Patient-specific intervertebral fusion devices and related systems and methods

Abstract

The present technology includes patient-specific intervertebral fusion devices, which can include an interbody implant designed to be positioned in a disc space between two vertebral bodies and one or more fixation elements capable of securing the interbody implant to the vertebral bodies. The intervertebral fusion device includes one or more retention mechanisms for retaining the fixation elements within corresponding internal cavities or bore holes extending through the interbody implant. Methods for designing and manufacturing patient-specific intervertebral fusion devices are also described herein.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 436,860, filed January 3, 2023, the disclosure of which is incorporated herein by reference in its entirety. (Technical field) The present disclosure relates generally to medical care, and more particularly to patient-specific medical implants, including systems and methods for designing and manufacturing patient-specific medical implants. [Background technology]

[0002] Surgical procedures to implant orthopedic implants are used to correct many different conditions in a variety of settings, 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. Spinal surgery itself can encompass a variety of procedures and targets in one or more of the cervical, thoracic, lumbar, and sacrum, and can be performed to treat spinal deformities or degeneration and / or associated back pain, leg pain, and other bodily pain. Common spinal deformities that can be treated with orthopedic implants include irregular spinal curvatures such as scoliosis, lordosis, and kyphosis (hypercurvature or hypocurvature), as well as irregular spinal displacements (e.g., spondylolisthesis). Other spinal conditions that can be treated with orthopedic implants include osteoarthritis, lumbar or cervical degenerative disc disease, lumbar spinal stenosis, and cervical spinal stenosis. Summary of the Invention

[0003] The accompanying drawings illustrate embodiments of the systems, methods, and various other aspects of the present disclosure. Those skilled in the art will understand that the boundaries of illustrated elements in the drawings (e.g., boxes, groups of boxes, or other shapes) represent example boundaries. In some examples, one element may be designed as multiple elements, or 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 of another element, and vice versa. Furthermore, elements may not be drawn to scale. A non-limiting and non-exhaustive description is provided with reference to the following drawings. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating principles. [Brief explanation of the drawings]

[0004] [Figure 1] 1 is a network connectivity diagram illustrating a system for providing patient-specific medical care in accordance with an embodiment of the present technology. [Figure 2] 2 illustrates a computing device suitable for use in connection with the system of FIG. 1, in accordance with an embodiment of the present technology. [Figure 3] FIG. 1 is a flow diagram illustrating a method for providing patient-specific medical care in accordance with an embodiment of the present technology. [Figure 4] 1 is a front view of an exemplary patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology. [Figure 5A] 5 is an isometric view of the interbody implant of the intervertebral fusion device of FIG. 4 with other features omitted to more clearly show the features of the interbody implant. [Figure 5B] 5 is a side view of the interbody implant of the intervertebral fusion device of FIG. 4 with other features omitted to more clearly show the features of the interbody implant. [Figure 6A] FIG. 5 is a front view of the intervertebral fixation device of FIG. 4, showing the device in an unlocked configuration. [Figure 6B] FIG. 5 is a front view of the intervertebral fixation device of FIG. 4, illustrating the device in a locked configuration. [Figure 7A] FIG. 1 is a perspective view of another patient-specific interbody implant constructed in accordance with selected embodiments of the present technique. [Figure 7B] 7B is a perspective view of an interbody implant taken along the plane indicated in FIG. 7A. [Figure 7C] 7B is a cross-sectional side view of an interbody implant taken along the plane indicated in FIG. 7A. [Figure 8A] FIG. 7B is a perspective view of the patient-specific interbody implant of FIG. 7A. [Figure 8B] 8B is a perspective view of the interbody implant taken along the plane indicated in FIG. 8A. [Figure 8C] 8B is a top cross-sectional view of the interbody implant taken along the plane indicated in FIG. 8A. [Figure 9A] FIG. 7B is a perspective view of the patient-specific interbody implant of FIG. 7A. [Figure 9B] FIG. 9B is a perspective view of the implant taken along the plane indicated in FIG. 9A. [Figure 9C] FIG. 9B is a front cross-sectional view of the implant taken along the plane indicated in FIG. 9A. [Figure 10A] FIG. 7B is a perspective view of the patient-specific interbody implant of FIG. 7A. [Figure 10B] 10B is a perspective view and a front cross-sectional view of the implant taken along the plane indicated in FIG. 10A. [Figure 10C] 10B is a perspective view and a front cross-sectional view of the implant taken along the plane indicated in FIG. 10A. [Figure 11A] 1A-1C are diagrams of another patient-specific implant constructed in accordance with selected embodiments of the present technology. [Figure 11B] 1A-1C are diagrams of another patient-specific implant constructed in accordance with selected embodiments of the present technology. [Figure 11C] 1A-1C are diagrams of another patient-specific implant constructed in accordance with selected embodiments of the present technology. [Figure 12A]FIG. 1 is a front view of another patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology and implanted in a patient's spine. [Figure 12B] 1 is a side view of another patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology and implanted in a patient's spine; [Figure 12C] FIG. 1 is a top view of another patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology and implanted in a patient's spine. [Figure 12D] FIG. 1 is a bottom view of another patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology and implanted in a patient's spine. [Figure 13A] FIG. 1 is a front view of another patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology and implanted in a cervical region of a patient's spine. [Figure 13B] FIG. 1 is a side view of another patient-specific intervertebral fusion device constructed in accordance with selected embodiments of the present technology and implanted in a cervical region of a patient's spine. [Figure 14] 1 is a flow diagram illustrating a method for manufacturing an implant in accordance with selected embodiments of the present technique. [Figure 15] FIG. 1 is a flow diagram illustrating a method for generating manufacturing orders in accordance with an embodiment of the present technique. [Figure 16] FIG. 1 is a flow diagram illustrating a method for generating a virtual model of an implant, in accordance with an embodiment of the present technology. [Figure 17] 1A-1C illustrate four delivery devices configured in accordance with selected embodiments of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0005] The present technology includes patient-specific intervertebral fusion devices. In many embodiments, the fusion device includes an interbody implant designed to be placed in the disc space between two vertebral bodies to facilitate fusion thereof. The fusion device can further include one or more fixation elements capable of securing the interbody implant to the vertebral bodies. In many embodiments described herein, the fusion device includes one or more retention mechanisms for retaining the fixation elements within corresponding internal cavities or bore holes extending through the interbody implant. The retention mechanisms can be advantageously designed to include specific features that limit rotation of the retention mechanism along a predefined path and through incremental predefined positions. Without wishing to be bound by theory, such features are expected to improve the performance of the retention mechanism, such as by simplifying the process of locking the retention mechanism and reducing accidental unlocking of the retention mechanism. Examples of patient-specific intervertebral fusion devices are described in detail throughout this detailed description, including in Section C below.

[0006] In some embodiments, the present technology includes a method for manufacturing a patient-specific intervertebral fusion device. The method can include obtaining a virtual model of the intervertebral fusion device. Manufacturing instructions can be generated based on the virtual model. A manufacturing machine can execute the manufacturing instructions to manufacture the intervertebral fusion device. In many embodiments, the method can include manufacturing an intervertebral fusion body, a retention feature, an instrument, or the like via additive manufacturing and / or subtractive manufacturing. The retention feature can be manufactured based on a design of the intervertebral fusion device. In many embodiments, the intervertebral fusion body can be a unitary unitary spacer body. The retention feature can be configured to be capturably held by the unitary unitary spacer body to secure the implant to bone tissue. Examples of methods for manufacturing patient-specific intervertebral fusion devices are described in detail throughout this detailed description, including in Section D below.

[0007] In some embodiments, the present technology includes systems and methods for designing a patient-specific surgical plan, which may include, for example, designing a patient-specific intervertebral fusion device to be implanted in the patient according to the patient-specific surgical plan. Examples of systems and methods for designing a patient-specific surgical plan, including designing a patient-specific intervertebral fusion device, are described in detail throughout this detailed description, including in Sections A and B below.

[0008] Embodiments of the present disclosure will now be described more fully with reference to the accompanying drawings, in which like numerals represent like elements throughout the several views and in which exemplary embodiments are shown. However, the claimed embodiments may 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.

[0009] The words "comprise," "have," "contain," and "include," as well as other forms thereof, are intended to be equivalent and open-ended in that the item or items following any one of these words are not intended to be an exhaustive list of such item or items, or to be limited to only the listed item or items.

[0010] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include their plural referents unless the context clearly dictates otherwise.

[0011] While the disclosure herein primarily describes systems and methods for treatment planning in the context of orthopedic surgery, the techniques of the present invention may be applied to medical procedures and devices in other fields (e.g., other types of surgical practices) as well. Furthermore, while many embodiments herein describe systems and methods related to implanted devices, the techniques of the present invention may be applied to other types of medical devices (e.g., non-implanted devices) as well.

[0012] Headings are provided for convenience only and should not be used to interpret the scope of the present technology.

[0013] Selected Embodiments of a System for Designing Patient-Specific Surgical Planning and Patient-Specific Implants 1 is a network connectivity diagram illustrating a system 100 for providing patient-specific medical care in accordance with an embodiment of the present technology. As described in further detail herein, the system 100 is configured to generate a medical plan for a patient. In some embodiments, the system 100 is configured to generate a medical plan for a patient suffering from an orthopedic or spinal disease or disorder, such as trauma (e.g., fracture), 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 discopathy, cervical degenerative discopathy, lumbar spinal stenosis, cervical spinal stenosis, or a combination thereof. The medical plan may include surgical information, technical recommendations (e.g., device and / or medication recommendations), and / or medical device design. For example, a medical plan may include at least a surgical 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 "implantation device") and / or an implant delivery instrument). In some embodiments, a medical plan may therefore also be referred to as a "surgical plan," a "patient-specific surgical plan," a "patient-specific treatment plan," etc.

[0014] In some embodiments, the system 100 generates a medical plan customized for a particular patient or group of patients, also referred to herein as a “patient-specific” or “personalized” treatment or surgical plan. A patient-specific surgical plan can include at least one patient-specific surgical procedure and / or at least one patient-specific medical device designed and / or optimized for the patient's particular characteristics (e.g., condition, anatomy, pathology, condition, medical history). For example, a patient-specific medical device can be designed and manufactured specifically for a particular patient rather than an off-the-shelf device. However, it should be understood that a patient-specific surgical plan can also include aspects that are not customized for a particular patient. For example, a patient-specific or personalized surgical procedure can include one or more instructions, portions, steps, etc. that are not patient-specific. Similarly, a patient-specific or personalized medical device can include one or more components that are not patient-specific and / or can be used with instruments or tools that are not patient-specific. The personalized implant design can be used to manufacture or select patient-specific technology, including medical devices, instruments, and / or surgical kits. For example, a personalized surgical kit may 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 planning information, or a combination thereof.

[0015] System 100 includes a client computing device 102, which may be a user device such as a smartphone, mobile device, laptop, desktop, personal computer, tablet, phablet, or other such device known in the art. As discussed further herein, client computing device 102 may include one or more processors and memory storing instructions executable by the one or more processors to perform the methods described herein. Client computing device 102 may be associated with a healthcare provider (e.g., a surgeon, a medical administrator, a hospital system, etc.) treating a patient. While FIG. 1 depicts a single client computing device 102, in alternative embodiments, client computing device 102 may be implemented as a client computing system including multiple computing devices, such that operations described herein with respect to client computing device 102 may instead be performed by the client computing system and / or multiple client computing devices.

[0016] The client computing device 102 is configured to receive a patient dataset 108 associated with a patient to be treated. The patient dataset 108 may include data representing the patient's condition, anatomy, pathology, medical history, preferences, and / or other information or parameters associated with the patient. For example, the patient dataset 108 may include medical history, surgical intervention data, treatment outcome data, progress data (e.g., physician's notes), patient feedback (e.g., quality of life questionnaires, feedback obtained using surveys), clinical data, provider information (e.g., physician, hospital, surgical team), patient information (e.g., demographics, gender, age, height, weighting, type of condition, occupation, activity level, organizational information, health assessment, comorbidities, health-related quality of life (HRQL)), vital signs, diagnostic results, medication information, allergies, imaging data (e.g., camera images, magnetic resonance imaging (MRI) images, ultrasound images, computed tomography (CAT) scan images, positron emission tomography (PET) images, x-ray images), diagnostic equipment information (e.g., manufacturer, model number, specifications, user-selected settings / configuration, etc.), or the like. In some embodiments, the patient dataset 108 includes data representing one or more of the patient's identification number (ID), age, sex, body mass index (BMI), lumbar lordosis, Cobb angle, pelvic intrinsic angle, disc height, segmental flexibility, bone quality, rotational displacement, and / or spinal treatment level.

[0017] The client computing device 102 is also configured to allow a user (e.g., a surgeon) to review one or more proposed surgical plans for a patient to be treated. In particular, the client computing device 102 may include a surgical plan review software module 123 ("review module 123"). The review module 123 may comprise computer-executable instructions for generating, displaying, and / or implementing a surgical plan review program or platform 125 ("review program 125") that facilitates a surgeon's or user's review of one or more patient-specific surgical plans via the client computing device 102.

[0018] The review module 123 may be stored in the form of computer-readable or computer-executable instructions on a memory (not shown) of the client computing device 102. In other embodiments, the review module 123 may be stored remotely from the client computing device 102 (e.g., in the cloud or on a remote server) and implemented on the client computing device 102 via a remote (e.g., wireless) connection. In still other embodiments, portions of the review module 123 may be stored locally at the client computing device 102, while other aspects of the review module 123 may be stored remotely.

[0019] The client computing device 102 is operatively connected to the server 106 via a communications network 104, thus enabling data transfer between the client computing device 102 and the server 106. The communications network 104 may be a wired and / or wireless network. If wireless, the communications network 104 may be implemented using communications technologies such as visible light communications (VLC), Worldwide Interoperability for Microwave Access (WiMAX), Long Term Evolution (LTE), Wireless Local Area Network (WLAN), infrared (IR) communications, Public Switched Telephone Network (PSTN), radio waves, and / or other communications technologies known in the art.

[0020] Server 106, which may also be referred to as a "therapeutic support network" or a "prescriptive analytics network," may include one or more computing devices and / or systems. As discussed further herein, server 106 may include one or more processors and memory that stores instructions executable by the one or more processors to perform some or all of the methods described herein. In some embodiments, server 106 is implemented as a distributed "cloud" computing system or facility across any suitable combination of hardware and / or virtual computing resources.

[0021] The client computing device 102 and the server 106 may individually or collectively perform some or all of the various methods described herein to provide patient-specific medical care. For example, some or all of the steps of the methods described herein may be performed by the client computing device 102 alone, the server 106 alone, or a combination of the client computing device 102 and the server 106. Thus, although certain operations are described herein with respect to the server 106, it will be understood that these operations may also be performed by the client computing device 102, and vice versa, unless the context clearly dictates otherwise.

[0022] The server 106 includes at least one database 110 configured to store reference data useful in 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 previous surgeries and / or other treatments of the patient by the same or other healthcare providers, data related to medical device designs, data collected from research groups or research groups, data from clinical 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, or the like.

[0023] In some embodiments, the database 110 includes multiple reference patient datasets, each associated with a corresponding reference patient. For example, the reference patients can be patients who have previously been treated or patients currently undergoing treatment. Each reference patient dataset can include data representing the corresponding reference patient's condition, anatomical structure, pathological structure, medical history, disease progression, preferences, and / or other information or parameters related to the reference patient, such as any of the data described herein with respect to the patient dataset 108. In some embodiments, the reference patient dataset includes pre-operative data, intra-operative data, and / or post-operative data. For example, the reference patient dataset can include data representing one or more of patient ID, age, gender, BMI, lumbar lordosis, Cobb angle, pelvic intrinsic angle, disc height, segmental flexibility, bone quality, rotational displacement, and / or treatment level of the patient's spine. As another example, the reference patient dataset can include treatment data related to at least one surgical procedure performed on the reference patient, such as a description of the surgical procedure or intervention (e.g., surgical approach, bone resection, surgical action, corrective action, placement of implant or other device). In some embodiments, the treatment data includes medical device design data of at least one medical device used to treat the reference patient, such as physical properties (e.g., size, shape, volume, material, mass, weighting), mechanical properties (e.g., stiffness, strength, modulus, hardness), and / or biological properties (e.g., osteointegration, cell adhesion, antibacterial properties, antiviral properties). In yet another example, the reference patient dataset can include outcome data describing the results of the treatment of the reference patient, such as corrected anatomical indices, whether or not union occurred, HRQL, pain level, activity level, return to work, complications, recovery time, efficacy, mortality, and / or follow-up surgery.

[0024] In some embodiments, the server 106 receives at least a portion of the reference patient datasets from multiple healthcare provider computing systems (e.g., systems 112a-112c, collectively 112). The server 106 may be connected to the healthcare provider computing systems 112 via one or more communication networks (not shown). Each healthcare provider computing system 112 may be associated with a corresponding healthcare provider (e.g., a pharmacy, a surgeon, a clinic, a hospital, a medical network, etc.). Each healthcare provider computing system 112 may include at least one reference patient dataset (e.g., reference patient datasets 114a-114c, collectively 114) associated with a reference patient treated by the corresponding healthcare provider. The reference patient datasets 114 may include, for example, electronic medical records, electronic health records, biomedical datasets, etc. The reference patient datasets 114 may be received by the server 106 from the healthcare provider computing systems 112 and may be reformatted into different formats for storage in the database 110. Optionally, the reference patient dataset 114 may be processed (e.g., cleaned) to ensure that the displayed patient parameters are likely to be useful in the treatment planning methods described herein.

[0025] As described in further detail herein, the server 106 may be configured with one or more algorithms that generate patient-specific surgical planning data (e.g., therapeutic procedures, target anatomical corrections, medical devices, etc.) based on the reference data. In some embodiments, the patient-specific data is generated based on a correlation between the patient dataset 108 and the reference data. Optionally, the server 106 may predict outcomes including recovery time, efficacy based on clinical endpoints, likelihood of success, predicted mortality, predicted associated follow-up surgeries, or the like. In some embodiments, the server 106 may continuously or periodically analyze patient data (including patient data obtained during the patient stay) to determine near real-time or real-time risk scores, mortality predictions, etc.

