US20220160518A1 - Patient-specific vertebral implants with positioning features - Google Patents

Abstract

The present technology provides patient-specific vertebral implants. The implants can include a cage having a geometry contoured to mate with an inferior surface of a superior vertebra and a superior surface of an inferior vertebra at a first target position. The implants can also include a plate having a geometry contoured to mate with an identified anatomical structure at a second target position. The cage and plate can be coupled in a predetermined three-dimensional orientation that simultaneously permits the cage to occupy the first target position and the plate to occupy the second target position when the implant is implanted.

Description

TECHNICAL FIELD
• The present disclosure is generally related to orthopedic implants, and more particularly to systems and methods for designing and implementing patient-specific orthopedic implants.
BACKGROUND
• Orthopedic implants are used to correct numerous different maladies in a variety of contexts, including spine surgery, hand surgery, shoulder and elbow surgery, total joint reconstruction (arthroplasty), skull reconstruction, pediatric orthopedics, foot and ankle surgery, musculoskeletal oncology, surgical sports medicine, and orthopedic trauma. Spine surgery itself may encompass a variety of procedures and targets, such as one or more of the cervical spine, thoracic spine, lumbar spine, or sacrum, and may be performed to treat a deformity or degeneration of the spine and/or related back pain, leg pain, or other body pain. Common spinal deformities that may be treated using an orthopedic implant include irregular spinal curvature such as scoliosis, lordosis, or kyphosis (hyper- or hypo-), and irregular spinal displacement (e.g., spondylolisthesis). Other spinal disorders that can be treated using an orthopedic implant include osteoarthritis, lumbar degenerative disc disease or cervical degenerative disc disease, lumbar spinal stenosis, and cervical spinal stenosis.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings illustrate various embodiments of systems, methods, and embodiments of various other aspects of the disclosure. Any person with ordinary skill in the art will appreciate that the illustrated element boundaries (e.g., boxes, groups of boxes, or other shapes) in the figures represent one example of the boundaries. It may be that in some examples one element may be designed as multiple elements or that multiple elements may be designed as one element. In some examples, an element shown as an internal component of one element may be implemented as an external component in another, and vice versa. Non-limiting and non-exhaustive descriptions are described with reference to the following drawings. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating principles.
• FIG. 1A is a side view of a patient-specific implant implanted in a patient's spinal column and configured in accordance with embodiments of the present technology.
• FIG. 1B is a front view of the patient-specific implant ofFIG. 1A implanted in the patient's spinal column.
• FIG. 2A is a side view of another patient-specific implant implanted in a patient's spinal column and configured in accordance with embodiments of the present technology.
• FIG. 2B is a front view of the patient-specific implant ofFIG. 2A implanted in the patient's spinal column.
• FIG. 3A is a side view of a plurality of patient-specific implants implanted in a patient's spinal column and configured in accordance with embodiments of the present technology.
• FIG. 3B is a front view of the plurality of patient-specific implants ofFIG. 3A implanted in the patient's spinal column.
• FIG. 4 is a partially schematic top view of a patient-specific implant with an interlocking cage and plate and configured in accordance with embodiments of the present technology.
• FIG. 5 is a partially schematic top view of another patient-specific implant with an interlocking cage and plate and configured in accordance with embodiments of the present technology.
• FIG. 6 is a flowchart of a method for implanting a patient-specific implant to a target position in a patient's spinal column in accordance with embodiments of the present technology.
• FIG. 7 is a flowchart of another method for implanting a patient-specific implant to a target position in a patient's spinal column in accordance with embodiments of the present technology.
• FIG. 8 is a network connection diagram illustrating a system for providing patient-specific medical care and configured in accordance with select embodiments of the present technology.
• FIG. 9 illustrates a computing device suitable for use in connection with the system ofFIG. 8, in accordance with select embodiments of the present technology.
• FIG. 10 is a partially schematic illustration of an operative setup for implanting a patient-specific implant into a patient, in accordance with embodiments of the present technology.
DETAILED DESCRIPTIONI. Overview of Technology
• The present technology is directed to patient-specific medical device implants that are designed based on a patient's anatomy. For example, in many of the embodiments disclosed herein, the present technology provides patient-specific vertebral implants designed to be implanted between two vertebral bodies. The vertebral implants can include both a patient-specific interbody device (e.g., a cage) and a patient-specific positioning feature. The interbody device can be designed to occupy a first target position between the two vertebral bodies. The positioning feature can be designed to occupy a second target position proximate at least one of the two vertebral bodies. The positioning feature can be a plate, and the plate and the interbody device can be mechanically coupled together by a connection mechanism. The connection mechanism can be designed to connect the interbody device to the plate to form a predetermined three-dimensional spatial relationship therebetween that simultaneously permits the cage to occupy the first target position and the plate to occupy the second target position. Because the plate and the interbody device are in a predetermined three-dimensional spatial relationship when coupled together, a surgeon implanting the implant need only confirm that either the plate is in the second target position or the interbody device is in the first target position. If, for example, the surgeon confirms the plate is in the second target position, the interbody device will be in the first target position by virtue of the predetermined spatial relationship between the interbody device and the plate.
• The present technology further provides methods for implanting the patient-specific implants. For example, in some embodiments, the interbody device and plate can be implanted in an uncoupled state. In such embodiments, the interbody device can be delivered proximate the first target position. The plate can then be delivered to the second target position. Once the plate is in the second target position, the plate can be coupled to the interbody device. The act of coupling the plate to the interbody device can move the interbody device into the first target position. The plate can be configured to match the geometry of anatomical features against which it rests. For example, the plate can have a curved surface that is generally geometrically congruent to region of the outer surface of the vertebral body. When the plate pressed against the region, the matching surfaces can engage one another to key the plate to the vertebral body. Accordingly, the patient specific configuration of the plate can be used to position and align the plate with the spine. In some embodiments, the interbody device and plate can be delivered in a coupled state. Regardless of whether the interbody device and the plate are delivered in a coupled or uncoupled state, the mechanical coupling between the interbody device and the plate can provides a desired orientation and positioning between the interbody device and the plate such that when the plate is in the second target position, the interbody device is in the first target position, and vice versa. Once implanted, the plate can also prevent and/or reduce movement (e.g., expulsion, migration, etc.) of the interbody device.
• Without being bound by theory, intervertebral implants provide the most efficacy when they are implanted at the correct position. This is especially true for “patient-specific” intervertebral implants, which, as described in detail below, are designed to mate with specific anatomical targets. However, depending on the surgical approach and the type of device being implanted, it can be difficult to deliver intervertebral implants (e.g., interbody devices such as cages) to precise target locations in an intervertebral disc space. For example, because the disc space is between two vertebral bodies, the precise target location often cannot be directly seen and/or accessed by the surgeon performing the implant procedure. The target location is also typically at the bottom of a narrow surgical corridor that can further reduce the ability of a surgeon to see the target site and/or reduce maneuverability of the implant once proximate the target site. The present technology thus provides systems, devices, and associated methods that direct the intervertebral implants into the target position without having to directly visualize the target size. Without being bound by theory, the present technology is therefore expected to improve the accuracy with which interbody devices can be delivered to relatively “difficult to visualize” target positions, such as intervertebral disc spaces.
• The plates described herein can therefore have at least two functions: ensuring the interbody device is positioned at the correct (and relatively difficult-to-visualize) target position and reducing movement of the interbody device once it is located at the target position. The plates can be designed to mate with a portion of patient anatomy at a second target position that is relatively easier to visualize and/or access than the interbody target position. For example, the plates can be designed to mate with one or more surfaces of the vertebral body (e.g., an anterior surface of a vertebral body, a lateral surface of a vertebral body, etc.). The plates can also be coupled to the interbody device to form a predefined three-dimensional spatial relationship therebetween. For example, when the plate is coupled to the interbody device, the interbody device can have a predefined position, orientation, alignment, and/or geometry relative to the plate. The predefined three-dimensional orientation can thus be designed to ensure that, when the plate is positioned at the relatively easier to visualize plate target position, the interbody device is directed into the relatively harder to visualize interbody target position. Thus, the plate can be used to help guide the interbody device into position. The plate can be mechanically coupled to the spine by one or more fasteners (e.g., bone screws, anchors, etc.). The fasteners can further prevent or limit movement of the plate relative to the adjacent vertebrae.
• In some embodiments, a patient-specific intervertebral implant includes an intervertebral cage configured to mate with endplates of adjacent vertebral bodies, a patient-specific positioning feature configured to mate with a target region of at least one of the adjacent vertebral bodies, and a connection mechanism. The connection mechanism can couple or be configured to couple the patient-specific positioning feature to the intervertebral cage to maintain a predetermined configuration of the patient-specific intervertebral implant when the intervertebral cage is between the endplates and the patient-specific positioning feature contacts the target region. The predetermined configuration can correspond to a target spatial relationship between the cage and positioning feature.
• The present technology thus provides systems and methods for designing and implanting “patient-specific” or “personalized” medical devices, that are expected to mitigate at least some of the disadvantages of conventional intervertebral implants. In particular, the present technology provides systems and methods for designing and implanting patient-specific implants that are optimized for the patient's particular characteristics (e.g., condition, anatomy, pathology, medical history, etc.). For example, the patient-specific medical device can be designed and manufactured specifically for the particular patient, rather than being an off-the-shelf device. However, it shall be appreciated that a patient-specific or personalized medical device can include one or more components that are non-patient-specific, and/or can be used with an instrument or tool that is non-patient-specific. For example, patient-specific positioning features can be used with non-patient-specific articulating intervertebral implants, fixed intervertebral implants, cages, etc. Personalized implant designs can be used to manufacture or select patient-specific technologies, including medical devices, instruments, and/or surgical kits. For example, a personalized surgical kit can include one or more patient-specific devices, patient-specific instruments, non-patient-specific technology (e.g., standard instruments, devices, etc.), instructions for use, patient-specific treatment plan information, or a combination thereof. The implants can include positioning features selected based on the implantation site, delivery paths, or the like. Positioning features can be or include, for example, plates, plate assemblies (e.g., plates and one or more fasteners, plates with locators, etc.), arms (e.g., deployable or nondeployed arms), or combinations thereof. For example, an implant can have arms that are deployed to contact specific positions along the spinal column.
• In some embodiments, the patient-specific implants described herein are designed to occupy a specific target position once implanted. As used herein, the terms “target position,” “target site,” and “target location,” refers to a predetermined optimal location for the implant to be placed during the implant procedure, and can be based on the patient's anatomy, condition, diagnosis, prognosis, activity-level, and the like. For example, the target position may be defined by one or more of the following parameters taken in relation to an anatomical landmark: an angle or degree of orientation, and angle or degree of translation, an insertion depth, an insertion angle, degree of contact between two surfaces, and the like. Suitable anatomical landmarks include, for example, specific vertebrae or other recognizable anatomical features. The target position can therefore include a three-dimensional position of the implant relative to patient anatomy (e.g., as defined by boundaries created by patient anatomy), and/or a target orientation of the implant relative to patient anatomy. In some embodiments, the target position may incorporate a desired correction to the patient's native anatomy such that, when the implant is implanted at the target position, it manipulates the patient's anatomy to achieve the desired correction. Without being bound by theory, placing the implant at the target position is expected to optimize the benefit of and/or minimize the side effects of the implant. In particular, the full benefit of the implant may only be realized when the implant is accurately placed at the target position. Various aspects of the implant (e.g., the interbody device and the plate) can have different target positions.
• Embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings in which like numerals represent like elements throughout the several figures, and in which example embodiments are shown. Embodiments of the claims may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. The examples set forth herein are non-limiting examples and are merely examples among other possible examples.
• The words “comprising,” “having,” “containing,” and “including,” and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items.
• As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.
• Although the disclosure herein primarily describes systems and methods for treatment planning in the context of orthopedic surgery, the technology may be applied equally to medical treatment and devices in other fields (e.g., other types of surgical practice). Additionally, although many embodiments herein describe systems and methods with respect to implanted devices, the technology may be applied equally to other types of medical devices (e.g., non-implanted devices).
