Patient-specific instruments and methods for ankle arthroplasty

Abstract

A patient-specific guide system and method for performing bone resection for ankle arthroplasty includes a bone guide device body and a bone resection block. The bone guide device body includes a patient-specific surface for engaging a surface of a talus or tibia, and a first pin hole and a first socket in the bone guide device body. The bone resection block is removably inserted into the first socket, receives a first pin insertable into the first pin hole, and includes a resection guide surface. The system further includes a floating bone trial attached to the bone resection block via a floating bone guide device. The floating bone trial receives a chamfer spacer and a guide device for further resection of the bone. The system further includes a pen needle for engagement with the resection guide surface to confirm a resection depth. The bone guide device body includes an alignment pin and a resection block snap lock feature.

Description

[0001] Priority requirements

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 923,301, filed October 18, 2019, and claims priority to it, the entire contents of which are incorporated herein by reference. Background Technology

[0003] This disclosure relates to devices and methods used in performing ankle arthroplasty, such as total ankle replacement.

[0004] Patient-specific instruments have been successfully used in many surgical procedures. By creating a three-dimensional (3D) model of a patient's anatomy from medical images, surgery can be customized using a virtual 3D surgical plan tailored to the specific patient. This virtual 3D surgical plan can be used to generate patient-specific cutting guides and instruments that are uniquely adapted to the specific patient's anatomy, allowing for precise replication of the planned procedure, compared to arthroplasty using conventional instruments.

[0005] Lian’s patent No. 8,337,503 and Mahfouz’s patent No. 2016 / 0361071 describe cutting guide devices and instruments for total ankle replacement surgery. Summary of the Invention

[0006] The inventors have recognized that the problems to be solved may include designing patient-specific surgical guidance devices capable of performing resections of different sizes. For example, a cutting guide surface or slot for bone resection can be designed to generate standard, wide, or narrow incisions based on the dimensions of a particular patient's anatomy. Sometimes, the required resection size cannot be determined during surgery before the bone is reached. If the dimensions of the anatomy differ from the surgical plan, for example, if a different sized cutting surface is required, it may sometimes be necessary to revert to using standard, non-patient-specific instruments, which can lead to a more complex, time-consuming process and potentially less accurate resections. Alternatively, producing multiple patient-specific devices due to uncertainty can be both expensive and wasteful.

[0007] The inventors also recognize that the problems to be solved may include damage to patient-specific devices during resection. Patient-specific devices can typically be made of materials that are easily molded to the contours of a particular patient's anatomy. However, such materials may be softer than bone and therefore may be accidentally cut during resection. This can lead to modifications of the surgical plan or potentially unsuitable implants.

[0008] This topic can help provide solutions to these and other problems, for example, by providing modular, patient-specific instruments where only the bone-jointing portion is patient-specific, while other parts can be generic for the surgical system being implanted. For instance, cutting guide components with cutting surfaces or slots can be manufactured in different sizes but have a common interface for engaging the bone joint (for joining the bone) and for the patient-specific component. In this way, cutting guide components can be mass-produced and reusable, while only a single, disposable patient-specific component is produced for each patient. Furthermore, cutting guide components can be made of a rigid material capable of withstanding engagement from cutting tools, thus protecting both the bone and the patient-specific portion.

[0009] In one example, a patient-specific guiding system for performing talar resection in total ankle arthroplasty may include a talar guide body, a talar resection block, a floating talar guide, and a floating talar specimen. The talar guide body may include a first patient-specific surface for engaging at least a portion of the anterior surface of the talus, a first pin hole extending through the talar guide body, and a first socket extending into the talar guide body. The talar resection block may include a connecting block removably insertable into the first socket, a second pin hole configured to align with the first pin hole, and a guide block including a resection guiding surface. The floating talar guide may be connected to the talar resection block and is configured to extend beyond the first patient-specific surface. The floating talar specimen may be connected to the floating talar guide, the floating talar specimen including a support surface and configured to extend coplanar with the resection guiding surface.

[0010] In another example, a method for performing total ankle arthroplasty may include removing a portion of the tibia, attaching a patient-specific talus guide body to the upper portion of the talus, attaching a size-specific talus cutting block to the patient-specific talus guide body, removing the upper portion of the talus, attaching a talus test component to the talus cutting block, determining the position of the talus test component, attaching the talus test component to the talus, removing the talus cutting block and the patient-specific talus guide body from the talus, chamfering the anterior portion of the talus using a chamfering guide attached to the talus test component, and attaching a prosthetic ankle component to the removed tibia and talus.

[0011] In another example, a patient-specific guiding device for performing osteotomy in total ankle arthroplasty may include a bone guiding device body and a bone resection block. The bone guiding device body may include a patient-specific surface for engaging a talus or tibial surface, a first pin hole extending through the bone guiding device body, and a first socket extending through the bone guiding device body. The bone resection block may be removably inserted into the first socket and configured to receive a first pin that can be inserted into the first pin hole. The bone resection block may also include a resection guiding surface.

[0012] This overview is intended to provide an overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. Detailed descriptions are included to provide further information regarding this patent application. Attached Figure Description

[0013] Figure 1 This is a perspective view of a tibial cutting guide device for total ankle arthroplasty, according to an example of this disclosure.

[0014] Figure 2 This is a perspective view of a talus cutting guide device for total ankle arthroplasty according to an example of this disclosure.

[0015] Figure 3A This is a schematic diagram of a prosthetic ankle component implanted in the tibia and talus.

[0016] Figure 3B , 3C 3D and 3D are respectively Figure 3A A perspective view of the tibial support component, tibial support component, and talus support component of a prosthetic ankle component, which is used as a device utilizing... Figure 1 and Figure 2 Total ankle replacement prostheses implanted with tibial cutting guide devices and talus cutting guide devices.

[0017] Figure 4 yes Figure 1 A front view of the patient-specific tibial guide body of the tibial cutting guide device.

[0018] Figure 5 Is Figure 4 An exploded perspective view of the hardware components used in a patient-specific tibial guide device.

[0019] Figure 6A , 6B 6C and 6D are Figure 5 After the hardware was removed Figure 4 The front, side, rear and perspective views of the patient-specific tibial guide device body.

[0020] Figure 6E yes Figure 4 A bottom perspective view of the patient-specific tibial guide device body, in which the aforementioned hardware is installed.

[0021] Figure 6F This is a schematic diagram of the main body of a patient-specific tibial guiding device with a tibial resection block attached thereto.

[0022] Figure 7A , 7B 7C and 7D are used with Figure 4The patient-specific tibial guide device body is used together with the front view, side view, top view and perspective view of the tibial resection block.

[0023] Figure 8A , 8B 8C and 8D are Figure 2 The front, side, top, and perspective views of the patient-specific talus cutting guide device.

[0024] Figure 8E yes Figures 8A-8D A top view of the patient-specific talus guide body, with the tenon removed to show the locking mechanism.

[0025] Figure 8F and 8G yes Figure 8E The rear and bottom views of the patient-specific talus guide body show the patient-specific contact surface.

[0026] Figure 9A , 9B 9C and 9D are side, front, bottom, and perspective views of a talus resection block for use with the patient-specific talus guide device body of 8A-8G.

[0027] Figure 10A , 10B Figures 10C and 10C are side, top, and bottom views of a floating talus specimen equipped with a floating talus guide device.

[0028] Figure 10D yes Figures 10A-10C Exploded perspective top view of the floating talus specimen and the floating talus guide device assembly.

[0029] Figure 10E yes Figures 10A-10C Exploded perspective bottom view of the floating talus specimen and the floating talus guide device assembly.

[0030] Figure 11 yes Figures 7A-7D Tibial resection block and Figure 4 A perspective view of the patient-specific tibial guide device body being assembled.

[0031] Figure 12 yes Figure 11 A perspective view showing the components being fastened to the anterior side of the distal tibia.

[0032] Figure 13 The alignment guide pin is being inserted into Figure 12 The perspective view of the aligned slot of the component.

[0033] Figure 14 It is aligned with the axis of the distal part of the tibia. Figure 13 A schematic diagram of the imaging of the alignment guide pin.

[0034] Figure 15 The tibialis pen needle is being inserted into Figure 13 A perspective view of the tibial resection block of the component.

[0035] Figure 16 It indicates the height of the tibia resection. Figure 15 A schematic diagram of the imaging of the tibia with a pen needle.

[0036] Figure 17 The guidewire is being inserted into Figure 13 A perspective view of the cutting slot of the tibial resection block of the component.

[0037] Figure 18 This is a frontal view of the tibia, with the distal and medial malleoli removed to create a flat surface.

[0038] Figure 19 yes Figure 8A-8G The patient-specific talus guide body is fastened to the anterior side of the proximal talus in a perspective view.

[0039] Figure 20 yes Figures 9A-9D talus resection block and Figure 19 A perspective view of the patient-specific talus guide device body being assembled.

[0040] Figure 21 It was inserted into Figure 20 A perspective view of the talus pen needle in the talus resection block of the component.

[0041] Figure 22 It indicates the height of talus resection. Figure 21 A schematic diagram of the imaging of the talus pen needle.

[0042] Figure 23 It was inserted through Figure 20 A perspective view of the cutting guide slot and cutting blade of the talus resection block component.

[0043] Figure 24 This is a perspective view of the talus, with the proximal end removed to create a flat surface.

[0044] Figure 25 yes Figures 10A-10E A perspective view of the floating talus specimen and the floating talus guide device being assembled.

[0045] Figure 26 yes Figures 9A-9D talus resection block and Figure 25 A perspective view of the floating talus guide device being assembled.

[0046] Figure 27 yes Figure 26 talus resection block and Figure 24 A perspective view of the patient-specific talus guide device body assembled together.

[0047] Figure 28 yes Figure 27 A schematic diagram of the imaging of the floating talus specimen and the floating talus guide device, showing the anterior and posterior positions.

[0048] Figure 29 yes Figure 28 A perspective view of a floating talus specimen held in place by a guide pin, wherein the floating talus guide device and the patient-specific talus guide device body are removed.

[0049] Figure 30 It is attached to Figure 29 A perspective view of the guide pin cut-out guide device.