[0026] In some embodiments, server 106 includes one or more modules for performing one or more steps of the patient-specific treatment planning methods described herein. For example, in the illustrated embodiment, server 106 includes a data analysis module 116, a treatment planning module 118, a disease progression module 120, and an intervention timing module 121. In alternative embodiments, one or more of these modules may be combined with one another or omitted. Thus, while particular operations are described herein with respect to a particular module or modules, this is not intended to be limiting, and such operations may be performed by a different module or modules in alternative embodiments.

[0027] The data analysis module 116 comprises one or more algorithms for identifying a subset of reference data from the database 110 that is likely to be useful in developing a patient-specific treatment plan. For example, the data analysis module 116 can compare patient-specific data (e.g., the patient dataset 108 received from the client computing device 102) with reference data (e.g., a reference patient dataset) from the database 110 to identify similar data (e.g., one or more similar patient datasets within the reference patient dataset). The comparison can be based on one or more parameters, such as age, gender, BMI, lumbar lordosis, pelvic intrinsic angle, and / or treatment level. The parameters can be used to calculate a similarity score for each reference patient. The similarity score can represent a statistical correlation between the patient dataset 108 and the reference patient dataset. Thus, similar patients can be identified based on whether the similarity score is above, below, or at a specified threshold. For example, as described in more detail below, the comparison can be performed by assigning a value to each parameter and determining an aggregate difference between the subject patient and each reference patient. Reference patients whose aggregated differences are below a threshold can be considered similar patients.

[0028] The data analysis module 116 may further comprise one or more algorithms for selecting a subset of the reference patient dataset based on, for example, similarity to the patient dataset 108 and / or treatment outcomes of corresponding reference patients. For example, the data analysis module 116 may identify one or more similar patient datasets within the reference patient dataset and then select the subset of similar patient datasets based on whether the similar patient datasets contain data indicative of a favorable or desired treatment outcome. The outcome data may include data representing one or more outcome parameters, such as corrected anatomical landmarks, whether or not union occurred, HRQL, activity level, complications, recovery time, efficacy, mortality, or follow-up surgery. As described in more detail below, in some embodiments, the data analysis module 116 calculates an outcome score by assigning a value to each outcome parameter. If the outcome score is above, below, or at a predetermined threshold, the patient is considered to have a favorable outcome.

[0029] In some embodiments, the data analysis module 116 selects a subset of the reference patient dataset based at least in part on user input (e.g., from a clinician, surgeon, physician, or healthcare provider). For example, the user input can be used in identifying similar patient datasets. In some embodiments, the weighting of the similarity and / or outcome parameters can be selected by the healthcare provider or physician to adjust the similarity and / or outcome score based on the clinician's 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.

[0030] In some embodiments, the data analysis module 116 includes one or more algorithms used to select a set or subset of reference patient datasets based on criteria other than patient parameters. For example, one or more algorithms can be used to select the subset based on healthcare provider parameters (e.g., based on healthcare provider rankings / scores, such as hospital / physician specialty, number of procedures performed, hospital rankings, etc.) and / or medical resource parameters (e.g., diagnostic equipment, facilities, surgical procedure equipment, such as surgical robots), or other non-patient-related information that can be used to predict the outcome and risk profile of a procedure for the current healthcare provider. For example, reference patient datasets with images taken from similar diagnostic devices can be aggregated to reduce or limit irregularities due to variability between diagnostic devices. Furthermore, patient-specific treatment plans can be created for a particular healthcare provider using data from similar healthcare providers (e.g., healthcare providers that traditionally have similar outcomes, physician specialties, surgical teams, etc.). In some embodiments, reference healthcare provider datasets, hospital datasets, physician datasets, surgical team datasets, post-treatment datasets, and other datasets can be utilized. As one example, a patient-specific surgical plan for performing a battlefield surgery can be based on reference patient data from similar battlefield surgeries and / or datasets related to battlefield surgeries. In another example, a patient-specific surgical plan can be generated based on available robotic surgical systems. The reference patient dataset can be selected based on patients operated on with comparable robotic surgical systems under similar conditions (e.g., surgical team size and capabilities, hospital resources, etc.).

[0031] The treatment planning module 118 comprises one or more algorithms that generate at least one surgical plan (e.g., a preoperative plan, an intraoperative plan, a postoperative plan, etc.) based on the output from the data analysis module 116. In some embodiments, the treatment planning module 118 is configured to develop and / or implement at least one predictive model for generating a patient-specific treatment plan, also referred to as a "prescriptive model." The predictive model can be developed using clinical knowledge, statistics, machine learning, AI, neural networks, or the like. In some embodiments, the output from the data analysis module 116 is analyzed (e.g., using statistics, machine learning, neural networks, AI) 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 surgical plan will result in a favorable outcome for a particular patient. The predictive model can be validated, for example, by inputting data into the model and comparing the model's output to an expected output.

[0032] In some embodiments, the treatment planning module 118 is configured to generate a surgical plan based on previous treatment data from a reference patient. For example, the treatment planning module 118 can receive a selected subset of the reference patient dataset and / or similar patient dataset from the data analysis module 116 and determine or identify treatment data from the selected subset. The treatment data can include, for example, treatment procedure data (e.g., surgical procedure or intervention data) and / or medical device design data (e.g., implant design data) that translates to a preferred or desired treatment outcome for the corresponding patient. The treatment planning module 118 can analyze the treatment procedure data and / or medical device design data to determine an optimal treatment protocol for the treated patient. For example, values ​​can be assigned to the treatment procedures and / or medical device designs and aggregated to generate a treatment score. A patient-specific surgical plan can be determined by selecting a surgical plan based on a score (e.g., higher or highest score; lower or lowest score; score above, below, or at a specified threshold). The personalized patient-specific surgical plan can be based, at least in part, on a patient-specific technique or a patient-specific selected technique.

[0033] Alternatively, or in combination, the treatment planning module 118 can generate a surgical plan based on correlations between data sets. For example, the treatment planning module 118 can correlate therapeutic procedure data and / or medical device design data from similar patients with good outcomes (e.g., as identified by the data analysis module 116). The correlation analysis can include converting the correlation coefficient values ​​into 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 surgical procedures and / or medical device designs that are likely to provide optimal or favorable outcomes for the patient being treated.

[0034] Alternatively, or in combination, the treatment planning module 118 can generate the surgical plan using one or more AI techniques. AI techniques can be used to develop computing systems that can simulate aspects of human intelligence, such as learning, reasoning, planning, problem-solving, decision-making, etc. AI techniques 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., naive 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.

[0035] In some embodiments, the treatment planning module 118 generates the surgical plan using one or more trained machine learning models. Various types of machine learning models, algorithms, and techniques are suitable for use with the techniques of the present invention. In some embodiments, the machine learning model is first trained on a training dataset, which is a set of examples used to adapt the model's parameters (e.g., the weights of the connections between "neurons" in an artificial neural network). For example, the training dataset may include any of the reference data stored in the database 110, such as multiple reference patient datasets or a selected subset thereof (e.g., multiple similar patient datasets).

[0036] In some embodiments, a machine learning model (e.g., a neural network or a naive Bayes classifier) ​​can be trained on a training dataset using supervised learning methods (e.g., gradient descent or stochastic gradient descent). The training dataset can include pairs of generated "input vectors" and associated corresponding "answer vectors" (commonly denoted as targets). The current model is run with the training dataset to generate results for each input vector in the training dataset that are compared to the targets. Based on the results of the comparison and the particular learning algorithm being used, the parameters of the model are adjusted. Model fitting can include both variable selection and parameter estimation. The fitted model can be used to predict valid responses for observations in a second dataset, called the validation dataset. The validation dataset can provide an unbiased assessment of model fit to the training dataset while tuning model parameters. The validation dataset can be used as a valid dataset for regularization by early stopping, e.g., stopping training when the error on the validation dataset increases. In some embodiments, the error in the validation dataset can fluctuate during training, and ad hoc rules can be used to determine when overfitting truly begins. Finally, a test dataset can be used to unbiasedly assess the fit of the final model to the training dataset.

[0037] To generate a surgical plan, the patient dataset 108 can be input into a trained machine learning model. Additional data, such as a selected subset of a reference patient dataset and / or similar patient datasets, and / or treatment data from the selected subset, can also be input into the trained machine learning model. The trained machine learning model can then calculate whether various candidate therapeutic procedures and / or medical device designs are likely to result in a favorable outcome for the patient. Based on these calculations, the trained machine learning model can select at least one surgical plan for the patient. In some embodiments, the trained machine learning model can determine candidate procedures (or candidate surgical plans), analyze the candidate procedures, select candidate surgical plans or portions thereof, score the plans, and / or generate a surgical plan for the patient. Each surgical plan can be scored (e.g., scored based on a favorable outcome, likelihood of outcome, etc.) and ranked according to the score. The trained machine learning model can determine a set of surgical plans that meet selection criteria for plan review by a user. The selection criteria can be based, for example, on regulatory requirements, reimbursement criteria, medical / provider expertise, available surgical equipment, manufacturing capabilities, exclusion criteria, or a combination thereof, etc. A user can input one or more selection criteria to control the type and / or features of the surgical plans for comparison. In embodiments where multiple trained machine learning models are used, the models can be run sequentially or simultaneously to compare results and can be periodically updated using training datasets. The treatment planning module 118 can use one or more of the machine learning models based on the model's predictive accuracy score.

[0038] The patient-specific surgical plan generated by the treatment planning module 118 may include at least one patient-specific surgical procedure (e.g., a surgical procedure or intervention) and / or at least one patient-specific medical device (e.g., an implant or implant-delivered agent). The patient-specific surgical plan may include an entire surgical procedure or a portion thereof. Additionally, one or more patient-specific medical devices may be specifically selected or designed for the corresponding surgical procedure, such that various components of the patient-specific technique may be used in combination to treat the patient.

[0039] In some embodiments, the patient-specific surgical procedure includes orthopedic surgery, such as spine surgery, hip surgery, knee surgery, temporomandibular joint surgery, hand surgery, shoulder surgery, elbow surgery, total joint reconstruction (arthroplasty), skull reconstruction, foot surgery, or ankle surgery. Spinal surgery can include intervertebral fusion procedures, such as posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion or transvertebral lumbar interbody fusion (TLIF), lateral lumbar interbody fusion (LLIF), direct lateral lumbar interbody fusion (DLIF), or extreme lateral lumbar interbody fusion (XLIF). In some embodiments, the patient-specific treatment procedure includes instructions and / or instructions for performing one or more aspects of the patient-specific surgical procedure. For example, the patient-specific surgical procedure can include one or more of a surgical approach, a corrective action, a bone resection, or an implant placement.

[0040] In some embodiments, the patient-specific medical device design includes the design of an orthopedic implant and / or the design of a medication for delivering the orthopedic implant. Examples of such implants include, but are not limited to, screws (e.g., bone screws, spinal screws, pedicle screws, facet screws), interbody implant devices (e.g., interbody implants), cages, plates, rods, discs, fixation devices, spacers, rods, expandable devices, stents, brackets, ties, scaffolding, fixation devices, anchors, nuts, bolts, rivets, connectors, tethers, fasteners, artificial joints, hip implants, etc. Examples of instruments include, but are not limited to, screw guides, cannulas, ports, catheters, insertion tools, removal tools, awls, drivers, etc.

[0041] A patient-specific medical device design may include data describing one or more of the physical properties (e.g., size, shape, volume, material, mass, weighting), mechanical properties (e.g., stiffness, strength, modulus, hardness), and / or biological properties (e.g., osteointegration, cell adhesion, antibacterial properties, antiviral properties) of a corresponding medical device. For example, a design for an orthopedic implant may include the shape, size, material, and / or effective stiffness (e.g., lattice density, number of struts, location of struts, etc.) of the implant. In some embodiments, the generated patient-specific medical device design is a design for the entire device. Alternatively, the generated design may be for one or more components of the device rather than the entire device.

[0042] In some embodiments, the design is for one or more patient-specific device components that can be used with standard, off-the-shelf components. For example, in spine surgery, an ALIF kit can include both standard components and patient-specific, customized components. In some embodiments, an ALIF kit can include a patient-specific interbody device that can be used with standard interbody screws. In some embodiments, the generator design is for a patient-specific implant that can be used with standard, off-the-shelf delivery instruments. For example, the implant (e.g., interbody device, screw, screw holder, rod, etc.) can be designed and manufactured for the patient, while the instrument for delivering the implant can be a standard instrument. This approach allows the implanted components to be designed and manufactured based on the patient's anatomy and / or surgeon's preferences, enhancing treatment. The patient-specific devices 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.

[0043] In embodiments in which the patient-specific surgical plan includes a specific surgical procedure to implant a medical device, the treatment planning module 118 can also store various types of implant procedure information, such as implant parameters (e.g., type, size), implant availability, aspects of pre-operative planning (such as initial implant configuration, detection and measurement of the patient's anatomy), FDA requirements for the implant (e.g., specific implant parameters and / or characteristics to comply with FDA regulations), or the like. In some embodiments, the treatment planning module 118 can convert the implant procedure information into a format usable for machine learning-based models and algorithms. For example, the implant procedure information can be tagged with a specific identifier for mathematical formulas or converted into a numerical representation suitable for feeding into a trained machine learning model. The treatment planning module 118 can also store information about the patient's anatomy, such as two-dimensional or three-dimensional images or models of the anatomy, and / or information about the biology, geometry, and / or mechanical properties of the anatomy. The anatomical information can be used to inform the design and / or placement of the implant.

[0044] The disease progression module 120 can be used to analyze, predict, and / or model the disease progression of a particular patient. As described in more detail below, the disease progression module 120 can estimate the rate of disease progression of a patient under a variety of different circumstances, including (a) when no surgical intervention is performed and (b) when one or more surgical plans (e.g., surgical procedures identified by the treatment plan module 118) are performed. Thus, the disease progression module 120 can include algorithms, machine learning models, or other software analysis tools for predicting disease progression in a particular patient.

[0045] In some embodiments, the disease progression module 120 includes a machine learning model or other software module that can be trained based on multiple reference patient data sets that include disease progression indicators for each of the reference patients in addition to the patient data described above. The progression indicators can include measurements of disease indicators over a period of time. Suitable metrics can include spinopelvic parameters (e.g., lordosis, pelvic tilt, sagittal vertical axis (SVA), Cobb Angel, coronal offset, etc.), disability scores, functional ability scores, flexibility scores, VAS pain scores, or the like. The progress of the metrics for each reference patient can be correlated with other patient information for the particular reference patient (e.g., age, sex, height, weight, activity level, diet, etc.). The disease indicators can include values ​​over a period of time. For example, the reference patient data can include values ​​of disease metrics on a daily, weekly, monthly, bimonthly, yearly, or other basis. By measuring the metrics over a period of time, changes in the metric values ​​can be tracked as an estimate of disease progression and correlated with other patient data.

[0046] In some embodiments, the disease progression module 120 can therefore estimate the rate of disease progression for a particular patient. Progression can be estimated by providing an estimated change in one or more disease metrics over a period of time (e.g., X% increase in disease metric per year). This rate can be constant (e.g., 5% increase in pelvic tilt per year) or variable (e.g., 5% increase in pelvic tilt in year 1, 10% increase in pelvic tilt in year 2, etc.). In some embodiments, the estimated rate of progression can be communicated to a surgeon or other healthcare provider as part of surgical planning, as described in more detail below.

[0047] As a non-limiting example, a particular patient who is a 55-year-old male may have an SVA value of 6 mm. The disease progression module 120 can analyze the patient reference dataset to identify disease progression for individual reference patients who share one or more similarities with the particular patient (e.g., individual reference patients who have an SVA value of approximately 6 mm and who are approximately the same age, weight, height, and / or gender as the patient). Based on this analysis, the disease progression module 120 can predict the rate of disease progression in the absence of surgical intervention (e.g., in the absence of surgical intervention, the patient's VAS pain score may increase by 5%, 10%, or 15% each year; in the absence of surgical intervention, the SVA value may continue to increase by 5% each year, etc.).

[0048] The surgical treatment plans and / or associated patient-specific implants described herein can also be based, at least in part, on estimated disease progression rates, enabling treatment plans with different outcomes over a desired time period. Furthermore, the models / simulations can consider any number of additional diseases or conditions to predict the patient's overall health, mobility, etc. These additional diseases or conditions can be combined with other patient health factors (e.g., height, weight, age, activity level, etc.) to generate a patient health score that reflects the patient's overall health. The patient health score can be displayed for review by the surgeon and / or incorporated into disease progression estimates. Thus, the technology of the present invention can generate one or more virtual simulations of predicted disease progression to show how the patient's anatomy is predicted to change over time. Physician input can be used to generate or modify the virtual simulations. The technology of the present invention can generate one or more post-treatment virtual simulations based on received physician input for review by healthcare providers, patients, etc.

[0049] In some embodiments, the present technology can also predict, model, and / or simulate disease progression based on one or more potential surgical plans. For example, the disease progression module 120 can simulate what a patient's anatomical and / or spinal metrics will look like one, two, five, or ten years after surgery for multiple different surgical plans. The simulations can also incorporate non-surgical factors, such as the patient's age, height, weight, gender, activity level, and other health conditions, as described above. The system and / or surgeon can use the disease progression to aid in selecting which surgical plan will provide the most long-term effectiveness, as described below. These simulations can also be used to determine patient-specific corrections to correct protrusions.

[0050] Thus, in some embodiments, multiple disease progression models (e.g., 2, 3, 4, 5, 6, or more) are simulated to provide disease progression data for multiple different surgical plans. For example, the disease progression module may generate a model that predicts post-operative disease progression for each of three different surgical plans. A surgeon or other healthcare provider can review the disease progression models and, based on their review, select the one of the three surgical plans that is likely to provide the best long-term outcome for the patient.

