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The system 900 may include a patient-specific device design apparatus 450. The patient-specific device design apparatus 450 may take the form of a design system, a design module, a design circuit, design software, design firmware, or the like. The patient-specific device design apparatus 450 manages the design features of the system 900 and can output a variety of information including designs, models, reports, plans, inventories, instrument lists, three-dimensional physical devices and/or models (e.g., a patient-specific device model, bone models, a physical patient-specific device, a physical bone model, a preoperative plan, a surgical instrument list, and the like) for a user. |
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In various examples, the memory 906 stores code executable by the processor 904 to generate and/or enable generation/fabrication of a patient-specific device by an apparatus such as patient-specific device design apparatus 450. In another example, the patient-specific device design apparatus 450 may generate the files and/or data needed for a manufacturing tool, including for example an additive manufacturing tool, to fabricate the patient-specific device based on instructions from the patient-specific device design apparatus 450. |
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In certain embodiments, the code may be configured to implement one or more features, functions, aspects, and/or attributes of the present disclosure. "Code" or "Executable Code" refers to a set of instructions configured for reading and executing by a processor of a computing device. The code may exist in machine-readable and/or human readable formats. Examples of code include binary code, machine code, scripts, compiled code, virtual machine code, and the like. The code may be stored on a computer-readable storage media. "Computer readable storage media" refers to any hardware, device, component, element, or circuit configured to maintain an alterable physical characteristic used to represent a binary value of zero or one either while a primary power source is available or after a primary power source is removed. Computer readable storage media may be used interchangeably herein with the term non-volatile memory media or volatile memory media. |
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In various example implementations, the system 900 receives a work instruction for a patient-specific device using the I/O interface 910, the processor 904, and/or the memory 906. The work instruction can include a workflow. The system 900 may navigate the workflow either independently, or together with a user, using the processor 904, memory 906, the communication interface 908, the storage device 914, and/or the I/O interface 910 to generate one or more bone models and/or one or more patient-specific device models. The system 900 may also use the processor 904, memory 906, the communication interface 908, the storage device 914, and/or the I/O interface 910 to fabricate a patient-specific device from a patient-specific model. |
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In one embodiment, the computing device 902 may include the apparatus, systems, and/or components to fabricate the patient-specific device. In another embodiment, the computing device 902 may use the communication interface 908 and/or I/O interface 910 to send instructions to another system, facility, apparatus, and/or third party that follows the instructions to fabricate the patient-specific device from the patient-specific device model. |
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FIG. 10 illustrates an exemplary system 1000 configured to generate and/or design a patient-specific device, according to one embodiment. Those of skill in the art will appreciate that the patient-specific device can be any device that is patient-specific. Examples of a patient-specific device include, but are not limited to, a patient-specific instrument, a patient-specific implant, a patient-specific preoperative plan, a patient-specific physical model of an anatomical body part of the patient, a resection guide, or any number and/or combination of these, or the like. |
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In the illustrated embodiment, the system 1000 can include the patient-specific device design apparatus 450 configured to communicate with a user 1002 by way of the I/O interface 910. The patient-specific device design apparatus 450 can communicate with the user 1002 by way of a display device 916 and/or an input device 918 of the I/O interface 910. In one embodiment, the user 1002 is a single person. The user 1002 may be specifically trained to work with the patient-specific device design apparatus 450. Alternatively, or in addition, the user 1002 may comprise a set of users. For example, the user 1002 may include a user trained to an entry level set of skills for operating and/or using the patient-specific device design apparatus 450 and the user 1002 may also include a manager for the entry level trained user. Alternatively, or in addition, the user 1002 may also include a person trained specifically to provide a quality assurance check and/or review of work and/or steps performed by an entry level user. A person trained in this manner is referred to herein as a quality control user 1002. Thus, one or more users 1002 may control, manage, and/or interact with the patient-specific device design apparatus 450 at various stages in a process of designing and/or fabricating a patient-specific device. |