II. Patient-Specific Vertebral Implants
• FIGS. 1A and 1B illustrate a patient-specific implant100 implanted in an intervertebral disc space between L4 and L5 vertebral bodies and configured in accordance with embodiments of the present technology. In particular,FIG. 1A is a side view of theimplant100 implanted between the L4 and L5 vertebral bodies (shown in dashed line), andFIG. 1B is front view of theimplant100 implanted between the L4 and L5 vertebral bodies (shown in dashed line). Referring first toFIG. 1A, theimplant100 includes an interbody element orcage110, a positioning element orplate120, and aconnection mechanism130 coupling thecage110 to theplate120. Thecage110 is positioned in the disc space between the L4 and L5 vertebral bodies and interfaces with an inferior aspect of the L4 vertebral body and a superior aspect of the L5 vertebral body. Theplate120 is positioned anterior to the vertebral column and contacts an anterior surface of the L4 vertebral body. In other embodiments, theplate120 can project in an inferior direction and contact an anterior surface of the L5 vertebral body. In some embodiments, and as described with respect toFIGS. 2A and 2B, theplate120 can project in both an anterior and inferior direction, thus contacting both the L4 and L5 anterior surfaces. In addition to, or in lieu of, having projections extending in an anterior and inferior direction, theplate220 can include one or more projections that extend laterally and are configured to interface with one or more lateral surfaces of the L4 or L5 vertebral bodies. A fastening element such as ascrew125 can be used to secure theplate120 to an adjacent anatomical structure, such as the L4 vertebral body, to resist expulsion and/or migration of thecage110. In some embodiments, and as best shown inFIG. 1B, theplate120 can include one ormore apertures124 that can receive a portion of thescrew125 for securing theplate120 to the appropriate vertebral structure.
• Returning toFIG. 1A, thecage110 includes a patient-specific geometry (e.g., size, shape, curvature, contouring, morphology, topography, etc.) designed to mate with the patient's anatomy. As used herein, the term “mate” can refer to the engagement of two surfaces to form a generally gapless interface with reduced and/or minimized empty space therebetween such that at least 80%, 90%, 95%, 97%, 98%, 99%, or 100% of a first surface contacts a second surface in at least some patient orientations (not including any engineered gaps, such as might exist for a chamber included in a central portion of the cage110). For example, in the illustrated embodiment, a first (e.g., upper)surface112 of thecage110 can have a topography designed to mate with a topography of an inferior surface S₁of the L4 vertebral body. When the patient stands and the spine is generally straight, at least 80%, 90%, 95%, 97%, 98%, 99%, or 100% of the surface area of thefirst surface112 contacts the inferior surface S₁(e.g., forming a “generally gapless” interface) such that loads are applied generally evenly across thecage110. In the illustrated embodiment, the inferior surface S₁has a generally “wavy” topography with several recesses and projections. Thefirst surface112 of thecage110 therefore has a generally “wavy” topography with several recesses and projections that mate with the generally wavy topography of the inferior surface S₁to form a generally gapless interface therebetween. A second (e.g., lower)surface114 of thecage110 can have a topography designed to mate with a topography of a superior surface S₂of the L5 vertebral body. When the patient stands and the spine is generally straight, at least 80%, 90%, 95%, 97%, 98%, 99%, or 100% of the surface area of thesecond surface114 can contact the inferior surface S₂(e.g., forming a “generally gapless” interface) such that loads are applied generally evenly across thecage110. In the illustrated embodiment, the superior surface S₂is generally flat. Thesecond surface114 of thecage110 therefore has a generally flat topography to mate with the generally flat topography of the superior surface S₂to form a generally gapless interface therebetween. In the illustrated embodiment, thefirst surface112 is shown slightly spaced apart from the inferior surface S₁, and thesecond surface114 is shown slightly spaced apart from the superior surface S₂, to more clearly show the topography of the various surfaces. However, as one skilled in the art will appreciate, thefirst surface112 contacts the inferior surface S₁and thesecond surface114 contacts the superior surface S₂when thecage110 is implanted in the patient. In addition to improving the fit of thecage100, the matching topographies can prevent, inhibit, or limit lateral movement of thecage110 relative to one or both adjacent vertebrae. For example, the topographies can be designed to keep movement of thecage110 less than 5%, 2%, or 1% of the maximum length of the inferior surface S₁.
• Theplate120 also includes a patient-specific geometry (e.g., size, shape, curvature, contouring, morphology, topography, etc.) designed to mate with the patient's anatomy. For example, a contact surface122 (e.g., a posterior surface) of theplate120 can have a topography designed to mate with a topography of an anterior surface S₃of the L4 vertebral body. In the illustrated embodiment, the anterior surface S₃is partially curved. Thecontact surface122 of theplate120 is therefore also partially curved to mate with the partially curved topography of the anterior surface S₃to form a generally gapless interface therebetween. In the illustrated embodiment, thecontact surface122 is shown slightly spaced apart from the contact surface S₃to more clearly show the topography of both surfaces. As one skilled in the art will appreciate, thecontact surface122 contacts the anterior surface S₃when theplate120 is implanted in the patient.
• Both thecage110 and theplate120 can have a predetermined target position, in which the patient-specific topographies of thecage110 and theplate120 mate with their corresponding anatomical structures. For example, thecage110 is shown in a first target position in which its patient-specific topography aligns with the anatomical structure having the corresponding topography (e.g., thefirst surface112 and thesecond surface114 align with the inferior surface S₁and the superior surface S₂, respectively). In some embodiments, the first target position may be generally centered between the lateral margins of the L4 and L5 vertebral bodies, although other positions are possible. Theplate120 is shown in a second target position in which the patient-specific topography aligns with the anatomical structure having the corresponding topography (e.g., thecontact surface122 aligns with the anterior surface S₃). As previously described, placing thecage110 and theplate120 at their respective target positions is expected to optimize the benefit of, and/or reduce the side effects associated with, theimplant100. For example, placing thecage110 in the first target position maximizes the contact between thecage110 and the L4 and L5 vertebral bodies, which can reduce the risk that the cage is ejected from the disc space between the L4 and L5 vertebral bodies.
• Thecage110 can be coupled to theplate120 via aconnection mechanism130. Theconnection mechanism130 can include a rigid or semi rigid interface. For example, and as described in greater detail below with respect toFIGS. 4 and 5, theconnection mechanism130 can include a rigid connection including one or more screws or bolts (e.g., a lag blot, a carriage bolt, a hex bolt, a machine screw, a wood screw, etc.), a rigid metal arm, etc. Semi-rigid connections can include a semi-rigid metal arm (e.g., a slotted arm, a flexible arm, etc.), arm with cut-out or bend points, etc. In some embodiments, theconnection mechanism130 can be a key and slot mechanism, a magnet, a rivet, a tether, or other suitable fastening element(s). In some embodiment, and as best shown inFIG. 1B, theplate120 can include anaperture126 or other feature to facilitate connection of theplate120 to thecage110. As described in greater detail below with respect toFIG. 6, thecage110 and theplate120 are coupled via theconnection mechanism130 before being delivered to the intervertebral disc space. In other embodiments, and as described in greater detail below with respect toFIG. 7, thecage110 and theplate120 can be delivered to the intervertebral disc space in an uncoupled state, and theconnection mechanism130 can be used to mechanically couple thecage110 and theplate120 once both are implanted.
• The spatial relationship (e.g., a one-dimensional relationship, a two-dimensional relationship, or the three-dimension relationship) of thecage110 relative to theplate120 therefore depends at least in part on theconnection mechanism130. As will be described in greater detail below, the desired spatial relationship between thecage110 and theplate120 following implantation depends on the relative location of the first target position and the second target position. Theconnection mechanism130 can be therefore be designed to connect thecage110 to theplate120 to form the specific dimensional spatial relationship that simultaneously permits thecage110 to occupy the first target position and theplate120 to occupy the second target position. For example, theconnection mechanism130 can be in the form of a flexible tether that maintains a one-dimensional spatial relationship (e.g., a maximum distance from the cage to the plate120). By way of another example, theconnection mechanism130 can be a semi-rigid arm capable of flexing in the inferior and superior direction to allow a desired level of flexion of the spine. The semi-rigid arm can maintain a two-dimensional relationship between thecage110 andplate120 to limit or prevent lateral movement of thecage110.
• FIGS. 2A and 2B illustrate another patient-specific implant200 implanted in an intervertebral disc space between L5 and S1 vertebral bodies and configured in accordance with embodiments of the present technology. In particular,FIG. 2A is a cross-sectional side view of theimplant200 implanted between the L5 and S1 vertebral bodies (shown in dashed line), andFIG. 2B is front view of theimplant200 implanted between the L5 and S1 vertebral bodies (shown in dashed line). Theimplant200 can include certain features generally similar to theimplant100 described above with respect toFIGS. 1A and 1B. For example, referring first toFIG. 2A, theimplant200 includes a patient-specific interbody element orcage210, a patient-specific positioning element orplate220, and aconnection mechanism230 coupling thecage210 to theplate220. Thecage210 is positioned in the disc space between L5 and S1 and is configured to interface with an inferior aspect of the L5 vertebral body and a superior aspect of the S1 vertebral body. Theplate220 is positioned anterior to the vertebral column.
• Thecage210 can be generally similar to thecage110 described in detail with respect toFIGS. 1A and 1B. For example, a first (e.g., upper)surface212 of thecage210 can have a topography designed to mate with a topography of an inferior surface S₂of the L5 vertebral body, and a second (e.g., lower)surface214 can have a topography designed to mate with a topography of a superior surface S₁of the S1 vertebral body (the geometry of thecage210 is shown as different than the geometry of thecage110 inFIG. 1 to demonstrate inter-patient anatomical variability, which further illustrates the need for the patient-specific implants described herein).
• Unlike theplate120 shown inFIGS. 1A and 1B, theplate220 projects in both a superior and inferior direction, and therefore contacts both an anterior surface of the L5 vertebral body and an anterior surface of the S1 vertebral body. In particular, theplate220 includes a first (e.g., superior) projection orwing221 and a second (e.g., inferior) projection orwing226. Thefirst projection221 includes afirst contact surface222 that is configured to interface with an anterior surface S₃of the L5 vertebral body. As described in detail with respect toFIG. 1A, thefirst contact surface222 can have a patient-specific geometry (e.g., size, shape, curvature, contouring, morphology, topography, etc.) designed to mate with the anterior surface S₃. Thefirst projection221 can also include one or more apertures224 (FIG. 2B) for receiving one or more fastening elements or screws225 (FIG. 2A) for securing theplate220 to the L5 vertebral body to resist expulsion and/or migration of thecage210. Thesecond projection226 includes asecond contact surface228 configured to interface with an anterior surface S₄of the S1 vertebral body. Thesecond contact surface228 can also have a patient-specific geometry designed to mate with the anterior surface S₄. Notably, because thesecond projection226 is configured to mate with a different surface than thefirst projection221, thesecond projection226 may have a different geometry than thefirst projection221. Thesecond projection226 can also include one or more apertures227 (FIG. 2B) for receiving one or more fastening elements or screws229 (FIG. 2A) for securing theplate220 to the S1 vertebral body to resist expulsion and/or migration of thecage210. In some embodiments, incorporating multiple wings/projections into theplate220 can provide fixation between adjacent vertebral bodies to reduce post-operative motion between the vertebral bodies, as well as increasing the stability provided by theplate220 to reduce migration and/or expulsion of thecage210.
• In addition to, or in lieu of, having projections extending in an anterior and inferior direction, theplate220 can include one or more projections that extend laterally and are configured to interface with one or more lateral surfaces of the L5 or S1 vertebral bodies. In such embodiments, the lateral projections can have a patient-specific geometry that is configured to mate with a lateral surface of the L5 and/or S1 vertebral bodies. The lateral projections can also be used to secure theplate220 to the vertebral bodies.
• FIGS. 3A and 3B illustrate additional patient-specific implants implanted in an intervertebral disc space bodies and configured in accordance with embodiments of the present technology. More specifically,FIGS. 3A and 3B illustrate three patient-specific implants:implant300 implanted between the L3 and L4 vertebral bodies (shown in dashed line),implant350 positioned between the L4 and L5 vertebral bodies (shown in dashed line), andimplant390, positioned between the L5 and S1 vertebral bodies (shown in dashed line). Although theimplants300,350, and390 are shown as implanted in the same spine, one skilled in the art will appreciate thatimplants300,350, and390 can be used alone and/or in combination with other implants beyond those shown.
• Theimplants300,350, and390 can include certain features generally similar to theimplants100,200 previously described. For example, theimplant300 can include an interbody element orcage310, a positioning element orplate320, and aconnection mechanism330 coupling thecage310 to theplate320. Thecage310 of theimplant300 is positioned at a first target position in the disc space between the L3 and L4 vertebral bodies and is configured to interface with an inferior aspect of the L3 vertebral body and a superior aspect of the L4 vertebral body. As described previously with respect to theimplants100,200, thecage310 can include a patient-specific geometry (e.g., size, shape, curvature, contouring, morphology, topography, etc.) designed to mate with the corresponding patient anatomy at the first target position. For example, anupper surface312 of thecage310 can be designed with a geometry/topography that mates with an inferior surface of the L3 vertebral body, and alower surface314 of thecage310 can be designed with a geometry/topography that mates with a superior surface of the L4 vertebra body. In the illustrated embodiment, theupper surface312 is shown slightly spaced apart from the inferior surface of the L3 vertebral body, and thelower surface314 is shown slightly spaced apart from the superior surface of the L4 vertebral body, to more clearly show the topography of the various surfaces. However, as one skilled in the art will appreciate, theupper surface312 contacts the inferior surface of the L3 vertebral body and thelower surface314 contacts the superior surface of the L4 vertebral body when thecage110 is implanted in the patient.
