Flexible circuit with longitudinally spaced position sensors for steerable medical devices

Abstract

An apparatus includes a shaft assembly having a proximal portion and a distal portion. The distal portion is configured to enable lateral deflection of a distal end relative to a longitudinal axis defined by the proximal portion. A distal navigation sensor positioned at or near the distal end of the distal portion is configured to indicate a position of the distal end of the flexible distal portion in three-dimensional space. A pair of proximal navigation sensors positioned at or near a proximal end of the flexible distal portion are configured to indicate a roll orientation of the proximal end of the flexible distal portion about the longitudinal axis.

Description

Cross-references to related applications

[0001] This application claims the benefit of U.S. Patent Application Serial No. 63 / 547,995, filed November 10, 2023, pursuant to 35 USC § 119(e), which is incorporated herein by reference. Background Technology

[0002] Image-guided surgery (IGS) is a technique that uses a computer to obtain real-time correlations between the position of an instrument already inserted into the patient and a set of preoperative images (e.g., CT or MRI scans, 3D mapping, etc.), allowing the computer system to overlay the current position of the instrument onto the preoperative images. An example of an electromagnetic IGS navigation system that can be used in IGS procedures is CARTO, provided by Biosense-Webster, Inc. (Irvine, California). ® 3. System. In some IGS procedures, a digital tomographic scan of the surgical area (e.g., CT or MRI, 3D mapping, etc.) is obtained prior to surgery. The digital tomographic data is then converted into a digital mapping using a specially programmed computer. During surgery, specialized instruments equipped with sensors (e.g., electromagnetic coils emitting electromagnetic fields and / or responding to externally generated electromagnetic fields) are used to execute the procedure, while the sensors send data to the computer indicating the current position of each surgical instrument. The computer correlates the data received from the sensors with the digital mapping generated from the preoperative tomographic scan. The tomographic images, along with indicative markers (e.g., crosshairs or luminous dots, etc.), are displayed on a video monitor, showing the real-time position of each surgical instrument relative to the anatomical structures shown in the scan images. Therefore, even if the surgeon cannot directly visually view the instruments at their current positions within the body, they can understand the exact position of each sensor-equipped instrument by viewing the video monitor.

[0003] In some cases, it may be desirable to dilate anatomical passages within a patient's body. This can include dilation of the paranasal sinus ostia (e.g., to treat sinusitis), laryngeal dilation, Eustachian tube dilation, dilation of other passages within the ear, nose, or larynx, etc. One method of dilating anatomical passages involves positioning an inflatable balloon within the anatomical passage using a guidewire and catheter, and then inflating the balloon with fluid (e.g., saline) to dilate the anatomical passage. For example, an inflatable balloon may be positioned within the ostium of a paranasal sinus and then inflated to dilate the ostium by remodeling the bone adjacent to it, without requiring incision of the mucosa or removal of any bone. The dilated ostium can then allow for improved drainage and ventilation from the affected paranasal sinus.

[0004] Ablation of tissue within the patient's ear, nose, or throat may also be desirable. For example, such ablation may be desired for tissue remodeling (e.g., to reduce the size of the nasal turbinates), to provide denervation (e.g., to disable the posterior nasal nerve), and / or for other purposes. Some such ablation treatments may include radiofrequency (RF) ablation using alternating current (AC) power; and / or irreversible electroporation (IRE) via pulsed direct current (DC) power. To achieve ablation, an end effector with one or more needle electrodes or other types of tissue contact electrodes can be activated using monopolar or bipolar power. Such ablation procedures may be performed in conjunction with or separately from dilation procedures.

[0005] It may also be desirable to have easily controlled placement of dilation catheters, ablation devices, or other ENT devices within the anatomical passage (including in procedures to be performed by a single operator). Although several systems and methods have been developed for positioning ENT devices within the anatomical passage, it is believed that no one has previously developed or used the invention described in the appended claims. Attached Figure Description

[0006] The following figures and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0007] Figure 1 This is a schematic diagram of an example of a surgical navigation system used on a patient sitting in a medical protocol chair.

[0008] Figure 2A This is a front perspective view of an example of an instrument, in which the slider is in a proximal position, such that the working element shaft of the instrument retracts proximal to the distal end of the opening of the shaft assembly of the instrument.

[0009] Figure 2B yes Figure 2A A front perspective view of the instrument, in which the slider is in the distal position, such that the working element shaft extends distally relative to the distal end of the opening of the shaft assembly.

[0010] Figure 3 yes Figure 2A A partial front perspective view of the distal portion of the instrument, wherein an example of a distal endoscope cover is removably attached to the distal end of the opening of the shaft assembly.

[0011] Figure 4A yes Figure 2A A partial front perspective view of the distal portion of the device, wherein an example of a flexible navigation sensor assembly is attached to the flexible distal portion of the shaft assembly, showing the flexible distal shaft portion of the device in a straight configuration, and further showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the flexible distal shaft portion in a first curved configuration.

[0012] Figure 4B yes Figure 4A A partial front perspective view of the distal portion of the device shows the flexible distal axis portion of the device in a bent configuration, and further shows a flexible navigation sensor assembly disposed along the outer cylindrical surface of the flexible distal axis portion in a second bent configuration; and

[0013] Figure 5 It is in a flat configuration Figure 4A Top plan view of the flexible navigation sensor assembly. Detailed Implementation

[0014] The following description of certain examples of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is illustrated by way of example, and a preferred mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different and obvious aspects, all of which are not departing from the invention. Therefore, the drawings and descriptions should be regarded as substantially illustrative and not restrictive.

