Surgical tours
Surgical guides with enhanced durability and visibility features address inefficiencies in ankle replacement surgeries by providing precise alignment and reduced component count, improving surgical precision and efficiency.
Patent Information
- Application Number
- DE202022003186
- Authority / Receiving Office
- DE · DE
- Patent Type
- Utility models
- Current Assignee / Owner
- Priority Date
- 2022-11-14
- Filing Date
- 2022-11-17
- Publication Date
- 2025-06-12
- Estimated Expiration
- 2032-11-30
AI Technical Summary
Existing surgical tools for ankle replacement surgeries are cumbersome, lack durability, and provide inadequate visibility during the procedure, often requiring multiple components and inefficient workflows.
Surgical guides with improved durability and reduced component count, featuring alignment features for precise anatomical plane alignment, visual indicators for implant positioning, and integrated tools for enhanced visibility and efficiency.
Enhances surgical precision and efficiency by allowing better manipulation and visibility during ankle replacement surgeries, reducing the number of components and improving the overall surgical workflow.
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Abstract
Description
CROSS-REFERENCE TO A RELATED APPLICATION
[0001] This application claims priority under 35 USC § 119(e) to U.S. Provisional Application No. 63 / 268,615, filed February 28, 2022, the entire contents of which are incorporated herein by reference. INCORPORATION BY REFERENCE
[0002] The disclosures of US Patent Nos. 9,480,571 and 10,136,904 are incorporated herein by reference in their entirety. PUBLICATION FIELD
[0003] The disclosed devices, systems, and methods relate to surgical tools. More specifically, the disclosed devices, systems, and methods relate to surgical tools for performing ankle surgery, including total ankle surgery. TECHNICAL BACKGROUND
[0004] The ankle is a joint that functions similarly to a hinge. The joint is formed by the joining of three bones. The talus is the talus. The tip of the talus fits into a socket formed by the lower leg, including the tibia and fibula. Osteoarthritis, bone wear, and / or injury can lead to deterioration of the ankle joint, manifesting as pain, limited mobility, and a decreased quality of life. In many cases, doctors recommend surgery to replace the ankle with an implant. An example of such an implant is the INBONE™ Total Ankle System, available from Stryker, Memphis, TN, although one of skill in the art understands that the disclosure is not limited to such implants. The process of implanting an ankle replacement system typically involves the use of sizing and / or cutting guides (e.g., drilling and / or resection guides). SUMMARY
[0005] The published guides, systems, and methods offer improved durability and a smaller size, improving the surgeon's ability to manipulate the guide during surgery. Furthermore, the published guides, systems, and methods provide improved visibility of the surface(s) to be cut during the procedure while reducing the number of components used compared to conventional instruments, resulting in a leaner and more efficient method.
[0006] As described above, in some embodiments, a surgical guide includes a body having a shape corresponding to the shape of an implant. In some embodiments, an outer perimeter of the body defines the shape corresponding to the shape of the implant. The body has an opening and at least one hole sized and configured to receive an instrument therein. A first alignment feature may be coupled to the body. The first alignment feature is configured to enable alignment of the surgical guide with a first anatomical plane.
[0007] In some embodiments, the first opening is defined between a first side of the body, a second side of the body, a third side of the body, and a fourth side of the body.
[0008] In some embodiments, a second alignment feature extends from the second side of the body and is configured to enable alignment of the surgical guide with a second anatomical plane that is different from the first anatomical plane.
[0009] In some embodiments, first and second legs may extend from the first side of the body. Each of the first and second legs may define a respective hole sized and configured to receive a connecting feature of a different surgical guide.
[0010] In some embodiments, the connection feature comprises a dowel.
[0011] In some embodiments, at least one of the first and second legs includes at least one step. The at least one step can provide a visual indication of the location of the surface of a prosthesis to be implanted.
[0012] In some embodiments, the first and second legs include a plurality of steps.
[0013] In some embodiments, the first and second legs have a beveled surface.
[0014] In some embodiments, the first anatomical plane is a sagittal plane and the second anatomical plane is a frontal plane.
[0015] In some embodiments, the first alignment feature comprises a first component and a second component. The first component may include an opening, and the second component may include a protrusion terminating in a shape complementary to a shape of the opening.
[0016] In some embodiments, the opening is defined by a block.
[0017] In some embodiments, the second alignment feature comprises an opening and a protrusion terminating in a shape complementary to a shape of the opening.
[0018] In some embodiments, the opening is defined by a block.
[0019] In some embodiments, the projection terminates at a flange having a cross-sectional geometry to facilitate connection of the surgical guide to another surgical instrument. In some embodiments, the cross-sectional geometry has a trapezoidal shape.
[0020] In some embodiments, the at least one hole comprises a first hole, a second hole, and a third hole disposed between the first hole and the second hole.
[0021] In some embodiments, the first hole is defined by a first bushing extending from the body, the second hole is defined by a second bushing extending from the body, and the third hole is defined by a third bushing extending from the body.
[0022] In some embodiments, the body defines at least one slot disposed between the opening and the second side. The at least one slot may be sized and configured to receive a tool, including at least one depth-indicating tool or a blade of a cutting tool.
[0023] In some embodiments, at least one of the posterior or anterior sides of the body includes a notch configured to provide a visual indication of the position of at least one surface of a prosthesis to be implanted when the surgical guide is viewed in a sagittal plane.
[0024] In some embodiments, the body includes a joint line indicator.
[0025] In some embodiments, the joint line indicator includes at least one protrusion extending into the opening defined by the body.
[0026] In some embodiments, the joint line indicator comprises a notch formed in at least one of the rear and / or front sides of the body.
[0027] In some embodiments, a first guide includes a first side, a second side, a third side, and a fourth side. The third and fourth sides extend between the first and second sides. The body defines a first opening between the first side, the second side, the third side, and the fourth side. The body may further define a first hole and a second hole, each sized and configured to receive at least one fastener and / or a cutting tool. A first alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a first anatomical plane, and a second alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a second anatomical plane.In some embodiments, the first anatomical plane and the second anatomical plane are identical. In some embodiments, the first anatomical plane and the second anatomical plane are different.
[0028] In some embodiments, the first guide includes first and second legs extending from the first side of the first guide body. A gap may be defined between the first leg, the second leg, and the first side of the first guide body.
[0029] In some embodiments, the system includes a second guide. The second guide may include a cross member extending between a first arm and a second arm. The second guide may be configured to be coupled to the first guide.
[0030] In some embodiments, first and second protrusions extend from the cross member of the second guide. The first and second protrusions may be sized and configured to be received in corresponding connection features defined by the first and second legs of the first guide body to connect the second guide to the first guide. In some embodiments, each connection feature includes a hole. In some embodiments, each connection feature includes a slot.
[0031] In some embodiments, each of the first and second arms of the second guide defines at least one connection feature for receiving an elongated radiopaque device therein. In some embodiments, the at least one connection feature comprises a hole. In some embodiments, the at least one connection feature comprises a slot.
[0032] In some embodiments, the system includes a drill bit extending from a first end to a second end. The first end may be configured to be connectable to a drive tool, and the second end may have at least one cutting surface. The drill bit may have at least one indicia located along its length at a distance from the second end. The distance of the at least one indicia from the second end may correspond to the length of an implant. The drill bit may be sized and configured to be received in a third hole defined by the first guide body.
[0033] In some embodiments, the third hole defined by the first guide body is located between the first and second holes.