[0050] Figure 31 Is Figure 30 A perspective view of the talus groove guide device attached to the talus after the anterior resection.

[0051] Figure 32 yes Figure 31 A perspective view of the talus groove guide device held in place by studs and a hinge hole device inserted therein.

[0052] Figure 33 This is a perspective view of the ankle joint formed by the tibia and talus, in which the talus support component is attached to the talus and a floating tibial specimen is positioned against the tibia.

[0053] Figure 34 yes Figure 33 A perspective view of the ankle joint, showing the tibia removed by a floating tibial specimen.

[0054] Figure 35 yes Figure 34 The image shows a side view of the ankle joint, where an insertion tool is being used to implant the assembled tibial support and tibial brace components into the tibia.

[0055] The accompanying drawings are not necessarily drawn to scale, and similar numbers in different views may describe similar parts. Similar numbers with different letter suffixes may represent different instances of similar parts. The accompanying drawings are intended to illustrate, by way of example and not limitation, the various embodiments discussed in this document. Detailed Implementation

[0056] It should be understood that the following detailed description of embodiments of the present invention is exemplary in nature and is not intended to constitute a limitation thereof. It should also be understood that variations of exemplary embodiments contemplated by those skilled in the art fall within the scope and spirit of the present invention.

[0057] Figure 1 This is a perspective view of a tibial cutting guide 10 for total ankle arthroplasty according to an example of this disclosure. The tibial cutting guide 10 may include a patient-specific tibial guide body 12 and a tibial resection block 14. The tibial guide body 12 may be secured to the tibial Tb using pins 16A and 16B. Alignment of the tibial resection block 14 with the tibial Tb may be checked using alignment pins 18. The tibial resection block 14 may include a cutting guide surface 20. Pins 22A and 22B may be positioned against the cutting guide surface 20 to protect the tibial guide body 12 from contact with cutting tools and to protect anatomical structures. As discussed in more detail below, the tibial cutting guide 10 may include modular components such that the tibial guide body 12 may be patient-specific, while the tibial resection block 14 may be standardized and configured to different sizes, for example, size-specific, to produce different sized incisions.

[0058] Tibial cutting guide device 10 can be used in conjunction with talus cutting guide device 30. Figure 2 (Total ankle replacement surgery)

[0059] Figure 2 This is a perspective view of a talus cutting guide 30 for total ankle arthroplasty according to an example of this disclosure.

[0060] The talus resection guide device 30 may include a patient-specific talus guide device body 32, a talus resection block 34, and a talus specimen device 36. The talus specimen device 36 may include a floating talus specimen 38 and a floating talus guide device 40. The talus guide device body 32 can be secured to the talus T1 using anchoring pins 42. Furthermore, the talus resection block 34 can be secured to the talus guide device body 32 using pins 44A and 44B. Alignment pins 46 can be inserted through the talus resection block 34 and the talus guide device body 32 to facilitate the connection and separation of the talus resection block 34 from the talus guide device body. The floating talus specimen 38 can be attached to the floating talus guide device 40 using fasteners 48. The floating talus specimen 38 can be secured to the talus T1 using pins 50A and 50B. As discussed in more detail below, the talus cutting guide device 30 may include modular components such that the talus guide device body 32 may be patient-specific, while the talus resection block 34 may be standardized and configured to different sizes, for example, size-specific, to produce incisions of different sizes.

[0061] The tibial cutting guide device 10 and the talus cutting guide device 30 can be used to remove the tibial Tb and talus T1, respectively, to prepare for use in Figure 3A The prosthetic ankle device of the ankle joint is 60.

[0062] In the following discussion, the terms "patient-specific," "customized," or "customized" are defined as applied to components that include specific geometric features (including surfaces, curves, or other lines), such as tools, implants, portions thereof, or combinations thereof, like alignment or drilling guides, and which are manufactured to closely or nestably conform and match, substantially as a mirror or inverse or complementary surface to a corresponding geometric feature or anatomical landmark of the patient's anatomy, obtained or collected by computer imaging methods during the preoperative planning phase, based on 3-D computer images of the corresponding anatomy reconstructed from image scans of the patient. Furthermore, patient-specific guiding features (e.g., guide holes or other holes or openings included in patient-specific guiding devices) are defined as features having the location, orientation, size, and axis of anatomy specific to a particular patient, including various anatomical or reverse alignment axes based on a patient-associated computer-aided preoperative plan.

[0063] Figure 3A This is a perspective view of a prosthetic ankle device 60 used as a prosthesis in total ankle replacement surgery, which can be used separately. Figure 1 and 2 The tibial cutting guide device 10 and the talus cutting guide device 30 are implanted. Figure 3B , 3C The 3D and 4D views are perspective views of the tibial support component 62, the tibial support component 64, and the talus support component 66 that together form the prosthetic ankle device 60.

[0064] like Figure 3A As shown, the tibial support component 64 can be attached to the tibia Tb and the talus support component 66 can be attached to the talus T1. The tibial support component 62 can be attached to the tibial support component 64 to engage with the talus support component 66.

[0065] refer to Figure 3C The tibial support component 64 may include a bone-facing side (the side facing the bone) 68, which may include fixation devices 70A and 70B and a projection 72. The bone-facing side 68 may include a porous material layer, and the projection 72 may be formed of porous material to promote inward bone growth. The tibial support component 64 may also include an attachment side 74, which may include attachment features 76 for engaging the tibial support component 62.

[0066] refer to Figure 3BThe tibial support member 62 may include an attachment feature 78 for engaging the attachment feature 76. In an example, attachment features 76 and 78 may include a snap-fit ​​interface or any other suitable means for attaching the tibial support member 62 and the tibial support member 64 into a locking configuration to inhibit movement between them. The tibial support member 62 may additionally include support surfaces 80A and 80B. Support surfaces 80A and 80B may be shaped to provide a smooth interface on which the talar support member 66 may be supported. The tibial support member 62 may be configured in different sizes to accommodate different ankle sizes in different patients.

[0067] refer to Figure 3D The talus support member 66 may include support surfaces 82A and 82B that can respectively engage support surfaces 80A and 80B. In an example, support surfaces 80A and 80B may be shaped as condyles or smooth ridges to engage the depressions formed by support surfaces 80A and 80B. The talus support member 66 may include a bone-facing side 84, which may include fixation features 86A and 86B. The talus support member 66 may be configured in different sizes to accommodate ankles of different sizes in different patients.

[0068] Figure 4 yes Figure 1 A front view of the patient-specific tibial guide body 12 of the tibial cutting guide device 10. The tibial guide body 12 may include a bone joining body 90, a pin block 92, and a socket block 94. The tibial guide body 12 can be assembled with an attachment block 96, bushings 98A, 98B, 98C, and 98D, and pins 100A and 100B.

[0069] Figure 5 Is Figure 4 An exploded perspective view of the hardware components used in the patient-specific tibial guide body 12. Bushings 98A-98D may include a cylindrical body having holes extending through it, for example, to receive guide pins. Bushings 98A-98D may be made of a rigid material, such as metal (e.g., stainless steel), to prevent damage to the bone-jointing body 90 by the guide pins, thereby avoiding any material debris generated by the bone-jointing body 90 that may become loose in the patient. Pins 100A and 100B may include solid tenons. Pins 100A and 100B may have a circular cross-section and may be made of a radiopaque material for observation in imaging (e.g., X-ray images). Thus, pins 100A and 100B can be used to verify the orientation of the tibial guide body 12 in imaging of the patient's anatomy, as discussed below.

[0070] The attachment block 96 may include a base 102, a neck 104, a support 106, and a hole 107. The attachment block 96 may be shaped to fit into a correspondingly shaped insertion port within the bone-jointing body 90 (see [link]). Figure 6A The socket is located inside the 120 socket.

[0071] Figure 6A , 6B 6C and 6D are Figure 4 The patient-specific tibial guiding device body 12 includes a front view, a side view, a rear view, and a perspective view, among which... Figure 5 The hardware was removed.

[0072] The pin block 92 may include holes 108A-108D, holes 110A and 110B, channel 112, and flanges 114A and 114B.

[0073] The insertion block 94 may include an extension 116, a housing 118, an insertion port 120, and a cutting flange 122. The bone joint body 90 may include a cutting opening 124, a mounting opening 126, and pin openings 128A and 128B.

[0074] The bone-jointing body 90 may include a patient-specific surface 91, which may be irregularly shaped to match and conform to the contour of the tibia Tb of a particular patient, which can be determined from a 3D model of the particular patient obtained preoperatively.

[0075] like Figure 6A As shown, holes 108A-108D include openings into which bushings 98A-98D can be inserted. Bushings 98A-98D can be press-fitted into holes 108A-108D and can be configured not to be manually removed from pin block 92. Pin block 92 may include holes 110A and 110B into which tenons 98A and 98B can be inserted. Tenons 98A and 98B can be press-fitted into holes 110A and 110B and can be configured not to be manually removed from pin block 92.

[0076] Pin 92 may include a means for receiving Figure 1 The alignment pin 18 has a channel 112. The channel 112 may extend along axis A1, the orientation of which relative to the bone-jointing body 90 can be determined preoperatively based on an image of the tibia Tb. Flanges 114A and 114B may be configured to partially enclose the alignment pin 18 to secure the pin 18 within the channel 112. A base 115 may be disposed between the pin block 92 and the extension 116 and may form the pin 18 ( Figure 1 The pin 92 can be arranged parallel to the channel 112, and the channel 112 can be centrally located in the pin 92 to facilitate visualization of the alignment of the pin 18 in the channel 112 with the tibia Tb. The pin 92 may additionally include a gripping feature 130, such as a ridge, to facilitate gripping of the tibia guide device 12.

[0077] The insertion block 94 may include structures for receiving and aligning the attachment block 96 with the channel 112. An extension 116 may protrude from the bone-jointing body 90 below the pin block 92. The extension 116 and the pin block 92 may be attached to each other. A housing 118 may laterally protrude from the extension 116 beyond the width of the cutting opening 124. Flanges 132A and 132B may extend downward from the housing 118 to provide alignment of the attachment block 96 with the mounting opening 126 and to provide a surface for gripping the tibial guide device 12. The exteriors of flanges 132A and 132B may be shaped or designed to provide a gripping surface, for example by being arcuately curved relative to axis A1 to facilitate the pushing and pulling of the tibial guide device 12 against and away from the tibia Tb. As described below, the interiors of flanges 132A and 132B may respectively include corner portions 133A and 133B, which facilitate alignment of the tibial resection block 14.

