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In one embodiment, the measurement circuit 330 can measure an orientation of the shaft 210 in relation to a reference axis 130 as a user tilts the shaft 210 to a desired orientation. The measurement circuit 330 may include an orientation sensor, described in more detail below. |
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The one or more arrow buttons 430 can be used to input a desired/target orientation. The electronic circuit 400 may store the desired/target orientation for comparison to measured orientation angles as a user operates the surgical device 200. For example, the input circuit 310 may include an up arrow indicating an increase in the degrees or tenths or hundredths of a degree that a user wants to set as the desired/target orientation. Similarly, the input circuit 310 may include a down arrow indicating a decrease in the degrees or tenths or hundredths of a degree that a user wants to set as the desired/target orientation. Of course either the up arrow or the down arrow may skip tens of degrees or tenths or hundredths based on how long a user presses and holds the respective arrow. |
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The output circuit 320 sends, conveys, signals, and/or communicates output data, instructions, signals or commands to someone or something outside the electronic circuit 300 (e.g., a user or operator). In one embodiment, an output circuit 320 can be a single output device. Alternatively, or in addition, the output circuit 320 can be a plurality of interconnected or intercommunicating devices, such as output devices. In one embodiment, the output circuit 320 is an output device that communicates output data (e.g., an orientation angle) to a user or another device. In certain embodiments, the output circuit 320 and/or output device is coupled to the control circuit 350. The output circuit 320 and/or output device may be configured to communicate the orientation angle determined by the electronic circuit 300 to a user. |
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The input circuit 310 receives input data, instructions, signals or commands from someone or something outside the electronic circuit 300. In one embodiment, an input circuit 310 can be a single input device. Alternatively, or in addition, the input circuit 310 can be a plurality of interconnected or intercommunicating devices, such as input devices. In one embodiment, the input circuit 310 is an input device that receives user input data. |
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In one embodiment, the electronic circuit 300 may include one or more of an input circuit 310, an output circuit 320, a measurement circuit 330, a calibration circuit 340, and a control circuit 350. The electronic circuit 300 may be coupled with a power supply 360. |
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"Controller" refers to any hardware, device, component, element, or circuit configured to manage, implement, or control the features, functions, and/or logic for a device, component, apparatus, or system, and may comprise one or more processors, programmable processors (e.g., FPGAs), ASICs, micro-controllers, electronic circuits, or the like. "Logic" refers to machine memory circuits, non-transitory machine readable media, and/or circuitry which by way of its material and/or material-energy configuration comprises control and/or procedural signals, and/or settings and values (such as resistance, impedance, capacitance, inductance, current/voltage ratings, etc.), that may be applied to influence the operation of a device. Magnetic media, electronic circuits, electrical and optical memory (both volatile and nonvolatile), and firmware are examples of logic. Logic specifically excludes pure signals or software per se (however does not exclude machine memories comprising software and thereby forming configurations of matter). "Electronic Circuit" or "Circuitry" refers to any circuit, sub-circuit, electronic component, hardware, module, logic, device, or apparatus configured, programmed, designed, arranged, or engineered to perform one or more features, functions, steps, methods, processes of portions thereof. In certain embodiments, an electronic circuit or circuitry may include electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, circuitry forming a state machine, circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program which at least partially carries out processes or devices described herein, or a microprocessor configured by a computer program which at least partially carries out processes or devices described herein), circuitry forming a memory device (e.g., forms of random access memory), circuitry forming a communications device (e.g., a modem, communications switch, or optical-electrical equipment), or the like. An electronic circuit or circuitry may include one or more modifiers that identify one or more particular functions, features, aspects, attributes, advantages, roles, purposes, modes of operation, or operations and/or particular structures relating to the an electronic circuit, circuit, or circuitry. Examples of such modifiers applied to a circuit or circuitry, include, but are not limited to, "control circuit," "test circuit," "calibration circuit," "sensing circuit," "output circuit," "input circuit," "I/O circuit," "measurement circuit," "display circuit," and the like. |
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FIG. 3 is a block diagram of an exemplary electronic circuit 300 according to one embodiment. The electronic circuit 300 can be used with embodiments described herein. For example, in one embodiment, the housing 220 may include the electronic circuit 300. The electronic circuit 300 serves to measure an orientation angle. Specifically, the electronic circuit 300 may measure an orientation angle of the shaft 210 and/or the surgical device 200a,b. In certain embodiments, an electronic circuit 300 may also measure a distance, as described in more detail below. In one embodiment, the electronic circuit 300 may serve as a controller for the surgical device 200a,b. |
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While the surgical device 200a,b may be a single use surgical device, certain functionality may provide an acceptable level of accuracy. For example, in such an embodiment, the orientation angle displayed to a user may be accurate to within three tenths of a degree. Such a level of accuracy may be sufficient for confirming an insertion trajectory for a pedicle screw while at the same time worth disposing of after the surgical procedure. While a single use surgical device may result in medical waste following the surgical procedure, the savings in costs of materials, fabrication, and distribution of the single use surgical device and advantage the single use surgical device provides for intraoperative angle/distance measurement over conventional high expense medical imaging technologies may support the trade-off. |
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In one embodiment of a single use surgical device, the power supply, electronic circuit 300, housing 220, head 240, shaft 210 and/or other components may be specifically engineered to provide the features, functions, and aspects of a surgical device 200a,b but only for a single surgical procedure. For example, the power supply may be large enough to function during the single surgical procedure, but not large enough for a second surgical procedure. Similarly, the materials used, and the manner of fabrication may be such that the other structural components may function for a single surgical procedure, but not a subsequent surgical procedure. This may mean that the fabrication costs are reduced and the cost of the surgical device 200a,b is also reduced. |