[0034] In some embodiments, the at least one marking comprises a plurality of markings. Each mark of the plurality of marks may be arranged at a respective distance from the second end of the drill. The respective distance may correspond to a respective length of a different implant.
[0035] In some embodiments, a method includes coupling a first guide to an alignment block, aligning a fluoroscope with the first guide in at least one anatomical plane using a first alignment feature and / or a second alignment feature of the first guide, and securing the first guide to a tibia once a desired alignment of the first guide is achieved. In some embodiments, the second guide includes first and second arms connected by a crossbar.
[0036] In some embodiments, a method includes connecting a second guide to the first guide, and connecting the second guide to the first guide includes inserting at least one protrusion extending from the crossbar of the second guide into at least one connecting feature of the first guide. In some embodiments, the at least one connecting feature of the first guide includes at least one hole defined by the first guide. In some embodiments, the at least one connecting feature of the first guide includes at least one slot defined by the first guide.
[0037] In some embodiments, a method includes determining a size of an implant to be implanted. The determination may be based at least in part on the view of the first guide under fluoroscopy.
[0038] In some embodiments, determining the size of the implant comprises inserting a drill into a hole defined by the first guide and into the tibia and identifying an indicator disposed along the length of the drill.
[0039] In some embodiments, a method includes preparing a tibia for resection by inserting a drill into a first corner drill hole defined by the first guide.
[0040] In some embodiments, a method includes inserting the drill bit into a second corner borehole defined by the first guide.
[0041] Further disclosed herein is a surgical guide comprising a body having a shape corresponding to the shape of an implant to be implanted, the body defining a first opening and at least one hole sized and configured to receive a tool, a first alignment feature configured to facilitate alignment of the surgical guide with a first anatomical plane being connected to the body. BRIEF DESCRIPTION OF THE CHARACTERS
[0042] These and other features and advantages of the devices and methods described herein are more fully disclosed in or made apparent by the following detailed description of the preferred embodiments, which should be considered in conjunction with the accompanying figures, in which like numerals refer to like parts. Fig. 1 is an isometric perspective view of an example of a guide in accordance with some embodiments; Fig. 2 is a front or front view of the Fig. 1 illustrated guide in accordance with some embodiments; Fig. 3 is a rear or rear side view of the Fig. 1 illustrated guide in accordance with some embodiments; Fig. 4 is a side view of the Fig. 1 illustrated guide in accordance with some embodiments; Fig. 5 is a side view of the Fig. 1 shown guide, which corresponds to the side view of Fig. 4 in accordance with some embodiments; Fig. 6 is a plan or top side view of the Fig. 1 illustrated guide according to some embodiments; Fig. 7 is a bottom or underside view of the Fig. 1 illustrated guide in accordance with some embodiments; Fig. 8 is a top side view of an example alignment aid according to some embodiments; Fig. 9 is a rear view of the Fig. 8 illustrated alignment aid according to some embodiments; Fig. 10 is a front view of the Fig. 8 illustrated alignment aid according to some embodiments; Fig. 11 is an isometric view of an example of the Fig. 8 shown alignment guide, which is connected to the Fig. 1 in a first position, in accordance with some embodiments; Fig. 12 is a side view of the Fig. 8 shown alignment guide, which is connected to the Fig. 1 in a first position, in accordance with some embodiments; Fig. 13 is an isometric view of an example of the Fig. 8 shown alignment guide, which is connected to the Fig. 1 in a second position according to some embodiments; Fig. 14 is a side view of the Fig. 8 shown alignment guide, which is connected to the Fig. 1 in the second position, in accordance with some embodiments; Fig. 15 is an isometric perspective view of an example of a drill bit that may be used with a guide according to some embodiments; Fig. 16 is a side view of an example of the Fig. 15, which is arranged in a hole formed by the Fig. 1-7, in accordance with some embodiments; Fig. 17 is an isometric perspective view of another example of a guide according to some embodiments; Fig. 18 is a front view of the Fig. 17 in accordance with some embodiments; Fig. 19 is a side view of the Fig. 17 in accordance with some embodiments; Fig. 20 is a side view corresponding to the Fig. 19 shown side view of the Fig. 17 in accordance with some embodiments; Fig. 21 is a side view of the Fig. 17 in accordance with some embodiments; Fig. 22 is a lower side view of the Fig. 17 in accordance with some embodiments; Fig. 23 is an isometric perspective view of the Fig. 15 and a saw blade arranged in a hole or a slot formed by the Fig. 17 is defined in accordance with some embodiments; Fig. 24 is a side view of the Fig. 15 and a saw blade arranged in a hole or a slot formed by the Fig. 17 is defined in accordance with some embodiments; Fig. 25 shows an example of a guide connected to an adjustment block attached to a shinbone, in accordance with some embodiments; Fig. 26 shows an example of a pin being inserted into a hole defined by a guide attached to a tibia, in accordance with some embodiments; Fig. 27 shows an example of a drill being guided through a first hole defined by a guide in a tibia, in accordance with some embodiments; and Fig. Figure 28 shows an example of a guide used to guide a drill to prepare a tibia for further resection, in accordance with some embodiments. DETAILED DESCRIPTION
[0043] This description of the exemplary embodiments should be read in conjunction with the accompanying figures, which are to be considered a part of the entire written description.
[0044] The published guides offer improved durability and a smaller size, improving the surgeon's ability to manipulate the guide during surgery. Furthermore, the published guides provide a better view of the surface(s) being cut during the procedure while reducing the number of components used compared to conventional instruments, resulting in a more streamlined and efficient method.
[0045] Furthermore, this description of the exemplary embodiments should be read in conjunction with the accompanying figures, which are to be considered part of the entire written description. Throughout the description, relative terms such as "lower", "upper", "horizontal", "vertical", "proximal", "distal", "top", "bottom", "high", "down", "topmost" and "bottommost" and their derivatives (e.g., "horizontal", "downward", "upward", etc.) should be understood to refer to the orientation then described or illustrated in the relevant figure. These relative terms are provided for convenience of description and do not require that the device be constructed or operated in any particular orientation. Terms relating to attachments, couplings, and the like, such as"Connected" and "interconnected" refer to a relationship in which structures are fastened or attached to one another, either directly or indirectly through intervening structures, and to movable or rigid attachments or relationships, unless expressly described otherwise.
[0046] The Fig. 1-7 show an example of a combined finishing and drilling guide 100 according to some embodiments. The guide 100 includes a body 102 extending from a lower side 104 to an upper side 106, as shown in FIGS. Fig. 2 and Fig. 3 is best seen. The body 102 further comprises opposite sides 108, 110 ( Fig. 2 and Fig. 3), a front side 112 and a rear side 114, as best shown in Fig. 4 and Fig. 5. The profile of the guide 100, as defined by the lower side 104, the upper side 106, and the opposing sides 108, 110, which has a generally trapezoidal shape, may correspond to the profile of a prosthetic component. For example, the profile and / or outer perimeter of the guide 100 defined by the lower side 104, the upper side 106, and the opposing sides 108, 110 may correspond to the tibial and / or talar prosthetic components of a total ankle replacement system, although one of ordinary skill in the art will understand that the body 102 of the guide 100 may have a shape corresponding to other types of implants.
