Patient tracker securable to bone

Abstract

A patient tracker apparatus can include a position sensor, an outer member, and an inner member. The outer member can have a tubular portion with a sidewall and define a longitudinal axis. The tubular portion can include an opening through the sidewall and be configured to secure to a bone of a patient. The inner member can include a securing protrusion that is configured to rotate within the tubular portion, along the longitudinal axis, between a first angular position and a second angular position. The securing protrusion can be in a retracted configuration such that the securing protrusion is positioned radially within the outer member when the inner member is at the first angular position. The securing protrusion can be in an expanded configuration such that the securing protrusion is positioned through the opening and radially beyond the sidewall when the inner member is at the second angular position.

Description

PATIENT TRACKER SECURABLE TO BONECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 562,722, filed March 8, 2024, the entirety of which is incorporated herein by reference.BACKGROUND

[0002] Image-guided surgery (IGS) is a technique where a computer is used to obtain a real-time correlation of the location of an instrument that has been inserted into a patient's body to a set of preoperatively obtained images (e.g., a CT or MRI scan, 3-D map, etc.), such that the computer system may superimpose the current location of the instrument on the preoperatively obtained images. An example of an electromagnetic IGS navigation system that may be used in IGS procedures is the TRUDI® Navigation System by Acclarent, Inc., of Irvine, California. In some IGS procedures, a digital tomographic scan (e.g., CT or MRI, 3-D map, etc.) of the operative field is obtained prior to surgery. A specially programmed computer is then used to convert the digital tomographic scan data into a digital map. During surgery, some instruments can include sensors (e.g., electromagnetic coils that emit electromagnetic fields and / or are responsive to externally generated electromagnetic fields), which can be used to perform the procedure while the sensors send data to the computer indicating the current position of each sensor-equipped instrument. The computer correlates the data it receives from the sensors with the digital map that was created from the preoperative tomographic scan. The tomographic scan images are displayed on a video monitor along with an indicator (e.g., crosshairs or an illuminated dot, etc.) showing the real-time position of each surgical instrument relative to the anatomical structures shown in the scan images. The surgeon is thus able to know the precise position of each sensor-equipped instrument by viewing the video monitor even if the surgeon is unable to directly visualize the instrument itself at its current location within the body.

[0003] One function that may be performed by an IGS system is obtaining one or more reference points that may be used to correlate various preoperatively obtained images with a patient's actual position during a procedure. This act may be referred to as patient registration. Such registration may be performed by using a positionally tracked instrument (e.g., a registration probe whose tip position may be detected in three-dimensional space) to trace or touch one or more positions on a patient's face. At each touch point, the IGS system may register that point in three-dimensional space; and, using a number of registered points,determine the position of the affected area in three-dimensional space. Once the affected area is fully mapped or registered, it may be correlated with preoperative images in order to provide a seamless IGS experience across varying types of preoperative images during the performance of the procedure.

[0004] While several systems and methods have been made and used in connection with IGS systems, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The drawings and detailed description that follow are intended to be merely illustrative and are not intended to limit the scope of the invention as contemplated by the inventors.

[0006] FIG. 1 depicts a schematic view of an example of an IGS system with a patient having their head turned to a side;

[0007] FIG. 2A depicts a perspective view of an example of a patient tracker that may be used with the IGS system of FIG. 1, the patient tracker being in a retracted configuration;

[0008] FIG. 2B depicts a perspective view of the patient tracker of FIG. 2A, the patient tracker being in an expanded configuration;

[0009] FIG. 2C depicts a perspective view of the patient tracker of FIG. 2A, the patient tracker being in a reverse-retracted configuration;

[0010] FIG. 3 A depicts a cross-sectional view of the patient tracker along line SA-SA of FIG. 2A in the retracted configuration;

[0011] FIG. 3B depicts a cross-sectional view of the patient tracker along line 3B- 3B of FIG. 2B in the expanded configuration;

[0012] FIG. 3C depicts a cross-sectional view of the patient tracker along line SA-SA of FIG. 2A in the reverse-retracted configuration; and

[0013] FIG. 4 depicts an exploded assembly view of the patient tracker of FIG. 2A.DETAILED DESCRIPTION

[0014] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the artfrom the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0015] For clarity of disclosure, the terms “proximal” and “distal” are defined herein relative to a surgeon, or other operator, grasping a surgical instrument having a distal surgical end effector. The term “proximal” refers to the position of an element arranged closer to the surgeon, and the term “distal” refers to the position of an element arranged closer to the surgical end effector of the surgical instrument and further away from the surgeon. Moreover, to the extent that spatial terms such as “upper,” “lower,” “vertical,” “horizontal,” or the like are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

[0016] As used herein, the terms “about” and “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.

[0017] I. Example of an Image Guided Surgery Navigation System

[0018] When performing a medical procedure within a head of a patient (P), it may be desirable to have information regarding the position of an instrument within the head of the patient (P), particularly when the instrument is in a location where it is difficult or impossible to obtain an endoscopic view of a working element of the instrument within the head of the patient (P). FIG. 1 shows an example of an IGS system (10) enabling a medical procedure to be performed within a head of a patient (P) using image guidance. In addition to or in lieu of having the components and operability described herein IGS navigation system (50) may be constructed and operable in accordance with at least some of the teachings of U.S. Pat. No. 7,720,521, entitled “Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” issued May 18, 2010, the disclosure of which is incorporated by reference herein, in its entirety; and / or U.S. Pat. No. 10,561,370, entitled “Apparatus to Secure Field Generating Device to Chair,” issued February 18, 2020, the disclosure of which is incorporated by reference herein, in its entirety.

