Intraoperative ultrasound probe system and related methods

Abstract

Described herein are intraoperative ultrasound imaging systems and methods that can use ultrasound imaging to safely place surgical access devices (e.g., guidewires, dilators, cannulas, etc.) through tissue (e.g., muscle, fat, brain, liver, lungs, etc.) without damaging nearby neurovascular structures. The intraoperative ultrasound system includes an ultrasound probe assembly configured to emit and receive ultrasound waves and a computer system including a processor and a display unit. Once the probe is in position, ultrasound imaging is performed, where the computer receives RF data from the probe and causes the display unit to display B-mode images of visible anatomical structures (e.g., muscle, bone, etc.).

Description

[Technical Field]

[0001] The present disclosure relates generally to ultrasound imaging, and more particularly to systems and methods for safely placing one or more instruments through tissue using ultrasound imaging without damaging nearby neurovascular structures.

[0002] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is an international application claiming benefit of priority to commonly-owned, co-pending U.S. Provisional Application No. 62 / 943,229, entitled "INTRAOPERATIVE ULTRASOUND PROBE SYSTEM AND RELATED METHODS," filed December 3, 2019, the entire contents of which are incorporated by reference into this disclosure as if fully set forth herein. [Background technology]

[0003] Ultrasound imaging, or sonography, is a diagnostic medical procedure that uses high-frequency sound waves to create visible images of anatomical features within the body, including, but not limited to, organs, tissues, and blood flow. As such, ultrasound imaging can be a useful tool for visualizing internal anatomical structures in real time prior to accessing a surgical target site. However, because conventional ultrasound techniques are ineffective at detecting certain types of tissue, including neural tissue, conventional ultrasound techniques can be unreliable for visualizing internal anatomical structures for the purposes of certain procedures, such as a lateral transpsoas approach to the spine. Summary of the Invention

[0004] The present disclosure describes an intraoperative ultrasound probe system and method that can use ultrasound imaging to safely guide the placement of one or more instruments (e.g., needles, guidewires, dilators, cannulas, etc.) through tissue (e.g., muscle, fat, brain, liver, lungs, etc.) without damaging nearby neurovascular structures. According to one embodiment, the intraoperative ultrasound probe system includes, by way of example only, an ultrasound transducer probe configured to emit and receive ultrasound waves, a computer system including a processor for processing data received by the probe, and a display unit configured to display ultrasound images based on the processed data. The ultrasound transducer probe is configured to be inserted into a surgical corridor of a surgical patient so that the distal end of the ultrasound transducer probe is proximate or in close proximity to a target anatomy. For example, in a lateral spinal approach procedure, the distal end of the ultrasound transducer probe may be positioned proximate the psoas muscle. Ultrasound imaging may then be used to locate and identify specific anatomical structures to help the surgeon visually determine the safe trajectory of a guidewire through the psoas muscle and into the target spinal disc space. Once the probe is in position adjacent to the psoas muscle (including but not limited to direct contact), ultrasound imaging may be performed, where a computer receives radio frequency (RF) data from the probe and causes a B-mode image of visible anatomical structures (e.g., muscle, bone, etc.) to be displayed on a display unit.

[0005] In some embodiments, an intraoperative ultrasound probe system includes a probe configured to emit and receive ultrasound waves in electronic communication with an electronic device (e.g., a computer) including a computer processor for processing data received by the probe, software for providing the processor with a set of executable instructions, and a display unit (integrated or standalone) configured to display an ultrasound image based on the processed data. The electronic device may be any stationary or portable computer system including a processor, software, and the ability to communicate with a display unit (integrated or standalone), including, but not limited to, laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, mobile phones, smartphones, tablet computers, cloud-based computing devices, and / or other similar computing devices. In some embodiments, the intraoperative ultrasound probe system may include various instruments and accessories, including, but not limited to, transducer stabilizers, stabilizer tubes, dilator guides, dilators, and K-wires.

[0006] In some embodiments, the ultrasound transducer probe comprises an elongated housing member having an elongated body portion, a distal end, a proximal end, an upper side, a lower side, an internal cavity, and a proximal aperture through which a communication cable passes that can connect the probe to one or more of a power source, a display device, a computer, etc. In some embodiments, the body portion includes an elongated coupling track positioned on the upper side that extends substantially the length of the body portion and can be configured to slidably couple with one or more attachments or accessories. In some embodiments, the body portion includes a passive locking element configured to engage with one or more accessories, including, but not limited to, a transducer stabilizer. In some embodiments, the passive locking element includes a recess formed in the upper side near the proximal end of the coupling track. The recess formation can create a pair of side walls positioned on either side of the recess and extending partially the length of the recess, leaving a gap between the distal ends of the side walls and the distal end of the recess. In some embodiments, the distal end has an enlarged width to accommodate an ultrasound transducer array disposed within the lumen at the distal end of the probe. In some embodiments, the distal end further comprises a generally flat tip face with rounded, smooth edges to minimize trauma to surrounding tissue as the probe is advanced and retracted through the surgical corridor. In some embodiments, the proximal end includes a curve such that the proximal end is laterally offset downwardly from the body portion.

[0007] In some embodiments, the intraoperative ultrasound probe system of the present disclosure further comprises a transducer stabilizer. In some embodiments, the distal region of the probe is sized and configured to slidably engage the stabilizer tube. However, the proximal region, which is narrower than the distal region (in some embodiments), does not itself engage the stabilizer tube and is therefore free to move (thereby changing the trajectory angle during use) without an intermediate stabilizing structure. Therefore, the transducer stabilizer is attached to the transducer probe near the proximal region and is configured to engage the stabilizer tube so that the narrow proximal region of the probe is fixed in place when the probe is inserted into the stabilizer tube.

[0008] In some embodiments, the transducer stabilizer has a body portion including an upper surface, a lower surface, and a central recess formed therein and opening to one side of the stabilizer. In some embodiments, the upper surface is generally planar with rounded, smooth edges, such that the stabilizer has a generally rounded, rectangular cross-sectional shape. In some embodiments, the central recess is sized and configured to receive a portion of the proximal region of the probe therein. In some embodiments, the stabilizer further includes a first engagement element located on a closed side (opposite the open side) of the recess and configured to engage with the probe to couple the stabilizer to the probe, such as by engaging a passive locking element (or similar feature) on the probe. In some embodiments, the stabilizer further includes a visual indicator to indicate secure locking engagement between the stabilizer and the probe.

[0009] In some embodiments, the transducer stabilizer may be further configured to securely engage the stabilizer tube while simultaneously being coupled to the probe. To facilitate this engagement, the stabilizer may include a pair of lower buttresses extending from the underside of the body portion. The lower buttresses may be located at either end of the stabilizer (e.g., one on each side of the central recess) and may have a curved perimeter corresponding to the perimeter of the stabilizer tube's internal lumen, such that the lower buttresses are sized and shaped to be snugly received within the stabilizer tube's internal lumen. The body portion (including its upper and lower surfaces) may have a slightly larger perimeter than the buttresses to create an overhang or lip that prevents the entire stabilizer from entering the stabilizer tube's internal lumen. A pair of elongated flanges may extend further downward into the internal lumen (when coupled to the stabilizer tube) to provide additional stability. As a result, in some embodiments, the transducer stabilizer can be configured to "seat" on the upper end of the stabilizer tube when engaged with the stabilizer tube and to maintain the proximal end of the probe in a constant orientation relative to the stabilizer tube.

[0010] In some embodiments, the transducer stabilizer may be fabricated from a medical-grade radiolucent material such as PEEK (polyetheretherketone), PEKK (polyetherketoneketone), or the like, and may further include a radiographic marker positioned to indicate the location of one or more of the dilator guide's guide channels under fluoroscopy. In some embodiments, the radiographic marker may be a spot marker indicating the location of the top opening of the dilator guide's guide channel and / or a linear marker indicating the alignment and / or angular orientation of the guide channel. In some embodiments, the transducer stabilizer may be made from anodized aluminum.

[0011] In some embodiments, the intraoperative ultrasound probe system of the present disclosure further includes a stabilizer tube. In some embodiments, the stabilizer tube includes an elongated cannulated sleeve having a proximal end, a distal end, and an internal lumen extending from the proximal end to the distal end. In some embodiments, the sleeve and internal lumen each have a generally rounded rectangular cross-sectional shape. In some embodiments, the internal lumen can be sized and configured to receive at least a portion of the stabilizer buttress therein at the proximal end and further to receive a dilator guide therein. In some embodiments, the sleeve further includes proximal and distal apertures at each end of the internal lumen to allow for the entry and exit of various surgical instruments through the stabilizer tube. In some embodiments, the proximal end may further include a superior flange that supports a laterally offset curved portion of the probe, and a laterally extending flange configured (for example) to engage with the articulating arm to align the stabilizer tube (and thus any instrument associated with the stabilizer tube, such as the probe, dilator guide, etc.) with the bed rail in a fixed orientation.

[0012] In some embodiments, the intraoperative ultrasound probe system of the present disclosure further includes a dilator guide. In some embodiments, the dilator guide comprises an elongated cannulated sleeve having a proximal end, a distal end, and one or more guide channels in the form of an internal lumen extending from the proximal end to the distal end, with proximal and distal openings that allow the entry and exit of various instruments. In some embodiments, the dilator guide may have multiple guide channels extending therethrough. In some embodiments, the dilator guide may have three cylindrical guide channels, including a central guide channel and a pair of lateral guide channels. In some embodiments, the guide channels may be sized and configured to receive at least one dilator therethrough, but any instrument having a diameter or width smaller than the diameter of the guide channels may pass through. In some embodiments, the proximal end of the dilator guide is configured to "seat" on the upper end of the stabilizer tube when engaged with the stabilizer tube and to maintain a constant orientation of the dilator guide (and importantly, the guide channels) relative to the stabilizer tube. In some embodiments, the distal end of the dilator guide has a peripheral surface that has a size and shape that corresponds to the peripheral size and shape of the internal lumen (when coupled with the stabilizer tube) so that the distal end is snugly received within the internal lumen, providing additional stability.

