INTRAOPERATIVE ADJUSTABLE GUIDES, SYSTEMS, AND METHODS

A system can include a first component having a first body and a second component having a second body. The first body can have a first side and an opposed second side. The first side can have at least one patient-specific surface configured to engage at least one bone in a predetermined manner. The first body can also have a coupling element. The second body can be sized and configured to engage the coupling element to couple the second component to the first component. The second body can include at least one guide surface, and a position of the at least one guide surface can be configured to be adjusted relative to the first component intraoperatively. Methods of using such systems also are disclosed.

INCORPORATION BY REFERENCE

FIELD

The disclosed guides, systems, and methods relate to surgical guides, systems, and methods. More specifically, the disclosed guides, systems, and methods relate to patient-specific surgical guides and systems that enable intraoperative adjustment by a surgeon or other user.

BACKGROUND

Total joint replacement prostheses typically include a specially designed jig or fixture to enable a surgeon to make accurate and precise bone resections in and around the joint being prepared to accept the prosthesis. The ultimate goal with any total joint prosthesis is to approximate the function and structure of the natural, healthy structures that the prosthesis is replacing. Should the prosthesis not be properly attached to the joint, i.e., an ankle or knee, the misalignment could result in discomfort to the patient, gait problems, or degradation of the prosthesis.

Accordingly, surgical devices and systems that provide for proper alignment of the bones of the joint are desirable.

SUMMARY

In some embodiments, a system can include a first component having a first body and a second component having a second body. The first body can have a first side and an opposed second side. The first side can have at least one patient-specific surface configured to engage at least one bone in a predetermined manner. The first body can also have a coupling element. The second body can be sized and configured to engage the coupling element to couple the second component to the first component. The second body can include at least one guide surface, and a position of the at least one guide surface can be configured to be adjusted relative to the first component intraoperatively.

A method can include placing a guide having at least one patient-specific surface into contact with at least one tissue of a patient and intraoperatively adjusting a location of at least one guide surface while the at least one patient-specific surface remains in contact with the at least one tissue.

DETAILED DESCRIPTION

This description of the exemplary embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description. It should be understood, however, that the present disclosure is not intended to be limited to the particular forms disclosed and that the drawings are not necessarily shown to scale. Rather, the present disclosure covers all modifications, equivalents, and alternatives that fall within the spirit and scope of these exemplary embodiments. The terms “couple,” “coupled,” “operatively coupled,” “operatively connected,” and the like should be broadly understood to refer to connecting devices or components together either mechanically, or otherwise, such that the connection allows the pertinent devices or components to operate with each other as intended by virtue of that relationship.

Patient-specific locator and/or cutting guides are created based on pre-operative imaging from which a surgeon or other medical professional prepares a preoperative plan. Conventional patient-specific locators and guides are designed to have one or more surfaces that are fabricated to mirror or be a negative of a surface of a patient's anatomy, such as bone and/or cartilage. The one or more patient-specific surfaces are designed to mate in a specific location on the patient's anatomy in a predefined manner, i.e., in accordance with the preoperative plan.

However, conventional patient-specific locators and mounts typically do not provide for deviation from the preoperative plan. Consequently, if a surgeon in the operating theater determines that the preoperative plan can not be suitable, such as due to unforeseen circumstances like ligament tension and/or issues in the preoperative imaging, then the only manner in which the surgeon can adjust the preoperative plan is by hand, i.e., without guidance from the patient-specific locator and/or guide.

To address such issues, the disclosed guides and systems can include multiple components, including at least one patient-specific locating component and one or more adjustable components for coupling to the patient-specific locating component, which advantageously enable a surgeon to make intraoperative adjustments to the preoperative plan while still providing the surgeon with guidance. For example, in some embodiments, a system can include a first component having a first body and a second component having a second body. The first body can have a first side and an opposed second side. The first side can have at least one patient-specific surface configured to engage at least one bone in a predetermined manner. The first body can also have a coupling element. The second body can be sized and configured to engage the coupling element to couple the second component to the first component. The second body can include at least one guide surface, and a position of the at least one guide surface can be configured to be adjusted relative to the first component intraoperatively.

In some embodiments, the at least one guide surface can include at least one hole sized and configured to receive a fixation device. The at least one hole can extend through the second body along an axis that is disposed perpendicular with respect to a plane defined by a first side of the second body. The at least one hole can be at least partially defined by a bushing that extends from the second body. The at least one hole can extend through the second body along an axis that is disposed at an oblique angle with respect to a plane defined by a first side of the second body. The at least one hole can be at least partially defined by a bushing that extends from the second body.

In some embodiments, the at least one guide surface can include at least one slot sized and configured to receive a cutting instrument. The at least one slot can include a first slot and a second slot. The first slot can be configured to guide a cutting instrument for resecting a first bone, and the second slot can be configured to guide a cutting instrument for resecting a second bone that is different from the first bone.

In some embodiments, the at least one guide surface can include at least one slot sized and configured to receive a cutting instrument.

In some embodiments, the coupling element can include an opening defined by the first body of the first component. The second body can be sized and configured to be at least partially received within the opening.

In some embodiments, the second body can be configured to rotate freely within the opening about an axis defined by the opening.

In some embodiments, the first body can include indicia adjacent to the opening.

In some embodiments, the second body can be configured to be rotated selectively within the opening about an axis defined by the opening.

In some embodiments, the second body can define at least one groove, and the first body can include at least one protrusion. The at least one protrusion can be sized and configured to be received in the at least one groove.

In some embodiments, the second body can be configured to pivot about an axis that is oriented at an angle relative to the axis defined by the opening.

In some embodiments, the second body can include at least one protrusion, and the first body can define at least one groove. The at least one protrusion can be sized and configured to be received in the at least one groove.

In some embodiments, the second body can be configured to pivot about an axis that is oriented at an angle relative to the axis defined by the opening.

In some embodiments, the second body can include a first body portion and a second body portion. The second body portion can define the at least one guide surface and can be configured to move relative to the first body portion.