[0019] IGS system (10) of the present example comprises a field generatorassembly (20), which comprises set of magnetic field generators (24) that are integrated into a horseshoe-shaped frame (22). Field generators (24) are operable to generate alternating magnetic fields of different frequencies around the head of the patient (P). An instrument, such as any of the instruments described below, may be inserted into the head of the patient (P). Such an instrument may be a standalone device or may be positioned on an end effector. In the present example, frame (22) is positioned on a table (18), with the patient (P) lying on their side on table (18) such that frame (42) is located adjacent to the head of the patient.

[0020] IGS system (10) of the present example further comprises a processor (12), which controls field generators (24) and other elements of IGS system (10). For instance, processor (12) is operable to drive field generators (24) to generate alternating electromagnetic fields; and process signals from the instrument to determine the location of a navigation sensor or position sensor in the instrument within the head of the patient (P). Processor (12) comprises a processing unit (e.g., a set of electronic circuits arranged to evaluate and execute software instructions using combinational logic circuitry or other similar circuitry) communicating with one or more memories. Processor (12) is coupled with field generator assembly (20) via a cable (26) in this example, though processor (12) may alternatively be coupled with field generator assembly (20) wirelessly or in any other suitable fashion.

[0021] A display screen (14) and user input feature (16) are also coupled with processor (12) in this example. User input feature (16) may comprise a keyboard, a mouse, a trackball, and / or any other suitable components, including combinations thereof. In some versions, display screen (14) is in the form of a touchscreen that is operable to receive user inputs, such that display screen (14) may effectively form at least part of user input feature (16). A physician may use input feature (16) to interact with processor (12) while performing a registration process, while performing a medical procedure, and / or at other suitable times.

[0022] As described in greater detail below, a medical instrument may include a navigation sensor or position sensor that is responsive to positioning within the alternating magnetic fields generated by field generators (24). In some versions, the navigation sensor or position sensor of the instrument may comprise at least one coil at or near the distal end of the instrument. When such a coil is positioned within an alternating electromagnetic field generated by field generators (24), the alternating magnetic field may generate electrical current in the coil, and this electrical current may be communicated as position-indicative signals via wire or wirelessly to processor (12). This phenomenon may enable IGS system (10) to determine the location of the distal end of the instrument within a three-dimensional space (i.e., within the head of the patient (P), etc.). To accomplish this, processor (12) executes analgorithm to calculate location coordinates of the distal end of the instrument from the position related signals of the coil(s) in the instrument. Thus, a navigation sensor may serve as a position sensor by generating signals indicating the real-time position of the sensor within three-dimensional space.

[0023] Processor (12) uses software stored in a memory of processor (12) to calibrate and operate IGS system (10). Such operation includes driving field generators (24), processing data from the instrument, processing data from user input feature (16), and driving display screen (14). In some implementations, operation may also include monitoring and enforcement of one or more safety features or functions of IGS system (10). Processor (12) is further operable to provide video and / or other images in real time via display screen (14), showing the position of the distal end of the instrument in relation to a video camera image of the head of the patient (P), in relation to preoperative image (e.g., a CT scan image) of the head of the patient (P), and / or in relation to a computer-generated three-dimensional model of anatomical structures of the head of the patient (P). Display screen (14) may display such images simultaneously and / or superimposed on each other during the medical procedure. Such displayed images may also include graphical representations of instruments that are inserted in the head of the patient (P), or at least a position indicator (e.g., crosshairs, etc.), such that the operator may observe a visual indication of the instrument at its actual location in real time via display screen (14).

[0024] In the example shown in FIG. 1, display screen (14) is displaying a three- dimensional rendering (30) of the head of the patient (P). By way of further example only, display screen (14) may provide images in accordance with at least some of the teachings of U.S. Pat. No. 10,463,242, entitled “Guidewire Navigation for Sinuplasty,” issued November 5, 2019, the disclosure of which is incorporated by reference herein, in its entirety. In the event that the operator is also using an endoscope, the endoscopic image may also be provided on display screen (14). The images provided through display screen (14) may thus help guide the operator in maneuvering and otherwise manipulating instruments within the head of the patient (P).

[0025] In the present example, field generators (24) are in fixed positions relative to the head of the patient (P), such that the frame of reference for IGS system (10) (i.e., the electromagnetic field generated by field generators (24)) does not move with the head of the patient (P). In some instances, the head of the patient (P) may not remain completely stationary relative to field generators (24) throughout the duration of a medical procedure, such that it may be desirable to track movement of the head of the patient (P) during a medical procedure.To that end, IGS system (10) of the present example includes a patient tracker (28) that is fixedly secured to the head of the patient (P). Patient tracker (28) includes one or more coils and / or other position sensors that are operable to generate signals in response to the alternating magnetic fields generated by field generators (24), with such signals indicating the position of patient tracker (28) in three-dimensional space. In the present example, these signals are communicated to processor (12) via a cable (29). In some other versions, these signals are communicated to processor (12) wirelessly.

