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In step 18, the system 1000 may display/illustrate an active model 1316 of a first proximal phalange 230 and an active model 1316 of a first distal phalange 240 in the same position as these bones where when the medical imaging 1030 was generated. In certain embodiments, the bone model of the first proximal phalange 230 and the bone model of the first distal phalange 240 may be active models 1316 because a surgeon may want to do other procedures on one or more of these bones, such as an Akin procedure. |
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In the illustrated embodiment, the model 1312 is a bone model 404 that includes a set of active models 1316. The set of active models 1316 includes a first metatarsal model, a medial cuneiform model, a first proximal phalange, and a first distal phalange. Those of skill in the art will appreciate that models of bones to be used in a procedure should be in the set of active models 1316 so that an osteotomy and/or interaction with implants and/or hardware can be presented to an operator and/or a surgeon. |
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In certain embodiments, the number of models that are active models 1316 may be kept to a minimum to preserve computing resources. In the illustrated embodiment, the bone models in the canvas 1304 that are not in the set of active models 1316 may be members of the set of context models 1318. Those of skill in the art will appreciate that models for bones that are not active models 1316 provides needed context for the surgical procedure but these models need not be active model 1316 where they are used for context rather than being actively used in a surgical procedure. With up to 26 bones in a human patient’s foot, those of skill in the art will appreciate the benefits of certain bone models being active models 1316 and others context models 1318. |
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In certain embodiments, the set of active models 1316 may also include any of the bones of a patient’s foot. For example, a bone of the second metatarsal 210 and/or a model of the third metatarsal 212 may also be in the set of active models 1316 depending on the set of work instructions 1040. However, the number of bone models that are active models 1316 may be kept to a minimum to conserve computing resources. |
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In one or more examples, the system 900 includes a processor 904, a memory 906 that is accessible by the processor 904, a communication interface 908, an I/O interface 910, and storage device 914. It may be noted by a person of ordinary skill in the art that the system 900 may include other components for performing various functions consistent with the type of computing device 902 being used (e.g., laptop, desktop, server, tablet, smartphone, and so forth). |
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In some examples, the system 900 utilizes the memory 906 to access program code, executable code, and/or data. The memory 906 may include volatile and/or nonvolatile memory and may include memory that may be coupled or decoupled to the system 900 such as a microSD card solid-state drive, or similar storage device. In various examples, the system 900 may access memory 906 that is virtual memory stored in a storage area network, a remote server, cloud-based data storage, or other discrete or distributed network storage devices. |
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In various examples, the system 900 includes a communication interface 908. The communication interface 908 may include hardware circuits and/or software (e.g., drivers, modem, protocol/network stacks) to support wired or wireless communication between the system 900 and another computing device or network. The wireless connection may include a mobile telephone network. The wireless connection may also employ a Wi-Fi network based on any one of the Institute of Electrical and Electronics Engineers (IEEE) 802.11 standards. Alternatively, the wireless connection may be a Bluetooth® connection. In addition, the wireless connection may employ a Radio Frequency Identification (RFID) communication including RFID standards established by the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), the American Society for Testing and Materials® (ASTM®), the DASH7™ Alliance, and EPCGlobal™. |
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The wireless connection may be an infrared connection including connections conforming at least to the Infrared Physical Layer Specification (IrPHY) as defined by the Infrared Data Association® (IrDA®). Alternatively, the wireless connection may be a cellular telephone network communication. All standards and/or connection types include the latest version and revision of the standard and/or connection type as of the filing date of this application. |
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In some examples, the system 900 includes an I/O interface 910 that is configured to communicate with accessories, peripheral devices, input devices, output devices, and so forth. In certain examples, the I/O interface 910 may support various industry standards, such as for example, universal serial bus (USB), USB 2.0, USB 3.0, USB3Vision®, USB 3.1, USB 3.2, FireWire®, HMDI, CameraLink, GigE, and so forth which may be used to communicate with devices, peripherals, accessories, and so forth. The foregoing lists of interfaces with a wired or wireless is not intended to be an exhaustive list of the interfaces that may be used in implementing the system 900 and is intended to show that certain interfaces can be used advantageously to implement the system 900. |
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The I/O interface 910 may include or be in communication with a display device 916 and/or an input device 918. The display device 916 may include any device (e.g., screens, TVs, touch screens, or monitors) configured to present a user interface to a user of the system 900. The input device 918 may include any device (e.g., touch screens, keypads, keyboards, etc.) configured to accept and/or interpret user input. |
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The storage device 914 may include one or more non-volatile storage devices and/or non-volatile storage media that can store data for the system 900. For example, the storage device 914 may store anatomic data 412, data that defines a model, user profile data, user preference data, and the like. "Non-volatile storage media" refers to any hardware, device, component, element, or circuit configured to maintain an alterable physical characteristic (deleted) used to represent a binary value of zero or one after a primary power source is removed. Non-volatile storage media may be used interchangeably herein with the term non-volatile memory media. |
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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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