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The system 1000 can also include a medical imager 1010 and a segmentor 1020. The medical imager 1010 captures medical imaging 1030 of anatomy of a patient. Those of skill in the art will appreciate a variety of different systems, devices, and/or apparatus that are capable of capturing medical imaging 1030 of a patient. In one embodiment, the medical imager 1010 may include a system that is part of the system 1000. Alternatively, or in addition, the medical imager 1010 may be a third party that provides medical imaging 1030 such as a clinic and/or a health care facility. |
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Once suitable medical imaging 1030 is captured / created, the medical imaging 1030 is provided to the segmentor 1020. The segmentor 1020 takes the medical imaging 1030 from the medical imager 1010 and produces a form of the medical imaging 1030 in a format suitable for use by the system 1000. For example, in one embodiment, medical imager 1010 may be embodied as a computed tomography (CT) scan scanner. The medical imager 1010 may scan a patient’s foot to generate medical imaging 1030 for bones and/or internal structures of a patient’s foot. The medical imaging 1030 captured by the medical imager 1010 may be stored in a file format known as a DICOM (Digital Imaging and Communications in Medicine) file or files. |
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The segmentor 1020 may be configured to accept one or more DICOM files as input and generate models of one or more internal structures, such as bones, captured and/or represented in the DICOM files. In one embodiment, the segmentor 1020 is configured to generate output files in a common or standard format that other systems, software, programs, or devices can interpret and/or understand. For example, the segmentor 1020 may generate Stereolithography (STL) files. |
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In one embodiment, the segmentor 1020 may be a module and/or subsystem within the system 1000. Alternatively, or in addition, the segmentor 1020 may be an independent system and/or apparatus specifically configured to accept DICOM files (medical imaging 1030) as input and generated STL files that define models of anatomical structures represented in the DICOM files. Alternatively, or in addition, the segmentor 1020 may be specifically configured to distinguish certain types of anatomy in the DICOM files such as bones as opposed to other anatomy such as soft tissue. In certain embodiments, the segmentor 1020 may be operated by a user/operator that interacts with the segmentor 1020 using a user interface to manually review and complete an image segmentation process. |
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In one embodiment, the segmentor 1020 may comprise an advanced computer analysis system such as software, a software add-in, and/or systems that implement one or more artificial intelligence methods (e.g., machine learning and/or neural networks (e.g., ANN, GAN, or the like)) for deriving, determining, or extrapolating, anatomic structures from medical imaging 1030. For example, in one embodiment, neural network may be trained to examine DICOM file(s) of a patient’s foot and identify each of the boundaries for each of the bones of the foot captured in the DICOM files. Once identified, the segmentor 1020 may present the identified bones in the form of a bone model that includes at least one bone of a patient’s foot. Additionally, the medical imaging 1030 may be configured to output an STL that defines the bone model such that a modeling computer program product can interpret, display, modify, and/or manipulate the bone model. |
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In one embodiment, the segmentor 1020 is configured to automatically import DICOM files, segment the medical imaging 1030 to identify one or more bone model(s) and automatically export the bone model to a form of medical imaging 1030 referred to herein as STL files. A segmentor 1020 configured to automatically segment medical imaging 1030 and convert the medical imaging 1030 into another form of medical imaging 1030, such as STL files for models of the structures is referred to herein as an autosegmentor. In one embodiment, the segmentor 1020 is an autosegmentor. |
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Referring to FIG. 10, the system 1000 may include a set of work instructions 1040. The set of work instructions 1040 may include the medical imaging 1030. In one embodiment, the medical imaging 1030 may be provided in the form of STL files that describe models of bones that a modeling computer program product can interpret, display, modify, and/or manipulate. In one embodiment, the set of work instructions 1040 is provided to the patient-specific device design apparatus 450. Alternatively, or in addition, medical imaging 1030 can be provided directly to the patient-specific device design apparatus 450. |
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In one embodiment, the set of work instructions 1040 provides at least the minimal amount of information, data, files, metadata, and/or resources needed for the patient-specific device design apparatus 450 to generate, or facilitate generation of, a patient-specific device. In the illustrated embodiment, the set of work instructions 1040 includes the medical imaging 1030 in the form of STL files generated by a segmentor 1020. The set of work instructions 1040 may also include a workflow 1050. The set of work instructions 1040 can include a variety of information such as patient identification information, information about the type of surgical procedure to be performed, the surgeon who will do the procedure, a prescription for the procedure and/or the patient-specific device, location information (i.e. file system location, server location, online service credentials, 3rd party facility access credentials, etc.) for the medical imaging 1030, the workflow 1050, and/or a repository of template patient-specific device models for use by the patient-specific device design apparatus 450, and the like. |