[0078] The insertion port 120 may extend from the rear wall 134 adjacent to the bone-jointing body 90 to be flush with or nearly flush with the front portion of the housing 118. The insertion port 120 may coincide with the mounting opening 126 through the bone-jointing body 90. The insertion port 120 may include flanges 136A and 136B to narrow the width of the insertion port 120. The support portion 106 of the attachment block 96 ( Figure 5 The attachment block 96 can be inserted into the socket 120 such that the neck 104 engages the flanges 136A and 136B. The thickness of the flanges 136A and 136B may be approximately equal to or slightly less than the height of the neck 104 to allow the attachment block 96 to be inserted into the socket 120, for example by press fit or interference fit.

[0079] Pin openings 128A and 128B can extend within the insertion port 120 through the bone-jointing body 90. For example... Figure 6E As shown, the socket 120 may also include biasing elements 138A and 138B. Biasing elements 138A and 138B can be used to position the attachment block 96 within the socket 120. Biasing elements 138A and 138B are spaced apart from the posterior wall 134, thus forming recesses 140A and 140B within the socket 120. Thus, biasing elements 138A and 138B can be cantilevered and may include tensioning members that push the tibial resection block 14, as shown in... Figure 6F As can be seen in the text and further discussed below regarding 7A-7D.

[0080] Figure 7A , 7B 7C and 7D are related to Figure 4 The patient-specific tibial guide body 12 is used in a front top view and perspective view of a tibial resection block 14. The tibial resection block 14 may include a front panel 142, a lower panel 144, a side panel 146, a first pin boss 148A, a second pin boss 148B, and a fastener 150.

[0081] The front panel 142 may include corner portions 133A and 133B for engaging. Figure 6A The front panel 142 may be a planar body having a rear surface 154 for engaging biasing elements 138A and 138B of the socket 120. The lower surface 156 of the front panel 142 may include a cutting guide surface that, together with the top surface 160 of the lower panel 144, forms part of a cutting guide slot 158.

[0082] The lower plate 144 can be a planar body with an upper surface 162, the upper surface 162 being oriented toward the cutting flange 122. Figure 6A The upper surface 162 extends rearward and aligns with the cutting opening 124 of the bone-jointing body 90. Thus, the upper surface 162 may include an elongated cutting guide surface against which a cutting instrument, such as a saw blade, can stop, slide, oscillate, or reciprocate. The lower plate 144 may additionally include a groove 163 to facilitate the insertion of a pin and a cutting instrument into the cutting guide slot 158, as shown below. Figure 17 To be discussed in more detail.

[0083] Side panel 146 may extend downward from front panel 142 through lower panel 144. Side panel 146 may include side surface 164, which may include a cut guide surface. In the example, lower surface 156 and upper surface 160 may be parallel to each other and side surface 164 may be angled relative to surfaces 156 and 160.

[0084] Pin bosses 148A and 148B can extend from the rear surface 154 of the front panel 142. Pin bosses 148A and 148B can include cylindrical bodies forming through holes. Pin bosses 148A and 148B can be aligned with holes 166A and 166B extending through the front panel 142. The axes of pin bosses 148A and holes 166A and the axes of pin block 148B and holes 166B can be aligned respectively, and the axes of holes 166A and 166B can be parallel. Furthermore, the axes of holes 166A and 166B can be parallel to surface 160. As discussed below, pin bosses 148A and 148B can engage biasing elements 138A and 138B to position the cut-out block 14 within the socket 120.

[0085] Fastener 150 may include a protrusion for engaging attachment block 96, for example at hole 107. Figure 5 Fastener 150 may include a shaft 168, a head 170, and a knob 172. In the example, shaft 168 may extend through a hole within front panel 144, and knob 172 may be individually attached to shaft 168. Therefore, fastener 150 can rotate within front panel 144, but can be held stationary by using fasteners or retaining screws, such as... Figure 7C As shown. The head 170 may include a threaded body integral with the shaft 168 for engagement with the hole 107. In this example, the threaded body may be complementaryly threaded to engage with the thread on the head 170. The knob 172 may include a hexagonal socket or some other torque-transmitting engagement structure for receiving a tool to rotate the fastener 150, facilitating engagement of the head 170 with the hole 107.

[0086] refer to Figure 6F When the attachment block 96 is placed in the bone-jointing body 90 and the tibial resection block 14 is placed within the housing 118 forming part of the insertion port 120, the biasing elements 138A and 138B can engage the pin bosses 148A and 148B, respectively. Specifically, the biasing elements 138A and 138B can push against the pin bosses 148A and 148B to push the tibial resection block 14 against the base 102 (…). Figure 5 The biasing element 138A can be curved to protrude laterally outward from the socket 120 and then downward toward the cutting flange 122. Thus, the biasing element 138A can push the pin boss 148A downward against the base 102 and inward against the flange 136A on the flange socket 120. The biasing element 138B can be straight to protrude laterally and straight from the socket 120. Thus, the biasing element 138B can push the pin boss 148B downward against the base 102. Therefore, the biasing elements 138A and 138B can be configured to eliminate free play and prevent rotation of the tibial resection block 14, to more repeatably position the tibial resection block 14 relative to the bone joining body 90 to allow for more precise resection.

[0087] Figure 8A , 8B 8C and 8D are Figure 2 The patient-specific talus guide body 32 of the talus cutting guide device 14 is shown in front, side, top, and perspective views. The guide body 32 may include a bone joining body 180, a socket block 182, an anchor body 184, and a locking device 186. The talus guide body 32 can be assembled with tenons 188A and 188B.

[0088] The bone-jointing body 180 may include a patient-specific surface 190, which may be irregularly shaped to match and conform to the bone contour of a particular patient. (As in...) Figure 8F and 8G As can be seen, the patient-specific surface 190 may include pads 191A, 191B, 191C, and 191D. Pads 191A-191D may include patient-specific surfaces 91, which may be irregularly shaped to match and conform to the contour of the talus T1 of a particular patient, as may be determined from a 3D model of the particular patient obtained preoperatively.

[0089] The bone joint body 180 may include holes 192A and 192B for receiving tenons 188A and 188B. Holes 192A and 192B may extend fully through the bone joint body 180 and the insertion block 182 and may extend parallel to each other to facilitate sliding of the talus resection block 34. Tenons 188A and 188B may be press-fitted into holes 192A and 192B and may be configured not to be manually removed from the bone joint body 180. The bone joint body 180 may additionally include a channel 194 that may allow a guide pin, such as pin 46 (… Figure 2 The bone-jointing body 180 passes through the holes 192A and 192B.

[0090] The insertion block 182 may include a lower cup 196, side walls 198A and 198B, and stops 200A and 200B. The lower cup 196 may provide an insertion port for receiving the talus resection block 34 and may include a rear portion 204 abutting against the bone-jointing body 180 and inclined portions 206A and 206B for supporting the lower side of the talus resection block 34. The inclined portions 206A and 206B may face the locking device 186. The side walls 198A and 198B may extend laterally outward from the lower cup 196 to provide a flat surface for supporting the talus resection block 34. The stops 200A and 200B may extend upward from the side walls 198A and 198B and may abut against the bone-jointing body 180. The stops 200A and 200B may include angled engagement surfaces 208A and 208B, which are angled toward pins 188A and 188B and perpendicular to surfaces 198A and 198B. ​​The angled engagement surfaces 208A and 208B may form acute angles with the axes of pins 188A and 188B, respectively. The angled engagement surfaces 208A and 208B may be centrally located on the lower cup 196.

[0091] Anchor body 184 may include a protrusion extending from bone-jointing body 180 for receiving a guide pin, such as pin 42. Figure 2 This allows the talus cutting guide device 30 to be anchored to the talus T1. In this example, the anchor body 184 may include a cylindrical element protruding from the bone-jointing body 180 adjacent to the insertion block 182. The anchor body 184 may include a hole 210 to receive the anchoring pin 42. Figure 2 Hole 210 can be oriented to avoid placing pin 42 in the trajectory of the cutting plane and is oriented at an angle to secure the bone engagement body 180. Hole 210 can be tilted relative to the central axis of channel 194 to prevent rotation of the talus guide body 32 relative to the talus T1.

[0092] The locking device 186 may include features for securing the talus resection block 34 within the insertion block 182. The locking device 186 may include a resilient or biased element that resists displacement of the talus resection block 34 from the insertion block 182. In an example, the locking device 186 may include a cantilever body 212 and a protrusion 214. The cantilever body 212 may extend forward from the rear portion 204 to the front of the inclined portions 206A and 206B and may act as a spring to secure the talus resection block 34. Figure 8E As can be seen, the cantilever body 212 is spaced apart from the inclined portions 206A and 206B, allowing the cantilever body 212 to be flexed. A protrusion 214 extends forward from the cantilever body 212 and extends above it relative to the cantilever body 212. Thus, the protrusion 214 can form a lip 216 that can engage the anterior surface of the talus resection block 34, as shown in... Figure 2 and 21 It is visible in the text.

[0093] Figure 9A , 9B 9C and 9D are used with Figure 8A-8G The patient-specific talus guide device body 32 is used in conjunction with a front view, side view, bottom view, and perspective view of a talus resection block 34. The talus resection block 34 may include a connecting block 220 and a resection guide block 222. The connecting block 220 may include holes 224A, 224B, and 224C, an anterior surface 225, a posterior surface 226, and curved sides 228A and 228B. The resection guide block 222 may include a slot 230, an upper surface 231, a guide surface 232, an anterior surface 233, grooves 234A and 234B, and angled engagement surfaces 236A and 236B.

