Instruments, systems, and methods for performing neuromonitoring during spinal procedures

Abstract

An instrument for use in spine surgery, and related systems and methods are disclosed. The instrument features a probe extending between a proximal end and a distal end. The probe includes a sensing tip at the distal end having a first diameter, the sensing tip including a first conducting area. An embed area is disposed adjacent to the sensing tip having a second diameter that is larger than the first diameter so that the probe may be supported in a free standing position. The probe further includes a depth stop defined by a third diameter that is larger than the second diameter. There is an initial dilator integrally formed with the probe including a sensing region having a second conducting area. The proximal end includes a third conducting area and a fourth conducting area that are in electrical communication with the first conducting area and second conducting area, respectively.

Description

Docket No. A0012877W001 (341387.47001)IN THE UNITED STATES PATENT AND TRADEMARK OFFICE APPLICATION FOR UNITED STATES LETTERS PATENTINVENTOR: CHRIS ITALIAIETITLE: INSTRUMENTS, SYSTEMS, AND METHODS FOR PERFORMING NEUROMONITORING DURING SPINAL PROCEDURESASSIGNEE: WARSAW ORTHOPEDIC, INC.2500 SILVEUS CROSSINGWARSAW, INDIANA 46581AN INDIANA CORPORATIONDocket No. A0012877W001 (341387.47001)INSTRUMENTS, SYSTEMS, AND METHODS FOR PERFORMING NEUROMONITORING DURING SPINAL PROCEDURESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application 63 / 737,846, entitled INSTRUMENTS, SYSTEMS, AND METHODS FOR PERFORMING NEUROMONITORING DURING SPINAL PROCEDURES and filed, December 23, 2024, the entire disclosure of which is incorporated by reference in its entirety.BACKGROUND

[0002] Dilators are used in spinal surgery to create a minimally invasive pathway to the spine by gently and progressively separating muscle and soft tissue fibers without cutting them. By inserting a series of dilators of increasing diameter, surgeons can gradually widen the surgical corridor, allowing access to the targeted spinal area while minimizing damage to surrounding tissues. This approach reduces muscle trauma, decreases postoperative pain, and promotes faster recovery. The use of dilators facilitates minimally invasive surgical interventions leading to improved patient outcomes. The use of dilators in spinal surgery procedures is described in U.S. Patent No.6,945,933 B2, hereby incorporated by reference in its entirety.

[0003] Neuromonitoring in medical procedures is performed to enhance patient safety by providing real-time feedback on the presence, location and proximity of neural structures. By monitoring nerve signals, surgeons can immediately detect any potential injury to nerves, allowing them to adjust their techniques to prevent permanent nerve damage. This proactive approach may help reduce the likelihood of postoperative neurological deficits such as muscle weakness, loss of sensation, or paralysis in certain procedures. Additionally, neuromonitoring may increase the success rates of complex surgeries by enabling surgeons to operate more precisely, potentially leading to better patient outcomes and faster recoveries.

[0004] Spinal surgery often requires navigating muscle including neural structures in order to access the spine and often uses dilators to prepare the surgical pathway for various surgical tools, such as retractors. Therefore, there exists a need for a neuromonitoring probe with an integrated dilator.SUMMARY

[0005] In one aspect of the disclosed technology, an instrument for use in spine surgery, includes a probe extending in a longitudinal direction from a proximal end to a distal end, the probe having: aDocket No. A0012877W001 (341387.47001)sensing tip disposed at the distal end and having a first diameter, wherein the sensing tip includes a first conducting area extending in the longitudinal direction along a side of the sensing tip; an embed area disposed adjacent to the sensing tip, the embed area having a second diameter that is larger than the first diameter, the embed area being configured to support the probe in a free standing position independently when inserted into the surrounding tissue; a depth stop having a contact surface extending radially away from the embed area, wherein the depth stop is defined by a third diameter that is larger than the second diameter; and an initial dilator integrally formed with the probe; wherein the proximal end includes a second conducting area, the second conducting area is in electrical communication with the first conducting area.

[0006] In another aspect of the disclosed technology, the instrument further includes a transition area between the depth stop and the embed area, the depth stop having a tapered diameter that is tapered towards the distal end, and wherein the first conducting area of the probe is configured for delivering directional stimulation.

[0007] In another aspect of the disclosed technology, the initial dilator includes a sensing region having a third conducting area extending in the longitudinal direction along a side of the initial dilator; and wherein the proximal end of the initial dilator further comprises a fourth conducting area, the fourth conducting area is in electrical communication with the third conducting area.

[0008] In another aspect of the disclosed technology, at least one of the initial dilator and the proximal end include one or more markings that align with the first conducting area of the sensing tip and the third conducting area of the initial dilator.

[0009] In another aspect of the disclosed technology, the instrument further includes a control unit, the control unit being electrically connectable to at least one of the second conducting area and fourth conducting area.

[0010] In another aspect of the disclosed technology, the probe further includes: a primary component including the first conducting area, the second conducting area and a first body extending between the first conducting area and the second conducting area, wherein a channel extends at least partially along a longitudinal direction of the first body; and a secondary component received within the channel of the primary component and including the third conducting area, the fourth conducting area and a second body extending between the third conducting area and the fourth conducting area, wherein the first body is configured as a first continuous conductive pathway between the first conducting area and the second conducting area, and wherein the second body is configured as a second continuous conductive pathway between the third conducting area and the fourth conducting area.Docket No. A0012877W001 (341387.47001)

[0011] In another aspect of the disclosed technology, the secondary component further includes a first exterior surface and a second exterior surface, wherein the first exterior surface at least partially insulates the second continuous conductive pathway from the external environment and the second exterior surface insulates the second continuous conductive pathway from the first continuous conductive pathway.

[0012] In another aspect of the disclosed technology, the first diameter at the distal tip of the probe does not exceed about 2 mm and the second diameter of the embed area measures between about 2 mm and about 4 mm.

[0013] In another aspect of the disclosed technology, the instrument further includes a navigation system removably connected to the proximal end of the probe, the navigation system being configured to identify the location of the probe in space relative to a known reference point, wherein the contact surface is configured to prevent the probe from penetrating the intervertebral disc anatomy beyond a first distance.

[0014] In another aspect of the disclosed technology, the instrument further includes one or more supplemental dilators configured to slide over the initial dilator, the one or more supplemental dilators including a corresponding distal conducting area and a corresponding proximal conducting area.

[0015] In another aspect of the disclosed technology, a system for use in spine surgery includes: a probe extending in a longitudinal direction from a proximal end to a distal end, the probe. The probe includes: a sensing tip disposed at the distal end and having a first diameter, wherein the sensing tip includes a first conducting area extending in the longitudinal direction along a side of the sensing tip for delivering directional stimulation; an embed area disposed adjacent to the sensing tip, the embed area having a second diameter that is larger than the first diameter, the embed area being configured to support the probe in a free standing position independently when inserted into the surrounding tissue; a depth stop having a contact surface extending radially away from the embed area and generally facing the distal end, wherein the depth stop is defined by a third diameter that is larger than the second diameter and abruptly increases at a location where the depth stop and embed area meet; an initial dilator integrally formed with the probe, wherein the proximal end includes a second conducting area that is in electrical communication with the first conducting area, a control unit, the control unit being electrically connectable to the second conducting area; and one or more recording electrodes electrically connected to the control unit.

[0016] In another aspect of the disclosed technology, the system further includes one or more tissue retractors having one or more blades configured to slide over the probe and circumferentially surround the probe.Docket No. A0012877W001 (341387.47001)

[0017] In another aspect of the disclosed technology, the system further includes one or more supplemental dilators configured to slide over the initial dilator, the one or more supplemental dilators including a corresponding distal conducting area and a corresponding proximal conducting area.

[0018] In another aspect of the disclosed technology, the system further includes a navigation system removably connected to the proximal end of the probe, the navigation system being configured to identify the location of the probe in space relative to a known reference point, wherein the contact surface is configured to prevent the probe from penetrating the intervertebral disc anatomy beyond a first distance.