[0013] In some embodiments, the ultrasound transducer probe may be inserted through a cannula, allowing advancement of surgical instruments (e.g., dilators, K-wires) through the probe. In some embodiments, the cannula extends substantially the length of the body portion and includes an internal passageway configured to allow passage of one or more surgical instruments (e.g., surgical guidewires).

[0014] In some embodiments, the surgical guidewire may include a series of echogenic elements configured to reflect sound waves to "visualize" the surgical guidewire during ultrasound imaging, hi some embodiments, the echogenic elements comprise one or more of notches, ridges, etc.

[0015] In some embodiments, the probe includes an elongated housing member having a generally hourglass shape. In some embodiments, the elongated housing member may include a widened distal end with an outer surface having a curved perimeter corresponding to the perimeter of the stabilizer tube's inner lumen, promoting a comfortable interaction between the distal end and the stabilizer tube to minimize or completely prevent non-translational movement of the distal end relative to the stabilizer tube during use. In some embodiments, the elongated housing member may include a widened proximal end with an outer surface having a curved perimeter corresponding to the perimeter of the stabilizer tube, promoting a comfortable interaction between the proximal end and the stabilizer tube to minimize or completely prevent non-translational movement of the proximal end relative to the stabilizer tube during use.

[0016] In some embodiments, the probe further comprises a proximal extension comprising an internal cavity through which communication cables pass that may connect the probe (e.g., including, but not limited to, the transducer array) to one or more of a power source, a display device, a computer, etc. In some embodiments, this proximal extension may be curved or angled such that the proximal end is laterally offset from the distal end, creating additional space for manipulating instrumentation when advancing or retracting the probe through the surgical corridor, such as via a stabilizer tube.

[0017] In some embodiments, the electronic device comprises a mobile unit having a computer housing (e.g., comprising a processor, software, a data storage module, and a communication module configured for wired and / or wireless communication with the probe), a base unit, and a display unit coupled to the vertical displacement element. In some embodiments, the base unit has a plurality of wheel elements (e.g., casters) that allow a user to move the mobile unit to any desired location in a room. In some embodiments, the electronic device including the computer housing and display unit can be connected to a power source, either integrated with the electronic device or connected to an A / C power source via a power cord. In some embodiments, the electronic device can be A / C-enabled with a battery backup. In some embodiments, the data storage module can include an internal memory or an external memory. In some embodiments, the display unit can have a screen with a touchscreen interface that allows a user to provide instructions to the computer by selecting buttons or icons that the computer presents on the screen.

[0018] In some embodiments, direct visualization of dilator / K-wire placement may be utilized prior to removal of the stabilizer tube.

[0019] In some embodiments, the system may include integration of 3D soft tissue mapping capabilities enabled by image-guided navigation. In some embodiments, robotic automation may be employed to increase accuracy and efficiency.

[0020] As additional explanation for the following embodiments, the following embodiments are described in this disclosure.

[0021] Embodiment 1 is an intraoperative ultrasound probe system for guiding access through intervening anatomical structures to reach a surgical target site, the system comprising: an ultrasound probe having a proximal end, a distal end, an electronic communication element; a transducer array positioned near the distal end, the transducer array including at least one emitting element configured to emit high frequency sound waves in a direction away from the distal end within the vicinity of the distal end, the transducer array further comprising at least one sensing element configured to receive reflected sound waves; an electronic device in electronic communication with the ultrasound probe via the electronic communication element, the electronic device having at least one computer processor and a data storage unit; a display unit in electronic communication with the electronic device; and a display unit that, when executed by the one or more processors, causes the computer processor to receive signals from the at least one emitting element. and a computer-readable medium containing instructions configured to cause the ultrasound probe to emit high-frequency sound waves at least one of toward and through an intervening anatomical structure; convert reflected sound waves received by at least one sensing element into radio frequency data; generate a B-mode image of the intervening anatomical structure in the vicinity of the distal end from the radio frequency data; and generate a secondary image of neurovascular anatomy in the vicinity of the distal end; and provide on a display unit a real-time presentation of (i) the generated B-mode image of the intervening anatomical structure, (ii) the secondary image of the neurovascular anatomy superimposed on the B-mode image, and (iii) an enhanced location of at least one of nerves, muscles, and bones superimposed on the secondary image and the B-mode image.

[0022] Embodiment 2 is the system of embodiment 1, wherein the electronic element comprises at least one of a communication cable and a wireless transmission platform.

[0023] Embodiment 3 is a system described in embodiment 1 or 2, further including an elongate access conduit having a proximal end, a distal end, and an internal lumen extending between the proximal and distal ends, the internal lumen being configured to receive a probe therethrough.

[0024] Embodiment 4 is a system described in any of embodiments 1 to 3, wherein the access conduit further comprises a laterally extending flange at the proximal end, the laterally extending flange configured to interact with the articulating arm to align the access conduit in a fixed orientation.

[0025] Embodiment 5 is a system described in any of embodiments 1 to 4, wherein the ultrasound probe includes one or more radiographic markers for indicating, under fluoroscopy, at least one of the position and orientation of a potential access route through the intervening anatomical structure.

[0026] Embodiment 6 is a system described in any of embodiments 1 to 5, wherein the computer-readable medium includes further instructions configured, when executed by one or more processors, to cause the computer processor to (iv) provide on a display unit a real-time presentation of one or more potential access paths through the intervening anatomical structures based on the position and orientation of radiographic markers superimposed on the B-mode image.

[0027] Embodiment 7 is a system described in any of embodiments 1 to 6, further comprising an elongated dilator guide configured to nest within the internal lumen of the access conduit, the elongated dilator guide having at least one guide channel extending therethrough, the at least one guide channel configured to receive a dilator therein.

[0028] Embodiment 8 is a system described in any of embodiments 1 to 7, wherein the expander has a shaped end configured to advance through the intervening anatomical structure and an inner lumen configured to allow a guidewire to pass therethrough.

[0029] Embodiment 9 is a system described in any of embodiments 1 to 8, wherein the elongate dilator guide comprises three guide channels extending parallel therethrough.

[0030] Embodiment 10 is a method of guiding access through intervening anatomical structures to a surgical target site of a patient positioned on a surgical surface, comprising the steps of: (1) providing an ultrasonic probe assembly including an ultrasonic probe disposed within an interior lumen of an access conduit; and (2) advancing a distal end of the ultrasonic probe assembly through an incision in the patient's skin to a surface of an anatomical structure between the patient's dura mater and the surgical target site, the probe including a proximal end, a distal end, an electronic communication element, and a transducer array positioned near the distal end, the transducer array configured to emit high frequency acoustic waves in a direction away from the distal end within the vicinity of the distal end, receive reflected acoustic waves, and convert the reflected acoustic waves into radio frequency data. (3) performing ultrasound imaging to generate a B-mode image of the intervening anatomical structure from radio frequency data acquired by the probe; (4) displaying the B-mode image of the intervening anatomical structure on a display device; (5) displaying a secondary image of neurovascular anatomy near the distal end superimposed on the B-mode image; (6) displaying an enhanced location of at least one of nerves, muscles, and bones superimposed on the secondary image and the B-mode image; and (7) selecting an access path through the intervening anatomical structure based on the displayed B-mode image and the superimposed secondary image.

[0031] Embodiment 11 is the method of embodiment 10, further comprising orienting the access conduit relative to the surgical surface.

[0032] Embodiment 12 is the method of embodiment 10 or 11, wherein the probe includes one or more radiographic markers for indicating at least one of the location and orientation of the potential access route under fluoroscopy.

[0033] Embodiment 13 is a method according to any of embodiments 10 to 12, further comprising a step of displaying a real-time presentation of one or more potential access routes through intervening anatomical structures based on the position and orientation of radiographic markers superimposed on the B-mode image.

[0034] Embodiment 14 is a method according to any of embodiments 10 to 13, further comprising the steps of removing the probe from the access conduit and advancing an elongate dilator guide into the internal lumen of the access conduit, wherein the dilator guide is configured to nest within the internal lumen of the access conduit, the elongate dilator guide having at least one guide channel extending therethrough, the at least one guide channel corresponding to the selected access pathway and configured to receive a dilator therein.

[0035] Embodiment 15 is a method according to any of embodiments 10 to 14, further comprising the step of advancing an elongate dilator along the selected access route through a guide channel corresponding to the selected access route and through the intervening anatomical structure, the dilator having a shaped end configured to facilitate advancement through the intervening anatomical structure and an inner lumen configured to allow a guide wire to pass therethrough.

[0036] Embodiment 16 is the method of any of embodiments 10 to 15, further comprising advancing a guidewire through the dilator until the distal end of the guidewire is aligned with the surgical target site.