[0094] Holes 224A and 224B can be configured to receive tenons 188A and 188B, respectively. Hole 224C can be configured to receive pin 46 (…). Figure 2The posterior surface 226 can be configured to abut against the rear portion 204 of the insertion block 182 of the talus guide device body 32. The curved sides 228A and 228B can be configured to engage the inclined portions 206A and 206B of the lower cup 196 of the talus guide device body 32, respectively. Thus, the holes 224A and 224B can slide around the tenons 188A and 188B to place the connecting block 220 within the insertion block 182 to connect the talus resection block 34 to the talus guide device body 32. With the connecting block 220 engaged with the insertion block 182, the resection guide block 222 can be positioned above the inclined portions 206A and 206B, such that the inclined extending engagement surfaces 236A and 236B contact the inclined extending engagement surfaces 208A and 208B of the stops 200A and 200B. The engagement of the inclined extending engagement surfaces 236A and 236B with the inclined extending engagement surfaces 208A and 208B helps ensure the alignment of the talus resection block 34 with the talus guide body 32, so that the slot 230 is aligned with the patient-specific surface 190. This allows the slot 230 to be correctly oriented relative to the talus T1, enabling the cutting instrument to be positioned against surface 232 for perpendicular engagement with the talus T1. Slots 234A and 234B can be provided within the slot 230 to facilitate the entry of the cutting instrument and guide pin into the slot 230.

[0095] Figure 10A , 10B 10C is a top view, a side view, and a bottom view of the floating talus specimen 38 assembled with the floating talus guide device 40. Figure 10D yes Figures 10A-10C Exploded perspective top view of the components of the floating talus specimen 38 and the floating talus guide device 40. Figure 10E yes Figures 10A-10C Exploded perspective bottom view of the components of the floating talus specimen 38 and the floating talus guide device 40. Figures 10A-10E They will be discussed simultaneously.

[0096] The floating talus specimen 38 may include a specimen body 240, a first condyle 242A, a second condyle 242B, holes 244A, 244B and 244C, collar portions 246A and 246B, a socket 248, a lower surface 249, a first indicator recess 250 and a mating surface 251.

[0097] The floating talus guide device 40 may include an interface body 252, a first flange 254A, a second flange 254B, a lip 256, a lower surface 257, a second indicator recess 258, a mating surface 259, a fastener block 260, and a fastener hole 262.

[0098] The floating talus specimen 38 and the floating talus guide device 40 can be connected together using a fastener 264, which may include a head 266, a shaft 268, and a threaded portion 270.

[0099] See below for reference Figure 27 and 28 The talus specimen 38 and the talus guide device 40, when connected to the patient-specific talus guide device 32 via the talus cutting guide device 34, can be considered to float against the resection surface (the surface formed by the resection operation) 302. Figure 24 The talus guide device 32, together with the talus resection block 34, the talus guide device 40, and the floating talus specimen 38, defines the orientation and position of the anterior resection surface of the talus T1.

[0100] Figure 11-35 An example method for performing total ankle arthroplasty is illustrated. Figure 11-35 The description illustrates specific steps of a method, any of which can be skipped or performed in a different order than described. This method describes a procedure for implantation. Figures 3A-3D The procedure for implanting a prosthetic ankle device 60, although other prosthetic devices and systems can also be implanted using the instruments, devices and procedures described herein.

[0101] Figure 11 yes Figures 7A-7D Tibial resection block 14 and Figure 4 A perspective view of the patient-specific tibial guide body 12 being assembled. A fastener 150 can be inserted into a hole 107 in the attachment block 96. In this example, a head 170 can be threaded into the hole 107. A knob 172 can be rotated to ensure threaded engagement with the hole 107. The knob 172 may include a socket, such as one for a 3.5mm hex screwdriver, to facilitate rotation of the fastener 150. A lower plate 144 can be inserted below the base 102. A front panel 142 can be pushed into a housing 118 defining a socket 120. Recesses 152A and 152B of the front panel 142 can receive corner portions 133A and 133B of flanges 132A and 132B of the housing 118, respectively. Furthermore, when the tibial resection block 14 is placed within the insertion port 120, biasing elements 138A and 138B can respectively push against pin bosses 148A and 148B extending from the rear side of the front panel 142 to facilitate alignment of the tibial resection block 14 with the patient-specific tibial guide device body 12, as shown in the reference. Figure 6F As described above. With such insertion, the upper surface 160 of the cutting guide slot 158 ​​can be aligned with the cutting flange 122 defining the cutting opening 124. Furthermore, holes 166A and 166B can respectively align with pin openings 128A and 128B of the tibial guide device body 12. Figure 6A and 6C )alignment.

[0102] The tibial resection block 14 can be configured in different sizes. This allows the surgeon to have access to multiple different tibial resection blocks 14, each with a different size of cutting guide slot 158. For example, in addition to larger blocks with wider cutting guide slots 158, standard-sized blocks can also be provided. The size of the tibial resection block 14 selected for a specific patient can be determined preoperatively based on the surgical plan and can be based on patient-specific imaging. The size of the tibial resection block 14 can be indicated on the block itself and on the patient-specific tibial guide device body 12. The standard-sized block is only compatible with the inlet 120 manufactured for this block, and markings on the tibial guide device body 12 can indicate the size of the inlet 120. Consultation with the surgical plan is necessary to ensure the selection of an appropriately sized block and tibial guide device body. Note that the size of the block does not need to correspond to the size of the prosthetic ankle device 60 selected for implantation.

[0103] Figure 12 yes Figure 11 A perspective view of the components fastened to the anterior aspect of the distal end of the tibia Tb. The bone-jointing body 90 can be pushed against the tibia Tb. The body 90 can be positioned proximally on the axis of the tibia Tb and slid downward toward the ankle joint. More specifically, the body 90 can be positioned against the diaphysis or metaphysis region of the tibia Tb and slid downward toward the distal epiphyseal region of the tibia Tb. The patient-specific surface 91 of the body 90 can engage with the epiphyseal region of the tibia Tb in a patient-specific manner, such that the contour and facets of the patient-specific surface 91 can engage with the specific surface features of the Tb in only one way, thereby facilitating the alignment of the incision opening 124 with the tibia Tb according to the surgical plan. The surgeon's fingers can engage the contours of the flanges 132A and 132B to manipulate the patient-specific tibial guide body 12. Similarly, the gripping feature 130 on the pin 92 can be engaged by the user to facilitate pushing the body 90 against the tibia Tb. The body 90 is fitted to the desired location to receive the tibial support component 62 by removing the distal end of the tibia Tb. Pins 116A and 116B can be inserted into bushings 98A and 98D to lock the body 90 in position against the tibia Tb. More or fewer pins, or different bushing combinations, can be used, depending on the judgment of the patient and the surgeon. To ensure adequate locking of the body 90, two pins can be used in two bushings arranged diagonally opposite each other in bushings 98A-98D. In the example, pins 16A and 16B may include a 2.4mm × 120mm guidewire.

[0104] Figure 13 The alignment guide pin 18 is being inserted into Figure 12A perspective view of the alignment channel 112 of the components. In the example, pin 18 may include a 2.4 mm guide wire. One end of pin 18 may be pushed in to engage with base 115 and rotated toward the tibia Tb at that end to be pushed between flanges 114A and 114B. Flanges 114A and 114B may deflect to receive pin 18 and relax to partially wrap around and retain pin 18. Thus, flanges 114A and 114B may include snap-fit ​​features to ensure proper placement and retention of pin 18. Flanges 114A and 114B may be along axis A1 ( Figure 6A Retaining pin 18. Axis A1 can be configured to extend along the mechanical axis of the tibia Tb, for example, through engagement with the patient-specific surface 91 that engages with the tibia Tb. The orientation of the cutting guide slot 158 ​​can be set based on axis A1 such that when pin 18 and axis A1 are aligned with the mechanical axis of the tibia Tb, the surgeon knows that the cutting guide slot 158 ​​will be correctly aligned for resection to receive the tibial support member 62 (e.g., Figure 18 (The cut surface 288A). In the example, pin 18 and axis A1 arrange the cutting guide slot 158 ​​perpendicular to the machine axis.

[0105] Figure 14 It is aligned with the mechanical axis AM of the distal portion of the tibia (Tb). Figure 13 A schematic diagram of the imaging of the alignment guide pin 18. Figure 14 Imaging of the tibial Tb can be performed in the frontal plane. Figure 14 In the image, excised block 14 is not shown in the fluorescence fluoroscopic image, but attached block 96 can be seen. Figure 11 To ensure that the surgeon can confirm that the patient-specific tibial guide body 12 is correctly mounted to and aligned with the tibial Tb, an image of the tibial Tb with the tibial guide body 12 can be obtained. For example, X-ray or fluoroscopic imaging of the tibial Tb can be obtained to observe the pin 18 extending relative to the tibial Tb. The orientation of the tibial guide body 12 can be confirmed by observing the ends of the tenons 100A and 100B in the imaging. For example, if the imaging produces a true anterior view perpendicular to the frontal plane, each of the pins 100A and 100B will appear as a dot or a circle. During the procedure, the patient's soft tissue obstructs the diaphysis of the tibia. Imaging can be used to observe the cortical bone of the tibial Tb relative to the entire extent of the pin 18. The surgeon can use judgment or reference to the surgical plan to verify that the pin 18 is adequately aligned with the mechanical axis AM, for example, parallel to the mechanical axis AM.

[0106] Figure 15 The tibial pen needle 276 was inserted into Figure 13A perspective view within the tibial resection block 14 of the components. The tibial pen needle 276 may include a U-shaped body 278, a plate 280, wings 282A-282D, an observer 284, and pins 286A and 286B. Pins 286A and 286B may be inserted into holes 166A and 166B, respectively, while plate 280 is inserted into cutting guide slot 158. Pins 286A and 286B, along with plate 280, provide three contact points between the pen needle 276 and the tibial resection block 14 to ensure proper alignment of the U-shaped body 278 with the patient-specific tibial guide body 12. The U-shaped body 278 may include a lateral extension 278A and sagittal arms 278B and 278C. The lateral extension 278A may be configured to extend from medial to lateral beyond the tibial Tb and the soft tissue attached thereto, allowing the sagittal arms 278A and 278B to be positioned adjacent to the tibial Tb. Arms 278A-278C can be configured to be coplanar, such that when the pen needle 276 is viewed from one side, arms 278B and 278C are positioned one behind the other. Wings 282A-282D can extend vertically from arm 278B. The pen needle 276 can be made of a radiopaque material, allowing it to be seen in imaging (e.g., X-ray imaging).