[0051] Based on the modeled disease progression, the systems and methods described herein can also (i) identify a recommended timing for surgical intervention and / or (ii) identify the type of surgical procedure recommended for the patient. In some embodiments, the present technology therefore includes an intervention timing module 121 that includes an algorithm, machine learning model, or other software analysis tool for determining the optimal timing of surgical intervention in a particular patient. This can be done, for example, by analyzing patient reference data that includes (i) preoperative disease progression indicators for individual reference patients, (ii) disease indicators at the time of surgical intervention for individual reference patients, (iii) postoperative disease progression indicators for individual reference patients, and / or (iv) scored surgical outcomes for individual reference patients. The intervention timing module 121 can compare a particular patient's disease metrics to a dataset of reference patients to determine the point in disease progression at which surgical intervention produced the most favorable outcomes for similar patients.

[0052] As a non-limiting example, the reference patient dataset may include data related to the sagittal vertical axis of the reference patient. This data may include (i) the individual patient's sagittal vertical axis value over a period of time before the surgical intervention (e.g., how quickly and to what extent the sagittal vertical axis value changed), (ii) the individual patient's sagittal vertical axis at the time of the surgical intervention, (iii) the change in the sagittal vertical axis after the surgical intervention, and (iv) the degree to which the surgical intervention was successful (e.g., based on pain, quality of life, or other factors). Based on the foregoing data, the intervention timing module 121 may identify at what point in time the surgical intervention is most likely to produce a favorable outcome based on the particular patient's sagittal vertical axis value. Of course, the aforementioned metrics are provided by way of example only, and the intervention timing module 121 can incorporate other metrics (e.g., lumbar lordosis, pelvic tilt, sagittal vertical axis, Cobb Angel, coronal offset, disability score, functional ability score, flexibility score, VAS pain score) in place of or in combination with sagittal vertical axis to predict when surgical intervention is most likely to have a favorable outcome for a particular patient.

[0053] The intervention timing module 121 can also incorporate one or more mathematical rules based on value thresholds for various disease indicators. For example, the intervention timing module 121 can indicate the need for surgical intervention if one or more disease indicators exceed a predetermined threshold or meet some other criteria. Exemplary thresholds indicating the need for surgical intervention include an SVA value greater than 7 mm, a lordosis-pelvic eigenangle misalignment greater than 10 degrees, a Cobb angle greater than 10 degrees, and / or a combination of a Cobb angle and LL / PI misalignment greater than 20 degrees. Of course, other thresholds and metrics can be used. In some embodiments, the aforementioned rules can be tailored to a particular patient population (e.g., for men over 50 years old, an SVA value greater than 7 mm indicates the need for surgical intervention). If a particular patient does not exceed a threshold indicating that surgical intervention is recommended, the intervention timing module 121 can provide an estimate of when the patient's indicators will exceed one or more thresholds, thereby providing the patient with an estimate of when surgical intervention will be recommended.

[0054] In some embodiments, the treatment planning module 118 identifies one or more types of surgical procedures for a patient based at least in part on the patient's disease progression as determined using the disease progression module 120 and / or the intervention timing module 121. The treatment planning module 118 may also incorporate one or more mathematical rules for identifying surgical procedures. As a non-limiting example, if the LL / PI mismatch is between 10 and 20 degrees, the treatment planning module 118 may recommend an anterior fusion procedure, but if the LL / PI mismatch is greater than 20 degrees, the treatment planning module may recommend both anterior and posterior fusion procedures. As another non-limiting example, if the SVA value is greater than or equal to 7 mm and less than or equal to 15 mm, the treatment planning module may recommend posterior fusion procedures, but if the SVA is greater than or equal to 15 mm, the treatment planning module may recommend both posterior and anterior fusion procedures. Of course, other rules may be used. The above are provided by way of example only.

[0055] Without being bound by theory, incorporating disease progression modeling into the patient-specific surgical planning described herein can further improve the effectiveness of surgical procedures and / or provide surgeons with more data for evaluating various surgical plans. For example, in many cases, it may be disadvantageous to perform surgery after a patient's disease has progressed to an irreversible or unstable state. However, it may also be disadvantageous to perform surgery too early, such as before the patient's disease causes symptoms and / or when the patient's disease is unlikely to progress further. Thus, disease progression module 120 and / or intervention timing module 121 can help identify the window in which surgical intervention for a particular patient has the highest probability of resulting in a favorable patient outcome.

[0056] The surgical plan generated by the treatment planning module 118 can be transmitted to the client computing device 102 via the communications network 104 for output to a user (e.g., a clinician, a surgeon, a healthcare provider, or a patient). In some embodiments, the client computing device 102 includes or is operably coupled to a display 122 for outputting the treatment plan. The display 122 can include a graphical user interface (GUI) for visually depicting various aspects of the surgical plan. For example, the display 122 can show various aspects of the surgical procedure to be performed on the patient, such as the surgical approach, treatment levels, corrective actions, tissue resections, and / or implant placements. To facilitate visualization, the surgical plan can include a virtual model of the surgical procedure, which can be displayed via the display 122. The display 122 can also display additional aspects of the surgical plan, such as predicted postoperative patient metrics, predicted disease progression metrics associated with the identified surgical procedures, etc. As another example, the display 122 can display a design of a medical device to be implanted in the patient according to the transmitted surgical plan, such as a two-dimensional or three-dimensional model of the device design. The display 122 may also display patient information, such as two-dimensional or three-dimensional images or models of the patient's anatomy where a surgical procedure will be performed and / or where a device will be implanted. The client computing device 102 may further include one or more user input devices (not shown) that allow a user to modify, select, accept, and / or reject the displayed treatment plan.

[0057] In some embodiments, one or more aspects of the surgical plan are displayed using a surgical plan review program 125. The review program 125, which may be implemented as, for example, a mobile phone application, a computer application, etc., may display (e.g., via the display 122) one or more aspects of the surgical plan (e.g., surgical procedures, a virtual model of the patient's anatomy, implants, etc.). The review program 125 may further provide an interactive interface that allows the surgeon to select between different patients, select between different surgical plans for the same patient, compare surgical plans for the same patient, review the status of the surgical plan, provide feedback on the proposed surgical plan, accept the surgical plan, reject the surgical plan, etc. The review program 125 may further allow the surgeon or other user to select between different views of the virtual model of the patient's anatomy and / or different views of the patient-specific implants used in the surgical plan.

[0058] In some embodiments, the medical device designs generated by the treatment planning module 118 can be transmitted from the client computing device 102 and / or the server 106 to a manufacturing system 124 for manufacturing the corresponding medical devices. The manufacturing system 124 can be located on-site or off-site. On-site manufacturing can reduce the number of patient sessions and / or the time to be able to perform a procedure, while off-site manufacturing is useful for manufacturing complex devices. Off-site manufacturing facilities can have specialized manufacturing equipment. In some embodiments, more complex device components can be manufactured off-site, while simpler device components can be manufactured on-site.

[0059] Various types of manufacturing systems are suitable for use in embodiments herein. For example, the manufacturing system 124 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 thermal sintering (SHM), electron beam melting (EBM), additive manufacturing (LOM), powder bed printing (PP), thermoplastic printing, direct material deposition (DMD), inkjet photoresist printing, or similar techniques, or a combination thereof. Alternatively, or in combination, the manufacturing system 124 can be configured for subtractive (traditional) manufacturing, such as CNC machining, electrical discharge machining (EDM), grinding, laser cutting, waterjet machining, manual machining (e.g., milling, lathe / turning), or similar techniques, or a combination thereof. The manufacturing system 124 can manufacture one or more patient-specific medical devices based on manufacturing instructions or data (e.g., CAD data, 3D data, digital blueprints, stereolithography data, or other data suitable for the various manufacturing techniques described herein). Different components of the system 100 can generate at least a portion of the manufacturing data used by the manufacturing system 124. The manufacturing data can include, but is not limited to, manufacturing instructions (e.g., programs executable by additive manufacturing equipment, subtractive manufacturing equipment, etc.), 3D data, CAD data (e.g., CAD files), CAM data (e.g., CAM files), path data (e.g., print head paths, tool paths, etc.), material data, tolerance data, surface finish data (e.g., surface roughing data), regulatory data (e.g., FDA requirements, reimbursement data, etc.), etc. The manufacturing system 124 can analyze the manufacturability of the implant design based on the received manufacturing data. The implant design can be finalized by modifying the shape, surfaces, etc., and then generating manufacturing instructions. In some embodiments, the server 106 generates at least a portion of the manufacturing data sent to the manufacturing system 124.

[0060] The manufacturing system 124 can generate CAM data, printing data (e.g., powder bed printing data, thermoplastic printing data, photoresist data, etc.), and can include additive manufacturing equipment, subtractive manufacturing equipment, thermal processing equipment, etc. Additive manufacturing equipment can include technologies such as 3D printers, stereolithography equipment, digital light processing equipment, fused deposition modeling equipment, selective laser sintering equipment, selective laser melting equipment, electron beam melting equipment, laminated layer manufacturing equipment, powder bed printers, thermoplastic printers, direct material deposition equipment, or inkjet photoresist printers. Subtractive manufacturing equipment can be CNC machines, electrical discharge machines, grinders, laser cutters, waterjet machines, manual machines (e.g., milling machines, lathes, etc.), or similar technologies. Both additive and subtractive technologies can be used to manufacture implants with complex shapes, surface finishes, material properties, etc. The generated manufacturing instructions can be configured to cause the manufacturing system 124 to manufacture patient-specific orthopedic implants that match or are therapeutically identical to the patient-specific design. In some embodiments, patient-specific medical devices can include shared features, agents, and designs between designs to simplify manufacturing. For example, deployable patient-specific medical devices for different patients can have similar internal deployment mechanisms but different deployment configurations. In some embodiments, components of the patient-specific medical device are selected from a set of available prefabricated components, and the selected prefabricated components can be modified based on manufacturing instructions or data.

[0061] The surgical plans described herein can be performed by a surgeon, a surgical robot, or a combination thereof, thus enabling treatment flexibility. In some embodiments, a surgical procedure can be performed entirely by a surgeon, entirely by a surgical robot, or a combination thereof. For example, one step of the surgical procedure can be performed manually by a surgeon and another step of the surgical procedure can be performed by a surgical robot. In some embodiments, the treatment planning module 118 generates control instructions configured to cause a surgical robot (e.g., a robotic surgical system, a navigation system, etc.) to perform part or all of the surgical procedure. The control instructions can be transmitted to the robotic device by the client computing device 102 and / or the server 106.

[0062] After treating the patient according to the surgical plan, the treatment progress can be monitored over one or more time periods to update the data analysis module 116, the treatment plan module 118, the disease progression module 120, and / or the intervention timing module 121. The post-treatment data can be added to the reference data stored in the database 110. The post-treatment data can be used to train machine learning models to develop patient-specific treatment plans, patient-specific medical devices, or a combination thereof.

[0063] It should be understood that the components of system 100 can be configured in many different ways. For example, in an alternative embodiment, database 110, data analysis module 116, treatment planning module 118, disease progression module 120, and / or intervention timing module 121 can be components of client computing device 102 rather than server 106. As another example, database 110, data analysis module 116, treatment planning module 118, disease progression module 120, and / or intervention timing module 121 can be located across multiple different servers, computing systems, or other types of cloud computing resources rather than on a single server 106 or client computing device 102.

[0064] Furthermore, in some embodiments, system 100 is operational with numerous other computing system environments or configurations. Examples of computing systems, environments, and / or configurations suitable for use with the techniques of the present invention 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, etc.

[0065] FIG. 2 illustrates a computing device 200 suitable for use in connection with the system 100 of FIG. 1 , according to one embodiment. The computing device 200 may be incorporated into various components of the system 100 of FIG. 1 , such as the client computing device 102 or the server 106. The computing device 200 includes one or more processors 210 (e.g., a CPU, a GPU, an HPU, etc.). The processor 210 may be a single processing unit or multiple processing units within a device, or may be distributed across multiple devices. The processor 210 may be coupled to other hardware devices using a bus, such as a PCI bus or a SCSI bus. The processor 210 may be configured to execute one or more computer-readable program instructions, such as program instructions for performing any of the methods described herein.

[0066] Computing device 200 may include one or more input devices 220 that provide input to processor 210, e.g., to communicate actions from a user of device 200. The actions may be mediated by a hardware controller that interprets signals received from the input devices and communicates the information to processor 210 using a communication protocol. Input devices 220 may include, for example, a mouse, keyboard, touchscreen, infrared sensor, touchpad, wearable input device, camera or image-based input device, microphone, or other user input device.

[0067] Computing device 200 may include a display 230 used to display various types of output, such as text, models, virtual procedures, surgical plans, implants, graphics, and / or images (e.g., images having voxels representing radiometric or Hounsfield units representing tissue density at a location). In some embodiments, display 230 provides graphical and textual visual feedback to the user. Processor 210 may communicate with display 230 through a hardware controller for the device. In some embodiments, display 230 includes input device 220 as part of display 230, such as when input device 220 includes a touchscreen or comprises an eye-gaze monitoring system. In alternative embodiments, display 230 is separate from input device 220. Examples of display devices include an LCD display screen, an LED display screen, a projection display, a holographic display, or an augmented reality display (e.g., a head-up display device or a head-mounted device), etc.

[0068] Optionally, other I / O devices 240 may also be coupled to processor 210, such as a network card, a video card, an audio card, a USB, Firewire or other external device, a camera, a printer, speakers, a CD-ROM drive, a DVD drive, a disk drive, or a Blu-ray device. Other I / O devices 240 may also include input ports for information from directly connected medical equipment, such as imaging devices, including MRI machines, X-ray machines, CT machines, etc. Other I / O devices 240 may further include input ports for receiving data from these types of machines via a network device or from other sources, such as previously captured data stored in a database.

[0069] In some embodiments, computing device 200 also includes a communications device (not shown) capable of wireless or wired communications with network nodes. The communications device can communicate with other devices or servers over a network using, for example, the TCP / IP protocol. Computing device 200 can utilize the communications device to distribute operations across multiple network devices, including imaging equipment, manufacturing equipment, etc.

[0070] Computing device 200 may include memory 250, which may be located within a single device or distributed across multiple devices. Memory 250 may include one or more of a variety of hardware devices for volatile and non-volatile storage, including both read-only and writable memory. For example, memory may 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, and device buffers. Memory is not a propagating signal separate from the underlying hardware; therefore, memory is non-transitory. In some embodiments, memory 250 is a non-transitory computer-readable storage medium that stores, for example, programs, software, data, and the like. In some embodiments, memory 250 may include program memory 260, which stores programs and software, such as an operating system 262, one or more therapeutic support modules 264, and other application programs 266. Treatment assistance module 264 may include one or more modules configured to perform various methods described herein (e.g., data analysis module 116 and / or treatment planning module 118 described with respect to FIG. 1 ). Memory 250 may also include data memory 270 that may include, for example, reference data, configuration data, settings, user options or preferences, etc., which may be provided to program memory 260 or any other element of computing device 200.

[0071] B. Selective Methods for Modeling and Designing Patient-Specific Surgical Plans and Associated Patient-Specific Implants The present technology includes systems and methods for designing and / or generating one or more patient-specific surgical plans and associated patient-specific implants. In some embodiments, the patient-specific surgical plan is for an intervertebral fusion surgery, and the patient-specific implant is a patient-specific fusion device. For example, the intervertebral fusion surgery can include an ALIF procedure, and the patient-specific implant can be a patient-specific interbody ALIF implant.

[0072] 3 is a flow diagram illustrating a method 300 for providing patient-specific medical care in accordance with one embodiment of the present technology. Portions or all of method 300 may be performed by various computing systems or software modules, including, for example, the computing systems described above with respect to FIGS. 1 and 2.

[0073] The method 300 may begin at block 302 by receiving a patient dataset for a particular patient requiring medical treatment. The patient dataset may include data representing the patient's condition, anatomical structure, pathological structure, symptoms, medical history, preferences, and / or any other information or parameters related to the patient. For example, the patient dataset may include surgical intervention data, treatment outcome data, progress data (e.g., surgeon's notes), patient feedback (e.g., feedback obtained using quality of life questionnaires, surveys), clinical data, patient information (e.g., demographics, gender, age, height, weights, type of condition, occupation, activity level, tissue information, health assessment, comorbidities, health-related quality of life (HRQL)), vital signs, diagnosis results, medication information, allergies, diagnostic equipment information (e.g., manufacturer, model number, specifications, user-selected settings / configuration, etc.), or the like. The patient dataset may also include image data such as camera images, magnetic resonance imaging (MRI) images, ultrasound images, computer-aided tomography (CAT) scan images, positron emission tomography (PET) images, x-ray images, etc. In some embodiments, the patient dataset includes data representing one or more of a patient's identification number (ID), age, sex, body mass index (BMI), lumbar lordosis, Cobb angle, pelvic intrinsic angle, disc height, segmental flexibility, bone quality, rotational displacement, and / or spinal treatment level. The patient dataset may be received on a server, computing device, or other computing system. For example, in some embodiments, the patient dataset may be received on server 106 shown in FIG. 1. In some embodiments, the computing system that receives the patient dataset in block 302 also stores one or more software modules (e.g., data analysis module 116, treatment planning module 118, disease progression module 120, and / or intervention timing module 121 shown in FIG. 1, or additional software modules for performing various operations of method 300).

[0074] In some embodiments, the received patient data set may include disease indicators such as lumbar lordosis, Cobb angle, coronal parameters (e.g., coronal balance, global coronal balance, coronal pelvic tilt, etc.), sagittal parameters (e.g., pelvic intrinsic angle, sacral tilt, thoracic lordosis, etc.), and / or pelvic parameters. The disease indicators may include micro-measurements (e.g., measures associated with specific or individual segments of the patient's spine) and / or macro-measurements (e.g., measures associated with multiple segments of the patient's spine). In some embodiments, the disease metrics are not included in the patient data set, and the method 300 includes determining (e.g., automatically determining) one or more disease metrics based on the patient image data, as described below. In some embodiments, the received patient data may include functional mobility test scores (e.g., step test, 6-meter walk test, sit-to-stand test, timed up-and-go test, etc.). The received patient dataset may include additional subjective test scores reflecting aspects of the patient, such as pain tests (e.g., visual analog scale (VAS) pain scores, low back pain rating scale scores, etc.), disability tests (e.g., Oswestry Disability Index scores, Quebec Low Back Pain Disability Examination scores, etc.), and quality of life tests (e.g., QOL scale scores).

