JP2023538543A - Linking patient-specific medical devices with patient-specific data and related systems and methods - Google Patents

Abstract

Systems and methods for providing patient-specific medical devices and patient-specific surgical plans are described herein. Some embodiments provide patient-specific implants that include an implant body configured to interface with one or more identified anatomical structures at and/or near a target location. The patient-specific implant also includes a data storage element positioned on and/or within the implant body. The data storage element may include memory for storing data that is accessible after the patient-specific implant is implanted in the patient. The data includes (i) first data specifying at least one stage of a patient-specific surgical plan for implanting a patient-specific implant at a target location; and (ii) specifying one or more characteristics of the patient-specific implant. and second data. [Selection diagram] Figure 4

Description

[Cross reference to related applications]
This application is based on U.S. Nonprovisional Patent Application No. 16/990,810, filed August 11, 2020, and US Pat. Claims priority to U.S. Provisional Patent Application No. 63/188,945.

TECHNICAL FIELD The present disclosure relates generally to designing and implementing medical care, and more specifically, to systems and methods for designing and implementing patient-specific surgical procedures and/or medical devices.

Orthopedic implants are used in 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. It is used to correct many different adverse effects in a variety of contexts, including , and orthopedic trauma. Spinal surgery itself may involve a variety of procedures and targets such as one or more of the cervical, thoracic, lumbar, or sacral vertebrae, and spinal deformity or degeneration and/or associated back pain. It can be performed to treat leg pain, or other body pain. Common spinal deformities that can be treated with orthopedic implants are irregular spinal curvatures, such as scoliosis, lordosis, or kyphosis (high or low), and irregular spinal dislocations (e.g. spondylolisthesis). Other spinal disorders that can be treated using orthopedic implants include osteoarthritis, lumbar or cervical disc disease, lumbar spinal stenosis, and cervical spinal stenosis.

U.S. Patent Application No. 16/987,113 U.S. Patent Application No. 16/735,222 U.S. Patent Application No. 17/342,439 U.S. Patent Application No. 16/207,116 U.S. Patent Application No. 16/990,801 U.S. Patent Application No. 16/048,167 U.S. Patent Application No. 16/242,877 U.S. Patent Application No. 16/352,699 U.S. Patent Application No. 16/383,215 U.S. Patent Application No. 16/569,494 U.S. Patent Application No. 16/699,447 U.S. Patent Application No. 17/085,564 U.S. Patent Application No. 17/100,396

The accompanying drawings illustrate various embodiments of systems, methods, and devices and other aspects of the present disclosure. Those skilled in the art will recognize that the element boundaries (eg, boxes, groups of boxes, or other shapes) shown in these figures represent one example of a boundary. It is contemplated that in some examples, one element may be designed as multiple elements, or multiple elements may be designed as one element. In some examples, elements shown as internal components of one element may be implemented as external components of another element, and vice versa. 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 the principles.

1 is a network connectivity diagram illustrating a system for providing patient-specific medical care and configured in accordance with selected embodiments of the present technology; FIG. 2 is a diagram illustrating a computing device suitable for use with the system of FIG. 1 in accordance with selected embodiments of the present technique; FIG. 1 is a schematic diagram of a patient-specific implant enclosed within packaging and having a search feature for accessing remotely stored patient-specific data, in accordance with an embodiment of the present technology; FIG. 1 is a schematic illustration of a patient-specific implant enclosed within packaging and having a data storage element for storing patient-specific data, according to an embodiment of the present technology; FIG. 1 is a schematic diagram of a patient-specific implant with patient-specific markings according to an embodiment of the present technology; FIG. 2 is a flowchart of a method for verifying that the actual position of an implanted patient-specific implant is the same as a predetermined target position, according to an embodiment of the present technique. 1 is a partial schematic diagram of an operating environment for accessing a patient-specific surgical plan and implanting a patient-specific implant into a patient according to an embodiment of the present technology; FIG. 2 is a partial schematic diagram for obtaining patient-specific information from a patient-specific implant prior to an actuation procedure according to an embodiment of the present technique; FIG. 2 is a partial schematic diagram for obtaining patient-specific information from a patient-specific implant during an operational procedure according to an embodiment of the present technique; FIG. 2 is a partial schematic diagram for obtaining patient-specific information from a patient-specific implant after an actuation procedure according to an embodiment of the present technique; FIG.

The present technology relates to systems and methods for providing patient-specific medical devices, instruments, and surgical plans. For example, in many embodiments, the techniques of the present invention provide patient-specific implants designed to be implanted at a target location within a particular patient. In some embodiments, the techniques of the present invention also include patient-specific instruments and/or patient-specific surgical plans that can be used to deliver the implant. For example, a patient-specific surgical plan can include instructions for implanting an implant at a target location. To link the surgical plan to the implant, the implant and/or its associated packaging may include at least one of a data storage element or a search feature. The data storage element may include memory for storing surgical plans and other patient-specific data. The search feature can be associated with surgical plans and other patient-specific data, and can be used to download or otherwise access a portion or the entire surgical plan and other data that may be stored on a remote server. can be used. In some embodiments, the implant also includes one or more markings, identifiers, and/or indicia (e.g., physical markings, digital markings, codes) in addition to or in place of the data storage elements and search features. markings, etc.). These markings can be positioned on, in, or coupled to the body of the implant and can include information related to the patient, the implant, and/or a patient-specific surgical plan. These markings thus allow the user to identify information related to the patient, the implant, and/or the patient-specific surgical plan.

In some embodiments, the techniques of the present invention include a system that can design a patient-specific implant suitable for implantation at a target location within a particular patient. A treatment planning module (eg, treatment planning module 118 of FIG. 1) may analyze images of the patient to identify anatomical structures at or around target locations suitable for engagement with the implant. The anatomy can be selected based on one or more corrections, target anatomical spacing (eg, intervertebral spacing between vertebral bodies), joint characteristics, target kinematics, or the like. The treatment planning module may use previous patient data sets to identify, select, and/or design features of the implant body. For example, the treatment planning module can identify design features from a pool of candidate features, such as parametric features, dimensions, structural features, and the like. The implant body can then be designed to provide the desired fit within the patient. The virtual model can be used to analyze a custom implant and evaluate how the structural features of the implant engage identified anatomical structures. The designer may adjust the implant body design, eliminate structural features of the implant body, or add additional features to the implant design. Data regarding the implant design and design process, as well as implant data, may be stored by the implant itself. For example, if the implant is an artificial disc, the data stored may include dynamic data (e.g., preoperative patient data, target dynamic data, etc.), manufacturing data, design parameters, target service life data, physician May include recommendations/medical certificates. The artificial disc may include an articulating implant body having discs contoured to match the vertebral endplates, custom articulating members between these discs to allow patient-specific motion, and the like. If the implant is an intervertebral cage, the stored data may include implant body material specifications, implant body dimensions, manufacturing data, design parameters, target service life data, physician recommendations/medical certificates, etc. After implantation, the physician can assess the compression of the current dimensions of the implant body by comparing it to the original implant dimensions stored by the implant.

In some embodiments, the techniques of the present invention relate to providing patient-specific techniques that are suitable for a particular patient. This technology can include custom implants designed to be suitable for delivery and implantation at a target site. Custom implants can be patient-specific implants designed based on anatomical features at or adjacent the implantation site. In some implementations, the implant is designed to include structural features suitable for contacting the identified anatomical features to improve treatment, reduce implant migration, etc. be able to. The structural feature can be a rigid surface (eg, an outer surface of the implant body), an anchor, an anchoring feature, or the like. Images of the implant site can be analyzed to identify these anatomical features. Because the implant has a custom configuration, standard implantation procedures may be suboptimal. Accordingly, a patient-specific surgical plan can be generated to provide an optimal implantation procedure.

In some implementations, the implant can provide or provide access to a patient-specific surgical plan to avoid human error, miscommunication of the plan. For example, the implant may contain implant information (e.g., lot number, material composition, manufacturing identification, etc.), patient information (e.g., patient name, date of birth, etc.), or treatment information (e.g., target implantation location suitable for the implant, surgical access, etc.). patient-specific markings that provide information such as route information, etc.). This marking can indicate that the implant has a data storage element and can provide information for accessing the stored information. Accordingly, in some embodiments, the implant includes a storage element having a memory capable of storing planning data that is retrievable by a physician, a robotic surgical system, or the like. In such embodiments, the robotic surgical system can retrieve the surgical plan and develop appropriate patient-specific implantation procedures to simplify implant delivery. This avoids the risk of operator error when planning a surgery or manually entering data into the robotic surgical system. After implantation (months or years after surgery), a physician may wish to obtain information related to the custom implant that is not contained within the patient's medical record. Using the reader or interrogator, the physician can then non-invasively obtain implant data (eg, implant dimensions, manufacturer, ID, etc.) from markings and/or storage elements within the patient. The storage element can be configured to permanently store data while remaining within the patient. Physicians can use this implant data when evaluating patients and developing additional treatment plans. If the data in the storage element is incomplete or inaccurate, the data can be rewritten, modified, or erased.

In some embodiments, the techniques of the present invention thus provide patient-specific implants designed to be implanted at a target location within a particular patient. The patient-specific implant includes an implant body configured to interface with one or more identified anatomical structures at and/or near the target location. The patient-specific implant further includes a data storage element positioned thereon and/or within. The data storage element may include memory for storing data that is accessible after the patient-specific implant has been implanted in the patient. The data includes (i) first data specifying at least one stage of a patient-specific surgical plan for implanting a patient-specific implant at a target location; and (ii) specifying one or more characteristics of the patient-specific implant. and second data.

In some embodiments, the techniques of the present invention provide patient-specific implants designed to be implanted at a target location within a particular patient. The patient-specific implant includes an implant body configured to interface with one or more identified anatomical structures at and/or near the target location. The patient-specific implant further includes a search feature positioned on and/or within the implant body. The search feature accesses (i) first data associated with a patient-specific surgical plan for implanting the patient-specific implant at the target location; and (ii) second data associated with the patient-specific implant. It can be used for. For example, the first data and the second data may be stored on a server and a search feature may be used to download or otherwise access the first data and the second data from the server. It is possible.

In some embodiments, the techniques of the present invention provide patient-specific implant designs that are implanted at target locations within a particular patient. The implant includes an implant body configured to interface with one or more identified anatomical structures at and/or near the target location. Additionally, the implant includes patient-specific markings or identifiers positioned on or within the implant body. The patient-specific marking or identifier includes: (i) first data associated with one or more elements of a patient-specific surgical plan for implanting a patient-specific implant at a target location; and (ii) associated with the patient-specific implant. and/or (iii) third data associated with the patient. For example, the first data, the second data, and/or the third data can be placed directly on the implant body such that the patient-specific markings can be read directly from the implant body.

In some embodiments, the present technology provides a kit with a patient-specific implant enclosed within packaging. Packaging for patient-specific implants can include data storage elements and/or search features. A data storage element confined within the packaging stores (i) first data associated with a patient-specific surgical plan for implanting a patient-specific implant at a target location; and (ii) first data associated with the patient-specific implant. 2 data. A search feature encapsulated within or otherwise imprinted upon the packaging includes (i) first data associated with a patient-specific surgical plan for implanting a patient-specific implant at a target location; and (ii) ) can be used to access second data associated with the patient-specific implant. For example, the first data and the second data may be stored on a server and a search feature may be used to download or otherwise access the first data and the second data from the server. It is possible.

In some embodiments, the techniques of the present invention include a patient-specific implant designed to be implanted at a target location within a particular patient and a patient-specific surgical plan that includes instructions for implanting the patient-specific implant at the target location. Provide a system that includes The system can further include means for transmitting the patient-specific surgical plan to a surgical platform configured to perform one or more aspects thereof. For example, if the patient-specific surgical plan is stored locally, such as on a data storage element, the system can include a transmitter for transmitting the surgical plan to the surgical platform. In some embodiments, the transmitter is an antenna or one or more proximity sensors, or the like. If the patient-specific surgical plan is stored remotely, the system may include one or more search features for downloading or otherwise accessing the remotely stored surgical plan. Once downloaded, the surgical plan can be sent to the surgical platform. In some embodiments, the surgical platform can be a robotic surgical platform configured to perform or otherwise assist in one or more aspects of surgical planning.

In some embodiments, the techniques of the present invention provide methods of providing patient-specific medical care associated with implanted patient-specific implants. The method can include obtaining patient-specific data from the implanted patient-specific implant. The patient-specific data may include an optimal implant location for a predetermined patient-specific implant based on the patient's anatomy and/or medical condition. The method may further include obtaining the actual location of the patient-specific implant by using one or more imaging techniques. Determining whether the actual location is the same as the predetermined optimal implantation location, thereby comparing the actual location with the predetermined optimal implantation location to provide optimal benefit to the patient. can.

Embodiments of the present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which like numerals represent like elements throughout the several figures, and in which illustrative embodiments are shown. However, the claimed embodiments can be embodied in many different forms and should not be construed as limited to the embodiments herein. The examples herein are non-limiting and only a few examples among other possible examples.

The words "comprise," "having," "containing," and "including" and other forms thereof are intended to be equivalent in meaning, and in addition, any of the words is intended to be non-limiting in that the item or items preceding it are not intended to be an inclusive enumeration thereof or to be limited only to the item or items listed; .

As used in this specification and claims, "a," "an," and "the" include singular and plural references unless the context clearly dictates otherwise.

Although the disclosure herein describes systems and methods suitable for treatment planning in the context of orthopedic surgery, the techniques of the present invention may be useful for treatment planning in other fields (e.g., other types of surgical practice). Equally applicable to medical devices. Furthermore, although many embodiments herein depict systems and methods related to implantable devices, the techniques of the present invention are equally applicable to other types of medical devices (eg, non-implantable devices).

The headings provided herein are for convenience only and do not describe the scope or meaning of the claimed invention.