[0019] In another aspect of the disclosed technology, a method of guiding a surgical tool includes: preparing a probe; electrically connecting the second conducting area to a control unit; inserting the sensing tip and the embed area into patient anatomy; rotating the probe while the sensing tip and embed area are inserted in the patient anatomy; electrically stimulating one or more nerves; sliding one or more supplemental dilators over the initial dilator; sliding one or more blades over the initial dilator and one or more supplemental dilators; verifying the probe is coaxially aligned in the center of the operative corridor of the retractor while the probe is in a free standing position in the patient anatomy; removing the probe and the one or more supplemental dilators; and retracting patient tissue with the one or more blades.

[0020] In another aspect of the disclosed technology, the method, further includes inserting the sensing tip and embed area in at least one of muscle tissue and intervertebral disc tissue.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The following drawings are illustrative of particular embodiments of the present disclosure and therefore do not limit the scope of the present disclosure. The drawings are not to scale and are intended for use in conjunction with the explanations in the following detailed description.

[0022] FIG. 1 illustrates a perspective view of a probe, according to one or more embodiments of the present disclosure;

[0023] FIG. 2 illustrates a view of a portion of the probe of FIG. 1, according to one or more embodiments of the present disclosure;

[0024] FIG. 3 illustrates an alternative view of the portion of the probe depicted in FIG. 2, according to one or more embodiments of the present disclosure;

[0025] FIG. 4 illustrates a top-down view of the probe of FIG. 1 according, according to one or more embodiments of the present disclosure;Docket No. A0012877W001 (341387.47001)

[0026] FIG. 5 illustrates an alternative perspective view of a portion of a probe, according to one or more embodiments of the present disclosure;

[0027] FIG. 6 illustrates a system for spinal procedures, according to one or more embodiments of the present disclosure;

[0028] FIG. 7 A illustrates a side view of the probe of FIG. 1 and one or more supplemental dilators, according to one or more embodiments of the present disclosure;

[0029] FIG. 7B illustrates the probe and one or more supplemental dilators depicted in FIG. 7A arranged in a nested assembly, according to one or more embodiments of the present disclosure;

[0030] FIG. 8 illustrates an exploded parts view of another probe including a primary component and a secondary component, according to one or more embodiments of the present disclosure;

[0031] FIG. 9 illustrates an alternative view of the secondary component illustrated in FIG. 8;

[0032] FIG. 10 illustrates a cross-sectional view of the primary component illustrated in FIG. 8 taken along the cross section line A-A shown in FIG. 8;

[0033] FIG. 11 illustrates a method of using a probe, according to one or more embodiments of the present disclosure;

[0034] FIG. 12 illustrates a perspective view of another probe, according to one or more embodiments of the present disclosure;

[0035] FIG. 13 illustrates a view of a portion of the probe of FIG. 12, according to one or more embodiments of the present disclosure; and

[0036] FIG. 14 illustrates a view of a portion of the probe of FIG. 12, according to one or more embodiments of the present disclosure.DETAILED DESCRIPTION

[0037] The present disclosure relates generally to a probe for use in spinal procedures, and more particularly, to a neuromonitoring probe, systems and methods for performing neuromonitoring during spinal surgical procedures. Exemplary embodiments of the devices, systems and methods are described below with reference to the Figures.

[0038] The following discussion omits or only briefly describes certain conventional features related to surgical systems for treating the spine, which are apparent to those skilled in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims appended hereto. Additionally, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible embodiments for the appended claims. Further, particular features describedDocket No. A0012877W001 (341387.47001)herein can be used in combination with other described features in each of the various possible combinations and permutations.

[0039] Unless otherwise specifically defined herein, all terms are to be given their broadest possible interpretation including meanings implied from the specification as well as meanings understood by those skilled in the art and / or as defined in dictionaries, treatises, etc. It must also be noted that, as used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless otherwise specified, and that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0040] Terms such as “same,” “equal,” “planar,” “coplanar,” “parallel,” “perpendicular,” etc. as used herein are intended to encompass a meaning of exactly the same while also including variations that may occur, for example, due to manufacturing processes. The term “substantially” may be used herein to emphasize this meaning, particularly when the described embodiment has the same or nearly the same functionality or characteristic, unless the context or other statements clearly indicate otherwise. Additionally, it shall be understood that the term “about” encompasses a variation of at least + / - 10% from the example values provide herein.

[0041] The following discussion omits or only briefly describes certain conventional features related to surgical navigation systems, such as, for example, those used in the FluoroNav™ system, which utilizes the Stealth Station® Treatment Guidance Platform, both of which are available from Medtronic Sofamor Danek, Inc. The Stealth Station® Treatment Guidance Platform, and in particular the StealthStation® Navigation System, is described in part in the “Stealth Station™ S8 Spinal Navigation Solution” brochure published by Medtronic, Inc. in 2019 and in “The Clinical and Economic Benefits of Using StealthStation® Navigation and O-Arm® Imaging Systems for Spine Surgery” brochure published by Medtronic, Inc. in 2014. Such surgical navigation systems are apparent to those skilled in the art. It is noted that various embodiments are described in detail with reference to the drawings, in which like reference numerals represent like parts and assemblies throughout the several views. Reference to various embodiments does not limit the scope of the claims appended hereto. Additionally, any examples set forth in this specification are intended to be non-limiting and merely set forth some of the many possible embodiments for the appended claims. Further, particular features described herein can be used in combination with other described features in each of the various possible combinations and permutations.

[0042] Unless otherwise specifically defined herein, all terms are to be given their broadest possible interpretation including meanings implied from the specification as well as meaningsDocket No. A0012877W001 (341387.47001)understood by those skilled in the art and / or as defined in dictionaries, treatises, etc. It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless otherwise specified, and that the terms “comprises” and / or “comprising,” when used in this specification, specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0043] Embodiments of the present disclosure relate generally, for example, to devices, methods, and systems for medical procedures, and more particularly, to medical probes for neuromonitoring. The following description provides an illustrative overview of various embodiments of the invention, but is not intended to limit the scope of the invention.

[0044] FIG. 1 shows a probe 100 having a proximal end 106 and a distal end 118. The probe 100 extends in the longitudinal direction between the proximal end 106 and the distal end 118 along a central longitudinal axis (not shown). As used herein, central longitudinal axis may mean the axis defined by the longitudinal direction of the probe 100 and extending through the center of the probe 100. In one or more embodiments the probe 100 has a solid center. In one or more embodiments the probe 100 includes an elongated rigid structure. In some embodiments the probe 100 includes a linear structure. At the distal end 118 of the probe 100 is a sensing tip 122 having a first conducting area 120. The diameter of the sensing tip 122 may fall within a range of about 2 mm to about 2.8 mm optimizing it for minimally invasive penetration into patient anatomy. The first conducting area 120 is an exposed conductive portion of the sensing tip 122 and is configured to come into direct contact with muscle or tissue. At the proximal end 106 of the probe 100 is an additional exposed conductive portion, third conducting area 107. The third conducting area 107 serves as the connection interface of the probe 100 with a current supply. Connecting the first conducting area 120 and the third conducting area 107 is a first continuous conductive pathway (not visible) along which the current supply flows. In various embodiments, the first continuous conductive pathway extends through a rigid linear structure of the probe 100 and is surrounded by insulative material such that it is not exposed or visible in the various drawings. This structural configuration is intentional as only the conductive portions at the distal end 118 of the probe 100 are most preferably intended to come into contact with patient tissue. This first continuous conductive pathway allows current or electrical signals to flow smoothly between the first conducting area 120 and the third conducting area 107.