[0015] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator holding a surgical instrument with a distal surgical end effector. The term "proximal" refers to a position where the element is positioned closer to the surgeon's placement, and the term "distal" refers to a position where the element is closer to the surgical end effector of the surgical instrument and further away from the surgeon's placement. Furthermore, the use of spatial terms such as "upper," "lower," "vertical," "horizontal," etc., with reference to the accompanying drawings, should be understood as such terms being used for illustrative purposes only and are not intended to be limiting or absolute. In this regard, it should 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 value or range indicate that a part or collection of parts is permitted to perform appropriate dimensional tolerances as described herein for its intended purpose.

[0017] I. Examples of Image-Guided Surgical Navigation Systems

[0018] When performing medical procedures within a patient's (P) head, it may be desirable to obtain information about the position of the instrument within the patient's (P) head (H), especially when the instrument is in a position where it is difficult or impossible to obtain an endoscopic view of the working element of the instrument within the patient's (P) head. Figure 1An example of an IGS navigation system 50 is shown that enables the use of image guidance to perform medical procedures within the head (H) of a patient (P). In addition to having, or in lieu of, the components and operability described herein, the IGS navigation system 50 may be constructed and operated in accordance with at least some of the teachings of the following U.S. patents: U.S. Patent No. 7,720,521, published May 18, 2010, entitled “Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 11,065,061, published July 20, 2021, entitled “Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” the disclosure of which is incorporated herein by reference in its entirety.

[0019] The IGS navigation system 50 of this example includes a field generator assembly 60 comprising a set of magnetic field generators 64 integrated within a horseshoe-shaped frame 62. The field generators 64 are operable to generate alternating magnetic fields of varying frequencies around the head (H) of a patient (P). An instrument can be inserted into the head (H) of the patient (P). Such instruments may include one or more position sensors, as described in more detail below. In this example, the frame 62 is mounted to a seat 70, in which the patient (P) sits, such that the frame 62 is positioned adjacent to the head (H) of the patient (P). By way of example only, the seat 70 and / or the field generator assembly 60 may be configured and operated in accordance with at least some of the teachings of the following U.S. Patent No. 10,561,370, published February 18, 2020, entitled “Apparatus to Secure Field Generating Device to Chair,” the disclosure of which is incorporated herein by reference in its entirety. In some other variations, the patient (P) lies on the table; and the field generator assembly 60 is positioned on or near the table.

[0020] The IGS navigation system 50 of this example also includes a processor 52 that controls the field generator 64 and other components of the IGS navigation system 50. For example, the processor 52 is operable to drive the field generator 64 to generate an alternating electromagnetic field; and to process signals from instruments to determine the position of the navigation sensors within the instruments in the patient's (P) head (H). The processor 52 includes processing units (e.g., a set of electronic circuits arranged to evaluate and execute software instructions using combinational logic circuitry or other similar circuitry) that communicate with one or more memories. The processor 52 of this example is mounted in a console 58 that includes operating controls 54, including a keyboard and / or pointing devices (such as a mouse or trackball). The physician uses the operating controls 54 to interact with the processor 52 while performing surgical procedures.

[0021] Although not shown, the device may include a navigation sensor that responds to positioning within an alternating magnetic field generated by field generator 64. A coupling unit (not shown) may be attached to the proximal end of the device and may be configured to provide communication of data and other signals between console 58 and the device. The coupling unit may provide wired or wireless communication of data and other signals.

[0022] In some configurations, the device's navigation sensor may include at least one coil at or near the distal end of the device. When such a coil is positioned within an alternating electromagnetic field generated by field generator 64, the alternating magnetic field induces a current in the coil, and this induced current is transmitted as a position indication signal along an electrical conduit within the device and further transmitted to processor 52 via a coupling unit. This phenomenon enables the IGS navigation system 50 to determine the position of the distal end of the device in three-dimensional space (i.e., within the patient's (P) head (H), etc.). To achieve this, processor 52 executes an algorithm to calculate the position coordinates of the distal end of the device based on position-related signals from the coil within the device (e.g., based on the induced current). Thus, by generating a signal indicating the real-time position of the sensor in three-dimensional space, or by otherwise indicating the real-time position of the sensor in three-dimensional space, the navigation sensor can be used as a position sensor.

[0023] Processor 52 uses software stored in its memory to calibrate and operate IGS navigation system 50. Such operations include driving field generator 64, processing data from instruments, processing data from operating controls 54, and driving display screen 56. In some embodiments, operations may also include monitoring and implementing one or more safety features or functions of IGS navigation system 50. Processor 52 is further operable to provide video in real time via display screen 56, showing the position of a video camera image of the distal end of the instrument relative to the patient's head (H), a CT scan image of the patient's head (H), and / or a computer-generated three-dimensional model of the anatomical structures within and adjacent to the patient's nasal cavity. Display screen 56 may simultaneously display such images and / or display such images superimposed on each other during surgical procedures. Such displayed images may also include a graphical representation of the instrument inserted into the patient's head (H), allowing the operator to view a virtual rendering of the instrument in its actual position in real time. By way of example only, display screen 56 may provide images based on at least some of the teachings of the following U.S. patent: U.S. Patent No. 10,463,242, entitled “Guidewire Navigation for Sinuplasty,” published November 5, 2019, the disclosure of which is incorporated herein by reference in its entirety. Endoscopic images may also be provided on display screen 56 when the operator is still using an endoscope.