In some embodiments, the second body portion can be coupled to the first body portion by at least one pivot bar.

In some embodiments, the second body portion can be configured to move in first and second directions relative to the first body portion. The first and second directions can be orthogonal relative to one another.

In some embodiments, the second body can include a first body portion, a second body portion, and a third body portion. The first body portion, second body portion, and third body portion can collectively form a gimbal.

In some embodiments, the first body can include a first patient-specific surface configured to engage a first bone a second patient-specific surface configured to engage a second bone.

In some embodiments, the second component can define a first guide surface and a second guide surface. The first guide surface can be configured to be disposed adjacent to the first bone when the second component is coupled to the first component and the first patient-specific surface engages the first bone. The second guide surface can be configured to be disposed adjacent to the second bone when the second component is coupled to the first component and the second patient-specific surface engages the second bone.

The various guides disclosed herein can also be used to perform one or more methods. For example, in some embodiments, a method includes placing a guide having at least one patient-specific surface into contact with at least one tissue of a patient and intraoperatively adjusting a location of at least one guide surface while the at least one patient-specific surface remains in contact with the at least one tissue.

In some embodiments, after placing the guide and before intraoperatively adjusting a location of the at least one guide surface, at least one first fixation element can be inserted into the guide to fix a location of the guide relative to the at least one tissue of the patient.

In some embodiments, the guide can include a locating component and an adjustable component. The at least one first fixation element can be inserted into the locating component of the guide.

In some embodiments, at least one second fixation element can be inserted into the adjustable component after intraoperatively adjusting the location of the at least one guide surface.

In some embodiments, the at least one tissue can be engaged with a first surgical tool. The first surgical tool can be guided by the at least one guide surface. The at least one guide surface can define a hole, and the first surgical tool can be a drill. The at least one guide surface can define a slot, and the first surgical tool can be a saw.

In some embodiments, placing the guide into contact with at least one tissue of the patient includes can include placing a first patient-specific surface of the guide into contact with a first tissue placing a second patient-specific surface of the guide into contact with a second tissue. The second tissue can be different from the first tissue. The first tissue can be a first bone, and the second tissue can be a second bone. In some embodiments, the guide can extend across a joint located between the first bone and the second bone.

In some embodiments, the first bone can be engaged with a first surgical, which can be guided by a first guide surface. The first guide surface can define a first slot, and the first surgical tool can be a saw.

In some embodiments, the second bone can be engaged with the first surgical tool, which can be guided by a second guide surface. The second guide surface can be a second slot. The second guide surface can define a hole, and the second surgical tool can be a drill. The second guide surface can define a hole, and the second surgical tool can be at least one of a k-wire or a pin.

In some embodiments, the at least one tissue can be engaged with a first surgical tool, which can be guided by the at least one guide surface.

In some embodiments, adjusting the location of the guide surface can include rotating an adjustable component of the guide relative to a locating component of the guide.

In some embodiments, the guide can include a locating component and a first adjustable component. Adjusting the location of the guide surface can include replacing the first adjustable component with a second adjustable component.

In some embodiments, the method can include selecting the second adjustable component from a plurality of adjustable components.

In some embodiments, adjusting the location of the guide surface can include pivoting an adjustable component of the guide relative to a locating component of the guide.

In some embodiments, adjusting the location of the guide surface can include moving a first body portion of an adjustable component of the guide relative to a second body portion of the adjustable component of the guide.

Turning now to the figures,FIGS.1and2illustrate one example of a patient-specific guide100. Guide100can include a locating component102, which can support or can be otherwise coupled to one or more adjustable components150, which also can be referred to as a “guide insert.” In some embodiments, the locating component102has a body104with a pair of outwardly extending arms106-1,106-2(collectively “arms106”). A pair of legs108-1,108-2(collectively, “legs108”) can extend from the inferior end110of body104. Body104can further include a first side112, which can be a bone facing side, and an opposed second side114. The bone-facing side112can include one or more patient specific surfaces that is based on preoperative imaging, as described in U.S. Pat. No. 5,768,134 issued to Swaelens et al., which is incorporated by reference herein in its entirety. In some embodiments, the locating component102can be formed from a medical-grade material that is capable of being 3D printed (e.g., additively manufactured), such as ABS (acrylonitrile butadiene styrene), PLA (polylactic acid), PETG (polyethylene terephthalate glycol), nylon, TPU (thermoplastic polyurethane), resin, and other suitable thermoplastics and thermosetting plastics, to list only a few possibilities. However, the locating component can be formed from other materials, including metals, ceramics, and other materials that are suitable for use in surgery as will be understood by one of ordinary skill in the art. In some embodiments, the locating component can be machined and/or formed using an additive manufacturing process, such as electron beam melting (EBM) or direct metal laser sintering (DMLS), to list only a few possibilities.

In some embodiments, the body defines one or more holes116-1,116-2(collectively, “holes116”). Holes116can be sized and configured to receive a k-wire, pin, or other fixation device for coupling the locating element102to one or more bones. The size of the holes116can be varied and are not necessarily shown to scale in the figures. In the example illustrated inFIGS.1and2, each arm106-1,106-2defines a respective hole116-1,116-2. It should be understood that body104can define other holes. For example, each leg108-1,108-2can define a respective hole (not shown) to either increase the securement of locating component102to a first bone or to couple the locating component102to a second bone (e.g., a talus) while the holes116couple the locating component102to a first bone (e.g., a tibia). One of ordinary skill in the art will understand that additional holes can be provided and/or holes can be provided at other locations of the body104.

The body104can further include one or more coupling element118. In the example shown inFIGS.1and2, the coupling element118can include an opening120defined by the body104and one or more protrusions122that extend inwardly into opening120from an angled or curved face124. Although opening120is shown as having a circular shape, it should be understood that opening120can have other shapes, including polygonal, oval, conical, to list only a few possibilities. Further, while three protrusions122are shown extending inwardly into opening120, fewer or more protrusions122can be provided as described in herein. Additionally or alternatively, one or more of the protrusions can be omitted or replaced with a channel or groove.

