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FLO-5PROV |
Once the user confirms that the expandable intervertebral implant is properly positioned and expanded, the user can rotate the knob 450 to extend the inserter fork 430. Extending the inserter fork 430 causes the bias member 540 to move the protrusions 522 out of the recesses 524 and thereby detach the expandable intervertebral implant 100 from the inserter 400. If needed, the process can be reversed to retrieve an expandable intervertebral implant 100 using the inserter 400. |
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FLO-5PROV |
Referring now to FIGs. 4A, 4B, and 5, examples of using the inserter 400 are described. With an expandable intervertebral implant 100 attached to the inserter 400, the knob 450 engages threads 550 of the inserter fork 430 such that the prongs 520 are retracted within the arm 414. In such a configuration, the legs 542 of the bias member 540 are biased against internal walls of the arm 414. A user can then take the inserter 400 by the handle 420 and position the expandable intervertebral implant between vertebral bodies for the procedure. Once, the expandable intervertebral implant 100 is positioned, a user can rotate the driver 440 which rotates the screw member 118 which expands the expandable intervertebral implant from a collapsed configuration to either a partially expanded configuration or a fully expanded configuration. |
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FLO-5PROV |
During a procedure, when a user rotates the driver handle 560 the drive member 580 rotates the screw member 118 to expand or collapse the expandable intervertebral implant. As the driver handle 560 rotates about the longitudinal axis 460, the shoulders 526 cooperate with the tabs 528 to retain the proximal wedge 114 such that the screw member 118 rotates but the proximal wedge 114 and expandable intervertebral implant do not rotate. |
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FLO-5PROV |
FIG. 5 illustrates in the exploded view that the driver 440 is configured to fit within the longitudinal opening 530 of the inserter fork 430. When installed within the inserter fork 430, the shaft 570 is long enough that the driver handle 560 remains outside the longitudinal opening 530 and the drive member 580 sits between the protrusions 522. With the protrusions 522 seated within the recesses 524 of the proximal wedge 114 of an attached expandable intervertebral implant, the expandable intervertebral implant is securely attached to the inserter 400. |
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FLO-5PROV |
The drive member 580 is configured to engage a drive recess 244 (See FIG. 2H) of a screw member 118. Accordingly, the drive member 580 is configured to have a shape and configuration that matches the type of drive recess 244 of the screw member 118. Depending on the type of recess 244, the drive member 580 has a corresponding type and shape such as a slot to fit a slotted recess 244, a torx end to fit a torx recess 244, a Philips end to fit a Philips recess 244, and the like. Of course, those of skill in the art recognize that the shape and configuration of the drive member 580 and the recess 244 can be reversed and thus comprise an embodiment within the scope of the present disclosure. The drive member 580 is configured to connect to the shaft 570 and fit within the inserter fork 430 such that the drive member 580 seats within the drive recess 244 when the expandable intervertebral implant is attached to the inserter 400. |
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FLO-5PROV |
The shaft 570 can be a solid piece of material that connects the driver handle 560 and the drive member 580. The shaft 570 can have a circular cross section and is sized to fit within the longitudinal opening 530. |
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FLO-5PROV |
The driver 440 includes a driver handle 560, a shaft 570, and a drive member 580. In an exemplary embodiment, the driver handle 560 can be connected to, or coupled to, the shaft 570. The driver handle 560 enables a user of the inserter 400 to rotate the shaft 570 and drive member 580 during a surgical procedure. The driver handle 560 has a circular cross section and is sized for convenient rotation in either direction about the longitudinal axis 460. |
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FLO-5PROV |
In certain embodiments, the inserter fork 430 can be splayed prior to assembly (for example by way of the the bias member 540) and insertion of the inserter fork 430 within the arm 414. Thus, assembling the inserter fork 430 within the arm 414 brings the prongs 520 closer together and movement of the inserter fork 430 to an extended position results in the prongs 520 moving further apart, which can release an attached expandable intervertebral implant 100. |
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OPT-9 |
The balance indicator 126 indicates a balance status. As used herein, a "balance indicator" refers to an apparatus, device, component, system, assembly, mechanism, hardware, software, firmware, circuit, module, or logic structured, organized, configured, programmed, designed, arranged, or engineered to indicate a balance status to a user of a device or apparatus that includes the balance indicator. The balance indicator can include one or more of an audible signal, a tactile signal, a visual signal or indication, and the like. Alternatively, or in addition, the balance indicator may comprise a mechanical device, an electromechanical device, an electronic device (analog or digital), and the like. As used herein, a "balance status" refers to a condition, state, attribute, value, and/or characteristic, of one or more members, components, structures, and/or openings relative to a state of desired, correct, and/or equal proportions between a reference set of one or more members, components, structures, and/or openings and the one or more members, components, structures, and/or openings being evaluated, measured, or examined. In certain embodiments, the balance status can be a binary condition, state, attribute, value, and/or characteristic. For example, a relationship between the one or more structures or openings and a reference set of one or more structures or openings may be either balanced or unbalanced (also referred to as imbalanced). |
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OPT-9 |
FIGURE 1E illustrates a side view of one embodiment of the gap gauge 100. The view shows the superior plate 118, inferior plate 120, separator 122, a grip 132, and a handle 134. In addition, the illustrated embodiment includes a superior body 136, an inferior body 138, a shaft 140, and a spring 142. As used herein, a "body" refers to a main or central part of a structure. In one embodiment, a body may include a housing or frame or framework for a larger system, component, structure, or device. As used herein, a "spring" refers to an elastic structure that stores mechanical energy. Springs can be made of a variety of elastic material such as spring steel and can be cylindrical and/or helical in shape. Various types of springs can be used including coil springs, torsion springs, and the like. (Search "spring (device)" on Wikipedia.com Nov. 28, 2020. Modified. Accessed Jan. 6, 2020.) |