[0075] Method 300 may proceed with identifying the patient as a candidate for intervertebral fusion surgery at block 303. In some embodiments, the operations at block 303 include analyzing the receiver dataset from the operations at block 302 to determine whether the patient would benefit from intervertebral fusion surgery. In some embodiments, the operations of identifying the patient as a candidate for intervertebral fusion surgery may be performed by one or more treatment planning programs or modules, such as those described with reference to FIG. 1.

[0076] If the patient is identified as a candidate for intervertebral fusion surgery, method 300 may proceed, at block 304, to generating a surgical plan based at least in part on the patient dataset received at block 302. As described in more detail below, the surgical plan may include a target site or region of interest for surgical intervention and one or more surgical procedures or interventions to be performed at the region of interest. The surgical plan may also include predicted post-operative data associated with performing the surgical procedure at the target site. For example, the surgical plan may include a predicted or target post-operative anatomical configuration depicted as a two-dimensional or three-dimensional virtual model. In some embodiments, the surgical plan also includes additional predicted post-operative analyses, such as predicted disease progression, predicted patient satisfaction, predicted patient mobility, predicted patient pain, and predicted patient quality of life.

[0077] In some embodiments, generating a surgical plan includes identifying specific target locations involved in the surgical procedure. For example, in the context of intervertebral fusion surgery, generating a surgical plan may include identifying one or more vertebral levels for fusion. In some embodiments, the vertebral levels are lumbar levels (e.g., L1-L5) and / or the sacrum. In some embodiments, the identified target locations include a specific range of vertebral levels involved in the surgery (e.g., L5-S1, L3-L4, etc.). The identified target locations may include two, three, four, five, or more vertebral levels. Of course, the aforementioned target locations are provided by way of example, and the techniques of the present invention are not limited to the above-mentioned anatomical locations. Indeed, in some embodiments, the target locations may include other vertebral levels, such as cervical and / or thoracic levels, and / or anatomical structures other than the spine, such as the hip, knee, ankle, shoulder, elbow, wrist, hand, jaw, skull, or other anatomical locations, as described throughout this detailed description.

[0078] Target locations can be identified by reviewing patient image data. In some embodiments, a computing system (e.g., server 106 of FIG. 1 ) and / or one or more software modules (e.g., treatment planning module 118 of FIG. 1 ) can review and analyze the patient image data and automatically identify target locations. In such embodiments, a trained machine learning program or other software-based program can analyze the patient image data, extract measurements from the patient image data, compare the extracted measurements to reference data (e.g., predetermined thresholds or ranges associated with “healthy” patients normalized for age, sex, gender, etc.), and identify anatomical sites that are candidates for surgical correction. Alternatively or additionally, target locations can be identified and / or confirmed by other suitable means, such as via a technician or healthcare provider who reviews the image data and identifies anatomical anomalies.

[0079] As provided above, in some embodiments, the act of generating a surgical plan also includes identifying a surgical procedure for the patient. In embodiments where the surgical plan includes identifying a target site, the surgical procedure can be associated with the target site. In the context of spine surgery, exemplary surgical procedures include intervertebral fusion, artificial disc replacement, laminoplasty, vertebroplasty, spinal laminectomy / decompression, discectomy, facetectomy, laminectomy, or other spinal surgical procedures. Examples of intervertebral fusion procedures include posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), lateral lumbar interbody fusion (TLIF), lateral lumbar interbody fusion (LLIF), direct lateral lumbar interbody fusion (DLIF), or extreme lateral lumbar interbody fusion (XLIF). The above is provided by way of example, and the techniques of the present invention can include identifying any type of spinal or other surgical procedure in block 304.

[0080] The surgical procedures associated with the surgical plan can be identified using any of the methods and systems described herein. For example, in some embodiments, the server 106 of FIG. 1 and / or associated software modules (e.g., treatment planning module 118) can identify one or more surgical procedures based on, for example, user input, receiver or extracted patient data, and / or identified target locations. For example, if the server 106 determines that the patient is suffering from L3-L5 disc degeneration, it can recommend an ALIF procedure to fuse L2-T12. Alternatively, the server 106 can recommend artificial disc replacements at L3-L4 and L4-L5 to correct the degeneration while preserving motion. Surgical procedures can also be identified using other methods and systems.

[0081] In some embodiments, the operations at block 304 may include reviewing and / or analyzing multiple types of surgical procedures and / or surgical steps to identify a surgical procedure for inclusion within the surgical plan. The type of surgical procedure and / or surgical step may be based on, for example, user input, insurance coverage of the procedure or step, healthcare provider parameters (e.g., based on healthcare provider rankings / scores such as hospital / physician specialty, number of similar procedures performed, hospital rankings for the procedure, etc.), medical resource parameters (e.g., diagnostic equipment, facilities, surgical equipment such as surgical robots), and / or other non-patient related information (e.g., procedure scores for current healthcare providers, predictions of outcome and risk profile, and / or information that can be used to rank procedures).

[0082] In some embodiments, the act of generating a surgical plan includes identifying or designing a corrective anatomical configuration for the patient (the corrective anatomical configuration may also be referred to herein as a “planned configuration,” “optimized shape,” “post-operative anatomical configuration,” or “target result”). The corrective anatomical configuration may reflect the patient's desired and / or predicted anatomical configuration if the surgical plan is performed. In some embodiments, generating the surgical plan includes generating one or more virtual models (e.g., two-dimensional model, three-dimensional model, etc.) representing the corrective anatomical configuration. The virtual model may include some or all of the patient's anatomical structures within the target location (e.g., any combination of tissue types, including, but not limited to, bony structures, cartilage, soft tissue, vascular tissue, neural tissue, etc.). In some embodiments, the corrective anatomical configuration is identified / determined prior to the surgical procedure and / or target location. That is, a computing system or a user can model a preferred anatomical outcome and, based on the desired anatomical outcome, identify a surgical procedure and target location that, when performed, will achieve the desired anatomical outcome.

[0083] In some embodiments, generating a surgical plan includes generating one or more patient metrics related to the anatomical configuration. In the context of spine surgery, patient metrics may include, for example, coronal parameters, sagittal parameters, pelvic parameters, Cobb angle, shoulder slope, iliolumbar angle, coronal balance, lordosis angle, disc space height, or other similar spinal parameters. Similar to the above, patient metrics can be determined prior to identifying target locations for surgical procedures and / or interventions. That is, a computing system or user can use the patient metrics to identify surgical procedures and target locations that, once performed, will achieve the patient metrics.

[0084] The surgical plan can include additional features. In some embodiments, for example, the surgical plan can include predicted disease progression, predicted patient satisfaction, predicted patient mobility, predicted patient pain, predicted patient quality of life, or the like. For example, the surgical plan can include an estimate of disease progression if the patient undergoes a specified surgical procedure at a specified target site. That is, the surgical plan can include a virtual model (e.g., a two-dimensional or three-dimensional virtual model) of the patient's anatomy at various intervals after surgery. For example, the surgical plan can include a predicted model of the patient's anatomy at one or more of the following time points: 6 months post-surgery, 1 year post-surgery, 2 years post-surgery, 3 years post-surgery, 4 years post-surgery, 5 years post-surgery, 6 years post-surgery, 7 years post-surgery, 8 years post-surgery, 9 years post-surgery, and / or 10 years post-surgery. The disease progression model may also include, in addition to or instead of including a virtual model of predicted patient anatomy, predicted patient metrics (e.g., any of the patient metrics described herein, including coronal parameters, sagittal parameters, pelvic parameters, Cobb angle, shoulder slope, iliolumbar angle, coronal balance, lordosis angle, disc space height, or other similar spinal parameters) at any of the various postoperative intervals identified above.

[0085] Once generated, the surgical plan may be digitally displayed as a surgical report on one or more display screens for easy review, editing, annotation, etc. In some embodiments, the surgical plan may be stored as computer-executable instructions that may be executed via the surgical plan review module 123 on the client computing device 102 of FIG.

[0086] In some embodiments, the act of generating a surgical plan in block 304 includes generating a plurality of candidate surgical plans (or a subset of surgical plans, such as surgical procedures) and then selecting a surgery from among the plurality of candidate surgical plans. For example, in some embodiments, the computing system may automatically identify a plurality (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, or more) of surgical plans (or a subset of surgical plans, such as surgical procedures) based on a patient dataset and / or one or more user-input criteria. The identified candidate surgical plans may be ranked and / or scored based on various factors, including predicted patient outcome, user reviews, etc. The identified candidate surgical plan that is highest ranked (e.g., based on predicted patient outcome) may be selected as the surgical plan. In some embodiments, a particular ranked surgical plan may not be selected as the surgical plan based on not satisfying user reviews and / or various user criteria. For example, if a particular surgical plan is identified as requiring a surgical procedure with which the physician is unfamiliar, the particular surgical plan is not selected, and the method may instead include selecting a suboptimal surgical plan as the surgical plan. Thus, in some embodiments, physician-specific scoring is used to score candidate procedures / surgical plans before selecting a surgical plan. For example, procedures having scores that meet a threshold score (e.g., a threshold postoperative index score, a physician-entered threshold score, a threshold outcome score, etc.) can be identified for user review. Thus, the system can compare the advantages and disadvantages of candidate procedures relative to each other before selecting a surgical plan.

[0087] Once the surgical plan is generated in block 304, the method 300 may proceed to transmitting the surgical plan to the surgeon in block 306. In some embodiments, the same computing system used in blocks 302 and 304 may transmit the surgical plan to a computing device (e.g., client computing device 102 depicted in FIG. 1 ) for review by the surgeon. This may include transmitting the surgical plan directly to the computing system or uploading the first and second surgical plans to a cloud or other storage system for subsequent download.

[0088] The surgeon may review the surgical plan and approve or disapprove the surgical plan in block 308. For example, the surgeon may review the surgical plan using the surgical plan review program 125 (FIG. 1) to determine whether the surgeon deems the surgical plan acceptable. This may include, for example, reviewing the surgical plan's target site, surgical procedure, target / projected post-operative anatomical configuration, and projected post-operative patient metrics.

[0089] In some embodiments, the surgeon may not approve the surgical plan at block 308. In such embodiments, the surgeon may optionally provide feedback and / or suggested revisions to the surgical plan (e.g., by adjusting the virtual model or changing one or more aspects of the plan, providing comments or further requested changes to the surgical plan, etc.). Accordingly, method 300 may optionally include receiving surgeon feedback and / or suggested revisions (e.g., via a computing system) at block 310. This may include, for example, modifying the target location of the surgical intervention, the surgical procedure, and / or the target post-operative anatomical configuration. If surgeon feedback and / or suggested revisions are received at block 310, method 300 may proceed at block 312 to modify (e.g., automatically via a computing system) the surgical plan based at least in part on the surgeon feedback and / or suggested revisions received at block 310. In some embodiments, the surgeon does not provide feedback and / or suggested revisions if he or she rejects the surgical plan. In such embodiments, block 310 may be omitted, and method 300 may proceed to revising the surgical plan (e.g., automatically via a computing system) at block 312 by selecting new and / or additional reference patient data sets and / or generating new candidate surgical plans. The revised and / or new surgical plan may then be sent to the surgeon for review. The operations at blocks 306, 308, 310, and 312 may be repeated as many times as necessary until the surgeon selects and approves a particular surgical plan.

[0090] Once the surgeon's approval of the surgical plan is received at block 308, method 300 can proceed at block 314 to designing a patient-specific fusion implant (e.g., via the same computing system that performed blocks 302-308) based on the selected surgical plan. For example, the patient-specific fusion implant can be designed based on the target location and surgical procedure included in the selected surgical plan. The patient-specific implant can also be specifically designed to guide the patient's anatomy so that, when implanted in a particular patient at the target location using the identified surgical procedure, the patient's anatomy occupies a target post-operative anatomy (e.g., transforming the patient's anatomy from the patient-specific anatomy to a corrected anatomy). Once implanted, the patient-specific fusion implant can be designed to occupy the corrected anatomy for the implant's expected lifespan (e.g., 5+ years, 10+ years, 20+ years, 50+ years, etc.). In some embodiments, the patient-specific fusion implant is designed based solely on a virtual model of the corrected anatomy and / or without reference to pre-operative patient images.

[0091] The patient-specific fusion implant can be any of the implants described herein. For example, the patient-specific fusion implant can be any of the ALIF interbody implants described in Section C of this detailed description. In other embodiments, the patient-specific fusion implant can be any of the implants described in, for example, U.S. Patent Application Nos. 16 / 048,167, 16 / 242,877, 16 / 207,116, 16 / 352,699, 16 / 383,215, 16 / 569,494, 16 / 699,447, 16 / 735,222, 16 / 987,113, 16 / 990,810, 16 / 100, ...

[0013] The present invention can include other implants, such as those disclosed in US Pat. Nos. 17 / 085,564, 17 / 100,396, 17 / 342,329, 17 / 518,524, 17 / 531,417, 17 / 835,777, 17 / 851,487, 17 / 867,621, and 17 / 842,242, each of which is incorporated herein by reference in its entirety.

[0014] The design of a patient-specific implant can include data describing one or more of the implant's physical properties (e.g., size, shape, volume, material, mass, weighting), mechanical properties (e.g., stiffness, strength, modulus, hardness), and / or biological properties (e.g., osteointegration, cell adhesion, antibacterial properties, antiviral properties). For example, the design of an orthopedic implant can include the shape, size, material, and / or effective stiffness of the implant (e.g., lattice density, number of struts, location of struts, etc.) In some embodiments, the patient-specific fusion implant can further include, in addition to the interbody device, one or more screws (e.g., bone screws, spinal screws, pedicle screws, facet screws), cages, plates, rods, discs, spacers, expansion devices, stents, brackets, ties, scaffolds, fixation devices, anchors, nuts, bolts, rivets, connectors, tethers, fasteners, etc.

[0092] In some embodiments, designing the implant at block 316 optionally includes generating manufacturing instructions for manufacturing the implant. For example, the computing system may generate computer-executable manufacturing instructions that, when executed by the manufacturing system, cause the manufacturing system to manufacture the implant.

[0093] In some embodiments, the patient-specific implant is designed in block 316 only after the surgeon selects the surgical plan. Thus, in some embodiments, the implant design is not implanted with the surgeon along with the surgical plan in block 308, nor is it manufactured prior to the surgeon's approval of the surgical plan. Without being bound by theory, waiting to design the patient-specific implant until the surgeon approves the surgical plan may increase the efficiency of method 300 and / or reduce the resources required to perform method 300. In other embodiments, one or more patient-specific implants may be designed and included in the surgical plan sent to the surgeon in block 306. For example, a virtual implant of a patient-specific fusion implant may be generated and sent for review by the surgeon simultaneously with the surgical plan during the operations of block 306. Thus, in some embodiments, the operations in block 314 may be included within block 304.

[0094] The method 300 may proceed at block 316 with manufacturing the patient-specific fusion implant. The implant may be manufactured using additive manufacturing techniques such as 3D printing, stereolithography, digital light processing, fused deposition modeling, selective laser sintering, selective laser melting, electron beam melting, additive manufacturing, powder bed printing, thermoplastic printing, direct material deposition, or inkjet photoresist printing, or a combination thereof. Alternatively or additionally, the implant may be manufactured using subtractive manufacturing techniques such as CNC machining, electrical discharge machining (EDM), grinding, laser cutting, waterjet machining, manual machining (e.g., milling, lathe / turning), or similar techniques, or a combination thereof. The implant may be manufactured by any suitable manufacturing system (e.g., manufacturing system 124 shown in FIG. 1 ). In some embodiments, the implant is manufactured by a manufacturing system executing computer-readable manufacturing instructions generated by a computing system at block 316.

[0095] Once the implant is manufactured at block 316, the method 300 may proceed at block 318 to execute the selected surgical plan and implant the patient-specific fusion implant into the patient. Aspects of the surgical plan, e.g., some or all of the surgical procedure, may be performed manually, by a robotic surgical platform (e.g., a surgical robot), or a combination thereof. In embodiments in which the surgical procedure is performed at least in part by a robotic surgical platform, the surgical plan may include computer-readable control instructions configured to cause the surgical robot to at least in part perform the patient-specific surgical procedure.

[0096] Method 300 can be implemented and performed in a variety of ways. In some embodiments, the operations in blocks 302-314 can be performed by a computing system associated with a first entity, block 316 can be performed by a manufacturing system associated with a second entity, and block 318 can be performed by a surgical provider, surgeon, and / or robotic surgical platform associated with a third entity. Any of the foregoing blocks can also be implemented as computer-readable instructions stored in memory and executable by one or more processors of the associated computing systems.

[0097] C. Selected Embodiments of Patient-Specific Intervertebral Fusion Devices The systems and methods described with reference to Figures 1-3 can be used to design and manufacture patient-specific medical devices for use with patient-specific surgical plans. In some embodiments, the patient-specific medical device includes a patient-specific intervertebral fusion device. The patient-specific intervertebral fusion device can include one or more interbody implants for intervertebral fusion procedures, such as a PLIF implant, an ALIF implant, a TLIF implant, a LLIF implant, a DLIF implant, and / or an XLIF implant. In some embodiments, the patient-specific fusion device further includes, in addition to the interbody device, one or more fixation elements or screws configured to secure the interbody device to the patient's anatomy. Thus, in some embodiments, the patient-specific intervertebral fusion device includes at least a patient-specific interbody device and one or more screws for securing the patient-specific interbody device to the patient's anatomy.

[0098] 4 is a front view of an exemplary patient-specific intervertebral fixation device 400 ("device 400") configured in accordance with selected embodiments of the present technology. Device 400 may include a patient-specific interbody implant 402 (which may also be referred to herein as an interbody spacer) and a plurality of fixation elements or screws. More specifically, the illustrated device 400 includes three fixation elements: a first fixation element 450a, a second fixation element 450b, and a third fixation element 450c (collectively referred to as "fixation elements 450").