• Theplate320 can also have a patient-specific geometry configured to mate with the corresponding patient anatomy at a second target position. However, unlike theplates120,220 described with respect toFIGS. 1A-2B, theplate320 is configured to reside substantially within the disc space between the L3 and L4 vertebral bodies. For example, in some embodiments theplate320 does not extend beyond the anterior and/or lateral margins of the L3 and/or L4 vertebral bodies. Theplate320 therefore has an upper (e.g., superior)surface322 having a geometry/topography designed to mate with an inferior surface of the L3 vertebral body and/or an anterior or lateral margin of the L3 vertebral body. Theplate320 has a lower (e.g. inferior)surface324 having a geometry/topography designed to mate with a superior surface of the L4 vertebral body and/or an anterior or lateral margin of the L4 vertebral body. Theplate320 can be secured in position using a first fastening element or screw325aprojecting from theupper surface322 and a second fastening element or screw325bprojecting from thelower surface324, thereby resisting expulsion and/or migration of thecage310. In some embodiments, thefeatures325a,325bare arms or anchors that can be driven into the vertebral bodies. One expected advantage of designing theplate320 to be positioned substantially within the disc space is reducing the overall profile of theimplant300, which may aid in delivery of theimplant300 and/or in the long-term efficacy of theimplant300.
• Theimplants350 and390 can be generally similar to theimplant300. For example, theimplant350 can include an interbody element orcage360, a positioning element orplate370, and aconnection mechanism380 coupling thecage360 to theplate370. Thecage360, theplate370, and/or theconnection mechanism380 can have patient-specific features (e.g., geometry, topography, etc.), such as any of the patient-specific features previously described herein.
• Theimplant390 can also be generally similar to theimplant300 and theimplant350. For example, theimplant390 can include an interbody element orcage392, a positioning element orplate394, and aconnection mechanism396. Thecage392, theplate394, and/or theconnection mechanism396 can have patient-specific features (e.g., geometry, topography, etc.), such as any of the patient-specific features previously described herein. Relative to theimplants300,350, theimplant390 does not include additional fastening elements or screws. Rather, theimplant390 is secured in position solely based on its frictional interface with the adjacent vertebrae. For example, anupper surface394aof theplate394 can have a geometry/topography designed to mate with an inferior surface of the L5 vertebral body and/or an anterior or lateral margin of the L5 vertebral body, and alower surface394bof theplate394 can have a geometry/topography designed to mate with a superior surface of the S1 vertebral body and/or an anterior or lateral margin of the S1 vertebral body.
• Although the implants inFIGS. 1A-3B are shown as implanted between specific vertebral bodies (e.g., theimplant100 is shown as implanted between the L4 and L5 vertebral bodies), one skilled in the art will appreciate that the implants described herein can be designed to be implanted between other vertebral bodies, including those in the cervical, thoracic, and lumbar regions. Moreover, although the implants shown inFIGS. 1A-3B include a “cage” and a “plate”, the present technology is not limited to such embodiments. Rather, the present technology can include other types of interbody devices and orthopedic implants. Additionally, because the implants described herein are designed to match individual patient anatomy, the size, shape, and geometry of the implants will vary according to individual patient anatomy. The present technology is thus not limited to any particular implant design or configuration, and can therefore include other implants beyond those expressly illustrated or described herein.
• FIG. 4 illustrates a patient-specific implant400 configured in accordance with embodiments of the present technology. Theimplant400 can be generally similar to any of the patient-specific implants previously described. For example, theimplant400 can include an interbody element orcage410, a positioning element orplate420, and aconnection mechanism430 configured to couple thecage410 to theplate420. Thecage410, theplate420, and/or theconnection mechanism430 can have patient-specific features (e.g., geometry, topography, etc.), such as any of the patient-specific features previously described herein. Theplate420 can have one ormore apertures424 that extend between a first (e.g., outer)surface423 and a second (e.g., inner)surface422. Once theimplant400 is implanted in a patient, one or more screws (not shown) can be inserted through theapertures424 and secured to an anatomical structure (e.g., screwed into one or more vertebral bodies).
• As illustrated, certain aspects of theconnection mechanism430 can be integral with theplate420. For example, theplate420 can be connected to or include an integral projection432 (e.g., arm, extension, lever, etc.) that extends transversely from theplate420. Theprojection432 can have a hollow interior defining a lumen orother opening434 that is aligned with anaperture426 extending through theplate420. As described below, a screw or other fastening element (e.g., a lag blot, a carriage bolt, a hex bolt, a machine screw, a wood screw, etc.) can be inserted into thelumen434 via theaperture426. A distal end portion of theprojection432 can fit within a corresponding recess or receivingfeature416 in thecage410. Therecess416 may have areceiver417, which in some embodiments defines a threaded female connector for receiving a corresponding threaded male connector. Thereceiver417 aligns with thelumen434 when theprojection432 is advanced into therecess416. The screw or other fastening element can be inserted through theaperture426 of theplate420, advanced through thelumen434 of theprojection432, and secured (e.g., threadably secured) to thereceiver417, thereby securing theplate420 to thecage410.
• Additionally or alternatively, theconnection mechanism430 can couple theplate420 to thecage410 using other suitable mechanisms. For example, in some embodiments thereceiver417 may comprise one or more magnets that adhere to the distal end portion of theprojection432 when it is inserted into therecess416 to magnetically couple theplate420 to thecage410. As another example, theconnection mechanism430 can utilize a key and slot mechanism, in which the projection includes one or more features configured to releasably engage one or more features in therecess416 to releasably couple theplate420 to thecage410. In yet other embodiments, theplate420 can be coupled to thecage410 using a rivet, a tether, or another suitable connection mechanism.
• In some embodiments, theconnection mechanism430 can form a rigid (e.g., inelastic) interface between theplate420 and thecage410 that minimizes and/or reduces strain in response to external stresses. For example, theconnection mechanism430 may be rigid so as to retain a predetermined three-dimensional orientation between thecage410 and theplate420 even if one or both of thecage410 or theplate420 is subjected to mechanical stress. In embodiments in which theconnection mechanism430 is rigid, theconnection mechanism430 may include one or more metal screws or bolts extending substantially the entire length of theprojection432.
• In some embodiments, theconnection mechanism430 can form a semi-rigid interface between theplate420 and thecage410 to minimize strain in response to external stresses while permitting some degree of relative motion between theplate420 and thecage410 to account for changes in patient anatomy during patient motion. For example, in some embodiments theconnection mechanism430 may permit motion of up to 5 degrees, 10 degrees, 15 degrees, etc. in at least one plane of motion. In embodiments in which theconnection mechanism430 is semi-rigid, one or more aspects of the connection mechanism430 (e.g., the projection432) can be composed of an at least partially elastic or flexible material (e.g., nitinol, silicone, rubber, etc.) and/or include one or more motion segments or joints.
• Regardless of its composition, theconnection mechanism430 provides a specific (e.g., patient-specific) three-dimensional spatial relationship/orientation between theplate420 and thecage410 when theplate420 is coupled to thecage410 via theconnection mechanism430. Accordingly, theprojection432, therecess416, and other associated features can be specifically designed such that, when theplate420 is secured to thecage410, theplate420 and thecage410 assume a predetermined orientation and position relative to each other. In particular, because thecage410 is designed to be implanted at a first target position and theplate420 is designed to be implanted at a second target position, coupling theplate420 to thecage410 causes theplate420 and thecage410 to assume an orientation that enables thecage410 to be in the first target position and simultaneously allows theplate420 to be in the first target position. As a result, and as described in more detail later, coupling theplate420 to thecage410 when theplate420 is at the second target position forces theplate420 and thecage410 into the predetermined orientation, which can direct thecage410 to occupy the first target position.
• FIG. 5 illustrates a patient-specific implant500 configured in accordance with embodiments of the present technology. Theimplant500 can be generally similar to any of the patient-specific implants previously described. For example, theimplant500 can include an interbody element orcage510, a positioning element orplate520, and aconnection mechanism530 configured to couple thecage510 to theplate520. Thecage510, theplate520, and/or theconnection mechanism530 can have patient-specific features (e.g., geometry, topography, etc.), such as any of the patient-specific features previously described herein. Theplate520 can have one ormore apertures524 that extend between a first (e.g., outer)surface523 and a second (e.g., inner)surface522. Once theimplant500 is implanted in a patient, one or more screws can be inserted through theapertures524 and secured to an anatomical structure (e.g., screwed into one or more vertebral bodies).
• As with theconnection mechanism430 of theimplant400, certain aspects of theconnection mechanism430 can be integral with theplate420. For example, theplate520 can be connected to or include an integrated projection532 (e.g., arm, extension, lever, etc.) that extends transversely from theplate520. Theprojection532 can have a hollow interior defining a lumen orother opening534 that is aligned with anaperture526 in theplate520. Unlike theconnection mechanism430 of theimplant400, thecage510 does not include a recess for slidable receiving a distal end portion of theprojection532. Rather, thecage510 includes a threadedreceiver517 defining a threaded female connector for receiving a corresponding threaded male connector. The threadedreceiver517 extends inwardly from an outer surface of the cage510 (as opposed to extending inwardly from a recess, such as therecess416 shown inFIG. 4). Once theprojection532 is generally aligned with the threadedreceiver517, a screw or other fastening element (not shown) can be inserted through theaperture526 of theplate520, advanced through thelumen534 of theprojection532, and threadably secured to the threadedreceiver517 to secure theplate520 to thecage510.
• In some embodiments, theconnection mechanism530 can form a rigid (e.g., inelastic) and/or semi-rigid connection interface between theplate520 and thecage510 that minimizes and/or reduces strain in response to external stresses. For example, theconnection mechanism530 may retain a predetermined three-dimensional orientation between thecage510 and theplate520 even if one or both of thecage510 or theplate520 is subjected to mechanical stress.
• Similar to theconnection mechanism430, theconnection mechanism530 provides a specific (e.g., patient-specific) three-dimensional spatial relationship/orientation between theplate520 and thecage510. Accordingly, theprojection532, the threadedreceiver517, and other associated features can be designed with an orientation such that, when theplate520 is secured to thecage510, theplate520 and thecage510 assume a predetermined orientation and position relative to each other. In particular, because thecage510 is designed to be implanted at a first target position and theplate520 is designed to be implanted at a second target position, coupling theplate520 to thecage510 causes theplate520 and thecage510 to assume an orientation that enables thecage510 to be in the first target position and simultaneously allows theplate520 to be in the first target position. As a result, and as described in more detail below, coupling theplate520 to thecage510 when theplate520 is at the second target position forces theplate520 and thecage510 into the predetermined orientation, which can direct thecage510 to occupy the first target position.
III. Methods for Implanting Patient-Specific Vertebral Implants
• The present technology also provides methods for implanting patient-specific vertebral devices to a target region at or proximate a patient's spine.FIG. 6 is a flowchart of amethod600 for implanting a patient-specific vertebral implant having a cage and a plate in a coupled state to a target region at or proximate a patient's spine. Themethod600 can include, instep602, providing a patient-specific implant having a cage and a plate. The cage is generally designed with patient-specific features (e.g., geometry, topography, etc.) configured to mate with a first identified anatomical structure at a first target position. The first target position is generally in the disc space between adjacent vertebral bodies, and the first identified anatomical structural is generally an inferior surface of a superior vertebral body and/or a superior surface of an inferior vertebral body. The plate is also generally designed with patient-specific features (e.g., geometry, topography, etc.) configured to mate with a second identified anatomical structure at a second target position. The second target position is generally adjacent an anterior surface of the vertebral column, a lateral surface of the vertebral column, and/or at an anterior margin of the disc space between adjacent vertebral bodies. Accordingly, the second identified anatomical structure is generally an anterior or lateral surface of a vertebral body, and/or an inferior surface of a superior vertebral body and/or a superior surface of an inferior vertebral body.
• Themethod600 can continue instep604 by coupling the plate to the cage, such as via any of the connection mechanisms described herein. Step604 is performed before the implant is implanted into the patient, and can be performed by a surgeon, a surgical robotic platform, and/or a surgeon assisted by a surgical robotic platform. In some embodiments, for example, the plate and cage are manufactured as separate components and are coupled together in the operating room as part of the pre-operative procedure. In other embodiments, the plate and the cage can be manufactured in a coupled state (e.g., the plate and the cage can be a unitary or integral component). In such embodiments, thestep604 can be omitted, and themethod600 can proceed fromstep602 directly to step606. Regardless, once coupled, the cage and plate can assume a predetermined three-dimensional orientation that enables the cage to occupy a first target position and the plate to simultaneously occupy a second target position.
• Themethod600 continues instep606 by delivering (e.g., implanting) the implant to the target region at or proximate the patient's spine. With the implant at or adjacent the target region, themethod600 continues instep608 by positioning the plate at the second target position. This can be done by a surgeon, a surgical robotic platform, and/or a surgeon assisted by a surgical robotic platform. In some embodiments, a surgeon performing or otherwise assisting with the surgery can directly visualize the second target position, enabling the surgeon to accurately position the plate at the second target position. In some embodiments, because the plate has a patient-specific topography/geometry configured to mate with the second anatomical structure at the second target position, the surgeon will be able to tell when the plate is at the second target position based on the physical interaction between the plate and the second anatomical structure (e.g., the plate “fits” with the second anatomical structure when placed at the second target position). In some embodiments, the plate can be secured at the second target position by inserting a screw or other fastening element through one or more apertures in the plate and into the second identified anatomical structure.