The one or more coupling elements118can be sized and configured to receive an adjustable component150, such as one or more guide inserts150in an adjustable manner. For example, guide insert150can have a disc-shaped body152as best seen inFIGS.2-5. The body152of guide insert150can be received within coupling element118such that guide insert150can move (e.g., rotate and/or pivot) in at least one direction within coupling element118and relative to locating component102. For example, body152of guide insert152can include an angled or curved face154that is complementary to the shape of the angled or curved face124of the coupling element118. In some embodiments, such as shown in the example illustrated inFIGS.2-5, body152can include one or more channels or grooves156that are sized and configured to receive one of the protrusions122. Protrusions122and grooves156provide for a keyed relationship and can prevent the body152of the guide insert150from moving in a first direction (e.g., rotating about a central axis defined by the opening120) while allowing movement in a second direction (e.g., rotating about an axis that is perpendicular to the central axis defined by the opening120). In some embodiments, the curved face124can taper or constrict to prevent downward translation of the guide insert150and the corresponding curved face154, thereby constraining the modular guide insert in a seated position within the body104. The guide insert can be locked, pinned, clipped or fastened into the seated position in a releasable or semi-permanent connection wherein the use of the cutting guides or drills does not dis-associate the connection beyond clinically desired restraints.

The location of the protrusions122along the angled or curved face124and/or the location of the channel or grooves156along body152can be selected to provide a predetermined amount of adjustment between the guide insert152and the locating component102. However, in some embodiments, the interface between coupling element118and the body152of guide insert150can allow for unconstrained adjustment, which allows guide insert150to be rotated in a complete circle within coupling element118as described herein. Further, while the body152of guide insert150is shown as being able to fit only partially within coupling element118, it should be understood that body152can be configured such that the entirety of the body152can be received within the coupling element118.

The body152of guide insert (e.g., adjustable component)150can have a shape other than a circular disk. For example, the body152can be shaped as a rectangular or square (FIG.21), triangular (FIG.22), cruciform (FIG.23), or gear shaped (FIG.24), to list one a few possibilities. It should be understood that the coupling element118can have a complementary shape to the body152of the guide insert such that the guide insert150can be coupled to the locating component102. In some embodiments, the guide insert can be configured to be moved (e.g., rotated, pivoted, and/or repositioned) relative to the locating component102. However, in some embodiments, as described below, the guide insert150can be coupled to locating component in a single orientation, but permit guide apertures and surfaces to be repositioned.

Guide insert150can include one or more guide apertures or surfaces158that can be used to facilitate a surgical process. For example, in the embodiment illustrated inFIGS.2-5, the body152of guide insert150is shown as including two pin guides158-1,158-2(collectively, “pin guides158”). Pin guides158can extend from a first side160of body152to an opposed second side162as best seen inFIGS.4-5. In the example illustrated inFIGS.2-5and10, the pin guides158are shown disposed on either side of a tab164that extends away from a planar surface defined by the side160and positioned along a first center line C1that bisects the body152in a first direction and are offset from a second center line that bisects the body152in a second direction that is perpendicular to the first direction as best seen inFIG.10. In some embodiments, the centerline C1extends through a first pair of channel or grooves156(e.g., channels156-1and156-3) and centerline C2extends through a second pair of channel or grooves156(e.g., channels156-2and156-4), as shown inFIG.10.

However, it should be understood that the number of pin guides158can be varied along with the location of the pin guides158. For example,FIG.11illustrates an example of a guide insert150in which a first pin guide158-1is positioned along center line C2and second pin guide158-2is positioned at an angle α from center line C2. In the example illustrated inFIG.12, the first and second pin guides158-1,158-2are both offset from the first and second centerlines C1and C2. In some embodiments, the first pin guide158-1is offset from the first centerline by a distance D11and is offset from the second centerline C2by a distance D12. The second pin guide158-2can be offset from the first centerline C1by a distance D21and can be offset from the second centerline C2by a distance D22. As will be understood by one of ordinary skill in the art, the distances D11, D12, D21, and D22can be the same or different from one another.

FIG.13illustrates another example of a guide insert150having a plurality of pin guides156. In the example illustrated inFIG.13, the guide insert150is provided with six pin guides158all disposed at a distance from the first centerline C1. Four of the pin guides158-1,158-3,158-4,158-6are disposed at a distance from the second center line C2, and two of the pin guides158-2,158-5are disposed along the second center line C2. It should be understood that the locations of the pin guides158and the number of pin guides158can be varied. For example, the pin guides158can be arranged in a circular, triangular, rectangular, or other geometric arrangement.

In some embodiments, pin guides158can include bushings to provide increased stability. For example,FIGS.14-16illustrate one example of a guide insert150including a pair of pin guides158-1,158-2each with a respective bushing166-1,166-2(collectively, “bushings166”). As shown inFIGS.14-16, the bushings166extend away from side160. In some embodiments, such as the example illustrated inFIGS.14-16, the bushings166and corresponding pin guides158are disposed at an oblique angle with respect to a planar surface defined by one of the sides160,162. In some embodiments, the bushings166and/or corresponding pin guides158can be disposed at other angles, including a right angle with respect to a planar surface defined by one of the sides160,162, as shown inFIG.17. In some embodiments, a system or kit can be provided with a locating component102and one or more guide inserts150, with each guide insert150being different. For example, a locating component102can be provided with multiple guide inserts150with each guide insert150having pin guides158oriented at different angles (e.g., 90°, 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50°, 45°, etc.) relative to a planar surface of the guide. Although increments of 5° degrees are provided as an example, it should be understood that other increments can be provided in a system and/or kit.

As noted above, the pin guides158are sized and configured to receive a pin, k-wire, or other fixation element, as will be understood by one of ordinary skill in the art. Additionally or alternatively, the opening of the pin guides158can be sized and configured to receive a bone removal tool, such as a drill bit or rotary cutting tool. In some embodiments, the body152of the guide insert150can be formed from a material that is more rigid and/or durable than the material from which the locating component is formed. For example, the guide insert body152can be formed from a medical-grade metal, such as titanium, stainless steel, cobalt, and/or chromium, to list only a few possible materials. Further, the guide insert body152can be machined and/or formed using an additive manufacturing process, such as electron beam melting (EBM) or direct metal laser sintering (DMLS), to list only a few possibilities.