[0037] Embodiment 17 is the method of any of embodiments 10 to 17, further comprising removing the access conduit from the incision and removing the dilator from the incision. [Brief explanation of the drawings]

[0038] The many advantages of the present disclosure will become apparent to those skilled in the art upon reading this specification in conjunction with the accompanying drawings, in which like reference numerals are applied to like elements and in which: [Figure 1] FIG. 1 is a block diagram illustrating an example of an intraoperative ultrasound probe system according to an embodiment of the present disclosure. [Figure 2] FIG. 2 is a perspective view of an example of an ultrasound transducer probe forming part of the intraoperative ultrasound probe system of FIG. 1. [Figure 3] FIG. 3 is a plan view of the proximal end of the ultrasound transducer probe of FIG. 2. [Figure 4] FIG. 3 is a side view of the ultrasonic transducer probe of FIG. 2. [Figure 5] FIG. 3 is a top view of the ultrasound transducer probe of FIG. 2. [Figure 6] FIG. 3 is a bottom view of the ultrasonic transducer probe of FIG. 2. [Figure 7] FIG. 2 is a perspective view of an example of a transducer stabilizer forming part of the intraoperative ultrasound probe system of FIG. 1. [Figure 8] FIG. 8 is a front view of the transducer stabilizer of FIG. 7. [Figure 9] FIG. 8 is a top view of the transducer stabilizer of FIG. 7. [Figure 10] FIG. 8 is an exploded perspective view of the transducer stabilizer of FIG. 7. [Figure 11] FIG. 2 is a perspective view of an example of a stabilizer tube forming part of the intraoperative ultrasound probe system of FIG. 1. [Figure 12] FIG. 12 is a top view of the stabilizer tube of FIG. 11. [Figure 13] FIG. 12 is a side view of the stabilizer tube of FIG. 11. [Figure 14] 13 is a cross-sectional side view of the stabilizer tube of FIG. 11 taken along line AA of FIG. 13. [Figure 15]2 is a perspective view of an example of a dilator guide forming part of the intraoperative ultrasound probe system of FIG. 1. [Figure 16] FIG. 16 is a top view of the dilator guide of FIG. 15. [Figure 17] FIG. 16 is a front view of the dilator guide of FIG. 15. [Figure 18] 17 is a front cross-sectional view of the dilator guide of FIG. 15 taken along line BB of FIG. 16. [Figure 19] 2 is a perspective view of another example of a transducer probe forming part of the ultrasound transducer probe system of FIG. 1. [Figure 20] FIG. 20 is a plan view of the transducer probe of FIG. 19. [Figure 21] FIG. 20 is a rear view of the transducer probe of FIG. 19. [Figure 22] FIG. 20 is a cross-sectional side view of the transducer probe of FIG. 19. [Figure 23] 2 is a perspective view of another example of a transducer probe forming part of the ultrasound transducer probe system of FIG. 1. [Figure 24] 2 is a perspective view of another example of a transducer probe forming part of the ultrasound transducer probe system of FIG. 1. [Figure 25] FIG. 24 is a front view of the transducer probe of FIG. 23. [Figure 26] FIG. 24 is a front view of the transducer probe of FIG. 23. [Figure 27] FIG. 24 is a side view of the transducer probe of FIG. 23. [Figure 28] 1. FIG. 4 is a perspective view of another example of a stabilizer tube forming part of the intraoperative ultrasound probe system of FIG. [Figure 29] FIG. 29 is a top perspective view of the stabilizer tube of FIG. 28. [Figure 30] FIG. 29 is a top view of the stabilizer tube of FIG. 28. [Figure 31] FIG. 29 is a side view of the stabilizer tube of FIG. 28. [Figure 32]29 is a cross-sectional side view of the stabilizer tube of FIG. 28 taken along line CC of FIG. 29. [Figure 33] 29 is a perspective view of the transducer probe of FIG. 23 coupled with the stabilizer tube of FIG. 28. FIG. [Figure 34] 29 is a perspective view of the transducer probe of FIG. 23 coupled with the stabilizer tube of FIG. 28. FIG. [Figure 35] 29 is a perspective view of the dilator guide of FIG. 15 coupled with the stabilizer tube of FIG. 28. [Figure 36] 29 is a top view of the dilator guide of FIG. 15 coupled with the stabilizer tube of FIG. 28. [Figure 37] FIG. 2 is a plan view of an example of an electronic device including a computer and a display unit that forms part of the intraoperative ultrasound probe system of FIG. 1. [Figure 38] FIG. 2 is a block diagram illustrating an exemplary operating room configuration for a method of using the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 39] 2A-2D are perspective views of various steps of a method of using the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 40] 2A-2D are perspective views of various steps of a method of using the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 41] 2A-2D are perspective views of various steps of a method of using the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 42] 2A-2D are perspective views of various steps of a method of using the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 43] 2A-2D are perspective views of various steps of a method of using the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 44] 2 is an example of a graphic user interface (GUI) screen forming part of the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 45]2 is an example of a graphic user interface (GUI) screen forming part of the intraoperative ultrasound probe system of FIG. 1 according to one embodiment. [Figure 46] 10A-10C are perspective views of additional method steps. [Figure 47] 10A-10C are perspective views of additional method steps. [Figure 48] FIG. 1 illustrates a perspective view of an example of an echogenic surgical implant according to one embodiment. [Figure 49] FIG. 2 is a block diagram of an example computer system forming part of the intraoperative ultrasound probe system of FIG. 1. [Figure 50] FIG. 2 is a block diagram of an example computer system forming part of the intraoperative ultrasound probe system of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION

[0039] Illustrative embodiments of the present invention are described below. For clarity, not all features of an actual implementation are described herein. It will, of course, be understood that developing any such actual embodiment will require numerous implementation-specific decisions to achieve the developer's particular goals, including compliance with system and business constraints, which will vary from implementation to implementation. It will further be understood that such a development effort may be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The intraoperative ultrasound probe systems and related methods disclosed herein possess various unique features and components that, individually and in combination, warrant patent protection.

[0040] The present disclosure describes an intraoperative ultrasound probe system and associated methods that can use ultrasound imaging to assist a surgeon in visually determining a trajectory for safely placing one or more instruments (e.g., needles, guidewires, dilators, cannulas, etc.) through tissue (e.g., muscle, fat, brain, liver, lungs, etc.) without damaging nearby neurovascular structures. FIG. 1 depicts an example of an intraoperative ultrasound probe system 10 according to one embodiment of the present disclosure. By way of example, the intraoperative ultrasound probe system 10 includes a probe 12 configured to emit and receive ultrasound waves in electronic communication with an electronic device 14 (or computer 14) that includes a computer processor 16 for processing data received by the probe 12, software 18 for providing a set of executable instructions to the processor, and a display unit 20 (integrated or standalone) configured to display ultrasound images based on the processed data. The electronic device 14 may be any stationary or portable computer system including a processor 16, software 18, and the ability to communicate with a display unit 20 (integrated or standalone), including, but not limited to, a laptop, desktop, workstation, personal digital assistant, server, blade server, mainframe, mobile phone, smartphone, tablet computer, and / or other similar computing device. The intraoperative ultrasound probe system 10 of the present disclosure further includes various instruments and accessories, including, but not limited to, a transducer stabilizer 22, a stabilizer tube 24, a dilator guide 26, a dilator 28, and a guidewire (e.g., K-wire) 30.

[0041] 2-6 depict an example of an ultrasound transducer probe 12 according to one embodiment of the present disclosure. By way of example only, the probe 12 comprises an elongated housing member having an elongated body portion 32, a distal end 34, a proximal end 36, an upper side 38, a lower side 40, an internal cavity 42, and a proximal aperture 44 through which a communication cable 46 passes that can connect the probe 12 to one or more of a power source, a display device, a computer, etc., by way of example only. The body portion 32 includes an elongated connecting track 48 positioned on the upper side 38 that extends substantially the length of the body portion 32. The connecting track 48 is configured to slidably couple with one or more attachments or accessories (not shown). By way of example, and as best shown in FIG. 3 , the connecting track 48 comprises an elongated central beam 50 having a pair of elongated lateral flanges 52 that create overhangs such that the connecting track 48 has a generally “T”-shaped cross-section (e.g., a “dovetail” configuration).

[0042] Body portion 32 further comprises a passive locking element 54 configured to engage with one or more accessories, including, but not limited to (and by way of example only), a cantilever locking element of a guide sleeve (not shown) and / or a portion of transducer stabilizer 22 described below. By way of example only, passive locking element 54 comprises a recess 56 formed in upper surface 38 near the proximal end of linkage track 48. The formation of recess 56 may create a pair of side walls 58 positioned on either side of recess 56 and extending partially the length of recess 56, leaving a gap 60 between the distal ends of side walls 58 and recess 56.

[0043] The distal end 34 has an enlarged width to accommodate (for example) an ultrasound transducer array 62 disposed within the internal cavity 42 at the distal end 34 of the probe 12. By way of example only, the transducer array 62 comprises at least one emitting element 63 and at least one sensing element 65. The at least one emitting element 63 may be configured to emit high-frequency sound pulses in a direction away from the distal end 34. At least a portion of the emitted high-frequency sound pulses may be reflected by boundaries between bodily tissues. The at least one sensing element 65 may be configured to receive the reflected sound pulses as radio frequency (RF) data, which is then transmitted to the processor 16 (for example) via a communication cable 46 or other suitable electronic communication method (e.g., wired, wireless, WiFi, Bluetooth, etc.). The distal end 34 further comprises a tip surface 64. The distal end surface 64 may, by way of example, be generally planar with rounded, smooth edges to minimize trauma to surrounding tissue as the probe 12 is advanced and retracted through the surgical channel.

[0044] Proximal end 36 includes a curved portion 66 such that proximal end 36 is laterally offset downwardly from body portion 32. By way of example, upper surface 38 and lower surface 40 are each generally planar with rounded, smooth edges to minimize trauma to surrounding tissue as probe 12 is advanced through the surgical channel.

[0045] 7-10 illustrate an example of a transducer stabilizer 22 configured for use with and forming a part of an intraoperative ultrasound probe system 10 according to one embodiment of the present disclosure. The distal region 34 of the probe 12 is sized and configured to slidably engage the stabilizer tube 24, as described below. However, the proximal region 36, which is narrower than the distal region 34, does not itself engage the stabilizer tube 24 and is therefore free to move (thereby changing its trajectory angle during use) without the stabilizing intermediate structure. The transducer stabilizer 22 is attached to the transducer probe 12 near the proximal region 36 and is further configured to engage the stabilizer tube 24 so that the narrow proximal region 36 of the probe 12 is fixed in place when the probe is inserted into the stabilizer tube 24.