[0024] The images provided by the display screen (56) can help guide the operator to manipulate and otherwise control the instrument within the patient's head (H). It should also be understood that other components of the surgical instruments described below, as well as other types of surgical instruments, may be combined with navigation sensors (such as those described above).

[0025] II. Examples of ENT instruments with distal endoscope caps

[0026] Figures 2A to 3 An example of a device 100 is shown, which can be used to move a working element 101 ( Figure 2B ) guide it into the anatomical passage, and the distal endoscope cover 110 ( Figure 3 Examples of this type of attachment can be removably or permanently attached to the device. For example... Figure 2B As shown, the working element 101 includes a shaft 102 and an end effector 104. In some embodiments, the working element 101 may include a dilating catheter. In this regard, the end effector 104 may have one or more balloons or other dilators, such that the instrument 100 can be used to guide the end effector 104 of the working element 101 into an anatomical passage, thereby dilating the anatomical passage. For example, the instrument 100 and the working element 101 can be used for dilation of paranasal sinus ostia (e.g., to treat sinusitis), dilation of the larynx, dilation of the Eustachian tube, dilation of other passages within the ear, nose, or larynx, etc.

[0027] Alternatively or additionally, the working element 101 may include an electrical energy (e.g., RF energy and / or pulsed field DC energy, etc.) delivery conduit. In this regard, the end effector 104 may have one or more electrodes, such that the instrument 100 can be used to guide the end effector 104 of the working element 101 into an anatomical channel to deliver electrical energy to tissue within or near the anatomical channel. For example, the instrument 100 and the working element 101 may be used to ablate nerves (e.g., posterior nasal nerves); ablate turbinates; or ablate, electroporate (e.g., to facilitate the absorption of therapeutic agents, etc.), or apply resistive heating to any other type of anatomical structure in the patient's head. It should be understood that the working element 101 may include any other suitable type of ENT treatment device.

[0028] The device 100 of this example includes a handle assembly 106 and a shaft assembly 108. The device 100 may be coupled to an inflation fluid source (not shown) operable to selectively supply inflation fluid to a balloon (not shown) of an end effector 104 for balloon inflation, thereby dilating the anatomical passage. Alternatively, the device 100 may be coupled to an ablation energy generator (not shown) operable to generate ablation energy for delivery to tissue via electrodes (not shown) of the end effector 104, thereby ablating, electroporating, or applying resistance heating to the tissue. The energy generated by the ablation energy generator may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high-voltage DC pulses that can be used to achieve irreversible electroporation (IRE), or combinations thereof.

[0029] The handle assembly 106 in this example includes a body 112 and at least one slider 114. The body 112 is sized and configured for single-handed gripping and operation by an operator, such as via a motorized grip, pencil grip, or any other suitable type of grip. The slider 114 is operable to translate longitudinally relative to the body 112. The slider 114 is coupled to the working element 101 and is therefore operable to position the working device 101 in a proximal retracted position. Figure 2A ) and distal extension position ( Figure 2B The slider (not shown) is longitudinally translated between the two. In some models, another slider (not shown) is operable to longitudinally translate the guide wire (not shown) for guiding the working device 101 along the guide wire.

[0030] The shaft assembly 108 in this example includes a rigid portion 116, a flexible portion 118 distal to the rigid portion 116, and an open distal end 120. A traction wire (not shown) is coupled to the flexible portion 118 and a deflection control knob 122 of the shank assembly 106. The deflection control knob 122 is rotatable relative to the body 112 about an axis perpendicular to the longitudinal axis of the shaft assembly 108 to selectively retract the traction wire proximally. When the traction wire is retracted proximally, the flexible portion 118 bends, causing the distal end 120 to laterally deflect away from the longitudinal axis of the rigid portion 116. The deflection control knob 122, the traction wire, and the flexible portion 118 thus cooperate to give the shaft assembly 108 steerability. By way of example only, this steerability of the shaft assembly 108 may be provided according to at least some of the teachings of the following U.S. Patent Publication No. 2021 / 0361912, entitled “Shaft Deflection Control Assembly for ENT Guide Instrument,” published November 25, 2021, the disclosure of which is incorporated herein by reference in its entirety. Other embodiments may provide some other kind of user input features (instead of the deflection control knob 122) to drive the steering of the flexible portion 118. In some alternative embodiments, the deflection control knob 122 is omitted, and the flexible portion 118 is extendable. In still other embodiments, the entire length of the shaft assembly 108 is rigid.

[0031] The shaft assembly 108 can also rotate relative to the handle assembly 106 about the longitudinal axis of the rigid portion 116. Such rotation can be driven via a rotary control knob 124, which is rotatably coupled to the body 112 of the handle assembly 106. Alternatively, the shaft assembly 108 can be rotated via some other form of user input; or it can be non-rotatable relative to the handle assembly 106. It should also be understood that the examples of the handle assembly 106 described herein are merely illustrative. The shaft assembly 108 can alternatively be coupled to any other suitable type of handle assembly or other support body.