[0026] Regardless of how processor (12) receives signals from patient tracker (28), processor (12) may utilize such signals to effectively track the real-time position of the head of the patient (P) and thereby account for any movement of the head of the patient (P) during a medical procedure. In other words, processor (12) may process position-indicative signals from patient tracker (28) in combination with position-indicative signals from a position sensor-equipped medical instrument that is disposed in the head of a patient (P) to accurately determine the real-time position of the distal end (or other working feature) of the medical instrument in the head of the patient (P) despite any movement of the head of the patient (P) during the medical procedure.

[0027] In the example shown in FIG. 1, patient tracker (28) is positioned posterior to the ear (E) of the patient (P), though it should be understood that patient tracker (28) may be positioned at any other suitable location on the head of the patient (P). By way of example only, patient tracker (28) may alternatively be positioned at the lateral forehead, at the upper orbital rim, or at some other location near the site at which the medical procedure will be performed in the head of the patient (P). In some variations, a patient tracker (28) is positioned in the mouth of the patient (P). It should also be understood that patient tracker (28) may be fixedly secured to the head of the patient (P) in numerous ways, including but not limited to adhesives, screws, tacks, sutures, etc. Further examples of how a tracking sensor such as patient tracker (28) may be secured to the patient (P) will be described in greater detail below.

[0028] II. Example of Patient Tracker Securable to Bone

[0029] As noted above, it may be beneficial to track the real-time position of the head of a patient (P) via a patient tracker (28). Some versions of patient tracker (28) may be secured to the skin of the patient (P), via an adhesive or otherwise. In some cases where patient tracker (28) is secured to the skin of the patient (P), the position of patent tracker (28) on the patient (P) may be unstable due to the elasticity or deformability of the skin. In cases where the position of a patient tracker (28) on the skin of the patient (P) shifts relative to the bone underlying the skin, the position data from patient tracker (28) may be unreliable; and theshifting of patient tracker (28) may cause shifting of the mapping / registration of the anatomy of the patient (P) with respect to IGS system (10). It may therefore be desirable to secure a patient tracker (28) directly to bone, to prevent patient tracker (28) from shifting relative to anatomy of the patient (P) during a procedure in which IGS system (10) is used.

[0030] In cases where a patient tracker (28) is secured directly to bone of a patient (P), it may also be desirable to minimize trauma to the bone and skin of the patient. Moreover, it may be desirable to protect the patient (P) from inadvertent slipping of any tools (e.g., a screwdriver) that may be used to secure a patient tracker (28) to the patient (P). The following describes examples of patient trackers that may provide one or more of the advantages described above.

[0031] FIGS. 2A-2B show an example of a patient tracker (100) that may be secured directly to bone of a patient (P). Patient tracker (100) may be substantially similar to patient tracker (28) except as described below. Patient tracker (100) includes an outer member (110) and an inner member (150). Outer member (110) includes a tubular body (115), an outer member flange (135), and a channel (143)(shown in FIG. 4); and also defines a longitudinal axis (LA). Tubular body (115) includes a set of windows (117), a knurled surface (120), a ridged surface (123), and a set of body cleats (125). Outer member flange (135) includes an outer member indicia (137), a set of flange cleats (140), and a cavity (145). These features of outer member flange (135) are optional and may be omitted in other versions.

[0032] Inner member (150) is coaxially positioned with outer member (110) along the longitudinal axis (LA). Inner member (150) includes a cylindrical body (155) positioned below an inner member flange (180); and a lumen (152) that is positioned along the longitudinal axis (LA). Cylindrical body (155) includes columns of arrays of resilient spikes (157) that are circumferentially positioned around cylindrical body (155). Cylindrical body (155) further includes an axial detent (160)(shown in FIG. 4). Spikes (157) may comprise stainless steel, nitinol, a resilient polymer material, or any other resilient / shape-memory material(s). While spikes (157) are provided in the present example, any other suitable form of securing protrusion may be used. Inner member flange (180) includes an inner member indicia (182), a sensing member (185), and a detent (187). Inner member flange (180) may further include a knurled or roughened surface to promote contact friction during rotation by an operator. In some versions, inner member indicia (182) and / or detent (187) are / is omitted.

[0033] In use, an operator may form a hole in bone (B) of the skull of the patient (P), such that tubular body (115) may be inserted into bone (B) to where outer member flange (135) contacts an outer surface of bone (B). In some versions, a portion of outer member flange(135) also contacts skin surrounding the hole over the bone (B). The hole made by the operator may be smaller than an outer diameter of outer member (110) such that patient tracker (100) is press-fit into the hole of the bone (B). Body cleats (125) and flange cleats (140) may be further pressed into bone (B) to restrict rotation of patient tracker (100) about the longitudinal axis (LA). Knurled surface (120) and ridged surface (123) may be used to further restrict rotation of patient tracker (100) about the longitudinal axis (LA).

[0034] Inner member (150) is coaxially positioned within outer member (110) along the longitudinal axis (LA) such that a bottom surface of inner member flange (180) contacts an upper surface of outer member flange (135). Inner member flange (180) and outer member flange (135) may be sized to have the same outer diameter such that upon a rotation of inner member (150) relative to outer member (110), visual indicia (137, 182) may align; and cavity (145) and detent (187) may align to thus engage with one another.