[0107] Figure 16 yes Figure 15 A schematic diagram of the imaging of the tibial pen needle 276, indicating the height or depth of tibial Tb resection. Figure 16 The imaging is taken in a lateral plane from the medial-lateral aspect of the patient-specific tibial guide body 12, such that arm 278C is behind arm 278B. The distal portion of arm 278C can be observed through an opening in observer 284, which may include a targeting slot. Figure 16Arms 278B and 278C extend in parallel. Through the parallel extending arms 278A and 278C, a true view of the position of the tibial guide body 12 along the mechanical axis AM can be observed. Thus, the amount of bone configured to be removed from the distal end of the tibia Tb can be seen. Specifically, the vertical extension of flaps 282A-282D can be seen. The lengths of flaps 282A-282D can each correspond to the desired resection thickness of the tibia Tb. In the example, flaps 282A-282D may include tabs with a length of 9 mm. Those flaps of flaps 282A-282D pointing towards the proximal portion of the distal end of the tibia Tb indicate the correct positioning of the tibial cutting guide body 12. In one example, the lengths of flaps 282A-282D can represent the amount of bone suitable for implantation of the tibial support member 62 and the tibial support member 64. As discussed, the placement of the tibial guide device 10 along the tibia Tb and thus the placement of the cutting guide slot 158 ​​can be determined based on the preoperative surgical plan. If the wings 282A-282D indicate that too much or too little bone needs to be removed based on the installation of the tibial guide device body 12, the surgical plan can be changed or it can be performed using other instruments (e.g., non-patient-specific cutting guides).

[0108] Figure 17 Pins 22A and 22B are inserted into Figure 13 A perspective view of the cutting guide slot 158 ​​in the tibial resection block 14 of the component. After using the pen needle 276 to orient the tibial resection guide body 12, the pen needle 276 can be removed and pins 22A and 22B can be inserted to prepare the cutting guide slot 158 ​​for receiving cutting instruments. The slot 163 can be used to facilitate the insertion of pin 22B. The gap between the lower plate 144 and the side plate 146 can be used to facilitate the insertion of pin 22A. In the example, pins 22A and 22B may include a 2.4 mm guide wire. Pins 22A and 22B can be positioned at the medial and lateral extents of the cutting guide slot 158 ​​and can be used to protect the tibial resection guide body 12 and the various parts of the tibia Tb from the cutting instruments. In particular, pins 22A and 22B can protect the parts of the tibial resection guide body 12 that may be made of soft materials such as plastic. In addition, pin 22A can extend into the ligamentous symphysis groove to protect the fibula, and pin 22B can be positioned to protect the medial malleolus. With pins 22A and 22B in place, the cutting instrument can be inserted into the cutting guide slot 158. In the example, a reciprocating or oscillating cutting or saw blade can be slid against the top surface 160 to ensure blade stability. Care should be taken to avoid damage to the posteromedial aspect of the neurovascular bundle and the center of the FHL tendon. Additionally, the cutting instrument can be guided along the side panel 146 for resection along the medial malleolus.

[0109] After the tibial Tb has been removed at two points along its distal end and medial malleolus, pins 22A and 22B can be removed. Next, pins 16A and 16B can be removed to separate the body 90 from the tibial Tb. After removing the tibial cutting guide 10, the tibial Tb can be examined to ensure that all removed bone has been removed.

[0110] Figure 18 This is a frontal view of the tibia Tb, with the distal end and medial malleolus of the tibia Tb removed. The distal end is removed, for example, by using a cutting guide slot 158 ​​to create a resection surface 288A, and the medial malleolus is removed, for example, by using a side panel 146 to create a resection surface 288B. Resection surface 288A may be perpendicular to the machine axis AM, and resection surface 288B may be inclined relative to resection surface 288A.

[0111] Figure 19 yes Figures 8A-8D A perspective view of the patient-specific talus guide body 32 fastened to the anterior side of the proximal end of the talus T1. The patient-specific surface 190 of the bone engagement body 180 can engage with the anterior side of the talus T1. Pads 191A-191D can engage with corresponding landmarks on the talus T1, as determined preoperatively in the surgical plan. The bone engagement body 180 can be pushed down against the talus neck until it reaches a locked position via pads 191A-191D. The body 180 can be held in place against the talus T1, and a pin 42 can be inserted into the hole 210 of the anchor body 184. In the example, the pin 42 may include a 2.4 mm × 120 mm guide wire. Tenon pins 188A and 188B can be pre-installed in the body 180, for example during the manufacture of the patient-specific talus guide body 32, for receiving the talus cutting resection block 34.

[0112] Figure 20 yes Figures 9A-9D A perspective view of the talus resection block 34 being assembled with the patient-specific talus guiding device body 32. The talus T1 and pin 42 are being removed from... Figure 20Omitted, but the talus resection block 34 can be assembled to the talus guide device body 32 with the talus T1 attached to it. The talus resection block 34 can be attached to the tenon pins 188A and 188B by sliding holes 224A and 224B on pins 188A and 188B, respectively. The talus resection block 34 can be pushed into engagement with the talus guide device body 32 until the posterior surface 226 engages with the posterior portion 204. Similarly, the inclined engagement surfaces 236A and 236B can be pushed into engagement with the inclined engagement surfaces 208A and 208B, respectively. As the talus resection block 34 slides, the posterior surface 226 can engage the locking device 186. In particular, the posterior surface 226 can engage the protrusion 214 and push the protrusion 214 downward so as to flex the cantilever body 212. In this way, the connecting block 220 can slide on the protrusion 214. When the talus resection block 34 is fully in place, the protrusion 214 extends from the cantilever body 212 abutting against the anterior surface 225 of the connecting block 220, thereby locking the talus resection block 34 into the patient-specific talus guiding device body 32. Furthermore, as in Figure 2 As can be seen, when the talus resection block 34 is correctly placed in the lower cup 196 of the patient-specific talus guiding device body 32, Figure 8D When the front surface 225 is inside the inclined portions 206A and 206B, it will be flush, even, or coplanar with the front surfaces of the inclined portions 206A and 206B. Figure 8D This provides the surgeon with a visual indication that the device has been correctly assembled.

[0113] Figure 21 It was inserted into Figure 20 A perspective view of the talus pen needle 290 in the talus resection block 34 of the assembly. The talus pen needle 290 may include a U-shaped body 292, a plate 294, wings 296A-296D, and an observer 298. After the talus resection block 34 is assembled with the patient-specific talus guide body 32, a pin 46 can be inserted into a hole 224C and extend through a channel 194 ( Figure 8C It then enters the T1 talus.

[0114] Plate 294 can be inserted into the cutting guide slot 230 of the talus resection block 34. Plate 280 can provide a wider contact point between the pen needle 290 and the talus resection block 34 to ensure proper alignment of the U-shaped body 292 with the patient-specific talus guide device body 32. The U-shaped body 292 may include a lateral extension 292A and sagittal arms 292B and 292C. The lateral extension 292A can be configured to extend medially-laterally beyond the talus T1 and the soft tissue attached thereto, allowing the sagittal arms 292A and 292B to be positioned adjacent to the talus T1. Arms 292A-292C can be configured to be coplanar such that when the pen needle 290 is viewed from one side, arms 292B and 292C are positioned one behind the other. Wings 296A-296D can extend vertically from arm 292B. The pen needle 290 can be made of a radiopaque material, so that the pen needle 290 can be observed in imaging (e.g., X-ray imaging).

[0115] Figure 22 yes Figure 21 An imaging diagram of the talus pen needle 290, indicating the resection height or depth of the talus T1. Figure 22 The imaging is captured in a lateral plane from the medial-lateral aspect of the patient-specific talus guide body 32, such that arm 292C is positioned behind arm 292B. The distal portion of arm 292C can be observed through an opening in observer 298, which may include a targeting slot. Figure 22 As can be seen, arms 292B and 292C extend in parallel. This is a true view of the position of the talus resection guide body 32 on the talus T1, with arms 292B and 292C extending in parallel. Therefore, the amount of bone configured to be removed from the proximal end of the talus T1 can be seen. Specifically, the vertical extension of wings 296A-296D can be seen. The lengths of wings 296A-296D can each correspond to the desired resection thickness of the talus T1. In this example, wings 296A-296D may include tabs with a length of 6.4 mm. Those wings 296A-296D pointing towards the proximal portion of the talus T1 indicate the correct positioning of the talus resection guide body 32. In one example, the lengths of wings 296A-296D can represent the amount of bone suitable for removal for implantation of the talus support member 66. As discussed, the placement of the talus cutting guide device 12 on the talus T1 and thus the placement of the cutting guide slot 230 can be determined based on the preoperative surgical plan. If the wings 296A-296D indicate that too much or too little bone will be removed according to the installation of the talus guide device body 32, the surgical plan can be changed or other instruments (e.g., non-patient-specific cutting guide devices) can be used to perform the procedure.

[0116] Figure 23It was inserted through Figure 20 A perspective view of the cutting guide slot 230 and the resection blade 298 of the talus resection block 34 component. Pins 300A and 300B can be inserted into the cutting guide slot 230 and into the talus T1. Pins 300A and 300B may include 2.4 mm threaded Kirschner wires. In this example, pin 300A may be 120 mm long and pin 300B may be 135 mm long, but in other examples, pins 300A and 300B may have the same length of 120 mm or 135 mm, depending on the patient and the details of the procedure to be performed. Slots 234A and 234B are used to facilitate the insertion of pins 300A and 300B into the cutting guide slot 230, respectively. After pins 300A and 300B are implanted, the resection blade 298 can be inserted into the slot 230 and manipulated to resect the proximal portion of the talus T1, for example by oscillation or reciprocating motion. Care should be taken to avoid damage to neurovascular structures.

