.

[0051] FIG. 13 is a perspective view of another proximal enlarged head feature of a guide configured for insertion into a reamed intramedullary canal of a tibia, according to an example of the present application.

[0052] FIGS. 14A and 14B are perspective views of a cutting instrument according to yet another example of the present application.

[0053] FIGS. 15A and 15B are plan view of an insertion tool coupled with the cutting instrument of FIGS. 14A and 14B according to another example of the present application.

[0054] FIG. 16 is a plan view showing the insertion tool of FIGS. 15A and 15B coupling the cutting instrument of FIGS. 14A and 14B with an instrument according to another example of the present application.

[0055] FIGS. 17 is a perspective view of a proximal end of the instrument of FIG. 16 having a bayonet connection for connection to the cutting instrument of FIGS. 14A and 14B according to an example of the present application.

[0056] FIGS. 18A and 18B are plan views that illustrate coupling of the instrument of FIG. 16 via the bayonet connection to the cutting instrument of FIGS. 14A and 14B according to an example of the present application.

[0057] FIG. 19 is a cross-sectional view that further illustrates the coupling of the instrument of FIG. 16 via the bayonet connection to the cutting instrument of FIGS. 14A and 14B.

[0058] FIG. 20 is a perspective view of the insertion tool of FIGS. 15A and 15B being coupled with a trial spacer according to an example of the present application.

[0059] FIG. 21 shows a system including a plurality of trial spacers according to an example of the present application.

[0060] FIGS. 22 and 23 are plan views showing different implants according to examples of the present application.

[0061] FIG. 24A is a perspective view of an insertion tool being used to grasp the implant of FIG. 23 along a side surface thereof using a coupling feature according to an example of the present application.

[0062] FIG. 24B is an enlarged cross-sectional view of the a portion of the insertion tool of FIG. 24A coupling with the implant of FIG. 23 according to an example of the present application.

[0063] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate examples of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.DETAILED DESCRIPTION

[0064] In describing the examples of the invention(s) illustrated and to be described with respect to the drawings, specific terminology will be used for the sake of clarity. However, the invention(s) are not intended to be limited to any specific terms used herein, and it is to be understood that each specific term includes all technical equivalents. Examples of the present application are described in reference to the tibiotalar joint of a patient. However, it should be recognized that the techniques, methods, systems and instruments described herein can be applicable to other suitable anatomical joints or features of the patient.

[0065] As used herein, the following directional definitions apply. Anterior and posterior mean nearer the front or nearer the rear of the body, respectively, proximal and distal mean nearer to or further from the root of a structure such as the center of the body, respectively, and medial and lateral mean nearer the sagittal plane or further from the sagittal plane, respectively. The sagittal plane is an imaginary vertical plane through the middle of the body or a body structure that divides the body or body structure into right and left halves. In addition, the terms implant and prosthesis, and variations thereof, can be used interchangeably and can include augments, fixation instruments such as intramedullary nail, compression device, fusion spacers, bone void fillers, bone graft(s) or other suitable known implantable devices.

[0066] The present disclosure is directed to intramedullary instruments, surgical techniques and instrument systems for preparing at least one of a tibia and a talus for an implant. The implant can be a bone augment(s) that can be used to replace and / or augment a patient’s bone. As anexample, the instruments, instrument systems, techniques described herein can prepare the bone for implantation of the bone augment(s) used to replace and / or augment a patient’s talus in the ankle and / or replace and / or augment part of the tibia e.g., in instances where such bone is diseased or damaged).

[0067] FIG. 1 shows a cutting instrument 100 according to an example of the present application. The cutting instrument 100 can be configured as a bone cutter such as a head of a reamer, a planar or other suitable bone cutting tool. According to some embodiments, the cutting instrument 100 can be shaped and sized to substantially match a shape and a size of the implant (not shown). The cutting instrument 100 can include a main body 102, a first cutting surface 104 and a second cutting surface 106. The cutting instrument 100 can also include a proximal side 108, a distal side 110, a first head 112, a second head 114, a thru hole 116, a slotted opening 118 and a coupling feature 120. The first cutting surface 104 and the second cutting surface 106 can include a plurality of passages 122 and bone cutting features 124.