A. System for designing patient-specific implants and patient-specific surgical plans
FIG. 1 is a network diagram illustrating a computer system 100 configured in accordance with selected embodiments of the present technology for the purpose of providing patient-specific medical care. As described in more detail herein, the system 100 is configured to design patient-specific implants (also referred to herein as "implants" unless the context clearly indicates otherwise) and/or for a patient. is configured to design a patient-specific surgical plan (also referred to herein as a "surgical plan" unless the circumstances clearly indicate otherwise). For example, the system 100 can be used to treat trauma (e.g., fractures), cancer, deformity, degeneration, pain (e.g., back pain, leg pain), irregular spinal curvature (e.g., scoliosis, lordosis, kyphosis), such as irregular spinal dislocations (e.g., spondylolisthesis, lateral dislocation), osteoarthritis, lumbar degenerative disc disease, cervical degenerative disc disease, lumbar spinal stenosis, or cervical spinal stenosis, or combinations thereof. Implants and/or surgical plans suitable for patients suffering from orthopedic or spinal diseases or disorders can be generated. Surgical planning may include surgical information, surgical planning (e.g., surgical implantation procedures, implant target location and/or orientation, etc.), technical recommendations (e.g., device and/or instrumentation recommendations), and/or medical device design. can include. For example, a surgical plan may include at least one therapeutic procedure (e.g., a surgical procedure or intervention) and/or at least one medical device (e.g., an implantable medical device (also referred to herein as an "implant" or "implanted device") or implant delivery instruments).

In some embodiments, the system 100 provides implants and/or surgeries that are customized to suit a particular patient or group of patients, also referred to herein as "patient-specific" or "personalized" implant and surgical plans. Generate a plan. Patient-specific implants and/or patient-specific surgical plans can be designed and/or optimized to suit the patient's particular characteristics (eg, condition, anatomy, medical condition, condition, medical history). For example, implants can be designed and manufactured specifically for a particular patient, rather than being off-the-shelf devices. However, it should be appreciated that patient-specific implants and/or patient-specific surgical plans may include aspects that are not customized to suit a particular patient. For example, a patient-specific surgical plan may include one or more instructions, parts, steps, etc. that are non-patient-specific. Similarly, patient-specific implants can include one or more components that are non-patient-specific and/or can be used in conjunction with instruments or tools that are non-patient-specific. Personalized implant designs 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 implants, patient-specific instruments, non-patient-specific technology (e.g., standard instruments, devices, etc.), usage instructions, patient-specific surgical planning information, or a combination thereof. can include.

System 100 includes a computing device 102, which can be a user device such as a smart phone, mobile device, laptop, desktop, personal computer, tablet, phablet, or other such device known in the art. include. As discussed in more detail with reference to FIG. 2, computing device 102 includes one or more processors and instructions executable by the one or more processors to perform the methods described herein. and a memory for storing the information. Computing device 102 may be associated with a health care provider treating a patient. Although FIG. 1 depicts a single computing device 102, in alternative embodiments, computing device 102 may instead be implemented as a computing system including multiple computing devices, and thus, herein with reference to computing device 102, The described operations may alternatively be performed by the computer system and/or these multiple computer devices.

Computing device 102 is configured to accept a patient data set 108 associated with a patient being treated. Patient data set 108 may include data representing the patient's condition, anatomy, medical condition, symptoms, medical history, preferences, and/or any other information or parameters related to the patient. For example, patient data set 108 may include 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, patient information (e.g., patient identity, demographics, gender, age, height, weight, type of medical condition, occupation, activity level, organizational information, health assessment, comorbidities, health-related quality of life (HRQL)) , daily life reactions, diagnosis results, medication information, allergies, image 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/configurations, etc.), or future scheduled medical procedures (e.g., scheduled surgery date). In some embodiments, patient data set 108 includes patient identification information (e.g., number (ID), name, initials, etc.), age, gender, body mass index (BMI), lumbar lordosis, Cobb angle, pelvic Includes data representative of one or more of: morphological angle, disc height, connection flexibility, bone quality, rotational dislocation, and/or treatment level of the spinal column.

In some embodiments, computing device 102 may be configured to accept surgical team data set 110. Surgical team data set 110 may include data representing a surgical team that will perform a surgery on a patient. For example, surgical team dataset 110 may include surgical team preferences (e.g., preferred implantation technique, preferred implantation instruments/tools, etc.), surgical team history (e.g., past procedures performed by the surgical team), or outcome scores of past procedures performed by the surgical team. As used herein, the term "surgical team" can mean a group of health care practitioners or one or more individual surgeons working together in the operating room during an implantation procedure.

In some embodiments, computing device 102 may be configured to accept facility or provider data sets 112. Facility dataset 112 may include data representative of the facility where the patient's surgery will be performed. For example, facility data set 112 may include facility preferences (e.g., preferred implantation techniques, preferred implantation devices/tools, etc.), facility history (e.g., past procedures performed at the facility), the outcome scores of previous procedures performed, the infrastructure available to support/perform the surgery (e.g., the availability of a robotic surgical platform, and the type of input). As used herein, the term "facility" can mean a single operating room facility, a hospital with multiple operating rooms, and/or a hospital network.

Computing device 102 is operably connected to server 106 through communication network 104, thereby enabling data communication between computing device 102 and server 106. Communication network 104 may be a wired and/or wireless network. The communication network 104 may be wireless, such as Visible Light Communication (VLC), Worldwide Interoperability for Microwave Access (WiMAX), Long Term Evolution (LTE), Wireless Local Area Network (WLAN), or Infrared (IR). ) communications, public switched telephone network (PSTN), radio waves, and/or other communications techniques known in the art.

Server 106, which may also be referred to as a "therapy support network" or "normative analysis network," may include one or more computing devices and/or systems. As discussed in further detail herein, server 106 includes one or more processors and memory that stores instructions executable by the one or more processors to perform the methods described herein. and may include. In some embodiments, server 106 is implemented as a distributed "cloud" computer system or facility spanning any suitable combination of hardware and/or virtual computer resources.

Computing device 102 and server 106 may individually or together perform the methods described herein to generate implant and/or surgical plans. For example, some or all of the steps of the methods described herein may be performed using computing device 102 alone, server 106 alone, or a combination of computing device 102 and server 106. Thus, while certain operations are described herein with respect to server 106, it should be appreciated that these operations can be performed by computing device 102, and vice versa.

In some embodiments, server 106 includes one or more modules for performing one or more stages of the treatment planning methods described herein. For example, in the illustrated embodiment, server 106 includes a data analysis module 116 and a treatment planning module 118. In alternative embodiments, one or more of these modules can be combined with each other or excluded. Therefore, while operation is described herein in the context of a particular module or modules, this description is not intended to be limiting, and such operation may, in one embodiment, Or it can be executed by multiple modules.

i. patient specific implant
Computing device 102 and/or server 106 may design a patient-specific implant (“implant”) based at least in part on patient data set 108, surgical team data set 110, and/or facility data set 112. For example, treatment planning module 118 may design an implant based on any of the data inputs described above. In some embodiments, the implant includes a design related to orthopedic implants. Examples of such implants are screws (e.g., bone screws, spinal column screws, arcuate screws, articular screws), interbody implant devices (e.g., intervertebral implants), cages, plates, rods, discs, fusions. devices, spacers, rods, expandable devices, stents, brackets, ties, scaffolds, anchoring devices, anchors, nuts, bolts, rivets, connectors, tethers, fasteners, joint replacements (e.g., artificial discs), or hip implants. including but not limited to. Patient-specific implant design depends on the implant's physical properties (e.g., size, shape, volume, material, mass, weight), mechanical properties (e.g., stiffness, strength, modulus, hardness), and/or biological properties (e.g., For example, data representing one or more of bone binding properties, cell adhesion properties, antibacterial properties, and antiviral properties can be included. For example, the design associated with an orthopedic implant can include the shape, size, material, and/or effective stiffness of the implant (eg, lattice density, number of struts, location of struts, etc.).

The implant can be designed to match and/or provide correction to the patient's existing anatomy. For example, as described in more detail below, treatment planning module 118 may analyze image data of a patient's natural anatomy to determine whether an anatomical correction is required. can. The image data can be indicative of the patient's natural anatomy (eg, preoperative anatomy), such as the shape, orientation, and topography of various anatomical features. For example, in some embodiments, the image data includes vertebral spacing, vertebral orientation, vertebral translation, abnormal bone growth, abnormal joint growth, joint inflammation, joint degeneration, tissue degeneration, stenosis, scar tissue, lumbar spine exhibiting (and/or determining) various anatomical characteristics including, but not limited to, lordosis, Cobb angle, pelvic morphology angle, disc height, connection flexibility, rotational dislocation, and other spinal tissue characteristics. ) can be used for If no anatomical correction is required, treatment planning module 118 can design the implant to match the patient's natural anatomy. If an anatomical correction is required, the treatment planning module 118 can design the implant to provide the anatomical correction when implanted in the patient. Further details regarding designing patient-specific implants to provide one or more desired anatomical corrections can be found in U.S. Patent Application No. 16/987,113, filed Aug. 6, 2020. The entire disclosure of this document is incorporated herein by reference.

In some embodiments, the generated implant 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. In some embodiments, the implant design involves one or more patient-specific device components that can be used in conjunction with standard off-the-shelf components. For example, in spinal surgery, a vertebral arch root screw kit can include both standard components and patient-specific custom components. In some embodiments, the generated design relates to a patient-specific medical device that can be used with standard off-the-shelf delivery equipment. For example, the implant (eg, screw, screw holder, rod) can be designed and manufactured to suit the patient, whereas the instrumentation for delivering the implant can be a standard instrument. This approach allows implanted components to be designed and manufactured based on patient anatomy and/or surgeon preference to improve treatment. The implants described herein are expected to improve delivery into a patient, placement at a treatment site, and/or interaction with a patient's anatomy.

ii. Patient-specific surgical planning
Computing device 102 and/or server 106 may design a patient-specific surgical plan (“surgical plan”) based on patient dataset 108, surgical team dataset 110, and/or facility dataset 112. The surgical plan can include detailed instructions for implanting the implant at a specific target location within the patient. For example, surgical planning may include preoperative planning (e.g., detecting and measuring patient anatomy, preparing the patient for a surgical procedure, etc.), surgical procedure, surgical technique (e.g., implantation technique), one or more surgical steps (preparing the tissue for the incision, making the incision, performing the resection, removing the tissue, manipulating the tissue, performing the corrective operation, delivering the implant to the target site) deploying the implant at the target site; adjusting the implant at the target site; manipulating the implant after implantation; securing the implant at the target site; removing the implant; suturing the tissue. stage, etc.), implant target position, region, or location (e.g., location, orientation, etc.), and other aspects related to preoperative, intraoperative, or postoperative planning.

In some embodiments, the surgical plan includes spine surgery, hip surgery, knee surgery, jaw surgery, hand surgery, shoulder surgery, elbow surgery, total joint reconstruction (arthroplasty), skull reconstruction, foot surgery, or including orthopedic surgical procedures such as ankle surgery. Spinal surgery can include posterior lumbar interbody fusion (PLIF), anterior lumbar interbody fusion (ALIF), unilateral entry lumbar interbody fusion, or transforaminal lumbar interbody fusion (TLIF). Spinal fusion procedures such as lumbar lateral lumbar interbody fusion (LLIF), lateral lumbar interbody fusion (DLIF), or lateral lumbar interbody fusion (XLIF) may be included. Spine surgery can include non-fusion surgery such as artificial disc replacement. In some embodiments, the surgical procedure includes instructions and/or instructions for performing one or more aspects of the patient-specific surgical procedure. For example, a surgical procedure can include one or more of a surgical technique, a corrective operation, or a bone resection.

In some embodiments, the surgical plan includes a target location for the implant. As used herein, the terms "target location," "target site," and "target location" refer to a predetermined optimal location suitable for placing an implant during an implantation procedure, and can be based on the anatomy, condition, diagnosis, prognosis, activity level, etc. For example, the target location is determined by one of the following parameters obtained with respect to the anatomical landmark: angle or degree of orientation, angle or degree of translation, depth of insertion, angle of insertion, degree of contact between two surfaces. It can be determined by one or more. Suitable anatomical landmarks include, for example, particular vertebrae, particular vertebral levels, or other significant anatomical features. Thus, the target location may include the three-dimensional position of the implant relative to the patient's anatomy (e.g., defined by boundaries generated by the patient's anatomy), and/or the target orientation of the implant relative to the patient's anatomy. can include. In some embodiments, the target location provides a desired correction to the patient's natural anatomy, such as manipulating the patient's anatomy such that the implant provides the desired correction when implanted therein. can be incorporated. Without being bound by theory, it is anticipated that by placing the implant at the target location, the benefits of the implant will be optimized and/or the side effects of the implant will be minimized. In particular, the greatest benefits of the implant can only be realized when the implant is accurately placed at the target location.

In some embodiments, the surgical plan optionally includes a recommendation to remove tissue to make room for directing the implant to the target location. For example, the surgical plan may include instructions to perform osteotomies, myectomies, soft tissue dissections, soft tissue retractions, etc. to prepare the patient to receive a patient-specific implant. In some embodiments, the surgical plan includes tissue manipulation to prepare the patient to receive the implant. For example, a surgical plan may include instructions to adjust the relative positions of two vertebrae, increase the distance between two vertebrae, and the like.

In some embodiments, the surgical plan includes machine-readable instructions for performing its various steps. The machine-readable instructions can be configured to cause the surgical robotic platform to perform various aspects of operational procedures related to implanting an implant when executed by the surgical robotic platform. For example, surgical platforms can be used to prepare tissue for incision, to make incisions, to perform resections, to remove tissue, to manipulate tissue, to perform corrective operations, and to target implants at sites. deploying the implant at the target site; adjusting the configuration of the implant at the target site; manipulating the implant after implantation; securing the implant at the target site; removing the implant; and can suture tissues. Accordingly, the instructions may include specific instructions for articulating robotic arms, instruments, and/or tools to effectuate or otherwise assist in delivery of patient-specific implants.