Advantageously, the coupling between locating component102and guide insert150allows a surgeon or other user to adjust a location at which a fixation element and/or bone removal tool is applied to bone. As noted above, the user can make the decision to adjust a relative position between the guide insert150and locating component102intraoperatively in response to viewing the surgical site.

In some embodiments, one or more fixation devices can be inserted into the pin guides150to establish a reference location that will serve the basis for placing one or more other guides, such as described in U.S. Pat. No. 10,413,308, which was incorporated by reference above. In such embodiments, the locating component102and guide insert150can be removed from their engagement with the bone once the one or more fixation devices have been placed and then other guides or fixtures can be coupled to the fixation devices. For example,FIG.8shows an example in which a guide100, including a locating device102and a guide insert150, is placed on a bone B1, which in this example is a tibia. One or more fixation elements can be inserted into the pin guides158, and then the guide100can be removed from its engagement with the bone B1by sliding the guide100off the fixation elements.

The guide can also be used to guide tools and instruments other than fixation devices. For example,FIGS.18-20illustrate examples of guide inserts including at least one cutting guide168to facilitate the removal of bone or tissue. Referring first toFIG.18, the cutting guide168can include a transverse slot170with a first angled slot172extending from a first end of the transverse slot170and a second angled slot174extending from a second end of the transverse slot170. As noted above, the size and orientation of the slots shown in the figures is not necessarily to scale, and the number, orientation, and/or size of the slots can be varied. The cutting guide168can be sized and configured to receive a cutting tool, such as a saw blade or rotary cutting tool, for cutting bone. It should be understood that the size and shape of cutting guide168can be varied and that a system and/or kit can be provided with multiple guide inserts150each having a cutting guide168with a different shape and/or size. For example, the different shapes and/or size of the cutting guides168can correspond to a respective implant that can be available to be implanted in a patient. The scale, pattern, depth, thickness, and orientation of the pin guides158and transverse slot170can be varied as is understood by one skilled in the art.

FIG.19illustrates another example of a guide insert150in accordance with some embodiments. The guide insert150illustrated inFIG.19includes a cutting guide168and pin guides158. Providing the pin guides158along with the cutting guide allows the user to fix the position of the guide insert150relative to the bone. In some embodiments, once one or more fixation devices are inserted into the one or more pin guides158, the assemblage of the locating component102and guide insert150can be slid off of the fixation devices, and then the guide insert150can be slid back onto the fixation devices prior to the bone being resected using a cutting tool guided by the cutting guide168. However, in some embodiments, the locating device102and guide insert150can remain positioned on the bone during the resection, as described in PCT/US2021/057014, which was incorporated by reference above.

FIG.20illustrates another example of a guide insert including one or more pin guides and one or more cutting guides. As shown inFIG.20, guide insert150includes pin guides158-1,158-1and cutting guides168-1,168-2(collectively, “cutting guides168”). The pin guides158and first cutting guide168-1can be similar to the pin guides158and cutting guide168described above with respect to the guide insert illustrated inFIG.19. Cutting guide168-2can include a slot176that can extend parallel to transverse slot170, although slot176can be oriented in a non-parallel fashion relative to transverse slot170.

In some embodiments, the pin guides158and first cutting guide168-1can be configured to be located relative to a first bone B1, e.g., a tibia, and the second cutting guide168-2can be configured to be located relative to a second bone B2, e.g., a talus, as shown inFIG.9. For example, the first cutting guide168-1can be configured to guide a cutting tool for resecting a tibia, and the second cutting guide168-2can be configured to guide a cutting tool for resecting a talus. However, it should be understood that the locating components and guide inserts can be used with other bones and/or joints, including the knee, shoulder, hip, elbow, and wrist, to list only a few possibilities.

Guide insert150can include one or more guide apertures or surfaces158that can be used to facilitate a surgical process. For example, in the embodiment illustrated inFIGS.2-5, the body152of guide insert150is shown as including two pin guides158-1,158-2(collectively, “pin guides158”). Pin guides158can extend from a first side160of body152to an opposed second side162as best seen inFIGS.4-5. In the example illustrated inFIGS.2-5and10, the pin guides158are shown disposed on either side of a tab164that extends away from a planar surface defined by the side160and positioned along a first center line C1that bisects the body152in a first direction and are offset from a second center line that bisects the body152in a second direction that is perpendicular to the first direction as best seen inFIG.10. In some embodiments, the centerline C1extends through a first pair of channel or grooves156(e.g., channels156-1and156-3) and centerline C2extends through a second pair of channel or grooves156(e.g., channels156-2and156-4), as shown inFIG.10.

However, it should be understood that the number of pin guides158can be varied along with the location of the pin guides158. For example,FIG.11illustrates an example of a guide insert150in which a first pin guide158-1is positioned along centerline C2and second pin guide158-2is positioned at an angle α from centerline C2. In the example illustrated inFIG.12, the first and second pin guides158-1,158-2are both offset from the first and second centerlines C1and C2. In some embodiments, the first pin guide158-1is offset from the first centerline by a distance D11and is offset from the second centerline C2by a distance D12. The second pin guide158-2can be offset from the first centerline C1by a distance D21and can be offset from the second centerline C2by a distance D22. As will be understood by one of ordinary skill in the art, the distances D11, D12, D21, and D22can be the same or different from one another.

FIG.13illustrates another example of a guide insert150having a plurality of pin guides156. In the example illustrated inFIG.13, the guide insert150is provided with six pin guides158all disposed at a distance from the first centerline C1. Four of the pin guides158-1,158-3,158-4,158-6are disposed at a distance from the second center line C2, and two of the pin guides158-2,158-5are disposed along the second center line C2. It should be understood that the locations of the pin guides158and the number of pin guides158can be varied. For example, the pin guides158can be arranged in a circular, triangular, rectangular, or other geometric arrangement.