[0032] like Figure 3 As shown, the flexible portion (also referred to as a flexible guide shaft or deflectable guide shaft) 118 of the shaft assembly 108 includes a linear array of articulated ribs 130, which are spaced apart from each other by generally C-shaped slots 131 and connected to each other by elastic ridges 132 to accommodate articulated movements of the articulated ribs 130 relative to the rigid portion 116 via the aforementioned traction wire. For this purpose, the flexible portion 118 may also include a pair of traction wire coupling holes (not shown) or other features near the distal end 120 of the opening for coupling with the distal end of the traction wire. Working cavity 121 ( Figures 4A to 4BThe shaft assembly 108 extends longitudinally from the proximal end of the opening (not shown) to the distal end of the opening 120 and is configured to slidably receive the working element 101, such that the shaft assembly 108 can receive the working element 101 at the proximal end of the opening and guide the working element 101 out through the distal end of the opening 120. In some embodiments, the working cavity 121 may have a diameter of approximately 2.9 mm. The flexible portion 118 of the shaft assembly 108 may be formed of a metallic material, such as stainless steel and / or nitinol. Alternatively or additionally, the flexible portion 118 may be constructed and operated in accordance with at least one or more of the teachings of the following U.S. Patent No. 11,376,401, entitled “Deflectable Guide for Medical Instrument,” published July 5, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0033] Continue to refer to Figure 3 The distal endoscope cover 110 may be attached to the distal end 120 of the opening of the shaft assembly 108 and is operable to provide visualization, navigation and / or flushing capabilities to the shaft assembly 108 while allowing the shaft assembly 108 to continue to be used to guide the working element 101 through the distal end 120 of the opening.

[0034] In this respect, the distal endoscope cover 110 of this example includes a body 140 having a generally cylindrical hub 142 extending between a proximal surface (not shown) and a distal surface 146. In the example shown, the body 140 also has a pair of laterally opposed coupling wings 148 extending proximally from the proximal surface of the hub 142. Each of the wings 148 of the distal endoscope cover 110 includes a laterally inward gripping surface (not shown) configured to frictionally engage the generally cylindrical outer surface of the flexible portion 118 of the shaft assembly 108 near the distal end of the opening 120 for removably attaching the distal endoscope cover 110 to the distal end of the opening 120. Although the gripping surface of the wing 148 for the cylindrical outer surface of the friction-engaging flexible portion 118 has been described, it should be understood that the distal endoscope cover 110 can be removably or permanently attached to the distal end of the opening 120 in any suitable manner, such as via adhesive, thermal bonding, welding, snap-fit ​​or any other attachment technique.

[0035] The distal endoscope cover 110 of this example also includes a generally cylindrical orifice 150 extending longitudinally between the proximal and distal surfaces 146 of the hub 142, and configured to axially align with the working cavity 121 of the shaft assembly 108 when the distal endoscope cover 110 is attached to the distal end of the opening 120, such that the working element 101 can pass through the orifice 150 when guided through the distal end of the opening 120. Therefore, a working channel 154 can extend along the orifice 150. In some configurations, the orifice 150 may have an internal cross-sectional dimension (e.g., diameter) between about 2.5 mm and about 2.9 mm. Alternatively, the orifice 150 may have any other suitable internal cross-sectional dimension.

[0036] As used herein, the term "axial alignment" should not be construed as requiring that the central axis of the bore 150 be coaxial with the central axis of the working cavity 121 of the shaft assembly 108. Rather, the term "axial alignment" should be understood to include arrangements in which the central axis of the working cavity 121 of the shaft assembly 108 passes through the bore 150, wherein the central axis of the working cavity 121 of the shaft assembly 108 is laterally offset from the central axis of the bore 150. Thus, "axial alignment" includes any arrangement in which the working element 101, which advances along the working cavity 121 of the shaft assembly 108, may ultimately pass through the bore 150. Of course, some forms of "axial alignment" arrangements may include arrangements in which the central axis of the bore 150 is coaxial with the central axis of the working cavity 121 of the shaft assembly 108.

[0037] The distal endoscope cover 110 of this example also includes an arched array of generally rectangular orifices 160, 162, each generally rectangular orifice extending longitudinally between the proximal and distal surfaces 146 of the hub 142 and positioned around (e.g., below) an orifice 150. More specifically, the distal endoscope cover 110 includes a pair of internally laterally opposed orifices 160 and a pair of externally laterally opposed orifices 162.

[0038] In the example shown, the distal endoscope cover 110 also includes a pair of imaging devices (also referred to as image sensors) and a pair of illumination elements 166. The pair of imaging devices are received in the form of a camera 164 within a respective internal aperture 160, and the pair of illumination elements are received in a respective external aperture 162. The camera 164 and the illumination elements 166 are configured to cooperate with each other to provide visualization capability to the shaft assembly 108. By way of example only, camera 164 may be configured and operated in accordance with at least some of the teachings of the following U.S. patents: U.S. Patent No. 10,955,657, entitled “Endoscope with Dual Image Sensors,” published March 23, 2021, the disclosure of which is incorporated herein by reference; U.S. Patent Publication No. 2020 / 0196851, entitled “3D Scanning of Nasal Tract with Deflectable Endoscope,” filed June 25, 2020, the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent No. 11,457,981, entitled “Computerized Tomography (CT) ImageCorrection Using Position and Direction (P&D) Tracking Assisted Optical Visualization,” published October 4, 2022, the disclosure of which is incorporated herein by reference in its entirety. In some cases, the centers of cameras 164 may be spaced apart by a distance between approximately 1 mm and approximately 2 mm. For example, each camera in camera 164 may have multiple leads (not shown) at its proximal end, which are configured to be operatively coupled to processor 52 and / or electrically coupled to a power source (not shown) via respective traces or wires, which extend proximally through a respective aperture 160 and along shaft assembly 108 to the coupling unit.

