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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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Traditionally, a surgeon inserts pedicle screws through one major central incision, where muscles and other tissues are dissected off of the spine and retracted to the side to facilitate visualization of the deep spinal bones. Under direct visualization, with or without radiological imaging, pedicle screws can be placed into the pedicles of the vertebral bodies, and then rods are typically placed to connect pedicle screws from one bone to those of other bones through the tulip head of a pedicle screw. |
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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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Spinal surgeries have advanced to address a variety of spinal conditions including scoliosis, spondylosis, kyphosis, lordosis, and the like. Certain spinal procedures include the use and placement of fixation devices and/or implants connected to, deployed into, or deployed between vertebrae of the spine. A spine includes a number of vertebrae interconnected by soft tissue of the body. |
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The present disclosure discloses an intraoperative angle measurement apparatus, system, and/or method of use. Conventional medical imaging technologies enable a surgeon to gather accurate information about body parts and structures of a patient. This information can enable a surgeon to preoperatively plan the surgery and determine a desired set of steps, equipment and/or timing for the surgery. |
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Improper screw placement and misaligned rods decrease the effectiveness of the spinal fixation and can increase surgical difficulty and time expenditure. Extended surgical procedures and related difficulties or complications are recognized as contributing influences for extended patient recovery and sub-optimal spinal fixation results. |
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In recent years, surgeons may place pedicle screws percutaneously through small incisions with reliance on radiographic visualization, not direct visualization. Percutaneously placed pedicle screws can potentially save the patient the significant trauma caused by the traditional open exposure of the spine through the central incision. Unfortunately, without direct visualization, pedicle screw placement is often tedious and inaccurate. Poorly placed pedicle screws can cause pain, early construct failure, or harm to the patient. |
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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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One spinal fixation technique includes using orthopedic contouring rods which run generally parallel to the spine. This technique often involves an invasive surgical procedure to expose the spine and attach pedicle screws to the pedicles of the appropriate vertebrae. The pedicle screws may be configured to receive the orthopedic contouring rod which can be bent to achieve the desired curvature of the spinal column. |
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Spinal fusion surgery can be used successfully to address spinal column disorders and to reduce pain and restore nerve function. In spinal fixation, implants can be used for fusing or immobilizing adjacent vertebrae. Spinal fixation can improve the position of the adjacent vertebrae relative to one another and can alter the overall alignment and/or curvature of the spine. Spinal fixation or instrumentation can immobilize the spine internally in order to promote fusion between vertebrae. Fusion is a process which can take up to several months or a year. |
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Trauma, abnormal growth, disease, tumors, degeneration, etc. can result in physiological and anatomical disorders in the spinal column and cause deformities such as spondylolisthesis, kyphosis, and scoliosis. These deformities can result in significant pain and diminished nerve function in the diseased spine. |
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In human anatomy, the vertebral column (i.e., backbone or spine) is a column typically consisting of bones and tissue, including 33 vertebrae, situated in the dorsal area of the torso. The vertebral column serves to house and protect the spinal cord in a spinal canal. |
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