In some embodiments, the surgical plan includes written, audio, and/or graphic step-by-step instructions that direct the surgeon how to perform the patient-specific surgical plan. The patient-specific surgical plan may be displayed to the surgeon (eg, through display 122) before and/or during the operating procedure. In some embodiments, written, audio, and/or graphical instructions may be encoded within computer readable instructions. The instruction code can be decoded and displayed to the surgeon before and/or during the operating procedure. In some embodiments, the patient-specific surgical plan includes both machine-readable instructions and written, audio, and/or graphic instructions.

iii. Use of reference patient datasets to design patient-specific implants and/or patient-specific surgical plans
In some embodiments, system 100 may consider one or more reference data sets when designing patient-specific implants and/or patient-specific surgical plans. For example, in some embodiments, server 106 includes at least one database 120 configured to store baseline data beneficial to treatment planning methods described herein. Reference data may include historical and/or clinical data from the same or other patients, data collected from the patient's previous surgeries and/or other treatments by the same or other health care providers, medical device design, data collected from research or research organizations, data from clinical databases, data from academic institutions, data from implant manufacturers or other medical device manufacturers, data from imaging studies, simulations, clinical It can include data from trials, demographic data, treatment data, outcome data, or mortality rates.

In some embodiments, database 120 includes multiple reference patient data sets, each associated with a corresponding reference patient. For example, a reference patient can be a patient who has previously been treated or is currently undergoing treatment. Each reference patient data set includes criteria such as the corresponding reference patient's condition, anatomy, medical condition, medical history, preferences, and/or any of the data described herein with respect to patient data set 108. Data representing any other information or parameters related to the patient may be included. In some embodiments, the reference patient data set includes preoperative data, intraoperative data, and/or postoperative data. For example, the reference patient data set may include patient ID, age, gender, BMI, lumbar lordosis, Cobb angle, pelvic morphology angle, disc height, connection flexibility, bone quality, rotational dislocation, and/or spinal treatment level. can include data representing one or more of the following. As another example, a reference patient data set may include a description of a surgical procedure or surgical intervention (e.g., surgical technique, bone resection, surgical procedure, corrective operation, placement of an implant or other device) performed on the reference patient. The treatment data may include treatment data relating to at least one treatment procedure. In some embodiments, the treatment data includes medical device design data, e.g., physical characteristics (e.g., size, shape, volume, material, mass, weight, etc.) regarding at least one medical device used to treat the reference patient. ), mechanical properties (eg, stiffness, strength, modulus, hardness), and/or biological properties (eg, osteointegration, cell adhesion, antibacterial, antiviral properties). In yet another example, the reference patient dataset includes outcome data representative of the outcome of the reference patient's treatment, such as corrective anatomy metrics, presence of fusion, HRQL, activity level, return to work, complications, recovery time. , efficacy, mortality, and/or reoperation.

In some embodiments, server 106 accepts at least a portion of the reference patient data set from multiple health care provider computer systems. Each health care provider computer system can include at least one reference patient data set (eg, multiple reference patient data sets) associated with a reference patient treated by the corresponding health care provider. Reference patient data sets may include, for example, dynamic records, electronic medical records, electronic health records, biomedical data sets, and the like.

In embodiments where implant and/or surgical plans are designed based on reference data, data analysis module 116 identifies subsets of reference data from database 120 that are likely to be advantageous in developing a treatment plan. may include one or more algorithms for. For example, data analysis module 116 compares patient-specific data (e.g., patient data set 108 received from computing device 102) to reference data (e.g., reference patient data set) from database 120 to compare similar data (e.g., reference patient data set) to One or more similar patient data sets within the patient data set can be identified. This comparison can be based on one or more parameters such as age, gender, BMI, medical condition, motion, lumbar lordosis, pelvic morphology, and/or treatment level. These parameters can be used to calculate a similarity score for each reference patient. A similarity score may represent a statistical correlation between patient dataset 108 and a reference patient dataset. Accordingly, similar patients can be identified based on whether the similarity score is above, below, or at a specified threshold. For example, as explained in more detail below, the above comparisons can be performed by assigning a value to each parameter and determining the aggregate difference between the test patient and each reference patient. Reference patients with aggregate differences lower than a threshold can be considered similar patients. In some embodiments, data analysis module 116 uses criteria other than patient parameters, such as surgical team dataset 110 (e.g., based on surgeon expertise, outcomes of particular types of procedures performed by the surgeon, etc.) and/or includes one or more algorithms that select a set or subset of reference patient data based on a facility data set 112 (eg, surgical equipment, such as a surgical robot).

Data analysis module 116 further includes, for example, one or more algorithms that select a subset of the reference patient data set based on similarity to patient data set 108 and/or corresponding reference patient treatment outcome. Can be configured. For example, data analysis module 116 identifies one or more similar patient datasets within the reference patient dataset and then determines whether the similar patient datasets contain data indicative of a favorable or desirable treatment outcome. A subset of similar patient datasets can be selected based on. Outcome data includes one or more outcomes such as corrected anatomy metrics, range of motion, kinetic data, HRQL, activity level, complications, recovery time, efficacy, mortality, or reoperation. Can include data representing parameters. As described in more detail below, in some embodiments, data analysis module 116 calculates an outcome score by assigning a value to each outcome parameter. A patient can be considered to have a favorable outcome if the outcome score is above, below, or at a specified threshold.

In some embodiments, data analysis module 116 selects a subset of the reference patient data set based at least in part on user input (eg, from a clinician, surgeon, physician, health care provider). For example, user input can be used to identify similar patient data sets. In some embodiments, the weighting of the similarity and/or outcome parameters may be selected by the health care provider or physician to adjust the similarity and/or outcome scores based on clinician input. can. In yet another embodiment, the health care provider or physician selects a set of similarity parameters and/or outcome parameters (or selects a new similarity score and/or outcome parameter set to be used to generate the similarity score and/or outcome score, respectively). and/or outcome parameters).

In some embodiments, data analysis module 116 includes one or more algorithms used to select a set or subset of reference patient data sets based on criteria other than patient parameters. For example, one or more of these algorithms may be used to determine health care provider parameters (e.g., hospital/physician expertise, number of procedures performed, health care provider ratings/scores such as hospital rating). (based on) and/or health care resource parameters (e.g., diagnostic equipment, facilities, surgical equipment such as surgical robots), or current health care provider procedures. The subset can be selected based on other non-patient related information available. For example, a reference patient dataset with images captured from similar diagnostic devices can be aggregated to reduce or limit irregularities due to variations between diagnostic devices. Additionally, data from similar health care providers (e.g., health care providers with traditionally similar outcomes, physician expertise, surgical teams, etc.) may be used to develop patient-specific treatment plans that are appropriate for a particular health care provider. can be developed. In some embodiments, reference health care provider datasets, hospital datasets, physician datasets, surgical team datasets, post-treatment datasets, and other datasets may be utilized. As an example, a patient-specific treatment plan for performing a field surgery can be based on reference patient data from similar field surgeries and/or related data sets. In another example, a patient-specific treatment plan can be generated based on available robotic surgical systems. A reference patient data set can be selected based on patients who have undergone surgery using comparable robotic surgical systems under similar conditions (eg, size and capabilities of surgical team, hospital resources, etc.).

In embodiments where the implant and/or surgical plan is designed based on reference data, the treatment planning module 118 may include one or more algorithms that generate the implant and/or surgical plan based on the reference data. . In some embodiments, treatment planning module 118 is configured to develop and/or implement at least one predictive model for generating a treatment plan, also known as a "normative model." Predictive models can be developed using clinical knowledge, statistics, machine learning, AI, neural networks, etc. In some embodiments, a data analysis module is used to identify correlations between datasets, patient parameters, health care provider parameters, health care resource parameters, treatment procedures, medical device designs, and/or treatment outcomes. The output from 116 is analyzed (eg, using statistics, machine learning, neural networks, AI, etc.). These correlations can be used to develop at least one predictive model that predicts the likelihood that a treatment plan will produce a favorable outcome for a particular patient. A predictive model can be verified, for example, by inputting data into the model and comparing the model's output to the expected output.

In some embodiments, treatment planning module 118 is configured to generate an implant design based on previous treatment data from a reference patient. For example, treatment planning module 118 can accept a selected subset of the reference patient dataset and/or similar patient dataset from data analysis module 116 and determine or identify treatment data from the selected subset. The treatment data may include, for example, range of motion and/or other kinetic data regarding favorable or desirable treatment outcomes for the corresponding patient, treatment procedure data (e.g., surgical procedure data or surgical intervention data), and/or medical Device design data (eg, implant design data) can be included. Treatment planning module 118 may analyze treatment procedure data and/or medical device design data to determine an optimal treatment protocol for the patient being treated. For example, values can be assigned and aggregated to treatment procedures and/or medical device designs to provide a treatment score. Patient-specific treatment planning by selecting a treatment plan based on this score (e.g., a higher or highest score, a lower or lowest score, a score above, below, or at a specified threshold) can be determined. This personalized treatment plan can be based at least in part on patient-specific or patient-specific selection techniques.

Alternatively or in combination, treatment planning module 118 can generate implant designs based on correlations between data sets. For example, treatment planning module 118 can correlate the implant design with medical device design data from implant designs for similar patients (eg, identified by data analysis module 116) with favorable outcomes. Correlation analysis can include converting correlation coefficient values into values or scores. Values/scores can be aggregated, filtered, or otherwise analyzed to determine statistical significance of one or more. These correlations can be used to determine treatment procedures and/or medical device designs that are optimal or likely to produce favorable outcomes for the treated patient.

Alternatively or in combination, treatment planning module 118 may generate the design using one or more AI techniques. AI technology can be used to develop computer systems that have capabilities that mimic human intelligence, such as learning, reasoning, planning, problem solving, decision making, etc. AI techniques include 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, Can include, but are not limited to, agent systems, swarm intelligence, data mining, machine learning (eg, supervised learning, unsupervised learning, reinforcement learning), and hybrid systems.

In some embodiments, treatment planning module 118 generates a treatment plan using one or more trained machine learning models. Various types of machine learning models, algorithms, and techniques are suitable for use with the techniques of the present invention. In some embodiments, a machine learning model is first constructed using a training data set, which is a set of examples used to fit the model's parameters (e.g., the weights of connections between "neurons" in an artificial neural network). will be trained. For example, the training data set may include any of the reference data stored in the database 120, such as a plurality of reference patient data sets or a selected subset thereof (eg, a plurality of similar patient data sets).

In some embodiments, the machine learning model (e.g., neural network or naive Bayes classifier) is trained on the training dataset using a supervised learning method (e.g., gradient descent or stochastic gradient descent). Can be done. A training data set may include pairs of occurrence "input vectors" and their associated corresponding "response vectors" (commonly referred to as targets). The current model is run with the training dataset to yield a result, which is then compared to the target for each input vector in the training dataset. Based on the results of this comparison and the particular learning algorithm 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 responses for observations in a second data set, referred to as the validation data set. The validation dataset can provide an unbiased evaluation of the model fit to the training dataset while adjusting model parameters. The validation dataset is regularized by stopping early, e.g. when errors increase on the validation dataset, this can be a sign of overfitting to the training dataset, so stop training at such times. It can be used for regularization. In some embodiments, the validation dataset error may change during training, so ad hoc rules can be used to determine when overfitting reliably begins. Finally, the test dataset can be used to provide an unbiased assessment of the final model fit to the training dataset.

To generate a treatment plan, patient dataset 108, surgical team dataset 110, and/or facility dataset 112 can be input into a trained machine learning model. Supplementary data can be input into the trained machine learning model, such as a selected subset of the reference patient dataset and/or similar patient dataset, and/or treatment data from the selected subset. The trained machine learning model can then calculate whether various treatment procedure and/or medical device design candidates are likely to provide a favorable outcome for the patient. Based on these calculations, the trained machine learning model can select at least one treatment plan for the patient. In embodiments where multiple trained machine learning models are used, these models can be run sequentially or simultaneously to compare outcomes, and can be updated periodically with training data sets. Treatment planning module 118 may use one or more of the machine learning models based on the models' predictive accuracy scores.

The implant design and/or surgical plan generated by treatment planning module 118 may be transmitted to computing device 102 over communication network 104 for output to a user (e.g., clinician, surgeon, health care provider, patient). can. For example, communication network 104 may transmit a surgical plan to computing device 102 in response to receiving a unique code associated with the implant and/or surgical plan, as described in more detail below. . In some embodiments, computing device 102 includes or is operably coupled to display 122. Display 122 may show various aspects of the surgical procedure performed on the patient, such as surgical technique, treatment level, corrective manipulation, tissue resection, and/or implant placement. To facilitate visualization, a virtual model of the surgical procedure can be displayed. Additionally or alternatively, display 122 may show a design for a medical device, such as a two-dimensional model or a three-dimensional model of the device design. Display 122 may show patient information, such as a two-dimensional or three-dimensional image or model of the patient's anatomy on which a surgical procedure is to be performed and/or a device to be implanted. Display 122 can display structural features of the implant suitable for contacting anatomical features to improve treatment, reduce implant migration, and the like. These structural features can be rigid surfaces (eg, the outer surface of the implant body), anchors, anchoring features, and the like. Images of the implant site may be analyzed to identify such anatomical features identified by treatment planning module 118. Computing device 102 may further include one or more user input devices (not shown) that allow the user to modify, select, approve, and/or reject the displayed treatment plan.

iv. Manufacture of patient-specific implants
In some embodiments, the patient-specific implant design generated by treatment planning module 118 may be transmitted from computing device 102 and/or server 106 to manufacturing system 124 for manufacturing a corresponding medical device. Manufacturing system 124 can be located on-site or off-site. On-site manufacturing can reduce patient visits and/or shorten the time a surgery can be performed, whereas off-site manufacturing can be advantageous for manufacturing complex devices. can do. Off-site manufacturing can involve specialized manufacturing equipment. In some embodiments, more complex device components can be produced off-site, whereas only simpler device components can be manufactured on-site.

