Modular Navigable Probe
20200352659 ยท 2020-11-12
Inventors
Cpc classification
Y10T29/4973
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61B34/20
HUMAN NECESSITIES
A61B2017/00039
HUMAN NECESSITIES
A61B2017/347
HUMAN NECESSITIES
A61B90/10
HUMAN NECESSITIES
International classification
A61B17/17
HUMAN NECESSITIES
A61B34/20
HUMAN NECESSITIES
Abstract
A navigable probe system and method of use is provided. The system may include a handle assembly having a locking mechanism enclosed and a stylus, a cannula, and a tracking device extending from the handle assembly. The stylus may include undercuts for receiving pins of the locking mechanism. A cam of the handle assembly may rotate such that in a first position, the pins of the locking mechanism may be engaged with the undercuts and in a second position, the pins of the locking mechanism may be disengaged from the undercuts releasing the stylus from the locking mechanism. The stylus may be slidably engaged with an inner diameter of the cannula. In some arrangements, the handle assembly may include a quick connect system that in a first position attaches the cannula to the handle assembly and in a second position releases the handle assembly and thus stylus from the cannula.
Claims
1. (canceled)
2. (canceled)
3. A method for replacing components of a modular navigable probe assembly comprising the steps of: rotating a first subassembly of a handle assembly relative to a second subassembly of the handle assembly from a first position in which the stylus is locked to the handle assembly to a second position in which the stylus is removable from the handle assembly; and moving a collar of a quick connect system along a portion of the handle assembly from a first position in which the cannula is locked to the handle assembly to a second position in which the cannula is removable from the second subassembly.
4. The method of claim 3, further comprising sliding at least a portion of the stylus through the cannula.
5. The method of claim 3, further comprising removing the handle assembly from both the stylus and the cannula when both the first subassembly of the handle assembly is rotated to the second position of the first subassembly and the collar of the quick connect system is moved to the second position of the collar.
6. The method of claim 3, further comprising, after removal of at least one of the stylus and the cannula, receiving in the handle assembly a drill guide, a drill, an awl, a neuromonitoring probe, an ultrasound probe, a bone aspiration and cement delivery needle, a probe-specific cannula, a needle-specific cannula, end plate preparation instruments, or interbody device insertion instruments.
7. The method of claim 3, further comprising inserting pins of a locking mechanism attached to the second subassembly into a proximal end of the stylus such that a resilient element changes between relaxed and compressed states.
8. The method of claim 7, further comprising, during rotation of the first subassembly to the first position of the first subassembly, rotating a cam of the first subassembly to supply a force against at least a portion of the pins such that the pins are inserted into the proximal end of the stylus and thereby fix the stylus in position relative to the handle assembly.
9. The method of claim 7, further comprising, during rotation of the first subassembly to the second position of the first subassembly, retracting the pins from the stylus by a force supplied by the resilient element.
10. The method of claim 9, further comprising, removing the handle assembly and the stylus from the cannula.
11. A surgical method, comprising: rotating a first subassembly of a handle assembly relative to a second subassembly of the handle assembly from a first position in which a stylus is removable from the handle assembly to a second position in which the stylus is locked to the handle assembly, wherein the handle assembly is part of a navigable probe assembly; inserting a cannula of the navigable probe assembly into a body to a predetermined depth at a predetermined orientation, wherein the depth and orientation are provided by a calibrated tracking module of the navigable probe assembly spaced from the cannula; and inserting the stylus through the cannula and into the body.
12. The method of claim 11, wherein the stylus inserting step further comprises striking a proximal surface of an impaction cap on a proximal end of the handle assembly.
13. The method of claim 11, further comprising replacing the stylus and the cannula with a second stylus and a second cannula in the navigable probe assembly; and recalibrating the tracking module with the second stylus and the second cannula such that the calibrated tracking module repeatably and reliably detects the position and orientation of the navigable probe assembly with the second stylus and the second cannula inserted.