[0099] In operation, the device 400 can be implanted into a patient's spine to facilitate fusion of two or more vertebral bodies. In particular, the interbody implant 402 can be implanted into the disc space between two vertebral end plates (e.g., after a discectomy). The interbody implant 402 can be secured to the vertebral end plates using the fixation elements 450. In the illustrated embodiment, the first fixation element 450a and the second fixation element 450b are angled superiorly and posteriorly (relative to the patient's anatomy when the device 400 is implanted), and the third fixation element 450c is angled inferiorly and posteriorly (relative to the patient's anatomy when the device 400 is implanted). As a result, the first fixation element 450a and the second fixation element 450b are configured to secure the interbody implant 402 to the superior vertebra, and the third fixation element 450c is configured to secure the interbody implant 402 to the inferior vertebra. For example, if the interbody implant 402 is positioned in the L5-S1 disc space, the first fixation element 450a and the second fixation element 450b can secure the interbody implant 402 to the L5 vertebral body, and the third fixation element 450c can secure the interbody implant 402 to the S1 vertebral body. In some embodiments, the device 400 can include more or fewer fixation elements 450, such as one, two, four, five, six, seven, or more fixation elements 450. Similarly, the fixation elements 450 can have a different orientation than that shown in FIG. 4. For example, in some embodiments, the device 400 can include one fixation element with a superior-posterior corner and two fixation elements with inferior-posterior corners. As another example, the device 400 can include one fixation element with a superior-posterior corner and one fixation element with an inferior-posterior corner. Without intending to be bound by theory, it is expected that securing the interbody implant 402 to both the superior and inferior vertebrae reduces the risk of the implant expelling from the disc space prior to fusion.

[0100] One or more aspects of device 400 may be "patient-specific," in that it is specifically designed for use with a particular patient. Thus, in some embodiments, device 400 may be designed and manufactured using the systems described with reference to Figures 1 and 2 and / or the methods described with reference to Figure 3. In other embodiments, device 400 may be manufactured using other suitable systems and methods that incorporate patient-specific parameters into the design of device 400.

[0101] Figure 5A is an isometric view of the interbody implant 402 of Figure 4 with the fixation elements 450 omitted to more clearly show the features of the interbody implant 402, and Figure 5B is a side view of the interbody implant 402 of Figure 4 with the fixation elements 450 also omitted to more clearly show the features of the interbody implant 402. Referring first to Figure 5A, the interbody implant 402 can include a front surface or face 504, a rear surface or face (not visible in Figure 5A), a first lateral surface or face 506, a second lateral surface or face (not visible in Figure 5A), a superior surface or face 508, and an inferior surface or face (not visible in Figure 5B). The implant 402 includes a first lumen 510a, a second lumen 510b, and a third lumen 510c (collectively referred to as lumens 510). The lumens 510 can be holes, screw holes, or anchor holes or channels configured to receive the fixation elements 450 ( FIG. 4 ). Accordingly, each of the lumens 510 can include a first (e.g., “entrance”) aperture and a second (e.g., “exit”) aperture on the anterior surface 504 of the implant 402. The exit aperture can be on either the superior surface 508 or the inferior surface (not shown), depending on the angular orientation of the corresponding lumen 510. For example, in the illustrated embodiment, the first lumen 510 a and the second lumen 510 b have exit apertures on the superior surface 508, and the third lumen 510 c has an exit aperture on the inferior surface. The angular orientation of the lumens 510 sets the angular orientation of the fixation elements 450 ( FIG. 4 ) and can therefore be adjusted based on a desired fixation angle and / or a desired fixation target.

[0102] In some embodiments, the inner surface of the lumen 510 is smooth, as opposed to roughened and / or textured. In such embodiments, the inner surface of the lumen 510 can be smoothed at a specific step during the manufacture of the implant 402, while in other embodiments, the inner surface is relatively smooth as a result of the manufacturing process used to manufacture the implant 402, without requiring an additional step to smooth the inner surface. Without intending to be bound by theory, having a relatively smooth inner surface of the lumen 510 is expected to be advantageous because it reduces friction between the fixation element 450 ( FIG. 4 ) and the inner surface, for example, as the fixation element 450 is advanced through the lumen 510 and secured to the patient's anatomy. Despite the relatively low friction between the fixation element 450 and the lumen 510, the fixation element 450 can be retained within the lumen 510 via other retention mechanisms, which are described in detail below. In some embodiments, such as those described below with reference to FIGS. 11A-11E, the inner surface of the lumen 510 can include threads for engaging the fixation element 450, even in embodiments where the surface is otherwise smooth. In some embodiments, the inner surface is a continuous surface that extends from the entrance aperture of each lumen 510 to the exit aperture of each lumen 510 (eg, without gaps or apertures).

[0103] The implant 402 may include one or more inner support walls or beams extending at least partially between the anterior surface 504 and the posterior surface. In the illustrated embodiment, for example, the implant 402 includes a first inner support wall 512a, a second inner support wall 512b, and a third inner support wall 512c (collectively referred to as inner support walls 512). The inner support walls 512 may be associated with the lumens 510. That is, each lumen may be at least partially formed within a corresponding inner support wall 512. For example, the first inner support wall 512a may be associated with the first lumen 510a, the second inner support wall 512b may be associated with the second lumen 510b, and the third inner support wall 512c may be associated with the third lumen 510c. In this manner, the inner support walls 512 provide structural integrity for the lumen 510.

[0104] The inner support wall 512 can be constructed of a solid material and / or a lattice structure. In some embodiments, the inner support wall 512 can be a bearing (e.g., in addition to the perimeter of the device being a bearing). In some embodiments, the implant 402 includes a high-density load-bearing portion 505 configured to bear a majority of the load exerted by the patient's spine (e.g., when the patient is standing upright). In such embodiments, the mass of the high-density load-bearing portion 505 can comprise a majority of the total mass of the implant 402.

[0105] The inner surface support wall 512 can also at least partially define one or more chambers or openings 514 (shown as first opening 514a and second opening 514b) that extend at least partially between the upper surface 508 and the lower surface (not shown) of the implant 402. In operation, the openings 514 can be filled with graft material (e.g., autogenous and / or allogeneic bone graft comprising cancellous and / or cortical bone) to promote bone growth and facilitate integration of the implant 402 into the patient's bony anatomy.

[0106] The implant 402 further includes a first retention mechanism 520a and a second retention mechanism 520b (collectively "retention mechanisms 520") for retaining the fixation element 450 within the lumen 510. As described in more detail below with reference to Figures 6A and 6B, the retention mechanisms 520 are selectively rotatable or otherwise operable between a first, unlocked configuration that allows a user to insert the fixation element 450 into the corresponding lumen 510 and a second, locked configuration that locks the fixation element 450 within the corresponding lumen 510. When in the locked configuration, the first retention mechanism can retain the first and third fixation elements 450a and 450c (FIG. 4) in the first and third lumens 510a and 510c, respectively (e.g., prevent backing), and the second retention mechanism can retain the second and third fixation elements 450b and 450c in the second and third lumens 510b and 510c, respectively.

[0107] The implant 402 can be a patient-specific implant designed to correspond to a particular patient's anatomy. In some embodiments, one or more implant surfaces can be designed to have a topography that matches (e.g., mates with) the topography of the patient's anatomy that the implant surface contacts when the implant 402 is implanted in the patient. For example, in an embodiment in which the implant is configured to be placed in the L5-S1 intervertebral disc space, the upper surface 508 of the implant 402 can have a topography configured to mate with the topography of the inferior endplate of the L5 vertebral body, and the lower surface (not shown) of the implant 402 can have a topography configured to mate with the topography of the superior endplate of the S1 vertebral body. As a result, the upper and lower surfaces 508, including the portions of these surfaces surrounding the exit aperture to the lumen 510, can have irregular contours to match the contours of the adjacent vertebral endplates. As a result, the implant 402 can also be asymmetric with respect to the midsagittal plane of the implant 402 and / or with respect to the transverse plane of the implant 402. Other characteristics of the implant can also be patient-specific, such as size, shape, load-bearing characteristics, shear strength, and any other characteristics that can be patient-specific as described with reference to FIGS.

[0108] In some embodiments, the implant 402 is a single, continuous component (e.g., a single, unitary interbody implant). For example, the implant 402 can be manufactured as a single structure using various additive manufacturing techniques, such as those described below with reference to FIGS. 14-16. In some embodiments, the implant 402 is constructed from a metal (e.g., titanium, etc.) and / or a metal alloy (e.g., stainless steel, nitinol, etc.). In other embodiments, the implant 402 can be constructed from a biocompatible plastic. The implant 402 can also include a combination of lattice and solid portions. For example, as shown in FIG. 5B, the first side 506 includes a lattice portion 515 and a solid portion 516. The combination of the lattice portion 515 and the solid portion 516 can be designed based on desired implant properties such as stiffness, bearing capacity, bone growth promotion, compatibility, cost, or the like.

[0109] As best shown in FIG. 5B , implant 402 can also include one or more visual indicators to provide information to a surgeon implanting implant 402. For example, implant 402 can include an orientation indicator 517 (shown as an "R" on implant 402). Direction indicator 517 can identify the correct orientation in which implant 402 should be implanted. For example, an "R" on implant 402 indicates that implant 402 should be upright and implanted on the patient's right side. Implant 402 can also include an implant indicator 518 (shown as "LXX-" on implant 402) that can designate the type of implant. In other embodiments, implant 402 can include more or fewer visual indicators.

[0110] As described above, device 400 can include one or more retention features 520 (e.g., cams) transitionable between an unlocked configuration, which allows a user to insert fixation element 450 into the corresponding lumen 510, and a locked configuration, which retains fixation element 450 within lumen 510. FIG. 6A is a front view of device 400 in the unlocked configuration, and FIG. 6B is a front view of device 400 in the locked configuration. Referring first to FIG. 6A , and specifically to the enlarged cutaway view of the portion of implant 402 shown in dashed lines, second retention feature 620b can include a cam head 621b having one or more ridges or raised portions 622b forming drive feature 624b. Cam head 621b has a longitudinal axis A extending through the center of cam head 621b (e.g., through drive feature 624b). In the unlocked configuration, longitudinal axis A has a first orientation that is within about 50 degrees of vertical in the illustrated embodiment. Notably, when in the unlocked configuration, cam head 621b does not block the entrance aperture to lumen 510. As a result, cam head 621 does not cover head 652b of second fixation element 650b or head 652c of third fixation element 650c in the unlocked configuration, thereby allowing a user to insert fixation element 450 into lumen 510.

[0111] 6B, cam head 621b has been rotated into a locked configuration. More specifically, cam head 621b has been rotated approximately 90 degrees clockwise relative to the configuration shown in FIG. 6A so that longitudinal axis A has a second orientation, which in the illustrated embodiment is within approximately 50 degrees of horizontal. Notably, in the locked configuration, cam head 621b at least partially blocks / covers the entrance apertures to second lumen 510b and third lumen 510c, and thus at least partially overlaps head 652b of second fixation element 650b and head 652c of third fixation element 650c. As a result, cam head 621b retains second fixation element 450b and third fixation element 450c within second lumen 510b and third lumen 510c, respectively. Cam head 621b can be rotated by inserting a tool into drive feature 624b of cam head 621b and rotating the tool in the desired direction.

[0112] The first retention mechanism 520a can operate in the same or generally similar manner as described for the second retention mechanism 520b. In some embodiments, the rotational direction for transitioning between the unlocked and locked configurations may be different for the first retention mechanism 520a and the second retention mechanism 520b. For example, the first retention mechanism 520a can be transitioned from the unlocked configuration to the locked configuration by rotating its cam head counterclockwise, while the second retention mechanism 520b can be transitioned from the unlocked configuration to the locked configuration by rotating its cam head clockwise. As a result, the first retention mechanism 520a can be transitioned from the locked configuration to the unlocked configuration by rotating its cam head clockwise, while the second retention mechanism 520b can be transitioned from the locked configuration to the unlocked configuration by rotating its cam head counterclockwise. In such embodiments, rotating either retention mechanism 520 away from the center of the front surface 504 locks the retention mechanism 520, and rotating the retention mechanism 520 toward the center of the front surface 504 unlocks the retention mechanism 520. In other embodiments, the retention mechanism 520 can be configured such that the rotational direction is the same for moving between the locked and unlocked configurations.

[0113] The retention mechanism 520 may also include one or more features to bias the retention mechanism 520 toward retaining a configuration it is in at any given time. That is, the retention mechanism 520 may resist rotational movement unless a substantial rotational force is applied (e.g., by engaging the drive feature 624b). This is expected to hold the retention mechanism 520 in its desired configuration and prevent accidental rotation of the retention mechanism 520. Examples of features for limiting rotational movement of similar retention mechanisms are described below with reference to Figures 10A-10C.

[0114] 7A-10C illustrate features of an interbody implant 702 ("implant 702") configured in accordance with selected embodiments of the present technology. As will be understood by those skilled in the art from the following description, implant 702 may include certain features generally similar to implant 402 described with reference to FIGS. 4-6B. For example, implant 702 may include one or more retention features that may be generally similar to or the same as retention feature 520 of implant 402 (FIGS. 4-6B). Accordingly, the following description of implant 702 equally applies to implant 402, and vice versa.

[0115] FIG. 7A is a perspective view of an implant 702. As shown, the implant 702 is generally similar to the implant 402 described with respect to FIGS. 4-6B. For example, the implant 700 is configured to be positioned within the interbody space of a patient's spine to facilitate intervertebral fusion. The implant 702 can include a first lumen 710a, a second lumen 710b, and a third lumen 710c (collectively referred to as "lumens 710"). The lumen 710 can be a bore or a threaded hole configured to receive a fixation element (not shown) to secure the implant 702 to the patient's anatomy. The implant 702 can further include a first retention mechanism 720a and a second retention mechanism 720b. During operation, the first retention mechanism 720a can help hold fixation elements positioned within the first lumen 710a and the third lumen 710c in place. Similarly, second retention mechanism 720b can assist in retaining fixation elements disposed within second lumen 710b and third lumen 710c in place. Similar to retention mechanism 520 described with reference to Figures 5A-6B, retention mechanism 720 can include corresponding cam heads 721a, 721b that enable a user to selectively rotate retention mechanism 720 between an unlocked configuration and a locked configuration.

[0116] FIG. 7B is a perspective view of implant 702 taken along the plane indicated in FIG. 7A, and FIG. 7C is a cross-sectional side view of implant 702 taken along the same plane. Referring collectively to FIGS. 7B and 7C, first retention feature 720a includes a shaft 725a extending distally from camming head 721a. Shaft 725a extends between a tapered shank region 726a proximal to camming head 721a and a distal end region 727a defining a tip. Shaft 725a further includes a raised lip or ridge 728a. As described in more detail below with respect to FIGS. 9A-9C, ridge 728a extends partially, but not completely, around the circumference of shaft 725a and helps define the range of rotational motion of retention feature 720a.

[0117] The implant 702 further includes a retention feature lumen 711 for receiving a shaft 725a of the retention feature. The retention feature lumen 711 may also include a corresponding channel 713 for receiving a ridge 728a on the shaft 725a. Like the ridge 728a, and as described in more detail below with respect to FIGS. 9A-9C, the channel 713 extends partially, but not completely, around the circumference of the retention feature lumen 711. In some embodiments, both the shaft 725a and the retention feature lumen 711 are smooth (e.g., unthreaded). In other embodiments, the shaft 725a and / or the retention feature lumen 711 may be threaded to aid in the connection between the retention feature 720a and the retention feature lumen 711.

[0118] 8A-8C illustrate additional features of implant 702. More specifically, FIG. 8A is a perspective view of implant 702, FIG. 8B is a perspective cross-sectional view of implant 702 taken along the plane indicated in FIG. 8A, and FIG. 8C is a top view of implant 702 taken along the same plane. Collectively referring to FIGS. 8B and 8C, distal end region 727a of shaft 725a includes first and second prongs 829a1 and 829a2 (collectively referred to as "prongs 829a") that extend distally to a tip portion of shaft 725a. Prongs 829a are separated by gap 830a. As described in more detail below with reference to FIGS. 10A-10C, prongs 829a can include features that prevent or at least reduce accidental rotation of retention mechanism 720a. In some embodiments, the prongs 829a can also help prevent the retention feature 720a from backing out of the retention feature lumen 711. For example, when the shaft 725a is inserted into the retention feature lumen 711, the prongs 829a can at least partially elastically deform (e.g., squeeze together to close or at least partially close the gap 830a). When the prongs 829a pass through the shoulder 815 ( FIG. 8C ) of the retention feature lumen 711, the prongs 829a can elastically snap back to and / or toward their undeformed shape, including the gap 830a. The back surface 833a ( FIG. 8C ) of the prongs 829a can then abut the shoulder 815 and prevent ejection of the retention feature 720a from the retention feature lumen 711. In some embodiments, the retention feature 720a can be manufactured (e.g., printed) in the retention feature lumen 711, as described below with reference to FIGS. 14-16 . In such an embodiment, prong 829a does not elastically deform (because shaft 725a is printed in its intended position) when shaft 725a is inserted into retention feature lumen 725. However, in such an embodiment, back surface 833a can still engage shoulder 815 to help retain retention feature 720a in retention feature lumen 711.

[0119] 9A-9C illustrate additional features of implant 702. More specifically, FIG. 9A is a perspective view of implant 702, FIG. 9B is a perspective cross-sectional view of implant 702 taken along the plane indicated in FIG. 9A, and FIG. 9C is a front view of implant 702 taken along the same plane. As shown in FIG. 9B, the cross-section shows a portion of shaft 725a within retention feature lumen 711. More specifically, and as best shown in FIG. 9C, the cross-section shows a portion of shaft 725a including ridge 728a. As shown, ridge 728a extends around approximately 180 degrees of the circumference of shaft 725a between first surface 928a1 and second surface 928a2 (the extent to which ridge 728a extends around shaft 725a may be referred to herein as the circumferential length of ridge 728a). In some embodiments, the ridge 728a can extend substantially around the shaft 725a, such as between about 90 degrees and about 270 degrees, or between about 135 degrees and about 225 degrees, or between about 160 degrees and about 200 degrees, or between about 170 degrees and about 190 degrees. The ridge 728a can have a height that is between about 10% and 100% of the diameter of the shaft 725a. For example, the ridge can have a height that is between about 20% and about 80% of the diameter of the shaft 725a, or between about 20% and about 50% of the diameter of the shaft 725a, or between about 20% and about 30% of the diameter of the shaft 725a. Although described separately, the ridge 725a can be continuous with the shaft 725a.