[0068] The cutting instrument 100 can have a centerline axis CL extending from the proximal side 108 to the distal side 110. The thru hole 116 can be positioned to extend along the centerline axis CL. The main body 102 can be generally cylindrical or a tapered cylinder and can extend between the first cutting surface 104 and the second cutting surface 106. The first cutting surface 104 can be opposite the second cutting surface 106. The first cutting surface 104 can be positioned at the proximal side 108 and the second cutting surface 106 can be at the distal side 110. The first cutting surface 104 can be an outer surface of the main body 102 or can be and outer surface of the first head 112, for example. Similarly, the second cutting surface 106 can be an outer surface of the main body 102 or an outer surface of the second head 114. Although both the first cutting surface 104 and the second cutting surface 106 are shown in FIG. 1, other examples contemplate the cutting instrument has only a single cutting surface or three or more cutting surfaces. As an example, the diameter of the first cutting surface 104 and / or the second cutting surface can be between 20 mm and 40 mm. A height of the cutting instrument 100 in a proximal -distal direction can be substantially 10 mm. However, other sizes including other heights are contemplated.

[0069] The first head 112 and the second head 114 can be features of the main body 102 or can be a separate features or components that are mechanically joined to the main body 102. The first head 112 and the second head 114 can be generally disk shaped, having a substantially truncated circular shape in cross-section and can have a relatively smaller thickness in a proximal-distal direction as compared with a radial direction, for example. The first cutting surface 104 and the second cutting surface 106 can be substantially planar (i.e., flat) save for the plurality of passages 122 and the bone cutting features 124. However, other examples contemplate the first head 112 and / or the second head 114 can have a different shape such as, for example, pyramidal, conical, frustoconical, hemispherical or other shape. Thus, the first cutting surface 104 and / or the second cutting surface 106 can have one of a substantially planar, hemispherical, conical, frustoconical shape or other shape as desired.

[0070] The thru hole 116 can have an opening at the first cutting surface 104 and a second opening at the second cutting surface 106. The slotted opening 118 can extend through portions of the main body 102, the first head 112 and the second head 114. The slotted opening 118 can have openings at the proximal side 108, the distal side 110 and a third side 126 of the cutting instrument 100. The third side 126 can be located between the proximal side 108 and the distal side 110. The slotted opening 118 can communicate with the thru hole 116 and provide a lateral or medial opening at the third side 126 to the thru hole 116.

[0071] The coupling feature 120 can be formed by any one or combination of the main body 102, the first head 112 and / or the second head 114. The coupling feature 120 can be threads 120A, for example, along a diameter of the thru hole 116. However, other suitable mechanical coupling connections (e.g., interference fit, bayonet, quick-connect, snap-in, etc.) and features (e.g., tab, etc.) other than or in addition to threads are also contemplated as known in the art.

[0072] The first cutting surface 104 and the second cutting surface 106 can be configured as a grater, for example, to cut and allow for passage of bone when performing a resection(s). The plurality of passages 122 can be thru holes, slots or other apertures that pass thru the first head 112 and / or the second head 114. The plurality of passages 122 can extend from the first cutting surface 104 distally. The plurality of passages 122 can extend from the second cutting surface 106 proximally. The plurality of passages 122 can be configured to allow for passage of cut bone away from the first cutting surface 104 and the second cutting surface 106 such as to the area radially outward of and around the main body 102. The bone cutting features 124 can be raised blade-like surfaces along one or more edges of the plurality of passages 122. The bone cutting features 124 can be form edge(s) of the plurality of passages 122, for example.

[0073] FIG. 2 shows a guide assembly 200 according to one example. The guide assembly 200 can include a first guide 202 and a second guide 204. Only proximal end portions of the firstguide 202 and the second guide 204 are shown in FIG. 2. Although shown as two distinct guides in FIG. 2, other examples contemplate a single guide can be utilized. The first guide 202 can be a guidewire such as K-wire or the like. The first guide 202 can be cannulated so as to fit over another smaller diameter guidewire, for example. In other examples, the first guide 202 may not be cannulated. The first guide 202 can have an enlarged head 206 with a larger diameter at a proximal end 208. The enlarged head 206 can be tapered or otherwise shaped so as to engage with a reamed intramedullary canal of the tibia, for example. The enlarged head 206 can provide a stop for the second guide 204. Although the guides shown herein are described as wire they could be a screw, post, pin, or other device according to some examples.