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"Thread" or "threads" refers to a helical structure used to convert between rotational and linear movement or force. A thread is a ridge wrapped around a cylinder or cone in the form of a helix, with the ridge wrapped around the cylinder being called a straight thread and the ridge wrapped around the cone called a tapered thread. Straight threads or tapered threads are examples of external threads, also referred to as male threads. Threads that a correspond to male threads are referred to as female threads and are formed within the inside wall of a matching hole, passage, or opening of a nut or substrate or other structure. A thread used with a fastener may be referred to as a screw thread and can be an important feature of a simple machine and also as a threaded fastener. The mechanical advantage of a threaded fastener depends on its lead, which is the linear distance the threaded fastener travels in one revolution. (Search 'screw thread' on Wikipedia.com July 17, 2022. Modified. Accessed Aug. 1, 2022.) |
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"Cutting tool" refers to any tool that can be used to cut or resect another object. In particular, a cutting tool can refer to a manual or power tool for cutting or resecting tissue of a patient. Examples of cutting tools include, but are not limited to, a burr, an oscillating saw, a reciprocating saw, a grater saw, a drill, a mill, a side-cutting burr, or the like. |
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As used herein, a "shaft" refers to a long narrow structure, device, component, member, system, or assembly that is structured, organized, configured, designed, arranged, or engineered to support and/or connect a structure, device, component, member, system, connected to each end of the shaft. Typically, a shaft is configured to provide rigid support and integrity in view of a variety of forces including tensile force, compression force, torsion force, shear force, and the like. In addition, a shaft can be configured to provide rigid structural support and integrity in view of a loads including axial loads, torsional loads, transverse loads, and the like. A shaft may be oriented and function in a variety of orientations including vertical, horizontal, or any orientation between these and in two or three dimensions. A shaft may be made from a variety of materials including, but not limited to, metal, plastic, ceramic, wood, fiberglass, acrylic, carbon, biocompatible materials, biodegradable materials or the like. A shaft may be formed of any biocompatible materials, including but not limited to biocompatible metals such as Titanium, Titanium alloys, stainless steel, carbon fiber, combinations of carbon fiber and a metallic alloy, stainless steel alloys, cobalt-chromium steel alloys, nickel-titanium alloys, shape memory alloys such as Nitinol, biocompatible ceramics, and biocompatible polymers such as Polyether ether ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others, or any combination of these materials. |
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"Head" refers to a device, apparatus, member, component, system, assembly, module, subsystem, circuit, or structure, organized, configured, designed, arranged, or engineered to have a prominent role in a particular feature, function, operation, process, method, and/or procedure for a device, apparatus, member, component, system, assembly, module, subsystem, circuit, or structure the includes, is coupled to, or interfaces with the head. In certain embodiments, the head may sit at the top or in another prominent position when interfacing with and/or coupled to a device, apparatus, member, component, system, assembly, module, subsystem, circuit, or structure. |
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As used herein, an "interface," "user interface," or "engagement interface" refers to an area, a boundary, or a place at which two separate and/or independent structures, members, apparatus, assemblies, components, and/or systems join, connect, are coupled, or meet and act on, or communicate, mechanically and/or electronically, with each other. In certain embodiments, "interface" may refer to a surface forming a common boundary of two bodies, spaces, structures, members, apparatus, assemblies, components, or phases. (search "interface" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 15 Nov. 2021. Modified.) In certain embodiments, the term interface may be used with an adjective that identifies a type or function for the interface. For example, an engagement or coupling interface may refer to one or more structures that interact, connect, or couple to mechanically join or connect two separate structures, each connected to a side of the interface. In another example, a user interface may refer to one or more mechanical, electrical, or electromechanical structures that interact with or enable a user to provide user input, instructions, input signals, data, or data values and receive output, output data, or feedback. |
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