Various types of manufacturing systems are suitable for use with embodiments herein. For example, manufacturing system 124 may include three-dimensional (3D) printing, stereolithography (SLA), digital light processing (DLP), fused deposition modeling (FDM), selective laser sintering (SLS), selective laser melting (SLM), etc. ), selective heat sintering (SHM), electron beam melting (EBM), layered object manufacturing (LOM), powder bed printing (PP), thermoplastic printing, direct material deposition (DMD), inkjet photocurable resins It may be configured to be suitable for additive manufacturing such as printing or similar techniques, or combinations thereof. Alternatively or in combination, manufacturing system 124 may include CNC machining, electrical discharge machining (EDM), grinding, laser cutting, water jet machining, hand machining (e.g., milling, lathe/turning), or similar techniques; Such combinations can be configured to be suitable for reduced (conventional) manufacturing. Manufacturing system 124 performs one or two operations based on processing instructions or processing data (e.g., CAD data, 3D data, digital blueprints, stereolithography data, or other data suitable for various manufacturing techniques described herein). The above patient-specific medical devices can be manufactured. In some embodiments, patient-specific medical devices can include features, materials, and designs that are shared across multiple 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, the components of the patient-specific medical device are selected from a set of available prefabricated components, and the selected prefabricated components are based on processing instructions or processing data. Can be fixed.

v. Additional features
The treatment plans described herein can be performed by a surgeon, a surgical robot, or a combination thereof, thereby providing treatment flexibility. In some embodiments, the surgical procedure can be performed entirely by a surgeon, entirely by a surgical robot, or a combination thereof. For example, one stage of a surgical procedure may be performed manually by a surgeon, and another stage of the procedure may be performed by a surgical robot. In some embodiments, treatment planning module 118 generates control instructions configured to cause a surgical robot (eg, a robotic surgical system, navigation system, etc.) to partially or fully perform a surgical procedure. Control instructions may be sent to the robotic device by computing device 102 and/or server 106.

Following treatment of a patient according to a treatment plan, the progress of treatment may be monitored over one or more time periods to update data analysis module 116 and/or treatment planning module 118. Post-treatment data can be added to the baseline data stored in database 120. 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.

It should be appreciated that the components of system 100 can be configured in many different ways. For example, in alternative embodiments, database 120, data analysis module 116, and/or treatment planning module 118 may be components of computing device 102 rather than server 106. As another example, the database 120, data analysis module 116, and/or treatment planning module 118 may be located on multiple different servers, computer systems, or other types of cloud computers, rather than being located on a single server 106 or computing device 102. Can be positioned across resources.

Additionally, in some embodiments, system 100 can be operated in many other environments or configurations of computer systems. Examples of computer systems, environments, and/or configurations that may be suitable for use with the techniques of the present invention include personal computers, server computers, handheld or laptop devices, cellular telephones, wearable electronic devices, tablet devices. , microprocessor systems, microprocessor-based systems, programmable garden appliances, network PCs, minicomputers, mainframe computers, or distributed computing environments containing any of these systems or devices. Not limited. In some embodiments, the system 100 is configured such that the system 100 may be configured as described in U.S. Patent Application No. 16/735,222, filed January 6, 2020; As described in the specification, U.S. Patent Application No. 16/207,116, filed December 1, 2018, and United States Patent Application No. 16/990,801, filed August 11, 2020. Additional features and functionality may be included, such as any of these documents, the entire disclosures of which are incorporated herein by reference.

FIG. 2 illustrates a computing device 200 suitable for use with the system 100 of FIG. 1 according to an embodiment. Computing device 200 may be incorporated within various components of system 100 of FIG. 1, such as computing device 102 or server 106. Computing device 200 includes one or more processors 210 (eg, CPU, GPU, HPU, etc.). Processor 210 may be a single processing unit or multiple processing units distributed within one device or across multiple devices. Processor 210 may be coupled to other hardware devices using a bus, such as a PCI bus or a SCSI bus, for example. Processor 210 may be configured to execute one or more computer readable program instructions, such as program instructions for implementing any of the methods described herein.

Computing device 200 may include one or more input devices 220 that provide input to processor 210 to notify processor 210 of actions from a user of computing device 200, for example. These actions can be mediated by a hardware controller that interprets signals it receives from input devices and communicates information to processor 210 using a communication protocol. Input device 220 may include, for example, a mouse, keyboard, touch screen, infrared sensor, touch pad, wearable input device, camera or image-based input device, microphone, or other user input device.

Computing device 200 may include text, models, virtual procedures, surgical plans, implants, graphics, and/or images (e.g., images having voxels indicative of radiodensity units or Hounsfield units representing the density of tissue at a location). ) may include a display 230 used to display various types of output, such as: In some embodiments, display 230 provides visual feedback of graphics and text 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 when input device 220 includes a touch screen or when input device 220 is equipped with an eye direction monitoring system. In an alternative embodiment, display 230 is separate from input device 220. Examples of display devices include LCD display screens, LED display screens, projection displays, holographic displays, or augmented reality displays (eg, head-up or head-mounted devices), and others.

Optionally, processor 210 includes a network card, video card, audio card, USB, firewire or other external device, camera, printer, speaker, CD-ROM drive, DVD drive, disk drive, or Blu-ray device. Other I/O devices 240 may be coupled. Other I/O devices 240 may include input ports for information from directly connected medical equipment, such as imaging devices, including MRI machines, X-ray machines, CT machines, and the like. Additionally, other I/O devices 240 include input ports for accepting data from these types of machines from other sources, such as across a network or from previously captured data stored in a database, for example. be able to.

In some embodiments, computing device 200 further includes a communications device (not shown) capable of communicating with network nodes wirelessly or on a wired basis. A communication device may communicate with another device or server over a network using, for example, the TCP/IP protocol. Computing device 200 may utilize communication devices to distribute operations across multiple network devices, including imaging equipment, manufacturing equipment, and the like.

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

B. Linking patient-specific implants to patient-specific datasets
As provided above, the techniques of the present invention include systems, devices, and methods for designing patient-specific techniques, devices (eg, implants, instruments, etc.), diagnostic plans, and surgical plans. In many embodiments, the surgical plan is tailored specifically to the implant (ie, the surgical plan provides instructions for implanting the implant at a target location). Therefore, the technique of the present invention relates or links a surgical plan to a corresponding implant to ensure that the appropriate surgical plan can be accessed/used to implant the corresponding implant. Systems, devices, and methods are further provided. In addition to surgical planning, the techniques of the present invention can link patient-specific implant information and other patient information to the implant (linking patient-specific surgical planning, patient-specific implant information, and other patient information to each other). (referred to as "patient-specific data", "patient-specific data set", or "data set"). Accordingly, aspects of the present technology ensure that patient-specific data sets are stored with and/or effortlessly accessible in combination with the corresponding implant.

Patient-specific data sets may include surgical plans, implant information, and/or other patient information. As mentioned above, surgical planning may include preoperative planning (e.g., detecting and measuring patient anatomy, preparing the patient for the surgical procedure, etc.), surgical procedures, surgical techniques (e.g., implantation techniques), or Two or more surgical steps (preparing the tissue for the incision, making the incision, performing the resection, removing the tissue, manipulating the tissue, performing the corrective operation, placing the implant at the target site) deploying the implant at the target site; adjusting the implant at the target site; manipulating the implant after implantation; securing the implant at the target site; removing the implant; aspects of the target location of the implant (e.g., location, orientation, etc.), and other aspects related to preoperative, intraoperative, or postoperative planning. Implant information can include implant dimensions, implant composition, unique implant identification code, implant part number, implant lot code, implant manufacturing date, implant placement date, implant expiration date, implant sterilization history, and/or implant manufacturing history. . Other patient information may include data representing the patient's condition, anatomy, medical condition, symptoms, medical history, preferences, and/or any other information or parameters related to the patient. For example, other patient information may include 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 (e.g., lumbar lordosis, Cobb angle, pelvic morphology, disc height, connection flexibility, bone quality, rotational dislocation, and/or spinal treatment level), patient information (e.g., patient ID number, demographics, gender, age, gender, BMI, height, weight, type of medical condition, occupation, activity level, organizational information, health assessment, comorbidities, health-related quality of life (HRQL)), lifestyle responses, diagnostic results, medication information, allergies, Image 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, or user-selected settings/configurations, etc.).

In some embodiments, patient-specific data sets are stored remotely (e.g., in the "cloud" and/or at a location away from the implant and implant packaging, such as on a server (e.g., server 106 shown in FIG. 1). ) is stored. In such embodiments, the implant or associated packaging may include one or more search features for downloading and/or otherwise accessing the data set. In some embodiments, patient-specific data sets are stored locally (on, in, or adjacent to the implant and/or implant packaging). In such embodiments, the implant or associated packaging may include one or more data storage elements for locally storing data sets. In some embodiments, data sets are stored both locally and remotely. In some embodiments, some aspects of the dataset are stored locally and some aspects of the dataset are stored remotely.

i. Remote storage of patient-specific datasets
As provided above, in some embodiments, patient-specific data sets are stored remotely, such as on server 106. In such embodiments, server 106 may store multiple patient-specific data sets associated with multiple different patients. Each individual patient-specific data set is identified by a unique code, such as a randomly generated alphanumeric code, a personal identification number (PIN) alphanumeric code, a patient medical record number (MRN), or an alphanumeric code containing the patient name, etc. can be associated with a unique identifier. Individual patient-specific data sets can be downloaded from server 106 using a unique identifier. For example, a user may send a request to download a particular patient-specific data set to server 106 (eg, using computing device 102 and communication network 104) by including a unique identifier in the request. Server 106 may compare the unique identifier received from the user to the unique identifier for the stored patient-specific data set. If the unique identifier received from the user matches a unique identifier for a stored patient-specific dataset, server 106 retrieves such stored patient-specific dataset and directs it for display to the user. and may be transmitted to computing device 102. If the unique identifier received from the user does not match a unique identifier for a stored patient-specific dataset, a message or other message indicating that no patient-specific dataset with the unique identifier was found on the server 106 is sent. A notification may be sent to computing device 102 for display to a user. Although the above describes querying the server 106 to retrieve particular patient-specific datasets, the same or similar techniques can be used to identify and retrieve particular patient-specific datasets from the cloud.

FIG. 3 is a schematic diagram of a patient-specific implant 300 contained within packaging 310 and associated with a remotely stored patient-specific data set. Although implant 300 is shown as an intervertebral implant, those skilled in the art will appreciate that implant 300 is only one example of a patient-specific implant and that the techniques of the present invention apply to both the type of intervertebral implant illustrated and to intervertebral implants in general. It will be understood that there is no limitation. The implant 300 is implanted at a target implantation site (e.g., between one or more vertebral bodies or between a vertebral body and a vertebral endplate) and/or around one or more identified anatomical structures (e.g., The vertebral body 302 has a body 302 configured to connect with one or more vertebral bodies or endplates. Implant body 302 includes one or more structural features designed to engage one or more identified anatomical structures. For example, in the illustrated embodiment, implant 300 can include an upper surface 305 and a lower surface (not shown) configured to seat against a vertebral body. In some embodiments, the upper and lower surfaces 305 and 305 can have contours that conform to the contours of the vertebral endplates so that they "merge" with the corresponding vertebral endplates they engage. In some embodiments, such as the illustrated embodiment, the top surface 305 and/or the bottom surface can be textured (eg, by roughening, knurling, ridges, etc.). In lordosis correction, the upper surface 305 and the lower surface can be angled with respect to each other. In other procedures, the implant 300 can be an interspinous spacer with structural features in the form of U-shaped sections designed to receive each spinous process. The dimensions of the U-shaped portion can be adapted to the dimensions of the spinous process. In other embodiments, the structural feature is designed to engage (e.g., contact, receive, etc.) one or more anatomical features (e.g., tissue, bony structure, etc.). may include shaped recesses, arms, or other contact features. Additional types, designs, and structural features of implants suitable for engaging identified anatomical features are described, for example, in U.S. patent application Ser. No. 16/207,116, filed December 1, 2018. and US Patent Application No. 16/987,113 filed Aug. 6, 2020, the entire disclosures of which are incorporated herein by reference.

As shown, implant 300 and/or packaging 310 can include one or more search features 320 for accessing remotely stored patient-specific data sets. Search feature 320 may be a machine readable (MR) graphic, rapid response (QR) code, barcode, or another feature associated with a unique identifier. In other embodiments, search feature 320 can include the unique identifier itself (e.g., the unique identifier is printed directly on implant 300 or printed on packaging 310 for implant 300). or a combination thereof).

A user (eg, a physician) can access patient-specific data sets using search features 320. For example, if search feature 320 is a barcode that corresponds to a unique identifier, the user may scan search feature 320 using, for example, one or more cameras on computing device 102 and/or Alternatively, a unique identifier may be entered into computing device 102 . Once the unique identifier is entered into computing device 102, computing device 102 can send the unique identifier to server 106 (e.g., over communications network 104) with a request to provide a corresponding patient-specific surgical data set. . If desired, as described above, the server 106 may locate a particular set of data regarding the unique identifier and transmit the set of data to the computing device 102 for display to the user. Although FIG. 3 shows where both the implant 300 and the packaging 310 include the search feature 320, in other embodiments, only one of the implant 300 or the packaging includes the search feature 320.

Once downloaded, the patient-specific data set may be used to review the surgical plan preoperatively, to guide the surgeon and/or the robotic surgical platform to perform various steps of the surgical plan intraoperatively, and Correct placement of the implant 300 can be confirmed after surgery. As mentioned above, the surgical plan can include detailed patient-specific procedures for implanting the implant 300 at a particular target location within the patient. In some embodiments, the surgical plan includes machine-readable instructions for performing various steps of the patient-specific surgical plan. These machine-readable instructions, when executed by the surgical robotic platform, can be configured to cause the surgical robotic platform to perform various aspects of the operational procedures associated with implanting the implant 300. For example, surgical platforms can be used to prepare tissue for incision, to make incisions, to perform resections, to remove tissue, to manipulate tissue, to perform corrective operations, to place implants at target sites. delivering the implant to the target site; adjusting the implant at the target site; manipulating the implant after implantation; securing the implant to the target site; removing the implant; It can be sutured, etc.

ii. Local storage of patient-specific datasets
As provided above, in some embodiments, the patient-specific data set is stored locally, such as on or within the patient-specific implant and/or packaging for the implant. FIG. 4 is a schematic diagram of a patient-specific implant 400 contained within packaging 410 having one or more data storage elements 430 with memory for storing patient-specific data sets. Although two data storage elements 430 are shown, in some embodiments a single data storage element 430 is provided, either positioned in or on implant 400 or included within packaging 410. be. Additionally, although implant 400 is shown as an intervertebral implant, those skilled in the art will appreciate that implant 400 is only one example of a patient-specific implant and that the techniques of the present invention apply to intervertebral implants of the type shown as well as general intervertebral implants. It will be understood that this is not limited to. For example, implant 400 can include any of the designs and constructions described above with respect to implant 300, etc.