[0045] On the proximal end 106 is an engagement feature 102 having a shape and size configured to fit or mesh with a corresponding tool. Such tool may include a handle or a driver that may fit to the engagement feature 102 to facilitate grasping, inserting, removing, rotating or maneuvering theDocket No. A0012877W001 (341387.47001)probe. For example, a handle may be attached to engagement feature 102 and a user can grasp the handle and rotate the probe while the probe is inserted in patient anatomy or guide the probe into an anatomical portion of a patient. Attaching a handle to engagement feature 102 is advantageous when more force is required to maneuver or rotate the probe, such as when the probe is already docked to a disc.

[0046] An initial dilator 110 is integrated with the probe 100 and extends in the longitudinal direction of the probe. In the embodiment shown in FIG. 1 the initial dilator 110 is cylindrical or substantially cylindrical, however, other configurations are contemplated, e.g., ovoid. The initial dilator 110 includes a tapered end 112 to facilitate insertion of the initial dilator 110 into an anatomical portion of a patient. The tapered end 112 tapers towards the distal end 118 to facilitate insertion in patient tissue. Located on tapered end 112 within a sensing region is a second conducting area 114. The second conducting area 114 is an exposed conductive portion of the tapered end 112 and is configured to come into direct contact with muscle or tissue. At the proximal end 106 of the probe 100 is an additional exposed conductive portion, fourth conducting area 109. The fourth conducting area 109, serves as a connection interface of the probe 100 with a current supply which may be the same current supply or a different current supply from the current supply associated with the third conducting area 107 discussed above. Connecting the second conducting area 114 and the fourth conducting area 109 is a second continuous conductive pathway (not visible) along which the current supply flows. This second continuous conductive pathway allows current or electrical signals to flow uninterrupted between the second conducting area 120 and the fourth conducting area 109. In various embodiments, the continuous conductive pathway extends through a rigid linear structure or sidewall of the initial dilator 110 and is surrounded by insulative material such that it is not exposed or visible in the various drawings. This structural configuration is intentional as only the second conducting area 114 of the initial dilator 110 are intended to come into contact with patient tissue. This second continuous conductive pathway allows current or electrical signals to flow smoothly between the second conducting area 114 and the fourth conducting area 109.

[0047] In some embodiments the initial dilator 110 is integrated or irremovably coupled to the probe 100. In other words, in such embodiments, the initial dilator 110 is an integral part of the probe 100 as opposed to a separate component or accessory to the probe 100. In these embodiments, there is no canulated portion of the initial dilator 110. In other embodiments, the initial dilator 110 is cannulated and the probe 100 is separable from the initial dilator 110 and may be inserted within the initial dilator 110.Docket No. A0012877W001 (341387.47001)

[0048] In the embodiment shown in FIG. 1, the initial dilator 110 includes an orientation marking 108. The marking 108 is a line running along the longitudinal length of the initial dilator 110, however, other types of markings are contemplated such as arrows or lines extending more or less along the initial dilator 110 than shown in FIG. 1 Such markings may also be located on other components of the probe 100. The marking 108 can be applied to the initial dilator 110 via pad printing, inkjet printing, laser etching or by other suitable means. The marking 108 may be aligned with first conducting area 120 and / or second conducting area 114 indicating their positions relative to the outer perimeter of probe 100. Marking 108 facilitates proper positioning of first conducting area 120 and second conducting area 114 during operation of probe 100. For example, marking 108 aids in proper positioning of these features for the purpose of performing directional neuromonitoring. Probe 100 may also include one or more additional markings, such as depth markings (not shown) or incremental indicators indicating how far probe 100 is penetrating into a substrate.

[0049] During spinal procedures, the probe 100 may be inserted into patient anatomy near nerves or neural structures to measure signals and help prevent nerve damage (neuromonitoring). The probe 100, including the sensing tip 122, is inserted by a user, such as a surgeon or healthcare professional, into a patient e.g., into muscle, tissue, or intervertebral disc anatomy. As the sensing tip 122 is advanced into patient anatomy the stimulation from the sensing tip 122 allows neurological information to be captured. The sensing tip 122 interacts with the surrounding tissue through the first conducting area 120. Recording electrodes can be placed on the patient near the probe 100 and / or surgical site e.g., on the patient’s skin. The probe 100 stimulates nearby nerves and / or neural structures and the recording electrodes can be configured to detect the response (electrical signals) in the patient’s muscles triggered by the stimulation of one or more nerves by the first conducting area 120. These signals are then transmitted from the recording electrodes, either through wires or wirelessly, to a connected device such as a processor, computer or other electronic device or system, that processes the signals for display, assessment or further analysis. In some embodiments, the signals are received by a monitoring system that is the same, similar to or substantially the same as monitoring system 200, discussed later in connection with FIG. 6.Therefore, the probe 100 allows for minimally invasive neuromonitoring helping prevent nerve damage and injury.

[0050] The recording electrodes discussed in relation to the embodiments disclosed herein may be electromyography (EMG) electrodes or recording electrodes that record muscle response to nerve stimulation. Alternately, other neuromonitoring techniques, such as motor evoked potentials (MEP) neuromonitoring and somatosensory evoked potentials (SSEP) neuromonitoring, may be used.Docket No. A0012877W001 (341387.47001)

[0051] Referring now to FIG. 2, the distal end 118 of the probe 100 is shown. The first conducting area 120 is located on the side of sensing tip 122. In the illustrated embodiment, the first conducting area 120 does not extend all the way around the probe 100360 degrees but rather is a relatively small slice or section on the sidewall. Placing the first conducting area 120 on only a portion of the sidewall of the sensing tip 122, as illustrated, allows the stimulation provided by the first conducting area 120 to be directional. In a method of operation, the stimulation to the muscle or tissue provided by the first conducting area 120 tracks with the rotation of the probe 100 as the probe 100 is rotated about its central longitudinal axis. The stimulation may follow a sweeping or arcuate path as the probe 100 is rotated by the surgeon. The directional stimulation of the first conducting area 120 allows the user to determine the location and / or proximity of nerves relative to the probe 100. Additionally or alternatively, the sensing tip 122 can be inserted into muscle as the probe 100 is advanced to the target surgical site and the stimulation provided by the first conducting area 120 to nearby nerves can be used to alert the user to nerves in the trajectory of insertion. This can facilitate assisting the user in navigating through the muscle to the target surgical site e.g., spinal anatomy such as an intervertebral disc. The sensing tip 122 may be appropriately pointed and narrow to allow it to penetrate tissue and / or bone with appropriate force. The proximal end of the probe 100 may be struck with a blunt instrument such as a hammer if penetrating bone. The first conducting area 120 may be configured as a rectangle, line, strip or other shape. In the illustrated embodiment, first conducting area 120 comprises a rectangular shape with an ovoid type distal end. Various shapes and sizes of the first conducting area 120 are contemplated in isolation and in combination.

[0052] Upstream (moving from the distal end 118 towards the proximal end 106) of the sensing tip 122 is the transition area 117 and then the embed area 116. The embed area 116 may have a larger diameter than the transition area 117 and the sensing tip 122, z.e., it is thicker in this section of the probe 100. For example, in some embodiments the cross-sectional diameter of the embed area 116 may fall within a range of about 2mm to about 4mm. Diameters within this range have been found to be optimal, allowing the probe to remain free-standing while still being small enough to minimize tissue damage. Diameters within this range provide a balance between minimizing tissue trauma and maintaining sufficient rigidity to prevent collapse or unintentional dislodgement. The enlarged diameter of the embed area 116 increases the contact area of the probe 100 with surrounding patient anatomy sufficiently to allow the probe 100 to remain free-standing in the patient anatomy. For example, the overall geometry of the probe 100, including the narrow distal end 118, tapered transition area 117, and the relatively thicker embed area 116 promote this freestanding capability because, at least in part, the embed area 116 is thick enough that theDocket No. A0012877W001 (341387.47001)compressive forces of patient tissue may hold the probe 100 upright and in place without any outside support from other tools or the surgeon. The free-standing nature of the probe 100 allows the user to easily verify that the probe 100 is inserted as desired and during a method of use this feature also helps ensure alignment of a tissue retractor as will be explained in detail below. By way of example, the sensing tip 122 can be navigated through muscle up to the disc. Once the end of the sensing tip 122 reaches the disc the probe 100 may be impacted so that the sensing tip 122 and the embed area 116 penetrate the disc. The user may then remove their hands and any tools from the area surrounding the probe 100 and may thus visually verify that the probe 100 has been positioned as desired without the surgeon’s hands or tools obstructing the view. It should be noted that the embed area 116 enables the probe 100 to be free-standing in disc tissue as well as muscle tissue. Therefore, a user can remove their hands from the probe 100 and verify that the probe 100 is positioned as desired prior to impaction into the disc.