• Because the plate is coupled to the cage in a predetermined three-dimensional orientation, positioning the plate at the second target position directs the cage to occupy the first target position. Accordingly, positioning the plate at the second target position also positions (e.g., automatically positions) the cage at the first target position. Without being bound by theory, placing the cage and plate at their respective target positions is expected to optimize the benefit of and/or minimize the side effects of the implant. In particular, the full benefit of the implant may only be realized when the implant is accurately placed at the target position. Themethod600 can optionally continue instep610 by confirming that the cage is in the first target position. The position of the cage can be confirmed using one or more conventional imaging technologies known in the art (e.g., X-Ray, MRI, CT-scan, etc.).
• FIG. 7 is a flowchart of amethod700 for implanting a patient-specific vertebral implant having a plate and a cage in an uncoupled state to a target region at or proximate a patient's spine. Themethod700 can include, instep702, providing a patient-specific implant having a cage and a plate. The cage is generally designed with patient-specific features (e.g., geometry, topography, etc.) configured to mate with a first identified anatomical structure at a first target position. The first target position is generally in the disc space between adjacent vertebral bodies, and the first identified anatomical structural is generally an inferior surface of a superior vertebral body and/or a superior surface of an inferior vertebral body. The plate is also generally designed with patient-specific features (e.g., geometry, topography, etc.) configured to mate with a second identified anatomical structure at a second target position. The second target position is generally adjacent an anterior surface of the vertebral column, a lateral surface of the vertebral column, and/or at an anterior margin of the disc space between adjacent vertebral bodies. Accordingly, the second identified anatomical structure is generally an anterior or lateral surface of a vertebral body, and/or an inferior surface of a superior vertebral body and/or a superior surface of an inferior vertebral body.
• Themethod700 can continue instep704 by delivering (e.g., implanting) the cage to a location proximate the first target position, and instep706 by delivering (e.g., implanting) the plate to a location proximate the second target position.Steps704 and706 can be performed by a surgeon, a surgical robotic platform, and/or a surgeon assisted by a surgical robotic platform. However, unlike described above with respect tomethod600, the cage and the plate are not coupled together before delivering the cage to the target position in themethod700. Without being bound by theory, delivering the cage and the plate in an uncoupled state is expected to increase the maneuverability of these components and/or reduce the size of the surgical corridor needed to deliver these components to the spinal cord region.
• Themethod700 can continue instep708 by positioning the plate at the second target position. This can also be performed by a surgeon, a surgical robotic platform, and/or a surgeon assisted by a surgical robotic platform. In some embodiments, a surgeon performing or otherwise assisting with the surgery can directly visualize the second target position, enabling the surgeon to accurately position the plate at the second target position. In some embodiments, because the plate has a patient-specific topography/geometry configured to mate with the second anatomical structure at the second target position, the surgeon will be able to tell when the plate is at the second target position based on the physical interaction between the plate and the second anatomical structure (e.g., the plate “fits” with the second anatomical structure when placed at the second target position). In some embodiments, the plate can be secured at the second target position by inserting a screw or other fastening element through one or more apertures in the plate and into the second identified anatomical structure.
• Once the plate is in the second target position, themethod700 continues instep710 by coupling (e.g., mechanically coupling) the plate to the cage. The plate can be coupled to the cage using any of the connection mechanisms previously described herein. Because the plate and cage assume a predetermined three-dimensional orientation when coupled, coupling the plate to the cage when the plate is positioned at the second target position directs the cage to occupy the first target position. Accordingly, coupling the plate to the cage positions (e.g., automatically positions) the cage at the first target position. In some embodiments, thesteps708 and710 can be reversed such that the plate is coupled to the cage before positioning the plate at the second target position. In such embodiments, once the cage and plate are coupled, positioning the plate at the second target position directs the cage to occupy the first target position. As previously described, positioning the cage and plate at their respective target positions is expected to optimize the benefit of and/or minimize the side effects of the implant. In particular, the full benefit of the implant may only be realized when the implant is accurately placed at the target position. Themethod700 can optionally continue instep712 by confirming that the cage is in the first target position. The position of the cage can be confirmed using one or more conventional imaging technologies known in the art (e.g., X-Ray, MRI, CT-scan, etc.).
• As one skilled in the art will appreciate from the foregoing description, the present technology utilizes the patient-specific nature of the implant components (e.g., the plate and the cage) to make it easier to position the cage at the first target position. For example, because the cage and the plate are coupled together in a predetermined three-dimensional orientation, positioning the plate at the second target position directs the cage toward and/or to the first target position. Thus, positioning the plate at the second target position also positions the cage at the first target position. Without being bound by theory, it is generally easier for a surgeon to position the plate at the second target position than it is to position the cage at the first target position. For example, plates are typically positioned along an anterior surface of the vertebral column and/or at an anterior margin of the disc space that is generally visible to the surgeon, whereas cages are typically positioned at a location in the disc space out of view of the surgeon. Therefore, by mechanically coupling the plate and cage in a predetermined three-dimensional orientation, the surgeon can simply position the plate at the easier-to-visualize second target position, simplifying the implant procedure. The patient-specific nature of the implants provides additional benefits, such as improved fit, improved outcomes, and/or reduced side effects, as previously described.
IV. Systems and Methods for Designing, Manufacturing, and Implanting Patient-Specific Implants
• The present technology also provides system and methods for designing and manufacturing patient-specific implants, such as any of the patient-specific vertebral implants described herein.FIG. 8 is a network connection diagram illustrating acomputing system800 for providing patient-specific medical care and configured in accordance with select embodiments of the present technology. Thesystem800 is configured to design a patient-specific implant and/or generate a patient-specific surgical plan for a patient. For example, thesystem800 can generate an implant and/or generate a surgical plan for a patient suffering from an orthopedic or spinal disease or disorder, such as trauma (e.g., fractures), cancer, deformity, degeneration, pain (e.g., back pain, leg pain), irregular spinal curvature (e.g., scoliosis, lordosis, kyphosis), irregular spinal displacement (e.g., spondylolisthesis, lateral displacement axial displacement), osteoarthritis, lumbar degenerative disc disease, cervical degenerative disc disease, lumbar spinal stenosis, or cervical spinal stenosis, or a combination thereof. The surgical plan can include surgical information, surgical plans (e.g., surgical implant procedure, target implant location and/or orientation, etc.), technology recommendations (e.g., device and/or instrument recommendations), and/or medical device designs. For example, the surgical plan can include at least one treatment procedure (e.g., a surgical procedure or intervention) and/or at least one medical device (e.g., an implanted medical device (also referred to herein as an “implant” or “implanted device”) or implant delivery instrument).
• Thesystem800 includes acomputing device802, which can be a user device, such as a smart phone, mobile device, laptop, desktop, personal computer, tablet, phablet, or other such devices known in the art. As discussed in greater detail with reference toFIG. 9, thecomputing device802 can include one or more processors, and memory storing instructions executable by the one or more processors to perform select methods described herein. Thecomputing device802 can be associated with a healthcare provider that is treating the patient. AlthoughFIG. 8 illustrates asingle computing device802, in alternative embodiments, thecomputing device802 can instead be implemented as a computing system encompassing a plurality of computing devices, such that the operations described herein with respect to thecomputing device802 can instead be performed by the computing system and/or the plurality of computing devices.
• Thecomputing device802 is configured to receive apatient data set808 associated with a patient to be treated. Thepatient data set808 can include data representative of the patient's condition, anatomy, pathology, symptoms, medical history, preferences, and/or any other information or parameters relevant to the patient. For example, thepatient data set808 can include surgical intervention data, treatment outcome data, progress data (e.g., physician notes), patient feedback (e.g., feedback acquired using quality of life questionnaires, surveys), clinical data, patient information (e.g., demographics, sex, age, height, weight, type of pathology, occupation, activity level, tissue information, health rating, comorbidities, health related quality of life (HRQL)), vital signs, diagnostic results, medication information, allergies, image data (e.g., camera images, Magnetic Resonance Imaging (MRI) images, ultrasound images, Computerized Aided Tomography (CAT) scan images, Positron Emission Tomography (PET) images, X-Ray images), diagnostic equipment information (e.g., manufacturer, model number, specifications, user-selected settings/configurations, etc.), or the like. In some embodiments, thepatient data set808 includes data representing one or more of patient identification number (ID), age, gender, body mass index (BMI), lumbar lordosis, Cobb angle(s), pelvic incidence, disc height, segment flexibility, bone quality, rotational displacement, and/or treatment level of the spine.
• In some embodiments, thecomputing device802 can also be configured to receive a surgicalteam data set810. The surgical team data set810 can include data representative of the surgical team that will perform the surgery on the patient. For example, the surgical team data set810 can include preferences of the surgical team (e.g., preferred implant techniques, preferred implant instruments/tools, etc.), experience of the surgical team (e.g., past procedures performed by the surgical team), scored outcomes of past procedures performed by the surgical team, or the like. As used herein, the term “surgical team” can refer to a group of healthcare practitioners that work together in an operating room during an implant procedure, or to one or more individual surgeons.
• In some embodiments, thecomputing device802 can also be configured to receive a facility orprovider data set812. Thefacility data set812 can include data representative of the facility at which the patient's surgery will occur. For example, thefacility data set812 can include preferences of the facility (e.g., preferred implant techniques, preferred implant instruments/tools, etc.), experience of the facility (e.g., past procedures performed at the facility), scored outcomes of past procedures performed at the facility, infrastructure available to assist/perform the surgery (e.g., availability of robotic surgical platforms, as well as the type of “input” required to control the “output” of the robotic surgical platforms), or the like. As used herein, the term “facility” can refer to a single operating room facility, a hospital having multiple operating rooms, and/or a network of hospitals.
• Thecomputing device802 is operably connected via acommunication network804 to aserver806, thus allowing for data transfer between thecomputing device802 and theserver806. Thecommunication network804 may be a wired and/or a wireless network. Thecommunication network804, if wireless, may be implemented using communication techniques such as Visible Light Communication (VLC), Worldwide Interoperability for Microwave Access (WiMAX), Long term evolution (LTE), Wireless local area network (WLAN), Infrared (IR) communication, Public Switched Telephone Network (PSTN), Radio waves, and/or other communication techniques known in the art.
• Theserver806, which may also be referred to as a “treatment assistance network” or “prescriptive analytics network,” can include one or more computing devices and/or systems. As discussed further herein, theserver806 can include one or more processors, and memory storing instructions executable by the one or more processors to perform the methods described herein. In some embodiments, theserver806 is implemented as a distributed “cloud” computing system or facility across any suitable combination of hardware and/or virtual computing resources.
• Thecomputing device802 and/or theserver806 can design a patient-specific implant (“implant”) based at least in part on thepatient data set808, the surgicalteam data set810, and/or thefacility data set812. For example, theserver806 may include atreatment planning module818 that can design, based off on any of the foregoing data inputs, the implant. In some embodiments, the implant includes a design for a vertebral implant including a cage and a plate, such as any of the vertebral implants described with respect toFIGS. 1A-5, that are specifically designed to mate with corresponding target anatomical structures. Thecomputing device802 and/or theserver806 can design an interbody device (e.g., a cage), a positioning feature (e.g., a plate), a connection mechanism, and/or one or more fastening elements (e.g., a screw). For example, to design the connection mechanism, the target position of the cage can be determined by analyzing images of the patient. The patient spine can be analyzed to identify a suitable target site for the positioning feature. For example, the vertebral bodies can be analyzed to identify regions with suitable geometry and mechanical properties to interface with a locking plate. Thecomputing device802 and/or theserver806 can design the connection mechanism based on a level of movement (e.g., a maximum level of relative movement) between the cage and the locking plate. In spinal fusion procedures, the connection mechanism can be a rigid arm that substantially prevents relative movement between the cage and the plate. In articulating disc procedures, the implant can include an articulating disk, a plate, and one or more flexible or semi rigid connection mechanisms coupling the disk and plate together. The target spatial relationship between the components of the implant can be determined based on the patient data and targeted outcome.
• Additional implants include, but are not limited to, screws (e.g., bone screws, spinal screws, pedicle screws, facet screws), other interbody implant devices, rods, discs, fusion devices, spacers, rods, expandable devices, stents, brackets, ties, scaffolds, fixation device, anchors, nuts, bolts, rivets, connectors, tethers, fasteners, joint replacements (e.g., artificial discs), hip implants, or the like. A patient-specific implant design can include data representing one or more of physical properties (e.g., size, shape, volume, material, mass, weight), mechanical properties (e.g., stiffness, strength, modulus, hardness), and/or biological properties (e.g., osteo-integration, cellular adhesion, anti-bacterial properties, anti-viral properties) of the implant. For example, a design for an orthopedic implant can include implant shape, size, material, and/or effective stiffness (e.g., lattice density, number of struts, location of struts, etc.).