[0047] In some embodiments, the body 102 may be made of a rigid, radiopaque material, such as a surgical-grade metal. One of ordinary skill in the art will appreciate that the guide 100 may also be made of other materials, such as a combination of radiolucent (e.g., Radel® polyphenylsulfone (PPSU), available from Solvay) and radiopaque (e.g., stainless steel, aluminum, titanium, cobalt, chromium) materials. The guide 100 may be machined, formed, or manufactured from a single block of material using an additive manufacturing process (e.g., Direct Metal Laser Sintered (DMLS), Electron Beam Melting (EBM)).
[0048] The bottom surface 104 may include a pair of spaced-apart legs 116, 118 extending downwardly from the body 102. A gap 120 is defined between the legs 116, 118 and the bottom surface 104. The gap 120 is generally illustrated as rectangular, with its length (e.g., the space between the legs 116, 118) being greater than its width (e.g., the length of the legs 116, 118), but it is understood that the gap 120 may also have a square shape with the length and width dimensions being equal. Furthermore, one of skill in the art will understand that the gap 120 may also have other shapes (e.g., arcuate, triangular, etc.) to facilitate visualization of the underlying bone. In some embodiments, a crossbar (not shown) may extend across the gap 120, e.g., from leg 116 to leg 118. The crossbar may have a surface (e.g.,a lower or inferior surface) corresponding to a site of a potential resection line (e.g., the site where a flat surface of a talus is formed), as described in more detail below.
[0049] In some embodiments, each leg 116, 118 may have one or more holes and / or slots. As shown in the Fig. 2 and Fig. 3, for example, the leg 116 may include a first hole 122 and a second hole 124 located above (e.g., above) the first hole 122, and the leg 118 may include a first hole 126 and a second hole 128 located above (e.g., above) the first hole 126. The holes 122, 124, 126, 128 are sized and configured to receive a pin or other engagement feature for connecting another surgical guide to the guide 100. For example, the holes 122, 124, 126, 128 may be sized and configured to include an engagement feature for coupling an alignment guide, such as an angel wing alignment guide 200 described below and illustrated in the Fig. 8-14, can be received with the guide 100, although one of ordinary skill in the art will understand that other guides or surgical devices can be coupled to the guide 100 via one or more holes 122, 124, 126, 128. One of ordinary skill in the art will understand that the features can be reversed, with the angel wing alignment guide 200 having holes 122, 126 and the guide 100 defining projections 210-1, 210-2.
[0050] In some embodiments, one or more of the holes 122, 124, 126, 128 may be elongated or in the form of slots to facilitate proper alignment and coupling of other tools and guides. In the embodiment shown in the Fig. 1 to 7, the holes 126, 128 are shown to be elongated, for example, and it is to be understood that one or more of the other holes 122, 124, 126, 128 or combinations of holes may have other shapes and forms.
[0051] The body 102 also defines a central opening 130 located between the lower side 104 and the upper side 106. In some embodiments, one or more protrusions 134-1, 134-2 extend inwardly into the opening 130. The protrusions 134-1, 134-2 may collectively be referred to as a "joint line indicator 134" because they are arranged to provide a surgeon or other medical professional with an indication of the location of the joint line of a prosthesis to be implanted. While the protrusions 134-1, 134-2 are illustrated as being pointed or arrow-shaped, one of ordinary skill in the art will understand that the protrusions 134-1, 134-2 may take other shapes to form a joint line indicator 134.
[0052] In some embodiments, a series of holes is provided on the top surface 106 of the body 102 above the opening 130. For example, the body 102 may include holes 136, 138, holes 140, 142, and hole 144. The holes 136, 138 may be referred to as corner holes 136, 138 and may be sized and configured to identify the location of the intersection points of the upper tibial resection. In other words, the corner holes 136, 138 are located at the upper medial and lateral corners of the tibial resection. In some embodiments, the corner holes 136, 138 may be used to guide a surgical tool, such as a drill, to perform work on the bone (e.g., drilling into the bone).
[0053] Holes 140, 142 are shown adjacent to holes 136, 138 such that hole 140 is located between hole 136 and hole 144 and hole 142 is located between hole 138 and hole 144. As will be understood by one of skill in the art, the position of holes 140, 142 can be selected in various arrangements to facilitate fixation to the bone. Holes 140, 142 are sized and configured to receive a pin, K-wire, or other fixation device. As will be understood by one of skill in the art, a fixation device can be received in one or both of holes 140, 142 to secure guide 100 to the bone. Hole 144 is sized and configured to receive a surgical tool, such as a drill, pin, and / or depth gauge.For example, a pin, drill, or other surgical tool may be inserted into hole 144 to determine an appropriate length for an implant, as shown in FIG. Fig. 16 is best seen.
[0054] In some embodiments, the guide 100 may include one or more alignment features, including one or more alignment features extending upwardly from the top side 106. For example, a first alignment feature, which may be a sagittal alignment feature, may extend from the top side 106 and include at least a first component 150-1 and a second component 150-2. In some embodiments, the first component 150-1 is in the shape of a block with a circular opening 152 ( Fig. 5), and the second component 150-2 has the shape of a projection ending in a circular shape 154 ( Fig. 4). As in the Fig. 4 and Fig. 5, when viewed from the side and the fluoroscope is properly aligned with the guide 100, the circular shape 154 appears approximately in the center of the circular opening 152 defined by the first component 150-1 (e.g., a bull's-eye). If the fluoroscope is not properly aligned, the circular shape 154 will not appear centered within the circular opening 152. Although the first and second components 150-1, 150-2 are described as circular shapes and openings, one of ordinary skill in the art will understand that other shapes, which may be complementary to one another, may be used for fluoroscopic alignment control.
[0055] In some embodiments, the guide 100 may include a second alignment feature, which may be a coronal alignment feature and may also extend from the upper side 106. The second alignment feature includes a base 156 and a flange 158 extending anteriorly from the base 156. The base 156 defines a hole 160 extending completely through the base 156, as shown in Fig. 3. The flange 158 extends from the base 156 in a forward direction and includes a protrusion 162 along its length. In some embodiments, the flange 158 has a trapezoidal cross-sectional geometry sized and configured to form a dovetail connection with another surgical tool, such as the adjustment block 300 with a tool holder 330 disclosed in U.S. Patent No. 10,136,904, which is incorporated by reference in its entirety above. However, it should be understood that the flange 158 may have other cross-sectional geometries to facilitate connection with other surgical tools.
[0056] As in Fig. 2, the projection 162 extends downwardly from the flange 158 and terminates in a circular shape. When a fluoroscope is properly aligned with the guide 100 in the coronal or frontal plane, the projection 162 appears to be located in the center of the hole 160 (e.g., a bull's-eye) to facilitate fluoroscopic alignment verification. Although the hole 160 and projection 162 are described and illustrated as circular, one skilled in the art will understand that the hole 160 and projection 162 may have other shapes.
[0057] The position of the base 156 along the upper side 106 can be varied. For example, while the base 156 is shown as being positioned along the rear side 114, the base 156 can also be located closer to or on the front side 112 along the upper side 106. In some embodiments, the base 156 can define a second hole 164 that is aligned with the circular opening 152 defined by the first component 150-1 of the first alignment feature, such that the second component 150-2 can be visible through both the circular opening 152 and the hole 164, as shown in Fig. 4. However, it should be understood that the hole 164 may be omitted depending on the relative positioning of the first alignment feature and the base 156.