[0117] Figure 24 This is a perspective view of the talus T1, where the proximal end has been removed to form a resection surface 302. Pins 300A and 300B can be removed from the talus resection block 34, and the talus resection block 34 can be removed from the patient-specific talus guide body 32. The talus resection block 34 can be removed by pressing the protrusion 214 to flex the cantilever body 212 and allow the talus resection block 34 to slide past the protrusion 214. The talus guide body 32 can be held attached to the talus T1 by pins 42 and 46.

[0118] Figure 25 yes Figures 10A-10C A perspective view of the floating talus specimen 38 and the floating talus guide 40 being assembled. Fastener 264 can be positioned within the fastener hole 262 of fastener block 260 such that the tip of the threaded portion 270 protrudes therefrom. The floating talus specimen 28 can then be positioned near the floating talus guide 40 such that the hole 244C of the socket 48 aligns with the fastener hole 262. The threaded portion 270 can then be rotated to engage threadedly with the hole 244C such that the engagement surface 259 of the floating talus guide 40 contacts the engagement surface 251 of the floating talus specimen 38. In one example, a BT10 Hexalobular Torque Handle can be used to rotate the head 266 of fastener 264.

[0119] The size of the floating talus specimen 38 can be selected based on the preoperative surgical plan. The floating talus guide 40 may be provided with markings indicating the size of each specific floating talus guide. The floating talus guide 40 may also be provided with markings indicating the correct orientation of the floating talus guide 40 relative to the talus resection block 34 (e.g., which side of the floating talus guide 40 is the top surface).

[0120] Figure 26 yes Figures 9A-9D 34 talus resection blocks and Figure 25 A perspective view of the floating talus guide device 40 being assembled. The second flange 254B of the floating talus guide device 40 can be inserted into the cutting guide slot 230 of the talus resection block 34, such that the first flange 254A extends across the upper surface 231 of the talus resection block 34. (As shown in...) Figure 27 and 2 As can be seen, the lip 256 extends inward from the first flange 254A to engage the anterior surface 233 of the talus resection block 34. The lip 256 thereby locks the talus resection block 34 into engagement with the floating talus guide device 40. Additionally, the lip 256 provides the surgeon with visual confirmation of the assembly of the floating talus guide device 40 and the talus resection block 34. When the talus guide device 40 and the talus specimen 38 are assembled together, the lower surfaces 257 and 249 can be aligned. Thus, the floating position of the talus guide device 40 and the talus specimen 38 relative to the resection surface 302 can be observed using imaging.

[0121] Figure 27 yes Figure 26 34 talus resection blocks and Figure 24 A perspective view of the patient-specific talus guide body 32 assembled. The talus resection block 34, when assembled with the floating talus guide device 40 and the floating talus specimen 38, can be attached to the patient-specific talus guide body 32 by inserting a pin 46 into the hole 224C to again position the curved sides 228A and 288B of the connecting block 220 in the inclined portions 206A and 206B of the lower cup 196. The protrusion 214 of the locking device 186 can again be used to secure the placement of the talus resection block 34 to the talus guide body 32. The floating talus guide device 40 can extend from the talus resection block 34 beyond the talus guide body 32 and extend above the resection surface 302. The floating talus specimen 38 can extend from the floating talus guide device 40 against the resection surface 302 to simulate the final placement of the talus support component 66. The anteroposterior position and rotation of the floating talus specimen 40 can be planned according to the preoperative surgical plan for the case.

[0122] Figure 28 yes Figure 27A schematic diagram of the imaging of the floating talus specimen 38, showing the anterior position. Figure 28 The imaging is taken from the medial-lateral aspect of the floating talus specimen 38 in a lateral plane, such that arm 292C is posterior to arm 292B. The positions of the floating talus guide device 40 and the floating talus specimen 38 can be verified using fluoroscopy according to the approved surgical plan. The indicator notches 250 and 258 of the floating talus specimen 38 and the floating talus guide device 40 can be used, respectively, to verify the anterior-posterior position of the floating talus specimen 38 and the floating talus guide device 40 relative to the resection surface 302. The positions of the indicator notches 250 and 258 relative to the total length of the floating talus specimen 38 and the floating talus guide device 40 can be known or predetermined before surgery, for example, to help determine the position of the floating talus specimen 38 relative to the anatomical structure.

[0123] Figure 29 yes Figure 28 A perspective view showing the floating talus specimen 38 held in place by guide pins 50A and 50B, with the floating talus guide device 40 and the patient-specific talus guide device body 32 removed. Pins 50A and 50B can be inserted and passed through holes 244A and 244B in collar portions 246A and 246B, respectively, to engage the bone of the resection surface 302. Pins 50A and 50B can be driven into the floating talus specimen 38 until the heads 304A and 304B are flush with the collar portions 246A and 246B, respectively. The heel portion can be pushed upwards while inserting pins 50A and 50B to prevent movement of the floating talus specimen 38. The position of the floating talus specimen 38 can be confirmed by fluoroscopic imaging to ensure that the floating talus specimen 38 has not moved and is positioned according to the surgical plan.

[0124] Figure 30 It was attached to Figure 29 A perspective view of the anterior resection guide 306 with guide pins 50A and 50B. The anterior resection guide 306 can be appropriately sized for the specific patient based on bone size, according to the preoperative surgical plan. The anterior resection guide 306 may include a chamfered guide body 308 and a reamer guide 310. The chamfered guide body 308 can be positioned against a floating talus specimen 38 and locked thereto with fasteners such as BT10 Hexalobular Torque positioning screws. The central boss of the anterior resection guide 306 can be positioned flush with the central boss on the floating talus specimen 38. Pins 318, such as a 2.4 mm long guide wire, can be placed through the distal hole 312 in the reamer guide 310 for additional fixation.

[0125] The spacer 314 can be positioned in two positions within the reamer guide 310 for reaming the distal and inferior portions of the talus T1. Flange 316A can be attached to pin 318 in the insertion hole 312 for reaming the inferior portion of the talus T1. Flanges 316B and 316C can be attached to pins 50A and 50B, respectively, for reaming the distal portion of the talus T1. When the spacer 314 is in either position, the reamer 320 can move back and forth within the reamer guide 310 until the hard stop 322 rests on the reamer guide 310.

[0126] Figure 31 Is Figure 30 A perspective view of the talus groove guide device 324 attached to the talus T1 after the anterior resection. Surfaces 326 and 328 of the talus groove guide device 324 can be flushed with the resection surfaces 302 and 330. The resection surface 330 can be aligned with... Figure 30 The procedure is performed to form the talus groove guide device 324. The medial-lateral position of the talus groove guide device 324 can be confirmed according to the surgical plan to ensure the correct medial-lateral positioning of the talus support component 66. Fluorescent fluoroscopy can be used to assess the position of the talus groove guide device 324, and the notch 331 can be used to verify that a true sagittal image has been obtained.

[0127] The stud 332 can be inserted into one of the ports 334A and 334B of the talar groove guide device. The stud 332 may include a hole for receiving a guide wire 333 to hold the talar groove guide device 324 in place. The first stud hole for the talar support member 66 can then be reamed using the other port of ports 334A and 334B where the stud 332 is not inserted. The positions of the stud 332 and the reamer can then be switched to ream a second stud hole for the talar support member 66. The reamer may include a hard stop to engage sleeves 334A and 334B when reaming is deep enough.

[0128] Figure 32 yes Figure 31 A perspective view of the talus groove guide device 324 held in place by a pair of studs 332. A socket 336 is used to ream the sulcus of the talus T1 to receive the talus support member 66. A reaming device 338 can be inserted into the socket 336 to remove bone. A hard stop can be provided on the reaming device 338 to engage the sleeve 336 when reaming is deep enough.

[0129] Figure 33 This is a perspective view of the ankle joint formed by the tibia (Tb) and talus (T1), wherein the talus support member 340 is attached to the talus (T1) and the floating tibia specimen 342 is positioned against the tibia (Tb). Reference Figure 31The studs of the talus support member 340 can be inserted into the reamed stud holes. The talus support member 340 may include a specimen used to simulate the talus support member 66 and to facilitate the placement of a floating tibial specimen 342, for example, to set tension in the ankle joint. The distal surface 344 of the floating tibial specimen 342 can be placed against the resection surface 228A, and the posterior surface 346 can be placed against the anterior surface of the tibia Tb. The support surface 348 can engage the talus support member 340. Pins can be inserted into holes 350A and 350B to hold the floating tibial specimen 342 in place. A drill bit can be inserted into the insertion port 352 to prepare the tibia Tb for receiving the protrusion 72 of the talus support member 66. A saw can be inserted into slots 354A and 354B to prepare the tibia Tb for receiving the fixation devices 70A and 70B of the talus support member 66. The drill bit can be inserted into the spherical end portions 355A and 355B of slots 354A and 354B to form guide pin holes 359A and 359B in the tibia Tb, which can be used for implantation of the tibia support component 62 and the tibia support component 64.

[0130] Figure 34 yes Figure 33 A perspective view of the ankle joint, showing the tibia Tb after resection via a floating tibia specimen 342. A notch 356 can be formed in the tibia Tb, and a protrusion 72 can abut within the notch 356. Slots 358A and 358B can be formed in the tibia Tb, and fixation devices 70A and 70B can be inserted into slots 358A and 358B. Pin holes 359A and 359B can be formed in the tibia Tb, and pins 362A and 362B (… Figure 35 The pins can be inserted into holes 359A and 359B to facilitate the insertion of the tibial support component 62 and the tibial support component 64.

[0131] Figure 35 yes Figure 34 A side view of the ankle joint shows an insertion tool 360 used to implant the assembled tibial support component 64 and tibial bearing component 62 into the tibia Tb. Pins 362A and 362B can be inserted into pin holes 359A and 359B. The base 364 of the insertion tool 360 may include attachment features for attachment to mating features on one or both of the tibial bearing component 62 and tibial support component 64. The base 364 may additionally include holes for receiving pins 362A and 362B to facilitate the insertion tool 360 sliding directly (e.g., in an anteroposterior direction) into the tibia Tb. In particular, fixation devices 70A and 70B can slide directly into slots 358A and 358B, and a protrusion 72 can slide directly into a socket 356. A handle 366 may be attached to the base and can be used to receive impacts from an impactor such as a hammer. The talus bearing component 66 and tibial support component 64 can be fixed in place using bone cement.