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"Single use" or "single use device" refers to a structure, assembly, system circuit, sub-circuit, circuitry, electronic component, hardware, software, firmware, module, logic, device, button, lever, or apparatus configured, programmed, designed, arranged, or engineered to be used one time to performed one or more functions, features, or operations. In certain embodiments, a single use device may include components, structures, or parts that are specifically engineered for use only one time. In certain embodiments, a single use device may include less expensive components that satisfy requisite specifications for use one time but are not expected to meet those same specifications after the single use. For example, a single use device may include a battery power supply with sufficient charge for one use but not more than one use. This configuration may enable the single use device to include a smaller component, like a battery, less reinforcement or use less expensive and/or less durable materials for components of the single use device. In certain embodiments, a single use device can be disposed of after the single use. |
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In one embodiment, a shaft 210 may extend through the head 240 and include an interface that enables the shaft 210 to couple to one or more other instruments that can be used for deployment of a pedicle screw. For example, a surgeon may connect the shaft 210 to a surgical drill and the bone probe 216 may include a drill bit configuration at the distal end such that the surgical device 200b may be rotated about its longitudinal axis to create a hole in bone of a patient, and specifically in certain embodiments, to create a hole in a pedicle of a patient. |
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"Bone bore" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module structured, organized, configured, designed, arranged, or engineered to form a bore, hole, or tunnel into and/or through bone of a patient. Examples of a bone bore include a surgical drill bit, an awl, a pedicle probe, and the like. "Pedicle probe" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module structured, organized, configured, designed, arranged, or engineered to probe and/or explore a pedicle structure of a patient's bone. In certain embodiments, a pedicle probe can be used to determine where the pedicle is and how its configuration relates to other structures in the body. In certain embodiments, a pedicle probe can be inserted into a pedicle and pressed through bone of the pedicle to form a pilot hole through the pedicle for a fixation device. |
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Alternatively, or in addition, the electronic circuit 400 may include a memory media 560. The memory media 560 is configured to store data representative of the reference axis. The measurement circuit 330 may retrieve data indicating the reference axis from the memory media 560. Data defining the reference axis may be stored in the memory media 560 during fabrication, during a calibration operation (a zeroing out operation), or at another time. The memory media 560 may be any of a variety of storage media and/or storage devices. In one embodiment, the memory media 560 is a non-volatile storage media. "Non-volatile 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 after a primary power source is removed. Non-volatile storage media may be used interchangeably herein with the term non-volatile memory media. In addition to storing data indicating a reference axis, the memory media 560 can store a variety of other data, including a set of desired/target orientation angles, a last measured orientation angle, measured linear distance, logic for operating or initializing the control circuit 350 and/or the like. |
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The user interface 254 may include a zero-out switch 256, an angle mode switch 258, a distance mode switch 260, a display 262, an up arrow button 610, and a down arrow button 612. |
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In the illustrated embodiment, the surgical device 200c may include a planar anterior surface 222, a planar posterior surface 224 (not shown in FIG. 5), a planar superior surface 226, a planar inferior surface 228, a planar first lateral surface 230 and a planar second lateral surface 232. The anterior surface 222 may include a user interface 254. In another embodiment, the posterior surface 224 may also include a user interface 254 and a user interface 254 on either side may be used by a user. Alternatively, or in addition, a user interface 254 may be on one side and a separate display 262 may be on each side or the same display 262 may be visible from either side of the housing 220. |
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Now further suppose that a surgeon wants to use the surgical device 200c during the surgical procedure. The surgeon or an assistant may calibrate the surgical device 200c in preparation for use. Once calibrated, the surgical device 200c may rest within the surgical field 602 until needed. |
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Now suppose, a surgical procedure, such as an orthopedic surgical procedure is to be performed on a patient. The patient may be positioned on an operating table in a prone position with the back of the patient facing upward. An area around, and/or including, the back of the patient may be prepared as a surgical field 602. FIG. 5 illustrates a cut-away view of the body 604, skin 606, and a vertebra 608 of the patient. |
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In the illustrated embodiment, the surgical device 200c can use one of the planar surfaces of the housing 220 to determine a horizontal plane and/or reference axis 130. For example, the electronic circuit 300/400 can operate in a calibration mode to determine the horizontal plane and/or reference axis 130. The calibration mode can include placement of the housing 220 in a specific orientation, a known orientation, from which the electronic circuit 300/400 can determine the horizontal plane and/or reference axis 130 which in turn can be used to measure or determine orientation angles from either of the horizontal plane and/or reference axis 130. In one embodiment, the electronic circuit 300/400 may determine an orientation angle (e.g., angle A and/or angle B) based on a reference axis 130 perpendicular to a horizontal plane that parallel to a ML axis 122. The horizontal plane may be defined by one of the surfaces 222, 224, 226, 228, 230, 232 of the housing 220 during a calibration mode of the electronic circuit 300/400. |
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In the illustrated embodiment, the surgical device 200c differs from the surgical device 200a or surgical device 200b because the surgical device 200c includes at least one surface of the housing 220 that is planar. In certain embodiments, one or more sensors (e.g., first sensor 510 and/or sensor 530) may be used by the electronic circuit 300/400 to determine a reference axis 130 and/or a horizontal plane from which a reference axis 130 can be determined. Alternatively, or in addition, the electronic circuit 300/400 can determine a reference axis 130 by retrieving data from memory media 560 that defines the reference axis 130. |
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The surgical device 200c may have many structures, features, and functions, operations, and configuration similar or identical to those of the surgical device 200a or surgical device 200b described above, like parts are identified with the same reference numerals. Accordingly, the surgical device 200c may include a shaft 210, a housing 220, a head 240, a handle 250, and/or an electronic circuit 300/400 (within the housing 220). |
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