[0058] Although the first and second alignment features are described as extending from the upper side 106 of the guide 100, the first and / or second alignment features may also be located at other locations on the guide 100. For example, one or both of the first and second alignment features may extend from other sides or surfaces of the guide, such as the front side 112, the lower side 104, or they may be otherwise integrated into the body 102 of the guide 100. Additionally or alternatively, the first and / or second alignment features may be positioned on another guide that may be connected to the guide 100. For example, the first, second, and / or additional alignment features could be located on or otherwise provided by the angel wing alignment guide 200, which is described in more detail below.
[0059] From the Fig. 4 and Fig. 5, it can be seen that the posterior side 114 may be angled or include a beveled surface 166. The beveled surface 166 may extend anteriorly from the posterior side 114 to provide clearance for the talus when the guide 100 is positioned against a tibia. In some embodiments, the posterior side 114 may include a notch or slot 168 extending inwardly (e.g., in an anterior direction). The notch 168 is aligned with the surface of the superior side 106 and provides a visual indicator of the superior surface of a prosthesis (not shown) that mates with the guide 100. For example, the guide 100 may be supplied in one or more sizes that correspond to one or more sizes of available implants, such as a tibial implant of a total ankle replacement.When the guide 100 is viewed under fluoroscopy in the sagittal plane, the notch 168 provides the surgeon with an indication of where the tibia will be resected and where the superior (e.g., top) surface of the tibial component of the ankle prosthesis will be located. One or more additional notches may be provided along the posterior side 114 to indicate the location of the inferior (e.g., lower) surface of the tibial component or talar component, or the superior (e.g., upper) surface of the talar component, as understood by one of ordinary skill in the art. It should also be noted that while the notch 168 is shown along the posterior side 114 so that the notch is positioned near the bone, other types of visual indicators may be used and placed at other locations on the body 102 of the guide 100.
[0060] The guide 100 may include further visualization indicators. For example, the legs 116, 118, as shown in the Fig. 2 and Fig. 3, one or more steps, such as steps 170-1, 170-2, 172-1, 172-2, to provide the surgeon with a visual indication of the position of an inferior or superior surface of a prosthesis (e.g., a talar prosthesis). As mentioned above, in some embodiments, multiple implant sizes may be provided, including sizes with multiple heights, e.g., short and tall heights. Steps 170-1, 170-2 (collectively, "steps 170") may correspond to a short or bevel-shaped implant, and steps 172-1, 172-2 (collectively, "steps 172") may correspond to a tall or shallow implant. Further, in some embodiments, a corresponding surface of the steps 170 may be coplanar with the bottom surface 104, and the steps 172 may be coplanar with a crossbar (not shown) extending between the legs 116, 116, if provided.
[0061] In some embodiments, the guide 100 may include one or more markings, such as the markings 174-1, 174-2 (collectively, “marks 174”) located on the front side 112 ( Fig. 2), the mark 176, which is on page 108 ( Fig. 5) and the mark 178, which is on page 110 ( Fig. 4). One or more of the markers 174, 176, 178 may be visible both with and without fluoroscopy. Providing markers that are visible under fluoroscopy advantageously allows the markers to be visible on x-rays or other fluoroscopically obtained images, allowing a surgeon and / or other medical professional to compare the relative sizes of the guides and thus assess which implant size should be used in the patient.
[0062] In the Fig. 8-10, an example of an angel wing alignment guide 200 is shown. As mentioned above and described in more detail below, the angel wing alignment guide 200 may be used in combination with the guide 100. The alignment guide 200 may have a generally arcuate or "U-shaped" body with a cross member 202 extending between a first arm 204 and a second arm 206. As shown in the Fig. 9 and Fig. 10, the cross member 202 may have an enlarged portion 208 whose width is greater than the width of the remainder of the cross member 202 and / or the width of the arms 204, 206. In some embodiments, one or more dowels or projections 210-1, 210-2 (collectively, "dowels 210" or "projections 210") extend from a rear surface 212 of the alignment guide 200. The projections 210 are sized and configured to be received in the holes 122, 124, 126, 128 defined by the legs 116, 118 of the guide 100 to connect the alignment guide 200 to the guide 100. As shown in Fig. As best seen in Figure 8, one or both of the protrusions 210 may include a spring arm, detent, or other coupling mechanism 214 to increase the frictional coupling between the protrusion(s) 210 and the holes 122, 124, 126, 128, and thus between the alignment guide 200 and the guide 100. One skilled in the art will understand that while the protrusions 210 have a generally circular cross-sectional shape, with the cross-section being measured along an axis perpendicular to a longitudinal axis of the protrusions, the protrusions 210 may also have other cross-sectional shapes, e.g., triangular, rectangular, etc.
[0063] In some embodiments, arm 204 includes one or more holes 216-1, 216-2, 216-3, 216-4 (collectively, "holes 216"), and arm 206 includes one or more holes 218-1, 218-2, 218-3, 218-4 (collectively, "holes 218"). Holes 216, 218 are sized and configured to receive a dowel, pin, rod, or other elongated radiopaque device. The elongated radiopaque device may be connected to alignment guide 200 to allow a surgeon to approximate the axis of a tibial implant to be implanted, so that the surgeon can assess the proper position of a cutting and / or reaming guide with a mechanical and / or anatomical axis of the patient. Although in Fig. 8 to provide the surgeon with multiple locations at which the alignment rod can be positioned, it is of course also possible to provide only a single hole or one or more slots along the longitudinal axes of the arms 204, 206 to enable the surgeon to adjust the position of such an alignment rod almost continuously.
[0064] As previously mentioned, the alignment guide 200 may include one or more alignment features, such as the sagittal and / or coronal alignment features described above. For example, the first and second components 150-1, 150-2 of the first alignment feature may be provided along the arms 204, 206 and / or the cross member 202. Additionally or alternatively, the base 156 and / or the flange 158 of the second alignment feature may be provided along the arms 204, 206 and / or the cross member 202, as would be understood by one of ordinary skill in the art.
[0065] The Fig. 11 and Fig. 12 show an example of an alignment guide 200 connected to the guide 100. In particular, in the Fig. 11 and Fig. 12, the projections 210 of the alignment guide 200 are disposed within the holes 124, 128 of the guide 100. In some embodiments, a surface (e.g., a lower or upper surface) of one or more of the arms 204, 206 may be aligned with the steps 170 when the projections 210 of the alignment guide 200 are disposed within the holes 124, 128 of the guide 100. The surface(s) of the arms 204, 206 may provide a visual indication of the position of a lower surface of an implant (e.g., a talar implant) and / or a position at which a talus is being resected.
[0066] The Fig. 13 and Fig. 14 show another example of an alignment guide 200 connected to the guide 100. In particular, in the Fig. 13 and Fig. 14, the projections 210 of the alignment guide 200 are disposed within the holes 122, 126 of the guide 100. In some embodiments, a surface (e.g., a lower or upper surface) of one or more of the arms 204, 206 may be aligned with the steps 172 when the projections 210 of the alignment guide 200 are disposed within the holes 122, 126 of the guide 100. The surface(s) of the arms 204, 206 may provide a visual indication of the position of a lower surface of an implant (e.g., a talar implant) and / or a position at which a talus is being resected.
[0067] In Fig. 15 illustrates an example of a drill bit 500 that may be used with the guide 100. The drill bit 500 extends from a first end 502, which may also be referred to as a "coupling end" or "rear end," to a second end 504, which may also be referred to as a "drilling end" or "front end." The coupling end 502 may include one or more flats 506 or other surfaces that facilitate engagement with a drive system or hand tool, as would be understood by one of ordinary skill in the art. The front end 504 may include one or more threads or cutting features 508 to facilitate a drilling operation. The drill bit 500 may further include one or more grooves or other indicia 510 disposed along the length of the drill bit 500. For example, the indicia 510 may include numbers and / or letters in addition to the flutes, as would be understood by one of ordinary skill in the art.In some embodiments, the one or more indicia 510 are located between the approximate center of the drill 500 and the proximal end of the cutting element(s) 508.
