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The surgical device 200a can include a bone probe 216. "Bone probe" refers to a structure, device, component, assembly, or apparatus configured, designed, engineered or configured to test, explore, investigate, or probe bone, bone parts, and/or attributes of bone of a patient. In certain embodiments, a bone probe can be configured to engage and penetrate bone of the patient. In another embodiment, a bone probe can be configured to contact and remain in contact with a bone or portion of a bone while a process or step is completed. The bone probe 216 serves to contact cortical bone of a patient when the surgical device 200a is in use. |
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The shaft 210 serves to structurally interconnect parts of the surgical device 200a. In certain embodiments, the shaft 210 is elongated and has a circular cross-section. In another embodiment, the shaft 210 can have a variety of cross sectional shapes including square, rectangular, and the like. In certain embodiments, the shaft 210 includes a proximal end 212 and a distal end 214. In certain embodiments, the proximal end 212 and distal end 214 may correspond to a respective proximal end and/or distal end of the surgical device 200a. In certain embodiments, the shaft 210 has a length that enables the distal end 214 to contact cortical bone of a vertebra and the proximal end 212 extend far enough for a surgeon to comfortably operate the surgical device 200a. In certain embodiments, the shaft 210 has a length that places the proximal end 212 outside a superficial layer of skin of the patient. |
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As used herein, a "surgical device" refers to an apparatus, instrument, structure, device, component, member, system, assembly, or module structured, organized, configured, designed, arranged, or engineered to be used in connection with a surgical procedure. |
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FIG. 2A is a perspective top front view of an intraoperative angle measurement apparatus according to one embodiment. The intraoperative angle measurement apparatus may be embodied as a surgical device 200a that include a shaft 210, a housing 220, a head 240, a handle 250, and/or an electronic circuit 300 (See FIG. 3). Those of skill in the art will appreciate that suitable intraoperative angle measurement apparatuses may have fewer components or more components than those illustrated in the embodiment of FIG. 2A. |
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As used herein, "surgical field," "operative field," or "operating field" refers to an area of a patient where surgery is or will be performed and includes one or more areas of a patient's body and all personnel and equipment that is used in the surgery. (Search "surgical field" on medical-dictionary.thefreedictionary.com Copyright 2021 Farlex Inc. Modified. Accessed Sept. 8, 2021.) |
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The surfaces of the housing 220 can have a variety of shapes, sizes, and contours. For example, in the illustrated embodiment, the superior surface 226 may be a curved surface that includes the head 240. In certain embodiments, the head 240 is at a proximal end of the surgical device 200a and/or a proximal end 212 of the shaft 210. The head 240 may include a planar surface and have a round cross-section. |
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Here too medical imaging solutions are available for use by surgeons to determine a deployment trajectory intraoperatively. However, such solutions can prohibitively expensive, can be of limited availability, increases exposure of a patient to radio or x-ray radiation used for the scan and can greatly increase the time needed for the procedure. The time can increase as the surgical field may need to be altered or reconfigured to accommodate the medical imaging equipment. However, the present disclosure provides an intraoperative angle measurement apparatus, system, and/or method of use that can determine and/or confirm that a surgeon’s pedicle screws trajectory during surgery matches one predetermined based on medical imaging scans, without requiring use of medical imaging equipment during the procedure. The intraoperative angle measurement apparatus, system, and/or method of use of the present disclosure is simple to use, low-cost, and effective. In certain embodiments, the intraoperative angle measurement apparatus may be disposed of after a single use. A single spinal surgery can involve a number of vertebrae of a patient and each vertebra includes two pedicles. A surgeon may need to confirm an insertion trajectory and/or orientation angle for each of the pedicles. |
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Now that the surgeon has the desired orientation angle for deployment of fixation devices within the pedicle, the surgeon works to locate the desired orientation angle for deployment when performing the surgery. This can be challenging as the surgeon may also desire to minimize the number and size of incisions and opening of wounds during the procedure. Generally, surgery on the spine that includes deployment of fixation devices in the pedicle is done using a posterior approach. The patient may lie in a prone on an operating table and the surgeon may make incisions in the skin and soft tissue of the back of the patient to gain access to the spine. Thus, the surgeon may have only a posterior view of the spinous process 104, first transverse process 106, and second transverse process 108 and the lamina connecting them. |