[0132] Various notes and examples

[0133] Example 1 may include or use a subject such as a patient-specific guiding system for performing talar resection in total ankle arthroplasty. The patient-specific guiding system may include a talar guiding device body, which may include a first patient-specific surface for engaging at least a portion of the anterior surface of the talus, a first pin hole extending through the talar guiding device body, and a first socket extending into the talar guiding device body; a talar resection block, which may include a connecting block removably insertable into the first socket, a second pin hole configured to align with the first pin hole, and a guiding block including a resection guiding surface; a floating talar guiding device capable of being coupled to the talar resection block and configured to extend beyond the first patient-specific surface; and a floating talar specimen capable of being coupled to the floating talar guiding device, the floating talar specimen including a supporting surface and configured to extend coplanarly with the resection guiding surface.

[0134] Example 2 may include the subject matter of Example 1 or may optionally combine it with the subject matter of Example 1 to optionally include a talus guide body made of plastic material, and the talus resection block is made of metal material.

[0135] Example 3 may include the subject matter of any or any combination of Examples 1 or 2, or may optionally combine it with the subject matter of any or any combination of Examples 1 or 2, to optionally include a metal bushing in the first pin hole.

[0136] Example 4 may include the subject matter of any or any combination of Examples 1 to 3, or may optionally combine the subject matter of any or any combination of Examples 1 to 3, to optionally include a floating talus guide device capable of being coupled to the talus resection block via an interface with the resection guide surface.

[0137] Example 5 may include the subject matter of any or any combination of Examples 1 to 4, or may optionally combine the subject matter of any or any combination of Examples 1 to 4, to optionally include an interface body for attachment to the floating talus specimen, a first flange extending from the interface body along the resection guide surface, and a second flange extending from the interface body in a relation to the first flange to clamp onto the talus resection block.

[0138] Example 6 may include the subject matter of any or any combination of Examples 1 to 5, or may optionally combine the subject matter of any or any combination of Examples 1 to 5, to optionally include a second flange that includes a lip for engaging the anterior portion of the talus resection block.

[0139] Example 7 may include the subject of any or any combination of Examples 1 to 6, or may optionally combine with the subject of any or any combination of Examples 1 to 6, to optionally include a floating talus specimen, which may include: a specimen body including an interface for engaging the floating talus guide device, and a support surface disposed on the upper side of the specimen body.

[0140] Example 8 may include the subject matter of any or any combination of Examples 1 to 7, or may optionally combine with the subject matter of any or any combination of Examples 1 to 7, to optionally include an interface including threaded fasteners.

[0141] Example 9 may include the subject matter of any or any combination of Examples 1 to 8, or may optionally combine with the subject matter of any or any combination of Examples 1 to 8, to optionally include a pair of guide holes that extend at an angle into the specimen body relative to the lower surface of the floating talus guide device, wherein the threaded fastener extends at the lower surface.

[0142] Example 10 may include the subject matter of any or any combination of Examples 1 to 9, or may optionally combine with the subject matter of any or any combination of Examples 1 to 9, to optionally include a floating talus guide device, which may include a first lower surface, and the floating talus specimen includes a second lower surface; and the first lower surface and the second lower surface may be configured to align when engaged at the interface.

[0143] Example 11 may include the subject matter of any or any combination of Examples 1 to 10, or may optionally combine the subject matter of any or any combination of Examples 1 to 10, to optionally include: a first recess on the first lower surface, which is visible from the inside or outside of the floating talus guide device, and a second recess on the second lower surface, which is visible from the inside or outside of the floating talus specimen.

[0144] Example 12 may include the subject matter of any or any combination of Examples 1 to 11, or may optionally combine with the subject matter of any or any combination of Examples 1 to 11, to optionally include a spring-actuated locking device for preventing the talus resection block from exiting the first socket when the talus resection block is fully positioned in the first socket.

[0145] Example 13 may include the subject matter of any or any combination of Examples 1 to 12, or may optionally combine with the subject matter of any or any combination of Examples 1 to 12, to optionally include a talus guide body, which may also include a bottom wall extending from the talus guide body in a direction opposite to the patient-specific surface, and first and second side walls extending from the bottom wall to define an insertion port above the bottom wall.

[0146] Example 14 may include the subject matter of any or any combination of Examples 1 to 13, or may optionally combine with the subject matter of any or any combination of Examples 1 to 13, to optionally include a spring-actuated locking device, which may include a cantilever protrusion extending above the bottom wall in front of the first and second sidewalls.

[0147] Example 15 may include the subject of any or any combination of Examples 1 to 14, or may optionally combine with the subject of any or any combination of Examples 1 to 14, to optionally include the front of the talus resection block, which is flush with the front of the first and second sidewalls when the talus resection block is fully positioned in the first socket.

[0148] Example 16 may include the subject of any or any combination of Examples 1 to 15, or may optionally combine with the subject of any or any combination of Examples 1 to 15, to optionally include a first pin hole that may be located within the first socket.

[0149] Example 17 may include the subject of any or any combination of Examples 1 to 16, or may optionally combine with the subject of any or any combination of Examples 1 to 16, to optionally include a third pin hole within the socket, wherein the first pin hole and the third pin hole are located in a plane parallel to the cut guide surface.

[0150] Example 18 may include the subject matter of any or any combination of Examples 1 to 17, or may optionally combine with the subject matter of any or any combination of Examples 1 to 17, to optionally include a talus resection block, which may also include a resection slot in the guide block, the resection slot being partially defined by the resection guide surface.

[0151] Example 19 may include the subject of any or any combination of Examples 1 to 18, or may optionally combine with the subject of any or any combination of Examples 1 to 18, to optionally include a guide block, which may include a pair of angled surfaces defining an angle bisecting the center of the cutting guide body; and a talus guide body, which may also include a pair of angled stops configured to engage flush with the pair of angled surfaces.

[0152] Example 20 may include the subject of any or any combination of Examples 1 to 19, or may optionally combine with the subject of any or any combination of Examples 1 to 19, to optionally include an inner-outer anchoring bushing that extends obliquely from the talus guide body into the first pin hole.

[0153] Example 21 may include or use the subject matter of a method such as performing a total ankle arthroplasty, the method comprising: removing a portion of the tibia; attaching a patient-specific talus guide body to a superior portion of the talus; attaching a size-specific cutting block to the patient-specific talus guide body; removing the superior portion of the talus; attaching a talus test component to the talus cutting block; confirming the position of the talus test component; attaching the talus test component to the talus; removing the talus cutting block and the patient-specific talus guide body from the talus; chamfering the anterior portion of the talus using a chamfering guide attached to the talus test component; and attaching a prosthetic ankle component to the removed tibia and talus.

[0154] Example 22 may include the subject matter of Example 21 or may optionally be combined with the subject matter of Example 21 to optionally include removing a portion of the tibia by: attaching a size-specific tibial cutting block to a patient-specific tibial guide body; and attaching the patient-specific tibial guide body to a lower portion of the tibia.

[0155] Example 23 may include the subject matter of any or any combination of Examples 21 to 22, or may optionally combine the subject matter of any or any combination of Examples 21 to 22, to optionally include using a cutting depth indicator pen needle inserted into the cutting guide slot of the size-specific tibial cutting block to confirm the alignment of the tibial cutting block.

[0156] Example 24 may include the subject matter of any or any combination of Examples 21 to 23, or may optionally combine the subject matter of any or any combination of Examples 21 to 23, to optionally include attaching the talus test component to the talus cutting block by: removing the talus cutting block from the patient-specific talus guide body; and attaching the talus test component to the talus cutting block at the cutting guide surface.

[0157] Example 25 may include the subject matter of any or any combination of Examples 21 to 24, or may optionally combine the subject matter of any or any combination of Examples 21 to 24, to optionally include attaching the talus test component to the talus cutting block by: attaching a floating talus specimen to a floating talus guide device; and attaching the floating talus guide device to the talus cutting block.

[0158] Example 26 may include the subject matter of any or any combination of Examples 21 to 25, or may optionally combine the subject matter of any or any combination of Examples 21 to 25, to optionally include attaching a floating tibial specimen to the resected tibia; and cutting a tibial support attachment slot into the tibia.

[0159] Example 27 may include the subject matter of any or any combination of Examples 21 to 26, or may optionally combine with the subject matter of any or any combination of Examples 21 to 26, to optionally include confirming the position of the talus test component by observing the anterior-posterior position of an indicator feature on the talus test component relative to the resection surface of the talus.

[0160] Example 28 may include the subject matter of any or any combination of Examples 21 to 27, or may optionally combine with the subject matter of any or any combination of Examples 21 to 27, to optionally include chamfering the anterior portion of the talus by using a chamfering guide attached to the talus test component: attaching the talus chamfering guide body to a pin that holds the talus test component to the talus to position the talus chamfering guide body against the talus test component and positioning the reamer guide near the anterior portion of the talus; and reaming the anterior portion of the talus by moving the reamer within the reamer guide.

[0161] Example 29 may include the subject matter of any or any combination of Examples 21 to 28, or may optionally combine with the subject matter of any or any combination of Examples 21 to 28, to optionally include using a cutting depth indicator pen needle inserted into a cutting guide slot of a size-specific talus cutting block to confirm the alignment of the talus cutting block.

[0162] Example 30 may include or use a subject such as a patient-specific guiding device for performing osteotomy in total ankle arthroplasty, the patient-specific guiding device including: a bone guiding device body, the bone guiding device body including: a patient-specific surface for engaging a surface of the talus or tibia, a first pin hole extending through the bone guiding device body, and a first socket extending through the bone guiding device body; and a bone resection block capable of being removably inserted into the first socket and configured to receive a first pin capable of being inserted into the first pin hole, the bone resection block including the resection guiding surface.

[0163] Example 31 may include the subject of Example 30 or may optionally be combined with the subject of Example 30 to optionally include the front surface of the first socket, which may be configured to be coplanar with the front of the bone resection block when the bone resection block is fully placed in the first socket.