[0039] Illumination elements 166 are configured and operable to illuminate the field of view of camera 164. Each illumination element in 166 is positioned outward relative to the adjacent camera 164. In this example, illumination elements 166 include LEDs. For example, each illumination element in 166 may have a pair of leads (not shown) at its proximal end, the pair of leads being configured to be electrically coupled to a power source (not shown) via a corresponding trace or wire extending proximally through a corresponding aperture 162 and along the shaft assembly 108 to the coupling unit.

[0040] While the device 100 has been described as being used to expand anatomical access within a patient's ear, nose, or larynx and / or to deliver electrical energy to tissues, it should be understood that the device 100 may be adapted to perform other surgical functions, such as via various other types of working elements 101, including, for example, diagnostic procedures, electrophysiological mapping, electrophysiologically guided catheter-guided surgery, and / or cardiac ablation procedures. By way of example only, the device 100 and / or the distal endoscope cap 110 may be constructed and operated in accordance with at least some of the teachings of the following U.S. patent application: U.S. Patent Application No. 18 / 115,310, filed February 28, 2023, entitled “ENT Guide Shaft with Deflectable Tip and Distal Endoscope Cap,” the disclosure of which is incorporated herein by reference in its entirety.

[0041] III. Example of a flexible circuit with longitudinally spaced position sensors

[0042] In some cases, it may be desirable to provide an apparatus 100 with a pair of proximal navigation sensors configured to generate position-related signals that collectively indicate the orientation of at least a portion of the shaft assembly 108 (e.g., the distal end of the rigid portion 116 and / or the proximal end of the flexible portion 118) about the longitudinal axis of the rigid portion 116 of the shaft assembly 108, also referred to as the “roll” of that portion of the shaft assembly 108. Such position-related signals may be provided by current induced in one or more coils of the navigation sensors by an electromagnetic field generated by a field generator 64.

[0043] Alternatively or concurrently, it may be desirable to provide an instrument 100 having at least one distal navigation sensor configured to generate a position-related signal indicating the position of the distal portion (e.g., the distal end of the flexible portion 118) of the distal endoscope cover 110 and / or shaft assembly 108. Likewise, such a position-related signal may be provided by a current induced in one or more coils of the navigation sensor by an electromagnetic field generated by the field generator 64.

[0044] In this arrangement of navigation sensors, the sensor located near the flexible portion 118 can provide real-time "roll" orientation information of the region of the shaft assembly 108 near the flexible portion; the sensor located near the flexible portion 118 can also provide real-time position information of the region of the shaft assembly 108 near the flexible portion in three-dimensional space; the sensor located far from the flexible portion 118 can also provide real-time position information of the region of the shaft assembly 108 far from the flexible portion in three-dimensional space; and the combination of the sensor located near the flexible portion 118 and the sensor located far from the flexible portion 118 can together provide information indicating the real-time bending angle of the flexible portion 118.

[0045] As described above, for example, each camera in camera 164 and each illumination element in illumination element 166 may have a corresponding lead at its proximal end, which is configured to be operatively coupled to processor 52 and / or electrically coupled to a power source (not shown) via a corresponding trace or wire (not shown), which extends proximally through corresponding apertures 160, 162 and along shaft assembly 108 to the coupling unit. In some cases, it may be desirable to lay such traces or wires along the resilient ridge 132 of the flexible portion 118 of shaft assembly 108. For example, laying such traces or wires along the resilient ridge 132 allows such traces or wires to avoid interfering with the ability of the flexible portion 118 to bend. Alternatively, laying such traces or wires along the elastic ridge 132 may allow them to experience tension when the distal end 120 deflects laterally away from the longitudinal axis of the rigid portion 116 (e.g., rather than compression when the distal end 120 deflects laterally away from the longitudinal axis, which might be the case if such traces or wires were laid along the articular movement rib 130 and crossed the slot 131 opposite the elastic ridge 132). It should be understood that tensioning such traces or wires during deflection of the distal end 120 may help prevent such traces or wires from unintentionally coming into contact with each other (e.g., short circuit).

[0046] Figures 4A to 5 An example of a navigation sensor assembly 210 with this functionality is shown. For example... Figures 4A to 4B As shown, the navigation sensor assembly 210 is disposed on the shaft assembly 108 and operable to provide navigation capability to the shaft assembly 108. More specifically, the navigation sensor assembly 210 is disposed in at least one generally curved configuration along the generally cylindrical outer surface of the flexible portion 118 of the shaft assembly 108, in which the navigation sensor assembly 210 is curved about the longitudinal axis of the flexible portion 118 of the shaft assembly 108 with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the flexible portion 118, thereby conforming to the outer circumference of the flexible portion 118. Figures 4A to 4BThe transformation shows that the flexible portion 118 of the shaft assembly 108 changes from a straight configuration ( Figure 4A ) Bending to bending configuration ( Figure 4B This causes the distal end 120 to deflect laterally away from the longitudinal axis of the rigid portion 116.