[0120] As described above, the retention feature lumen 711 includes a channel 713 for receiving the ridge 728a. As shown, the channel 713 extends about 270 degrees of the circumference of the retention feature lumen 711 between the first channel wall 913a and the second channel wall 913b (the extent to which the channel 713 extends about the retention feature lumen 711 may be referred to herein as the circumferential length of the channel 713). In some embodiments, the channel 713 can extend one or more lengths around the retention feature lumen 711, such as between about 325 degrees and about 180 degrees, or between about 325 degrees and about 225 degrees, or between about 300 degrees and about 240 degrees. Notably, the channel 713 extends further than the ridge 728a so that the ridge 728a can rotate within the channel 713, as described in more detail below. That is, ridge 728a can have a first circumferential length that is less than a second circumferential length of channel 713. Channel 713 can have a height that corresponds to (e.g., equal to or slightly greater than) the height of ridge 728a.

[0121] In operation, shaft 725a can rotate within retention feature lumen 711 as retention feature 720a transitions between the unlocked and locked configurations. Ridge 728a and channel 713 define the degree to which retention feature 720a can rotate. For example, when retention feature 720a is in the unlocked configuration, first surface 928a1 of ridge 728a is positioned proximate (e.g., in contact with) first channel wall 913a. Thus, when retention feature 720a is in the unlocked configuration, engagement between first surface 928a1 and first channel wall 913a prevents clockwise rotation of retention feature 720a. From the unlocked configuration, retention feature 720a can be rotated counterclockwise approximately 90 degrees until second surface 928a2 of ridge 728a contacts second channel wall 913b, which corresponds to the locked configuration. Thus, when retention feature 720a is in the locked configuration, engagement of second surface 928a2 with second channel wall 713b prevents counterclockwise rotation of retention feature 720a (FIG. 9C shows retention feature 720a in an intermediate configuration between the unlocked and locked configurations). In this manner, ridge 728a and channel 713 limit rotation of retention feature 720a to a predetermined path and extent.

[0122] The distance (e.g., degrees of rotation) that retention feature 720a can rotate is set based on the difference between the circumferential length of ridge 728a and the circumferential length of channel 713. In the illustrated embodiment, for example, ridge 728a extends approximately 180 degrees, and channel 713 extends approximately 270 degrees. Thus, retention feature 720a can rotate approximately 90 degrees (the difference between 270 degrees and 180 degrees). Therefore, the dimensions of ridge 728a and channel 713 can be selected based on the desired amount of rotation of retention feature 720a.

[0123] 10A-10C illustrate additional features of implant 702. More specifically, FIG. 10A is a perspective view of implant 702, FIG. 10B is a perspective cross-sectional view of implant 702 taken along the plane indicated in FIG. 10A, and FIG. 10C is a front view of implant 702 taken along the same plane. As shown in FIG. 10B, the cross-section shows a portion of distal end region 727a of shaft 725a. More specifically, and as best shown in FIG. 10C, the cross-section illustrates the cross-sectional profile of prong 829a. As shown, first prong 829a1 includes a first protrusion 1031a1 (e.g., a first nipple, nub, bump, etc.), and second prong 829a2 includes a second protrusion 1031a2 (e.g., a second nipple, nub, bump, etc.). The protrusion 1031a can extend transversely or at least generally transversely to the longitudinal axis of the shaft 725a.

[0124] The portion of the retention feature lumen 711 that receives the prong 829a can include a first groove or notch 1011a, a second groove or notch 1011b, and a third groove or notch 1011c. The retention feature lumen 711 can include similar grooves or cutouts that correspond to the second protrusion 1031a2. As a result, the portion of the retention feature lumen 711 that receives the prong 829a has an at least partially irregularly shaped cross-section (e.g., a flower-shaped cross-section). In some embodiments, the retention feature lumen 711 can include one or more grooves, such as two, four, five, six, seven, or eight grooves.

[0125] In actuation, the prong 829a rotates within the retention mechanism lumen 711 as the retention mechanism 720a is rotated between the unlocked and locked configurations. When the retention mechanism 720a is in the unlocked configuration, the protrusion 1031a1 is positioned within the first groove 1011a. When the retention mechanism 720a is in the locked configuration, the protrusion 1031a1 is positioned within the third groove 1011c. When the retention mechanism 720a is positioned in an intermediate configuration between the unlocked and locked configurations, the protrusion 1031a1 can be positioned within the second groove 1011b. In embodiments with more grooves 1011, each groove can correspond to a different intermediate configuration. In embodiments with only two grooves 1011 (e.g., only the first groove 1011a and the second groove 1011b), the grooves can correspond to the unlocked and locked configurations.

[0126] Collectively, the first protrusion 1031a1 and the groove 1011 define incremental predetermined positions for the retention mechanism 720a. For example, in the illustrated embodiment, there are three predefined positions: an unlocked configuration, an intermediate configuration, and a locked configuration. Each of these configurations represents a relatively “low energy” state of the retention mechanism 720a, while the other configuration, in which the protrusion 1031a1 is not within the groove 1011, represents a relatively high energy state of the retention mechanism 720a. Thus, the retention mechanism 720a can be biased to occupy three predefined positions. To move between the incremental predetermined positions, a rotational force must be applied to the retention mechanism 720a sufficient to cause the protrusion 1031a to jump the step between the two grooves 1011 (e.g., sufficient to cause the retention mechanism 720a to pass through the relatively high energy state). Without wishing to be bound by theory, the protrusions 1031 a and grooves 1011 are therefore expected to reduce unintentional rotation of the retention mechanism 1020 a. Thus, the protrusions 1031 a and grooves 1011 help to retain the retention mechanism 1020 a in whatever configuration (e.g., locked configuration) a user places it in.

[0127] 11A-11C illustrate another patient-specific intervertebral fusion device 1100 ("device 1100") configured in accordance with selected embodiments of the present technology. Device 1100 may include certain features generally similar to device 400 described with reference to FIGS. 4-6B and implant 702 described with reference to FIGS. 7A-10C. Accordingly, the following description of device 1100 is applicable to device 400 and implant 702, and vice versa.

[0128] FIG. 11A is a perspective view of device 1100. Similar to device 400 of FIG. 4, device 1100 includes a patient-specific interbody device 1102 and a plurality of fixation elements or screws 1150a-c. The device further includes first and second retention mechanisms 1120a, 1120b ("retention mechanisms 1120") that are similar to or can operate similarly to retention mechanism 520 described with reference to FIGS. 5A-6B. For example, retention mechanisms 1120 can be selectively and independently rotated between an unlocked configuration and a locked configuration.

[0129] 11B is a perspective view of implant 1102 with fixation elements 1150a-c removed to more clearly show certain features of implant 1102. As shown, implant 1102 includes a first lumen 1110a for receiving first fixation element 1150a, a second lumen 1110b for receiving second fixation element 1150b, and a third lumen 1110c for receiving third fixation element 1150c (collectively referred to as "lumens 1110"). In relation to the threaded lumens described above with reference to FIGS. 4-6B, each of lumens 1110 includes threads adjacent its entrance (e.g., at and / or extending from the entrance aperture). In particular, first lumen 1110a includes first threaded portion 1111a, second lumen 1110b includes second threaded portion 1111b, and third lumen 1110c includes third threaded portion 1111c (collectively referred to as "threaded portions 1111"). In some embodiments, threaded portions 1111 extend only partially along the length of lumens 1110. For example, each threaded portion 1111 can extend less than about 25%, less than about 20%, less than about 15%, less than about 10%, or less than about 5% along the length of the corresponding lumen 1110. In other embodiments, threaded portion 1111 can extend along substantially the entire length of the corresponding lumen 1110 (e.g., at least about 80%, or at least about 90%, or at least about 95% of the entire length of lumen 1110).

[0130] The threaded portion 1111 can threadably mate with threads on the fixation element 1150 to, for example, improve the connection between the fixation element 1150 and the implant 1102. For example, FIG. 11C is a close-up view of the proximal head portion 1152a of the first fixation element 1150a. As shown, the proximal head portion 1152a can include a first thread 1154a. The first thread can be sized and shaped to threadably mate with the first threaded portion 1111a of the first lumen 1110a (FIG. 11B). Without intending to be bound by theory, providing a threaded connection between the fixation element 1150 and the implant 1102 may further improve the stability of the connection therebetween, which in turn may further improve the stability of the device 1100 when implanted in a patient.

[0131] 12A-12D illustrate a patient-specific intervertebral fixation device 1200 ("device 1200") implanted in a patient's spine S and configured in accordance with selected embodiments of the present technology. More specifically, FIG. 12A is a front (e.g., anterior) view of device 1200 implanted in a patient's spine S, FIG. 12B is a side (e.g., lateral) view of device 1200 implanted in a patient's spine S, FIG. 12C is a top view of device 1200 implanted in a patient's spine S, and FIG. 12D is a bottom view of device 1200 implanted in a patient's spine S. Collectively referring to FIGS. 12A-12D, device 1200 can include an interbody implant 1202 that is implanted within an intervertebral disc space of a spine S. The implant 1202 can be generally similar to or the same as the implant 402 described with respect to Figures 4-6B, the implant 702 described with respect to Figures 7A-10C, and / or the implant 1102 described with respect to Figures 11A-11C. The device 1200 can also include a first fixation element 1250a, a second fixation element 1250b, and a third fixation element 1250c (collectively referred to as "fixation elements 1250"). The fixation elements 1250 can secure the implant 1202 to the patient's spine S, as described throughout this detailed description.

[0132] Device 1200 is shown implanted at a sacral / lumbar location of a patient's spine S, e.g., between L5 and S1. In other embodiments, device 1200 can be implanted at other vertebral levels, including other lumbar, thoracic, or cervical levels. For example, FIGS. 13A and 13B are front and side views of device 1200 implanted between adjacent cervical vertebrae of a patient's spine S, e.g., to provide cervical fusion. As will be appreciated by those skilled in the art, FIGS. 12A-13B are provided by way of example only, and the devices described herein can be implanted at any vertebral level of a patient's spine S to facilitate interbody fusion.

[0133] As will be appreciated by those skilled in the art, the patient-specific intervertebral fusion devices described with respect to Figures 4-13B are provided as representative embodiments, and the present technology includes variations of these embodiments, including devices having combinations of the features described with respect to Figures 4-13B and devices having only some of the features described with respect to Figures 4-13B.

[0134] D. Selection of Manufacturing Methods for Patient-Specific Intervertebral Fusion Devices FIG. 14 is a flow chart illustrating a method 1400 for manufacturing an implant in accordance with selected embodiments of the present technology. Method 1400 can include obtaining a virtual model of the implant. Manufacturing instructions can be generated based on the virtual model. The manufacturing instructions can be designed to be executed by a manufacturing system to form the implant in a single manufacturing step performed by a single manufacturing machine, multiple manufacturing steps performed by a single manufacturing machine, and / or multiple manufacturing steps performed by multiple manufacturing machines at the same site or different manufacturing sites (e.g., manufacturing sites remote from a healthcare provider). Details of method 1400 are described with reference to FIGS. 12-14.

[0135] At block 1410 (FIG. 14), a virtual model is obtained. The virtual model may represent an implant designed to provide a correction to a patient's anatomy. The virtual model may be obtained, for example, from a virtual model database, an implant design server, a digital filing cabinet, or other component of the system. In some embodiments, a manufacturing system (e.g., manufacturing 124 of FIG. 1) may obtain the implant virtual model from a client computing device (e.g., client computing device 102 of FIG. 1), a database (e.g., database 110 of FIG. 1), a server (e.g., server 106 of FIG. 1), or other component of system 100 of FIG. 1. In some embodiments, the virtual model is received from CAD software, manufacturing software (e.g., additive manufacturing software running on server 106 of FIG. 1, substrate manufacturing software, etc.), etc.

[0136] The virtual model can be a two-dimensional or three-dimensional virtual model and can include, for example, CAD data, material data, surface modeling, manufacturing data, regulatory data, etc. CAD data can include, for example, solid modeling data (e.g., part files, assembly files, libraries, part / object identifiers, etc.), model geometry, objective volume representations, parametric data, object representations, topology data, surface data, assembly data, metadata, etc. Material data can include, for example, material properties, material types, material manufacturing data (e.g., allowable manufacturing techniques, manufacturing steps, etc.), etc. Regulatory data can include, for example, government regulatory requirements, reimbursement requirements, etc. Object representations can be polygonal representations, boundary representations, etc. Further details of an embodiment for generating a virtual model based on patient data are described in conjunction with FIG. 16 .

[0137] In block 1420 ( FIG. 14 ), manufacturing instructions can be generated for a manufacturing system capable of, for example, additive manufacturing, subtractive manufacturing, or other manufacturing techniques. The system can analyze the manufacturability of the implant based on the virtual model, modify features of the implant (e.g., modify the shape, dimensions, features, topology, composition, etc. of the virtual model), and then generate manufacturing instructions according to the modified virtual model. In some embodiments, the system can identify implant characteristics that may be modified so that the modified implant meets a manufacturable design match score. The manufacturable design match score can indicate a match of bone-contacting features, orthotics, biomechanics, etc. A user can select a manufacturable design match score (or other score) based, for example, on one or more dimensions between surfaces (e.g., opposing load-bearing surfaces), topology (e.g., topology of bone-contacting surfaces, retention feature interface surfaces, etc.), configuration of features for implanting additional components (e.g., retention features, anchors, screws, etc.), biomechanics of the implant, etc. Details of exemplary manufacturing instructions are described with reference to FIG. 15 .

[0138] At block 1430, the manufacturing system can manufacture the implant according to the manufacturing instructions. In additive manufacturing embodiments, the additive manufacturing machine can sequentially apply layers of material to form the implant. For example, layers of the same or different materials can be sequentially applied to form at least a portion of the implant (e.g., a unitary unitary spacer body, a unitary unitary vertebral endplate of an articular spinal implant, etc.). Additional features of the implant can be formed in the same or different manufacturing steps. For example, the unitary unitary body of the intervertebral spacer 402 of FIG. 5A can be formed, and then, for example, the retention features 520a, 520b can be formed based on the manufacturing of the unitary unitary body. The manufacturing system can store manufacturing machine data (e.g., data generated by the manufacturing machine during the manufacturing of the implant 405), images / scans of the implant 402, etc., to generate or modify manufacturing instructions for designing, modifying, and / or manufacturing the retention features. This allows subsequently manufactured articles to be designed, modified, and / or manufactured based on previously manufactured articles.

[0139] 15 is a flow chart illustrating a method 1500 for generating manufacturing instructions in accordance with an embodiment of the present technology. Method 1500 may include analyzing a virtual model of an implant, determining manufacturing parameters based on the analysis, and generating manufacturing steps based on the manufacturing parameters. The manufacturing instructions may be generated based on the manufacturing steps. The manufacturing steps may be simulated, reordered, modified, or removed, for example, based on data collected during manufacturing, thereby providing real-time adaptive manufacturing. New or modified manufacturing instructions may be modified based on the modified manufacturing steps in real time.

[0140] In block 1510, the virtual model of the implant is analyzed, for example, by analyzing regions of the virtual model and then generating a manufacturing plan based on the analysis. The individually analyzed regions can be components, bearing features (e.g., regions or surfaces), discrete regions (e.g., sliced ​​regions), etc. In some embodiments, the virtual model is virtually sliced. For additive or subtractive manufacturing, the virtual model (or the negative space surrounding the virtual model) can be divided to generate sliced ​​regions. The number, location, and orientation of the virtual slices can be selected based on the directional manufacturability of the virtual model. Additive or subtractive toolpaths can be planned based on the virtual slices. In additive manufacturing processes, the virtual model can be sliced ​​to identify toolpaths for applying material. The spacing between slices can correspond to the thickness of the material layer that can be formed for each toolpath. For example, each virtual slice can represent one or more layers of material to be applied. In subtractive manufacturing processes, the negative space surrounding the virtual model can be sliced ​​to identify toolpaths for removing material. The technique for analyzing the virtual model can be selected based on the manufacturing technology and manufacturing equipment used.

[0141] At block 1520, manufacturing parameters are determined based on the implant analysis at block 1510. The manufacturing parameters may include, but are not limited to, the order of manufacturing steps (e.g., the order of manufacturing features or components of the implant), orientation parameters (e.g., the orientation of the implant relative to the manufacturing machine, the orientation of the implant relative to the toolpath, etc.), material parameters (e.g., material properties, material composition, etc.), equipment settings (e.g., manufacturing speed, material application temperature, etc.), etc. In some multi-component implant embodiments, the manufacturing parameters may include component-toolpath orientation (e.g., the vertical / horizontal orientation of the component for a vertical / horizontal toolpath), component material properties, manufacturing steps for the manufacturing machine (e.g., toolpath steps, manufacturing settings, etc.), or the like. For example, the virtual model can be sliced ​​in different directions to generate multiple slice data sets. The slice data sets can be analyzed to select an orientation of the implant relative to the manufacturing equipment, for example, based on the location and orientation of patient-specific features of the implant, available toolpaths, etc.

[0142] At block 1530, manufacturing steps are generated based on the manufacturing parameters. The manufacturing steps can include, for example, establishing a coordinate system in which the virtual implant model is positioned. The system can then determine tool paths based on the coordinate system. For additive manufacturing, the manufacturing steps can include paths and print settings for three-dimensional printing, light settings for digital light processing, deposition settings for fused deposition melting, laser paths and deposition steps for selective laser melting, and other manufacturing steps for additive manufacturing. For subtractive manufacturing, the manufacturing steps can include tool paths and sequences for CNC machining, grinding tool directions and paths for grinding, laser directions and paths for laser cutting, pressures and tool paths for waterjet cutting, or the like.

[0143] At block 1540, the manufacturing steps can be converted into manufacturing instructions. The manufacturing instructions can include code executable by a manufacturing device. For example, the manufacturing instructions can be a program executable by a manufacturing device (e.g., manufacturing device 124 of FIG. 1 ), an additive manufacturing device, a subtractive manufacturing device, or other manufacturing device. The manufacturing steps can optionally be converted into executable manufacturing instructions configured to cause a manufacturing system to simultaneously or sequentially manufacture features or components of the implant.