[0068] Fig. 16 shows an example of the drill 500 disposed within the hole 144 defined by the guide 100. In use, one or more of the markings 510 are visible when the guide 100 and drill 500 assembly is viewed in the sagittal plane under fluoroscopy. The markings 510 indicate a depth of the tip of the drill 500, which may correspond to a length of a prosthetic component. In some embodiments, the markings correspond, for example, to the length of a tibial tray of a total ankle replacement, such as the tibial tray of the INBONE™ total ankle replacement.
[0069] The Fig. 17-22 show another example of a finishing and drilling guide 400 in accordance with some embodiments. The guide 400 includes a body 402 extending from a lower side 404 to an upper side 406, as shown in Fig. 18 is best seen. The body 402 further includes opposite sides 408, 410 ( Fig. 18), an anterior side 412 and a posterior side 414, as in the Fig. 19 and Fig. 20. The profile of the guide 400, as defined by the lower side 404, the upper side 406, and the opposing sides 408, 410, which has a generally trapezoidal shape, may correspond to the profile of a prosthetic component. For example, the profile of the guide 400 defined by the lower side 404, the upper side 406, and the opposing sides 408, 410 may correspond to the tibial and / or talar prosthetic components of a total ankle replacement system, although one skilled in the art will understand that the body 402 of the guide 400 may have a shape corresponding to other types of implants.
[0070] In some embodiments, the body 402 may be made of a rigid, radiopaque material, such as a surgical-grade metal. Those skilled in the art will appreciate that the guide 400 may also be made of other materials, such as a combination of radiolucent (e.g., Radel® polyphenylsulfone (PPSU), available from Solvay) and radiopaque (e.g., stainless steel, aluminum, titanium, cobalt, chromium) materials. The guide 400 may be machined, formed, or manufactured from a single block of material using an additive manufacturing process (e.g., DMLS, EBM).
[0071] One or more slots 416-1, 416-2 (collectively, "slots 416") may be defined through the body 402 adjacent the lower side 404. The slots 416 extend from the front side 412 of the body 402 to the back side 414 of the body 402 and are sized and configured to receive a resection height indicator and / or the blade of a cutting instrument, such as a saw. In some embodiments, the slots 416 are aligned with each other such that a longitudinal axis defined by the slot 416-1 is collinear with a longitudinal axis defined by the slot 416-2, although it is understood that the slots 416 may be arranged differently with respect to each other. As shown in the Fig. 19 and Fig. 20, the posterior side 414 may include one or more notches 418 aligned with the slots 416 and one or more notches 438 aligned with the superior surface 406 of the body 402. The one or more notches 418 provide a surgeon or other medical professional with a visual cue as to the location of the slots 416, which may correspond to the location of a bone resection and / or an inferior surface of an implant when the guide 400 is viewed under fluoroscopy in the sagittal plane. Similarly, the one or more notches 438 may provide a surgeon or other medical professional with a visual cue as to the location of the superior surface of the body 402, which may correspond to an superior surface of an implant, such as the tibial implant of a total ankle replacement.
[0072] The body 402 may also include a central opening 420 located between the lower side 404 and the upper side 406, and between the opposing sides 408, 410. In some embodiments, one or more projections 422-1, 422-2, which may collectively be referred to as "projections 422" or "joint line indicators 422," extend inwardly into the opening 420. The projections 422 are arranged along the body 402 to provide a surgeon or other medical professional with a visual indication of the location of the joint line of a prosthesis, such as a total ankle replacement, to be implanted, as viewed in the frontal plane. While the projections 422 are illustrated as being pointed or arrow-shaped, one of ordinary skill in the art will understand that the projections 422 may take other shapes to provide a joint line indicator 422. As shown in the Fig. 19 and Fig. 20, the anterior side 412 and the posterior side 414 may each have notches 424, 426 aligned with the joint line indicator 422. The notches 424, 426 provide a surgeon or other medical professional with a visual indication of the location of the joint line when the guide 400 is viewed under fluoroscopy in the sagittal plane.
[0073] Again with reference to the Fig. 17 and Fig. 18, a series of holes may be provided adjacent the upper side 406 of the body 402 above the opening 420. For example, the body 402 may have corner holes 428-1, 428-2 (collectively, "holes 428" or "corner holes 428") and a central hole 430. The corner holes 428 may be sized and configured to receive a drill and / or to identify the location where a drill is used to prepare the corners of a tibial resection. In other words, the corner holes 428 are located at the upper medial and lateral corners of the tibial resection. The hole 430 may be sized and configured to receive a surgical tool, such as a drill, a pin, and / or a depth gauge. For example, a pin, drill, or other surgical tool may be inserted into the hole 430 to determine a suitable length for an implant, as shown in the Fig. 23 and Fig. 24. In some embodiments, holes 428, 430 may be formed in portions of body 402 extending from front side 412 to form bushings 432, 434, 436. It should be understood that body 402 may include additional holes, such as holes for receiving fixation elements (e.g., pins, K-wires, or other suitable devices) for securing guide 400 to bone or other tissue.
[0074] The guide 400 may also include one or more alignment features. For example, the guide 400 may include a first alignment feature, which may be a sagittal alignment feature, and a second alignment feature, which may be a coronal alignment feature. The first alignment feature may extend upwardly from the superior side 406 and include a first component 440-1 and a second component 440-2. In some embodiments, the first component 440-1 is in the shape of a block with a circular opening 442 ( Fig. ), and the component 440-2 has the shape of a projection that ends in a circular shape 444 ( Fig. ). As in the Fig. 19 and Fig. 20, when viewed from the side and the fluoroscope is properly aligned with the guide 400, the circular shape 444 appears approximately in the center of the circular opening 442 defined by the first component 440-1 to form a fluoroscopic inspection (e.g., a bull's eye). If the fluoroscope is not properly aligned, the circular shape 444 will not appear in the center of the circular opening 442. Although the first and second components 440-1, 440-2 are described as having circular shapes and openings, one of ordinary skill in the art will understand that other shapes may be used to facilitate fluoroscopic alignment verification.
[0075] The second alignment feature may include a base 446 and a flange 448 extending forwardly from the base 446. The base 446 defines a hole 450 extending completely through the base 446, as shown in Fig. 18. The flange 448 extends from the base 446 in a forward direction and includes a projection 452 along its length. In some embodiments, the flange 448 has a trapezoidal cross-sectional geometry sized and configured to form a dovetail connection with another surgical tool, such as the adjustment block 300 with a tool holder 330 disclosed in U.S. Patent No. 10,136,904, which is incorporated by reference in its entirety above. However, it should be understood that the flange 448 may have other cross-sectional geometries to facilitate connection with other surgical tools. As in Fig. 18, the projection 452 extends downwardly from flange 448 and terminates in a circular shape. When a fluoroscope is properly aligned with the guide 400 in the coronal or frontal plane, the projection 452 appears to be located in the center of the hole 450 (e.g., a bull's eye) to allow for fluoroscopic alignment control. Although the hole 450 and projection 452 are described and illustrated as circular, one skilled in the art will understand that the hole 450 and projection 452 may have other shapes.