[0053] It should be noted that the embed area 116 is separated from the sensing tip 122 by a transition area 117 (shown in FIG. 3). The transition area 117 has a tapered diameter that tapers towards the distal end 118. The transition area 117 allows the embed area 116 of the probe to easily penetrate anatomy as the diameter of the probe increases at the embed area 116. Once the embed area 116 is inserted in the anatomy the constant diameter of the embed area 116 securely anchors probe 100 within the surrounding anatomy as explained above. The constant diameter of the embed area 116 provides improved anchoring when compared to similar probes that have only a tapered diameter at the insertion end.

[0054] Upstream of the embed area 116 is the tapered end 112 of the initial dilator 110. On the side of the initial dilator 110 is the exposed second conducting area 114. In some embodiments, the second conducting area 114 is aligned with the first conducting area 120 z.e., the first conducting area 120 and the second conducting area 114 are not circumferentially offset about the circumference of the initial dilator 110. The second conducting area 114 is also directional in nature in the same, similar, or substantially the same manner as first conducting area 120 i.e., second conducting area stimulates the surrounding nerves in a sweeping or arcuate path as the probe 100 is rotated about its central longitudinal axis. Before or after insertion of the sensing tip 122 into the disc space, the second conducting area 114 can allow the user to determine nerve location and / or proximity (this method is discussed in more detail in reference to FIG. 8). The second conducting area 114 may be configured as a rectangle, line, strip or other shape. In the illustrated embodiment, first conducting area 120 comprises a rectangular shape with an ovoid type proximal end. Various shapes and sizes of the second conducting area 114 are contemplated in isolation or in combination.Docket No. A0012877W001 (341387.47001)

[0055] In some embodiments, the first conducting area 120 is formed by exposing a portion of conductive material of probe 100 so that the portion of the conductive material may come into contact with patient anatomy. For example, the sensing tip 122 may be constructed from a conductive material surrounded by or coated with a non-conductive material (an insulator) and a portion of the non-conductive material may be removed by a subtractive manufacturing process to form the first conducting area 120. The conductive material may extend from the first conducting area 120 along the length of probe 100 to the third conducting area 107 forming the first continuous conductive path discussed previously. The remainder of the sensing tip 122 apart from the first conducting area 120 may include a non-conductive material. Likewise, in some embodiments, the second conducting area 114 is also formed by exposing a portion of a conductive material of probe 100 so that the portion of the conductive material may come into contact with patient anatomy. The conductive material may extend from the second conducting area 114 along the length of probe 100 to the fourth conducting area 109 forming the second continuous conductive path discussed previously. The tapered end 112 and the remainder of initial dilator 110 apart from the second conducting area 114 may include a non-conductive or insulated material. The conductive material discussed above may include a metal, an alloy, stainless steel, aluminum, titanium, titanium alloy, a conductive polymer, conductive composite or other conductive material. The non-conductive or insulating material discussed above may include epoxy, polyurethane, polycarbonate, PEEK or any other polymer. It should be appreciated that the third conducting area 107 and the fourth conducting area 109 may be formed in the same or similar manner and with the same or similar materials as the first conducting area 120 and second conducting area 114.

[0056] In some embodiments, the probe 100 is configured so that the current flow between the third conducting area 107 and the first conducting area 120 (z.e., the first continuous conductive path) is insulated from the current flow extending between the fourth conducting area 109 and the second conducting area 114 (z.e., the second continuous conductive path).

[0057] The distal end of tapered end 112 terminates at a depth stop 123, which can be best seen in FIG. 3. The depth stop 123 may include a contact surface at the portion of tapered end 112 where the tapered end 112 meets the embed area 116 and the contact surface may be situated on tapered end 112 so that the contact surface faces the distal end 118. The plane defining the contact surface may extend radially away from the embed area 116. The diameter of the depth stop 123 exceeds that of the embed area 116 and the sensing tip 122. As illustrated, the diameter of the probe 100 abruptly increases at the depth stop 123 region relative to the diameter of the embed area 116. In other words, the diameter of the probe 100 increases along a rapidly changing gradient when transitioning from the embed area 116 to the depth stop 123. The depth stop 123, due to itsDocket No. A0012877W001 (341387.47001)enlarged diameter, prevents the sensing tip 122 and embed area 116 from being impacted into anatomy e.g., an intervertebral disc, further than the length, X. The distance X includes the length of the sensing tip 122 and the length of the embed area 116. For example, when sensing tip 122 and / or embed area are inserted in patient anatomy the contact surface of depth stop 123 may contact or abut the patient anatomy preventing tapered end 112 from penetrating the patient anatomy.Therefore, the depth stop 123 reduces the risk of any damage that may result from over impacting the probe 100.

[0058] Referring now to FIGS. 4 and 5, the proximal end 106 of the probe 100 is shown. The proximal end 106 includes an indicator 101, which may be an etching or printed marking. In the embodiment shown in FIGS. 4 and 5 the indicator 101 is an arrow, however, other symbols and shapes are contemplated. The indicator 101 indicates to the user the location of the first conducting area 120 and the second conducting area 114 relative to the central longitudinal axis of the probe 100. Additionally, the proximal end 106 terminates in an engagement feature 102 having chamfered edges 105 and cutouts 103. The engagement feature 102 may be configured to engage a tool or handle so that torque may be applied to the probe 100 for rotating it. The chamfered edges 105 and cutouts 103 allow the engagement feature 102 to mate with a tool such as a driver or handle. The tool can be used to aid a user in rotating the probe 100 in instances where increased force is needed e.g., when the sensing tip 122 and / or embed area 116 are in disc anatomy. This configuration provides the user the flexibility to rotate the probe 100 and, thereby, perform neuromonitoring either before or after the probe 100 has been docked to the disc. In the embodiment shown in FIGS. 4 and 5 the engagement feature 102 has four chamfered edges 105 and four cutouts 103, however, other configurations are contemplated. For example, the engagement feature 102 may be configured as a hex, square, socket, or torx in some embodiments. Additionally, the proximal end 106 includes a notch 104 to which a navigation system can be attached. Such navigation systems are apparent to those of skill in the art, such as those described in U.S. Patent No. 8,634,897 B2, U.S. Patent No. 10,322,012, U.S. Patent No. 10,881,530 and U.S. Patent No. 11,701,181. For example, the navigation system may have a button including a protrusion or tab that aligns with the notch 104 and is configured to lock in place in the notch 104. The button may be configured to allow the navigation system to be engaged and disengaged repeatedly from the probe 100.

[0059] The rigidity of the sensing tip 122 and the probe 100 facilitates in navigating the probe 100 to the target surgical site. Traditional k-wires lack strength and are more difficult to mallet into the disc. Additionally, older patients may have osteophytes or bony growths obstructing the target surgical site. Osteophytes may need to be removed prior to traditional k-wire insertion if theyDocket No. A0012877W001 (341387.47001)obstruct the path of the k-wire or the k-wire must be navigated through the osteophytes. The rigidity of probe 100 eliminates the need for removal of bony growths prior to insertion and the need to navigate the probe 100 around such bony growths because the probe 100 can be malleted or impacted through any osteophytes that may be obstructing the path of the probe 100.