[0144] 16 is a flow chart illustrating a method 1600 for generating a virtual model of an implant, according to an embodiment of the present technology. Components can be designed based on other components of the implant. For example, retention features can be designed to couple to bone tissue using a virtual model of a spacer body or cage positioned along a virtual spinal model of the patient. The system can determine the number, orientation, and configuration of retention features based, for example, on the anatomical correction to be achieved. The order and protocol for designing the implant components and features can be selected, for example, by the system, the user, or both.

[0145] The method 1600 may include receiving a patient dataset (block 1610). The subset of reference patient data may be selected based on, for example, similarity to the patient dataset and / or treatment outcomes of corresponding reference patients. For example, a similarity score may be generated for each reference patient dataset based on a comparison of the patient dataset and the reference patient dataset. The similarity score may represent a statistical correlation between the patient data and the reference patient dataset. One or more similar patient datasets may be identified based at least in part on the similarity score. The patient dataset may be compared to multiple reference patient datasets to identify one or more similar patient datasets in the multiple reference patient datasets. Each of the multiple reference patient datasets may include data representing one or more of age, gender, BMI, lumbar lordosis, Cobb angle, pelvic intrinsic angle, disc height, segmental flexibility, bone quality, rotational displacement, or treatment level of the patient's spine.

[0146] At block 1620, a surgical procedure and / or medical device design is generated. The generating step can include developing at least one predictive model (e.g., using statistics, machine learning, neural networks, AI, or the like) based on a selected subset of the patient dataset and / or reference patient dataset. The predictive model can be configured to generate the surgical procedure and / or medical design. In some embodiments, the predictive model includes one or more trained machine learning models that generate, at least in part, the surgical procedure and / or medical device design. In some embodiments, a user can generate the surgical procedure and / or medical device design based on an inspection of the receiver data. Block 1620 can include a data analysis stage to identify or determine surgical procedure data and / or medical device design data associated with advantageous treatment outcomes for at least one patient dataset of the selected subset (e.g., for at least one similar patient dataset).

[0147] In block 1630, a virtual model of the implant is generated. The virtual model can be designed to fit a virtual anatomical model of the patient. The virtual model of an implant component can be based on the design of other implant components. For example, after the spacer body or cage is designed, the virtual model of the retention features can be designed. This allows the bearing components (or features) to be designed before the fixation components. The system can determine the number, orientation, and configuration of the retention features. In other embodiments, the anchoring components are designed prior to the design of the load-bearing components. The order and sequence in which the implant components and features are designed can be selected by the system, the user, or a combination of both.

[0148] E. Selected Devices and Methods for Implanting Patient-Specific Intervertebral Fusion Devices In some embodiments, the present technology includes devices / instruments for implanting patient-specific intervertebral fusion devices, such as those described with reference to FIGS. 4-13B. For example, FIG. 17 illustrates four delivery devices configured in accordance with selected embodiments of the present technology. More specifically, FIG. 17A shows an inserter device 1700, an angled awl 1710, a driver 1720, and a U-joint driver 1730. The inserter 1700 is coupled to the front of the implant (e.g., via a threaded connection) and can be used to deliver the implant to a target location. Once the implant is implanted and its position is confirmed (e.g., using an imaging system or technique), the imaging device 1700 can be disconnected from the implant (e.g., rotated counterclockwise to disengage the threaded connection between the imaging device 1700 and the implant). The angled awl 1710 has an angled distal end that can be used to prepare a pilot hole for a screw (e.g., by extending the angled distal end of the angled awl 1710 through a screw hole or bore in the implant and drilling a pilot hole in the adjacent bone structure). The driver 1720 and / or U-joint driver 1730 can be used to load a fixation element (e.g., a screw) into the implant and through the pilot hole formed by the angled awl 1710.

[0149] In some embodiments, the present technology includes a surgical kit including a patient-specific intervertebral fusion system (e.g., device 400) and one or more delivery instruments, such as any of the instruments described with reference to FIG. 17. In such embodiments, one or more of delivery devices 1700-1730 can be patient-specific and / or have patient-specific features. However, in other embodiments, one or more of delivery devices 1700-1730 can be standardized for use with multiple different patient-specific intervertebral fusion systems. Furthermore, delivery devices 1700-1730 are provided by way of example only—in some embodiments, the patient-specific intervertebral fusion systems described herein can be implanted using other appropriate delivery instruments. [Example]

[0150] F. Working Example Several aspects of the present technology are described in the following examples. 1. A patient-specific intervertebral fixation device, comprising: 1. An interbody implant configured to be positioned between a superior vertebral body and an inferior vertebral body, comprising: an upper surface configured to contact an inferior surface of the superior vertebral body; a lower surface configured to contact a superior surface of the inferior vertebral body; The front and an interbody implant comprising: a first lumen extending through the implant between a first aperture on the anterior surface and a second aperture on the superior surface, the first lumen configured to receive a first fixation element for fixing the implant to the superior vertebral body; a second lumen extending through the implant between a third aperture on the anterior surface and a fourth aperture on the inferior surface, the second lumen configured to receive a second fixation element for fixing the implant to the inferior vertebral body; a rotatable retention mechanism configured to retain the first fixation element and the second fixation element to the implant, a head defining one or more drive features for rotating the retention mechanism; a shaft extending from the head to the implant; a ridge extending partially around the circumference of the shaft; a rotatable retention mechanism including: a retention mechanism lumen configured to receive the shaft, the retention mechanism lumen including a channel extending partially around a circumference of the lumen for receiving the ridge; Equipped with the rotatable retention mechanism is rotatable between (i) an unlocked configuration in which the head does not block the first aperture and the second aperture, and (ii) a locked configuration in which the head at least partially covers the first aperture and the second aperture, and a degree of rotation between the unlocked configuration and the locked configuration is determined at least in part based on the ridge and the channel. Patient-specific intervertebral fusion devices. 2. The device of Example 1, wherein the ridge has a first circumferential length and the channel has a second circumferential length greater than the first circumferential length such that the ridge can rotate within the channel. 3. The device of example 2, wherein a difference between the first circumferential length and the second circumferential length defines a degree of rotation between the unlocked configuration and the locked configuration. 4. A device described in any of Examples 1 to 3, wherein the ridge extends around about 90 degrees to about 270 degrees of the circumference of the shaft and the channel extends around between about 180 degrees to about 325 degrees of the circumference of the retention mechanism lumen. 5. A device described in any of Examples 1 to 3, wherein the ridge extends around approximately 180 degrees of the circumference of the shaft and the channel extends around approximately 270 degrees of the circumference of the retention mechanism lumen. 6. The device of Example 5, wherein the shaft is configured to rotate approximately 90 degrees between the unlocked configuration and the locked configuration. 7. The ridge extends between a first surface and a second surface, the channel extends between a first channel wall and a second channel wall, and the first surface is adjacent to the first channel wall when the retention mechanism is in the unlocked configuration, and the second surface is adjacent to the second channel wall when the retention mechanism is in the locked configuration. Example: A device according to any one of Examples 1 to 6. 8. The first channel wall allows the retention mechanism to rotate only in a first direction when the retention mechanism is in the unlocked position; the second channel wall permits the retention mechanism to rotate only in a second direction when the retention mechanism is in the locked position; the first direction is opposite to the second direction; The device described in Example 7. 9. The device of any of Examples 1-8, wherein the ridge has a height between about 20% and about 80% of the diameter of the shaft. 10. The device of any one of Examples 1-9, wherein the patient-specific intervertebral fixation device is configured to provide patient-specific correction to the patient's spine when implanted in the patient. 11. The device of any one of Examples 1-10, wherein the patient-specific intervertebral fusion device is an ALIF device. 12. A patient-specific intervertebral fixation device, comprising: 1. An interbody implant configured to be positioned between a superior vertebral body and an inferior vertebral body, comprising: an upper surface configured to contact an inferior surface of the superior vertebral body; a lower surface configured to contact a superior surface of the inferior vertebral body; The front and an interbody implant comprising: a first lumen extending through the implant between a first aperture on the anterior surface and a second aperture on the superior surface, the first lumen configured to receive a first fixation element for fixing the implant to the superior vertebral body; a second lumen extending through the implant between a third aperture on the anterior surface and a fourth aperture on the inferior surface, the second lumen configured to receive a second fixation element for fixing the implant to the inferior vertebral body; a rotatable retention mechanism configured to retain the first fixation element and the second fixation element to the implant, a head defining one or more drive features for rotating the retention mechanism; a shaft extending from the head to the implant, the shaft including a protrusion extending transversely to a longitudinal direction of the shaft; a rotatable retention mechanism including: a retention mechanism lumen configured to receive the shaft, the retention mechanism lumen including at least a first groove and a second groove; Equipped with The rotatable retention mechanism is rotatable between (i) an unlocked configuration in which the head does not block the first aperture and the second aperture and the protrusion is in the first groove, and (ii) a locked configuration in which the head at least partially covers the first aperture and the second aperture and the protrusion is in the second groove. Patient-specific intervertebral fusion devices. 13. A device described in Example 12, wherein the protrusion is configured to at least partially restrict rotational movement of the retention mechanism when the protrusion is in the first groove or the second groove. 14. A device described in Example 12 or Example 13, wherein the unlocked configuration and the locked configuration are relatively low energy states, and the device is configured such that transitioning the retention mechanism between the unlocked configuration and the locked configuration includes passing the retention mechanism through a relatively high energy state. 15. A device described in any of Examples 12 to 14, wherein the retention mechanism lumen includes a third groove, the rotatable retention mechanism is rotatable through an intermediate configuration between the unlocked configuration and the locked configuration, and the protrusion is within the third groove when the retention mechanism is in the intermediate configuration. 16. The device of any of Examples 12-15, wherein the shaft comprises at least two prongs at least partially separated by a gap. 17. The device of Example 16, wherein the protrusion is formed on at least one of the two prongs. 18. The device of example 16 or example 17, wherein each of the at least two prongs includes a projection. 19. The device of any one of Examples 16-18, wherein the at least two prongs include a back surface configured to abut a shoulder portion of the retention mechanism lumen. 20. A device described in any of Examples 12 to 19, wherein the patient-specific intervertebral fixation device is configured to provide patient-specific correction to the patient's spine when implanted in the patient. 21. The device of any of Examples 12-20, wherein the patient-specific intervertebral fixation device is an ALIF device. 22. A spinal implant comprising: 1. A patient-specific interbody spacer having a unitary unitary spacer body, comprising: a first surface configured to contact a first endplate of a first vertebra of the patient; a second surface configured to contact a second endplate of a second vertebra of the patient; and A side wall; a first anchor channel extending from the sidewall to the first surface, a contoured portion of the first surface surrounding an exit aperture of the first anchor channel, the contoured portion having an irregular contour configured to match a contour of a contoured portion of the first endplate; a patient-specific interbody spacer comprising: a first screw configured to extend through the first anchor channel, out the exit aperture, and into the first vertebra, the first screw configured to fixably hold the contoured portion against the contoured portion of the first endplate; Equipped with Spinal implants. 23. The spinal implant of Example 22, wherein the contoured portion comprises layers of material defining an endplate contact surface on the first side, and the layers of material are fused, melted, and / or bonded together. 24. The first anchor channel includes a tubular sidewall defining a continuous surface extending from an entrance opening in the sidewall to the exit aperture; the unitary unitary spacer body having a dense load-bearing portion and a porous portion connecting the tubular sidewall to the dense load-bearing portion; the high-density load-bearing portion is configured to bear a majority of the load exerted by the subject's spine when the subject is standing upright; The spinal implant of Example 22 or Example 23. 25. The spinal implant of Example 24, wherein the mass of the high-density load-bearing portion is a majority of the total mass of the single unitary spacer body. 26. The unitary unitary spacer body further includes a second anchor channel extending from the sidewall to the second surface; the spinal implant further includes a retention mechanism rotatably coupled to the unitary unitary spacer body and rotatable between an unlocked position that allows the first screw to be inserted into the first anchor channel and a second screw to be inserted into the second anchor channel, and a locked position that capturably retains the first and second screws in the first and second anchor channels, respectively. A spinal implant according to any one of Examples 22 to 25. 27. A spinal implant according to any of Examples 22-26, wherein the unitary unitary spacer body is asymmetric with respect to the midsagittal plane of the unitary unitary spacer and asymmetric with respect to the transverse plane of the unitary unitary spacer. 28. A manufacturing method comprising: obtaining a virtual model of a patient-specific interbody spacer configured to be implanted between adjacent vertebrae of the patient; generating additive manufacturing instructions based on the virtual model; and applying sequential layers of material using a manufacturing machine that executes the additive manufacturing instructions; at least a portion of a unitary, unitary spacer body of the patient-specific interbody spacer; a retention mechanism configured to be assembled with the single unitary spacer body, the retention mechanism being rotatable between a screw-insertion position and a screw-locking position; and forming A method comprising: 29. The method of claim 28, further comprising designing the retention mechanism based on the design of the single unitary spacer body. 30. The method of example 28 or example 29, further comprising designing the retention mechanism using a virtual model of the single unitary spacer body positioned along a virtual model of the adjacent vertebrae. 31. Determining an orientation of the patient-specific interbody spacer to be manufactured with respect to the orientation of the applied material layers; generating a plurality of tool paths for simultaneously forming sections of the unitary unitary spacer body and sections of the retention feature; The method of any of Examples 28 to 30, further comprising: 32. Determining a first set of tool paths for forming sections of the unitary unitary spacer body; determining a second set of tool paths for forming the one or more lock cams; Further comprising: A method according to any of Examples 28 to 31, wherein the first set of tool paths and the second set of tool paths are designed to be executed by a single additive manufacturing machine or multiple additive manufacturing machines. 33. A method according to any of Examples 28 to 32, further comprising determining a manufacturing direction for the patient-specific interbody spacer based on one or more potential tool paths for manufacturing one or more load-bearing surfaces of the patient-specific interbody spacer. 34. The method of any of Examples 28-33, further comprising forming the non-planar load-bearing surface of the unitary unitary spacer body layer by layer. 35. Slicing the virtual model; generating an additive manufacturing path plan for the manufacturing machine to apply the material layer based on the slices; The method of any of Examples 28 to 34, further comprising: 36. Designing one or more porous regions of the patient-specific interbody spacer; designing one or more non-porous portions of the patient-specific interbody spacer; analyzing the one or more porous regions and the one or more non-porous regions to generate additive manufacturing instructions; The method of any of Examples 28 to 35, further comprising: 37. Establishing a coordinate system; positioning the virtual model using the coordinate system; determining a tool path for the manufacturing machine to apply material layers of the virtual model positioned using the coordinate system; The method of any of Examples 28 to 36, further comprising: 38. A patient-specific interbody spacer manufactured by a process comprising: The above process is obtaining a virtual model of a patient-specific interbody spacer configured to be implanted between adjacent vertebrae of the patient; generating additive manufacturing instructions based on the virtual model; Using a manufacturing machine that executes additive manufacturing instructions, layers of material are applied sequentially to at least a portion of a unitary, unitary spacer body of the patient-specific interbody spacer; a retention mechanism configured to be assembled with the single unitary spacer body, the retention mechanism being rotatable between a screw-insertion position and a screw-locking position; and forming manufacturing a unitary unitary spacer body and a portion of said retention mechanism; Including, Patient-specific interbody spacers. 39. The patient-specific interbody spacer of Example 38, wherein the patient-specific interbody spacer comprises a layer-by-layer microstructure.

[0151] G. Conclusion As will be appreciated by those skilled in the art, any of the software modules described above can be combined into a single software module for performing the operations described herein. Similarly, the software modules can be distributed across any combination of computer systems and devices described herein and are not limited to the explicit arrangements described herein. Thus, any of the operations described herein can be performed by any of the computer devices or systems described herein, unless expressly stated otherwise.

[0152] The foregoing detailed description describes various embodiments of devices and / or processes through the use of block diagrams, flowcharts, and / or examples. To the extent that such block diagrams, flowcharts, and / or examples include one or more functions and / or operations, those skilled in the art will appreciate that each function and / or operation within such block diagrams, flowcharts, or examples can be individually and / or collectively implemented by a wide range of hardware, software, firmware, or substantially any combination thereof. In some embodiments, portions of the subject matter described herein can be implemented via an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a digital signal processor (DSP), or other integrated form. However, it will be within the skill of one of ordinary skill in the art in light of this disclosure to design circuitry and / or write software and / or firmware code such that certain aspects of the embodiments disclosed herein, in whole or in part, are implemented in an integrated circuit, 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 substantially any combination thereof. Furthermore, one of ordinary skill in the art will understand that the subject matter mechanisms described herein can be distributed as a program product in various forms, and that the exemplary embodiments of the subject matter described herein apply regardless of the particular type of signal-bearing medium used to actually effect the distribution. Examples of signal bearing media include, but are not limited to, recordable media such as floppy disks, hard disk drives, CDs, DVDs, digital tape, computer memory, and transmission media such as digital and / or analog communications media (e.g., fiber optic cables, wave guides, wired communications links, wireless communications links, etc.).

[0153] Those skilled in the art will recognize that it is common in the art to describe devices and / or processes in the manner set forth herein and then use engineering techniques to integrate such described devices and / or processes into a data processing system. That is, at least a portion of the devices and / or processes described herein can be integrated into a data processing system through a reasonable amount of experimentation. Those skilled in the art will recognize that a typical data processing system generally includes one or more of the following: a system unit housing; a video display device; memory, such as volatile and non-volatile memory; a processor, such as a microprocessor and a digital signal processor; computational entities, such as an operating system, drivers, a graphical user interface, and application programs; one or more interaction devices, such as a touchpad or screen; and / or a control system, 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 can be implemented utilizing any suitable commercially available components, such as those typically found in data computing / communication and / or network computing / communication systems.