[0076] The position of the base 446 along the upper side 406 can be varied. For example, while the base 446 is shown as being positioned along the rear side 414, the base 446 can also be located closer to or on the front side 412 of the body 402. In some embodiments, the base 446 can define a second hole 454 that is aligned with the circular opening 442 defined by the first component 440-1 of the first alignment feature, such that the second component 440-2 can be visible through both the circular opening 442 and the hole 454, as best shown in Fig. 20. However, it should be understood that the hole 454 may be omitted depending on the relative positioning of the first alignment feature and the base 446.
[0077] Although the first and second alignment features are described as extending from the top side 406 of the guide 400, the first and / or second alignment features may be located at other locations on the guide 400. For example, one or both of the first and second alignment features may extend from other sides or surfaces of the guide 400, such as the front side 412, the bottom side 404, or they may be otherwise integrated into the body 402 of the guide 400.
[0078] In some embodiments, the guide 400 may include one or more markings, such as the markings 458-1, 458-2 (collectively, "marks 458") located on the front side 412, the marking 460 located on the side 408 ( Fig. ), and the mark 462, which is located on page 410 ( Fig. ). One or more of the markers 458, 460, 462 may be visible both with and without fluoroscopy. Providing markers that are visible under fluoroscopy advantageously allows the markers to be visible on x-rays or other fluoroscopically obtained images, allowing a surgeon and / or other medical professional to compare the relative sizes of the guides and thus assess which implant size should be used in the patient.
[0079] The Fig. 23 and Fig. 24 shows an example of the drill 500 disposed in the hole 430 defined by the guide 400 and a saw blade 600 disposed in one of the slots 416. As described above with respect to the guide 100, the markings 510 of the drill 500 are visible when viewed in the sagittal plane under fluoroscopy. The markings 510 indicate the depth of the drill, which may correspond to the length of a prosthetic component.
[0080] Although guides 100 and 400 are described separately and as having some different features, guides 100 and 400 may be modified to include additional features, including the features of the other guide. For example, guide 400 may be modified to include legs 116, 118 and / or a rear surface with a taper or bevel 166, as described above with respect to guide 100. Additionally or alternatively, guide 100 may be modified to include one or more of notches 418, 426 to provide visualization lines for a surgeon or other medical professional.
[0081] The guides described herein may be used by a surgeon or other medical professional to determine the size of a prosthesis to be implanted in a patient. In some embodiments, the guides may also be used to perform corner drilling to prepare a tibia for resection and receipt of a prosthesis. While the following description refers to the Fig. 1-7, but the following description of an example method of using the guide 100 also applies to the guide 400 as well as to other guides according to the present disclosure.
[0082] In some embodiments, the guide 100 is coupled to another surgical tool that has been previously applied to a patient's tibia TB. For example, the guide 100 may be Fig. 25, can be coupled to the tool holder 330 of the adjustment block 300 disclosed in U.S. Patent No. 10,136,904 and secured to the tibia TB by pins P1, P2. In some embodiments, the flange 158, which may have a trapezoidal shape, is received between the rails of the tool holder 330 to form a dovetail joint. The position of the guide 100 can be adjusted using the adjustment block 300, as described in U.S. Patent No. 10,136,904.
[0083] The position of the guide 100 can be adjusted to assess the size and / or orientation of the guide 100 relative to the tibia TB and / or the talus TS. For example, the profile of the guide, as provided by the inferior side 104, the superior side 106, and the opposing sides 108, 110, which may correspond to a profile of a tibial implant, can be used to assess whether the size of the corresponding implant is appropriate for the patient in the frontal plane and / or sagittal plane. Sizing of the implant in the sagittal plane can be performed by a surgeon or other medical professional using one or more notches 168 and / or an alignment guide 200, which may be arranged on the guide 100 to correspond to the superior side 106 and / or the inferior side 104. Such an assessment can be performed using fluoroscopy.To ensure that the fluoroscopy device is properly aligned with the guide 100, one or more of the first and second alignment features may be used to ensure proper alignment of the fluoroscopy device and the guide 100.
[0084] For example, the first alignment feature, which may be a sagittal alignment feature, may be used to verify that the shape 154 of the second component 150-2 appears at the approximate center of the opening 152 defined by the first component 150-1. If the fluoroscope is not properly aligned, the shape 154 will not appear at the center of the opening 152. Additionally or alternatively, the second alignment feature, which may be a coronal alignment feature, may be used to verify proper alignment between the fluoroscope and the coronal or frontal plane. For example, if a fluoroscope is properly aligned with the guide 100 in the coronal or frontal plane, the protrusion 162 will appear to be in the center of the hole 160.
[0085] A guide 200 may be coupled to the guide 100 while determining the size and / or orientation of an implant. For example, one or more projections 210 may be inserted into the holes 122, 126 or holes 124, 128 defined by the legs 116, 118 to couple the alignment guide 200 to the guide 100, as shown in Fig. 11-14. As mentioned above, in some embodiments, a surface (e.g., a lower or upper surface) of one or more arms 204, 206 may be aligned with the steps 170 when the protrusions 210 of the alignment guide 200 are disposed in the holes 124, 128 of the guide 100. Thus, the surface(s) of the arms 204, 206 may provide a visual cue to the location of a lower surface of an implant (e.g., a talar implant) and / or a site at which a talus is being resected. In some embodiments, a surface (e.g., a lower or upper surface) of one or more arms 204, 206 may be aligned with the steps 172 when the protrusions 210 of the alignment guide 200 are disposed in the holes 122, 126 of the guide 100. The surface(s) of the arms 204, 206 may provide a visual indication of the position of a lower surface of an implant (e.g.a talar implant) and / or a position at which a talus is resected. Furthermore, an elongated radiopaque device may be inserted into one or more of the holes or slots 216, 218 defined by the arms 204, 206 of the guide 200 to assess the alignment of the guide 100 with an axis of the tibia TB (e.g., a mechanical and / or anatomical axis).
[0086] Once the size and desired position of the implant have been determined, the guide 100 can be attached to the tibia TB by inserting one or more pins P3, P4 into the holes 140, 142, as shown in Fig. 26-28. When the guide 100 is attached to the tibial TB, the drill 500 can be inserted through the hole 144 into the tibial TB, as shown in Fig. 27. The drill 500 can be advanced until it reaches the posterior surface of the tibia TB. The position of the drill 500 can be determined using fluoroscopy, as would be understood by one of ordinary skill in the art. Furthermore, the length of the implant (e.g., the anterior to posterior dimension) can be determined using the visible markings 510 along the length of the drill 500.
[0087] In some embodiments, after determining the implant size, the guide 100 is used to drill the corners for the tibial resection. For example, a drill 700 can be inserted into the corner holes 136, 138 and into the tibia TB, as shown in Fig.28. Once the corner holes are drilled, the guide 100 can be removed from its engagement with the tibia TB and / or the adjustment block 300. The tibia and talus can be further prepared using any suitable surgical technique, including the technique disclosed in U.S. Patent No. 10,136,904, incorporated by reference above.
[0088] The published guides, systems, and methods offer improved durability and a smaller size, improving the surgeon's ability to manipulate the guide during surgery. Furthermore, the published guides, systems, and methods provide improved visibility of the surface(s) to be cut during the procedure while reducing the number of components used compared to conventional instruments, resulting in a leaner and more efficient method.