As noted above, guide inserts can be configured to be coupled to a locator component in a single orientation while providing a surgeon or other medical professional or user with the ability to adjust a location and/or orientation of a guide structure intraoperatively. Examples of such guide inserts are illustrated inFIGS.25-31. Turning first toFIGS.25and26, guide insert250includes a body252including multiple portions that are movably coupled to one another. More particularly, guide insert250illustrated inFIGS.25and26includes a first body portion251-1, which can be referred to as an outer body portion and have a circular shape, a second body portion252-2, which can be referred to as a middle body portion and have a circular shape, and a third body portion252-3, which can be referred to as an inner body portion and have a circular shape. While three body portions are shown, it should be understood that fewer or more body portions can be provided.

Body portions252-1,252-2,252-3(collectively, “body portions252” or “body252”) can be pivotably coupled to one another about pivot bars253-1,253-2(collectively, “pivot bars253”) to form a gimbal structure. In the example illustrated inFIGS.25and26, body portion252-1includes a curved or angled face254and one or more channels or grooves256defined by the curved or angled face254. Face254can facilitate coupling to a coupling element, such as the coupling element118described above, or can be omitted depending on the configuration of the coupling element118. Similarly, the channels or grooves256can be configured to receive a protrusion122of coupling element. The channels or grooves256can permit movement of body portion252-1relative to the locating component102, or channels or grooves256can prevent movement of the body portion252-1relative to the locating component102.

Inner body portion252-3is shown as defining a pair of spaced-apart guide apertures258-1,258-2(collectively, “guide apertures258”), which can be sized and configured to receive a fixation element or device (e.g., k-wire or pin) or other surgical tool (e.g., drill or trocar, to list only a couple of potential tools). As described above, although two pin guides258are shown, fewer or more pin guides258can be provided. Further, other guide elements can be provided by any one of the body portions252. For example, one or more cutting guides and/or guide apertures can be provided on any or all of the body portions252. The gimbal structure of body252advantageously enables the pin guides or other guide surfaces or apertures to be adjusted intraoperatively by the surgeon or user in a controlled fashion with respect to a reference point provided by the locating component102.

FIGS.27and28illustrate another example of a guide insert that permits adjustment of a guide aperture or surface intraoperatively. Guide insert250illustrated inFIGS.27and28includes a first body portion252-1and a second body portion252-2. First body portion252-1can have a generally circular shape having a periphery defining one or more channels or grooves256for engaging one or more protrusions122of a locating component102. Body portion252-1further defines an opening255that is sized and configured to receive second body portion252-2in a slidable manner. Opening255is shown as having a generally rectangular shape, but can have a variety of shapes and sizes. Second body portion252-2is shown as having a rectangular shape and defining a pair of guide apertures258-2, although second body portion252-2can be configured to define fewer or more guide apertures and/or different types of guide apertures as discussed herein. It should be understood that fewer or more body portions can be provided, and one or more of the body portions can include guide apertures.

As indicated by the arrows inFIGS.27and28, second body portion252-2can be coupled to the first body portion252-1such that second body portion252-2is configured to move relative to first body portion252-1in at least one direction (e.g., vertically). For example, the coupling between the first and second body portions252-1,252-2can include one or more cooperative mechanical interfaces that permit relative motion between the first and second body portions (e.g., corresponding channels and protrusions, a mortise and tenon, or dovetail connection, to list only a few possibilities).

FIG.29illustrates another example of a guide insert in accordance with some embodiments. Guide insert250can include a first body portion252-1having a generally circular shape that defines one or more channels or grooves256along its outer periphery. As described above, the channels or grooves256can be configured to receive a protrusion, such as a protrusion122, of a locating component102to coupling and aligning the guide insert250to the locating component. Body portion252-1can define an opening255sized and configured to receive second body portion252-2.

Second body portion252-2can have a rectangular shape and define guide apertures258. While guide apertures258are shown as being round holes sized and configured to receive a fixation element (e.g., k-wire, pin, or the like) and/or other tool (e.g., drill, rotary cutting tool, or the like), one or more of the guide apertures258can take other forms (e.g., slots or surfaces). In some embodiments, the second guide body252-1can be coupled to one or more pivot bars253. Pivot bar253can allow the second guide body252-2to rotate about a longitudinal axis defined by the pivot par53and also can allow for the second guide body252-2to slide along the axis in a first direction (e.g., horizontally on the page).

In some embodiments, the second guide body252-2can be able to move relative to the first guide body252-1in a second direction (e.g., vertically on the page) that is different from the first direction. For example, the pivot bar253can be able to move within a channel (not show) defined by the first body portion252-1. One of ordinary skill in the art will understand that other configurations allowing for movement of the second body portion252-2relative to the first body portion252-1are possible.

Turning now toFIG.30, another example of a guide insert that permits movement relative to a locating component is shown. The guide insert250shown inFIG.30includes a body252having a first body portion252-1, which can be referred to as an outer body portion, a second body portion252-2, which can be referred to as a middle body portion, and a third body portion252-3, which can be referred to as an inner body portion. The first body portion252-1is shown as having a circular shape defining one or more grooves or channels256along its peripheral surface. In some embodiments, first body portion252-1defines a first opening255-1sized and configured to receive at least one of the second body portion255-2and third body portion255-3.

Second body portion252-2is shown inFIG.30as having a circular shape, but second body portion252-2can have other shapes or forms. In some embodiments, second body portion252-2can be coupled to the first body portion252-1via one or more pivot bars, such as pivot bars253-1,253-2shown inFIG.30. Second body portion252-2can define an opening255-2that is sized and configured to receive third body portion252-3.