[0047] The navigation sensor assembly 210 of this example is provided in the form of a flexible printed circuit board (PCB) and includes a generally L-shaped flexible circuit board 212 having a plurality of navigation sensors 214a, 214b, 216, including a pair of laterally adjacent proximal navigation sensors 214a, 214b and a distal navigation sensor 216, multiple traces 218, and multiple proximal leads (e.g., pads) 220 positioned on the multiple traces. As shown, the flexible board 212 extends longitudinally between a proximal end 222 and a distal end 224. In the example shown, a plurality of flexible tabs 226 on which corresponding distal leads (e.g., pads) 228 are positioned extend distally from the distal end 224 of the board 212. In some embodiments, the tabs 226 and the board 212 may be integrally formed as a single unit (e.g., monolithic). The substrate 212 and / or tabs 226 may be formed of an electrically insulating flexible plastic material (such as polyimide or liquid crystal polymer (LCP)), while the traces 218 and / or leads 220, 228 may each be formed of a conductive metallic material (such as copper). In some types, the substrate 212 is attached to the outer surface of the flexible portion 118 of the shaft assembly 108 via an adhesive. Alternatively, the substrate 212 may be attached to the shaft assembly 108 in any other suitable manner. The navigation sensor assembly 210 may have a relatively low profile, at least compared to conventional coil sensors. In some types, the navigation sensor assembly 210 may have a thickness of approximately 50 micrometers.

[0048] The substrate 212 in this example includes a proximal portion 230, an intermediate portion 232 extending distally from the proximal portion 230, and a distal portion 234 extending laterally outward away from the intermediate portion 232. Proximal navigation sensors 214a, 214b and a proximal lead 220 are positioned on the proximal portion 230. A trace 218 is at least partially positioned on each of the proximal portion 230, the intermediate portion 232, and the distal portion 234. A distal navigation sensor 216 is positioned on the distal portion 234. In the example shown, at least when the navigation sensor assembly 210 is in a flat configuration (… Figure 5When the substrate 212 is in the middle, the proximal portion 230 extends laterally outward relative to each side of the middle portion 232, such that the proximal portion 230 and the middle portion 232 together define a “T” shape, while the distal portion 234 of the substrate 212 extends laterally outward only relative to one side of the middle portion 232, such that the distal portion 234 and the middle portion 232 together define an “L” shape.

[0049] like Figures 4A to 4B As shown, the proximal portion 230 is sized and configured to at least partially wrap around the shaft assembly 108 at or near the proximal end of the flexible portion 118 (such as proximal to the articulation rib 130 and slot 131); the distal portion 234 is sized and configured to at least partially wrap around the shaft assembly 108 at or near the distal end 120 of the shaft assembly 108 (such as distal to the articulation rib 130 and slot 131); and the intermediate portion 232 is sized and configured to extend along the elastic ridge 132 between the proximal portion 230 and the distal portion 234. In some embodiments, at least the intermediate portion 232 comprises a longitudinally stretchable material.

[0050] In some configurations, the flexible tabs 226 may be spaced apart by a distance corresponding to the distance between the camera 164 and the illumination element 166, and / or may be arranged along the distal portion 234 such that when the distal portion 234 is at least partially wound around the shaft assembly 108 at or near the distal end 120, it is angled toward the camera 164 and the illumination element 166 relative to the longitudinal axis of the flexible portion 118 of the shaft assembly 108 (and / or relative to the longitudinal axis of the rigid portion 116 of the shaft assembly 108). In other words, the flexible tab 226 can be arranged at an angle to the longitudinal axis of the flexible portion 118 of the shaft assembly 108 (and / or the longitudinal axis of the rigid portion 116 of the shaft assembly 108) when the distal portion 234 is at least partially wound around the shaft assembly 108 at or near the distal end 120, at a position substantially the same as the position of the camera 164 and the illumination element 166.

[0051] In the example shown, navigation sensors 214a, 214b, and 216 are each freely formed (e.g., printed and / or embedded) within concentric loop portions of corresponding conductive traces on the top surface of substrate 212, and each is operable to generate signals indicating the position of the respective navigation sensors 214a, 214b, and 216, and thus indicating the position of at least a portion of device 100 (e.g., the flexible portion 118 of shaft assembly 108) in three-dimensional space. In this regard, when the concentric loop portions of the corresponding conductive traces are positioned within an alternating electromagnetic field generated by field generator 64, the alternating magnetic field can generate a current in the concentric loop portions, and this current can be transmitted to processor 52, for example, via coupling units (not shown) electrically coupled to navigation sensors 214a, 214b, and 216. Position data generated from such position-related signals can be processed by processor 52 to provide visual indications to the operator, displaying in real-time the position of shaft assembly 108 of device 100 within the patient (P). Such visual indications can be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy.

[0052] In some configurations, the traces of each of the navigation sensors 214a, 214b, and 216 are concentric about a corresponding axis orthogonal to the axes of the other two navigation sensors 214a, 214b, and 216, so that the navigation sensors 214a, 214b, and 216 can operate together as a triaxial sensor (TAS). For example, the distal portion 234 may be wound substantially entirely around the flexible portion 118 of the shaft assembly 108 at or near the distal end 120, such that the distal navigation sensor 216 may also be wound substantially entirely around the shaft assembly 118, such that the trace defining the distal navigation sensor 216 may be concentric about the longitudinal axis of the flexible portion 118; while the proximal portion 230 may be wound partially around the shaft assembly 108 at or near the proximal end of the flexible portion 118, such that the proximal navigation sensors 214a, 214b may each be wound only partially around the shaft assembly 108 and may be spaced apart from each other, such that the trace defining the proximal navigation sensor 214a, 214b may be concentric about the corresponding transverse axis, wherein the transverse axis is orthogonal to and orthogonal to the longitudinal axis of the flexible portion 118.