[0035] FIG. 2 A shows patient tracker (100) in a retracted configuration, with patient tracker (100) initially positioned in bone, visual indicia (137, 182) may be misaligned from each other, and cavity (145) and detent (187) may be misaligned from each other. Further, spikes (157) may be misaligned from windows (117) such that spikes (157) do not protrude radially beyond tubular body (115). In other words, the regions of tubular body (115) that are between windows (117) may bear against spikes (157), deforming spikes (157) inwardly.

[0036] FIG. 2B shows patient tracker (100) in an expanded configuration where, upon a rotation by operator of inner member (150) relative to outer member (110) and bone (B) in a first angular direction, visual indicia (137, 182) may align with each other, and cavity (145) and detent (187) may align with each other to indicate an expanded configuration to the operator. Further, spikes (157) may be aligned with windows (117) such that spikes (157) protrude radially beyond tubular body (115) and into bone (B). Such radial protrusion may be accomplished by resiliently biasing spikes (157) to project radially outwardly. Spikes (157) projecting beyond tubular body (115) may engage bone (B) and thereby further limit rotational and axial movement of patient tracker (100) relative to bone (B).

[0037] In some versions, reversing a rotation of inner member (150) relative to outer member (110) may have the reverse effect of retracting spikes (157) away from bone (B). In particular, if inner member (150) is rotated relative to outer member (110) in a second angular direction that is opposite to the first angular direction, the regions of tubular body (115) that are between windows (117) may re-engage against spikes (157), thereby deforming spikes (157) back inwardly and then covering spikes (157) such that spikes (157) no longer contact bone (B). Patient tracker (100) may further include a stop (not shown) to prevent over-rotationof inner member (150) relative to outer member (110) in either rotational direction. After reverse rotation and once spikes (157) have been retracted away from bone (B), removal of patient tracker (100) may be accomplished by pulling any portion of patient tracker (100) away from bone (B).

[0038] As another variation, rather than reversing rotation of inner member (150) by rotating inner member in the second angular direction to retract spikes (157) relative to outer member (110), inner member (150) may be further rotated in the first angular direction to retract spikes (157) relative to outer member (110). FIG. 2C shows patient tracker (100) in a reverse-retracted configuration where the operator has continued rotation of inner member (150) relative to outer member (110) and bone (B) in the first angular direction beyond the state shown in FIG. 2B. In the state shown in FIG. 2C, visual indicia (137, 182) are misaligned with each other. Further, cavity (145) and detent (187) are misaligned with each other to indicate the reverse-retracted configuration to the operator. Upon the continued rotation of inner member (150) from the expanded configuration during the transition from the state shown in FIG. 2B to the state shown in FIG. 2C, spikes (157) contact an opposing side of windows (117) to thereby deflect away from the direction of rotation. Spikes (157) are then fully contained within outer member (110) in the reverse-retracted configuration such that spikes (157) do not protrude radially beyond outer member (110).

[0039] After patient tracker (100) reaches the reverse-retracted configuration shown in FIG. 2C, the operator may rotate inner member (150) in the second angular direction, back toward the state shown in FIG. 2B, to again extend spikes (157) radially beyond outer member (110) and into bone (B). Alternatively, in some versions, the operator may continue rotating inner member (150) relative to outer member (110) and bone (B) in the first angular direction after reaching the state shown in FIG. 2C until spikes (157) reach the next set of windows (117) and protrude outwardly therethrough.

[0040] In some versions, spikes (157) are pointing in respective clockwise orientations as shown in FIG. 3B when spikes (157) are in a deployed state. In some other versions, spikes are pointing in respective counterclockwise orientations (not shown) when spikes (157) are in a deployed state. The orientations of deployed spikes (157) may depend on whether the first angular direction in which inner member (150) is rotated relative to outer member (110) is clockwise or counterclockwise. In addition, or in the alternative, the orientations of deployed spikes (157) may depend on other factors, including but not limited to how spikes (157) are mounted to inner member (150), etc. In still other variations, spikes (157) are pointing directly radially outwardly when spikes (157) are in a deployed state, such thatthere is no tangential / clockwise / counterclockwise aspect to the orientation of spikes (157) when spikes (157) are in a deployed state.

[0041] Detent (187) and cavity (145) may be reversed such that detent (187) is positioned on outer member (110) and cavity (145) is positioned on inner member (150). While transitioning into and out of alignment with each other, detent (187) and cavity (145) may be operable to visually, audibly, and / or tactilely indicate alignment or misalignment.

[0042] In the present example, lumen (152) is positioned along patient tracker (100) and is coaxially aligned with longitudinal axis (LA). In some other versions, lumen (152) is offset from longitudinal axis (LA). Lumen (152) is sized to accommodate a separate medical instrument, thereby providing a passageway for insertion of the instrument to access areas of the patient (P) that are below patient tracker (100). In some versions, lumen (152) is omitted.

[0043] Sensing member (185) may be coaxially aligned or offset from longitudinal axis (LA). While sensing member (185) is integrated with inner member (150) in the present example, some variations may provide sensing member (185) integrated with outer member (110); while still other variations may provide a first sensing member (185) integrated with inner member (150) and a second sensing member (185) integrated with outer member (110). Such integrating may include embedding sensing member (185) within inner member (150) or outer member (110), securing sensing member (185) to inner member (150) or outer member (110), or otherwise integrating sensing member (185) with inner member (150) or outer member (110). Sensing member (185) may be in electrical communication with cables (29) to thus communicate a real-time position of patient (P) to processor (12). Sensing member (185) may comprise an electromagnetic sensor (e.g., one or more coils, etc.) as described above. While patient tracker (100) is secured to the patient (P), sensing member (185) may provide signals indicating the real-time position of the patient (P) even if the patient (P) moves.