[0089] As described above, in some embodiments, a surgical guide includes a body having a shape that conforms to the shape of an implant to be implanted. The body defines a first opening and at least one hole sized and configured to receive a tool therein. A first alignment feature is configured to facilitate alignment of the surgical guide with a first anatomical plane.
[0090] In some embodiments, an outer perimeter of the body defines the shape corresponding to the shape of the implant.
[0091] In some embodiments, the body includes a first side, a second side, a third side, and a fourth side, and the first opening is defined by the first side, the second side, the third side, and the fourth side.
[0092] In some embodiments, a second alignment feature is coupled to the body and configured to facilitate alignment of the surgical guide with a second anatomical plane that is different from the first anatomical plane.
[0093] In some embodiments, first and second legs may extend from the first side of the body. Each of the first and second legs may define a respective hole sized and configured to receive a connector of a different surgical guide.
[0094] In some embodiments, the connecting element comprises a dowel.
[0095] In some embodiments, at least one of the first and second legs includes at least one step. The at least one step can provide a visual indication of the location of the surface of a prosthesis to be implanted.
[0096] In some embodiments, the first and second legs include a plurality of steps.
[0097] In some embodiments, the first and second legs have a beveled surface.
[0098] In some embodiments, the first anatomical plane is a sagittal plane and the second anatomical plane is a frontal plane.
[0099] In some embodiments, the first alignment feature comprises a first component and a second component. The first component may include an opening, and the second component may include a protrusion terminating in a shape complementary to a shape of the opening.
[0100] In some embodiments, the opening is defined by a block.
[0101] In some embodiments, the second alignment feature comprises an opening and a protrusion terminating in a shape complementary to a shape of the opening.
[0102] In some embodiments, the opening is defined by a block.
[0103] In some embodiments, the projection terminates at a flange having a cross-sectional geometry that facilitates connection of the surgical guide to another surgical tool. In some embodiments, the cross-sectional geometry is trapezoidal.
[0104] In some embodiments, the at least one hole comprises a first hole, a second hole, and a third hole disposed between the first hole and the second hole.
[0105] In some embodiments, the first hole is defined by a first bushing extending from the body, the second hole is defined by a second bushing extending from the body, and the third hole is defined by a third bushing extending from the body.
[0106] In some embodiments, the body defines at least one slot disposed between the opening and the second side. The at least one slot may be sized and configured to receive a tool, including a depth indicator or a blade of a cutting tool.
[0107] In some embodiments, at least one of the posterior or anterior sides of the body includes a notch configured to provide a visual indication of the position of at least one surface of a prosthesis to be implanted when the surgical guide is viewed in a sagittal plane.
[0108] In some embodiments, the body includes a connection line indicator.
[0109] In some embodiments, the gap indicator includes at least one protrusion extending into the opening defined by the body.
[0110] In some embodiments, the joint line indicator comprises a notch formed in at least one of the rear and / or front sides of the body.
[0111] In some embodiments, a first guide comprises a first guide body having a first side, a second side, a third side, and a fourth side. The third and fourth sides extend between the first and second sides. The body defines a first opening between the first side, the second side, the third side, and the fourth side. The body may further define a first hole and a second hole, each sized and configured to receive a fixation tool and / or a cutting tool. A first alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a first anatomical plane, and a second alignment feature may extend from the second side of the body and be configured to facilitate alignment of the first guide with a second anatomical plane.In some embodiments, the first anatomical plane and the second anatomical plane are identical. In some embodiments, the first anatomical plane and the second anatomical plane are different.
[0112] In some embodiments, the first guide includes first and second legs extending from the first side of the first guide body. A gap may be defined between the first leg, the second leg, and the first side of the first guide body.
[0113] In some embodiments, the system includes a second guide. The second guide may include a cross member extending between a first arm and a second arm. The second guide may be configured to be coupled to the first guide.
[0114] In some embodiments, first and second protrusions extend from the cross member of the second guide. The first and second protrusions may be sized and configured to be received within respective connection features defined by the first and second legs of the first guide body to connect the second guide to the first guide. In some embodiments, each connection feature includes a hole. In some embodiments, each connection feature includes a slot.
[0115] In some embodiments, each of the first and second arms of the second guide defines at least one connection feature for receiving an elongated radiopaque device therein. In some embodiments, the at least one connection feature comprises a hole. In some embodiments, the at least one connection feature comprises a slot.
[0116] In some embodiments, the system includes a drill bit extending from a first end to a second end. The first end may be configured to be connectable to a drive tool, and the second end may have at least one cutting surface. The drill bit may have at least one indicia located along its length at a distance from the second end. The distance of the at least one indicia from the second end may correspond to the length of an implant. The drill bit may be sized and configured to be received in a third hole defined by the first guide body.
[0117] In some embodiments, the third hole defined by the first guide body is located between the first and second holes.
[0118] In some embodiments, the at least one marking comprises a plurality of markings. Each mark of the plurality of marks may be arranged at a respective distance from the second end of the drill. The respective distance may correspond to a respective length of a different implant.
[0119] In some embodiments, a method includes coupling a first guide to an alignment block, aligning a fluoroscope with the first guide in at least one anatomical plane using a first alignment feature and / or a second alignment feature of the first guide, coupling a second guide, and securing the first guide to a tibia once a desired alignment of the first guide is achieved. In some embodiments, the second guide includes first and second arms connected by a crossbeam.
[0120] In some embodiments, connecting the second guide to the first guide comprises inserting at least one protrusion extending from the cross member of the second guide into at least one connecting feature of the first guide. In some embodiments, the at least one connecting feature of the first guide comprises at least one hole defined by the first guide. In some embodiments, the at least one connecting feature of the first guide comprises at least one slot defined by the first guide.
[0121] In some embodiments, a method includes determining a size of an implant to be implanted. The determination may be based at least in part on the view of the first guide under fluoroscopy.
[0122] In some embodiments, determining the size of the implant comprises inserting a drill into a hole defined by the first guide and into the tibia and identifying an indicator disposed along the length of the drill.
[0123] In some embodiments, a method includes preparing a tibia for resection by inserting a drill into a first corner drill hole defined by the first guide.
[0124] In some embodiments, a method includes inserting the drill bit into a second corner borehole defined by the first guide.
[0125] Although the guides, systems, and methods have been described in terms of exemplary embodiments, they are not limited thereto. Rather, the appended claims should be broadly interpreted to include other variations and embodiments of the guides, systems, and methods that may be made by those skilled in the art without departing from the scope and range of equivalents of the guides, systems, and methods.