• The implant can be designed to match the patient's existing anatomy. For example, the implant can be designed such that various surfaces of the implant mate with corresponding surfaces of patient anatomy, as previously described. In some embodiments, the implant can be designed to provide a correction to the patient's existing anatomy in addition to mating with one or more surfaces of the patient anatomy. For example, thetreatment planning module818 may analyze image data of the patient's native anatomy to determine whether an anatomical correction is needed. The image data may show the patient's native anatomical configuration (e.g., pre-operative anatomy), such as the geometry, orientation, and topography of various anatomical features. In some embodiments, for example, the image data may show (and/or be used to determine) various anatomical characteristics, including, but not limited to, vertebral spacing, vertebral orientation, vertebral translation, abnormal bony growth, abnormal joint growth, joint inflammation, joint degeneration, tissue degeneration, stenosis, scar tissue, lumbar lordosis, Cobb angle(s), pelvic incidence, disc height, segment flexibility, rotational displacement, and other spinal tissue characteristics. If an anatomical correction is not required, thetreatment planning module818 can design the implant to fit the patient's native anatomy. If an anatomical correction is required, thetreatment planning module818 can design the implant such that, when the implant is implanted in the patient, it provides the anatomical correction. Additional details for designing patient-specific implants to provide one or more desired anatomical corrections can be found in U.S. application Ser. No. 16/987,113, filed Aug. 6, 2020, the disclosure of which is incorporated by reference herein in its entirety.
• In some embodiments, the generated implant design is a design for an entire device. Alternatively, the generated design can be for one or more components of a device (e.g., a plate or a cage), rather than the entire device. In some embodiments, the implant design is for one or more patient-specific device components that can be used with standard, off-the-shelf components. For example, in a spinal surgery, a pedicle screw kit can include both standard components and patient-specific customized components. In some embodiments, the generated design is for a patient-specific medical device that can be used with a standard, off-the-shelf delivery instrument. For example, the implants (e.g., screws, screw holders, rods) can be designed and manufactured for the patient, while the instruments for delivering the implants can be standard instruments. This approach allows the components that are implanted to be designed and manufactured based on the patient's anatomy and/or surgeon's preferences to enhance treatment. The implants described herein are expected to improve delivery into the patient's body, placement at the treatment site, and/or interaction with the patient's anatomy.
• Thecomputing system802 and/or theserver806 can also design a patient-specific surgical plan (“surgical plan”) based on thepatient data set808, the surgicalteam data set810, and/or thefacility data set812. The surgical plan can include a detailed procedure for implanting the implant to a specific target position within the patient. For example, the surgical plan can include aspects of a pre-operative plan (e.g., detection and measurement of patient's anatomy, preparation of patient for a surgical procedure, etc.), a surgical procedure, a surgical approach (e.g., implant technique), one or more surgical steps (preparing tissue for an incision, making an incision, making a resection, removing tissue, manipulating tissue, performing a corrective maneuver, delivering the implant to a target site, deploying the implant at the target site, adjusting the implant at the target site, manipulating the implant once it is implanted, securing the implant at the target site, explanting the implant, suturing tissue, etc.) a target position, site, or location of the implant (e.g., a location, orientation, etc.), and other aspects related to pre-operative, operative, or post-operative plans.
• In some embodiments, the surgical plan includes an orthopedic surgical procedure such as spinal surgery, hip surgery, knee surgery, jaw surgery, hand surgery, shoulder surgery, elbow surgery, total joint reconstruction (arthroplasty), skull reconstruction, foot surgery, or ankle surgery. Spinal surgery can include spinal fusion surgery, such as posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), transverse or transforaminal lumbar interbody fusion (TLIF), lateral lumbar interbody fusion (LLIF), direct lateral lumbar interbody fusion (DLIF), or extreme lateral lumbar interbody fusion (XLIF). Spinal surgery can also include non-fusion surgeries, such as artificial disc replacements. In some embodiments, the surgical procedure includes descriptions of and/or instructions for performing one or more aspects of a patient-specific surgical procedure. For example, the surgical procedure can include one or more of a surgical approach, a corrective maneuver, or a bony resection.
• In some embodiments, the surgical plan includes a target position of the implant. In some embodiments, the surgical plan optionally includes a recommendation to remove tissue to clear space for the implant at the target position. For example, the surgical plan may include instructions to perform an osteotomy, muscular resection, soft tissue detachment, soft tissue retraction, or the like to prepare the patient to receive the patient-specific implant. In some embodiments, the surgical plan includes a manipulation of tissue to prepare the patient to receive the implant. For example, the surgical plan may include instructions to adjust a relative position of two vertebrae, increase a distance between two vertebrae, or the like.
• In some embodiments, the surgical plan includes machine-readable instructions for carrying out various steps of the surgical plan. The machine-readable instructions can be configured such that, when executed by a surgical robotic platform, the machine-readable instructions cause the surgical robotic platform to execute various aspects of an operative procedure associated with implanting the implant. For example, the surgical platform may prepare tissue for an incision, make an incision, make a resection, remove tissue, manipulate tissue, perform a corrective maneuver, deliver the implant to a target site, deploy the implant at the target site; adjust a configuration of the implant at the target site, manipulate the implant once it is implanted, secure the implant at the target site, explant the implant, suture tissue, and the like. The instructions may therefor include particular instructions for articulating robotic arms, instruments, and/or tools to perform or otherwise aid in the delivery of the patient-specific implant.
• In some embodiments, the surgical plan includes step-by-step written, verbal, and/or graphic instructions that show a surgeon how to perform the patient-specific surgical plan. The patient-specific surgical plan can be displayed to the surgeon before and/or during the operative procedure (e.g., via display822). In some embodiments, the written, verbal, and/or graphic instructions can be encoded in computer-readable instructions. The encoded instructions can be decoded and displayed to the surgeon before and/or during the operative procedure. In some embodiments, the patient-specific surgical plan includes both machine-readable instructions and written, verbal, and/or graphic illustrations.
• In some embodiments, thesystem800 may consider one or more reference data sets when designing the patient-specific implant and/or the patient-specific surgical plan. For example, in some embodiments theserver806 includes at least onedatabase820 configured to store reference data useful for the treatment planning methods described herein. The reference data can include historical and/or clinical data from the same or other patients, data collected from prior surgeries and/or other treatments of patients by the same or other healthcare providers, data relating to medical device designs, data collected from study groups or research groups, data from practice databases, data from academic institutions, data from implant manufacturers or other medical device manufacturers, data from imaging studies, data from simulations, clinical trials, demographic data, treatment data, outcome data, mortality rates, or the like.
• In some embodiments, thedatabase820 includes a plurality of reference patient data sets, each patient reference data set associated with a corresponding reference patient. For example, the reference patient can be a patient that previously received treatment or is currently receiving treatment. Each reference patient data set can include data representative of the corresponding reference patient's condition, anatomy, pathology, medical history, preferences, and/or any other information or parameters relevant to the reference patient, such as any of the data described herein with respect to thepatient data set808. In some embodiments, the reference patient data set includes pre-operative data, intra-operative data, and/or post-operative data. For example, a reference patient data set can include data representing one or more of patient ID, age, gender, BMI, lumbar lordosis, Cobb angle(s), pelvic incidence, disc height, segment flexibility, bone quality, rotational displacement, and/or treatment level of the spine. As another example, a reference patient data set can include treatment data regarding at least one treatment procedure performed on the reference patient, such as descriptions of surgical procedures or interventions (e.g., surgical approaches, bony resections, surgical maneuvers, corrective maneuvers, placement of implants or other devices). In some embodiments, the treatment data includes medical device design data for at least one medical device used to treat the reference patient, such as physical properties (e.g., size, shape, volume, material, mass, weight), mechanical properties (e.g., stiffness, strength, modulus, hardness), and/or biological properties (e.g., osteo-integration, cellular adhesion, anti-bacterial properties, anti-viral properties). In yet another example, a reference patient data set can include outcome data representing an outcome of the treatment of the reference patient, such as corrected anatomical metrics, presence of fusion, HRQL, activity level, return to work, complications, recovery times, efficacy, mortality, and/or follow-up surgeries.
• In some embodiments, theserver806 receives at least some of the reference patient data sets from a plurality of healthcare provider computing systems. Each healthcare provider computing system can include at least one reference patient data set (e.g., reference patient data sets) associated with reference patients treated by the corresponding healthcare provider. The reference patient data sets can include, for example, kinematic records, electronic medical records, electronic health records, biomedical data sets, etc.
• In embodiments in which the implant and/or the surgical plan is designed based on the reference data, thedata analysis module816 can include one or more algorithms for identifying a subset of reference data from thedatabase820 that is likely to be useful in developing a treatment plan. For example, thedata analysis module816 can compare patient-specific data (e.g., thepatient data set808 received from the computing device802) to the reference data from the database820 (e.g., the reference patient data sets) to identify similar data (e.g., one or more similar patient data sets in the reference patient data sets). The comparison can be based on one or more parameters, such as age, gender, BMI, pathology, kinematics, lumbar lordosis, pelvic incidence, and/or treatment levels. The parameter(s) can be used to calculate a similarity score for each reference patient. The similarity score can represent a statistical correlation between thepatient data set808 and the reference patient data set. Accordingly, similar patients can be identified based on whether the similarity score is above, below, or at a specified threshold value. For example, as described in greater detail below, the comparison can be performed by assigning values to each parameter and determining the aggregate difference between the subject patient and each reference patient. Reference patients whose aggregate difference is below a threshold can be considered to be similar patients. In some embodiments, thedata analysis module816 includes one or more algorithms that select a set or subset of the reference patient data based on criteria other than patient parameters, such as the surgical team data set810 (e.g., based on surgeon expertise, outcomes of particular types of procedures performed by the surgeon, etc.) and/or the facility data set812 (e.g., surgical equipment such as surgical robots).
• Thedata analysis module816 can further be configured with one or more algorithms to select a subset of the reference patient data sets, e.g., based on similarity to thepatient data set808 and/or treatment outcome of the corresponding reference patient. For example, thedata analysis module816 can identify one or more similar patient data sets in the reference patient data sets, and then select a subset of the similar patient data sets based on whether the similar patient data set includes data indicative of a favorable or desired treatment outcome. The outcome data can include data representing one or more outcome parameters, such as corrected anatomical metrics, range of motion, kinematic data, HRQL, activity level, complications, recovery times, efficacy, mortality, or follow-up surgeries. As described in further detail below, in some embodiments, thedata analysis module816 calculates an outcome score by assigning values to each outcome parameter. A patient can be considered to have a favorable outcome if the outcome score is above, below, or at a specified threshold value.
• In some embodiments, thedata analysis module816 selects a subset of the reference patient data sets based at least in part on user input (e.g., from a clinician, surgeon, physician, healthcare provider). For example, the user input can be used in identifying similar patient data sets. In some embodiments, weighting of similarity and/or outcome parameters can be selected by a healthcare provider or physician to adjust the similarity and/or outcome score based on clinician input. In further embodiments, the healthcare provider or physician can select the set of similarity and/or outcome parameters (or define new similarity and/or outcome parameters) used to generate the similarity and/or outcome score, respectively.
• In some embodiments, thedata analysis module816 includes one or more algorithms used to select a set or subset of the reference patient data sets based on criteria other than patient parameters. For example, the one or more algorithms can be used to select the subset based on healthcare provider parameters (e.g., based on healthcare provider ranking/scores such as hospital/physician expertise, number of procedures performed, hospital ranking, etc.) and/or healthcare resource parameters (e.g., diagnostic equipment, facilities, surgical equipment such as surgical robots), or other non-patient related information that can be used to predict outcomes and risk profiles for procedures for the present healthcare provider. For example, reference patient data sets with images captured from similar diagnostic equipment can be aggregated to reduce or limit irregularities due to variation between diagnostic equipment. Additionally, patient-specific treatment plans can be developed for a particular health-care provider using data from similar healthcare providers (e.g., healthcare providers with traditionally similar outcomes, physician expertise, surgical teams, etc.). In some embodiments, reference healthcare provider data sets, hospital data sets, physician data sets, surgical team data sets, post-treatment data set, and other data sets can be utilized. By way of example, a patient-specific treatment plan to perform a battlefield surgery can be based on reference patient data from similar battlefield surgeries and/or datasets associated with battlefield surgeries. In another example, the patient-specific treatment plan can be generated based on available robotic surgical systems. The reference patient data sets can be selected based on patients that have been operated on using comparable robotic surgical systems under similar conditions (e.g., size and capabilities of surgical teams, hospital resources, etc.).