[0060] The probe 100 can be used with a surgical retractor. Furthermore, the probe 100 can be used as a means of verifying that the retractor has been placed as desired. The initial dilator 110 can be used along with one or more supplemental dilators that slide concentrically over the initial dilator 110 to dilate muscle and promote ease of insertion of the retractor. Additionally, the probe 100 can help ensure accurate placement of the surgical retractor during operation and / or expansion of an operative corridor. For example, a user can insert the probe 100 in the desired position and any number of dilators may be slid over the probe until the operative corridor is sufficiently enlarged. The blades of the surgical retractor can be slid over the outermost dilator so that the blades of the surgical retractor are concentric with the probe 100, e.g., the center point of the operative corridor is defined by the center point of the probe. The user can ensure the retractor has been inserted in the desired position by assessing the position of the probe 100 relative to the blades of the retractor. For example, if the probe 100 is not centered between the blades of the surgical retractor that may indicate that the user has not inserted the retractor in the desired position or that the retractor has shifted during operation following insertion. A surgeon may visually verify that the probe 100 is centered relative to the blades after removing the dilators and because the probe 100 is configured to be a free-standing probe and remain in place. Various methods of using the probe 100 with a surgical retractor are discussed in more detail below.

[0061] Referring now to FIG. 6, system 200 will now be discussed. A current supply (not shown) may be electrically connected to probe 100 e.g., via a clip connected to third conducting area 107 or fourth conducting area 109 and may provide the current necessary to stimulate the first conducting area 120 and second conducting area 114. Providing a current supply to first conducting area 120 and / or seconding conducting area 114 causes nerves that come into close or relative proximity to the probe 100 to innervate and, subsequently, the muscles associated with the innervated nerves to respond e.g., contract. The electrical signal associated with the muscle contractions may be received by one or more recording electrodes 204 on a patient’s skin. FIG. 6 shows an example configuration of monitoring system 200 having a device 202 and other components. The recording electrodes 204 may be connected to or in electrical communication with device 202 via one or more data cables, wires or other suitable connection. The device 202 includes a display 201 and a storage 203, which includes the software for interacting with the monitoring system 200. In some embodiments the device 202 is a processor, a computer, terminal,Docket No. A0012877W001 (341387.47001)server or another electronic device. The probe 100 is connected directly e.g., via a data cable or wireless connection or indirectly through one or more intermediary devices to the device 202 via a data cable, which enables the probe 100 to operate in conjunction with the device 202. Device 202 may receive user commands via display 201, and such commands may provide current to probe 100, process signal data e.g., responses from the recording electrodes 204, and / or display received parameters and processed data. The display 201 may include a graphical user interface (GUI) capable of communicating information to the user and receiving instructions from the user. For example, information related to the proximity and / or location of nerves relative to probe 100 may be displayed on the GUI. Additionally or alternatively, monitoring system 200 can provide a user with audio indicators indicating information related to the location or proximity of nerves to the probe 100. Monitoring system 200 can include those disclosed in U.S. Pat. No. 7,987,001 B2, the entire disclosure of which is hereby incorporated by reference.

[0062] FIG. 7A shows supplemental dilators 124a and 124b as well as probe 100. Supplemental dilators 124a and 124b may be cannulated or have a channel extending therethrough so that one supplemental dilator may be received within or nested within another supplemental dilator.Additionally, probe 100 (and / or initial dilator 110) may be received within or nested within supplemental dilators 124a and / or 124b. Supplemental dilator 124a has a tapered end 113 that may be similar to tapered end 112 of probe 100. Supplemental dilator 124b may have a larger diameter than supplemental dilator 124a so that supplemental dilator 124b may slide over supplemental dilator 124a. Both supplemental dilators 124a and 124b have a proximal conducting area 111 and a distal conducting area 115 adjacent and / or on tapered end 113. Proximal conducting area 111 and distal conducting area 115 may operate in the same or similar manner as explained above with respect to fourth conducting area 109 and second conducting area 120 of probe 100, respectively. It should be noted that two supplemental dilators 124a and 124b have been discussed here but more or fewer supplemental dilators are contemplated depending on preference and the total intended size of the operative corridor. For example, sets of two, three, four or more supplemental dilators of increasing diameter may be used with probe 100.

[0063] FIG. 7B shows supplemental dilators 124a, 124b and probe 100 arranged in a nested assembly 300. Probe 100 is partially received in supplemental dilator 124a and supplemental dilator 124a and probe 100 are partially received in supplemental dilator 124b. The arrangement of nested assembly 300 as depicted in FIG 7B is for ease of understanding and may not be the exact arrangement employed in operation. For example, in operation substantially the entirety of probe 100 and supplemental dilator 124a may be co-extensive with supplemental dilator 124b when arranged in nested assembly 300 i.e., supplemental dilator 124b may slid over substantially theDocket No. A0012877W001 (341387.47001)entirety of supplemental dilator 124a. In turn, supplemental dilator 124a may slide over substantially the entirety of probe 100. Supplemental dilator 124a may be of a length such that when in nested assembly 300 sensing tip 122 and third conducting area 107 of probe 100 are exposed or uninsulated and second conducting area 114 and fourth conducting area 109 of probe 100 are concealed or insulated. Likewise, supplemental dilator 124b may be of a length such that when in nested assembly 300 sensing tip 122 and third conducting area 107 of probe 100 are exposed or uninsulated and the respective conductive portions of initial dilator 110 (second conducing area 114 and fourth conducting area 109) and supplemental dilator 124a (distal conducting area 115 and proximal conducting area 111) are concealed or insulated.

[0064] Referring now to FIG. 8, an alternative embodiment of a probe 400 is shown. Probe 400 may share the same or similar features as probe 100 and the above description related to probe 100 applies to probe 400, accordingly. FIG. 8 shows probe 400 in an exploded parts view. Probe 400 includes a primary component 400a and a secondary component 400b. Primary component 400a includes a body 411 including a channel 431 and an exterior surface 436. Secondary component 400b is received in channel 431 to form the assembled probe 400. Primary component 400a extends longitudinally between a proximal end 406 and a distal end 418 and channel 431 extends along body 411 in the longitudinal (proximal to distal) direction. Channel 431 extends through body 411 such that channel 431 opens on a side of primary component 400a to form an opening in which to insert secondary component 400b. Channel 431 may have a cross section that corresponds to the size and shape of secondary component 400b e.g., semi-circular or substantially semicircular.

[0065] Referring now to FIG. 9, secondary component 400b will be discussed in more detail. FIG.9 shows secondary component 400b slightly rotated from the orientation in FIG. 8. Secondary component 400b includes a first exterior surface 432. First exterior surface 432 may be flush with body 411 when secondary component 400b is assembled with primary component 400a. Secondary component 400b also includes a body 435 and a second exterior surface 434. Second exterior surface 434 may be of a size and shape that corresponds to channel 431 e.g., hemispherical or substantially hemispherical. First exterior surface 432 and second exterior surface 434 may include an insulating material and / or be non-conductive. Collectively, body 411 and secondary component 400b form initial dilator 410 of probe 400.

[0066] Probe 400 includes a first conducting area 420 on sensing tip 422 of primary component 400a and a second conducting area 407 on proximal end 406 of primary component 400a. Probe 400 also includes a second conducting area 414 on a distal end of secondary component 400b and a fourth conducting area 409 on a proximal end of secondary component 400b. When secondaryDocket No. A0012877W001 (341387.47001)component 400b is assembled with primary component 400a secondary conducting area 414 is proximate to distal end 418 and fourth conducting area 409 is proximate to proximal end 406. First conducting area 420 and second conducting area 414 are configured to be directional as discussed above in relation to probe 100 z.e., they extend along only a portion of a sidewall of probe 400. In other embodiments first conducting area and / or conducting area may not be configured to be directional z.e., they extend around the perimeter of probe 200. When secondary component 400b and primary component 400a are assembled, second conducting area 414 and fourth conducting area 409 extend along a side of primary component 400a in channel 431 and align with the opening of channel 431 so they are exposed to the exterior of probe 400.