[0046] By way of example only, the transducer stabilizer 22 has a body portion 68 including an upper surface 70, a lower surface 72, a central recess 74 formed therein and opening to one side of the stabilizer 22, and a side channel 75 extending therethrough. The upper surface 70 is generally planar with rounded, smooth edges, such that the stabilizer 22 has a generally rounded, rectangular cross-sectional shape (see, e.g., FIG. 9 ). The central recess 74 is sized and configured to receive a portion of the proximal region 36 of the probe 12 therein. The stabilizer 22 further includes a first engagement element 76 and a locking bar 77 configured to engage the probe 12 to couple the stabilizer 22 to the probe 12. By way of example, the engagement element 76 is positioned on the closed side of the recess (opposite the open side) and is configured to engage with the passive locking element 54 (or similar feature) on the probe 12. The locking bar 77 is sized and configured to be received within the side channel 75 and includes a pair of locking recesses 79, a pair of engagement recesses 81, and an upper aperture 83. The locking recesses 79 are configured to receive the distal end of a locking screw 85 therein when the locking recesses 79 are aligned with threaded holes 87 formed in the body portion 68. The engagement recesses 81 are configured to receive at least a portion of the side wall 58 therein when the transducer stabilizer 22 is coupled to the probe 12. The stabilizer 22 further includes a visual indicator window 78 that indicates secure locking engagement between the stabilizer 22 and the probe 12. More specifically, the visual indicator window 78 includes an indicator pin 89 that is coupled to the locking bar 77 via the upper aperture 83. As an example, the position of the indicator pin 89 relative to markings on the top surface 70 may indicate to the user whether the stabilizer 22 is locked to the probe 12 .

[0047] The transducer stabilizer 22 is further configured to securely engage the stabilizer tube 24 while simultaneously being coupled to the probe 12. To facilitate this engagement, the stabilizer 22 further includes a pair of lower buttresses 80 extending from the lower surface 72 of the body portion 68. The lower buttresses 80 are located at either end of the stabilizer (e.g., one on each side of the central recess 74) and have a curved peripheral shape corresponding to the peripheral shape of the internal lumen 96 of the stabilizer tube 24 such that the lower buttresses 80 are sized and shaped to be snugly received within the internal lumen 80 of the stabilizer tube 24. The body portion 68 (including the upper surface 70 and lower surface 74) has a slightly larger circumference than the buttresses 80 to create an overhang or lip 82 that prevents the entire stabilizer 22 from entering the internal lumen 96 of the stabilizer tube 24. A pair of elongated flanges 84 extend further downwardly into the inner lumen 96 (when coupled to the stabilizer tube 24) to provide additional stability. As a result, the transducer stabilizer 22 is configured to "seat" on the upper end of the stabilizer tube 24 when engaged with the stabilizer tube 24 and to maintain the proximal end 46 of the probe 12 in a constant orientation relative to the stabilizer tube 24.

[0048] The transducer stabilizer 22 may be fabricated from a medical-grade radiolucent material, such as PEEK (polyetheretherketone), PEKK (polyetherketoneketone), or the like, and may further include radiographic markers 86, 88 positioned to indicate, under fluoroscopy, the location of one or more of the guide channels 116 (described below) of the dilator guide 26, and thus the location of possible access paths. By way of example, the radiographic marker 86 may be a spot marker indicating the location of the upper opening of the guide channel 116 of the dilator guide 26. The radiographic marker 88 may be a linear marker indicating the alignment and / or angular orientation of the guide channel 116. In some embodiments, the transducer stabilizer may be made from anodized aluminum. In some embodiments, the probe 10 may include an internal metal structure that acts as an X-ray imaging element to indicate where the multiple guide channels 116 of the dilator guide 26 are located as the dilator guide 26 advances into the stabilizer tube 24, thereby allowing the surgeon to ensure that all of the potential guide channels 116 are aligned with the surgical target site 426.

[0049] 11-14 illustrate an example of a stabilizer tube 24 configured for use in an intraoperative ultrasound probe system 10 according to an embodiment of the present disclosure. The stabilizer tube 24 includes, by way of example only, an elongated cannulated sleeve 90 having a proximal end 92, a distal end 94, and an internal lumen 96 extending from the proximal end 92 to the distal end 94. By way of example only, the sleeve 90 and the internal lumen 96 each have a generally rounded rectangular cross-sectional shape. The sleeve 90 has a smooth outer surface 98 to minimize trauma to surrounding tissue during use. The internal lumen 96 is sized and configured to receive at least a portion of the buttress 80 at the proximal end 92 therein, and further to receive a dilator guide 26 therein, as described below. The proximal end 92 further includes a proximal rim 100 configured to engage the lip 82 of the stabilizer 22 to prevent the stabilizer 22 from fully entering the internal lumen 96. The sleeve 90 further includes a proximal aperture 102 and a distal aperture 104 at each end of the internal lumen 96 to allow for the entry and exit of various surgical instruments through the stabilizer tube 24. The proximal end 92 further includes a superior flange 106 that supports the laterally offset curved portion 66 of the probe 12, and a laterally extending flange 108 configured to engage (for example) an articulating arm to orient the stabilizer tube 24 (and thus the probe 12, dilator guide 26, or any instruments associated with the stabilizer tube 24) to a patient's bed rail.

[0050] 15-18 illustrate an example of a dilator guide 26 configured for use in an intraoperative ultrasound probe system 10 according to an embodiment of the present disclosure. By way of example only, the dilator guide 26 comprises an elongated cannulated sleeve 110 having a proximal end 112, a distal end 114, and one or more guide channels 116 in the form of internal lumens extending from the proximal end 112 to the distal end 114, and having proximal and distal openings 118, 120 that allow for the entry and exit of various instrumentation. By way of example only, the dilator guide 26 shown and described herein has three cylindrical guide channels, including a central guide channel 116 and a pair of lateral guide channels 116′, 116″. However, it should be understood that the dilator guide 26 may be provided with any number of guide channels 116 without departing from the scope of this disclosure. As explained below, multiple guide channels 116 allow a user to simultaneously explore multiple potential entry trajectories while also allowing the user to select and adopt any one of the explored trajectories without moving the stabilizer tube 24 (and thereby any instrumentation associated therewith). The cannulated sleeve 110 has a smooth outer surface to minimize trauma to the surrounding tissue during use. Each of the guide channels 116, 116′, 116″ is sized and configured to receive at least one dilator therethrough, although any instrument having a diameter or width smaller than the diameter of the guide channel may be passed therethrough.

[0051] Proximal end 112 includes an upper surface 122, a lower surface 124, and a plurality of side walls 126 extending between upper surface 122 and lower surface 124. The upper surface is generally planar and has a rounded rectangular perimeter shape and includes a plurality of apertures 118 (e.g., proximal guide channel apertures 118, 118', 118") formed therein. Lower surface 124 includes a lower buttress 128 extending downwardly therefrom, the lower buttress 128 having a perimeter sized and shaped to correspond to the perimeter shape of the inner lumen 96 of stabilizer tube 24 such that lower buttress 128 is snugly received within inner lumen 96 of stabilizer tube 24. Lower surface 124 24 has a slightly larger circumference than the buttress 128 so as to create an overhang or lip 130 that prevents the proximal end 112 of the dilator guide 26 from entering the internal lumen 96 of the stabilizer tube 24. As a result, the proximal end 112 is configured to "seat" against the upper end of the stabilizer tube 24 when engaged with the stabilizer tube 24 and to maintain the dilator guide 26 (and importantly, the guide channel 116) in a constant orientation relative to the stabilizer tube 24. Similarly, the distal end 114 of the dilator guide 26 has a peripheral surface 132 that has a size and shape that corresponds to the peripheral size and shape of the internal lumen 96 (when coupled with the stabilizer tube 24) so ​​that the distal end 114 is snugly received within the internal lumen 96 to provide additional stability.

[0052] The sidewall 126 forms the outer periphery of the proximal end 112 and includes a plurality of friction elements 134 (e.g., ridges, knobs, surface roughening, etc.) distributed thereon. The friction elements 134 allow a user to grip and apply a pulling force to the dilator guide 26 to remove it from the stabilizer tube 24 after use.

[0053] 19-22 depict another example of a probe 140 forming part of the intraoperative ultrasound probe system 10 of the present disclosure. As described below, the probe 140 of this example may be cannulated so that the probe 140 is advanced over a surgical guidewire (e.g., a K-wire 30). By way of example, the probe 140 comprises an elongated housing member having an elongated body portion 142, a distal end 144, a proximal end 146, an upper surface 148, a lower surface 150, an internal cavity 152, and a proximal aperture 154 through which a communication cable 156 passes that may connect the probe 140 to one or more of a power source, a display device, a computer, etc., by way of example only. In some embodiments, the body portion 142 may include an elongated connector track 158 positioned on the upper surface 148 that extends substantially the length of the body portion 142, the connector track 158 having a structure and function similar to the connector track 48 described above. Body portion 142 further comprises a passive locking element 164 configured to engage one or more accessories, including, but not limited to (and by way of example only), a portion of transducer stabilizer 22 described above. By way of example only, passive locking element 164 comprises an upper recess 166 formed in upper surface 148 near proximal end 146. The formation of recess 166 may create a pair of side walls 168 positioned on either side of recess 166 and extending partially the length of recess 166, leaving a gap 170 between the distal ends of side walls 168 and the distal end of recess 166.