Third body portion252-3is shown inFIG.30as having a rectangular shape, but can have other shapes or forms as discussed herein. In some embodiments, third body portion252-3can define one or more guide apertures or surfaces258for receiving a tool, such as a fixation device or bone removal tool as described above. The third body portion252-3can be coupled to one or more pivot bars253-3, which can be coupled to or supported by second body portion252-2such that third body portion252-3can move in one or more directions. For example, as indicated by the arrows inFIG.30, third body portion252-3can be able to move in both a first direction (e.g., vertically on the page) and a second direction (e.g., horizontally on the page) relative to at least one of the first and second body portions252-1,252-2. In some embodiments, third body portion252-3can be configured to rotation about a longitudinal axis defined by pivot bar253-3.

As noted above, the guide inserts can be provided with various types of guide apertures or surfaces.FIG.31illustrates one example of a guide insert250having a first body portion252-1and a second body portion252-2, with the second body portion252-2being movably coupled to the first body portion252-1via a pivot bar253. The second body portion252-2can include a first pin guide258-1, a second pin guide258-2, and a cutting guide268. As shown inFIG.31, the cutting guide268can include a transverse slot270and first and second angled slots272,274that extend from opposite ends of transverse slot270at oblique angles relative to each other and/or transverse slot270.

The guide inserts shown inFIGS.25-31can be configured to be coupled to a locator component in a single orientation while providing a surgeon or other medical professional or user with the ability to adjust a location and/or orientation of a guide structure intraoperatively. However, it should be understood that the guide inserts illustrated inFIGS.25-31can be configured to be adjustable relative to a locating component as described above.

FIG.32partially illustrates another example of a guide300including a locating component302and a guide insert350. The locating component302can have a body304with a similar shape to that of locating component102described above. The coupling element318can be located at a more inferior location compared to the location of coupling element118described above with respect toFIGS.1,2, and9. For example and as shown inFIG.32, the coupling element318can be located at least partially between legs308-1,308-2(collectively, legs “308”) that extend from the inferior end310of body304such that a portion of the body304surrounding and defining the coupling element318extends below (e.g., inferiorly) and between legs308. However, in some embodiments, the body304can only partially surround coupling element318, as will be understood by one of ordinary skill in the art and shown above inFIG.1.

The guide insert350can interface with the body304of the locating component302such that adjustment of the guide insert relative to the locating component is selectively constrained. For example, the coupling element318can define an opening320and include one or more notches or recesses322in communication with the opening320. Each recess of the plurality of recesses322is sized and configured to receive a protruding detent356that extends outwardly from a peripheral edge354of the body352of the guide insert350. Although the recesses322are shown as being defined by the body304of locating component302and the detent356is shown as extending from the insert guide body352, it should be understood that the configuration could be reversed such that a detent is located on the locating component body304and a plurality of recesses are located along the periphery of the guide insert's body352. The location of the recesses322and/or detent356can be predetermined such that a predetermined angular correction can be provided by selecting a recess-protrusion pair for engagement (e.g., in increments of 1°, 2°, 3°, 4°, 5°, etc.). Such angular correction can be selected by a user intraoperatively to correct a varus/valgus alignment of the guide apertures358to facilitate a desired change in varus/valgus deformity of the patient. Although not shown inFIG.32, indicia can be provided adjacent to the notches322(or elsewhere along the body304of locating component302) to provide a visual indication of the amount of adjustment provided by the recesses322. Further, although guide apertures358are shown as a pair of holes, it should be understood that the guide insert350can be provided with any number of guide apertures and/or surfaces, including those described above with respect toFIGS.10-20and25-31, for example.

FIG.33illustrate another example of a guide300having a locating component302and a guide insert350, where the guide insert has a gear-shaped interface. More particularly, the example illustrated inFIG.33shows locating guide302having a coupling element318including an opening320and a plurality of triangularly shaped recesses322encircling the opening, and the body352of guide insert350including a plurality of detents356that have complementary triangular shape. The corresponding recesses322and detents356can be triangular, as shown, rectangular, or they can have other shapes that are complementary to one another. The detents356and recesses322can be provided at predetermined intervals that correspond to a specific angular adjustment (e.g., 1°, 2°, 3°, 4°, 5°, etc.) to provide the surgeon or other user with the ability to make a constrained adjustment to the preoperative plan intraoperatively.

FIG.34illustrates another example of a guide400having a locating component402and a guide insert450that interface with one another. In the example illustrated inFIG.34, the interface includes a single protruding detent456and a single elongated groove or recess422. The recess422is elongated so that the guide insert450can be rotated within an angular range defined by the two ends of the elongated recess422. The rotation of the guide insert450would be around a central axis that is located at the center of the guide insert450and oriented orthogonal to the plane of theFIG.34. One or more markers or indicia428can be provided along (e.g., adjacent to) the recess422. The indicia428can provide a visual indication of the angular adjustment when the insert guide450is rotated relative to the locating component402.

FIG.35illustrates another example of a guide500having a locating component502and a guide insert550. In the example illustrated inFIG.35, the locating component502includes a coupling element518disposed between first and second legs508-1,508-2. The coupling element can include a non-symetrically shaped opening520and a guide insert550that has a shape that is complementary to the non-symmetrical shape of the opening520. This configuration allows the guide insert550to be received within the opening520in one orientation only. Put another way, the shape of the opening520and body504of the guide insert550are orientationally keyed to one another. The guide insert550is shown as including a pair of spaced apart guide apertures558-1,558-2and a cutting guide568, but it should be understood that the cutting guide can include other features to facilitate the insertion of fixation elements and/or removable of bone as described herein.

FIGS.36-39illustrate another example of a patient-specific guide600. Guide600can include a locating component604, which can support or can be otherwise coupled to an adjustable component650. In some embodiments, the locating component604has a body with a pair of outwardly extending arms606-1,606-2(collectively “arms606”). A pair of legs608-1,608-2(collectively “legs608”) can extend from the inferior end610of the body of the locating component604. The body of the locating component604can further include a first side612, which can be a bone facing side, and an opposed second side614. The bone-facing side612can include one or more patient specific surfaces that is based on preoperative imaging, as described in U.S. Pat. No. 5,768,134 issued to Swaelens et al., which was incorporated by reference above. In some embodiments, the locating component604can be formed from a medical-grade material that is capable of being 3D printed (e.g., additively manufactured), such as ABS, PLA, PETG, nylon, TPU, resin, and other suitable thermoplastics and thermosetting plastics, to list only a few possibilities.