[0074] The second guide 204 can be cannulated to receive and pass over most portions of the first guide 202 save for the enlarged head 206. The second guide 204 can be configured as a guidewire having a shaft portion 210 that is distal of an enlarged head 212 with a larger diameter at the proximal end 208. The enlarged diameter head 212 can engage or can be spaced slightly distal from the enlarged head 206. The enlarged head 212 can be shaped as a bullet or other enlarged tapered, chamfered, curved or radiused component. The enlarged head 212 can have opposing tapered surfaces. Thus, the enlarged head 212 can have a first tapered portion 214, a maximum diameter portion 216 and a second tapered portion 218. The first tapered portion 214 can have a decreasing diameter traveling from the maximum diameter portion 216 proximally to the proximal end 208. The second tapered portion 218 can have an increasing diameter traveling from a distal most part of the enlarged head 212 proximally to the maximum diameter portion 216. The enlarged head 212 can be configured (shaped and sized) to center in the guide assembly 200 with respect to a reamed intramedullary canal of the tibia and can fixate the guide assembly 200 within the reamed intramedullary canal of the tibia. The second guide 204, and indeed the first guide 202, can be available in a range of different sizes. For example, the second guide 204 at the enlarged head 212 at the maximum diameter portion 216 can have diameters of 11 mm, 12 mm and 13 mm.

[0075] FIG. 3 shows a part of an example surgical method 300. Further examples of the surgical method 300 and / or other surgical methods are discussed in reference to FIGS. 3-12. FIG. 3 shows a third guide 302 such as a K-wire inserted in a calcaneus 304, a talus 306 and a tibia 308. FIG. 3 additionally shows a reamer 310 being inserted into the foot 312 along the third guide 302 from a position on a distal side of the foot 312. The reamer 310 can be configured to create apassage to a tibiotal ar joint space and can be configured to ream the calcaneus 304, the talus 306 and the intramedullary canal of the tibia 308 to receive the guide assembly 200 of FIG. 2 and an implant such as an intramedullary nail, for example. In some examples, the reamer 310 can be flexible so as to bend or curve to form a curved passage through the bone.

[0076] FIG. 4 shows a side view of the tibia 308, the talus 306 and the calcaneus 304 with the first guide 202 (previously discussed in FIG. 2) inserted therein along the passage created by the reamer 310 of FIG. 3. The first guide 202 extends into the reamed intramedullary canal of the tibia 308, and additionally, through a tibiotalar joint space 314, which as been created by resecting portions of the tibia 308 and the talus 306.

[0077] FIG. 5 shows the side view of the tibia 308, the talus 306 and the calcaneus 304 with the second guide 204 inserted over the first guide 202 (as previously discussed in FIG. 2). The second guide 204 can be inserted into the reamed intramedullary canal along the passage created by the reamer 310 of FIG. 3. The second guide 204 can have a head or other features that centers the second guide 204 (and the entire guide assembly 200) with respect to the reamed intramedullary canal of the tibia 308 and can fixate the second guide 204 (and the entire guide assembly 200) within the reamed intramedullary canal of the tibia 308.

[0078] FIG. 6 shows an example of the cutting instrument 100 being inserted into (or removed from) the tibiotalar joint space 314 between the tibia 308 and the talus 306 via a lateral or medial access incision 316. FIG. 6 additionally shows a portion of the second guide 204 extending within the tibiotalar joint space 314. The cutting instrument 100 is configured to receive the second guide 204 via the slotted opening 118 and thru hole 116 in one example. FIG. 7 shows the cutting instrument 100 coupled to the second guide 204 within the tibiotalar joint space 314 via the slotted opening 118 and thru hole 116 having received the second guide 204 therein.

[0079] FIG. 8 shows an instrument 400 having a cannulated shaft 402 being inserted from the distal side of the foot 312 through the passage and along the second guide 204 toward the tibiotalar joint space 314. Thus, the cannulated shaft 402 can be configured to receive at least a portion of second guide 204 therein. The cannulated shaft 402 can be flexible according to some examples to follow a curved passageway if desired.