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OPT-9 |
FIGURE 1D illustrates a bottom view of one embodiment of the gap gauge 100. The view shows the inferior plate 120, lock-out mechanism 130, grips 132, and handle 134. |
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OPT-9 |
In certain embodiments, the lock-out mechanism 130 can be used by a user to disable, prevent, or turn off actuation of the balance indicator 126 to indicate a balance status. As used herein, a "lock-out mechanism" refers to an apparatus, instrument, structure, device, component, system, assembly, hardware, software, firmware, circuit, module, or logic structured, organized, configured, programmed, designed, arranged, or engineered to prevent, mitigate, or stop operation of a balance indicator of a gap gauge such that the balance indicator does not report a balance status when the gap gauge is actuated. In one embodiment, the lock-out mechanism can prevent rotation of a plate connected to the balance indicator of a gap gauge. The pair of grips 132 can be used by a user to position the superior plate 118 relative to the inferior plate 120. For example, a user may grab the pair of grips 132 with one hand and hold the handle 134 with another hand and pull up on the grips 132 to separate the superior plate 118 and the inferior plate 120. |
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OPT-9 |
Figures 1C – 1I illustrate a top view (FIGURE 1C), bottom view (FIGURE 1D), side views (FIGURE E-G), rear view (FIGURE 1H), and front view (FIGURE 1I) of one embodiment of a gap gauge 100. FIGURE 1C illustrates an embodiment that includes a lock-out mechanism 130, a pair of grips 132, and a handle 134. As used herein, a "handle" 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 in one or more hands of a user. |
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OPT-9 |
The balance indicator 126 can be connected to one, or the other, or both, of superior plate 118 and the inferior plate 120. In one embodiment, the balance indicator 126 connects to the superior plate 118. The balance indicator 126 is illustrated as a dashed region of the gap gauge 100 because one or more components or elements in the dashed region can serve as the balance indicator 126 in different embodiments. For example, in one embodiment, a user may observe a non-parallel position of the superior plate 118, or part of the superior plate 118, and such observation may serve as the balance indicator 126. |
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OPT-9 |
In one embodiment, the balance indicator 126 indicates a balance status between the superior plate 118 and the inferior plate 120. Alternatively, or in addition, the balance indicator 126 may indicate a balance status for a joint 108 and/or between a medial collateral ligament and a lateral collateral ligament of a joint 108. Alternatively, or in addition, the balance indicator 126 may indicate a balance status between a first bone and a second bone. In the context of knee arthroplasty, the balance indicator 126 may indicate whether the arthroplasty procedure, if completed with implants on the measured bone surfaces, is likely to be varus, valgus, or balanced. |
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OPT-9 |
In certain embodiments, a balance status can represent whether, or not, a superior resection of one bone of a joint is parallel to an inferior resection of another bone of the joint. In another embodiment, a balance status can represent a degree to which a superior resection of one bone of a joint is, or is not, parallel to an inferior resection of another bone of the joint. In another embodiment, a balance status can represent how two bones of a joint and space / opening between them relate to a medial collateral ligament and a lateral collateral ligament interact to each other to achieve a desired relationship with the joint. |
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OPT-9 |
Alternatively, or in addition, a balance status can be a condition, state, attribute, value, and/or characteristic within a range of possible conditions, states, attributes, values, and/or characteristics. For example, in one embodiment, a balance status may be measured with respect to a scale or range of degrees between a positive maximum value and a negative minimum value where a balance status of zero on the range represents a balanced state and a non-zero value along the range represents an unbalanced state. In one embodiment, a range used to measure the balance status may extend from -5 degrees to +5 degrees. |
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OPT-9 |
The superior body 136 provides structural support and integrity for the gap gauge 100 and may house one or more parts of the gap gauge 100. The inferior body 138 provides structural support and integrity for the gap gauge 100 and may house one or more parts of the gap gauge 100. In one embodiment, the superior plate 118 extends from the superior body 136 and the inferior plate 120 extends from the inferior body 138. |
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OPT-9 |
The separation indicator 124 indicates the displacement 128 between the superior plate 118 and the inferior plate 120. The separation indicator 124 can be coupled to the separator 122. As used herein, a "separation indicator" refers to an apparatus, device, component, system, assembly, hardware, software, firmware, circuit, module, or logic structured, organized, configured, programmed, designed, arranged, or engineered to indicate a displacement between two or more structures to a user. The separation indicator can include one or more of an audible signal, a tactile signal, a visual signal or indication, and the like. In one embodiment, a visual indicator for the separation indicator may comprise a number or set of numbers that represent a unit of measure for the displacement (or distance) between the two or more structures. Alternatively, or in addition, the separation indicator may comprise a mechanical device, an electromechanical device, an electronic device (analog or digital), and the like. |
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OPT-9 |
The separator 122 connects to the superior plate 118 and to the inferior plate 120. The separator 122 can adjust the displacement 128. In one embodiment, actuation of the separator 122 adjusts the displacement 128. As used herein, a "separator" refers to an apparatus, instrument, structure, device, component, system, assembly, or module structured, organized, configured, programmed, designed, arranged, or engineered to separate a first structure from another structure. In one embodiment, the separator is structured, organized, configured, programmed, designed, arranged, or engineered to separate a first plate from a second plate and thereby create a distance between the first plate and the second plate. The separator 122 can actively adjust the displacement 128 and/or retain the superior plate 118 and inferior plate 120 in a certain state of separation, thereby maintaining a desired displacement 128. |
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