14. The method of claim 11, further comprising replacing the stylus and the cannula with a second stylus and a second cannula in the navigable probe assembly such that the tracking module repeatably and reliably detects the position and orientation of the navigable assembly with the second stylus and the second cannula inserted.
15. The method of claim 11, further comprising rotating the handle assembly to transmit a corresponding angular rotation to the stylus and the cannula to cut a bone of the body.
16. The method of claim 11, further comprising rotating the handle assembly to thereby rotate a tapered blade of the stylus to cut a bone of the body.
17. The method of claim 11, further comprising rotating the handle assembly to thereby rotate one or more cutting flutes of the cannula to cut a bone of the body.
18. The method of claim 11, further comprising inserting pins of a locking mechanism attached to the second subassembly into a proximal end of the stylus and a resilient element.
19. The method of claim 18, further comprising, during rotation of the first subassembly to the first position of the first subassembly, rotating a cam of the first subassembly to supply a force against at least a portion of the pins such that the pins are inserted into the proximal end of the stylus and thereby fix the stylus in position relative to the handle assembly.
20. The method of claim 18, further comprising, during rotation of the first subassembly to the second position of the first subassembly, retracting the pins from the stylus by a force supplied by the resilient element.
21. The method of claim 20, wherein the retracting step includes altering a resilient element between a compressed state and a relaxed state.
22. The method of claim 20, further comprising, after rotating the first subassembly of the handle assembly to the first position, removing the handle assembly and the stylus from the cannula such that the cannula remains inserted into the bone.
23. The method of claim 22, further comprising: dilating soft tissue of the body to a first diameter with the cannula; sliding a dilator over the cannula; and further dilating the soft tissue of the body with the dilator to a second diameter larger than the first diameter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0024] Where reference is made herein to directional terms such as proximal, proximal most, distal, and distal most, it is to be understood that proximal and proximal most refer to locations closer to a user or operator of the device or method being described and that distal and distal most refer to locations further from a user or operator of the device or method being described.
[0025] Referring to
[0026] As illustrated in
[0027] The upper cap assembly 21 may include at least two tabs 24 extending from opposing positions around an inner perimeter 25 of the upper cap assembly 21 as well as a flat lower surface 26. The lower handle 40 may include at least two recesses 42 within a boss 45 extending from a flat upper surface 46 of the lower handle 40 and having a boss undercut 47 (as best shown in
[0028] The upper cap assembly 21 and the lower handle 40 may have corresponding shapes such that upon their relative rotation, the upper cap assembly 21 and the lower handle 40 may be locked together, and the flat lower surface 26 of the upper cap assembly 21 and the flat upper surface 46 of the lower handle 40 may rest flush against each other around respective perimeters of these surfaces. The ability to engage and disengage the upper cap assembly 21 and the lower handle 40 may allow for cleaning debris out of an interior of the handle assembly 20. In some arrangements, such as shown in
[0029] As shown in
[0030] As further shown in
[0031] As illustrated in
[0032] As illustrated in
[0033] As best shown in
[0034] Referring to
[0035] As illustrated in
[0036] As shown in
[0037] The tracker arm 100 may include a striking plate 102 on a distal surface thereof. Such a plate may be a flat region stamped into the arm 100 that provides a greater surface area than the rest of the arm 100 along the distal portion of the arm with which to strike the arm and provide an impaction force in a proximal direction for use in separating the cannula from the other components of the navigable probe assembly 10, especially when the cannula is inserted into bone.