[0080] A proximal end portion 404 of the cannulated shaft 402 can include a coupling head 406 having a thread 408 or other mechanical connection feature(s) such as a snap-in or quickconnect feature(s). The coupling head 406 with the thread 408 can be for coupling with thecoupling feature 120 of the cutting instrument 100 as shown in FIG. 9. FIG. 9 shows the coupling head 406 of the cannulated shaft 402 being threaded into attachment with the coupling feature 120 (the threads 120A) of the cutting instrument 100 for mechanical connection between the cannulated shaft 402 and the cutting instrument 100.

[0081] FIGS. 10A-10C show the tibiotalar joint space 314 having three different sizes 314A (FIG. 10A), 314B (FIG. 10B) and 314C (FIG. 10C) requiring different sizes of implant. FIG. 10A shows the cutting instrument 100 performing a 10 mm implant cut. FIG. 10B shows the cutting instrument 100 performing a 15 mm implant cut. FIG. 10C shows the cutting instrument 100 performing a 35 mm implant cut. The cannulated shaft 402 can include indicia 410 for visualization distal of the proximal end. The indicia 410 can be in 5 mm increments, for example. The indicia 410 can indicate a depth of insertion of the cannulated shaft 402 into the bone, and hence, a size of the implant required after cutting the bone.

[0082] FIGS. 10B and 10C additionally show that the cannulated shaft 402 and the attached bone cutting instrument 100 can be translated (in addition to being rotated) as indicated by arrows Al in performing the cutting. The translation (pistoning proximal-distal, for example) of the cutting instrument 100 via the cannulated shaft 402 can resect both of the spaced apart surfaces of the tibia 308 and the talus 306 using the two spaced apart and opposing cutting surfaces of the cutting instrument 100. Thus, the cannulated shaft 402 can be configured to actuate rotation and proximal-distal translation of the cutting instrument 100 about the second guide 204 as shown in FIGS. 10B and 10C.

[0083] FIG. 11 shows a surgical method 500 of preparing at least one of a tibia and a talus for an implant. The surgical method 500 can create a surgical exposure to access the tibiotalar joint 502. This exposure can be lateral or medial of the tibiotalar joint, for example. The tibiotalar and subtalar joints can be resected 504 to create the tibiotalar joint space. This can be via the surgical exposure and can be performed using standard resection instruments. A guidewire such as a K- wire can be inserted into the foot, the tibiotalar joint space and / or the intramedullary canal of the tibia 506. At least the calcaneus and the talus can be reamed 508. The guidewire can be removed and replaced by a guidewire such as the first guide 202 of FIG. 2 at step 510. The tibial canal can be reamed to a desired size 512. The second guide 204 of FIG. 2 can be placed in the reamed tibial canal such as over the first guide 202 of FIG. 2 at step 514. The cutting instrument can be placed over the guidewire (e.g., the second guide) between the tibia and talus 516. The cannulated shaftcan be introduced to the tibiotalar joint space over the guidewire and through the reamed passageway 518. The cannulated shaft can be coupled to the cutting instrument within the tibiotalar joint space 520. Resection(s) can be performed using the cutting instrument as actuated by the cannulated shaft 522. The cannulated shaft can be uncoupled from the cutting instrument 524 and removed. Implants such as augments, bone substitute, an intramedullary rod and / or other devices can then be implanted in the prepared bone of the tibiotalar joint space 526.

[0084] FIG. 12 shows another example of a cutting instrument 600 that is modified so as not to use the plurality of passages 122 and the bone cutting features 124 of FIG. 1 but rather utilizes an array of toothed blades 624 as cutting features.

[0085] Augments contemplated by the present disclosure, as an example can be created to fill between a five millimeter (5 mm) and a fifty millimeter (50 mm) void in bone, merely as examples. Thus, the cutting instruments contemplated can be appropriately sized and variously shaped according to the augment(s) shape and size. The augment(s) can be used in instances where amputation might be a consideration because of, for instance, a failed ankle replacement or cancer resulting in significant amounts of diseased or degraded bone.

[0086] FIG. 13 illustrates another example of an enlarged head 1212 that can be used with the guide assembly 200 of FIG. 2 according to one example. The enlarged diameter head 1212 can engage or can be spaced slightly distal from the enlarged head 206 of FIG. 2. The enlarged head 1212 can be shaped as a bullet or other enlarged tapered, chamfered, curved or radiused component. The enlarged head 1212 can have single arcuate ortapered surface. Thus, the enlarged head 1212 can have a first curved portion 1214, and a second portion 1216 having a relatively constant diameter. The second portion 1216 can have an extended elongate length relative to the first curved portion 1214. The enlarged head 1212 can be configured (shaped and sized) to center in the guide assembly 200 (FIG. 2) with respect to a reamed intramedullary canal of the tibia and can fixate the guide assembly 200 (FIG. 2) within the reamed intramedullary canal of the tibia. The enlarged head 1212 can be available in a range of different sizes. For example, the enlarged head 1212 can have diameters of 11 mm, 12 mm and 13 mm.