• In embodiments in which the implant and/or the surgical plan is designed based on the reference data, thetreatment planning module818 can include one or more algorithms that generate the implant and/or the surgical plan based on the reference data. In some embodiments, thetreatment planning module818 is configured to develop and/or implement at least one predictive model for generating the treatment plan, also known as a “prescriptive model.” The predictive model(s) can be developed using clinical knowledge, statistics, machine learning, AI, neural networks, or the like. In some embodiments, the output from thedata analysis module816 is analyzed (e.g., using statistics, machine learning, neural networks, AI, etc.) to identify correlations between data sets, patient parameters, healthcare provider parameters, healthcare resource parameters, treatment procedures, medical device designs, and/or treatment outcomes. These correlations can be used to develop at least one predictive model that predicts the likelihood that a treatment plan will produce a favorable outcome for the particular patient. The predictive model(s) can be validated, e.g., by inputting data into the model(s) and comparing the output of the model to the expected output.
• In some embodiments, thetreatment planning module818 is configured to generate the implant design based on previous treatment data from reference patients. For example, thetreatment planning module818 can receive a selected subset of reference patient data sets and/or similar patient data sets from thedata analysis module816, and determine or identify treatment data from the selected subset. The treatment data can include, for example, range of motion and/or other kinematic data, treatment procedure data (e.g., surgical procedure or intervention data) and/or medical device design data (e.g. implant design data) that are associated with favorable or desired treatment outcomes for the corresponding patient. Thetreatment planning module818 can analyze the treatment procedure data and/or medical device design data to determine an optimal treatment protocol for the patient to be treated. For example, the treatment procedures and/or medical device designs can be assigned values and aggregated to produce a treatment score. The patient-specific treatment plan can be determined by selecting treatment plan(s) based on the score (e.g., higher or highest score; lower or lowest score; score that is above, below, or at a specified threshold value). The personalized treatment plan can be based on, at least in part, the patient-specific technologies or patient-specific selected technology.
• Alternatively or in combination, thetreatment planning module818 can generate the implant designs based on correlations between data sets. For example, thetreatment planning module818 can correlate implant designs and medical device design data from implant designs for similar patients with favorable outcomes (e.g., as identified by the data analysis module816). Correlation analysis can include transforming correlation coefficient values to values or scores. The values/scores can be aggregated, filtered, or otherwise analyzed to determine one or more statistical significances. These correlations can be used to determine treatment procedure(s) and/or medical device design(s) that are optimal or likely to produce a favorable outcome for the patient to be treated.
• Alternatively or in combination, thetreatment planning module818 can generate designs using one or more AI techniques. AI techniques can be used to develop computing systems capable of simulating aspects of human intelligence, e.g., learning, reasoning, planning, problem solving, decision making, etc. AI techniques can include, but are not limited to, case-based reasoning, rule-based systems, artificial neural networks, decision trees, support vector machines, regression analysis, Bayesian networks (e.g., naïve Bayes classifiers), genetic algorithms, cellular automata, fuzzy logic systems, multi-agent systems, swarm intelligence, data mining, machine learning (e.g., supervised learning, unsupervised learning, reinforcement learning), and hybrid systems.
• In some embodiments, thetreatment planning module818 generates the treatment plan using one or more trained machine learning models. Various types of machine learning models, algorithms, and techniques are suitable for use with the present technology. In some embodiments, the machine learning model is initially trained on a training data set, which is a set of examples used to fit the parameters (e.g., weights of connections between “neurons” in artificial neural networks) of the model. For example, the training data set can include any of the reference data stored indatabase820, such as a plurality of reference patient data sets or a selected subset thereof (e.g., a plurality of similar patient data sets).
• In some embodiments, the machine learning model (e.g., a neural network or a naïve Bayes classifier) may be trained on the training data set using a supervised learning method (e.g., gradient descent or stochastic gradient descent). The training dataset can include pairs of generated “input vectors” with the associated corresponding “answer vector” (commonly denoted as the target). The current model is run with the training data set and produces a result, which is then compared with the target, for each input vector in the training data set. Based on the result of the comparison and the specific learning algorithm being used, the parameters of the model are adjusted. The model fitting can include both variable selection and parameter estimation. The fitted model can be used to predict the responses for the observations in a second data set called the validation data set. The validation data set can provide an unbiased evaluation of a model fit on the training data set while tuning the model parameters. Validation data sets can be used for regularization by early stopping, e.g., by stopping training when the error on the validation data set increases, as this may be a sign of overfitting to the training data set. In some embodiments, the error of the validation data set error can fluctuate during training, such that ad-hoc rules may be used to decide when overfitting has truly begun. Finally, a test data set can be used to provide an unbiased evaluation of a final model fit on the training data set.
• To generate the treatment plan, thepatient data set808, the surgicalteam data set810, and/or thefacility data set812 can be input into the trained machine learning model(s). Additional data, such as the selected subset of reference patient data sets and/or similar patient data sets, and/or treatment data from the selected subset, can also be input into the trained machine learning model(s). The trained machine learning model(s) can then calculate whether various candidate treatment procedures and/or medical device designs are likely to produce a favorable outcome for the patient. Based on these calculations, the trained machine learning model(s) can select at least one treatment plan for the patient. In embodiments where multiple trained machine learning models are used, the models can be run sequentially or concurrently to compare outcomes and can be periodically updated using training data sets. Thetreatment planning module818 can use one or more of the machine learning models based the model's predicted accuracy score.
• The implant design and/or the surgical plan generated by thetreatment planning module818 can be transmitted via thecommunication network804 to thecomputing device802 for output to a user (e.g., clinician, surgeon, healthcare provider, patient). In some embodiments, thecomputing device802 includes or is operably coupled to adisplay822. Thedisplay822 can show various aspects of a surgical procedure to be performed on the patient, such as the surgical approach, treatment levels, corrective maneuvers, tissue resection, and/or implant placement. To facilitate visualization, a virtual model of the surgical procedure can be displayed. Additionally or alternatively, thedisplay822 can show a design for the implant, such as a two- or three-dimensional model of the device design. Thedisplay822 can also show patient information, such as two- or three-dimensional images or models of the patient's anatomy where the surgical procedure is to be performed and/or where the device is to be implanted. Thedisplay822 can also display structural features of the implant suitable for contacting anatomical features to improve treatment, reduce implant movement, etc. The structural features can be rigid surfaces (e.g., outer surfaces of an implant body), anchors, fixation features, etc. Images of the implantation site can be analyzed to identify such anatomical features identified by thetreatment planning module818. Thecomputing device802 can further include one or more user input devices (not shown) allowing the user to modify, select, approve, and/or reject the displayed treatment plan(s).
• In some embodiments, the patient-specific implant design generated by thetreatment planning module818 can be transmitted from thecomputing device802 and/or theserver806 to amanufacturing system824 for manufacturing a corresponding medical device. Themanufacturing system824 can be located on site or off site. On-site manufacturing can reduce the number of sessions with a patient and/or the time to be able to perform the surgery whereas off-site manufacturing can be useful make the complex devices. Off-site manufacturing facilities can have specialized manufacturing equipment. In some embodiments, more complicated device components can be manufactured off site, while simpler device components can be manufactured on site.
• Various types of manufacturing systems are suitable for use in accordance with the embodiments herein. For example, themanufacturing system824 can be configured for additive manufacturing, such as three-dimensional (3D) printing, stereolithography (SLA), digital light processing (DLP), fused deposition modeling (FDM), selective laser sintering (SLS), selective laser melting (SLM), selective heat sintering (SHM), electronic beam melting (EBM), laminated object manufacturing (LOM), powder bed printing (PP), thermoplastic printing, direct material deposition (DMD), inkjet photo resin printing, or like technologies, or combination thereof. Alternatively or in combination, themanufacturing system824 can be configured for subtractive (traditional) manufacturing, such as CNC machining, electrical discharge machining (EDM), grinding, laser cutting, water jet machining, manual machining (e.g., milling, lathe/turning), or like technologies, or combinations thereof. Themanufacturing system824 can manufacture one or more patient-specific medical devices based on fabrication instructions or data (e.g., CAD data, 3D data, digital blueprints, stereolithography data, or other data suitable for the various manufacturing technologies described herein). In some embodiments, the patient-specific medical device can include features, materials, and designs shared across designs to simplify manufacturing. For example, deployable patient-specific medical devices for different patients can have similar internal deployment mechanisms but have different deployed configurations. In some embodiments, the components of the patient-specific medical devices are selected from a set of available pre-fabricated components and the selected pre-fabricated components can be modified based on the fabrication instructions or data.
• The treatment plans described herein can be performed by a surgeon, a surgical robot, or a combination thereof, thus allowing for treatment flexibility. In some embodiments, the surgical procedure can be performed entirely by a surgeon, entirely by a surgical robot, or a combination thereof. For example, one step of a surgical procedure can be manually performed by a surgeon and another step of the procedure can be performed by a surgical robot. In some embodiments thetreatment planning module818 generates control instructions configured to cause a surgical robot (e.g., robotic surgery systems, navigation systems, etc.) to partially or fully perform a surgical procedure. The control instructions can be transmitted to the robotic apparatus by thecomputing device802 and/or theserver806.
• Following the treatment of the patient in accordance with the treatment plan, treatment progress can be monitored over one or more time periods to update thedata analysis module816 and/ortreatment planning module818. Post-treatment data can be added to the reference data stored in thedatabase820. The post-treatment data can be used to train machine learning models for developing patient-specific treatment plans, patient-specific medical devices, or combinations thereof.
• It shall be appreciated that the components of thesystem800 can be configured in many different ways. For example, in alternative embodiments, thedatabase820, thedata analysis module816 and/or thetreatment planning module818 can be components of thecomputing device802, rather than theserver806. As another example, thedatabase820, thedata analysis module816, and/or thetreatment planning module818 can be located across a plurality of different servers, computing systems, or other types of cloud-computing resources, rather than at asingle server806 orcomputing device802.
• Additionally, in some embodiments, thesystem800 can be operational with numerous other computing system environments or configurations. Examples of computing systems, environments, and/or configurations that may be suitable for use with the technology include, but are not limited to, personal computers, server computers, handheld or laptop devices, cellular telephones, wearable electronics, tablet devices, multiprocessor systems, microprocessor-based systems, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above systems or devices, or the like. In some embodiments, thesystem800 may include additional features and/or capabilities, such as any of those described in U.S. application Ser. No. 16/735,222, filed Jan. 6, 2020, the disclosure of which is incorporated by reference herein in its entirety.
• FIG. 9 illustrates acomputing device900 suitable for use in connection with thesystem800 ofFIG. 8, according to an embodiment. Thecomputing device900 can be incorporated in various components of thesystem800 ofFIG. 8, such as thecomputing device802 or theserver806. Thecomputing device900 includes one or more processors910 (e.g., CPU(s), GPU(s), HPU(s), etc.). The processor(s)910 can be a single processing unit or multiple processing units in a device or distributed across multiple devices. The processor(s)910 can be coupled to other hardware devices, for example, with the use of a bus, such as a PCI bus or SCSI bus. The processor(s)910 can be configured to execute one more computer-readable program instructions, such as program instructions to carry out of any of the methods described herein.
• Thecomputing device900 can include one ormore input devices920 that provide input to the processor(s)910, e.g., to notify it of actions from a user of thecomputing device900. The actions can be mediated by a hardware controller that interprets the signals received from the input device and communicates the information to the processor(s)910 using a communication protocol. Input device(s)920 can include, for example, a mouse, a keyboard, a touchscreen, an infrared sensor, a touchpad, a wearable input device, a camera- or image-based input device, a microphone, or other user input devices.
• Thecomputing device900 can include adisplay930 used to display various types of output, such as text, models, virtual procedures, surgical plans, implants, graphics, and/or images (e.g., images with voxels indicating radiodensity units or Hounsfield units representing the density of the tissue at a location). In some embodiments, thedisplay930 provides graphical and textual visual feedback to a user. The processor(s)910 can communicate with thedisplay930 via a hardware controller for devices. In some embodiments, thedisplay930 includes the input device(s)920 as part of thedisplay930, such as when the input device(s)920 include a touchscreen or is equipped with an eye direction monitoring system. In alternative embodiments, thedisplay930 is separate from the input device(s)920. Examples of display devices include an LCD display screen, an LED display screen, a projected, holographic, or augmented reality display (e.g., a heads-up display device or a head-mounted device), and so on.