[0044] FIG. 3 A shows a cross-sectional view of patient tracker (100) in the retracted configuration as shown in FIG. 2A about line 3A-3A. As shown, spikes (157) may be positioned within tubular body (115) and away from windows (117) such that they do not protrude in bone (B). As mentioned above, spikes (157) may be resiliently biased such that they continually contact an inner surface of tubular body (115). Spikes (157) may also be hinged with inner member (150) such that, upon a rotation of inner member (150), spikes (157) may rotate outwardly through window (117) and into bone (B).

[0045] FIG. 3B shows a cross-sectional view of patient tracker (100) in the expanded configuration as shown in FIG. 2B about line 3B-3B. As shown, inner member (150) has been rotated relative to outer member (110) such that spikes (157) align with windows(117) to thereby protrude radially into bone (B). As mentioned above, transitioning from the expanded configuration to the retracted configuration may be accomplished by reversing the rotation of inner member (150).

[0046] FIG. 3C shows a cross-sectional view of patient tracker (100) taken about line 3A-3A and in the reverse-retracted configuration. As shown, spikes (157) may be positioned within tubular body (115) and away from windows (117) such that they do not protrude in bone (B), albeit in a different direction from the retracted configuration shown in FIG. 3 A. Spikes (157) may be resiliently biased such that continually contact an inner surface of tubular body (115). Spikes (157) may also be hinged with inner member (150) such that, upon a rotation of inner member (150), spikes (157) may rotate outwardly through window (117) and into bone (B) but in an opposite direction from that shown in FIG. 3A.

[0047] FIG. 4 shows patient tracker (100) in an exploded assembly view where inner member (150) axially aligns with outer member (110) along the longitudinal axis (LA). To inhibit axial movement of inner member (150) relative to outer member (110) during use, axial detent (160) may engage channel (143). While engaged, inner member (150) may be free to rotate relative to outer member (110) about the longitudinal axis (LA). Axial detent (160) and channel (143) may be reversed such that axial detent is positioned on outer member (110) and channel (143) is positioned on inner member (150). Channel (143) may further be positioned angularly around a portion of outer member (110) rather than entirely around to thereby define a rotational boundary of inner member (150). Such rotational boundary may be useful to inhibit over rotation of inner member (150) in either rotational direction.

[0048] In some scenarios, patient tracker (100) may be provided as a single-use component, while sensing member (185) may be provided as a reusable component. Such an arrangement may minimize waste and expense.

[0049] While inner and outer members (150, 110) are used to secure patient tracker (100) to bone in this example, in some versions at least a portion of patient tracker (100) may include an adhesive that further secures patient tracker (100) relative to skin and bone. Such an adhesive may facilitate mounting of patient tracker (100) to bone, though such an adhesive may not necessarily contribute to the fixation of patient tracker (100) relative to the patient once spikes (157) has been sufficiently expanded.

[0050] In some cases, patient tracker (100) is secured to bone (B) on the lateral side of the head of the patient (P) (e.g., to the temporal bone). In some other cases, patient tracker (100) is secured to bone on the anterior or posterior side of the head of the patient (P). It should therefore be understood that patient tracker (100) may be secured to any suitablelocation on the patient (P). Patient tracker (100) and sensing member (185) may be used in various kinds of medical procedures, including but not limited to ear, nose, and throat (ENT) procedures, cranial procedures, otology procedures, spinal procedures, neurosurgery procedures where a craniotomy is required, neurotology procedures, etc.

[0051] III. Examples of Combinations

[0052] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

[0053] Example 1 : An apparatus comprising: (a) a position sensor, the position sensor being configured to provide a signal indicating a position of the position sensor in three- dimensional space; (b) an outer member including a tubular portion having a sidewall and defining a longitudinal axis, the tubular portion including an opening through the sidewall and being configured to secure to a bone of a patient; and (c) an inner member having a securing protrusion and being configured to rotate within the tubular portion, along the longitudinal axis and in a first angular direction, between a first angular position and a second angular position, the securing protrusion being configured to be in a retracted configuration such that the securing protrusion is positioned radially within the outer member when the inner member is at the first angular position, the securing protrusion being configured to be in an expanded configuration such that the securing protrusion is positioned through the opening and radially beyond the sidewall when the inner member is at the second angular position; the position sensor being integrated with the outer member or the inner member such that signals of the position sensor indicate the position of the outer member or the inner member in three- dimensional space.

[0054] Example 2: The apparatus of Example 1, the securing protrusion beingresiliently biased toward the expanded configuration.

[0055] Example 3 : The apparatus of any of Examples 1 through 2, the securing protrusion comprising nitinol.

[0056] Example 4: The apparatus of any of Examples 1 through 3, the inner member including a plurality of securing protrusions positioned circumferentially along the inner member, the outer member including a plurality of openings through the sidewall, each securing protrusion of the plurality of securing protrusions being configured to angularly align with a respective opening of the plurality of openings along the longitudinal axis when the inner member is at the second angular position.

