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"Patient specific instrument" (PSI) refers to a structure, device, guide, tool, instrument, apparatus, member, component, system, assembly, module, or subsystem that is adjusted, tailored, modified, organized, configured, designed, arranged, engineered, and/or fabricated to specifically address the anatomy, physiology, condition, abnormalities, needs, or desires of a particular patient. In certain aspects, one patient. In one aspect, a patient specific instrument is unique to a single patient and may include features unique to the patient such as a surface contour, component position, component orientation, and/or other features. In other aspects, one patient specific instrument may be useable with a number of patients having a particular class of characteristics. |
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As used herein, a "handle" or “knob” refers to a structure used to hold, control, or manipulate a device, apparatus, component, tool, or the like. A “handle” may be designed to be grasped and/or held using one or two hands of a user. In certain embodiments, a handle or knob may be an elongated structure. In one embodiment, a knob may be a shorter stubby structure. |
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As used herein, "implant" refers to a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Often medical implants are man-made devices, but implants can also be natural occurring structures. The surface of implants that contact the body may be made of, or include a biomedical material such as titanium, cobalt chrome, stainless steel, carbon fiber, another metallic alloy, silicone, polymer, Synthetic polyvinyl alcohol (PVA) hydrogels, biomaterials, biocompatible polymers such as PolyEther Ether Ketone (PEEK) or a polylactide polymer (e.g. PLLA) and/or others, or apatite, or any combination of these depending on what is functional and/or economical. Implants can have a variety of configurations and can be wholly, partially, and/or include a number of components that are flexible, semiflexible, pliable, elastic, supple, semi-rigid, or rigid. In some cases implants contain electronics, e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. Orthopedic implants may be used to alleviate issues with bones and/or joints of a patient's body. Orthopedic implants can be used to treat bone fractures, osteoarthritis, scoliosis, spinal stenosis, discomfort, and pain. Examples of orthopedic implants include, but are not limited to, a wide variety of pins, rods, screws, anchors, spacers, sutures, all-suture implants, ball all-suture implants, self-locking suture implants, cross-threaded suture implants, plates used to anchor fractured bones while the bones heal or fuse together, and the like. (Search "implant (medicine)" on Wikipedia.com May 26, 2021. CC-BY-SA 3.0 Modified. Accessed June 30, 2021.) |
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As used herein, a "body" refers to a main or central part of a structure. The body may serve as a structural component to connect, interconnect, surround, enclose, and/or protect one or more other structural components. A body 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 body may be formed of any biocompatible materials, including but not limited to biocompatible metals such as Titanium, Titanium alloys, 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. In one embodiment, a body may include a housing or frame or framework for a larger system, component, structure, or device. A body may include a modifier that identifies a particular function, location, orientation, operation, and/or a particular structure relating to the body. Examples of such modifiers applied to a body, include, but are not limited to, "inferior body," "superior body," "lateral body," "medial body," and the like. |
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As used herein, "bone engagement surface" refers to a surface of an object, instrument, or apparatus, such as an implant that is oriented toward or faces one or more bones of a patient. In one aspect, the bone engagement surface may abut, touch, or contact a surface of a bone. In another aspect, the bone engagement surface or parts of the bone engagement surface may be close to, but not abut, touch, or contact a surface of the bone. In certain aspects, the bone engagement surface can be configured to engage with a surface of one or more bones. Such a bone engagement surface may include projections and recesses that correspond to and match projections and recesses of the one or more bone surfaces. |
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"Frangible" refers to a type of material designed, engineered, and/or configured to break easily under an expected force. Frangible objects may be designed to break easily under the expected force to provide a safety feature, a convenience feature, or the like. Frangible objects can be made from metal, plastic, ceramics, wood, paper, or the like. Frangible also includes something that is breakable or fragile; especially something that is intentionally made so. (Search "frangible" on wordhippo.com. WordHippo, 2023. Web. Accessed 11 May 2023. Modified.) |
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As used herein, “side” refers to a structure or part of a structure including, but not limited to: one of a longer bounding surfaces or lines of an object especially contrasted with the ends, a line or surface forming a border or face of an object, either surface of a thin object, a bounding line or structure of a geometric figure or shape, and the like. (search "side" on Merriam-Webster.com. Merriam-Webster, 2021. Web. 03 Aug. 2021. Modified.) A side can also refer to a geometric edge of a polygon (two-dimensional shape) and/or a face or surface of a polyhedron (three-dimensional shape). (Search "side" on Wikipedia.com July 21, 2021. CC-BY-SA 3.0 Modified. Accessed Aug. 03, 2021.) Side can also refer to a location on a structure. For example, a side can be a location on a structure at, or near, a furthest position away from a central axis of the structure. As used herein, the term “side” can include one or more modifiers that define and/or orient and/or distinguish the side of an object from others based on based on where and/or how the object is deployed within or in relation to a second object. For example, in the context of an implant for a patient, sides of the implant may be labeled based on where the sides are relative to the patient when the implant is deployed. As one example, an “anterior side” of an implant refers to a side that is anterior to other sides of the implant in relation to a patient when the implant is deployed in the patient. As another example, in the context of an instrument used with a patient, sides of the instrument may be labeled based on where the sides are when the instrument is being used for its purpose. As one example, a “front side” of an instrument refers to a side that is facing a user of the instrument when the instrument is in use. |
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As used herein, a “deploy” or "deployment" refers to an act, action, process, system, method, means, or apparatus for inserting an implant or prosthesis into a part, body part, and/or patient. “Deploy” or "deployment" can also refer to an act, action, process, system, method, means, or apparatus for placing something into therapeutic use. A device, system, component, medication, drug, compound, or nutrient may be deployed by a human operator, a mechanical device, an automated system, a computer system or program, a robotic system, or the like. |