[0126] Furthermore, the subject matter of the following paragraphs is disclosed here: 1. A surgical guide consisting of: a body having a shape corresponding to the shape of an implant to be implanted, the body defining a first opening and at least one hole sized and configured to receive a tool therein; and a first alignment feature connected to at least one side of the body and configured to facilitate alignment of the surgical guide with a first anatomical plane. 2. The surgical guide according to paragraph 1 further comprises a second alignment feature connected to the body and configured to facilitate alignment of the surgical guide to a second anatomical plane different from the first anatomical plane. 3. The surgical guide of paragraph 2, wherein the body has a first side, a second side, a third side, and a fourth side, and wherein the first alignment feature extends from the second side of the body. 4. The surgical guide of paragraph 3, wherein the second alignment feature extends from the second side of the body. 5. The surgical guide of paragraph 3, wherein first and second legs extend from the first side of the body, each of the first and second legs defining a respective hole sized and configured to receive a connector of another surgical guide. 6. The surgical guide of paragraph 5, wherein at least one of the first and second legs includes at least one step, the at least one step providing a visual indication regarding the location of a surface of a prosthesis to be implanted. 7. The surgical guidance according to paragraph 6, wherein the first and second legs have a plurality of stages. 8. The surgical guide according to paragraph 5, wherein the first and second legs have a bevelled surface. 9. Surgical guidance according to paragraph 1 or one of the preceding paragraphs, the first anatomical plane being a sagittal plane. 10. Surgical guidance according to paragraph 1 or any of paragraphs 1-8, where the first anatomical plane is a frontal plane. 11. The surgical guide of paragraph 1 or any of the preceding paragraphs, wherein the first alignment feature comprises a first component and a second component, the first component comprising a second opening and the second component comprising a projection terminating in a shape complementary to a shape of the second opening. 12. The surgical guide of paragraph 1 or any of paragraphs 1-10, wherein the first alignment feature includes a second opening and a projection terminating in a shape complementary to a shape of the second opening. 13. The surgical guide of paragraph 12, wherein the projection is disposed at one end of a flange having a cross-sectional geometry to facilitate coupling of the surgical guide to another surgical tool. 14. The surgical guide of paragraph 1 or any of the preceding paragraphs, wherein the at least one hole comprises a first hole, a second hole, and a third hole disposed between the first hole and the second hole. 15. The surgical guide of paragraph 14, wherein the first hole is defined by a first bushing extending from the body, the second hole is defined by a second bushing extending from the body, and the third hole is defined by a third bushing extending from the body. 16. The surgical guide of paragraph 1 or any of the preceding paragraphs, wherein the body defines at least one slot sized and configured to receive at least one depth indicating tool or a blade of a cutting tool. 17. The surgical guide of paragraph 1 or any of the preceding paragraphs, wherein at least one of the posterior or anterior sides of the body includes a notch configured to provide a visual indication of a position of at least one surface of a prosthesis to be implanted when the surgical guide is viewed in a sagittal plane. 18. The surgical guidance according to paragraph 1 or any of the preceding clauses, the body containing a joint line indicator. 19. The surgical guide of paragraph 18, wherein the joint line indicator includes at least one projection extending into the first opening defined by the body. 20. The surgical guide of paragraph 19, wherein the joint line indicator comprises a notch formed in at least one of the two sides, posterior or anterior, of the body. 21. A system comprising: a first tour, including: a first guide body having a first side, a second side, a third side, and a fourth side, the third and fourth sides extending between the first and second sides, the body defining a first opening between the first side, the second side, the third side, and the fourth side, the body further defining a first hole and a second hole, each sized and configured to receive at least one fastener or cutting tool, a first alignment feature extending from the body and configured to facilitate alignment of the first guide with a first anatomical plane, and a second alignment feature extends from the body and is configured to facilitate alignment of the first guide with a second anatomical plane different from the first anatomical plane. 22. The system of paragraph 21, wherein the first guide comprises first and second legs extending from the first side of the first guide body, a gap being defined between the first leg, the second leg, and the first side of the first guide body. 23. The system referred to in paragraph 22, which also includes: a second guide, the second guide having a cross member extending between a first arm and a second arm, the second guide being configured to be coupled to the first guide. 24. The system of paragraph 23, wherein first and second projections extend from the cross member of the second guide, the first and second projections being sized and configured to be received in corresponding connection features defined by the first and second legs of the first guide body to connect the second guide to the first guide. 25. The system of paragraph 23, wherein each of the first and second arms of the second guide defines at least one connection feature for receiving an elongated radiopaque device therein. 26. The system under paragraph 21 or under any of paragraphs 21 to 25, which also includes: a drill extending from a first end to a second end, the first end being configured to be coupled to a drive tool, and the second end having at least one cutting surface, the drill further comprising at least one indicia disposed along a length of the drill at a distance from the second end corresponding to a length of an implant, wherein the drill is dimensioned and configured to be received in a third hole defined by the first guide body. 27. The system of paragraph 26, wherein the third hole defined by the first guide body is located between the first hole and the second hole. 28. The system of paragraph 26 or any of paragraphs 26-27, wherein the at least one marker comprises a plurality of markers, and wherein each marker of the plurality of markers is disposed at a respective distance from the second end of the drill corresponding to a length of a respective implant. 29. A procedure comprising: coupling a first guide with an adjustment block; Aligning a fluoroscope with the first guide in at least one anatomical plane using at least one alignment feature coupled to the first guide; and Attach the first guide to one shin once a desired orientation of the first guide has been determined. 30. The procedure under paragraph 29, which further includes: Coupling a second guide to the first guide, the second guide comprising a first and a second arm connected to each other by a cross member, wherein connecting the second guide to the first guide comprises inserting at least one projection extending from the cross member of the second guide into at least one connecting feature of the first guide. 31. The method referred to in paragraph 29 further comprises determining the size of an implant to be implanted, the determination of the size of the implant being based at least in part on viewing the first guide under fluoroscopy. 32. The procedure referred to in paragraph 31, where the determination of the size of the implant includes: Inserting a drill into a hole in the tibia defined by the first guide; and the identification of a mark arranged along the length of the drill. 33. The procedure referred to in paragraph 29 further comprises preparing the tibia for resection by inserting a drill into a first corner drill hole defined by the first guide. 34. The method of paragraph 33 further comprises inserting the drill bit into a second corner hole defined by the first guide. QUOTES CONTAINED IN THE DESCRIPTION
[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature
[0000] US 63 / 268,615
[0001] US 10,136,904 [0055, 0075, 0082, 0087]
Claims
[1] System comprising: a first tour, including: a first guide body having a first side, a second side, a third side, and a fourth side, the third and fourth sides extending between the first and second sides, the body defining a first opening between the first side, the second side, the third side, and the fourth side, the body further defining a first hole and a second hole, each sized and configured to receive at least one fastener or cutting tool, a first alignment feature extending from the body and configured to facilitate alignment of the first guide with a first anatomical plane, and a second alignment feature extending from the body and configured to facilitate alignment of the first guide with a second anatomical plane different from the first anatomical plane. [2] The system of claim 1, wherein the first guide has first and second legs extending from the first side of the first guide body, a gap being defined between the first leg, the second leg, and the first side of the first guide body. [3] System according to claim 2, further comprising: a second guide, the second guide having a cross member extending between a first arm and a second arm, the second guide being configured to be coupled to the first guide. [4] The system of claim 3, wherein first and second projections extend from the cross member of the second guide, the first and second projections being sized and configured to be received in corresponding coupling features defined by the first and second legs of the first guide body to couple the second guide to the first guide. [5] The system of claim 3, wherein each of the first and second arms of the second guide defines at least one connecting feature to receive an elongated radiopaque device. [6] System according to one of claims 1 to 5, further comprising: a drill extending from a first end to a second end, the first end being configured to couple to a drive tool, and the second end having at least one cutting surface, the drill further having at least one marker disposed along a length of the drill at a distance from the second end corresponding to a length of an implant, the drill being sized and configured to be received in a third hole defined by the first guide body. [7] The system according to claim 6, wherein the third hole defined by the first guide body is arranged between the first hole and the second hole. [8] System according to claim 6 or any one of claims 6-7, wherein the at least one marking comprises a plurality of markings, and wherein each marking of the plurality of markings is arranged at a respective distance from the second end of the drill corresponding to a length of a respective implant.
Citation Information
Patent Citations
US-ANMELDUNGNR.63/268,615
US-PATENTNR.10,136,904