[0053] As shown in the figure, proximal navigation sensors 214a and 214b are arranged on the proximal portion 230, such that the first proximal navigation sensor 214a is positioned laterally outward on the first side of the intermediate portion 232, and the second proximal navigation sensor 214b is positioned laterally outward on the second side of the intermediate portion 232 opposite to the first side. The proximal lead 220 is arranged approximately in series with the intermediate portion 232. The proximal navigation sensors 214a and 214b can each be directly electrically coupled to their respective proximal lead 220. In the example shown, trace 218 extends distally from the corresponding proximal lead 220 on the proximal portion 230 and longitudinally along the intermediate portion 232, and may further extend laterally along the distal portion 234 to the corresponding distal lead or distal navigation sensor 216 in the distal lead 228, such that the distal navigation sensor 216 may be electrically coupled to the corresponding proximal lead 220 via the corresponding trace 218, and / or such that the distal lead 228 may be electrically coupled and / or operatively coupled to the corresponding proximal lead 220 via the corresponding trace 218.

[0054] In this respect, the distal lead 228 of each tab in tab 226 is configured to be electrically coupled and / or operatively coupled to a corresponding camera or illumination element in camera 164 or illumination element 166, such that camera 164 can be electrically coupled and / or operatively coupled to a corresponding proximal lead 220 via respective trace 218 and distal lead 228, and illumination element 166 can be electrically coupled to a corresponding proximal lead 220 via respective trace 218 and distal lead 228. For example, each tab in tab 226 may be angled about the longitudinal axis of shaft assembly 108 at a position substantially the same as the position of a corresponding camera or illumination element in camera 164 or illumination element 166, such that the distal lead 228 of each tab in tab 226 can be directly electrically coupled and / or operatively coupled to the corresponding camera lead or illumination element lead of the corresponding camera or illumination element in camera 164 or illumination element 166 (e.g., without intermediate electrical conductors). More specifically, each outer tab 226 carrying two distal leads 228 may be angled relative to the longitudinal axis of the shaft assembly 108 and aligned with the corresponding illumination element 166 to place the corresponding distal lead 228 in direct electrical communication with the corresponding illumination element lead of the corresponding illumination element 166, while each inner tab 226 carrying four distal leads 228 may be angled relative to the longitudinal axis of the shaft assembly 108 and aligned with the corresponding camera 164 to place the corresponding distal lead 228 in direct electrical communication with the corresponding camera lead of the corresponding camera 164.

[0055] The proximal leads 220 can then be operatively coupled to the processor 52 and / or electrically coupled to a power source (not shown) via respective conductors (not shown) extending proximally from the navigation sensor assembly 210 along the shaft assembly 108, for example, such that position-related signals can be transmitted from navigation sensors 214a, 214b, 216 to the coupling unit, powering the camera 164 and illumination element 166, and image signals can be transmitted from the camera 164 to the coupling unit via such conductors. In some cases, such conductors may be bundled together in one or more cables. Alternatively or additionally, such conductors may be routed proximally from the navigation sensor assembly 210 through a rigid portion 116 of the shaft assembly 108, such that such conductors can be substantially concealed within the rigid portion 116. It should be understood that the specific number of proximal leads 220, traces 218 and distal leads 228 shown are for illustrative purposes only, and any suitable number of proximal leads 220, traces 218, distal leads 228 and corresponding wires can be used.

[0056] like Figure 5 As shown, the navigation sensor assembly 210 may initially have a generally flat configuration, such as when the substrate 212 is initially formed and / or during the initial positioning of the navigation sensors 214a, 214b, 216 on the substrate. Figure 4A As shown, the navigation sensor assembly 210 can have a laterally curved, longitudinally straight configuration, with the proximal portion 230 and the distal portion 234 curving downwards from the middle portion 232. Thus, when mounted on the flexible portion 118, the navigation sensor assembly 210 can bend around the longitudinal axis of the flexible portion 118 of the shaft assembly 108 with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the flexible portion 118, thereby conforming to the outer circumference of the flexible portion 118. Figure 4B As shown, the navigation sensor assembly 210 can present a laterally bent longitudinally folded configuration, in which the proximal portion 230 and the distal portion 234 bend downward from the middle portion 232, wherein the navigation sensor assembly 210 is at least partially deflected from the longitudinal direction. When the flexible portion 118 of the shaft assembly 108 is in its straight configuration, the navigation sensor assembly 210 can be in its laterally bent longitudinally straight configuration, and when the flexible portion 118 of the shaft assembly 108 is in its folded configuration, the navigation sensor assembly 210 can be in its laterally bent longitudinally folded configuration. In this way, the navigation sensor assembly 210 can adapt to the bending of the flexible portion 118 between its straight and folded configurations, so that navigation of the flexible portion 118 can be performed regardless of whether the flexible portion 118 is in its straight or folded configuration.