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Both MRI images and CT images can be used specifically to determine a location of pedicles of each vertebra of the patient. Both MRI images and CT images provide cross-sectional images of the patient and body parts of the patient. Each of these images may be referred to as a slice or “cut” because it is a two-dimensional image of the three-dimensional structure. During preoperative planning or even intraoperatively a surgeon can review a CT cut for each pedicle 114, 116 of a vertebra 100. The CT imaging system may include a coordinate system overlay and/or a data reading of the orientation angle (e.g., angle A) of the longitudinal axis of each pedicle. The surgeon may note that orientation angle for use during the procedure. The orientation angle serves as the desired orientation angle for deployment of fixation devices (e.g., pedicle screws) in relation to the pedicle. Alternatively, or in addition, the surgeon may determine that the desired orientation angle for deployment is +/- 1-3 degrees (or tenths of degrees) of the orientation angle reported by the CT cut. The desired orientation angle for deployment can serve as a trajectory for deployment of a pedicle screw from a posterior surface of the second lamina 112 between the spinous process 104 and second transverse process 108. |
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Advantageously, medical imaging technologies enable a surgeon to view and obtain accurate measurements of parts of the vertebra 100, such as the pedicles. Accurate measurements of pedicles can provide information about the location, orientation, diameter and length of the pedicles. This measurement information is useful to determine the type, size, and features of pedicle implants, such as pedicles screws to be used in a procedure. |
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Arrow 128 may be representative of a longitudinal axis of the second pedicle 116. Arrow 128 defines an angle A between the AP axis 124 and arrow 128 and an angle B between the arrow 128 and the ML axis 122. In embodiments described herein, angle A is used to represent the desired orientation angle. However, those of skill in the art appreciate that either angle A or angle B may be used to represent a desired orientation angle and one angle can be readily converted into the other by subtracting the one angle from 90 degrees. In embodiments where angle A is used to represent the desired orientation angle, the AP axis 124 serves as a reference axis 130. In embodiments where angle B is used to represent the desired orientation angle, the ML axis 122 serves as a reference axis. "Reference axis" refers to an axis positioned and/or configured to serve as a reference in measuring or determining an attribute such as an angle and/or a distance measurement. The attribute is measured with respect to the reference axis. |
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In the illustrated embodiment, the medical imaging system can be configured such that the center point 120 of the coordinate system of the medical imaging system is in the center of the body 102 of a particular vertebra 100 of a patient. Those of skill in the art will appreciate that the center point 120 could also be on the most anterior surface of the cortical wall of the body, or any other location on the vertebra 100. In one embodiment, the coordinate system includes a medial-lateral (ML) axis 122, an anterior-posterior (AP) axis 124, and a cephalad-caudal (CC) axis 126 (going into and out of the page). The ML axis 122 can lie within the coronal plane and/or may be parallel to the coronal plane. The AP axis 124 can lie within the sagittal plane and/or may be parallel to the sagittal plane, AP plane, median plane, and/or the midline plane. The CC axis 126 can be perpendicular to the transverse plane or axial plane and/or may be parallel to the transverse plane or axial plane. |
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Often this planning includes determining a desired orientation angle for the deployment of the pedicle screw. As used herein, "orientation" refers to a direction, angle, position, condition, state, or configuration of a first object, component, part, apparatus, system, or assembly relative to another object, component, part, apparatus, system, assembly, reference point, reference axis, or reference plane. "Orientation angle" refers to an angle indicating how an orientation of one apparatus, device, component, module, structure, assembly, or system relates to another apparatus, device, component, module, structure, assembly, or system. An orientation angle may be measured in degrees or radians. Those of skill in the art will appreciate that the orientation angle used during preoperative planning and during the surgery can be measured based on an accepted coordinate system of a medical imaging system calibrated or registered to the body of the patient. Often such calibration of the medical imaging system to the cardinal planes and cardinal axis of the patient includes the use of certain landmarks on the body parts of the image. |
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Fortunately, surgeons can use medical imaging technologies to determine dimensions and orientation of pedicles for each vertebra and use that information for the planning of the placement and/or deployment of pedicle fixation devices such as pedicle screws. For example, MRI and CT scans can be used. The surgeon may preoperatively determine the trajectory needed for the approach and placement/deployment of the pedicle screw for each pedicle of each vertebra. |