Data storage element 430 may include a memory chip (e.g., a microchip) having non-volatile memory such as programmable ROM, erasable programmable ROM, electrically erasable programmable ROM, flash memory, mask ROM, and the like. It can be any suitable data storage medium, including but not limited to. In some embodiments, data storage element 430 is a radio frequency identification (RFID) chip. The RFID chip can be active (e.g., powered by a battery or other energy storage component) or passive (e.g., powered by energy from the RFID reader's energy). . Data storage element 430 can be integral to implant 400 or physically coupled to implant 400 or otherwise linked to implant 400 (e.g., within packaging 410 with implant 400). can be included). In embodiments in which data storage element 430 is physically coupled to implant 400, data storage element 430 is connected to a computer to remove it from implant 400 and to access patient-specific data sets stored on the computing device. It can optionally be removably coupled to implant 400 so that it can be connected to a device. In other embodiments, data storage element 430 is coupled to a patient-specific implant and configured to be implanted with implant 400. In some embodiments, data storage element 430 is biocompatible (eg, constructed of a biocompatible material that includes a biocompatible coating).

In embodiments in which data storage element 430 is included within or otherwise coupled to implant 400, implant 400 includes one or more transmitters or searchers for establishing a wireless connection with data storage element 430. Feature 420 is optionally included. The one or more transmitter or search features 420 may include MR codes, QR codes, bar codes, and/or telecommunications features (e.g., antennas, proximity sensors, location sensors, radio frequency transmission features, wireless transmission features, etc.), but are not limited to these. The wireless connection may be established using WiFi, Bluetooth, RF communication, near field communication, or other suitable wireless communication technology. To establish a wireless connection with data storage element 430, computing device may utilize search feature 420. For example, in embodiments where search feature 420 is a bar code, a user may scan search feature 420 using one or more cameras on computing device 102 (shown in FIG. 1). Once search feature 420 is scanned, computing device 102 may automatically establish a wireless connection with data storage element 430. In embodiments where search feature 420 is a proximity sensor, data storage element 430 automatically establishes a wireless connection with data storage element 430 when a computing device or other scanner is brought within a specified distance of data storage element 430. can be established. In embodiments where search feature 420 is connected to an antenna, a wireless connection is established between the computing device and data storage element 430 by directing RF energy toward the antenna or by exposing search feature 420 to a magnetic and/or electric field. can be established. As one skilled in the art will appreciate, the need to have the search feature 420 will depend, for example, on the type of wireless connection formed using the data storage element 430, and therefore, in some embodiments the need to have the search feature 420 section 420 will be excluded.

Once a wireless connection is established with data storage element 430, data storage element 430 can automatically transmit some or all patient-specific data to an external device (eg, computing device 102). In other embodiments, once the wireless connection is established, the user may request to retrieve some or all of the patient-specific data from the data storage element 430; Elements can send request patient-specific data sets. Once a patient-specific data set is retrieved from data storage element 430, this data set can be used to review the surgical plan preoperatively, and to direct the surgeon and/or robotic surgeon to perform various stages of the surgical plan intraoperatively. The platform can be guided and correct placement of the implant 400 can be confirmed post-operatively. Additional details of retrieving information from data storage element 430 after implant 400 is implanted are described in section (B)(iii) below.

In some embodiments, data storage element 430 can be paired with other data storage elements in a peer-to-peer relationship to form a blockchain of data. For example, in some embodiments, a patient may include more than one implant 400 and each implant 400 may include a corresponding data storage element 430. Each data storage element includes, in addition to a first patient-specific data set associated with the implant to which it is connected, a second patient-specific data set associated with other implants to which it is not physically coupled. Can be done. Additionally, data storage element 430 accommodates relationships between multiple implants, such as whether the implants were implanted at the same time, by the same surgeon, or at the same facility. Can contain data. Accordingly, a user can access either or both of the first patient-specific data set and the second patient-specific data set by communicating with a single implant. Without being bound by theory, it is anticipated that this access will simplify the process of searching through data sets when a patient has multiple implants. Additionally, distributing the data set across multiple data storage elements allows data storage element 430 to be encrypted as part of a distributed network associated with (moving with) the patient.

In embodiments where data storage element 430 is included within packaging 410 or removably coupled to implant 400, data storage element 430 is accessible for patient-specific data sets by connecting to a computing device. be. The connecting step includes physically connecting the data storage element 430 into the computing device, such as by plugging or inserting it, or using WiFi, Bluetooth, RF communications, near field communication, or other suitable technology. The wireless connection can be made at any stage. In either case, connecting data storage element 430 to a computing device may allow a user to access data sets stored on data storage element 430.

iii. Patient-specific markings printed directly on the implant
In addition to or in place of the search feature 320 shown in FIG. 3 and/or the data storage element 430 shown in FIG. Patient-specific markings or patient-specific identifiers (eg, descriptors, words, and/or characters) associated with (eg, comprising part of) the information contained therein may be included. For example, FIG. 5 depicts an implant 500 constructed in accordance with an embodiment of the present technique. Implant 500 may be substantially similar to implants 300 and 400 (with or without search features and data storage elements) described with respect to FIGS. 3 and 4. However, compared to implants 300 and 400, implant 500 includes one or more patient-specific markings 525 printed directly on its surface 502. Patient-specific markings 525 may include some or all of the data contained within the patient-specific data set. For example, patient-specific markings 525 may include the patient's name, patient's initials, date (e.g., patient intake date, surgery date, implant manufacturing date, etc.), target location within the patient's spinal column for which the implant is intended to be inserted ( (e.g., L4-L5 disc space), treatment level of the patient's spine (e.g., vertebral level), and data about the implant 500 (e.g., size, dimensions, shape, material, implant ID, manufacturer, etc.). be able to. Patient-specific markings 525 may be printed, stamped, written, engraved, or otherwise inscribed on implant 500 in any language and using any technique suitable for providing text on an object. can. In some embodiments, patient-specific markings 525 can be radiopaque for viewing by fluoroscopy or other suitable methods.

In addition to or in place of string information, patient-specific marking 525 may include machine-readable (MR) features (e.g., images, symbology, graphics, etc.), mechano-optical readable features, one or more codes ( (e.g., QR codes, barcodes, alphanumeric codes, etc.), identifiers associated with patient-specific data sets, and/or any combination thereof. However, even in embodiments where the patient-specific marking 525 includes cryptographic information, e.g., in the form of one or more codes, the patient-specific marking 525 may represent a portion of the patient-specific data set (e.g., the patient's name). Encode directly. This allows the user to access that portion of the patient-specific data set without having to access a remote server. Further, this is in contrast to the search feature 320 described with respect to FIG. 3 that allows a user to access patient-specific data by providing access to remotely stored patient-specific data sets.

A user (e.g., clinician, physician, etc.), computing device, and/or imaging system obtains patient- and/or implant-related information directly from the implant itself using one or more patient-specific markings 525. be able to. For example, rather than being forced to retrieve/access information stored locally (e.g., on data storage element 430) or remotely (e.g., on server 10), the user may Information (eg, patient name, date of surgery, target implant level, etc.) can be read directly. However, in some embodiments, a user may access a remotely stored patient-specific dataset, similar to the process for accessing a remotely stored dataset using search features 320 described above with respect to FIG. Information provided by patient-specific markings 525 (eg, patient name or MRN) may also be used to access additional data from the patient. In some embodiments, patient-specific markings can be configured to be readable by X-ray, CAT scan, MRI, and/or radiometry before, during, and/or after implantation.

In some embodiments, patient-specific markings 525 are included on implant 500 in combination with search feature 320 and/or data storage element 430. In such embodiments, patient-specific markings 525 may be used to verify information obtained using search features 320 and/or data storage elements 430. For example, by using patient-specific markings 525, a user can directly image, read, or observe an implant to identify one or more elements of a patient-specific data set (e.g., patient name and target vertebral level). ) can be determined. The user can then compare these elements to the same type of information obtained using search features 320 and/or from data storage element 430 (eg, patient name and target vertebra level). In this way, the user can confirm that the information obtained using search feature 320 and/or data storage element 430 is indeed relevant to implant 500.

Patient-specific markings 525 may be formed using any suitable process or technique. For example, the patient-specific markings 525 can be formed using an embossing or debossing process, extruded from a surface of the implant 500 (e.g., by additive manufacturing), printed on the implant 500, or printed on the implant 500. (e.g., by selectively removing material from implant 500). In some embodiments, patient-specific markings 525 are configured to be permanently or removably coupled to implant 500. For example, patient-specific markings 525 can be formed on a substrate, which can be coupled to implant 500 by fasteners, adhesives, and/or any other suitable bonding process or technique.

Without being bound by theory, the use of patient-specific markings 525 allows a surgeon or other user to quickly obtain and/or verify information related to a patient and/or implant by simply reading the information printed on the implant. make it possible to This step includes accessing remotely stored patient data (e.g., using search feature 320 shown in FIG. 3) and/or a computer readable data storage element (e.g., data storage element 430 shown in FIG. 4). It is anticipated that this will be a faster process than accessing locally stored patient data. However, the amount of information that can be provided using patient-specific markings 525 is of course limited by the size and shape of the implant 500 itself. Additionally, depending on the implant targeting and implant placement, patient-specific markings 525 may be difficult to locate and/or read after implant 500 is implanted in a patient. In some embodiments, therefore, as described above, implants according to the present techniques include search features (e.g., search features 320 or 420) and/or data storage elements described with respect to FIGS. 3 and 4, respectively. (eg, data storage element 430) as well as patient-specific markings 525.

iv. Access to patient-specific datasets after implantation
In some embodiments, patient-specific data sets are accessible after the implant is implanted in the patient (eg, days, months, or years after surgery). For example, in embodiments where the implant includes a data storage element (eg, as shown in FIG. 4), the data storage element is implanted with the implant. After the implant is implanted, data sets can be subsequently retrieved from the data storage element using various wireless communication techniques. For example, in some embodiments, an external device can retrieve information from the data storage element using RF communications after implantation.

In some embodiments, the implant includes an antenna or other conductive element (e.g., a transmitter on the patient-specific implant 400/ search feature section 420). In some embodiments, one or more portions of the implant can be designed to function as antennas for data storage elements. For example, in some embodiments, the implant is an interbody device and the lattice of the interbody device is designed to function as an antenna for the data storage element. The lattice or other three-dimensional structure of the implant can function as an omnidirectional antenna with the ability to transmit data in the presence of a directional or omnidirectional energy field. Without being bound by theory, the use of a grating or other three-dimensional structure as a transmitting or conducting element allows the data storage element to transmit RF energy without first having to orient the data storage element (and thus the patient) in a particular direction. enable you to respond to In some embodiments, the implant has a plurality of directional or omnidirectional gratings or other three-dimensional structures, each capable of transmitting when a respective field is applied. In some embodiments, the implant includes a dedicated structure that acts as an antenna for communicating with external devices. Regardless of the design, the antenna is configured to receive information from an external device and/or configured to transmit information stored on the data storage element to an external device. For example, in some embodiments, the data storage element receives a request for some or all of the patient-specific data set through an antenna. If necessary, the data storage element transmits some or all of the data set through the antenna to the external device. In some embodiments, instead of transmitting the data set itself, the data storage element can transmit the unique identifier to the external device. This unique identifier can be used to access data sets stored remotely, such as on server 106. The unique identifier may be the same as the unique identifier described above.

In some embodiments, accessing patient-specific data sets after implant 400 can be used to verify various aspects of the implant and/or implantation procedure. For example, in some embodiments, data storage element 430 (or search feature 320 or patient-specific marking 525) may include a unique identifier specific to a patient, medical condition, implantation procedure, section of anatomy, etc. I can do it. At some point after implantation, the unique identifier can be retrieved from data storage element 430 and compared to a database (e.g., database 120 shown in FIG. 1) storing information associated with such a particular patient. . As mentioned above, database 120 may store medical records associated with a patient that may include a description of the surgical procedure the patient undergoes to receive a patient-specific implant. The medical record may include a unique identifier associated with the patient-specific implant. Accordingly, to verify the implant 400 as authentic, the unique identifier retrieved from the data storage element 430 may be compared to a unique identifier stored with the patient's medical record. In some embodiments, data may be sent back to the implant 400 to indicate that the implant 400 has been verified as authentic.

Accessing patient-specific data sets after implant 400 is expected to be advantageous for several additional reasons. For example, as previously discussed, the dataset includes implant dimensions, implant composition, unique implant identification code, implant part number, implant lot code, batch number, implant manufacturing date, implant implantation date, implant expiration date, and implant sterilization history. , and/or information related to the implant including, but not limited to, implant manufacturing history. Accordingly, a medical professional or other user may review and/or verify information related to the implant after the implant has been implanted, such as that the implant was properly sterilized before being implanted in the patient. You may wish to access a dataset in order to do so. The data set may further include information associated with the patient, such as medical history, diagnosis, prognosis, and the like. Therefore, a medical professional or other user may use the data set to review the medical history after an implant has been placed, to see if surgical outcomes matched the patient's prognosis, or for similar purposes. You may wish to access it. In some embodiments, a medical professional can use the data set when evaluating a patient and developing additional treatment plans. The data set may further include a target location of the implant. Accordingly, a medical professional or other user may wish to access the data set to confirm that the actual position of the implant matches the target position, as described below.