[0057] Example 5: The apparatus of any of Examples 1 through 4, the inner member including a flange positioned at an end of the tubular portion, the flange being configured to restrict axial translation of the inner member relative to the outer member.

[0058] Example 6: The apparatus of Example 5, the position sensor being positioned along the flange of the inner member.

[0059] Example 7: The apparatus of any of Examples 1 through 6, the apparatus including an indicator configured to indicate to an operator when the inner member is in the expanded configuration.

[0060] Example 8: The apparatus of Example 7, the indicator being configured to provide visual indication to an operator when the inner member is in the expanded configuration.

[0061] Example 9: The apparatus of any of Examples 7 through 8, the indicator being configured to provide tactile indication to an operator when the inner member is in the expanded configuration.

[0062] Example 10: The apparatus of any of Examples 7 through 9, the indicator being configured to provide audible indication to an operator when the inner member is in the expanded configuration.

[0063] Example 11 : The apparatus of any of Examples 1 through 10, the outer member including a cleat projecting parallel to the longitudinal axis, the cleat being configured to inhibit rotation of the outer member relative to the patient.

[0064] Example 12: The apparatus of any of Examples 1 through 11, the tubular portion including a surface feature configured to inhibit rotation of the outer member relative to the patient.

[0065] Example 13: The apparatus of Example 12, the surface feature including knurling.

[0066] Example 14: The apparatus of any of Examples 12 through 13, the surface feature including ridges.

[0067] Example 15: The apparatus of any of Examples 1 through 14, the apparatus including a channel defining an angular rotation boundary of the inner member relative to the outer member, the defined angular rotation boundary being less than 360 degrees.

[0068] Example 16: The apparatus of any of Examples 1 through 15, the securing protrusion comprising a spike.

[0069] Example 17: The apparatus of any of Examples 1 through 16, the inner member including one or more arrays of securing protrusions, each securing protrusion of the one or more arrays being configured to be in a retracted configuration such that each securing protrusion of the one or more arrays is positioned being radially within the outer member when the inner member is at the first angular position, each securing protrusion of the one or more arrays being configured to be in an expanded configuration such that each securing protrusion of the one or more arrays is positioned through the opening and radially beyond the sidewall when the inner member is at the second angular position.

[0070] Example 18: The apparatus of Example 17, one or more arrays of securing protrusions including: (i) a first array of securing protrusions extending along a first axis, and (ii) a second array of securing protrusions extending along a second axis.

[0071] Example 19: The apparatus of Example 18, the first axis and the second axis each being parallel with the longitudinal axis.

[0072] Example 20: The apparatus of any of Examples 18 through 19, the first array of securing protrusions being angularly offset from the second array of securing protrusions about an outer circumference of the inner member.

[0073] Example 21 : The apparatus of any of Examples 18 through 20, the outer member having: (i) a first opening, the first array of securing protrusions being configured to extend through the first opening when the inner member is at the second angular position, and (ii) a second opening, the second array of securing protrusions being configured to extend through the second opening when the inner member is at the second angular position.

[0074] Example 22: The apparatus of any of Examples 1 through 21, the securing protrusion defining a first direction when in the retracted configuration, the inner member being further configured to rotate within the tubular portion in the first angular direction to a third angular position that is beyond the second angular position relative to the first angular position, the securing protrusion being configured to be in a reverse-retracted configuration such that the securing protrusion is positioned radially within the outer member when the inner member isat the third angular position, the securing protrusion defining a second direction when in the reverse-retracted configuration, the second direction being different from the first direction.

[0075] Example 23: The apparatus of any of Examples 1 through 22, the inner member being further configured to rotate within the tubular portion in a second angular direction opposite to the first angular direction, the tubular portion being configured to drive the securing protrusion back to the retracted configuration in response to rotation of the inner member within the tubular portion in the second angular direction.

[0076] Example 24: A method of affixing a patient tracker to bone, the method including: (a) positioning a combination of an inner member and an outer member of the patient tracker into a hole in the bone, the inner member having a securing protrusion that is in a retracted configuration and covered by the outer member during the act of positioning such that the securing protrusion does not extend outwardly from the outer member during the act of positioning, the securing protrusion being resiliently biased toward an expanded configuration; and (b) rotating the inner member relative to the outer member about a longitudinal axis while the inner member and the outer member are positioned in the hole in the bone, the rotation of the inner member relative to the outer member about the longitudinal axis providing a transition of the securing protrusion from the retracted configuration to the expanded configuration, the securing protrusion in the expanded configuration extending outwardly from the outer member and into the bone.

[0077] Example 25: The method of Example 24, the bone being positioned in the head of a patient.

[0078] Example 26: The method of any of Examples 24 through 25, the method further including rotating the inner member relative to the outer member about the longitudinal axis and in the first angular direction through a second range of angular motion while the inner member and the outer member are positioned in the hole in the bone, the rotation of the inner member relative to the outer member about the longitudinal axis in the first angular direction and through the second range of angular motion providing a transition of the securing protrusion from the expanded configuration to a retracted configuration.

[0079] Example 27: The method of any of Examples 24 through 26, the method further including reversing a rotation of the inner member relative to the outer member about the longitudinal axis to thereby drive the securing protrusion from the expanded configuration back toward the retracted configuration.