• Optionally, other I/O devices940 can also be coupled to the processor(s)910, such as a network card, video card, audio card, USB, firewire or other external device, camera, printer, speakers, CD-ROM drive, DVD drive, disk drive, or Blu-Ray device. Other I/O devices940 can also include input ports for information from directly connected medical equipment such as imaging apparatuses, including MRI machines, X-Ray machines, CT machines, etc. Other I/O devices940 can further include input ports for receiving data from these types of machine from other sources, such as across a network or from previously captured data, for example, stored in a database.
• In some embodiments, thecomputing device900 also includes a communication device (not shown) capable of communicating wirelessly or wire-based with a network node. The communication device can communicate with another device or a server through a network using, for example, TCP/IP protocols. Thecomputing device900 can utilize the communication device to distribute operations across multiple network devices, including imaging equipment, manufacturing equipment, etc.
• Thecomputing device900 can includememory950, which can be in a single device or distributed across multiple devices.Memory950 includes one or more of various hardware devices for volatile and non-volatile storage, and can include both read-only and writable memory. For example, a memory can comprise random access memory (RAM), various caches, CPU registers, read-only memory (ROM), and writable non-volatile memory, such as flash memory, hard drives, floppy disks, CDs, DVDs, magnetic storage devices, tape drives, device buffers, and so forth. A memory is not a propagating signal divorced from underlying hardware; a memory is thus non-transitory. In some embodiments, thememory950 is a non-transitory computer-readable storage medium that stores, for example, programs, software, data, or the like. In some embodiments,memory950 can includeprogram memory960 that stores programs and software, such as anoperating system962, one or moretreatment assistance modules964, andother application programs966. The treatment assistance module(s)964 can include one or more modules configured to perform the various methods described herein (e.g., thedata analysis module816 and/ortreatment planning module818 described with respect toFIG. 1).Memory950 can also includedata memory970 that can include, e.g., reference data, configuration data, settings, user options or preferences, etc., which can be provided to theprogram memory960 or any other element of thecomputing device900.
• FIG. 10 illustrates various aspects of an operative setup configured in accordance with the present technology. As shown, the operative setup can be used to implant a patient-specific artificial implant1000 (which can be the same or generally similar to the implants described with respect toFIGS. 1A-5) into a patient P using a robotic surgical platform1050 (hereinafter referred to as the “platform1050”). Theplatform1050 can be configured to perform or otherwise assist with one or more aspects of the operative procedure, including, for example, preparing tissue for an incision, making an incision, making a resection, removing tissue, manipulating tissue, performing a corrective maneuver, delivering the implant to a target site, deploying the implant at the target site, adjusting the implant at the target site, manipulating the implant once it is implanted, securing the implant at the target site, explanting the implant, suturing tissue, etc. For example, theplatform1050 can include one ormore arms1055 and end effectors for holding various surgical tools (e.g., graspers, clips, needles, needle drivers, irrigation tools, suction tools, staplers, screw driver assemblies, etc.), imaging instruments (e.g., cameras, sensors, etc.), and/or medical devices (e.g., the implant1000) and that enable theplatform1050 to perform the one or more aspects of the surgical plan (e.g., positioning cages, forming mechanical connections, installing positioning features, implanting plates, etc.). Although shown as having onearm1055, one skilled in the art will appreciate that theplatform1050 can have a plurality of arms (e.g., two, three, four, or more) and any number of joints, linkages, motors, and degrees of freedom. In some embodiments, theplatform1050 may have a first arm dedicated to holding one or more imaging instruments, while the remainder of the arms hold various surgical tools. In some embodiments, the tools can be releasably secured to the arms such that they can be selectively interchanged before, during, or after an operative procedure. The arms can be moveable through a variety of ranges of motion (e.g., degrees of freedom) to provide adequate dexterity for performing various aspects of the operative procedure.
• Theplatform1050 can include acontrol module1060 for controlling operation of the arm(s)1055. In some embodiments, thecontrol module1060 includes a user input device (not shown) for controlling operation of the arm(s)1055. The user input device can be a joystick, a mouse, a keyboard, a touchscreen, an infrared sensor, a touchpad, a wearable input device, a camera- or image-based input device, a microphone, or other user input devices. A user (e.g., a surgeon) can interact with the user input device to control movement of the arm(s)1055. In some embodiments, thecontrol module1060 includes one or more processors for executing machine-readable instructions that, when executed, automatically control operation of thearm1055. In such embodiments, thecontrol module1060 may receive machine-readable instructions specifying one or more steps of a surgical procedure that, when executed by thecontrol module1060, cause theplatform1050 to perform the one or more steps of the surgical procedure. For example, the machine-readable instructions may direct theplatform1050 to prepare tissue for an incision, make an incision, make a resection, remove tissue, manipulate tissue, perform a corrective maneuver, deliver theimplant1000 to a target site, deploy theimplant1000 at the target site, adjust a configuration of theimplant1000 at the target site, manipulate theimplant1000 once it is implanted, secure theimplant1000 at the target site, explant theimplant1000, suture tissue, and the like. The instructions may therefor include particular instructions for articulating thearm1055 to perform or otherwise aid in the delivery of the patient-specific implant.
• If the surgical plan includes executable instructions, theplatform1050 can execute instructions to perform at least a portion of the surgical procedure. In some embodiments, theplatform1050 can generate executable instructions based on the surgical plan. For example, the surgical plan can include information about the delivery path, tools, and implantation site. Theplatform1050 can analyze the surgical plan and develop executable instructions for performing the patient-specific procedure based on the capabilities (e.g., configuration and number of robotic arms, functionality of and effectors, guidance systems, visualization systems, etc.) of the robotic system. This enables thesystem800 to be compatible with a wide range of different types of robotic surgery systems.
• Theplatform1050 can include one or more communication devices (e.g., components having VLC, WiMAX, LTE, WLAN, IR communication, PSTN, Radio waves, Bluetooth, and/or Wi-Fi operability) for establishing a connection with a network1006 (which can be the same as theserver806 shown inFIG. 8) and/or a computing device1040 (which can be the same as the computing device902 shown inFIG. 9) for accessing and/or downloading the patient-specific plan. For example, thenetwork1006 can receive a request for a particular surgical plan from theplatform1050 and send the plan to theplatform1050. Once identified, thenetwork1006 can transmit the surgical plan directly to theplatform1050 for execution. In some embodiments, thenetwork1006 can transmit the surgical plan to one or more intermediate networked devices, rather than transmitting the surgical plan directly to theplatform1050. For example, thenetwork1006 may transmit the surgical plan to thecomputing device1040 and/or thecomputing device900, described previously with respect toFIG. 9. A user can review the surgical plan using the computing device before transmitting the surgical plan to theplatform1050 for execution. Additional details for identifying, storing, downloading, and accessing patient-specific surgical plans are described in U.S. application Ser. No. 16/990,810, filed Aug. 11, 2020, the disclosure of which is incorporated by reference herein in its entirety.
• Theplatform1050 can include additional components not expressly shown inFIG. 10. For example, in various embodiments theplatform1050 may include one or more displays (e.g., LCD display screen, an LED display screen, a projected, holographic, or augmented reality display (e.g., a heads-up display device or a head-mounted device), one or more I/O devices (e.g., a network card, video card, audio card, USB, firewire or other external device, camera, printer, speakers, CD-ROM drive, DVD drive, disk drive, or Blu-Ray device), and/or a memory (e.g., random access memory (RAM), various caches, CPU registers, read-only memory (ROM), and writable non-volatile memory, such as flash memory, hard drives, floppy disks, CDs, DVDs, magnetic storage devices, tape drives, device buffers, and so forth). In some embodiments, the foregoing components can be generally similar to the like components described in detail with respect tocomputing device900 inFIG. 9.
• Without being bound by theory, using a robotic surgical platform to perform various aspects of the surgical plans described herein is expected to provide several advantages over conventional operative techniques. For example, use of robotic surgical platforms may improve surgical outcomes and/or shorten recovery times by, for example, decreasing incision size, decreasing blood loss, decreasing a length of time of the operative procedure, increasing the accuracy and precision of the surgery (e.g., the placement of the implant at the target location), and the like. Theplatform1050 can also avoid or reduce user input errors, e.g., by including one or more scanners for obtaining information from instruments (e.g., instruments with retrieval features), tools, the patient specific implant1000 (e.g., after theimplant1000 has been gripped by the arm1055), etc. Theplatform1050 can confirm use of proper instruments prior and during the surgical procedure. If theplatform1050 identifies an incorrect instrument or tool, an alert can be sent to a user that another instrument or tool should be installed. The user can scan the new instrument to confirm that the instrument is appropriate for the surgical plan. In some embodiments, the surgical plan includes instructions for use, a list of instruments, instrument specifications, replacement instruments, and the like. Theplatform1050 can perform pre- and post-surgical checking routines based on information from the scanners.
CONCLUSION
• The foregoing detailed description has set forth various embodiments of the devices and/or processes via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. In some embodiments, several portions of the subject matter described herein may be implemented via Application Specific Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs), digital signal processors (DSPs), or other integrated formats. However, those skilled in the art will recognize that some aspects of the embodiments disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry and/or writing the code for the software and or firmware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as a program product in a variety of forms, and that an illustrative embodiment of the subject matter described herein applies regardless of the particular type of signal bearing medium used to actually carry out the distribution. Examples of a signal bearing medium include, but are not limited to, the following: a recordable type medium such as a floppy disk, a hard disk drive, a CD, a DVD, a digital tape, a computer memory, etc.; and a transmission type medium such as a digital and/or an analog communication medium (e.g., a fiber optic cable, a waveguide, a wired communications link, a wireless communication link, etc.).
• Those skilled in the art will recognize that it is common within the art to describe devices and/or processes in the fashion set forth herein, and thereafter use engineering practices to integrate such described devices and/or processes into data processing systems. That is, at least a portion of the devices and/or processes described herein can be integrated into a data processing system via a reasonable amount of experimentation. Those having skill in the art will recognize that a typical data processing system generally includes one or more of a system unit housing, a video display device, a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors, computational entities such as operating systems, drivers, graphical user interfaces, and applications programs, one or more interaction devices, such as a touch pad or screen, and/or control systems including feedback loops and control motors (e.g., feedback for sensing position and/or velocity; control motors for moving and/or adjusting components and/or quantities). A typical data processing system may be implemented utilizing any suitable commercially available components, such as those typically found in data computing/communication and/or network computing/communication systems.
• The herein described subject matter sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely examples, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved. Hence, any two components herein combined to achieve a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermediate components. Likewise, any two components so associated can also be viewed as being “operably connected,” or “operably coupled,” to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “operably couplable” to each other to achieve the desired functionality. Specific examples of operably couplable include but are not limited to physically mateable and/or physically interacting components and/or wirelessly interactable and/or wirelessly interacting components and/or logically interacting and/or logically interactable components.
• The embodiments, features, systems, devices, materials, methods and techniques described herein may, in some embodiments, be similar to any one or more of the embodiments, features, systems, devices, materials, methods and techniques described in the following:
• • U.S. application Ser. No. 16/048,167, filed on Jul. 27, 2017, titled “SYSTEMS AND METHODS FOR ASSISTING AND AUGMENTING SURGICAL PROCEDURES;”
  • U.S. application Ser. No. 16/242,877, filed on Jan. 8, 2019, titled “SYSTEMS AND METHODS OF ASSISTING A SURGEON WITH SCREW PLACEMENT DURING SPINAL SURGERY;”
  • U.S. application Ser. No. 16/207,116, filed on Dec. 1, 2018, titled “SYSTEMS AND METHODS FOR MULTI-PLANAR ORTHOPEDIC ALIGNMENT;”
  • U.S. application Ser. No. 16/352,699, filed on Mar. 13, 2019, titled “SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION;”
  • U.S. application Ser. No. 16/383,215, filed on Apr. 12, 2019, titled “SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION;”
  • U.S. application Ser. No. 16/569,494, filed on Sep. 12, 2019, titled “SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS;”
  • U.S. Application No. 62/773,127, filed on Nov. 29, 2018, titled “SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS;”
  • U.S. Application No. 62/928,909, filed on Oct. 31, 2019, titled “SYSTEMS AND METHODS FOR DESIGNING ORTHOPEDIC IMPLANTS BASED ON TISSUE CHARACTERISTICS;”
  • U.S. application Ser. No. 16/735,222, filed Jan. 6, 2020, titled “PATIENT-SPECIFIC MEDICAL PROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMS AND METHODS;”
  • U.S. application Ser. No. 16/987,113, filed Aug. 6, 2020, titled “PATIENT-SPECIFIC ARTIFICIAL DISCS, IMPLANTS AND ASSOCIATED SYSTEMS AND METHODS;” and
  • U.S. application Ser. No. 16/990,810, filed Aug. 11, 2020, titled “LINKING PATIENT-SPECIFIC MEDICAL DEVICES WITH PATIENT-SPECIFIC DATA, AND ASSOCIATED SYSTEMS, DEVICES, AND METHODS.”
• All of the above-identified patents and applications are incorporated by reference in their entireties. In addition, the embodiments, features, systems, devices, materials, methods and techniques described herein may, in certain embodiments, be applied to or used in connection with any one or more of the embodiments, features, systems, devices, or other matter.