C. Confirmation of patient-specific implant positioning
A patient-specific implant can include one or more positioning features that allow a user to confirm the positioning of the implant post-operatively. As mentioned above, patient-specific surgical planning is the step of identifying target locations for implants that define the optimal location for the implant, based on patient conditions, the patient's natural anatomy, or desired corrections thereto. can include. The one or more positioning features allow the user to confirm that the implant is positioned at the target location.

In some embodiments, one or more positioning features can include a data storage element (eg, data storage element 430 on patient-specific implant 400). For example, in addition to storing and transmitting the information described above, the data storage element can be configured to transmit the position of the implant. In particular, a data storage element may transmit a positioning signal (eg, an RF positioning signal) indicating its location. The data storage element may generate and transmit signals itself and/or may reflect signals transmitted from an externally located energy source. The transmitted position can be compared to an expected position of the data storage element with respect to the target position of the implant. If the transmitted position is the same as (or within a threshold degree of deviation from) the expected position, the implant can be confirmed as located at the target position. If the transmitted position is not the same as (or within a threshold deviation from) the expected position, then the implant is not at the target position.

In some embodiments, one or more positioning features can include one or more sensors. The one or more sensors can be configured to detect, measure, or otherwise determine the position of the implant. The detected location can be transmitted to an external device (eg, computing device 102 shown in FIG. 1) and compared to a target location. If the detected position is the same as (or within a threshold degree of deviation from) the target position, then the implant can be confirmed as positioned at the target position. If the detected position is not the same as (or within a threshold degree of deviation from) the target position, then the implant is not at the target position.

In some embodiments, images of the implanted implant can be constructed using conventional imaging techniques (e.g., X-ray, RF imaging techniques, e.g., return intensity signal signature, MRI, CAT scan, etc.) . The configuration image can be compared to a virtual model depicting an implant implanted at a target location within the patient to determine whether a patient-specific implant is at the target location. In some embodiments, an image analysis module, such as an artificial intelligence architecture, can be used to compare the constituent images to the virtual model. In some embodiments, the image analysis module is a convolutional neural network. In some embodiments, the one or more positioning features can include one or more x-ray imaging markers to assist in comparing the constituent images to the virtual model.

FIG. 6 is a flowchart of a method 600 for locating an implanted patient-specific implant. The method 600 can include obtaining patient-specific data from the implant at step 602. The patient-specific data may include a target location for the implant that defines an optimal predetermined location for the implant based on the patient's anatomy and/or medical condition. Patient-specific data can be obtained from the implant using any of the techniques described herein above. For example, in some embodiments, the implant includes a data storage element that stores patient-specific data. In such embodiments, obtaining patient-specific data at step 602 may include accepting patient-specific data from a data storage element. Patient-specific data may be obtained from the data storage elements described above, such as by exposing the implant to an electric and/or magnetic field and/or by exposing the implant to RF energy. In some embodiments, the implant includes a search feature encoded with a unique identifier. In some embodiments, in step 602, obtaining patient-specific data includes obtaining a unique identifier using a search feature and using the unique identifier to retrieve patient-specific data stored remotely, such as on a server. The steps may include accessing the data.

In addition to the target location, the patient-specific data may include other patient-specific information, such as any of the information described herein above. For example, patient-specific data can include patient data and implant data. Patient data may include patient information, patient medical history, patient medical record numbers, physician notes regarding the patient, and the like. Implant data can include implant dimensions, implant composition, unique implant identification code, implant part number, implant lot code, implant manufacturing date, implant implantation date, implant expiration date, implant sterilization history, implant manufacturing history, and the like. The patient-specific data may further include other aspects related to the surgical plan used to place the implant.

The method 600 can further include determining the actual position of the implant at step 604. In some embodiments, the actual position of the implant can be determined by capturing image data of the implant. Suitable image data may include, for example, camera images, magnetic resonance imaging (MRI) images, ultrasound images, computed tomography (CAT) scans, positron emission tomography (PET) images, and X-ray images. I can do it. Additionally or alternatively, the actual position of the patient-specific implant can be determined using one or more positioning elements included on the implant, as described herein above.

The method 600 can further include, at step 606, comparing the actual position of the implant obtained at step 604 with the target position of the implant obtained at step 602. This comparison can be done manually, semi-automatically, or fully automatically. For example, in some embodiments, comparing the actual location to the target location includes using an image analysis module as described above. If the actual location is not the same as the target location (or within a threshold deviation from the target location), the method optionally generates an alert indicating that the actual location is not the same as the target location. and/or provide one or more corrective maneuver recommendations for moving the implant from the actual location to the target location. If the actual location is the same as the target location (or within a threshold deviation degree from the target location), the method optionally sends a notification confirming that the actual location is compatible with the target location. can be provided.

The techniques described above can be used to confirm proper placement of the implant during and/or after the implantation procedure. For example, in some embodiments, any of the techniques described above may be used to ensure that the implant is positioned at the target location prior to completing the implantation procedure. The techniques described above can be used during postoperative patient follow-up visits to ensure that the implant remains in the target location (e.g., to ensure that the implant is not displaced or extruded). ).

D. Patient-specific implants and robotic surgical platforms
FIG. 7 shows that a robotic surgical platform 750 (hereinafter referred to as "platform 750") is used to access a patient-specific surgical plan (hereinafter referred to as "surgical plan") and a patient-specific prosthetic implant 700 (hereinafter referred to as "implant 700"). 2 shows various aspects of the procedure for implanting a patient P into a patient P. Implant 700 may include a screw (e.g., bone screw, spinal screw, vertebral root screw, facet screw), interbody implant device (e.g., intervertebral implant), cage, plate, rod, disc, fusion device, spacer, Items herein such as rods, extendable devices, stents, brackets, strings, scaffolds, anchoring devices, anchors, nuts, bolts, rivets, connectors, tethers, fasteners, joint replacements (e.g., artificial discs), or hip implants, etc. It can be any of the implants mentioned above in the book.

Platform 750 can be used, for example, to prepare tissue for an incision, to make an incision, to perform an ablation, to remove tissue, to manipulate tissue, to perform a corrective operation, or to target an implant to a site. deploying the implant at the target site; adjusting the implant at the target site; manipulating the implant after implantation; securing the implant at the target site; removing the implant; The device may be configured to perform or otherwise assist in one or more aspects of an operating procedure, including suturing and the like. For example, platform 750 may be used to carry various surgical tools (e.g., grasping forceps, clips, needles, needle drives, irrigation tools, suction tools, stapling anastomoses, etc.), imaging instruments (e.g., cameras, sensors, etc.), and/or medical The platform 750 can include one or more arms 755 and an end effector for holding a device (e.g., an implant 700) and allowing the platform 750 to carry out one or more aspects of a surgical plan. can. Although shown as having one arm 755, those skilled in the art will appreciate that platform 750 can have multiple (e.g., two, three, four, or more) arms and any number of joints, connections, It will be appreciated that it can have motors and degrees of freedom. In some embodiments, platform 750 can have a first arm dedicated to holding one or more imaging instruments, whereas the remainder of the arms hold various surgical tools. do. In some embodiments, these tools can be removably secured to the arm so that they can be selectively replaced before, during, or after the actuation procedure. The arm can be movable through various ranges of motion (eg, degrees of freedom) to provide sufficient agility to perform various aspects of the actuation procedure.

Platform 750 can include a control module 760 for controlling actuation of arm 755. In some embodiments, control module 760 includes a user input device (not shown) to control actuation of arm 755. A user input device can be a joystick, mouse, keyboard, touch screen, infrared sensor, touch pad, wearable input device, camera-based or image-based input device, microphone, or other user input device. A user (eg, a surgeon) can interact with a user input device to control movement of arm 755. In some embodiments, control module 760 includes one or more processors for executing machine-readable instructions that, when executed, automatically control operation of arm 755. In such embodiments, control module 760 may specify one or more steps of a surgical procedure and cause platform 750 to perform the one or more steps of the surgical procedure when executed by control module 760. Readable instructions can be received. For example, the machine-readable instructions may provide tissue for an incision, make an incision, make a resection, remove tissue, manipulate tissue, perform a corrective operation, deliver implant 700 to a target site, to the target site, adjust the configuration of the implant 700 at the target site, manipulate the implant 700 after implantation, secure the implant 700 to the target site, remove the implant 700, suture tissue, etc. Surgical platform 750 can be guided to do so. To that end, these instructions may include specific instructions for articulating arm 755 to perform or otherwise assist in delivery of a patient-specific implant.

Platform 750 may include additional components not explicitly shown in FIG. For example, in various embodiments, platform 750 may include one or more displays (e.g., 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)), one or more I/O devices (e.g., network card, video card, audio card, USB, Firewire or other external device, camera, printer, speaker, CD-ROM drive, DVD drive, disk one or more communication devices (e.g., components with VLC, WiMax, LTE, WLAN, IR communication, PSTN, radio, Bluetooth, and/or Wi-Fi operational capabilities); / or memory (e.g., random access memory (RAM), various caches, CPU registers, read-only memory (ROM), as well as writable non-volatile memory, e.g., flash memory, hard drives, floppy disks, CDs, DVDs, (magnetic storage devices, tape drives, device buffers, etc.). In some embodiments, the components described above may be substantially similar to similar components described in detail with respect to computing device 200 of FIG.

Implant 700 can be transported to the operating room within packaging 710. As mentioned above, the surgical plan for implanting the implant 700 into the patient P can be linked to the packaging 710 and/or the implant 700 itself. Surgical plans can be stored locally, remotely, or both locally and remotely. For example, the surgical plan can be stored remotely in cloud 706, locally in data storage element 730, or both in cloud 706 and data storage element 730. In embodiments where the surgical plan is stored remotely, in addition to or instead of being stored in the cloud 706, the surgical plan is stored on a server (e.g., server 106 shown in FIG. 1) or on another network-connected server. It may be stored on a device or system (eg, system 100 of FIG. 1). Cloud 706 (or a server or other network-attached data storage system) receives requests for specific surgical plans from computing devices (such as computing device 740 or computing device 102 shown in FIG. 1) and posts such plans to the platform. You can send it to 750. If the surgical plan includes executable instructions, platform 750 can execute the instructions to perform at least a portion of the surgical procedure. In some embodiments, platform 750 can generate executable instructions based on the surgical plan. For example, a surgical plan can include information about delivery routes, tools, and implantation sites. Platform 750 analyzes surgical plans and develops executable instructions to perform patient-specific procedures based on robotic system capabilities (robot arm configuration and number, end effector capabilities, guidance systems, visualization systems, etc.). can do. This allows system 100 to be compatible with a wide variety of different types of robotic surgical systems.

As described above, the implant 700 and/or the packaging 710 may include one or more components for accessing, downloading, and/or transmitting surgical planning and/or other information contained within patient-specific data sets. Including the above features. For example, in some embodiments where the surgical plan is stored remotely, the packaging 710 can include one or more search features, such as a QR code 722 and/or a barcode 720. Packaging 710 may include other search features, such as any of the search features described herein above, in addition to or in place of QR code 722 and barcode 720. Using the QR code 722 and/or barcode 720, the surgical plan can be downloaded or otherwise accessed. For example, a user may scan a QR code 722 and/or barcode 720 using a scanner or other computing device 740 (e.g., using a camera on a smart phone) to identify the implant 700 and the surgical plan associated with the implant 700 and the surgical plan. A unique identifier can be obtained. A scanner or other computing device 740 can send (eg, automatically send) a request including this unique identifier to cloud 706 to identify a surgical plan for implant 700. Computing device 740 may be in communication with cloud 706 (or other server) and/or platform 750 through wired or wireless connections. In some embodiments, computing device 740 may be part of platform 750.

Once identified, cloud 706 can directly send the surgical plan to platform 750 for execution. In some embodiments, cloud 706 may transmit surgical plans to one or more intermediate network connected devices rather than directly to platform 750. For example, cloud 706 can send the surgical plan to computing device 740 and/or computing device 102 described above with respect to FIG. 1 . A user may use a computing device to review the surgical plan before submitting it to platform 750 for execution. Although shown positioned on packaging 710, the search feature can be positioned on the implant 700 itself as described herein above.

In some embodiments, implant 700 includes one or more patient-specific markings 725. As discussed above with respect to implant 500 shown in FIG. 5, patient-specific markings 725 can include string information about implant 500 and/or patient P (eg, patient name, patient MRN, target implant location, etc.). In some embodiments, this information (patient name or patient MRN) is used to access the surgical plan by entering it into the computing device 740 (e.g., manual entry, such as typing). can do. The surgical plan can then be accessed in a manner substantially similar to that described above with respect to search features 720, 722.

The surgical plan may be stored locally on data storage element 730. Data storage element 730 may be any suitable data storage element described herein above. Data storage element 730 can include a transmitter (not shown) for wirelessly transmitting the surgical plan to platform 750 for execution. In some embodiments, data storage element 730 may route the surgical plan to one or more intermediate devices rather than directly to platform 750. For example, data storage element 730 can transmit the surgical plan to computing device 740 or computing device 102 (eg, for review by a surgeon). Similarly, data storage element 730 can be coupled directly to computing device 102, computing device 740, and/or platform 750 for transmitting surgical plans through wires or other physical connections. For example, data storage element 730 can be coupled directly to computing device 740 and computing device 740 can be used to transmit a surgical plan to platform 750. As discussed herein above, data storage elements can be incorporated within the implant 700 itself.

Without being bound by theory, it is anticipated that using a robotic surgical platform to perform various aspects of the surgical planning described herein provides several advantages over conventional surgical techniques. For example, the use of robotic surgical platforms can reduce incision size, reduce blood loss, shorten the length of the operating procedure, and improve surgical precision and precision (e.g., implant placement at target locations). Surgical outcomes can be improved and/or recovery times can be shortened, such as by improving the placement of the Similarly, platform 750 may be configured to use one or more devices to obtain information from an instrument (e.g., an instrument with a search feature), a tool, a patient-specific implant 700 (e.g., after being grasped by arm 755), etc. By including a scanner, errors in user input may be avoided or reduced. Platform 750 can confirm proper instrument usage before and during the surgical procedure. If platform 750 identifies an incorrect instrument or tool, a notification may be sent to the user that another instrument or tool should be attached. The user can scan the new instrument to confirm that it is appropriate for the surgical plan. In some embodiments, the surgical plan includes usage instructions, a list of instruments, instrument specifications, replacement instruments, and the like. Platform 750 can perform pre-operative and post-operative prescribed tests based on information from the scanner.