[0067] FIG. 10 shows a cross-section of probe 400 taken along the cross-section line A- A shown in FIG. 8. When probe 400 is assembled a first continuous conductive pathway, the same or similar to that described in relation to probe 100, extends through probe 400 from second conducting area 407 to first conducting area 420. A second continuous conductive pathway, the same or similar to that described in relation to probe 100, extends through probe 400 from third conducting area 409 to second conducting area 414. Stated differently, the first continuous conductive pathway extends longitudinally through primary component 400a and the second continuous conductive pathway extends longitudinally through the secondary component 400b. The first continuous conductive pathway and the second continuous conductive pathway are insulated from one another because the interface between the primary component 400a and the secondary component 400b (secondary exterior surface 434) contains an insulating material. Referring to FIG. 10, the interior of body 411 may include a conductive material for the first continuous conductive pathway to flow through. Likewise, the interior of body 435 may include a conductive material for second continuous conductive pathway to flow through. Exterior surface 436 of body 411 may include an insulating material to insulate the first continuous conductive pathway from the external environment. First exterior surface 432 may also include an insulating material to insulate the second continuous conductive pathway from the external environment. This configuration insulates the first continuous conductive pathway and second continuous conductive pathway from the external environment and from one another so current may travel between first and second conducting area 407, 420 and third and fourth conducting areas 409, 414.

[0068] In some embodiments primary component 400a and secondary component 400b may be joined together via welding. In other embodiments primary component 400a and secondary component 400b may be joined together by an adhesive. In still other embodiments primary component 400a and secondary component 400b may be joined so that a portion of primary component 400a and secondary component 400b do not contact one another. For example,Docket No. A0012877W001 (341387.47001)secondary component 400b may be received in channel 431 of primary component 400a so that there is clearance or a gap between these components. Such clearance or gap may exist along the interface between primary component 400a and secondary component 400b defined by second exterior surface 434.

[0069] The insulating materials described above may include, without limitation, ceramic coatings polymer powder coatings, polymer coatings or wraps or any other suitable material. Insulating properties of the components of the embodiments of probes described above may also be achieved through anodization.

[0070] FIG. 11 is a flowchart of method 1000, an exemplary method for using probe 100, according to one or more embodiments of the present disclosure. This method 1000 is described in relation to probe 100 for convenience, however, it is contemplated that this method 1000 may apply to other embodiments of probes described herein, e.g., probe 400, probe 100a (see FIGS. 11-14). At step 1001 a user prepares the probe 100. For example, the probe 100 might be sterilized, integrated with a system such as system 200, and placed in or near the area where the associated procedure is to be performed. At step 1002 the user connects the third conducting area 107 to a current supply, or the second conducting area 107a if the probe 100a is used. The user may at this time connect a navigation system to the proximal end 106 of the probe 100, via the notch 104, for example. At step 1003 the user inserts the probe 100 into a patient. At this step 1003 the probe 100 may penetrate muscle and / or intervertebral disc anatomy. The user may use the navigation system to guide the probe 100 towards target anatomy e.g., disc space as desired. With the third conducting area 107 connected to the current supply the sensing tip 122 stimulates nearby nerves so the user can ensure the probe 100 does not hit any unintended anatomy or cause nerve damage during insertion. The responses or electrical signals from the stimulated nerves and / or muscles associated with the stimulated nerves are processed by a processor e.g., device 202 of system 200. At step 1004 the user may disconnect the third conducting area 107 from the current supply. Additionally, the user connects the fourth conducting area 109 to the current supply. With the fourth conducting area 109 connected to the current supply the second conducting area 114 of the initial dilator 110 stimulates nearby nerves. At step 1005 the user rotates the probe 100 about its central longitudinal axis. Rotating the probe 100 stimulates surrounding nerves and the responses or electrical signals from the stimulated nerves and / or associated muscles are processed by the processor. The rotation can assist with directional discernment of the nerve. The positioning of the second conducting area 114 on the initial dilator 110 allows the user to perform directional neuromonitoring when the probe 100 is rotated z.e., determine the location and / or proximity of one or more stimulated nerves relative to the probe 100. At step 1006 the user disconnects the fourth conducting area from theDocket No. A0012877W001 (341387.47001)current supply and slides a supplemental dilator over the probe 100. At step 1007 the user may repeat steps 1004 to 1006 for each supplemental dilator. The user connects a corresponding conducting area of the supplemental dilator to the current supply, which may be the same, similar or substantially the same as the fourth conducting area 109. The user then rotates the supplemental dilator stimulating nearby nerves and triggering a response also to be processed by a current supply or processor as in step 1005. At step 1008 the user slides one or more tissue retractors over the probe 100 and dilators. The user then removes the dilators and the probe 100 and retracts the patient tissue. Retraction of patient tissue may be performed before or after removal of one or more of the probe and dilators.

[0071] FIG. 12 shows an alternative embodiment of a probe 100a. The probe 100a is the same or substantially the same as the probe 100, with the exception of the differences described below. Accordingly, duplicative description will be omitted. The probe 100a includes a sensing tip 122, a transition area 117 (see FIG. 13), and an embed area 116 arranged in the same or similar manner as described in relation to the probe 100. The probe 100a also includes an initial dilator 110 including a tapered end 112 adjacent the embed area 116. The distal end of the tapered end 112 terminates in a depth stop 123 (see FIG. 13). The initial dilator 110 includes an orientation marking 108 that is aligned with the conductive area at the distal end. A first conducting area 120a extends continuously across a portion of the sensing tip 122, the embed area 116, the transition area 117, and the tapered end 112 of the initial dilator 110. In other words, the first conducting area 120a constitutes an uninterrupted exposed conductive portion across the sensing tip 122, the embed area 116, the transition area 117, and the tapered end 112. The first conducting area 120a is configured to come into direct contact with muscle or tissue. Additionally, the proximal end 106 includes a notch 104 to which a navigation system can be attached, and an engagement feature 102. At the proximal end 106 of the probe 100 is an additional exposed conductive portion, second conducting area 107a, which may be connected to a current supply. The second conducting area 107a serves as the connection interface of the probe 100a with an electrical current supply. Connecting the first conducting area 120a and the second conducting area 107a forms a continuous conductive pathway (not visible) along which the electrical current supply flows. In various embodiments, the continuous conductive pathway extends through a rigid linear structure of the probe 100a and is surrounded by insulative material such that it is not exposed or visible in the various drawings. This structural configuration is intentional as only the conductive portions at the distal end 118 of the probe 100a are intended to come into contact with patient tissue. This continuous conductive pathway allows current or electrical signals to flow unimpeded between the first conducting area 120a and the second conducting area 107a.Docket No. A0012877W001 (341387.47001)

[0072] The first conducting area 120a of the probe 100a is shown in more detail in FIG. 13. The first conducting area 120a is located on the side of sensing tip 122, the transition area 117, the embed area 116, and the tapered end 112 of the initial dilator 110. In the illustrated embodiment, the first conducting area 120a does not extend all the way around the probe 100a by 360 degrees but rather is a relatively small slice or section on the sidewall of probe 100a. Placing the first conducting area 120a on only a portion of the sidewall of the sensing tip 122, as illustrated, allows the stimulation provided by the first conducting area 120a to be directional, i.e., the first conducting area 120a tracks with the rotation of the probe 100 as the probe 100 is rotated about its central longitudinal axis. Conversely, if the conducting area 120a traversed the entire sidewall of the sensing tip 122 by 360 degrees it would not be considered or capable of directional sensing and monitoring.

[0073] The second conducting area 107a of the probe 100a is shown in more detail in FIG. 14. The second conducting area 107a may encompass varying portions of the proximal end 106 depending on the embodiment. In some embodiments, the second conducting area 107a may extend the length di and encompass the circumference of the proximal end 106 along the length di. In alternative embodiments, the second conducting area 107a may extend less than the length of di. For example, the second conducting area 107 may extend only the length d2 and encompass the circumference of the proximal end 106 along the length d2.