[0080] Example 28: The method of any of Example 24 through 27, the method further including engaging a cleat of the outer member with the bone to thereby inhibit rotationof the outer member relative to the bone.

[0081] Example 29: The method of any of Examples 24 through 28, the outer member defining a window, the securing protrusion being offset from the window during the act of positioning, the securing protrusion being positioned within the window after the act of rotating the inner member relative to the outer member, such that the securing protrusion protrudes outwardly through the window in the expanded configuration.

[0082] Example 30: The method of any of Examples 24 through 29, the inner member having one or more arrays of securing protrusions that are in a retracted configuration and covered by the outer member during the act of positioning such that the securing protrusions of the one or more arrays do not extend outwardly from the outer member during the act of positioning.

[0083] Example 31 : The method of Example 30, the rotation of the inner member relative to the outer member about the longitudinal axis providing a transition of the securing protrusions of the one or more arrays from the retracted configuration to the expanded configuration, the securing protrusions of the one or more arrays in the expanded configuration extending outwardly from the outer member and into the bone.

[0084] Example 32: The method of any of Examples 24 through 30, further comprising inserting an instrument through a lumen defined by the inner member, to thereby access an anatomical region with the instrument via the lumen.

[0085] Example 33: An apparatus, comprising: (a) an outer member including: (i) a flange, and (ii) a tubular portion having a sidewall and defining a longitudinal axis, the tubular portion including a number of openings through the sidewall, the flange being positioned at an end of the tubular portion; (b) an inner member having a plurality of securing protrusions, the securing protrusions being arranged in a number of columns and being configured to rotate within the tubular portion and about the longitudinal axis, the number of columns being equal to the number of openings, the inner member being movable relative to the outer member to thereby enable each securing protrusion of the plurality of securing protrusions to extend through a respective opening of the plurality of openings to thereby engage bone and inhibit movement of the apparatus relative to the bone; and (c) a position sensor integrated with the outer member or the inner member, the position sensor being configured to provide a signal indicating a position of the outer member or the inner member in three-dimensional space.

[0086] IV. Miscellaneous

[0087] It should be understood that any of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any of the otherteachings, expressions, embodiments, examples, etc. that are described herein. The abovedescribed teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0088] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[0089] Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0090] By way of example only, versions described herein may be sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0091] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one skilled in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

I / We claim:

1. An apparatus comprising:(a) a position sensor, the position sensor being configured to provide a signal indicating a position of the position sensor in three-dimensional space;(b) an outer member including a tubular portion having a sidewall and defining a longitudinal axis, the tubular portion including an opening through the sidewall and being configured to secure to a bone of a patient; and(c) an inner member having a securing protrusion and being configured to rotate within the tubular portion, along the longitudinal axis and in a first angular direction, between a first angular position and a second angular position, the securing protrusion being configured to be in a retracted configuration such that the securing protrusion is positioned radially within the outer member when the inner member is at the first angular position, the securing protrusion being configured to be in an expanded configuration such that the securing protrusion is positioned through the opening and radially beyond the sidewall when the inner member is at the second angular position; the position sensor being integrated with the outer member or the inner member such that signals of the position sensor indicate the position of the outer member or the inner member in three-dimensional space.

2. The apparatus of Claim 1, the securing protrusion being resiliently biased toward the expanded configuration.

3. The apparatus of any of Claims 1 through 2, the securing protrusion comprising ni tinol.

4. The apparatus of any of Claims 1 through 3, the inner member including a plurality of securing protrusions positioned circumferentially along the inner member, the outer member including a plurality of openings through the sidewall, each securing protrusion of the plurality of securing protrusions being configured to angularly align with a respective opening of the plurality of openings along the longitudinal axis when the inner member is at the second angular position.

5. The apparatus of any of Claims 1 through 4, the inner member including a flange positioned at an end of the tubular portion, the flange being configured to restrict axial translation of the inner member relative to the outer member.

6. The apparatus of Claim 5, the position sensor being positioned along the flange of the inner member.

7. The apparatus of any of Claims 1 through 6, the apparatus including an indicator configured to indicate to an operator when the inner member is in the expanded configuration.

8. The apparatus of Claim 7, the indicator being configured to provide visual indication to an operator when the inner member is in the expanded configuration.

9. The apparatus of any of Claims 7 through 8, the indicator being configured to provide tactile indication to an operator when the inner member is in the expanded configuration.

10. The apparatus of any of Claims 7 through 9, the indicator being configured to provide audible indication to an operator when the inner member is in the expanded configuration.

11. The apparatus of any of Claims 1 through 10, the outer member including a cleat projecting parallel to the longitudinal axis, the cleat being configured to inhibit rotation of the outer member relative to the patient.

12. The apparatus of any of Claims 1 through 11, the tubular portion including a surface feature configured to inhibit rotation of the outer member relative to the patient.

13. The apparatus of Claim 12, the surface feature including knurling.

14. The apparatus of any of Claims 12 through 13, the surface feature including ridges.

15. The apparatus of any of Claims 1 through 14, the apparatus including a channel defining an angular rotation boundary of the inner member relative to the outer member, the defined angular rotation boundary being less than 360 degrees.