[0154] The subject matter described herein sometimes depicts different components contained within or connected to different other components. It should be understood that such depicted architectures are merely examples, and that in fact, many other architectures that achieve the same functionality may be implemented. In a conceptual sense, an arrangement of components to achieve the same functionality is substantially “associated” such that the desired functionality is achieved. Accordingly, for the purposes of this specification, any two components that combine to achieve a particular function may be considered to be “associated” with one another such that the desired functionality is achieved, regardless of the architecture or intermediate components. Similarly, any two components so associated may also be considered to be “operably connected” or “operably coupled” to one another to achieve the desired functionality, and any two components so associated may also be considered to be “operably coupleable” to one another to achieve the desired functionality. Specific examples of operably coupleable include, but are not limited to, components that are physically matable and / or physically interactable, components that are wirelessly interactable and / or wirelessly interactable, and / or components that are logically interactable and / or logically interactable.

[0155] The embodiments, features, systems, devices, materials, methods, and techniques described herein can, in some embodiments, be similar to any one or more of the embodiments, features, systems, devices, materials, methods, and techniques described below. U.S. Patent Application No. 16 / 048,167, filed July 27, 2017, entitled "Systems and Methods for Assisting and Augmenting Surgical Procedures" U.S. Patent Application No. 16 / 242,877, filed January 8, 2019, entitled "System and Method for Assisting Surgeons with Screw Placement During Spinal Surgery" U.S. Patent Application No. 16 / 207,116, filed December 1, 2018, entitled "System and Method for Multiplanar Orthopedic Alignment" U.S. Patent Application No. 16 / 352,699, filed March 13, 2019, entitled "Systems and Methods for Orthopedic Implant Fixation" U.S. Patent Application No. 16 / 383,215, filed April 12, 2019, entitled "Systems and Methods for Orthopedic Implant Fixation" U.S. Patent Application No. 16 / 569,494, filed September 12, 2019, entitled "Systems and Methods for Orthopedic Implants" U.S. Application No. 16 / 699,447, filed November 29, 2019, entitled "Systems and Methods for Orthopedic Implants" and U.S. Application No. 16 / 735,222, filed January 6, 2020, entitled "Patient-Specific Medical Procedures and Devices, and Related Systems and Methods" U.S. Application No. 16 / 987,113, filed August 6, 2020, entitled "Patient-Specific Artificial Discs, Implants, and Related Systems and Methods" U.S. Patent Application No. 16 / 990,810, filed August 11, 2020, entitled "Linking Patient-Specific Medical Devices with Patient-Specific Data, and Related Systems and Methods" U.S. Patent Application No. 17 / 085,564, filed October 30, 2020, entitled "System and Method for Designing Orthopedic Implants Based on Tissue Properties" U.S. Patent Application No. 17 / 100,396, filed November 20, 2020, entitled "Patient-Specific Vertebral Implant with Positioning Features" U.S. Application No. 17 / 342,439, filed June 8, 2021, entitled "Patient-Specific Medical Procedures and Devices, and Related Systems and Methods" U.S. Application No. 17 / 463,054, filed August 31, 2021, entitled "Blockchain-Managed Medical Implant" U.S. Application No. 17 / 518,524, filed November 3, 2021, entitled "Patient-Specific Arthroplasty Devices and Related Systems and Methods" U.S. Application No. 17 / 531,417, filed November 19, 2021, entitled "Patient-Specific Fixture for Personalized Surgery" U.S. Application No. 17 / 678,874, filed February 23, 2022, entitled "Non-Fungible Token System and Method for Storing and Accessing Healthcare Data" U.S. Application No. 17 / 835,777, filed June 8, 2022, entitled "Patient-Specific Expandable Interbody Implant" U.S. Application No. 17 / 842,242, filed June 16, 2022, entitled "Patient-Specific Posterior Plate Implant" U.S. Application No. 17 / 851,487, filed June 28, 2022, entitled "Patient-Specific Adjustment of Spinal Implants, and Related Systems and Methods" U.S. Application No. 17 / 856,625, filed July 1, 2022, entitled "Spinal Implant for Mesh Network" U.S. Application No. 17 / 867,621, filed July 18, 2022, entitled "Patient-Specific Sacral Implants, and Systems and Methods Thereof" U.S. Application No. 17 / 868,729, filed July 19, 2022, entitled "System for predicting intraoperative patient mobility and system for identifying surgical steps related to mobility" U.S. Application No. 17 / 951,085, filed September 22, 2022, entitled "Patient-Specific Implant Manufacturing and Pre-Operative Testing System" U.S. Application No. 17 / 978,673, filed November 1, 2022, entitled "Spinal Implants and Surgical Procedures with Reduced Subsidence, and Implanted Systems and Methods" U.S. Application No. 17 / 978,746, filed November 1, 2022, entitled "Patient-Specific Spinal Instrumentation for Implants and Weight Loss Surgery" U.S. Application No. 18 / 102,444, filed January 27, 2023, entitled "Technique for mapping three-dimensional human anatomical data onto two-dimensional human anatomical data" U.S. Application No. 18 / 113,573, filed February 24, 2023, entitled "Patient-Specific Implant Design and Manufacturing System with Digital Filing Cabinet" U.S. Application No. 18 / 120,979, filed March 13, 2023, entitled "Multi-Stage Patient-Specific Surgical Plans, and Systems and Methods for Creating and Implementing the Same" U.S. Application No. 18 / 455,881, filed August 25, 2023, entitled "System and Method for Creating Multiple Patient-Specific Surgical Plans and Manufacturing Patient-Specific Implants" U.S. Application No. 18 / 384,762, filed October 28, 2023, entitled "Systems and Methods for Selecting, Reviewing, Modifying, and / or Approving Surgical Plans" U.S. Application No. 18 / 537,600, filed December 12, 2023, entitled "Patient-Specific Implant Design and Manufacturing System with Regulatory Reimbursement Manager" U.S. Application No. 63 / 437,966, filed January 9, 2023, entitled "System for Edge Case Pathology Identification and Implant Manufacturing" U.S. Application No. 63 / 437,975, filed January 9, 2023, entitled "System for Modeling Patient Spinal Changes" U.S. Application No. 63 / 522,815, filed June 23, 2023, entitled "Systems and Methods for Diagnosing Spinal Conditions and Determining Treatment Therefor" U.S. Application No. 63 / 530,427, filed August 2, 2023, entitled "Medical Device Insertion Tool with Retractable Coupling Element and Method of Use" U.S. Application No. 63 / 542,264, filed October 3, 2023, entitled "Patient-Specific Surgical Positioning Guide and Methods of Making and Using the Same" is.

[0156] All of the above-identified patents and applications are incorporated by reference in their entirety. Additionally, the embodiments, features, systems, devices, materials, methods, and techniques described herein may be applied to or used in connection with any one or more of the embodiments, features, systems, devices, or other items in particular embodiments.

[0157] Ranges disclosed herein also encompass any and all overlapping portions, subranges, and combinations thereof. Expressions such as "up to," "at least," "greater than," "less than," "between," or similar terms include the recited number. As used herein, numbers preceded by terms such as "approximately," "about," and "substantially" are inclusive of the recited number (e.g., about 10% = 10%) and also represent an amount close to the recited amount that still performs the desired function or achieves the desired result. For example, the terms "approximately," "about," and "substantially" can refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the recited amount.

[0158] From the foregoing, it will be understood that various embodiments of the present disclosure have been described herein for purposes of illustration, and that various modifications may be made without departing from the scope and spirit of the present disclosure. Accordingly, the various embodiments disclosed herein are not intended to be limiting. [Explanation of symbols]

[0159] 400 Patient-Specific Intervertebral Fusion Devices 402 Interbody Implants 450a, 450b, 450c Fixing Elements

Claims

1. 1. A patient-specific intervertebral fixation device comprising:

1. An interbody implant configured to be positioned between a superior vertebral body and an inferior vertebral body, comprising: an upper surface configured to contact an inferior surface of the superior vertebral body; a lower surface configured to contact a superior surface of the inferior vertebral body; The front and the interbody implant comprising: a first lumen extending through the implant between a first aperture on the anterior surface and a second aperture on the superior surface, the first lumen configured to receive a first fixation element for fixing the implant to the superior vertebral body; a second lumen extending through the implant between a third aperture on the anterior surface and a fourth aperture on the inferior surface, the second lumen configured to receive a second fixation element for fixing the implant to the inferior vertebral body; a rotatable retention mechanism configured to retain the first fixation element and the second fixation element to the implant, a head defining one or more drive features for rotating the retention mechanism; a shaft extending from the head into the implant; a ridge extending partially around the circumference of the shaft; the rotatable retention mechanism including: a retention mechanism lumen configured to receive the shaft and including a channel extending partially around the circumference of the lumen for receiving the ridge; Equipped with the rotatable retention mechanism is rotatable between (i) an unlocked configuration in which the head does not block the first aperture and the second aperture, and (ii) a locked configuration in which the head at least partially covers the first aperture and the second aperture, and a degree of rotation between the unlocked configuration and the locked configuration is determined at least in part based on the ridge and the channel. Patient-specific intervertebral fusion devices.

2. 2. The device of claim 1, wherein the ridge has a first circumferential length and the channel has a second circumferential length greater than the first circumferential length such that the ridge can rotate within the channel.

3. The device of claim 2 , wherein a difference between the first circumferential length and the second circumferential length defines the degree of rotation between the unlocked configuration and the locked configuration.

4. 2. The device of claim 1, wherein the ridge extends about 90 degrees to about 270 degrees of the circumference of the shaft and the channel extends between about 180 degrees to about 325 degrees of the circumference of the retention feature lumen.

5. The device of claim 1 , wherein the ridge extends about 180 degrees of the circumference of the shaft and the channel extends about 270 degrees of the circumference of the retention feature lumen.

6. The device of claim 5 , wherein the shaft is configured to rotate approximately 90 degrees between the unlocked and locked configurations.

7. the ridge extends between a first surface and a second surface, the channel extends between a first channel wall and a second channel wall, the first surface is adjacent to the first channel wall when the retention mechanism is in the unlocked configuration, and the second surface is adjacent to the second channel wall when the retention mechanism is in the locked configuration. The device of claim 1 .

8. the first channel wall permits the retention mechanism to rotate only in a first direction when the retention mechanism is in the unlocked position; the second channel wall permits the retention mechanism to rotate only in a second direction when the retention mechanism is in the locked position; the first direction is opposite to the second direction; The device of claim 7.

9. The device of claim 1 , wherein the ridge has a height between about 20% and about 80% of the diameter of the shaft.

10. The device of claim 1 , wherein the patient-specific intervertebral fusion device is configured to provide a patient-specific correction to the patient's spine when implanted in the patient.

11. The device of claim 1 , wherein the patient-specific intervertebral fusion device is an ALIF device.

12. 1. A patient-specific intervertebral fixation device comprising:

1. An interbody implant configured to be positioned between a superior vertebral body and an inferior vertebral body, comprising: an upper surface configured to contact an inferior surface of the superior vertebral body; a lower surface configured to contact a superior surface of the inferior vertebral body; The front and the interbody implant comprising: a first lumen extending through the implant between a first aperture on the anterior surface and a second aperture on the superior surface, the first lumen configured to receive a first fixation element for fixing the implant to the superior vertebral body; a second lumen extending through the implant between a third aperture on the anterior surface and a fourth aperture on the inferior surface, the second lumen configured to receive a second fixation element for fixing the implant to the inferior vertebral body; a rotatable retention mechanism configured to retain the first fixation element and the second fixation element to the implant, a head defining one or more drive features for rotating the retention mechanism; a shaft extending from the head to the implant, the shaft including a protrusion extending transversely to a longitudinal direction of the shaft; the retention mechanism including: a retention mechanism lumen configured to receive the shaft, the retention mechanism lumen including at least a first groove and a second groove; Equipped with the rotatable retention mechanism is rotatable between (i) an unlocked configuration in which the head does not block the first aperture and the second aperture and the protrusion is in the first groove, and (ii) a locked configuration in which the head at least partially covers the first aperture and the second aperture and the protrusion is in the second groove. Patient-specific intervertebral fusion devices.

13. 13. The device of claim 12, wherein the protrusion is configured to at least partially limit rotational movement of the retention feature when the protrusion is in the first groove or the second groove.

14. 13. The device of claim 12, wherein the unlocked configuration and the locked configuration are relatively low energy states, and the device is configured such that transitioning the retention mechanism between the unlocked and locked configurations includes passing the retention mechanism through a relatively high energy state.

15. 13. The device of claim 12, wherein the retention mechanism lumen includes a third groove, the rotatable retention mechanism is rotatable through an intermediate configuration between the unlocked configuration and the locked configuration, and the protrusion is within the third groove when the retention mechanism is in the intermediate configuration.

16. The device of claim 12 , wherein the shaft includes at least two prongs at least partially separated by a gap.

17. The device of claim 16 , wherein the protrusion is formed on at least one of the two prongs.

18. The device of claim 16 , wherein each of the at least two prongs includes a projection.

19. The device of claim 16 , wherein the at least two prongs include a back surface configured to abut a shoulder in the retention mechanism lumen.

20. The device of claim 12 , wherein the patient-specific intervertebral fusion device is configured to provide a patient-specific correction to the patient's spine when implanted in the patient.

21. The device of claim 12 , wherein the patient-specific intervertebral fusion device is an ALIF device.

22. 1. A spinal implant comprising:

1. A patient-specific interbody spacer having a unitary unitary spacer body, comprising: a first surface configured to contact a first endplate of a first vertebra of the patient; a second surface configured to contact a second endplate of a second vertebra of the patient; A side wall; a first anchor channel extending from the sidewall to the first surface, a contoured portion of the first surface surrounding an exit aperture of the first anchor channel, the contoured portion having an irregular contour configured to match a contoured region of the first endplate; the patient-specific interbody spacer, a first screw configured to extend through the first anchor channel, out the exit aperture, and into the first vertebra, thereby fixably holding the contoured portion against the contoured region of the first endplate; Equipped with Spinal implants.

23. 23. The spinal implant of claim 22, wherein the contoured portion comprises layers of material defining an endplate contact surface on the first side, the layers of material being fused, melted, and / or bonded together.

24. the first anchor channel includes a tubular sidewall defining a continuous surface extending from an entrance opening in the sidewall to the exit aperture; the unitary unitary spacer body having a dense load-bearing portion and a porous portion connecting the tubular sidewall to the dense load-bearing portion; the high-density load-bearing portion is configured to bear a majority of the load exerted by the subject's spine when the subject is standing upright; 23. The spinal implant of claim 22.

25. 25. The spinal implant of claim 24, wherein the mass of the high density load bearing portion is a majority of the total mass of the unitary unitary spacer body.

26. the single unitary spacer body further includes a second anchor channel extending from the sidewall to the second surface; the spinal implant further includes a retention mechanism rotatably coupled to the unitary unitary spacer body and rotatable between an unlocked position that allows the first screw to be inserted into the first anchor channel and a second screw to be inserted into the second anchor channel, and a locked position that constrains and retains the first and second screws in the first and second anchor channels, respectively.

23. The spinal implant of claim 22.

27. 23. The spinal implant of claim 22, wherein the unitary unitary spacer body is asymmetrical relative to a midsagittal plane of the unitary unitary spacer and asymmetrical relative to a transverse plane of the unitary unitary spacer.

28. A manufacturing method comprising: obtaining a virtual model of a patient-specific interbody spacer configured to be implanted between adjacent vertebrae of the patient; generating additive manufacturing instructions based on the virtual model; and applying the layers of material sequentially using a manufacturing machine that executes the additive manufacturing instructions; at least a portion of a unitary, unitary spacer body of the patient-specific interbody spacer; a retention mechanism configured to be assembled with the unitary unitary spacer body, the retention mechanism being rotatable between a screw-insertion position and a screw-lock position; and forming A method comprising:

29. 30. The method of claim 28, further comprising designing the retention feature based on a design of the single unitary spacer body.

30. 30. The method of claim 28, further comprising designing the retention mechanism using a virtual model of the unitary unitary spacer body positioned along virtual models of the adjacent vertebrae.

31. determining an orientation of the patient-specific interbody spacer to be manufactured relative to an orientation of the applied layers of material; generating a plurality of tool paths for simultaneously forming sections of the unitary unitary spacer body and sections of the retention feature; 30. The method of claim 28, further comprising:

32. determining a first set of tool paths for forming sections of the unitary unitary spacer body; determining a second set of tool paths for forming the one or more lock cams; Further comprising:

30. The method of claim 28, wherein the first and second sets of toolpaths are designed to be executed by a single additive manufacturing machine or by multiple additive manufacturing machines.

33. 30. The method of claim 28, further comprising determining a manufacturing direction for the patient-specific interbody spacer based on one or more potential tool paths for manufacturing one or more load-bearing surfaces of the patient-specific interbody spacer.

34. 30. The method of claim 28, further comprising forming the non-planar load bearing surface of the unitary unitary spacer body layer by layer.

35. slicing the virtual model; generating an additive manufacturing path plan for the manufacturing machine to apply the material layer based on the slices; 30. The method of claim 28, further comprising:

36. designing one or more porous regions of the patient-specific interbody spacer; designing one or more non-porous portions of the patient-specific interbody spacer; analyzing the one or more porous regions and the one or more non-porous regions to generate additive manufacturing instructions; 30. The method of claim 28, further comprising:

37. Establishing a coordinate system; positioning the virtual model using the coordinate system; determining a tool path for the manufacturing machine to apply the material layer of the virtual model positioned using the coordinate system; 30. The method of claim 28, further comprising:

38. 1. A patient-specific interbody spacer manufactured by a process comprising: The process comprises: obtaining a virtual model of a patient-specific interbody spacer configured to be implanted between adjacent vertebrae of the patient; generating additive manufacturing instructions based on the virtual model; applying the layers of material sequentially using a manufacturing machine that executes the additive manufacturing instructions; at least a portion of a unitary, unitary spacer body of the patient-specific interbody spacer; a retention mechanism configured to be assembled with the unitary unitary spacer body, the retention mechanism being rotatable between a screw-insertion position and a screw-lock position; and forming manufacturing said portion and said retention feature in a single unitary spacer body; Including, Patient-specific interbody spacers.

39. 39. The patient-specific interbody spacer of claim 38, wherein the patient-specific interbody spacer comprises a layer-by-layer microstructure.

Images