[0054] The distal end 144 has an enlarged width to accommodate (for example) an ultrasound transducer array 172 disposed therein. By way of example only, the transducer array 172 comprises at least one emitting element and at least one sensing element. The at least one emitting element may be configured to emit high-frequency sound pulses in a direction away from the distal end 144. At least a portion of the emitted high-frequency sound pulses may be reflected by boundaries between bodily tissues. The at least one sensing element may be configured to receive the reflected sound pulses as radio frequency (RF) data, which is then transmitted to the processor 16 (for example) via the communication cable 156 or other suitable electronic communication method (e.g., wired, wireless, WiFi, Bluetooth, etc.). The distal end 144 further comprises a tip surface 174. The tip surface 174 may, by way of example, be generally planar with rounded, smooth edges to minimize trauma to surrounding tissue as the probe 140 is advanced and retracted through the surgical corridor. Proximal end 146 may include a curved portion 176 such that proximal end 146 is laterally offset downwardly from body portion 142. By way of example, upper surface 148 and lower surface 150 are each generally planar with rounded, smooth edges to minimize trauma to surrounding tissue as probe 140 is advanced through the surgical channel.

[0055] By way of example, the probe 140 may be cannulated such that it includes an internal passageway 178 extending substantially the length of the body portion 142 and configured to allow one or more surgical instruments (e.g., dilators 28, K-wire 30) to pass therethrough. The distal end 144 of the probe 140 includes a distal aperture 180 formed in the tip surface 174, which comprises the distal terminus of the internal passageway 178 and allows for entry and / or exit from the internal passageway 178. The proximal terminus of the internal passageway 178 includes a proximal aperture 182 positioned distal to the curved portion 176. The proximal aperture 182 comprises the proximal terminus of the internal passageway 178 and allows for entry and / or exit from the internal passageway 178. The K-wire 30 may include a series of echogenic elements 184 (e.g., notches, ridges, etc.) configured to reflect sound waves to make the K-wire 30 “visible” during ultrasound imaging.

[0056] By way of example only, the internal passageway 178 may occupy space within the internal cavity 152 of the probe 140, but is physically separated from the internal cavity 152 to ensure that foreign matter (such as patient tissue) does not enter the internal cavity 152. As such, the internal probe elements (e.g., the transducer array 172, the communication cable 156, etc.) may be positioned within the internal cavity 152 around the internal passageway 178. Providing the probe 140 with a cannula (e.g., the internal passageway 178) allows instruments (e.g., the dilators 28, the K-wires 30) to be advanced directly through the probe 140 without the need for a separate insertion passageway (e.g., the dilator guide 26), which may be advantageous in some surgical situations in that the instruments are inserted directly through the field of view rather than alongside the field of view.

[0057] 23-27 depict another example of a probe 190 configured for use with (and to form a part of) the intraoperative ultrasound probe system 10 of the present disclosure. For purposes of illustration, the probe 190 of this exemplary embodiment is described for use with the stabilizer tube 240 described below, although it should be understood that the probe 190 may also be used with the stabilizer tube 24 described above. By way of example only, the probe 190 comprises an elongated housing member 192 having a distal end 194, a proximal end 196, an upper surface 198, a lower surface 200, and an internal cavity 202 extending therethrough. The elongated housing member 192 may have generally smooth, planar surfaces (e.g., including the upper surface 198 and the lower surface 200) and rounded, smooth edges to minimize trauma to surrounding patient tissue during use. By way of example, elongated housing member 192 includes a connecting track 203 positioned on upper side 198 that extends substantially the length of housing member 192. Connecting track 203 comprises (by way of example only) an elongated beam element configured to slidably connect with one or more attachments or accessories, including, but not limited to, stabilizer tube 240 (see, e.g., FIG. 34 ), described below.

[0058] The distal end 194 has an enlarged width to accommodate (for example) an ultrasound transducer array 204 (e.g., including at least one emitting element and at least one sensing element) disposed within the internal cavity 202 at the distal end 194 of the probe 190. The distal end 194 further comprises a tip surface 206. The tip surface 206 may, by way of example, be generally planar with rounded, smooth edges to minimize trauma to surrounding tissue as the probe 190 is advanced and retracted through the surgical corridor. By way of example only, the distal end 194 of the elongated housing member 192 comprises an outer surface 207 having a curved peripheral shape corresponding to the peripheral shape of the internal lumen 248 of the stabilizer tube 240 (and / or the internal lumen 96 of the stabilizer tube 24). This shape promotes a good interaction between distal end 194 and stabilizer tube 240 to minimize or completely prevent non-translational movement of distal end 194 relative to stabilizer tube 240 during use. By way of example only, proximal end 196 of elongate housing member 192 may also have an enlarged width, giving elongate housing member 192 a generally hourglass shape.

[0059] The probe 190 further comprises a proximal extension 208 extending proximally from the proximal end 196 of the elongate housing member 192. The proximal extension 208 comprises an elongate body 210 having a distal end 212, a proximal end 214, and an internal cavity 216 extending therethrough from the distal end 212 to the proximal end 214. A distal portion of the internal cavity 216 is continuous with the internal cavity 202 of the elongate housing member 192. The proximal end 214 further comprises a proximal aperture 218 through which a communication cable 220 passes that may connect the probe 190 (e.g., including, but not limited to, the transducer array 204) to one or more of a power source (not shown), a display device 20, a computer 14, etc., by way of example only.

[0060] By way of example, proximal extension 208 includes a curved portion 222 configured such that proximal end 214 is laterally offset from distal end 212 , ie, downwardly from elongate housing member 192 .

[0061] By way of example, probe 190 is configured to securely engage stabilizer tube 240 and / or stabilizer tube 24 without the need for additional accessories. As such, proximal end 196 of elongate housing member 192 may have an enlarged width, giving elongate housing member 192 a generally hourglass shape. More specifically, proximal end 196 of elongate housing member 192 includes outer surface 224 having a curved peripheral shape that corresponds to the peripheral shape of inner lumen 248 of stabilizer tube 240, such that proximal end 196 is sized and shaped to be snugly received within inner lumen 248 of stabilizer tube 240. This shape promotes a smooth interaction between proximal end 196 and stabilizer tube 240, minimizing or eliminating non-translational movement of proximal end 196 relative to stabilizer tube 240 during use of probe 190. The distal end 212 of the proximal extension 208 may have a slightly larger circumference than the proximal end 196 of the elongated housing member 192 so that when engaged with the stabilizer tube 240, the distal end 212 prevents the proximal extension 208 from entering the upper end of the internal lumen of the stabilizer tube 240, forcing the probe 190 to stop advancing through the stabilizer tube 240 and creating an overhang or lip 226 that maintains the proximal end 196 of the probe 190 in a fixed orientation relative to the stabilizer tube 240.

[0062] The distal end 212 of the proximal extension 208 may further include, by way of example, radiographic markers 228, 230 (see, e.g., FIG. 34 ) positioned to indicate, under fluoroscopy, the location of one or more of the guide channels 116 of the dilator guide 26, and thus the location of possible access paths. By way of example, the radiographic marker 228 may be a spot marker indicating the location of the upper opening of the guide channel 116 of the dilator guide 26. The radiographic marker 230 may be a linear marker(s) indicating the alignment and / or angular orientation of the guide channel 116. In some embodiments, the distal end 212 of the proximal extension 208 may further include (by way of example only) one or more surface markings 232 configured to indicate and identify the future location of the guide channel 116 of the dilator guide 26 once the probe 190 is removed from the stabilizer tube 240 and replaced with the dilator guide 26, as described below. By way of example, the surface markings 232 may include a numerical designation that correlates to a particular guide channel 116 (e.g., a "1" indicating the location of guide channel 116, a "2" indicating the location of guide channel 116', a "3" indicating the location of guide channel 116", etc.). This relationship is illustrated, by way of example, in FIGS. 33-36.

[0063] In some embodiments, the probe 190 may be cannulated so as to extend substantially the length of the elongated housing member 192 and include an internal passageway (not shown) configured to allow one or more surgical instruments (e.g., K-wires 30) to pass therethrough.

[0064] 28-32 illustrate an example of a stabilizer tube 240 configured for use in an intraoperative ultrasound probe system 10 according to an embodiment of the present disclosure. The stabilizer tube 240 includes, by way of example only, an elongated, cannulated sleeve 242 having a proximal end 244, a distal end 246, and an internal lumen 248 extending from the proximal end 244 to the distal end 246. By way of example only, the sleeve 242 and the internal lumen 248 each have a generally rounded rectangular cross-sectional shape. The sleeve 242 has a smooth outer surface 250 to minimize trauma to surrounding tissue during use. The inner lumen 248 is sized and configured to snugly receive the wide distal end 194 and / or the wide proximal end 196 of the probe 190 (and / or the wide distal end 34 of the probe 12 and / or at least a portion of the lower buttress 80 of the transducer stabilizer 22) therein, as well as the dilator guide 26, as shown, for example, in FIGS. 35-36 . The inner lumen further includes a longitudinally oriented, elongated guide recess 252 configured to receive the coupling track 203 of the probe 190 therein to securely maintain the orientation of the probe 190 during use. The proximal end 244 further includes a proximal rim 254 configured to engage the lip 226 of the probe 190 to prevent the probe 190 from fully entering the inner lumen 248. Sleeve 242 further includes proximal and distal apertures 256, 258 at each end of internal lumen 248 to allow for the entry and exit of various surgical instruments through stabilizer tube 240. Proximal end 244 further includes a laterally extending flange 260 that includes one or more attachment elements 261 configured to engage (for example) an articulating arm to orient stabilizer tube 240 (and thus any instruments associated with stabilizer tube 240, such as probe 190, dilator guide 26, etc.) to a patient's bed rail.