[0087] FIGS. 14A and 14B are perspective views of another example of a cutting instrument 1100 according to an example of the present application. The cutting instrument 1100 can be similar in construction to the cutting instrument 100 (FIG. 1) described previously but can differ in several ways therefrom. The cutting instrument 1100 can be configured as a bone cutter suchas a head of a reamer, a planar or other suitable bone cutting tool. According to some embodiments, the cutting instrument 1100 can be shaped and sized to substantially match a shape and a size of the implant (not shown). The cutting instrument 1100 can include a main body 1102, a first cutting surface 1104 and a second cutting surface 106. The cutting instrument 1100 can also include a proximal side 1108, a distal side 1110, a thru hole 1116, a slotted opening 1118 and a coupling feature 1120 (shown in FIG. 14A but shown in further detail subsequently). The first cutting surface 1104 and the second cutting surface 1106 can include a plurality of passages 1122, a plurality of grooves 1123 and bone cutting features 1124 such as blades 1124A.

[0088] Rather than include a first head and a second head as with the cutting instrument 100 of FIG. 1, the cutting instrument of FIGS. 14A and 14B can include the main body 1102 that forms many of the features discussed. The cutting instrument 1100 can have a centerline axis CL extending from the proximal side 1108 to the distal side 1110. The thru hole 1116 can be positioned to extend along the centerline axis CL. The main body 1102 can be generally cylindrical or a tapered cylinder and can extend between the first cutting surface 1104 and the second cutting surface 1106. The first cutting surface 1104 can be opposite the second cutting surface 1106. The first cutting surface 1104 can be positioned at the proximal side 1108 and the second cutting surface 1106 can be at the distal side 1110. The first cutting surface 1104 can be an outer surface of the main body 1102 and can include surfaces / edges defined by the bone cutting features 1124, for example. Similarly, the second cutting surface 1106 can be an outer surface of the main body 1102 can include surfaces / edges defined by the bone cutting features 1124. Although both the first cutting surface 1104 and the second cutting surface 1106 are shown in FIG. 1, other examples contemplate the cutting instrument has only a single cutting surface or three or more cutting surfaces. As an example, the diameter of the first cutting surface 1104 and / or the second cutting surface 1106 can be between 20 mm and 40 mm. A height of the cutting instrument 1100 in a proximal-distal direction can be substantially 10 mm. However, other sizes including other heights are contemplated.

[0089] The main body 1102 can additionally define the thru hole 1116, the slotted opening 1118 the coupling feature 1120, the plurality of passages 1122, the plurality of grooves 1123 and the bone cutting features 1124. However, some of these according to further examples could be part of dedicated heads similar to those of the example of FIG. 1. The main body 1102 can be generally cylindrically shaped. The first cutting surface 1104 and the second cutting surface 1106can be substantially planar (i.e., flat) save for the plurality of passages 1122, the plurality of grooves 1123 and the bone cutting features 1124. However, other examples contemplate other shapes for the main body 1102 such as, for example, pyramidal, conical, frustoconical, hemispherical or other shape. Thus, the first cutting surface 1104 and / or the second cutting surface 1106 can have one of a substantially planar, hemispherical, conical, frustoconical shape or other shape as desired.

[0090] The thru hole 1116 can have an opening at the first cutting surface 1104 and a second opening at the second cutting surface 1106. The slotted opening 1118 can extend through portions of the main body 1102. The slotted opening 1118 can have openings at the proximal side 1108, the distal side 1110 and a third side 1126 (side surface) of the cutting instrument 1100. The third side 1126 can be located between the proximal side 1108 and the distal side 1110. The slotted opening 1118 can communicate with the thru hole 1116 and provide a lateral or medial opening at the third side 1126 to the thru hole 1116.