[0074] In some embodiments, the first conducting area 120a and the second conducting area 107a are formed by exposing a portion of conductive material of probe 100a so that the portion of the conductive material may come into contact with patient anatomy or be attached to an electrical current. For example, the probe 100a, from the proximal end 106 to the distal end 118, may be constructed from a conductive material surrounded by or coated with a non-conductive material (an insulator). Portions of the non-conductive material may be removed from the sensing tip 122, the embed area 116, the transition area 117, and the tapered end 112 of the initial dilator 110 by a subtractive manufacturing process to form the first conducting area 120a (see FIG. 13). Portions of the non-conductive material may similarly be removed from the proximal end 106 to form the second conducting area 107a. Alternatively, the non-conductive material may not be applied at all to the proximal end 106 to allow for a continuous second conducting area 107a. The conductive material may extend from the first conducting area 120a along the length of probe 100a to the second conducting area 107a forming the conductive pathway therebetween. The remainder of the probe 100a, apart from the exposed areas of the first conducting area 120a and the second conducting area 107a, may include a non-conductive material that insulates the conductive pathway between the first conducting area 120a and the second conducting area 107a.Docket No. A0012877W001 (341387.47001)

[0075] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device. In one or more examples, the described techniques, may be implemented in hardware software, firmware or any combination thereof. If implemented in software, the functions may be stored as one or more computer-readable program instructions or code on a computer-readable medium and executed by a hardware-based processing unit, such as a processor. Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0076] The one or more processors may include one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. A processor may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0077] The various embodiments described above are provided by way of illustration only and should not be construed to limit the claims attached hereto. Those skilled in the art will readily recognize various modifications and changes that may be made without following the embodiments and applications illustrated and described herein, and without departing from the true spirit and scope of the claims.

[0078] Without excluding further possible embodiments, certain example embodiments are included in the following clauses:

[0079] Clause 1: An instrument for use in spine surgery, comprising: a probe extending in a longitudinal direction from a proximal end to a distal end, the probe having: a sensing tip disposed at the distal end and having a first diameter, wherein the sensing tip includes a first conducting area extending in the longitudinal direction along a side of the sensing tip; an embed area disposed adjacent to the sensing tip, the embed area having a second diameter that is larger than the firstDocket No. A0012877W001 (341387.47001)diameter, the embed area being configured to support the probe in a free standing position independently when inserted into the surrounding tissue; a depth stop having a contact surface extending radially away from the embed area, wherein the depth stop is defined by a third diameter that is larger than the second diameter; and an initial dilator integrally formed with the probe; wherein the proximal end includes a second conducting area, the second conducting area is in electrical communication with the first conducting area.

[0080] Clause 2: The instrument of clause 1, further comprising a transition area between the depth stop and the embed area, the depth stop having a tapered diameter that is tapered towards the distal end, and wherein the first conducting area of the probe is configured for delivering directional stimulation.

[0081] Clause 3 : The instrument of any one of clauses 1 through 2, wherein the initial dilator further comprises a sensing region comprising a third conducting area extending in the longitudinal direction along a side of the initial dilator; and wherein the proximal end of the initial dilator further comprises a fourth conducting area, the fourth conducting area is in electrical communication with the third conducting area.

[0082] Clause 4: The instrument of clause 3, wherein at least one of the initial dilator and the proximal end include one or more markings that align with the first conducting area of the sensing tip and the third conducting area of the initial dilator.

[0083]

[0084] Clause 5: The instrument of any one of clauses 3 through 4, further comprising a control unit, the control unit being electrically connectable to at least one of the second conducting area and fourth conducting area.

[0085] Clause 6: The instrument of any one of clauses 3 through 5, wherein the probe further comprises: a primary component including the first conducting area, the second conducting area and a first body extending between the first conducting area and the second conducting area, wherein a channel extends at least partially along a longitudinal direction of the first body; and a secondary component received within the channel of the primary component and including the third conducting area, the fourth conducting area and a second body extending between the third conducting area and the fourth conducting area, wherein the first body is configured as a first continuous conductive pathway between the first conducting area and the second conducting area, and wherein the second body is configured as a second continuous conductive pathway between the third conducting area and the fourth conducting area.

[0086] Clause 7: The instrument of clause 6, wherein the secondary component further comprises a first exterior surface and a second exterior surface, wherein the first exterior surface at leastDocket No. A0012877W001 (341387.47001)partially insulates the second continuous conductive pathway from the external environment and the second exterior surface insulates the second continuous conductive pathway from the first continuous conductive pathway.

[0087] Clause 8: The instrument of any one of clauses 1 through 7, wherein the first diameter at the distal tip of the probe does not exceed about 2 mm and the second diameter of the embed area measures between about 2 mm and about 4 mm.

[0088] Clause 9: The instrument of any one of clauses 1 through 8, further comprising a navigation system removably connected to the proximal end of the probe, the navigation system being configured to identify the location of the probe in space relative to a known reference point, wherein the contact surface is configured to prevent the probe from penetrating the intervertebral disc anatomy beyond a first distance.

[0089] Clause 10: The instrument of any one of clauses 1 through 9, further comprising one or more supplemental dilators configured to slide over the initial dilator, the one or more supplemental dilators including a corresponding distal conducting area and a corresponding proximal conducting area.

[0090] Clause 11 : A system for use in spine surgery comprising: a probe extending in a longitudinal direction from a proximal end to a distal end, the probe, the probe comprising: a sensing tip disposed at the distal end and having a first diameter, wherein the sensing tip includes a first conducting area extending in the longitudinal direction along a side of the sensing tip for delivering directional stimulation; an embed area disposed adjacent to the sensing tip, the embed area having a second diameter that is larger than the first diameter, the embed area being configured to support the probe in a free standing position independently when inserted into the surrounding tissue; a depth stop having a contact surface extending radially away from the embed area and generally facing the distal end, wherein the depth stop is defined by a third diameter that is larger than the second diameter and abruptly increases at a location where the depth stop and embed area meet; an initial dilator integrally formed with the probe, wherein the proximal end includes a second conducting area that is in electrical communication with the first conducting area, a control unit, the control unit being electrically connectable to the second conducting area; and one or more recording electrodes electrically connected to the control unit.

[0091] Clause 12: The system of clause 11, wherein the first conducting area of the probe is configured for delivering directional stimulation.

[0092] Clause 13: The system of any one of clauses 11 through 12, wherein the initial dilator further comprises a sensing region comprising a third conducting area extending in the longitudinal direction along a side of the initial dilator; and wherein the proximal end of the initial dilatorDocket No. A0012877W001 (341387.47001)further comprises a fourth conducting area, the fourth conducting area is in electrical communication with the third conducting area.

[0093] Clause 14: The system of clause 13, wherein the probe further comprises: a primary component including the first conducting area, the second conducting area and a first body extending between the first conducting area and the second conducting area, wherein a channel extends at least partially along a longitudinal direction of the first body; and a secondary component received within the channel of the primary component and including the third conducting area, the fourth conducting area and a second body extending between the third conducting area and the fourth conducting area, wherein the first body is configured as a first continuous conductive pathway, and wherein the second body is configured as a second continuous conductive pathway.

[0094] Clause 15: The system of clause 14, wherein the secondary component further comprises a first exterior surface and a second exterior surface, wherein the first exterior surface at least partially insulates the second continuous conductive pathway from the external environment and the second exterior surface insulates the second continuous conductive pathway from the first continuous conductive pathway.

[0095] Clause 16: The system of any one of clauses 11 through 15, further comprising one or more tissue retractors having one or more blades configured to slide over the probe and circumferentially surround the probe.

[0096] Clause 17: The system of any one of clauses 11 through 16, further comprising one or more supplemental dilators configured to slide over the initial dilator, the one or more supplemental dilators including a corresponding distal conducting area and a corresponding proximal conducting area.