[0065] In some embodiments, the proximal end 244 of the stabilizer tube 240 may further include (by way of example only) one or more surface markings 262 configured to indicate and identify the location of the guide channel 116 of the dilator guide 26, regardless of the instrument (e.g., probe 190, dilator guide 26, etc.) used with the stabilizer tube 240. By way of example, the surface markings 262 may match the surface markings 232 on the probe 190 and may include a numeric designation correlating to a particular guide channel 116 (e.g., a "1" to indicate the location of guide channel 116, a "2" to indicate the location of guide channel 116', a "3" to indicate the location of guide channel 116", etc.). Similarly, the laterally extending flange 260 of the stabilizer tube 240 may further include (by way of example only) one or more surface markings 264 configured to indicate and identify the location of the guide channel 116 of the dilator guide 26, regardless of the instrument (e.g., probe 190, dilator guide 26, etc.) used with the stabilizer tube 240. By way of example, the surface markings 264 may match the surface markings 232 on the probe 190 and the surface markings 262 on the proximal end 244 and may include a numerical designation correlating to a particular guide channel 116 (e.g., a "1" indicating the location of the guide channel 116, a "2" indicating the location of the guide channel 116', a "3" indicating the location of the guide channel 116", etc.). This relationship is depicted, by way of example, in FIGS. 33 through 36.

[0066] FIG. 37 illustrates an example of an electronic device 14 suitable for placement in an operating room (“OR”) and configured for use with an intraoperative ultrasound probe system 10, according to one embodiment of the present disclosure. The electronic device 14 of this example comprises a mobile unit 300 having a computer housing 302 (e.g., comprising a processor 16, software 18, a data storage module 304, and a communications module 306 configured for wired and / or wireless communications with the probe 12), a base unit 308, and a display unit 20 coupled to a vertical displacement element 310. By way of example only, the base unit 308 is generally parallel to the floor and has a plurality of wheel elements 312 (e.g., casters, etc.) that allow a user to move the mobile unit 300 to any desired location within the room. The vertical displacement element 310 may comprise any suitable structure, including, by way of example only, but not limited to, a pole, a post, scaffolding, a ladder, etc., capable of securely maintaining the display unit 20 at a usable height. Although not shown, the electronic device 14, including the computer housing 302 and display unit 20, may be connected to a power source, either integrated with the electronic device or connected to an A / C power source via a power cord. In one embodiment, the electronic device 14 may be A / C capable with a battery backup (not shown). The data storage module 304 may include internal or external storage. As an example, the display unit 20 may have a screen 314 with a touchscreen interface that allows a user to provide instructions to the computer by selecting buttons or icons that the computer presents on the screen.

[0067] 38 through 47 depict several steps of an exemplary method for safely determining an access trajectory to a surgical target site using the presently disclosed intraoperative ultrasound probe system 10. By way of example only, the method is described herein in connection with establishing a lateral access trajectory through the psoas muscle to a surgical target site comprising an intervertebral disc space. However, it should be understood that the methods described herein for identifying and locating specific tissue types and determining a safe trajectory to a surgical target site using ultrasound imaging may be used in any surgical situation.

[0068] The first step in the exemplary method is to position the display unit 20 of the electronic device 14 outside the sterile field within the field of view of a primary user in the OR. The primary user is typically a surgeon performing a surgical procedure on a patient. FIG. 38 is a block diagram representing an exemplary OR configuration 400 for the methods described herein. By way of example, a patient 402 lies on his or her side on an operating table or bed 404. A surgeon 406 is positioned behind 408 the patient 402. Generally, the OR configuration 400 further includes an anesthesia machine and personnel 412 positioned at or near the head of the operating table 404, a C-arm 414 and C-arm technician 416 positioned in front 410 of the patient 402, a C-arm display 418, a Mayo stand 420, and one or more back tables 422. 38, the optimal position for the display unit 20 (e.g., Sono Vision™) is at the foot of the patient's bed 404, and also close to the C-arm display 418 so that the surgeon can simultaneously view both the fluoroscopic image (on the C-arm display 418) and the ultrasound image (on the display unit 20). The next step is to connect the articulating arm 424 (e.g., a Metrx flexible arm or equivalent) to the patient's operating table or bed 404 (e.g., on a rail or similar structure). The attachment point of the articulating arm 424 should be positioned anterior 410 and caudal (e.g., toward the patient's feet) of the surgical target site 426.

[0069] 39 depicts a portion of a patient's body 402 covered by a surgical drape 430 having a window 432 in the patient's skin 434 that exposes an area where an access passage needs to be formed to access a surgical target site 426. Once the equipment is set up in the correct location, the next step is to use fluoroscopy to identify the surgical target site 426 (e.g., the vertebral level) and make a marking 436 on the patient's skin 434. After the skin is marked, an initial incision is made over the marking 436. The surgeon may then use one or more fingers and / or a blunt tissue dissector to palpate the patient's tissue posterior to the peritoneum and up to the superficial psoas muscle.

[0070] At this point, probe 12 (or probe 190 and / or any probe described herein) may be connected to electronic device 14, for example, by connecting cable 46 of probe 12 to communications module 306 of electronic device 14. By way of example only, connecting cable 46 may have a connector element that is securely received within a port on electronic device 14, the port being in electronic communication with communications module 306. In one embodiment, the port may have a locking feature that securely locks the connector element within the port.

[0071] Once the probe 12 is connected to the electronic device 14, the probe 12 and stabilizer tube 24 may be coupled in preparation for insertion into the patient through the incision. To accomplish this, the transducer stabilizer 22 may be coupled to the probe 12 in the manner described above, and the probe 12 with the coupled stabilizer 22 may be inserted into the inner lumen 96 of the stabilizer tube 24, for example, such that the buttress 80 of the stabilizer 22 is received within the inner lumen 96 of the stabilizer tube 24. The distal face 64 of the probe 12 should be aligned (or come very close to being aligned) with the distal aperture 104 to ensure that the distal surface is as smooth as possible during advancement through the patient tissue.

[0072] As shown in FIG. 40 , the probe 12 / stabilizer 22 / conduit 24 assembly (hereinafter “probe assembly 438”) may be oriented parallel to the incision and then carefully advanced through the incision and fascia until the distal end 94 of the stabilizer tube 24 and the tip surface 64 of the probe 12 reach the surface of the external oblique muscle. At this point, the probe assembly 438 may be rotated 90° (clockwise or counterclockwise) so that the probe assembly 438 is perpendicular to the incision and therefore parallel to the muscle fibers of the external oblique muscle. After the rotation is complete, the probe assembly 438 is further advanced through the external oblique muscle. Once the distal end 94 of the stabilizer tube 24 and the tip surface 64 of the probe 12 have advanced out of the external oblique muscle and into the retroperitoneal space, the probe assembly 438 may be rotated 90° and returned to its original orientation parallel to the incision and the target disc space (see, e.g., FIG. 41 ). The assembly is then positioned so that the distal surface 64 of the probe 12 rests on the surface of the psoas muscle.

[0073] Once the distal surface of the probe 64 rests on the superficial psoas muscle, the probe assembly 438 may be aligned with the operating table or bed 404 via connection with the articulating arm 424. As shown in FIG. 42 , this may be accomplished by connecting a connecting element 428 on the distal end of the articulating arm 424 to the laterally extending flange 108 of the stabilizer tube 24. This connection ensures that the stabilizer tube 24, and any instruments securely coupled thereto (e.g., including but not limited to, the probe 12, dilator guide 26, dilator 28, or K-wire 30), remain securely locked in place relative to the surgical target site.

[0074] 43 , the next step is to position the probe 12 over the disc space using fluoroscopic imaging of the C-arm 414. As the dilator guide 26 is advanced into the stabilizer tube 24, radiographic elements on the probe 10 and / or stabilizer 22 can indicate where the multiple guide channels 116 of the dilator guide 26 are located, allowing the surgeon to also ensure that all of the potential guide channels 116 are aligned with the surgical target site 426. By way of example only, such radiographic elements may include radiographic markers 86, 88 on the stabilizer 22, radiographic markers 228, 230 on the probe 190, and / or internal metal structure of the probe 10 or probe 190.

[0075] The user may then use the software 18 of the intraoperative ultrasound probe system 10 to determine whether any of the available psoas muscle passageways (as determined by the location of the radiographic markers 86 on the stabilizer 22) are free of nerves and / or vasculature and therefore suitable for advancement of a dilator. By way of example only, FIGS. 44-45 depict exemplary graphic user interface (GUI) screens 440, 442 that the electronic device 14 presents on the display unit 20 and that a user may encounter while using the intraoperative ultrasound probe system 10 according to one embodiment of the present disclosure. By way of example, the GUI screen 440 of FIG. 44 may have three main sections. For example, on the right side of the screen, a standard B-mode ultrasound image 444 is displayed. The left section displays a top view 446 and a front view 448 of the probe assembly 438 currently in use, with numbers (e.g., 1, 2, 3) visible that correspond to the guide channels 116′, 116, 116″ (in this example) of the dilator guide 26 being used. The center section presents a computer-generated color B-mode overlay 450 of the psoas muscle, including approximate available psoas muscle passage paths based on the dilator guide 26 being used and the current position of the probe assembly 438. In this example, a first displayed path 452 corresponds to position “1” on the image in the left section of the GUI 440, and this number corresponds to the guide channel 116′ of the dilator guide 26. A second displayed path 454 corresponds to position “2” on the image in the left section of the GUI 440, and this number corresponds to the guide channel 116 of the dilator guide 26. The third displayed path 456 corresponds to the position "3" on the image in the left section of the GUI 440, which number corresponds to the guide channel 116" of the dilator guide 26.