[0091] The coupling feature(s) 120 can be formed by the main body 1102. The coupling feature 1120 and can be a bayonet type connection as further described and illustrated. The coupling feature 1120 can be located along a diameter of the thru hole 1116. However, other suitable mechanical coupling connections (e.g., threaded, interference fit, stylet, snap-in, etc.) and features (other than or in addition to the bayonet) are also contemplated as known in the art.

[0092] Rather than having the grater type configuration as in the example of FIG. 1, in FIGS. 14A and 14B the first cutting surface 1104 and the second cutting surface 1106 can be configured with the cutting features 1124 configured as the outward extending blades 1124A. The blades 1124A can extend from at or adjacent the thru hole 1116 to an outer edge of each of the first cutting surface 1104 and the second cutting surface 1106. The cutting features 1124 are configured to cut bone. Additionally, the plurality of passages 1122 and the plurality of grooves 1123 allow for passage of bone when performing a resection(s). The plurality of passages 1122 can be thru holes, slots or other apertures that pass thru the main body 1102. The plurality of grooves 1123 can be positioned adjacent the cutting features 1124 and can extend generally parallel therewith (e.g., angulated so as to be spaced a distance from the centerline axis CL and extending outward from the thru hole 1116 to the outer surface 1126. Additionally, the plurality of grooves 1123 can communicate and intersect with the plurality of passages 1122 to communicate bone received in the plurality of grooves 1123 into the plurality of passages 1122. The plurality of passages 1122can extend from the first cutting surface 1104 distally. The plurality of passages 1 122 can extend from the second cutting surface 1106 proximally. Each of the passages 1122 can have an opening 1122A (outlet) located at the side surface 1126. These openings 1122A can allow bone fragments to pass from the cutting instrument 1100 generally radially outward. The plurality of passages 1122 via the openings 1122A can be configured to allow for passage of cut bone away from the first cutting surface 1104 and the second cutting surface 1106 such as to the area radially outward of and around the main body 1102. The bone cutting features 1124 can be raised blade-like surfaces extending generally in a straight line manner along the plurality of grooves 1123 above a remainder of the first cutting surface 1104 and the second cutting surface 1106. The bone cutting features 1124 can be form edge(s) of the plurality of grooves 1123, for example.

[0093] As shown in FIGS. 14A and 14B, the cutting instrument 1100 can additionally include a connection feature 1128 located along or adjacent the outer surface 1126 and communicating therewith. The connection feature 1128 can be used for coupling of the cutting instrument 1100 with an insertion tool as further described and illustrated herein.

[0094] FIGS. 15A and 15B show the connection feature 1128 (shown in FIG. 15B only) being used to couple the cutting instrument 1100 with an insertion tool 1300. The insertion tool 1300 can be used to insert the cutting instrument 1110 into the joint as illustrated and described previously with regard to FIG. 6, for example.

[0095] FIG. 16 shows the insertion tool 1300 being used to couple the cutting instrument 1100 to an instrument 1400. The instrument 1400 can be configured in a manner similar to that of the instrument 400 described in regard to FIGS. 8-10C.

[0096] FIG. 17 shows further details of the instrument 1400 including a bayonet connection 1401 used at a proximal end thereof. The instrument 1400 can additionally comprise a cannulated shaft 1402 being inserted from the distal side of the foot as previously described and illustrated along the second guide 204 (FIG. 8) toward the tibiotalar joint space 314 (FIG. 8). Thus, the cannulated shaft 1402 can be configured to receive at least a portion of second guide 204 (FIG. 8) therein. The cannulated shaft 1402 can be flexible according to some examples to follow a curved passageway if desired.

[0097] FIGS. 18A and 18B show a process of inserting, aligning and then rotating the bayonet connection 1401 of the instrument 1400 relative to the coupling feature 1120 (FIG. 18A) to accomplish connection of the cutting instrument 1100 with the instrument 1400. FIG. 19 furtherillustrates in cross-section a locked connection between the cutting instrument 1100 and the instrument 1400 using the bayonet connection 1401 and the coupling feature 1120. The joint can then be resected in the manner illustrated previously in FIGS. 10A-10C.

[0098] FIG. 20 shows the insertion tool 1300 coupled to insert a spacer trial 1500B. The spacer trial 1500B can be sized (e.g., have a width and / or thickness) to simulate a size of the implant (shown subsequently). The spacer trial 1500B can be inserted in the joint space once the joint space has been prepared using the cutting instrument 100, 600 or 1100 as previously described.