[0164] Example 32 may include the subject matter of any or any combination of Examples 30 or 31, or may optionally combine with the subject matter of any or any combination of Examples 30 or 31, to optionally include a first pin hole that can extend along an axis parallel to the resection guide surface when the bone resection block is fully positioned in the first socket.

[0165] Example 33 may include the subject matter of any or any combination of Examples 30 to 32, or may optionally combine with the subject matter of any or any combination of Examples 30 to 32, to optionally include a pin that is coupled to the bone guide body and configured to receive an anchoring pin.

[0166] Example 34 may include the subject of any or any combination of Examples 30 to 33, or may optionally combine with the subject of any or any combination of Examples 30 to 33, to optionally include a pin body, which may include a pin block including a plurality of through holes parallel to the first pin hole for receiving the pin.

[0167] Example 35 may include the subject of any or any combination of Examples 30 to 34, or may optionally combine with the subject of any or any combination of Examples 30 to 34, to optionally include a pin body, which may include a cylindrical protrusion extending from the bone guide body, the cylindrical protrusion including a through hole inclined to the first pin hole for receiving the pin.

[0168] Example 36 may include the subject matter of any or any combination of Examples 30 to 35, or may optionally combine the subject matter of any or any combination of Examples 30 to 35, to optionally include alignment features for facilitating alignment of the bone resection block with the first insertion port.

[0169] Example 37 may include the subject of any or any combination of Examples 30 to 36, or may optionally combine with the subject of any or any combination of Examples 30 to 36, to optionally include alignment features, which may include a pair of biasing elements disposed within the first socket to push the bone resection block against the wall surface of the first socket.

[0170] Example 38 may include the subject of any or any combination of Examples 30 to 37, or may optionally combine with the subject of any or any combination of Examples 30 to 37, to optionally include alignment features, which may include a pair of angled stops configured to engage the angled walls of the bone resection block.

[0171] Example 39 may include the subject matter of any or any combination of Examples 30 to 38, or may optionally combine with the subject matter of any or any combination of Examples 30 to 38, to optionally include a snap-locking feature for receiving an alignment pin orthogonal to the first pin hole.

[0172] Example 40 may include the subject matter of any or any combination of Examples 30 to 39, or may optionally combine the subject matter of any or any combination of Examples 30 to 39, to optionally include a locking device for holding the bone resection block in the first socket.

[0173] Each of these non-restrictive examples may exist independently or may be combined with one or more other examples in various permutations or combinations.

[0174] The detailed description above includes reference to the accompanying drawings, which form a part of the detailed description. The drawings illustrate, by way of schematic representation, specific embodiments in which the invention may be practiced. These embodiments are also referred to herein as “examples.” Such examples may include elements other than those illustrated or described. However, the inventors have also contemplated examples in which only those elements illustrated or described are provided. Furthermore, the inventors have contemplated examples of any combination or arrangement of those elements (or one or more aspects thereof) illustrated or described, whether relative to a particular example (or one or more aspects thereof) or relative to other examples (or one or more aspects thereof) shown or described herein.

[0175] In the event of any inconsistency between the usage in this document and any other document incorporated by reference, the usage in this document shall prevail.

[0176] In this document, as is common in patent documents, no quantifier modifications are made to include one or more, regardless of any other instance or use of "at least one" or "one or more". In this document, the term "or" is used to refer to a non-exclusive "or", such that "A or B" includes "A but not B", "B but not A", and "A and B", unless otherwise stated. In this document, the terms "comprising" and "wherein" are used as their simplified English equivalents. Furthermore, in the following claims, the terms "comprising" and "including" are open-ended, meaning that a system, apparatus, article, composition, formulation, or method including elements other than those listed after such terms in the claims is also considered to fall within the scope of that claim. Additionally, 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.

[0177] The methods described herein can be implemented, at least in part, by a machine or computer. Some examples may include a computer-readable or machine-readable medium encoded with instructions operable to configure an electronic device to perform the methods described in the examples above. Implementations of these methods may include code, such as microcode, assembly language code, high-level language code, etc. This code may include computer-readable instructions for performing various methods. This code may form part of a computer program product. Furthermore, in the examples, the code may be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media, for example, during execution or at other times. Examples of such tangible computer-readable media may include, but are not limited to, hard disks, removable disks, removable optical disks (e.g., optical discs and digital video disks), magnetic tapes, memory cards or memory sticks, random access memory (RAM), read-only memory (ROM), etc.

[0178] The above description is intended to be illustrative and not restrictive. For example, the examples (or one or more aspects thereof) described above may be used in combination with each other. Other embodiments may be used, for example, by one of ordinary skill in the art after reading the above description. The abstract is provided to conform to 37C.FR §1.72(b) to enable the reader to quickly determine the nature of the technical disclosure. It should be understood that it is not intended to be construed as limiting the scope or meaning of the claims. Furthermore, in the above detailed description, various features may be combined together to simplify this disclosure. This should not be construed as meaning that any unclaimed disclosed features are essential to any claim. Rather, the subject matter of the invention may not be limited to all features of the particular disclosed embodiments. Therefore, the following claims are incorporated herein by way of example or embodiment, each claim existing independently as a separate embodiment, and these embodiments are contemplated to be combined with each other in various combinations or arrangements. The scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents.

[0179] From the above detailed embodiments and description of the invention, those skilled in the art should understand that although the methods and apparatus described herein constitute exemplary embodiments of the present invention, it should be understood that the invention contained herein is not limited to the precise embodiments described above, and changes can be made without departing from the scope of the invention as defined by the novelty points set forth below. Similarly, it should be understood that in order to fall within the scope of the invention, it is not necessary to satisfy any or all of the defined advantages or objectives of the invention disclosed herein, as inherent and / or unforeseen advantages of the invention may exist even if they are not explicitly discussed herein.

Claims

1. A patient-specific guiding system for performing talus resection in total ankle arthroplasty, the patient-specific guiding system comprising: The talus guiding device body includes: A first patient-specific surface for joining at least a portion of the anterior surface of the talus; The first pin hole extends through the body of the talus guide device; and The first insertion port extends into the body of the talus guiding device; The talus resection block includes: A connector block that can be removably inserted into the first socket; The second pin hole is configured to align with the first pin hole; and This includes removing the guide block from the guide surface; A pin, which is coupled to the talus guide body and configured to receive an anchoring pin; a floating talus guide, which is coupled to the talus resection block and configured to extend beyond a first patient-specific surface; and A floating talus specimen, connectable to a floating talus guide device, the floating talus specimen including a support surface and configured to extend coplanarly with a resection guide surface, wherein the floating talus specimen and the floating talus guide device are configured to float against the resection surface when connected to the talus guide device body via the talus resection block, and the talus guide device body, together with the talus resection block and the floating talus guide device and the floating talus specimen, defines the orientation and position of the resection surface.

2. The patient-specific guidance system according to claim 1, wherein, The talus guiding device body is made of plastic material, and the talus resection block is made of metal material.

3. The patient-specific guidance system according to claim 1, further comprising: Metal bushing in the first pin hole.

4. The patient-specific guidance system according to claim 1, wherein, The floating talus guide device can be connected to the talus resection block via an interface with the resection guide surface.

5. The patient-specific guidance system according to claim 1, wherein, The floating talus guide device includes: An interface body for attaching to the floating talus specimen; A first flange, which extends from the interface body to extend along the cut-out guide surface; and The second flange extends from the interface body in a relationship opposite to the first flange to clamp onto the talus resection block.

6. The patient-specific guidance system according to claim 5, wherein, The second flange includes a lip for engaging the anterior portion of the talus resection block.

7. The patient-specific guidance system according to claim 1, wherein, The floating talus specimen includes: The specimen body includes an interface for engaging the floating talus guide device; and The support surface is located on the upper side of the specimen body.

8. The patient-specific guidance system according to claim 7, wherein, The interface includes threaded fasteners.

9. The patient-specific guidance system according to claim 8, wherein, The specimen body also includes a pair of guide holes that extend at an angle into the specimen body relative to the lower surface of the floating talus guide device, and the threaded fastener extends at the lower surface.

10. The patient-specific guidance system according to any one of claims 7 to 9, wherein: The floating talus guide device includes a first lower surface, and the floating talus specimen includes a second lower surface; and The first and second lower surfaces are configured to align when engaged at the interface.

11. The patient-specific guidance system of claim 10, further comprising: A first recess on the first lower surface, visible from the inside or outside of the floating talus guide device; and The second pit on the second lower surface is visible from the inside or outside of the floating talus specimen.

12. The patient-specific guidance system according to any one of claims 1 to 9, wherein, The talus guiding device body also includes a spring-actuated locking device for preventing the talus resection block from exiting the first insertion port when the talus resection block is fully placed in the first insertion port.

13. The patient-specific guidance system according to claim 12, wherein, The talus guiding device body also includes: The bottom wall of the talus guiding device body extends in a direction opposite to the patient-specific surface; and First and second sidewalls extend from the bottom wall to define the first socket above the bottom wall.

14. The patient-specific guidance system according to claim 13, wherein, The spring-actuated locking device includes a cantilever protrusion that extends above the bottom wall and in front of the first and second side walls.

15. The patient-specific guidance system according to any one of claims 13 and 14, wherein, When the talus resection block is fully inserted into the first port, the front of the talus resection block is flush with the front of the first and second sidewalls.

16. The patient-specific guidance system according to any one of claims 1 to 9, wherein, The first pin hole is inside the first socket.

17. The patient-specific guiding system of claim 16, further comprising a third pin hole within the insertion port, wherein the first pin hole and the third pin hole are located in a plane parallel to the resection guiding surface.

18. The patient-specific guidance system according to claim 16, wherein, The talus resection block also includes a resection slot in the guide block, the resection slot being partially defined by the resection guide surface.

19. The patient-specific guidance system according to claim 18, wherein: The guide block includes a pair of angled surfaces that define an angle bisecting the center of the talus guide body; and The talus guide body also includes a pair of angled stops, which are configured to engage flush with the pair of angled surfaces.

20. The patient-specific guiding system according to any one of claims 1 to 9, further comprising an inner-outer anchoring bushing extending obliquely from the talus guiding device body into the first pin hole.

Images