[0076] At this point, the user may tap the "I in a circle" icon 458 in the lower right corner of the GUI screen 440 to instruct the computer to present a pop-up menu 460 shown on the GUI screen 442 of FIG. 45. The pop-up menu 460 includes several icons that the user can tap to instruct the computer to display specific information on the B-mode overlay 450. For example, as shown in FIG. 45, the user may select the "Nerve" icon 462, which instructs the computer to display the location and proximity information of any nerves in the psoas muscle that are within the field of view of the probe 12. Optional indications, such as color-coded shapes (e.g., circles 464 as shown in FIG. 45), may then be displayed by the computer, along with indications of dangerous areas surrounding the nerve that should be avoided. By way of example, the displayed nerve may be up to 120% or larger than the specified size to provide a safety margin. Similar icons may also be presented to instruct the computer to display similar information for other structures. For example, the GUI 442 in this example includes a "Bone" icon 466, a "Muscle" icon 468, a "Doppler" icon 470, a "Grid" icon 472, and an "More" icon 474, which represents additional options that are likely to be used less frequently. The displayed information may be displayed until the user deselects the information by tapping the icon twice. Additionally, the user may instruct the computer to simultaneously display multiple sets of information by selecting some icons (e.g., nerve 462 and bone 466).

[0077] The pop-up menu 460 may further include a "Shutdown" icon 476 that, when tapped by the user, instructs the computer to begin a shutdown process, a "Restart" icon 478 that, when tapped by the user, instructs the computer to restart the system, and a "Report" icon 480 that, when selected by the user, instructs the system to generate and store a session report to provide a record of system events during the surgical procedure. Each of the GUI screens 440, 442 (and any others) may also include a "Camera" icon 482 that, when selected by the user, instructs the computer to capture and store a screenshot image, and a pull-down menu icon 484 that, when selected by the user, instructs the computer to present a pull-down menu that may present the user with additional options (e.g., including, but not limited to, login, surgical procedure information, patient information, etc.).

[0078] If one or more of the indicated candidate paths 452, 454, 456 is determined to be free of nerves, vasculature, and / or other structures to avoid and is therefore suitable for advancing a dilator through the psoas muscle, a guide number (e.g., 1, 2, 3, etc.) is noted for later use. If no path is determined to be suitably clear, the probe assembly 438 may be repositioned and the process repeated until a suitable path is identified.

[0079] At this point, the surgeon may remove the probe 12 from the stabilizer tube 24 (held in place by the articulating arm 424) and directly visualize (e.g., with their own eyes) the interior lumen 96 of the conduit 24 to ensure that the intended dilation path is free of, for example, the genitofemoral nerve (and other issues). In some embodiments, a light source (e.g., an illumination source, camera, etc.) may be advanced through the stabilizer tube 24 to aid in direct visualization of the intended dilation path.

[0080] Next, the dilator guide 26 may be fully inserted into the stabilizer tube 24 as described above. Thereafter, the dilator 28 may be advanced through the guide channel 116 (e.g., guide channels 116, 116', 116") that corresponds to the selected pathway. The dilator 28 is then advanced through the psoas muscle along the selected pathway. The surgical guidewire 30 may then be inserted through the dilator 28 into the target disc space (see, e.g., FIG. 46).

[0081] After the dilators 28 and K-wires 30 are placed, the dilator guide 26 may be removed from the stabilizer tube 24, leaving the stabilizer tube 24, dilators 28, and K-wires 30 in place. The stabilizer tube 24 may then be disconnected from the articulating arms 424 and removed from the incision, leaving the dilators 28 and K-wires 30 in place (see, e.g., FIG. 47). The lateral spinal approach procedure may then continue with sequential dilation and retractor insertion as is known in the art of lateral spinal approach surgery.

[0082] While the presently disclosed intraoperative ultrasound probe system 10 is described herein as configured to facilitate navigating tissue and neurovascular structures to determine an operative pathway to a surgical target site, in some embodiments, the system 10 may be configured to locate and identify surgical implants (e.g., interbody implants, fixation plates, bone screws, rods, etc.) and distinguish between surgical implants and anatomical structures. In such embodiments, these surgical implants may be modified or enhanced to include one or more echogenic elements configured to reflect sound waves in order to "visualize" them during ultrasound imaging. In some embodiments, these echogenic elements may comprise surface features including (by way of example only) but not limited to notches, ridges, grooves, etc. In some embodiments, these surgical implants may be fabricated from echogenic materials. By way of example only, FIG. 48 depicts an exemplary interbody fusion implant 500 that includes a series of echogenic elements 502 (e.g., notches, ridges, grooves, etc.) configured to reflect sound waves in order to "visualize" the implant 500 during ultrasound imaging.

[0083] In some embodiments, the presently disclosed intraoperative ultrasound probe system 10 may be configured to receive data collected by other modalities, such as electromyography (EMG), integrate that data with the ultrasound data, and display the combined data on the ultrasound image (e.g., as an additional overlay or adjacent image) to create a confirmatory multimodal display of the planned path and surrounding anatomical structures. By way of example only, a cannulated probe (e.g., the cannulated probe 140 of FIGS. 19-22) may be provided in which the internal passage 178 is electrically insulated to facilitate accurate delivery of electrical stimulation to the target site without shorting. In some embodiments, the surgical guidewire (e.g., the K-wire 30) may also be electrically insulated to minimize shorting, except for a portion of its tip that is exposed to accommodate directional electrical stimulation. By way of example, the internal passage 178 may be sized and configured to permit passage of a blunt guidewire (e.g., a thin and / or low-profile blunt guidewire) to puncture the annulus of the target disc while avoiding penetration of tissue (e.g., neural tissue). Sequential dilation can then be performed using the deployed guidewire. The guidewire can include ultrasound-detectable markers that allow visual tracking of the guidewire as it advances through tissue and can indicate the direction in which EMG stimulation is directed. EMG results collected during advancement of the guidewire through the cannulated probe and through tissue can then be displayed on the display unit 20 (e.g., as part of GUI screen 440 of FIG. 44 and / or GUI screen 442 of FIG. 45), and a confirmatory multimodal display can be created by providing the spatially aligned EMG results to the same display as the ultrasound. The EMG results can, for example, be combined with the ultrasound image (e.g., as an additional overlay) or displayed next to the ultrasound image as a separate image.

[0084] 49-50 are exemplary block diagrams of computer-implemented electronic devices 600, 650 that may be used to implement the systems and methods described herein, either as a client or a server or multiple servers. Computing device 600 is intended to represent various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other suitable computers. Computing device 650 is intended to represent various forms of mobile devices, such as personal digital assistants, mobile phones, smartphones, and other similar computing devices. In this example, computing device 650 may represent a handheld computing device 14, while computing device 600 may represent a physically larger system, such as stationary computer 14 of FIG. 37 and / or mobile electronic device 300, and / or a computing system that is a cloud server. The components, the connections and relationships of those components, and the functionality of those components shown herein are merely examples and do not limit the implementations described and / or claimed herein.

[0085] Referring to FIG. 49, computing device 600 includes a processor 602, a memory 604, a storage device 606, a high-speed interface 608 connecting to memory 604 and a high-speed expansion port 610, and a low-speed interface 612 connecting to a low-speed bus 614 and storage device 606. Components 602, 604, 606, 608, 610, and 612 are each interconnected using various buses and may be mounted on a common motherboard or in other manners as appropriate. Processor 602 can process instructions for execution within computing device 600, including instructions stored in memory 604 or storage device 606 to display graphical information for a graphic user interface (GUI) on an external input / output device, such as a display 616 coupled to high-speed interface 608. In other implementations, multiple processors and / or multiple buses may be used, along with multiple memories and multiple types of memory as appropriate. For example, one or more graphics processing units (GPUs) may be used to accelerate the creation of images for display. Also, multiple computing devices 600 may be connected, each providing a portion of the required operations (eg, as a server bank, a group of blade servers, or a multi-processor system).

[0086] The memory 604 stores information within the computing device 600. By way of example only, the memory 604 may be a volatile memory unit, a non-volatile memory unit, or another form of computer-readable medium, such as (for example) a magnetic or optical disk.

[0087] The storage device 606 can provide mass storage for the computing device 600. In one implementation, the storage device 606 can be or include a non-transitory computer-readable medium (e.g., any computer-readable medium other than a transitory propagating signal), such as a floppy disk device, a hard disk device, an optical disk device, a tape device, a flash memory or other similar solid-state memory device, or a collection of devices including devices in a storage area network or other configuration. A computer program product can be tangibly embodied in an information carrier. The computer program product can also include instructions that, when executed, perform one or more methods, such as those described above. The information carrier is a computer-readable or machine-readable medium, such as memory 604, the storage device 606, or memory on the processor 602.

[0088] The high-speed interface 608 manages bandwidth-intensive operations of the computing device 600, while the low-speed interface 612 manages less bandwidth-intensive operations. Such functional allocation is by way of example only. In one implementation, the high-speed interface 608 is coupled to the memory 604, the display 616 (e.g., through a graphics processor or accelerator), and a high-speed expansion port 610 that can accept various expansion cards (not shown). In this implementation, the low-speed interface 612 is coupled to the storage device 606 and the low-speed expansion port 614. The low-speed expansion port may include various communication ports (e.g., USB, Bluetooth, Ethernet, wireless Ethernet) and may be coupled to one or more input / output devices, such as a keyboard 618, a printer 620, a scanner 622, or a network-connected device, such as a switch or router 624, for example, via a network adapter.