[0099] FIG. 21 shows a system 1502 of a plurality of spacer trials 1500A and 1500B. Although FIG. 21 shows two spacer trials, other examples contemplate these spacer trials 1500A and 1500B available in two or more different longitudinal lengths (e.g., thicknesses) and / or two or more widths (diameters) according to some examples. Thus, the plurality of spacer trials can include about a 10 mm thickness, 15 mm thickness, 20 mm thickness, 60 mm thickness, 25 mm diameter, 35 mm diameter, etc. The plurality of spacer trials 1500A and 1500B can include coupling features 1504A and 1504B, respectively, for connection to the insertion tool 1300 as shown previously in FIG. 20. Each of the plurality of spacer trials 1500A and 1500B can include a slot 1506 extending from a proximal surface 1508 to a distal surface 1510. The slot 1506 can be configured to receive the guide assembly 200 or second guide assembly as previously described.

[0100] FIG. 22 shows a first example of an implant 1600A according to a first example. The implant 1600A can be an augment 1602A, for example. However, other examples according to the present application contemplate other components in alternative to the augment 1602A. The implant 1600A includes a first thickness T1 and a first diameter DI.

[0101] FIG. 23 shows a second example of an implant 1600B according to another example. The implant 1600B can be an augment 1602B, for example. However, other examples according to the present application contemplate other components in alternative to the augment 1602B. The implant 1600B includes a second thickness T2 and a second diameter D2 that differ from that of the first implant 1600A of FIG. 22.

[0102] As shown in FIGS. 22 and 23, the implants 1600A and 1600B can additionally include coupling features 1604 on side surfaces 1606 thereof. The implants 1600A and 1600B can include other features such as apertures, slots, etc. to induce bone ingrowth and on-growth, for example. Turning to FIGS. 24A and 24B, these Figures illustrate an inserter 1700 being used to grasp the implant 1600B for insertion into the joint space. Such grasping can be via the coupling features1604 using prongs or figures of the inserter 1700 inserted into the coupling features 1604 (e.g., slots).

[0103] The above Detailed Description includes references to the accompanying drawings, which form a part of the Detailed Description. The drawings show, by way of illustration, specific embodiments in which the handle assembly and related methods can be practiced. These embodiments are also referred to herein as “examples.”

[0104] The above Detailed Description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more elements thereof) can be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. Also, various features or elements can be grouped together. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter can lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

[0105] In this document, the terms “a” or “an” are used to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, “anterior” refers to a direction generally toward the front of a patient, “posterior” refers to a direction generally toward the back of the patient, “medial” refers to a direction generally toward the middle of the patient, and “lateral” refers to a direction generally toward the side of the patient. In this document, the phrase “anterior / posterior direction” is used to include an anterior to posterior direction or a posterior to anterior direction.

[0106] In the appended claims, the terms “generally”, “substantially” and “about” mean within ± 15% of the example described. The terms “including” and “in which” are used as the plain- English equivalents of the respective terms “comprising” and “wherein.” The terms “including” and “comprising” are open-ended, that is, an apparatus, system, kit, or method that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,”etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0107] It will be readily understood to those skilled in the art that various other changes in the details, material, and arrangements of the parts and method stages which have been described and illustrated in order to explain the nature of the inventive subject matter can be made without departing from the principles and scope of the inventive subject matter as expressed in the subjoined claims. For example, the order of method steps or stages can be altered from that described above, as would be appreciated by a person of skill in the art.

[0108] It will also be appreciated that the various dependent claims, examples, and the features set forth therein can be combined in different ways than presented above and / or in the initial claims. For instance, any feature(s) from the above examples can be shared with others of the described examples, and / or a feature(s) from a particular dependent claim may be shared with another dependent or independent claim, in combinations that would be understood by a person of skill in the art.

Claims

WHAT IS CLAIMED IS:

1. A system for preparing at least one of a tibia and a talus with a defect, comprising: a cutting instrument configured to receive a guide at a tibiotalar joint space, wherein the cutting instrument is configured to resect at least one of the tibia and talus to prepare for an implant; and a shaft configured to couple with the cutting instrument within the tibiotalar joint space.