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Many spinal implants, implant systems, fixation devices, and/or assemblies include deployment of one or more fixation devices, such as bone anchors or bone screws, within a pedicle of the vertebra. Such fixation devices are referred to herein as pedicle screws. It is desirable that pedicle screws be deployed coaxial with a longitudinal axis of the pedicle. Unfortunately, pedicles within a single vertebra can have different sizes, diameters, and orientations relative to other landmarks of the vertebra. Furthermore, pedicles of different vertebra can have different sizes, diameters, and orientations relative to each other and relative to other vertebra. |
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FIG. 1 is a perspective top view of vertebra 100 illustrating certain parts of the vertebra. The vertebra includes a body 102, a spinous process 104, a first transverse process 106, a second transverse process 108 (other processes omitted for clarity), a first lamina 110, a second lamina 112, a first pedicle 114, a second pedicle 116, and a vertebral foramen 118. The body 102 is anterior to the spinous process 104, the first transverse process 106, the second transverse process 108, the first lamina 110, the second lamina 112, the first pedicle 114, and the second pedicle 116 which together form the vertebral arch. The vertebral foramen 118 cooperates with vertebral foramen 118 of adjacent vertebra to form a spinal canal that houses a bundle of nerves that interconnect the brain to various parts of the patient’s body. |
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"Input device" refers to any apparatus, device, component, module, circuit, sub-circuit, structure, electronic component, hardware, or logic configured, programmed, designed, arranged, or engineered to receive input data, input instructions, input information, input signals, or the like from an environment. Often, a user may interact with an input device to provide input information. Examples of input devices includes, but are not limited to a button, a switch, a sensor, a keyboard, a keypad, a touch screen incorporated into a graphical user interface, audio input devices such as voice recognition systems, microphones, transceivers, receivers, other types of input devices, and the like. In various embodiments, input devices can be incorporated into a user interface. "Output device" refers to any apparatus, device, component, module, circuit, sub-circuit, structure, electronic component, hardware, or logic configured, programmed, designed, arranged, or engineered to output data, instructions, information, signals, audio information, visual information, video information, or the like. Examples of output devices includes, but are not limited to one or more of a switch, a sensor, an LED, a light, a speaker, a transceiver, a transmitter, a display and the like. In various embodiments, output devices can be incorporated into a user interface. |
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As used herein, an “opening” refers to a gap, a hole, an aperture, a port, a portal, a space or recess in a structure, a void in a structure, or the like. In certain embodiments, an opening can refer to a structure configured specifically for receiving something and/or for allowing access. In certain embodiments, an opening can pass through a structure. In other embodiments, an opening can exist within a structure but not pass through the structure. An opening can be two-dimensional or three-dimensional and can have a variety of geometric shapes and/or cross-sectional shapes, including, but not limited to a rectangle, a square, or other polygon, as well as a circle, an ellipse, an ovoid, or other circular or semi-circular shape. As used herein, the term “opening” can include one or more modifiers that define specific types of “openings” based on the purpose, function, operation, position, or location of the “opening.” As one example, a “fastener opening” refers to an “opening” adapted, configured, designed, or engineered to accept or accommodate a “fastener.” |
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In the illustrated embodiment, the surgical device 200b differs from the surgical device 200a because the surgical device 200b includes an opening 266 that extends from a proximal end of the surgical device 200b to a distal end of the surgical device 200b. Alternatively, or in addition, the opening 266 may extend from a proximal end 212 to a distal end 214 of the shaft 210. In this manner, the shaft 210 may be cannulated. The opening 266 may be coaxial with, and may pass through, the head 240, housing 220, shaft 210, handle 250, flange 252, and/or bone probe 216. In the illustrated embodiment, the surgical device 200b may serve as a cannula that can be used for one or more steps of a surgical procedure (e.g., pedicle screw deployment). The opening 266 may have a diameter that accepts passage of a variety of instruments that a surgeon may use as part of a procedure to deploy a fixation device (e.g., a pedicle screw). |
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FIGS. 2F, 2G illustrate a top view and a bottom view of an alternative embodiment for an intraoperative angle measurement apparatus, surgical device 200b. The surgical device 200b may have many structures, features, and functions, operations, and configuration similar or identical to those of the surgical device 200a described in relation to FIGS. 2A-2E, like parts are identified with the same reference numerals. Accordingly, the surgical device 200b may include a shaft 210, a housing 220, a head 240, a handle 250, and/or an electronic circuit 300 (See FIG. 3). |
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