Claims (30)

I/We claim:

1. A patient-specific intervertebral implant, comprising:

a cage having a first patient-specific geometry contoured to mate with an inferior surface of a superior vertebra and a superior surface of an inferior vertebra at a first target position;

a plate having a second patient-specific geometry contoured to mate with an identified anatomical structure at a second target position different than the first target position; and

a connection mechanism coupling or configured to couple the plate to the cage in a predetermined configuration that directs the cage to occupy the first target position when the plate is positioned at the second target position.

2. The patient-specific implant ofclaim 1 wherein, when the cage is implanted at the first target position, the cage forms a generally gapless interface with the inferior surface of the superior vertebra and the superior surface of the inferior vertebra.

3. The patient-specific implant ofclaim 2 wherein the cage has an upper surface contoured to mate with the inferior surface of the superior vertebra and a lower surface contoured to mate with the superior surface of the inferior vertebra, and wherein, when the cage is implanted at the first target position, at least 90% of the surface area of the upper surface contacts the inferior surface of the superior vertebra and at least 90% of the surface area of the lower surface contacts the superior surface of the inferior vertebra.

4. The patient-specific implant ofclaim 1 wherein, when the plate is implanted at the second target position, the plate forms a generally gapless interface with the identified anatomical structure.

5. The patient-specific implant ofclaim 4 wherein when the plate has a surface contoured to mate with the identified anatomical structure, and wherein, when the plate is implanted at the second target position, at least 90% of the surface area of the surface contacts the identified anatomical structure.

6. The patient-specific implant ofclaim 1 wherein the identified anatomical structure includes (i) an anterior surface of the first and/or second vertebrae, (ii) a lateral surface of the first and/or second vertebrae, and/or (iii) a portion of the inferior surface of the first vertebra and the superior surface of the second vertebra adjacent an anterior margin of the first and second vertebrae.

7. The patient-specific implant ofclaim 1 wherein the cage includes:

an upper surface having an upper surface topography contoured to mate with the inferior surface of the superior vertebra; and

a lower surface having a lower surface topography contoured to mate with the superior surface of the inferior vertebra,

wherein the upper surface topography is different than the lower surface topography.

8. The patient-specific implant ofclaim 1 wherein, when the cage is implanted at the first target position and the plate is implanted at the second target position, the plate is configured to reduce migration of the cage.

9. The patient-specific implant ofclaim 8 wherein the plate includes one or more apertures for receiving one or more fastening elements configured to secure the plate to the identified anatomical structure.

10. The patient-specific implant ofclaim 1 wherein the connection mechanism is rigid.

11. The patient-specific implant ofclaim 10 wherein the connection mechanism includes a screw, a bolt, a rivet, and/or a key-and-slot mechanism.

12. The patient-specific implant ofclaim 1 wherein the connection mechanism is semi-rigid.

13. The patient-specific implant ofclaim 12 wherein the connection mechanism includes a semi-rigid arm or tether.

14. The patient-specific implant ofclaim 1 wherein the connection mechanism includes an extension projecting from the plate and having a lumen extending therethrough for receiving a bolt or a screw, and wherein the extension is configured to interface with the cage.

15. A method for implanting a patient-specific vertebral implant including a cage and a plate into a patient, the method comprising:

delivering the cage to a first location proximate a first target position at the patient's spinal column, wherein the cage is designed to mate with a first anatomical structure at the first target position;

delivering the plate to a second location proximate a second target position at the patient's spinal column, wherein the plate is designed to mate with a second anatomical structure at the second target position;

positioning the plate at the second target position such that the plate mates with the second anatomical structure; and

coupling the plate to the cage, wherein coupling the plate to the cage automatically positions the cage at the first target position such that the cage mates with the first anatomical structure.

16. The method ofclaim 15 wherein:

the first anatomical structure includes an inferior surface of a superior vertebra or a superior surface of an inferior vertebra; and

the second anatomical structure includes (i) an anterior surface of the first and/or second vertebrae, (ii) a lateral surface of the first and/or second vertebrae, or (iii) a portion of the inferior surface of the first vertebra and the superior surface of the second vertebra adjacent an anterior margin of the first and second vertebrae.

17. The method ofclaim 15 wherein positioning the plate at the second target position such that the plate mates with the second anatomical structure comprises forming a generally gapless interface between the plate and the second anatomical structure.

18. The method ofclaim 17 wherein forming the generally gapless interface between the plate and the second anatomical structure includes positioning a surface of the plate in contact with the second anatomical structure such that at least 90% of a surface area of the surface contacts the second anatomical structure.

19. The method ofclaim 15 wherein automatically positioning the cage at the first target position such that the cage mates with the first anatomical structure comprises forming a generally gapless interface between the cage and the first anatomical structure.

20. The method ofclaim 19 wherein forming the generally gapless interface between the cage and the first anatomical structure includes positioning a surface of the cage in contact with the first anatomical structure such that at least 90% of a surface area of the surface contacts the first anatomical structure.

21. The method ofclaim 15, further comprising securing the plate to the second anatomical structure.

22. The method ofclaim 15 further comprising confirming that the cage is positioned at the first target position after coupling the plate to the cage.

23. A method for implanting a patient-specific vertebral implant into a patient, the method comprising:

delivering the patient-specific vertebral implant to a target region proximate the patient's spine, wherein the patient-specific implant includes:

a cage designed to occupy a first target position between a first superior vertebra and a second inferior vertebra, the cage having a first patient-specific geometry contoured to mate with an inferior surface of the first superior vertebra and a superior surface of the second inferior vertebra at the first target position; and

a plate designed to occupy a second target position, the plate having a second patient-specific geometry contoured to mate with an identified anatomical structure at the second target position; and

positioning the plate at the second target position such that the cage is automatically positioned at the first target position.

24. The method ofclaim 23 wherein positioning the plate at the second target position includes forming a generally gapless interface between the plate and the identified anatomical structure.

25. The method ofclaim 24 wherein forming the generally gapless interface between the plate and the identified anatomical structure includes positioning a surface of the plate in contact with the identified anatomical structure such that at least 90% of a surface area of the surface contacts the identified anatomical structure.

25. The method ofclaim 23 wherein automatically positioning the cage at the first target position includes forming a generally gapless interface between the cage and the inferior surface of the superior vertebra and the superior surface of the inferior vertebra.

26. The method ofclaim 25 wherein the cage has an upper surface contoured to mate with the inferior surface of the superior vertebra and a lower surface contoured to mate with the superior surface of the inferior vertebra, and wherein forming the generally gapless interface between the cage and the inferior surface of the superior vertebra and the superior surface of the inferior vertebra includes:

positioning the upper surface of the cage in contact with the inferior surface of the superior vertebra such that at least 90% of a surface area of the upper surface contacts the inferior surface of the superior vertebrae, and

positioning the lower surface of the cage in contact with the superior surface of the inferior vertebra such that at least 90% of a surface area of the lower surface contacts the superior surface of the inferior vertebra.

27. The method ofclaim 23 further comprising coupling the plate to the cage before delivering the patient-specific vertebral implant to the target region.

28. The method ofclaim 23, further comprising securing the plate to the identified anatomical structure.

29. The method ofclaim 23 further comprising confirming that the cage is positioned at the first target position after positioning the plate at the second target position.

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