[0038] On an end of the tracker arm 100 may be one or more posts 105 for connection with a tracking module, such as the tracking module 150 shown in
[0039] Referring to the configuration of
[0040] Referring to
[0041] Still referring to
[0042] The inner tube 32 of the handle base assembly 30 may have a physical hard stop 36 such that, upon placement of the handle assembly 20 onto the cannula 70, a step 73 (as best shown in
[0043]
[0044] Referring again to
[0045] In use, in accordance with an embodiment, a cannula 70 of a navigable probe assembly 10 may be inserted through the skin of a patient. The cannula 70 may have a larger diameter through most of the distal end 80 and act as a dilator as it enters through the skin of the patient. After passing the cannula 70 through the skin a predetermined depth at a predetermined orientation as determined by a calibrated tracking module 150 extending from the navigable probe assembly, as described in the '114 patent, which may be a depth determined prior to or during a surgery, a distal end 68 of a stylus 60 located within the tapered distal end 82 of the cannula 70 of the navigable probe assembly 10 may be inserted into the spine or other bone of a patient. In general, a user may strike a proximal surface of an impaction cap 53 exposed on a proximal end of a handle assembly 20 in order to supply the necessary force to insert. A rounded, ergonomic shape of the handle assembly 20 of the navigable probe assembly 10 may provide a smooth surface on which to press the navigable probe assembly 10 through the skin and into the spine of the patient.
[0046] Prior to or during insertion of the navigable probe assembly 10, the upper cap assembly 21 of the probe assembly 10 may be rotated to a locked position to cause a cam 23 that may be located within the handle assembly 20 to rotate a corresponding angle of rotation. The cam 23 may have a varying diameter such that, upon rotation of the upper cap assembly 21 to the locked position, a diameter of the cam 23 that is relatively smaller than the rest of the cam 23 causes pins 52 of a locking mechanism 50 to move toward the center of the cam 23 and become engaged with the stylus 60 of the probe assembly 10.
[0047] Due to the engagement of the respective flats 65, 75 of the stylus 60 and the cannula 70 with the respective portions of the respective flats 34 of the inner tube 32 of the handle assembly 20, rotation of the handle assembly 20 may transmit a corresponding angular rotation to the stylus 60 and the cannula 70 such that a rotation of the handle assembly 20 by the user has a corresponding rotation of the stylus 60 and the cannula 70, allowing the user to control the angular movement of the stylus 60 and the cannula 70. As the distal end 68 of the stylus 60 may have a tapered blade thereon, and the cannula 70 may have cutting flutes or other non-cylindrical features (not shown), such control of the stylus 60 and the cannula 70 can enhance the ability of the user of the navigable probe assembly 10 to cut through bone.
[0048] After the stylus 60 and the cannula 70 are embedded into the body to a predetermined depth, in some arrangements, a user may disengage the stylus 60 and the other components of the probe assembly 10 from the cannula 70 when the upper cap assembly 21 of the probe assembly 10 is in locked position by releasing the quick connect system 90 and by pulling the probe assembly 10 with the stylus 60 engaged thereto such that the stylus 60 may slide axially in the proximal direction through the inner diameter of the cannula 70. In this manner, the cannula 70 alone may remain in the bone. In such a configuration, a K-Wire (not shown) may be inserted into the inner diameter of the cannula 70 and further may be advanced into the bone to mark the cannula and stylus trajectory and to serve as a guide for subsequent steps in the procedure.
[0049] After the stylus 60 and the cannula 70 are embedded into the body to a predetermined depth, or the stylus 60 and the probe assembly 10 are disengaged from the cannula 70, a user may rotate the upper cap assembly 21 to an unlocked position to cause the cam 23 to rotate a corresponding angle of rotation. Upon such rotation, the diameter of the cam 23 that is relatively larger than the rest of cam 23 may provide a space for the pins 52 to move outwardly from the center of the cam 23. One or more springs of the locking mechanism 50 may be compressed against pin flanges 57 on the pins 52 such that as the cam 23 rotates to provide a space for the pins 52 to move, the one or more springs push the pins 52 outwardly from the center of the cam 23 such that the pins 52 remain against the changing diameter of the cam 23. As the pins 52 reach a predetermined radial position from the center of the cam 23 as they move outwardly from the center of the cam 23, the pins 52 may disengage from undercuts 64 of the stylus 60. In this manner, when the pins 52 become disengaged from the stylus 60, the stylus 60 may be removed from the navigable probe assembly 10 in the absence of other restrictions, such as constriction in some arrangements that may be caused by a quick connect system, as described further herein. The ability to disengage the cannula 70 and the stylus 60 from the probe assembly 10 provides an option to leave the stylus 60 inside the cannula 70 while embedded in the bone, allowing for one or both of intra-operative fluoroscopy images to be produced and photos to be taken along the longitudinal axis of the cannula 70 without interference from the probe assembly 10. Subsequently, the probe assembly 10 may be reattached to the cannula 70, and also may be reattached to the stylus 60, to continue the procedure.