[0097] Clause 18: The system of any one of clauses 11 through 17, further comprising a navigation system removably connected to the proximal end of the probe, the navigation system being configured to identify the location of the probe in space relative to a known reference point, wherein the contact surface is configured to prevent the probe from penetrating the intervertebral disc anatomy beyond a first distance.

[0098] Clause 19: A method of guiding a surgical tool, the method comprising: preparing a probe according to clause 1; electrically connecting the second conducting area to a control unit; inserting the sensing tip and the embed area into patient anatomy; rotating the probe while the sensing tip and embed area are inserted in the patient anatomy; electrically stimulating one or more nerves; sliding one or more supplemental dilators over the initial dilator; sliding one or more blades over the initial dilator and one or more supplemental dilators; verifying the probe is coaxially aligned inDocket No. A0012877W001 (341387.47001)the center of the operative corridor of the retractor while the probe is in a free standing position in the patient anatomy; removing the probe and the one or more supplemental dilators; and retracting patient tissue with the one or more blades.

[0099] Clause 20: The method of clause 19, further comprising inserting the sensing tip and embed area in at least one of muscle tissue and intervertebral disc tissue.

Claims

1. Docket No. A0012877W001 (341387.47001)WHAT IS CLAIMED IS:

1. An instrument for use in spine surgery, comprising:a probe extending in a longitudinal direction from a proximal end to a distal end, the probe having:a sensing tip disposed at the distal end and having a first diameter, wherein the sensing tip includes a first conducting area extending in the longitudinal direction along a side of the sensing tip;an embed area disposed adjacent to the sensing tip, the embed area having a second diameter that is larger than the first diameter, the embed area being configured to support the probe in a free standing position independently when inserted into the surrounding tissue;a depth stop having a contact surface extending radially away from the embed area, wherein the depth stop is defined by a third diameter that is larger than the second diameter; andan initial dilator integrally formed with the probe;wherein the proximal end includes a second conducting area, the second conducting area is in electrical communication with the first conducting area.

2. The instrument of claim 1, further comprising a transition area between the depth stop and the embed area, the depth stop having a tapered diameter that is tapered towards the distal end, and wherein the first conducting area of the probe is configured for delivering directional stimulation.

3. The instrument of any one of claims 1 through 2, wherein the initial dilator further comprises a sensing region comprising a third conducting area extending in the longitudinal direction along a side of the initial dilator; and wherein the proximal end of the initial dilator further comprises a fourth conducting area, the fourth conducting area is in electrical communication with the third conducting area.

4. The instrument of claim 3, wherein at least one of the initial dilator and the proximal end include one or more markings that align with the first conducting area of the sensing tip and the third conducting area of the initial dilator.Docket No. A0012877W001 (341387.47001)5. The instrument of any one of claims 3 through 4, further comprising a control unit, the control unit being electrically connectable to at least one of the second conducting area and fourth conducting area.

6. The instrument of any one of claims 3 through 5, wherein the probe further comprises: a primary component including the first conducting area, the second conducting area and a first body extending between the first conducting area and the second conducting area, wherein a channel extends at least partially along a longitudinal direction of the first body; anda secondary component received within the channel of the primary component and including the third conducting area, the fourth conducting area and a second body extending between the third conducting area and the fourth conducting area,wherein the first body is configured as a first continuous conductive pathway between the first conducting area and the second conducting area, andwherein the second body is configured as a second continuous conductive pathway between the third conducting area and the fourth conducting area.

7. The instrument of claim 6, wherein the secondary component further comprises a first exterior surface and a second exterior surface, wherein the first exterior surface at least partially insulates the second continuous conductive pathway from the external environment and the second exterior surface insulates the second continuous conductive pathway from the first continuous conductive pathway.

8. The instrument of any one of claims 1 through 7, wherein the first diameter at the distal tip of the probe does not exceed about 2 mm and the second diameter of the embed area measures between about 2 mm and about 4 mm.

9. The instrument of any one of claims 1 through 8, further comprising a navigation system removably connected to the proximal end of the probe, the navigation system being configured to identify the location of the probe in space relative to a known reference point, wherein the contact surface is configured to prevent the probe from penetrating the intervertebral disc anatomy beyond a first distance.

10. The instrument of any one of claims 1 through 9, further comprising one or more supplemental dilators configured to slide over the initial dilator, the one or more supplementalDocket No. A0012877W001 (341387.47001)dilators including a corresponding distal conducting area and a corresponding proximal conducting area.

11. A system for use in spine surgery comprising:a probe extending in a longitudinal direction from a proximal end to a distal end, the probe, the probe comprising:a sensing tip disposed at the distal end and having a first diameter, wherein the sensing tip includes a first conducting area extending in the longitudinal direction along a side of the sensing tip for delivering directional stimulation;an embed area disposed adjacent to the sensing tip, the embed area having a second diameter that is larger than the first diameter, the embed area being configured to support the probe in a free standing position independently when inserted into the surrounding tissue;a depth stop having a contact surface extending radially away from the embed area and generally facing the distal end, wherein the depth stop is defined by a third diameter that is larger than the second diameter and abruptly increases at a location where the depth stop and embed area meet;an initial dilator integrally formed with the probe,wherein the proximal end includes a second conducting area that is in electrical communication with the first conducting area,a control unit, the control unit being electrically connectable to the second conducting area; andone or more recording electrodes electrically connected to the control unit.

12. The system of claim 11, wherein the first conducting area of the probe is configured for delivering directional stimulation.

13. The system of any one of claims 11 through 12, wherein the initial dilator further comprises a sensing region comprising a third conducting area extending in the longitudinal direction along a side of the initial dilator; and wherein the proximal end of the initial dilator further comprises a fourth conducting area, the fourth conducting area is in electrical communication with the third conducting area.

14. The system of claim 13, wherein the probe further comprises:Docket No. A0012877W001 (341387.47001)a primary component including the first conducting area, the second conducting area and a first body extending between the first conducting area and the second conducting area, wherein a channel extends at least partially along a longitudinal direction of the first body; anda secondary component received within the channel of the primary component and including the third conducting area, the fourth conducting area and a second body extending between the third conducting area and the fourth conducting area,wherein the first body is configured as a first continuous conductive pathway, and wherein the second body is configured as a second continuous conductive pathway.

15. The system of claim 14, wherein the secondary component further comprises a first exterior surface and a second exterior surface, wherein the first exterior surface at least partially insulates the second continuous conductive pathway from the external environment and the second exterior surface insulates the second continuous conductive pathway from the first continuous conductive pathway.

16. The system of any one of claims 11 through 15, further comprising one or more tissue retractors having one or more blades configured to slide over the probe and circumferentially surround the probe.

17. The system of any one of claims 11 through 16, further comprising one or more supplemental dilators configured to slide over the initial dilator, the one or more supplemental dilators including a corresponding distal conducting area and a corresponding proximal conducting area.

18. The system of any one of claims 11 through 17, further comprising a navigation system removably connected to the proximal end of the probe, the navigation system being configured to identify the location of the probe in space relative to a known reference point, wherein the contact surface is configured to prevent the probe from penetrating the intervertebral disc anatomy beyond a first distance.

19. A method of guiding a surgical tool, the method comprising:preparing a probe according to claim 1;electrically connecting the second conducting area to a control unit;inserting the sensing tip and the embed area into patient anatomy;Docket No. A0012877W001 (341387.47001)rotating the probe while the sensing tip and embed area are inserted in the patient anatomy; electrically stimulating one or more nerves;sliding one or more supplemental dilators over the initial dilator;sliding one or more blades over the initial dilator and one or more supplemental dilators; verifying the probe is coaxially aligned in the center of the operative corridor of the retractor while the probe is in a free standing position in the patient anatomy;removing the probe and the one or more supplemental dilators; andretracting patient tissue with the one or more blades.

20. The method of claim 19, further comprising inserting the sensing tip and embed area in at least one of: muscle tissue and intervertebral disc tissue.

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