8A-8C illustrate additional representative examples for accessing patient-specific data using the various features described herein before, during, and after a surgical procedure. For simplicity, FIGS. 8A-8C illustrate an implant 700 that includes only patient-specific markings 725. Although each of FIGS. 8A-8C only illustrates retrieving data using patient-specific markings 725, those skilled in the art will appreciate that search features 720, 722 (FIG. 7) and/or data storage elements 730 ( It will be appreciated that the same or similar steps can be performed when obtaining information using Figure 7).

Referring first to FIG. 8A, a user may determine patient-specific information using computing device 740 to scan, read, image, or otherwise interact with patient-specific markings 725. For example, in embodiments where patient-specific markings 725 include a QR code, a user can scan the QR code using a camera on computing device 740. Accordingly, computing device 740 can display information encoded within the QR code. Of course, in some embodiments, computing device 740 may be used to scan search features 720, 722 (shown in FIG. 7) in a substantially similar manner to access patient data sets stored on a remote server. can do. In some embodiments, the implant 700 is removed from the patient and then read to obtain information used, for example, to select a replacement implant.

Referring now to FIG. 8B, a user may determine patient-specific information using computing device 740 during a surgical procedure. For example, a user may use computing device 740 to scan, read, image, or otherwise interact with patient-specific markings 725 in a manner generally similar to that described with respect to FIG. 8A. Additionally, surgical platform 750 can be configured to read or otherwise determine information from patient-specific markings 725 (and/or search features 720, 722 and data storage element 730) during a surgical procedure. For example, in embodiments where patient-specific markings 725 include an alphanumeric code and/or one or more words and/or characters, robotic surgical platform 750 may include one having the ability to perform optical character recognition (OCR) techniques. Or it can include two or more cameras. In embodiments where the patient-specific markings 725 include an MR code, barcode, and/or QR code, the robotic surgical platform 750 scans, reads, and/or It can also include one or more cameras with other acquisition capabilities.

Referring now to FIG. 8C, a user can determine patient-specific information after implant 700 is implanted within patient P. For example, positioning an imaging system 770 (e.g., a system for acquiring one or more of MRI, CAT scan, PET scan, X-ray, ultrasound, etc.) over the portion of patient P that includes implant 700. be able to. Imaging system 770 can capture images of implant 700 including patient-specific markings 725. A computer module (e.g., computer device 740) may analyze image data obtained by imaging system 770 and extract information from implant 700 (e.g., patient-specific markings 725, search features such as barcodes, etc.). (e.g., by OCR, convolutional neural networks, etc.). The computer module can then configure a virtual model of the reconstructed information and display the virtual model to the user. For example, in embodiments where patient-specific marking 725 is a string of text, the computer module can reconstruct a virtual rendering of the string and display the string to the user. In embodiments where the implant includes barcodes or QR codes, the computer module can reconstruct a virtual rendering of the barcodes or QR codes and display it to the user, so that the user can The code or QR code can be scanned to access the corresponding patient-specific data set. In some embodiments, the computer module may perform additional analysis or transformations while reconstructing the information. For example, in some embodiments, patient-specific markings 725 can include machine-readable information (e.g., barcodes, alphanumeric codes, shapes, etc.), and the computer module extracts this machine-readable information and can be converted (e.g., decoded) into virtually rendered human-readable information and displayed to the user.

Conclusion The detailed description provided above illustrates various embodiments of devices and/or processes through the use of block diagrams, flowcharts, and/or example implementations. Such block diagrams, flow diagrams, and/or embodiments may vary insofar as they include one or more features and/or acts within such block diagrams, flow diagrams, and/or embodiments. Those skilled in the art will appreciate that they can be implemented individually and/or in conjunction with hardware, software, firmware, or virtually any combination thereof. In some embodiments, some portions of the subject matter described herein are implemented in application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), digital signal processors (DSPs), or other integrated formats. It can be executed by However, those skilled in the art will appreciate that aspects of some embodiments disclosed herein may be implemented, in whole or in part, as one or more computer programs running on one or more computers (e.g., one or more computers). 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. running on one or more microprocessors) that it can equally be implemented in an integrated circuit as one or more programs), as firmware, or as virtually any combination thereof; It will be appreciated that the steps of writing code for are considered to be well within the skill of those skilled in the art in light of the present disclosure. Additionally, those skilled in the art will appreciate that the features of the subject matter described herein can be provided as program products in various forms, and that the exemplary embodiments of the subject matter described herein may be provided in practice. It will be appreciated that this holds true regardless of the particular type of signal-bearing medium used in the implementation. Examples of signal-bearing media include recordable media such as floppy disks, hard disk drives, CDs, DVDs, digital tape, computer memory, and digital and/or analog communication media (e.g., fiber optic cables, waveguides, etc.). , wired communication links, wireless communication links, etc.).

It is common practice in the art to describe devices and/or processes in the manner described herein and thus use technical methods to integrate such described devices and/or processes into data processing systems. Those skilled in the art will recognize that 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 appreciate that a typical data processing system includes 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, an operating system, drives, a graphical user interfaces and computer entities such as application programs, one or more interaction devices such as touch pads or touch screens, and/or feedback loops and control motors (feedback components for sensing position and/or velocity); and/or control motors for moving and/or adjusting quantities. A typical data processing system may be implemented using any suitable commercially available components such as those commonly found in data computer/communication systems and/or network computer/communication systems.

The subject matter described herein depicts various components sometimes contained within or connected to different other components. It should be appreciated that the architecture so illustrated is only an example and that in practice many other architectures with the same effect may be implemented. In a conceptual sense, any arrangement of like-acting components is substantially "associated" such that the desired functionality is provided. Thus, any two components that are combined to perform a particular function can be viewed as "associated" with each other such that the desired functionality is provided regardless of the architecture or intermediate components. Similarly, any two components so associated may be considered to be "operably connected" or "operably coupled" to each other so as to effect the desired effect. Any two components having functionality associated with can be considered to be "operably combinable" with each other to produce a desired effect. Particular examples of operably connectable components include physically matable and/or physically interacting components, wirelessly interactive and/or wirelessly interacting components, and/or logical components. including, but not limited to, logically interactive and/or logically interactive components.

The embodiments, features, systems, devices, materials, methods, and techniques described herein are, in some embodiments, the embodiments, features, systems, devices, materials, methods, and techniques described below. It may be similar to any one or more of:
U.S. Patent Application No. 16/048,167 entitled “SYSTEMS AND METHODS FOR ASSISTING AND AUGMENTING SURGICAL PROCEDURES,” filed July 27, 2018;
``SYSTEMS AND METHODS OF ASSISTING A SURGEON WITH SCREW PLACEMENT DURING SPINAL SURGERY'' filed on January 8, 2019 US Patent Application No. No. 16/242,877,
U.S. Patent Application No. 16/207,116 entitled ``SYSTEMS AND METHODS FOR MULTI-PLANAR ORTHOPEDIC ALIGNMENT'' filed December 1, 2018
U.S. Patent Application No. 16/352,699 entitled "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION," filed March 13, 2019;
U.S. Patent Application No. 16/383,215 entitled "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION," filed April 12, 2019;
U.S. Patent Application No. 16/569,494 entitled "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS," filed September 12, 2019;
U.S. Patent Application No. 16/699,447 entitled "SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS," filed November 29, 2019;
A U.S. patent application entitled “SYSTEMS AND METHODS FOR DESIGNING ORTHOPEDIC IMPLANTS BASED ON TISSUE CHARACTERISTICS” filed on October 30, 2020 Patent Application No. 17/085, Specification No. 564,
U.S. Patent Application No. 16 entitled “PATIENT-SPECIFIC MEDICAL PROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMS AND METHODS,” filed January 6, 2020. /735, Specification No. 222,
U.S. Patent Application No. 16/98 entitled “PATIENT-SPECIFIC ARTIFICIAL DISCS, IMPLANTS AND ASSOCIATED SYSTEMS AND METHODS” filed August 6, 2020 7,113 No. specification,
U.S. Patent Application No. 17/100,396 entitled “PATIENT-SPECIFIC VERTEBRAL IMPLANTS WITH POSITIONING FEATURES,” filed November 20, 2020, and June 2021; U.S. Patent Application No. 17/342,439 entitled "PATIENT-SPECIFIC MEDICAL PROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMS AND METHODS," filed on the 8th. No. specification.

All patents and applications identified above are incorporated by reference in their entirety. In addition, the embodiments, features, systems, devices, materials, methods, and techniques described herein may, in certain embodiments, It may be applied to one or more of the above or used in combination with the above.

400 Patient-Specific Implant 410 Packaging 420 Search Features 430 Data Storage Elements

Claims (91)