In some embodiments, the body of the locating component604defines one or more holes616-1,616-2(collectively, “holes616”). Holes616can be sized and configured to receive a k-wire, pin, or other fixation device for coupling the locating component604to one or more bones. In the example illustrated inFIGS.36and37, each arm606-1,606-2defines a respective hole616-1,616-2. It should be understood that the body of the locating component604can define other holes. For example, each leg608-1,608-2can define a respective hole (not shown) to either increase the securement of locating component604to a first bone or to couple the locating component604to a second bone (e.g., a talus) while the holes616couple the locating component604to a first bone (e.g., a tibia). One of ordinary skill in the art will understand that additional holes can be provided and/or holes can be provided at other locations in the body of the locating component604, such as holes630-1,630-2(collectively, “holes630”), which can be sized and configured to receive a radiopaque element. For example, one or more radiopaque elements can be received in the one or more holes630to provide aid in the alignment of a fluoroscopic device with the guide600. In some embodiments, the holes630are arranged perpendicular with respect to an orientation of holes616; however, one of ordinary skill in the art will understand that the holes630can be arranged parallel to one another and/or holes616or can be oriented at other angles.

The body of the locating component604can further include a coupling element618. In the example shown inFIGS.36and37, the coupling element618can include an opening620defined by the body of the locating component604and one or more protrusions622that extend inwardly into opening620from a peripheral side624. Although opening620is shown as having a circular shape, it should be understood that opening620can have other shapes, including those shapes described elsewhere herein. Further, while two protrusions612are shown extending inwardly into opening620, fewer or more protrusions622can be provided. Additionally or alternatively, one or more of the protrusions can be omitted or replaced with a channel or groove.

The coupling element618can be sized and configured to receive an adjustable component, such as one or more guide inserts650in an adjustable manner. The guide insert650can include one or more guide apertures or surfaces658that can be used to facilitate a surgical process. For example, in the embodiment illustrated inFIGS.36-39, the body652of guide insert650is shown as including four pin guides658-1,658-2,658-3,658-4(collectively, “pin guides658”). Pin guides658can extend from a first side660of body652to an opposed second side662as best seen inFIGS.38-39. In the illustrated example, the pin guides658are shown as being equidistantly spaced about body652. However, it should be understood that the number of pin guides658can be varied along with the location of the pin guides658as described herein.

The guide insert650and the coupling element618are configured to allow the orientation of the guide insert650within the coupling element618can be selectively adjusted. For example, guide insert650can have a disc-shaped body652as best seen inFIGS.38and39. The body652of guide insert650can be configured to be inserted into the coupling element618in certain rotational orientation similar to the embodiment shown inFIG.33. The rotational orientation refers to the orientation of the guide insert650rotated about the central axis A shown inFIGS.36and37.

Referring toFIG.37, the guide insert650can move in or out of the coupling element618in axial direction along the central axis A defined by the opening620but once situated within the coupling element618, the coupling element618and the guide insert650are configured to prevent the guide insert650from rotating about the central axis A relative to the locating component604. For example, the coupling element618can include one or more protruding detents622provided along the periphery of the opening620. The body652of guide insert650can include complementary slots or grooves656that are sized and configured to receive the detents622. The grooves656are spaced apart on the guide insert650at predetermined intervals such that the guide insert650can be inserted into the opening620at various rotational orientation about the central axis A that are rotationally shifted at the predetermined intervals. This allows the operator or surgeon to adjust the orientation of the pin guides658.

The grooves656can be provided on the guide insert650at any desired intervals and the number of grooves656provided on the guide insert650can vary accordingly. For example, the example of the guide insert650shown inFIG.36has four grooves656that are located 90° apart at 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock positions and two detents622are provided along the periphery of the opening620at the corresponding 12 o'clock and 3 o'clock positions. In such embodiment, the guide insert650can be inserted into the opening620at different rotational orientations at 90° intervals.

In another example of the guide insert650shown inFIG.37, eight grooves656are provided on the guide insert650located at intervals that are 45° apart. With the two detents622provided along the periphery of the opening620that are 90° apart, the guide insert650can be inserted into the opening620at different rotational orientations at 45° intervals.

In yet another example of guide insert650shown inFIG.38, twelve grooves656are provided on the guide insert650located at intervals that are 30° apart. With the two detents622provided along the periphery of the opening620that are 90° apart, the guide insert650can be inserted into the opening620at different rotational orientations at 30° intervals.

In some embodiments, the guide insert650can have a side surface654that is convex, preferably a spherical surface. The internal surface624of the coupling element618would be complementary to the spherical contour of the side surface654of the guide insert650. With the embodiments where the side surface654has a spherical surface, by configuring the coupling element618to have two detents622that are positioned at diametrically opposed locations along the periphery of the opening620, with the guide insert650is received and positioned within the opening620, the guide insert650can be rotated about an axis that is orthogonal to the central axis A of the opening620and also orthogonal to an imaginary line connecting the two diametrically opposed detents622. In other words, the detents622and grooves656provide for a keyed relationship and can prevent the body652of the guide insert650from moving in a first direction (e.g., rotating about the central axis A) while allowing movement in a second direction (e.g., rotating about an axis that is perpendicular to the central axis defined by the opening620). The direction of this rotating motion in the second direction in relation to the guid600will be predetermined by the locations of the two diametrically opposed detents622in a particular version of the guide600.

The location of the detents622along the side624and/or the location of the channel or grooves656along body652can be selected to provide a predetermined amount of adjustment between the guide insert652and the locating component602. However, in some embodiments, the interface between coupling element618and the body652of guide insert650can allow for unconstrained adjustment, which allows guide insert650to be rotated in a complete circle within coupling element118as described herein. The body652of guide insert150can be able to fit only partially within coupling element618, or body652can be configured such that the entirety of the body652can be received within the coupling element618as shown inFIG.37.