2. The system of claim 1, further comprising: a reamer configured to access a tibiotalar joint space through an incision at a distal side of a foot and create a reamed intramedullary canal in the tibia; and the guide configured to be insertable into the tibiotalar joint space from the distal side of the foot and insertable along a passage formed by the reamer into the reamed intramedullary canal in the tibia; wherein the shaft is insertable into the tibiotalar joint space from the distal side of the foot, and wherein the shaft is cannulated to be configured to receive at least a portion of the guide.

3. The system of claim 2, wherein at least one of the shaft and the reamer is flexible.

4. The system of any one of claims 2-3, wherein the guide has an enlarged head configured to center in the guide with respect to the reamed intramedullary canal and fixate the guide within the reamed intramedullary canal.

5. The system of any one of claims 1-4, wherein the shaft includes visualization indicia to indicate a depth of resection to the at least one of the tibia and talus.

6. The system of any one of claims 1-5, wherein the shaft is configured to actuate rotation and proximal-distal translation of the cutting instrument about the guide.

7. The system of any one of claims 1-6, wherein the cutting instrument is shaped and sized to substantially match a shape and a size of the implant.

8. The system of any one of claims 1-7, wherein the cutting instrument has two opposing cutting surfaces and is configured to form resection planes in both the tibia and talus.

9. The system of any one of claims 1-8, wherein the cutting instrument includes a thru hole passing from a proximal side to a distal side thereof, wherein the cutting instrument includes a slotted opening communicating with the thru hole, and wherein the slotted opening is configured to receive the guide and allow for passage of the guide to the thru hole.

10. A method of preparing at least one of a tibia and a talus for an implant, comprising: exposing a tibiotalar joint space from one of a medial access location or lateral access location; reaming a passage in a calcaneus and the talus from a distal side of a foot; passing a cutting instrument into the tibiotalar joint space from one of the medial access location or the lateral access location; inserting a shaft into the tibiotalar joint space from the distal side of the foot; coupling the shaft to the cutting instrument in the tibiotalar joint space; and resecting the at least one of the tibia and the talus with the cutting instrument.

11. The method of claim 10, further comprising: reaming an intramedullary canal of the tibia; placing a guide in the intramedullary canal of the tibia; coupling the cutting instrument to the guide in the tibiotalar joint space; and inserting the shaft over the guide from the distal side of the foot.

12. The method of claim 11, wherein the placing the guide in the intramedullary canal of the tibia includes fixating and centering the guide within the intramedullary canal.

13. The method of any one of claims 11-12, wherein the coupling the cutting instrument to the guide includes passing the guide through a slotted side opening and into a thru hole of the cutting instrument.

14. The method of any one of claims 10-13, wherein the resecting the at least one of the tibia and the talus includes cutting both the tibia and the talus with opposing cutting surfaces of the cutting instrument.

15. The method of any one of claims 10-13, wherein the resecting the at least one of the tibia and the talus includes translating the shaft and the cutting instrument proximal and distal within the tibiotalar joint space.

16. The method of any one of claims 10-15, further comprising measuring a depth of resection with indicia of the shaft or with one or more of a plurality of trials.

17. The method of any one of claims 10-16, wherein the coupling the shaft to the cutting instrument includes one of: threading a threaded proximal end of the shaft into mating thread of the cutting instrument, snapping the shaft in to a first corresponding feature of the cutting instrument, or quick connecting the shaft with a second corresponding feature of the cutting instrument.

18. A cutting instrument for preparing at least one of a tibia and a talus for an implant, comprising: a main body having a thru hole passing from a proximal side to a distal side; a first cutting surface configured to resect the at least one of the tibia and the talus, wherein the first cutting surface forms one of the proximal side or the distal side of the main body; and a coupling feature positioned along the main body for coupling with a shaft.

19. The cutting instrument of claim 18, wherein the main body and cutting surface are shaped and sized to substantially match a shape and a size of the implant.

20. The cutting instrument of any one of claims 18-19, further comprising a second cutting surface configured to resect one of the tibia and the talus, wherein the second cutting surface is on an opposing side of the main body from the first cutting surface.

21. The cutting instrument of any one of claims 18-20, wherein the first cutting surface has one of a substantially planar, hemispherical, conical or frustoconical shape.

22. The cutting instrument of any one of claims 18-21, wherein the main body forms a slotted opening that communicates with the thru hole.

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