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"Joint" or "Articulation" refers to the connection made between bones in a human or animal body which link the skeletal system to form a functional whole. Joints may be biomechanically classified as a simple joint, a compound joint, or a complex joint. Joints may be classified anatomically into groups such as joints of hand, elbow joints, wrist joints, axillary joints, sternoclavicular joints, vertebral articulations, temporomandibular joints, sacroiliac joints, hip joints, knee joints, articulations of foot, and the like. (Search "joint" on Wikipedia.com Dec. 19, 2021. CC-BY-SA 3.0 Modified. Accessed Jan 20, 2022.) |
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“Topographical” refers to the physical distribution of parts, structures, or features on the surface of, or within, an organ or other anatomical structure, or organism. (Search “define topographical” on google.com. Oxford Languages, Copyright 2022. Oxford University Press. Web., Modified. Accessed 15 Feb. 2022.) |
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"Landmark registration features" or “Landmark” refers to a structure configured to engage with a feature, aspect, attribute, or characteristic of a first object to orient and/or position a second object that includes the landmark registration feature with respect to the first object. A variety of structures can serve as a landmark registration feature. For example, a landmark registration feature may include a protrusion, a projection, a tuberosity, a cavity, a void, a divot, a tab, an extension, a hook, a curve, or the like. In the context of bones of a patient a landmark registration feature can include any protuberance, void, divot, concave section, sesamoid, bone spur or other feature on, or extending from, a bone of a patient. |
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"Probe bone engagement surface" refers to a bone engagement surface on one surface of a probe or part of a probe. |
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"Bone attachment feature" refers to a structure, feature, component, aspect configured to securely connect, couple, attach, and/or engage a structure, component, object, or body with a bone and/or a bone fragment. Examples of a bone attachment feature, include, but are not limited to, a pin, K-wire, screw, or other fastener alone, or in combination with, a hole, passage, and/or opening. |
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As used herein, "patient-specific osteotomy procedure" refers to an osteotomy procedure that has been adjusted, tailored, modified, or configured to specifically address the needs or desires or a particular patient. In certain aspects, one patient-specific osteotomy procedure may be useable in connection with only one patient. In other aspects, one patient-specific osteotomy procedure may be useable with a number of patients having a particular class of characteristics. |
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In certain embodiments, the model 1312 may include a bone model 404 that includes bone models for bones as those bones existed when the medical imaging 1030 was generated. In addition, where one or more osteotomies are to be performed, the model 1312 may also include a bone model for each bone that is to receive an osteotomy. For example, where a Lapidus procedure is to be performed on a patient, the model 1312 may include a bone model 404 that includes an active model 1316 of a first metatarsal 208 and an active model 1316 of a medial cuneiform 202 in the same condition as these bones are when the medical imaging 1030 was generated. In addition, the model 1312 may include in the set of active models 1316, a cut first metatarsal 208 model and a cut medial cuneiform 202 model. The cut versions of these models may be used in the workflow 1050 to design a patient-specific device 1090 based on where those cuts are in the respective models. |
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FIG. 13D illustrates an exemplary user interface 1300 for one step, one stage, of a workflow 1050 for generating a patient-specific device 1090, according to one embodiment. At this stage, the workflow 1050 has progressed to step 22. In the highlighted 1314 step 22, a user, different from a first user that may have completed a plurality of prior steps in the sequence of steps 1202, may complete step 22. Having another user do one or more steps in the sequence of steps 1202 can provide a safeguard against inadvertent errors and/or mistakes in completing the workflow 1050. |
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In the illustrated embodiment, the other user that performs step 22 may be quality control user who reviews the model 1312 of the bone model 404. A quality control user is a user who may have more experience and/or possess more skill and/or expertise than a primary user executing steps of the workflow 1050. Alternatively, or in addition, the quality control user may possess additional training, certifications, and/or licenses than the primary user. The quality control user may review the model 1312, one or more bone model 404, a set of active model 1316, a set of context model 1318, a patient-specific device model 1072, a set of work instructions 1040, a prescription 1100, as well as any logs or notes the primary user is expected to maintain in order to confirm that the steps of the workflow 1050 have been performed to a desired level of quality and excellence. If the quality control user identifies something that can or should be corrected, the quality control user may instruct a user 1002 to make the correction and/or the quality control user may interact with the model 1312 to make the correction. |
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After completing step 22, a quality control user or a primary user 1002 may signal that the workflow 1050 can continue and the system 1000 can start step 23 by activating a control labeled “I’m done.” |
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FIG. 13D illustrates the set of active models 1316 and the context models 1318 together in the canvas 1304. Advantageously, the bone models shown on the canvas 1304 are in a three dimensional space and oriented in the same position and/or configuration as the bones of a patient when the medical imaging 1030 was captured. Those of skill in the art will appreciate that a medical imager 1010 may user a coordinate system to provide a main point of reference for the anatomical structures captured in the medical imaging 1030. |
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The medical imaging 1030 of the bones of a patient are represented in the same position and orientation to each other as in the foot of the patient. In certain embodiments of the present disclosure, same position and/or orientation of the bones of the patient in the medical imaging 1030 is maintained as the medical imaging 1030 is used to generate the active models 1316 and the context models 1318 presented to a user 1002 in the canvas 1304. |
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