[0089] Computing device 600 may be implemented in several different forms. For example, it may be implemented as a standard server or multiple times in a cluster of such servers. It may also be implemented as part of a rack server system. Additionally, it may be implemented in a personal computer, such as a laptop computer. Alternatively, components from computing device 600 may be combined with other components in a mobile device, such as device 650 (FIG. 49). Each such device may include one or more of computing devices 600, 650, and the entire system may be made up of multiple computing devices 600, 650 communicating with each other.

[0090] 50, computing device 650 includes, among other components, a processor 652, memory 654, an input / output device such as a display 656, a communications interface 658, and a transceiver 660. Device 650 may also be provided with a storage device such as a microdrive or other device for additional storage capacity. Device 650 may further include one or more graphics processing units (GPUs) for accelerating the creation of images for display. Components 650, 652, 654, 656, 658, and 660 are each interconnected using various buses, and some of the components may be mounted on a common motherboard or in other manners as appropriate.

[0091] The processor 652 can execute instructions within the computing device 650, including instructions stored in memory 654. The processor may be implemented as a set of chips including separate and multiple analog and digital processors. Additionally, the processor may be implemented using any of several architectures. For example, the processor 652 may be a CISC (Complex Instruction Set Computer) processor, a RISC (Reduced Instruction Set Computer) processor, or a MISC (Minimum Instruction Set Computer) processor. The processor may coordinate other components of the device 650, such as, for example, the user interface, applications run by the device 650, and control of wireless communications by the device 650.

[0092] The processor 652 may communicate with a user via a control interface 662 and a display interface 664 coupled to a display 656. The display 656 may be, for example, a TFT (thin film transistor liquid crystal display) display, an OLED (organic light emitting diode) display, or other suitable display technology. The display interface 664 may comprise appropriate circuitry for driving the display 656 to present graphical and other information to the user. The control interface 662 may receive commands from the user and convert them for passing to the processor 652. Additionally, an external interface 666 may be provided in communication with the processor 652 to enable short-range communication of the device 650 with other devices. The external interface 666 may, for example, provide for wired communication in some implementations or wireless communication in other implementations, and multiple interfaces may also be used.

[0093] Memory 654 stores information within computing device 650. Memory 654 may be implemented as one or more of non-transitory computer-readable medium(s) (e.g., as described above), volatile memory unit(s), or non-volatile memory unit(s). Expansion memory 668 may also be provided and connected to device 650 by expansion interface 670, which may include, for example, a Single In Line Memory Module (SIMM) card interface. Such expansion memory 668 may provide additional storage space for device 650 or may also store applications or other information for device 650. Specifically, expansion memory 668 may include instructions for performing or complementing the processes described above and may also include secure information. Thus, expansion memory 668 may be provided, for example, as a security module for device 650 and may be programmed with instructions that enable device 650 to be used securely. Additionally, secure applications may be provided via SIMM cards along with additional information, such as placing identifying information on the SIMM card in an unhackable manner.

[0094] The memory may include, for example, flash memory and / or NVRAM memory, as described below. In one implementation, a computer program product is tangibly embodied in an information carrier. The computer program product includes instructions that, when executed, cause one or more methods, such as those described above, to be performed. The information carrier is a computer-readable or machine-readable medium, such as memory 654, expansion memory 668, or memory on processor 652, which may be received, for example, via transceiver 660 or external interface 666.

[0095] Device 650 may communicate wirelessly through communication interface 658, which may include digital signal processing circuitry, if necessary. Communication interface 658 may provide communication via various modes or protocols, such as GSM voice calls, SMS, EMS, or MMS messaging, CDMA, TDMA, PDC, WCDMA, CDMA6000, or GPRS, among others. Such communication may occur, for example, through radio frequency transceiver 660. Additionally, short-range communication may occur, such as using Bluetooth, WiFi, or other such transceivers (not shown). In addition, a GPS (Global Positioning System) receiver module 672 may provide additional navigation-related and location-related wireless data to device 650, which may be used as appropriate by applications running on device 650.

[0096] Device 650 may also communicate audibly using audio codec 674, which may receive verbal information from a user and convert that information into usable digital information. Audio codec 674 may likewise generate audible sounds for the user, such as through a speaker in the handset of device 650. Such sounds may include sounds from voice telephone calls, recorded sounds (e.g., voice messages, music files, etc.), and sounds generated by applications running on device 650.

[0097] Computing device 650 may be implemented in several different forms, some of which are shown in the figure. For example, it may be implemented as a mobile phone, or it may be implemented as part of a smartphone, personal digital assistant, or other similar mobile device.

[0098] Additionally, computing device 600 or 650 may include a Universal Serial Bus (USB) flash drive. The USB flash drive may store an operating system and other applications. The USB flash drive may include input / output components such as a wireless transmitter or a USB connector that can be inserted into a USB port of another computing device.

[0099] Various implementations of the systems and techniques described herein can be realized in digital electronic circuitry, integrated circuits, specially designed ASICs (application-specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations can include implementations in one or more computer programs executable and / or interpretable on a programmable system that includes at least one programmable processor, which can be special-purpose or general-purpose, coupled to receive data and instructions from, and transmit data and instructions to, a storage system, at least one input device, and at least one output device.

[0100] These computer programs (also referred to as programs, software, software applications, or code) include machine instructions for a programmable processor and may be implemented in a high-level procedural and / or object-oriented programming language and / or an assembly / machine language. As used herein, the terms "machine-readable medium" and "computer-readable medium" refer to any computer program product, apparatus, and / or device (e.g., magnetic disk, optical disk, memory, programmable logic device (PLD)) used to provide machine instructions and / or data to a programmable processor.

[0101] To provide for user interaction, the systems and techniques described herein can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user, and a keyboard and pointing device (e.g., a mouse or trackball) by which the user can provide input to the computer. Other types of devices can also be used to provide for user interaction; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback), and input from the user can be received in any form, including acoustic, speech, or tactile input.

[0102] The systems and techniques described herein can be implemented in a computing system that includes back-end components (e.g., as data servers), middleware components (e.g., application servers), front-end components (e.g., client computers having a graphical user interface or web browser through which a user can interact with an implementation of the systems and techniques described herein), or any combination of such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communications network). Examples of communications networks include a local area network ("LAN"), a wide area network ("WAN"), a peer-to-peer network (with ad hoc or static members), a grid computing infrastructure, and the Internet.

[0103] A computing system may include clients and servers. Clients and servers are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.

[0104] While the inventive features described herein have been described in terms of preferred embodiments for achieving the objectives, those skilled in the art will recognize that modifications can be made in light of these teachings without departing from the spirit or scope of the present disclosure. While various components have been described in terms of a system, it should be noted that some components may be used independently of other components. Furthermore, while illustrated and described herein with reference to specific examples, it should be understood that the principles of the present disclosure are not limited to the specific examples described herein, and various modifications and improvements may be made without departing from the scope of the present disclosure. For example, in some embodiments, a retractor may be used to stabilize the probe 12. In some embodiments, direct visualization of dilator / K-wire placement may be utilized prior to removal of the stabilizer tube. In some embodiments, the system may include integration of three-dimensional soft tissue mapping capabilities enabled by image-guided navigation. In some embodiments, robotic automation may be employed to enhance accuracy and efficiency.

Claims

1. 1. An intraoperative ultrasound probe system for guiding access through intervening anatomical structures to a surgical target site, comprising: an ultrasound probe having a proximal end, a distal end, an electronic communication element, and a transducer array positioned near the distal end, the transducer array including at least one emitting element configured to emit high frequency sound waves in a vicinity of the distal end and in a direction away from the distal end, the transducer array further comprising at least one sensing element configured to receive reflected sound waves; an elongated access conduit having a proximal end, a distal end, and an internal lumen extending between the proximal end and the distal end, the internal lumen configured to receive the ultrasonic probe therethrough; an electronic device in electronic communication with the ultrasound probe via the electronic communication element, the electronic device having at least one computer processor and a data storage unit; a display unit in electronic communication with the electronic device; a computer-readable medium containing instructions; Equipped with The instructions, when executed by one or more processors, cause the computer processor to: directing the ultrasound probe to emit high frequency acoustic waves from the at least one emission element at least one of toward and through the intervening anatomical structure; converting reflected acoustic waves received by the at least one sensing element into radio frequency data; generating a B-mode image of the intervening anatomical structure in the vicinity of the distal tip from the radio frequency data; generating a secondary image of the neurovascular anatomy in the vicinity of the distal end; In the display unit, (i) a generated B-mode image of the intervening anatomical structure; (ii) the secondary image of the neurovascular anatomy superimposed on the B-mode image; and (iii) an enhanced location of at least one of a nerve, a muscle, and a bone superimposed on the secondary image and the B-mode image; and providing a real-time presentation of The method is configured to: an elongated dilator guide configured to nest within the internal lumen of the access conduit, the elongated dilator guide having three guide channels extending therethrough, the three guide channels configured to receive dilators therein, and including a central guide channel and a pair of lateral guide channels; the ultrasound probe including one or more radiographic markers for indicating, under fluoroscopy, at least one of a location and an orientation of a potential access route through the intervening anatomical structure; The computer-readable medium, when executed by one or more processors, causes the computer processors to: (iv) determining one or more potential access paths through the intervening anatomical structures based on the positions and orientations of the radiographic markers superimposed on the B-mode image; and further instructions configured to cause the display unit to provide a real-time representation of the

2. The system of claim 1 , wherein the electronic communication element comprises at least one of a communication cable and a wireless transmission platform.

3. 10. The system of claim 1, wherein the access conduit further comprises a laterally extending flange at the proximal end, the laterally extending flange configured to interact with an articulating arm to orient the access conduit.

4. 10. The system of claim 1, wherein the dilator has a shaped end configured for advancement through the intervening anatomical structure and an inner lumen configured to allow passage of a guidewire.

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