The body652of guide insertion650can have a shape other than a circular disk. For example, the body652can be shaped as a rectangular or square, triangular, cruciform, or gear shaped, to list one a few possibilities. It should be understood that the coupling element618can have a complementary shape to the body652of the guide insert such that the guide insert650can be coupled to the locating component602. In some embodiments, the guide insert can be configured to be moved (e.g., rotated, pivoted, and/or repositioned) relative to the locating component. However, in some embodiments, as described below, the guide insert650can be coupled to locating component in a single orientation, but permit guide apertures and surfaces to be repositioned.

As described above, the pin guides658can be arranged parallel to one another and disposed perpendicular with respect to a plane defined by one or more of the faces of the body652. However, the pin guides658can also be disposed in a non-parallel arrangement with one another and at an oblique angle with respect to a plane defined by the one or more faces of the body652. Further, pin guides can be provided with a bushing (not shown). The pin guides658can be sized and configured to receive a pin, k-wire, or other fixation element, as will be understood by one of ordinary skill in the art. Additionally or alternatively, the opening of the pin guides658can be sized and configured to receive a bone removal tool, such as a drill bit or rotary cutting tool. In some embodiments, the body652of the guide insert650can be formed from a material that is more rigid and/or durable than the material from which the locating component is formed. For example, the guide insert body652can be formed from a medical-grade metal, such as titanium, stainless steel, cobalt, and/or chromium, to list only a few possible materials. Further, the guide insert body652can be machined and/or formed using an additive manufacturing process, such as EBM or DMLS, to list only a couple possibilities.

Advantageously, the coupling between locating component602and guide insert650allows a surgeon or other user to adjust a location at which a fixation element and/or bone removal tool is applied to bone. As noted above, the user can make the decision to adjust a relative position between the guide insert650and locating component602intraoperatively in response to viewing the surgical site.

In use, a locating component102,302,402,502,602can be placed relative to a first bone such that at least one patient-specific surface of the locating component is coupled to at least one bone. As will be understood by one of ordinary skill in the, the at least one patient-specific surface can engage a predetermined area of a first tissue (e.g., bone or cartilage) in a predetermined way based on preoperative imaging and analysis. One or more fixation elements, such as a k-wire or pin, can be inserted into the locating element to secure the locating element to a first tissue (e.g., bone or cartilage).

In some embodiments, the locating component102,302,402,502,602can be configured to engage more than one bone. For example, the locating component102,302,402,502,602can include a first patient-specific surface configured to engage a first bone and a second patient-specific surface configured to engage a second bone. In such embodiments, the locating component102,302,402,502,602can be placed such that the first patient-specific surface engages the first bone and the second patient-specific surface engages the second bone. It should be understood that the locating component can include additional patient-specific surfaces, which can be configured to engage the first bone, the second bone, and/or a third bone.

An adjustable component150,250,350,450,550,650can be coupled to the locating component102,302,402,502,602prior to and/or after the locating component102,302,402,502,602is coupled to the one or more bones. As described above, the adjustable component150,250,350,450,550,650can be coupled to the locating component102,302,402,502,602via a coupling element.

With an adjustable component150,250,350,450,550,650coupled to locating component102,302,402,502,602and the locating component positioned against one or more bones, a surgeon or other medical professional or user can adjust a position of a guide aperture or surface intraoperatively. For example, the adjustable component150,250,350,450,550,650can be pivoted and/or rotated relative to the locating component102,302,402,502,602to adjust a location of at least one guide aperture or surface of the adjustable component. The adjustment can be made by the surgeon or medical professional in response to conditions present in the operating theater, which can not have been identified during the preoperative planning stages. For example, bone quality and/or one or more deformities can have changed since the preoperative planning stage or during the surgical intervention, and the surgeon or medical professional would like to make an adjustment based on the conditions identified intraoperatively. Accordingly, the adjustable component can be used to provide the desired adjustment, such as by rotating or otherwise moving the adjustable component relative to the locating component.

As described above, there can be one or more ways in which an adjustable component150,250,350,450,550,650can be moved to provide the adjustment of a guide surface or aperture relative to the locating component102,302,402,502,602. For example, in some embodiments, a first adjustable component can be removed from its engagement with the locating component and replaced with a second locating component, which can be selected from a plurality of available adjustable components.

In some embodiments, the adjustable component150,250,350,450,550,650can be pivoted, rotated, and/or moved linearly in one or more directions, such as by sliding, relative to the locating component102,302,402,502,602. For example, the entire locating component and/or a portion of a locating component can be moved relative to the locating component as described herein.

Once the desired adjustment has been made, the adjustable component150,250,350,450,550,650can be used to guide another surgical tool. For example, one or more holes defined by the adjustable component150,250,350,450,550,650can be used to guide the placement of a fixation element or device (e.g., a k-wire or pin) into one or more bones. Additionally or alternatively, one or more guide surfaces or slots of the adjustable component150,250,350,450,550,650can be used to guide a cutting instrument (e.g., a saw or drill) to remove tissue (e.g., bone, cartilage, etc.) from the patient in a controlled manner. As noted above, the locating component can be left in position on the one or more bones while the fixation element and/or cutting instrument is used, or the locating component can be removed from its engagement with the one or more bones while the fixation element and/or cutting instrument is used.

The systems, guides, and kits described herein advantageously enable a surgeon or other medical professional to make an intraoperative adjustment to a location of a guide aperture or surface that is placed relative to a tissue using a patient-specific locating guide. The intraoperative adjustability of the guide aperture or surface advantageously enables a surgeon to adjust a preoperative plan to address issues identified in the operating theatre.

Although the systems, guides, kits, and methods have been described in terms of exemplary embodiments, they are not limited thereto. Rather, the appended claims should be construed broadly, to include other variants and embodiments of the systems, guides, kits, and methods, which can be made by those skilled in the art without departing from the scope and range of equivalents.