A system for providing medical care,
A patient-specific implant designed to be implanted at a target site within a particular patient, the patient-specific implant having at least one structure designed to engage one or more identified anatomical structures at the target site. the patient-specific implant including a feature;
a patient-specific surgical plan comprising instructions for implanting the patient-specific implant at the target site such that the at least one structural feature engages the one or more identified anatomical structures;
a data storage module having a memory for storing the patient-specific surgical plan;
a retrieval module configured to transmit the patient-specific surgical plan from the data storage module to a surgical platform configured to perform one or more aspects of the patient-specific surgical plan;
A system characterized by comprising: The data storage module includes a data storage element positioned on or within (i) the patient-specific implant or (ii) packaging configured to hold the patient-specific implant;
the retrieval module includes one or more transmitters for transmitting the patient-specific surgical plan from the data storage element to the surgical platform;
The system according to claim 1, characterized in that: 3. The system of claim 2, wherein the one or more transmitters include an antenna, a proximity sensor, and/or a location sensor. the data storage module includes a cloud-based storage module or a remote server;
the search module includes one or more search features for downloading the patient-specific surgical plan stored on the cloud-based storage module or the remote server;
The system according to claim 1, characterized in that: 5. The system of claim 4, wherein the one or more search features include an MR code, a QR code, and/or a barcode. The system of claim 1, wherein the search module is positioned on or within the patient-specific implant. further comprising packaging for the patient-specific implant;
the search feature is positioned on or within the packaging;
The system according to claim 1, characterized in that: the surgical platform is a robotic surgical platform;
the instructions include machine-readable instructions that, when executed by the robotic surgical platform, cause the robotic surgical platform to perform one or more aspects of the patient-specific surgical plan;
The system according to claim 1, characterized in that: The one or more aspects include preparing the tissue for incision, making the incision, performing the resection, removing the tissue, manipulating the tissue, performing a corrective operation, delivering a patient-specific implant to the target site; deploying the patient-specific implant to the target site; adjusting the configuration of the patient-specific implant at the target site; 9. The system of claim 8, further comprising the steps of: manipulating the patient-specific implant after implantation; securing the patient-specific implant to the target site; and/or suturing tissue. 2. The instructions of claim 1, wherein the instructions include computer readable instructions that, when executed by a processor coupled to a display, cause at least one step for performing the patient-specific surgical plan to be displayed through the display. patient-specific implants. A patient-specific implant designed to be implanted at a target location within a particular patient, the patient-specific implant comprising:
an implant body configured to interface with one or more identified anatomical structures at and/or near the target location;
a data storage element positioned on and/or within the implant body and configured to be implanted with the patient-specific implant, the data storage element having a memory for storing data, the data comprising: (i) first data specifying at least one stage of a patient-specific surgical plan for implanting the patient-specific implant at the target location; and (ii) second data specifying at least one characteristic of the patient-specific implant. the data storage element containing data;
A patient-specific implant characterized by comprising: the implant body includes at least one structural feature designed to engage a respective one of the one or more identified anatomical structures;
The first data is configured to deliver the implant body to the target location such that the at least one structural feature engages the respective one of the one or more identified anatomical structures. comprising instructions for executing said patient-specific surgical plan to
12. Patient-specific implant according to claim 11. 13. The patient-specific surgical method of claim 12, wherein the instructions include machine-readable instructions that, when executed by the robotic surgical platform, cause the robotic surgical platform to perform one or more aspects of the patient-specific surgical plan. implant. 13. The instructions of claim 12, wherein the instructions include computer readable instructions that, when executed by a processor coupled to a display, cause at least one step for performing the patient-specific surgical plan to be displayed through the display. patient-specific implants. The instructions are encoded;
the instructions are configured to be decoded and used to execute the patient-specific surgical plan;
13. Patient-specific implant according to claim 12. 12. The patient-specific implant of claim 11, wherein the data includes the target location. 12. The patient-specific implant of claim 11, wherein the data includes one or more of preoperative planning, surgical procedure, surgical technique, and/or one or more surgical steps. The second data may include implant dimensions, implant composition, unique implant identification code, implant part number, implant lot code, implant manufacturing date, implant implantation date, implant expiration date, implant sterilization history, and/or implant manufacturing history. 12. A patient-specific implant according to claim 11, characterized in that it comprises one or more of: 12. The patient-specific implant of claim 11, wherein the data storage element further includes third data associated with the particular patient. 20. The patient-specific implant of claim 19, wherein the third data includes patient information, patient medical history, patient medical record number, and/or physician's certificate regarding the patient. 12. The patient-specific implant of claim 11, wherein the data is accessible after the patient-specific implant is implanted in the patient. and configured to transmit at least a portion of the first data and/or the second data from the data storage element to a device positioned external to the patient when the patient-specific implant is implanted in the patient. 12. The patient-specific implant of claim 11, further comprising a transmitter. The transmitter is configured to transmit the portion of the first data and/or the second data to the external device when the transmitter is exposed to an electric field and/or a magnetic field. 23. The patient-specific implant of claim 22. 23. The patient-specific implant of claim 22, wherein the implant body includes a structural feature that acts as the transmitter. 25. The patient-specific implant of claim 24, wherein the transmitter includes an antenna. 12. The patient-specific implant includes a location sensor configured to wirelessly transmit information regarding the location of the patient-specific implant when the patient-specific implant is implanted in the patient. Patient-specific implants. 27. Patient-specific implant according to claim 26, characterized in that the position sensor is included on and/or within the data storage element. 12. The patient-specific implant of claim 11, wherein the data storage element is an implantable microchip. A patient-specific implant designed to be implanted at a target location within a particular patient, the patient-specific implant comprising:
an implant body configured to interface with one or more identified anatomical structures at and/or near the target location;
(i) a data storage element positioned on and/or within the patient-specific implant, the data storage element having a memory for storing patient-specific data that is accessible after the patient-specific implant has been implanted; ii) a search feature positioned on and/or within the patient-specific implant, said search feature configured to provide access to the patient-specific data after the patient-specific implant is implanted; at least one of
Equipped with
The patient-specific data includes:
first data associated with a patient-specific surgical plan for implanting the patient-specific implant at the target location;
second data associated with the patient-specific implant;
including,
A patient-specific implant characterized by: 30. The patient-specific implant of claim 29, comprising the data storage element. 31. The patient-specific implant of claim 30, wherein the data storage element is an implantable microchip. 30. The patient-specific implant of claim 29, comprising the search feature. 33. The patient-specific implant of claim 32, wherein the search feature is an MR graphic, a QR code, a bar code, or an alphanumeric code. 30. The patient-specific implant of claim 29, comprising both the data storage element and the search feature. 35. The patient-specific implant of claim 34, wherein the search feature is a transmitter. 30. The patient-specific implant according to claim 29, wherein the first data includes one or more of a preoperative plan, a surgical procedure, a surgical technique, and/or one or more surgical steps. . A system for providing personalized medical care,
a patient-specific implant configured to interface with one or more identified anatomical structures at and/or near the target location;
the patient-specific implant; and at least one of (i) a data storage element having a memory for storing patient-specific data; or (ii) a machine-readable search feature configured to provide access to the patient-specific data. and packaging including;
Equipped with
The patient-specific data includes data specifying at least one stage of a patient-specific surgical plan for implanting the patient-specific implant at the target location.
A system characterized by: the patient-specific implant includes at least one structural feature designed to engage a respective one of the one or more identified anatomical structures;
The first data directs the patient-specific implant to the target location such that the at least one structural feature engages the respective one of the one or more identified anatomical structures. including instructions for executing the patient-specific surgical plan to be sent;
38. The system of claim 37. 38. The system of claim 37, including the machine readable search feature. 40. The system of claim 39, wherein the machine readable search feature is an MR graphic, a QR code, or a barcode. 38. The system of claim 37, wherein the patient-specific implant includes both the data storage element and the machine-readable search feature. 38. The system of claim 37, wherein the first data includes one or more of a preoperative plan, a surgical procedure, a surgical technique, and/or one or more surgical steps. A system for storing a plurality of patient-specific data sets associated with a plurality of patient-specific implants, the system comprising:
one or more processors;
a memory storing said plurality of patient-specific data sets, each individual patient-specific data set comprising:
first data associated with a patient-specific surgical plan for implanting a corresponding patient-specific implant at a target location within a particular patient, the one or more of the patient-specific surgical plans when executed by the robotic surgical platform; and second data associated with the corresponding patient-specific implant; and second data associated with the corresponding patient-specific implant.
the memory including;
A system characterized by comprising: each individual patient-specific data set of the plurality of patient-specific data sets is associated with a unique identifier;
The memory, when executed by the one or more processors,
receiving a unique identifier;
comparing the received unique identifier with each of the unique identifiers associated with each of the patient-specific data sets;
transmitting a respective patient-specific data set if the received unique identifier matches one of the respective unique identifiers associated with the respective patient-specific data set;
storing instructions that cause the system to perform operations comprising;
44. The system of claim 43. an alert indicating that no patient-specific data sets have been identified if the received unique identifier does not match one of the plurality of unique identifiers associated with each of the patient-specific data sets; 45. The system of claim 44, characterized by the step of transmitting. 45. The system of claim 44, wherein the unique identifier is a randomly generated alphanumeric code, a PIN number, a patient medical record number, or a patient name. 44. The patient-specific implant of claim 43, wherein the first data includes the target location. 44. The patient-specific implant of claim 43, wherein the first data includes one or more of a preoperative plan, a surgical procedure, a surgical technique, and/or one or more surgical steps. . The second data may include implant dimensions, implant composition, unique implant identification code, implant part number, implant lot code, implant manufacturing date, implant implantation date, implant expiration date, implant sterilization history, and/or implant manufacturing history. 44. The patient-specific implant of claim 43, comprising one or more of: A method of providing medical care associated with an implanted patient-specific implant, the method comprising:
obtaining patient-specific data from the implanted patient-specific implant, including a predetermined target implant location for the patient-specific implant based on the patient's anatomy and/or medical condition;
determining the actual location of the patient-specific implant;
comparing the actual location of the patient-specific implant to the predetermined target implant location for the patient-specific implant;
A method characterized by comprising: 51. The method of claim 50, wherein obtaining the patient-specific data includes receiving the patient-specific data from a data storage element included on the patient-specific implant. 52. The method of claim 51, wherein acquiring the patient-specific data includes exposing the patient-specific implant to an electric field and/or a magnetic field. 52. The method of claim 51, wherein acquiring the patient-specific data includes exposing the patient-specific implant to RF energy. 52. The method of claim 51, wherein the data storage element includes a transmitter for transmitting the patient-specific data from the data storage element to an external device. 55. The method of claim 54, wherein the transmitter is an antenna. the patient-specific data is stored on a server;
Obtaining the patient-specific data includes:
obtaining a unique identifier from the patient-specific implant;
using the unique identifier to access the patient-specific data stored on a server;
including,
51. The method of claim 50. 51. The method of claim 50, wherein determining the actual location of the patient-specific implant includes capturing image data of the actual location of the patient-specific implant. The step of comparing the actual position of the patient-specific implant with the predetermined target implantation location for the patient-specific implant includes the step of comparing the actual position of the patient-specific implant with the predetermined target implant location for the patient-specific implant. 51. The method of claim 50, comprising using an image analysis module to identify if the implant location is different. 59. The method of claim 58, wherein the image analysis module is an artificial intelligence architecture. 51. The method of claim 50, wherein the patient-specific data further includes patient data and patient-specific implant data. 61. The method of claim 60, wherein the patient data includes patient information, patient medical history, patient medical record numbers, and/or a physician's note regarding the patient. The patient-specific implant data includes implant dimensions, implant composition, unique implant identification code, implant part number, implant lot code, implant manufacturing date, implant implantation date, implant expiration date, implant sterilization history, and/or implant manufacturing history. 61. The method of claim 60. A method of providing patient-specific medical care, the method comprising:
identifying a target location within the patient;
designing a patient-specific implant configured to be implanted at the target location, the patient-specific implant comprising: (i) a data storage element having a memory for storing patient-specific data; or (ii) the patient-specific data. said designing further configured to include at least one of the search features configured to provide access to;
generating a patient-specific surgical plan for implanting the patient-specific implant at the target location, wherein at least some aspects of the patient-specific surgical plan are included along with the patient-specific data;
A method characterized by comprising: Generating the patient-specific surgical plan includes generating machine-readable instructions that, when executed by the surgical robotic platform, cause the surgical robotic platform to perform one or more aspects of the patient-specific surgical plan. 64. The method of claim 63, characterized in that: 64. The patient-specific implant of claim 63, wherein the patient-specific implant includes the data storage element. 66. The patient-specific implant of claim 65, wherein the data storage element is an implantable microchip. 64. The patient-specific implant of claim 63, wherein the patient-specific implant includes the search feature. 68. The patient-specific implant of claim 67, wherein the search feature is an MR graphic, a QR code, a bar code, or an alphanumeric code. 64. The patient-specific implant of claim 63, wherein the patient-specific implant includes both the data storage element and the search feature. 70. The patient-specific implant of claim 69, wherein the search feature is a transmitter. A system for providing medical care,
A patient-specific implant designed to be implanted at a target site within a particular patient, the patient-specific implant having at least one structure designed to engage one or more identified anatomical structures at the target site. the patient-specific implant including a feature;
a patient-specific surgical plan comprising instructions for implanting the patient-specific implant at the target site such that the at least one structural feature engages the one or more identified anatomical structures;
means for transmitting the patient-specific surgical plan to a surgical platform configured to perform one or more aspects of the patient-specific surgical plan;
A system characterized by comprising: The means for transmitting includes an antenna coupled to the patient-specific implant, a transmitter coupled to the patient-specific implant, one or more search features coupled to the patient-specific implant, and/or communication. 72. A system for providing medical care according to claim 71, comprising a module. A patient-specific implant,
an implant body configured to interface with one or more identified anatomical structures at and/or near the target location;
patient-specific markings coupled to or otherwise imprinted on a surface of the implant body and corresponding to data regarding the patient and/or the patient-specific implant, the patient-specific identifier comprising letters, words, symbols, said patient-specific markings comprising one or more of an alphanumeric code, a QR code, a barcode, and/or an MR code;
Equipped with
the patient-specific markings are configured to be readable by an imaging system after the patient-specific implant is implanted in the patient;
A patient-specific implant characterized by: 74. The patient-specific implant of claim 73, wherein the patient-specific identifier is configured to be read using an external imaging system. 10. The data includes at least one of a patient's name, patient's initials, target location information, treatment level of the patient's spinal column, and/or one or more specifications of the implant. 73. Patient-specific implant according to 73. 74. The patient-specific implant of claim 73, wherein the patient-specific identifier includes at least one of a printed marking, an embossed marking, or a debossed marking. A system for providing medical care,
A patient-specific implant designed to be implanted at a target site within a patient, the patient-specific implant comprising:
at least one structural feature designed to engage one or more identified anatomical structures at the target site; and at least one structural feature coupled to or otherwise imprinted on a surface of the implant. at least one patient-specific identifier;
said patient-specific implant comprising;
a surgical plan comprising instructions for implanting the patient-specific implant at the target site such that the at least one structural feature engages the one or more identified anatomical structures;
a data storage module having a memory for storing the surgical plan;
a retrieval module configured to transmit the patient-specific surgical plan from the data storage module to a surgical platform configured to perform one or more aspects of the patient-specific surgical plan;
A system characterized by comprising: 78. The system of claim 77, wherein the at least one patient-specific marking provides search information for retrieving data from the data storage. 79. The system of claim 78, wherein the search data includes patient information, surgical procedure information, and/or implant information. 78. The system of claim 77, wherein the at least one patient-specific identifier corresponds to information related to the patient, the patient-specific implant, and/or the surgical plan. 78. The information includes at least one of a patient's name, patient's initials, date, target site, treatment level of the patient's spinal column, and/or data regarding the implant. System described. A method of providing patient-specific medical care, the method comprising:
identifying a target location within the patient;
designing a patient-specific implant configured to be implanted at the target location, the patient-specific implant having a patient-specific implant attached to or otherwise imprinted on the body of the patient-specific implant; the step of designing, including an identifier;
generating a patient-specific surgical plan for implanting the patient-specific implant at the target location;
Equipped with
the patient-specific identifier corresponds to information related to at least one of (i) the patient, (ii) the patient-specific implant, and/or (iii) the patient-specific surgical plan;
The patient-specific identifier includes one or more of letters, words, symbols, alphanumeric codes, QR codes, bar codes, and/or MR codes.
A method characterized by: 83. The information includes at least one of a patient's name, patient's initials, date, target location, treatment level of the patient's spinal column, and/or data regarding the implant. Method described. The method further comprises using the patient-specific identifier to determine the information corresponding to (i) the patient, (ii) the patient-specific implant, and/or (iii) the patient-specific surgical plan. 83. The method of claim 82. A method of providing patient-specific medical care, the method comprising:
receiving image data of a spinal region of a patient having a previously implanted patient-specific implant positioned at or near the patient's spinal column;
analyzing the image data to identify one or more patient-specific markings on the one or more patient-specific implants;
using the one or more patient-specific markings to retrieve a remotely stored patient-specific data set that includes data associated with the patient and the patient-specific implant, and further includes target locations for the patient-specific implant; and the step of
comparing the target location for the patient-specific implant with the actual location of the patient-specific implant by analyzing the image data;
generating a first alarm containing information regarding the deviation if the actual position of the patient-specific implant deviates from the target position of the patient-specific implant by a threshold amount;
the actual position of the patient-specific implant is within the threshold of deviation from the target position if the actual position of the patient-specific implant does not deviate by the threshold amount from the target position of the patient-specific implant; generating a second alarm including indicating;
A method characterized by comprising: 86. The method of claim 85, wherein comparing the target location to the actual location includes using a trained machine learning model. 86. The method of claim 85, wherein analyzing the patient-specific markings includes using a trained machine learning model. 86. The method of claim 85, further comprising providing one or more recommended medical procedures to perform if the actual location deviates from the target location by the threshold amount. Method. A method of providing patient-specific medical care, the method comprising:
identifying patient-specific markings on the patient-specific implant;
accessing a first patient-specific data set stored on a remote server storing a plurality of patient-specific data sets;
comparing the patient-specific markings to the first patient-specific data set to determine whether the first patient-specific data set corresponds to the patient-specific implant;
downloading the first patient-specific data set if the first patient-specific data set is confirmed as corresponding to the patient-specific implant;
accessing a second patient-specific data set if the first patient-specific data set is not confirmed as corresponding to the patient-specific implant;
A method characterized by comprising: The patient-specific data set includes machine-readable instructions configured to guide a surgical robotic platform to perform one or more aspects of a surgical plan for implanting the patient-specific implant into a subject patient. including,
downloading the patient-specific data set includes downloading the machine-readable instructions;
90. The method of claim 89. 90. The method of claim 89, wherein identifying the patient-specific markings includes identifying the patient-specific markings after the patient-specific implant is implanted in a subject.

Images