16. The apparatus of any of Claims 1 through 15, the securing protrusion comprising a spike.

17. The apparatus of any of Claims 1 through 16, the inner member including one or more arrays of securing protrusions, each securing protrusion of the one or more arrays being configured to be in a retracted configuration such that each securing protrusion of the one or more arrays is positioned being radially within the outer member when the inner member is at the first angular position, each securing protrusion of the one or more arrays being configured to be in an expanded configuration such that each securing protrusion of the one or more arrays is positioned through the opening and radially beyond the sidewall when the inner member is at the second angular position.

18. The apparatus of Claim 17, one or more arrays of securing protrusions including:(i) a first array of securing protrusions extending along a first axis, and(ii) a second array of securing protrusions extending along a second axis.

19. The apparatus of Claim 18, the first axis and the second axis each being parallel with the longitudinal axis.

20. The apparatus of any of Claims 18 through 19, the first array of securing protrusions being angularly offset from the second array of securing protrusions about an outer circumference of the inner member.

21. The apparatus of any of Claims 18 through 20, the outer member having:(i) a first opening, the first array of securing protrusions being configured to extend through the first opening when the inner member is at the second angular position, and(ii) a second opening, the second array of securing protrusions being configured to extend through the second opening when the inner member is at the second angular position.

22. The apparatus of any of Claims 1 through 21, the securing protrusion defining a first direction when in the retracted configuration, the inner member being further configured to rotate within the tubular portion in the first angular direction to a third angular position that is beyond the second angular position relative to the first angular position, the securing protrusion being configured to be in a reverse-retracted configuration such that the securing protrusion is positioned radially within the outer member when the inner member is at the third angular position, the securing protrusion defining a second direction when in the reverse- retracted configuration, the second direction being different from the first direction.

23. The apparatus of any of Claims 1 through 22, the inner member being further configured to rotate within the tubular portion in a second angular direction opposite to the first angular direction, the tubular portion being configured to drive the securing protrusion back to the retracted configuration in response to rotation of the inner member within the tubular portion in the second angular direction.

24. A method of affixing a patient tracker to bone, the method including:(a) positioning a combination of an inner member and an outer member of the patient tracker into a hole in the bone, the inner member having a securing protrusion that is in a retracted configuration and covered by the outer member during the act of positioning such that the securing protrusion does not extend outwardly from the outer member during the act of positioning, the securing protrusion being resiliently biased toward an expanded configuration; and(b) rotating the inner member relative to the outer member about a longitudinal axis and in a first angular direction through a first range of angular motion while the inner member and the outer member are positioned in the hole in the bone, the rotation of the inner member relative to the outer member about the longitudinal axis in the first angular direction and through the first range of angular motion providing a transition of the securing protrusion from the retracted configuration to the expanded configuration, the securing protrusion in the expanded configuration extending outwardly from the outer member and into the bone.

25. The method of Claim 24, the bone being positioned in the head of a patient.

26. The method of any of Claims 24 through 25, the method further including rotating the inner member relative to the outer member about the longitudinal axis and in the first angular direction through a second range of angular motion while the inner member and the outer member are positioned in the hole in the bone, the rotation of the inner member relative to the outer member about the longitudinal axis in the first angular direction and through the second range of angular motion providing a transition of the securing protrusion from the expanded configuration to a retracted configuration.

27. The method of any of Claims 24 through 25, the method further including rotating the inner member relative to the outer member about the longitudinal axis and in a second angular direction, opposite to the first angular direction, to thereby drive the securing protrusion from the expanded configuration back toward the retracted configuration.

28. The method of any of Claim 24 through 27, the method further including engaging a cleat of the outer member with the bone to thereby inhibit rotation of the outer member relative to the bone.

29. The method of any of Claims 24 through 28, the outer member defining a window, the securing protrusion being offset from the window during the act of positioning, the securing protrusion being positioned within the window after the act of rotating the inner member relative to the outer member, such that the securing protrusion protrudes outwardly through the window in the expanded configuration.

30. The method of any of Claims 24 through 29, the inner member having one or more arrays of securing protrusions that are in a retracted configuration and covered by the outer member during the act of positioning such that the securing protrusions of the one or more arrays do not extend outwardly from the outer member during the act of positioning.

31. The method of Claim 30, the rotation of the inner member relative to the outer member about the longitudinal axis providing a transition of the securing protrusions of theone or more arrays from the retracted configuration to the expanded configuration, the securing protrusions of the one or more arrays in the expanded configuration extending outwardly from the outer member and into the bone.

32. The method of any of Claims 24 through 31, further comprising inserting an instrument through a lumen defined by the inner member, to thereby access an anatomical region with the instrument via the lumen.

33. An apparatus comprising:(a) an outer member including:(i) a flange, and(ii) a tubular portion having a sidewall and defining a longitudinal axis, the tubular portion including a number of openings through the sidewall, the flange being positioned at an end of the tubular portion;(b) an inner member having a plurality of securing protrusions, the securing protrusions being arranged in a number of columns and being configured to rotate within the tubular portion and about the longitudinal axis, the number of columns being equal to the number of openings, the inner member being movable relative to the outer member to thereby enable each securing protrusion of the plurality of securing protrusions to extend through a respective opening of the plurality of openings to thereby engage bone and inhibit movement of the apparatus relative to the bone; and(c) a position sensor integrated with the outer member or the inner member, the position sensor being configured to provide a signal indicating a position of the outer member or the inner member in three-dimensional space.

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