[0050] In some arrangements in which the cannula 70 is connected to a handle base assembly 30 of a handle assembly 20 by a quick connect system, such as the quick connect system 90, the quick connect system 90 may be operated by sliding a collar 91 axially to release the cannula 70 which may then be separated from the handle assembly 20. In some arrangements, such separation of the cannula 70 may allow a second dilator having an inner diameter larger than the outer diameter of the original dilator to be slid over the original dilator, whether with or without the stylus 60 or K-wire inserted, without assistance from the navigation tracking system. The option of sliding the larger diameter dilator over the cannula 70 and the stylus 60 is possible due to the fact that the shapes of the exteriors of both the cannula 70 and the stylus 60 are bound by a predetermined outer diameter that is smaller than an inner diameter of the larger dilator. Due to the larger diameter of the second dilator, the user may further enlarge or dilate the incision produced by the original cannula. By serving the function of the initial dilator, the cannula 70 may save a surgical step of removing the cannula 70 and replacing the cannula 70 with the initial dilator.
[0051] In the example of navigated probe assembly 10, when the pins 52 are disengaged from the stylus 60, removal of the cannula 70 may permit the stylus 60 to also be removed from the handle assembly 20. After removing the stylus, the user may later reinsert one or both of the original stylus 60 and the cannula 70 or may replace one or both of the original stylus 60 and the cannula 70 with one of both of a second stylus and a second cannula, respectively. The tracking module 150 may then be recalibrated with one or both of the second stylus and the second cannula such that the tracking module 150 can repeatably and reliably detect the position and orientation of the navigable probe assembly 10 with one or both of the second stylus and the second cannula inserted. Moreover, through control of precise dimensions of the stylus and cannula during manufacturing thereof, the original calibration parameters of the tracking module 150 may remain valid and the recalibration step may be avoided.
[0052] In some arrangements (not shown), with the stylus removed from the handle assembly, an instrument or portion of an instrument, such as but not limited to a drill bit, a needle for one or both of aspirating bone and delivering bone cement, a neuromonitoring probe, and an ultrasound probe (including but not limited to a Doppler type of the ultrasound probe) may be inserted and removed through the aperture 61 in the impaction cap 53 and the inner tube 32 of the handle assembly 20, and in some arrangements, further through the cannula 70. Additionally, in some arrangements (not shown) with the stylus inserted in the handle assembly, a neuromonitoring cable or a neuromonitoring connected may be passed through the aperture of the impaction cap and connected to the stylus. Additionally, in other arrangements (not shown), with the stylus 60 and the cannula 70 removed, an instrument or a portion of an instrument, such as but not limited to a drill guide, a probe or a needle-specific cannula, an awl, end plate preparation instruments and interbody device insertion instruments can be inserted through the distal end of the probe assembly. In some arrangements, these instruments may be configured to be engaged with one or both of the locking mechanism 50 and the quick connect system 90.
[0053] It is to be understood that the disclosure set forth herein includes all possible combinations of such particular features. For example, where a particular feature is disclosed in the context of a particular aspect, arrangement, configuration, or embodiment, or a particular claim, that feature can also be used, to the extent possible, in combination with and/or in the context of other particular aspects, arrangements, configurations, and embodiments of the invention, and in the invention generally.
[0054] Furthermore, although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.