[0057] In the example shown, the distal navigation sensor 216 is positioned at or near the distal end 120 of the shaft assembly 108 to facilitate navigation of the distal end 120, while the proximal navigation sensors 214a, 214b are positioned at or near the proximal end of the flexible portion 118 to facilitate determining the orientation of the proximal end of the flexible portion 118 about the longitudinal axis of the rigid portion 116. More specifically, the distal navigation sensor 216 is positioned distal to the articular movement rib 130 and the slot 131 such that when the distal end 120 is laterally deflected away from the longitudinal axis of the rigid portion 116, the distal navigation sensor 216 is laterally deflected away from the longitudinal axis of the rigid portion 116. Conversely, proximal navigation sensors 214a and 214b are positioned proximal to the articulated rib 130 and slot 131 such that when the distal end 120 is laterally deflected away from the longitudinal axis of the rigid portion 116, the proximal navigation sensors 214a and 214b do not laterally deflect away from the longitudinal axis of the rigid portion 116. Therefore, position data from the distal navigation sensor 216 can be used to determine the position of the distal end of the flexible portion 118, while position data from the proximal navigation sensors 214a and 214b can be used to determine the orientation or "roll" of the proximal end of the flexible portion 118 about the longitudinal axis of the rigid portion 116 of the shaft assembly 108 (in addition to providing a signal indicating the position of the proximal end of the flexible portion 118 in three-dimensional space). In some cases, position data from the proximal navigation sensors 214a and 214b can be compared with position data from the distal navigation sensor 216 to accurately determine the degree of lateral deflection of the distal end 120 relative to the reference frame of the IGS navigation system 50. Of course, navigation sensors 214a, 214b, 216 can be positioned at any other suitable location relative to the components of the instrument 100 to be navigated; and can be used in any other suitable manner.

[0058] like Figures 4A to 4BAs shown, the intermediate portion 232 of the substrate 212 extends along the elastic ridge 132 of the flexible portion 118 of the shaft assembly 108, such that the trace 218 also extends along the elastic ridge 132. In this way, the trace 218 avoids interfering with the bending capability of the flexible portion 118. Alternatively or additionally, the trace 218 may be subjected to tension when the distal end 120 is laterally deflected away from the longitudinal axis of the rigid portion 116, to help prevent the traces 218 from unintentionally contacting each other (e.g., short-circuiting) during the deflection of the distal end 120. As described above, at least the intermediate portion 232 of the substrate 212 may contain a stretchable material to further accommodate any stretching of the intermediate portion 232 that may occur during bending of the flexible portion 118. Additionally, the trace 218 may be configured to accommodate any stretching that may occur along the intermediate portion 232 during bending of the flexible portion 118. For example, the trace 218 can be formed in a wavy or serpentine configuration, thereby allowing the effective length of the trace 218 to increase during the bending of the flexible portion 118.

[0059] While the navigation sensor assembly 210 of this example is disposed along the generally cylindrical outer surface of the flexible portion 118 of the shaft assembly 108, the navigation sensor assembly 210 may alternatively be disposed along the generally cylindrical inner surface of the flexible portion 118 of the shaft assembly 108 in at least one generally curved configuration, in which the navigation sensor assembly 210 is curved about the longitudinal axis of the flexible portion 118 of the shaft assembly 108 with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface of the flexible portion 118, thereby conforming to the inner circumference of the flexible portion 118. In addition to the foregoing, the navigation sensor assembly 210 may be configured and operated in accordance with at least some of the teachings in the following U.S. Publication No. 2022 / 0257093, entitled “Flexible Sensor Assembly for ENT Instrument,” published August 18, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0060] IV. Examples of Combinations

[0061] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0062] Example 1

[0063] An apparatus comprising: (a) a shaft assembly including a proximal portion and a distal portion, the distal portion being configured such that a distal end can laterally deflect away from or toward a longitudinal axis defined by the proximal portion; (b) a distal navigation sensor positioned at or near the distal end of the distal portion, the distal navigation sensor being configured to indicate the position of the distal end of the distal portion in three-dimensional space; and (c) a pair of proximal navigation sensors positioned at or near the proximal end of the distal portion, the pair of proximal navigation sensors being configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

[0064] Example 2

[0065] According to the device of Embodiment 1, the distal portion includes a linear array of articular ribs.

[0066] Example 3

[0067] According to the device described in Embodiment 2, the distal navigation sensor is positioned distal to the linear array of the joint motion ribs.

[0068] Example 4

[0069] According to any one of embodiments 2 to 3, the pair of proximal navigation sensors are positioned proximal to the linear array of the joint motion rib.

[0070] Example 5

[0071] According to any one of embodiments 2 to 4, the articular movement ribs are connected to each other by elastic ridges.

[0072] Example 6

[0073] The device according to Embodiment 5 further includes at least one conductive element extending along the elastic ridge.

[0074] Example 7

[0075] According to the device described in Embodiment 6, the at least one conductive element is electrically coupled to the remote navigation sensor.

[0076] Example 8

[0077] The device according to any one of embodiments 1 to 7 further includes a flexible substrate fixed to the distal portion, and each of the proximal navigation sensor and the distal navigation sensor is disposed on the flexible substrate to define a navigation sensor assembly.

[0078] Example 9

[0079] According to the device of embodiment 8, the navigation sensor assembly includes a plurality of proximal leads, each of the proximal navigation sensor and the distal navigation sensor being electrically coupled to a corresponding proximal lead of the plurality of proximal leads.

[0080] Example 10

[0081] According to any one of embodiments 8 to 9, the navigation sensor assembly includes at least one distal lead configured to be electrically coupled to at least one of an image sensor or an illumination element.

[0082] Example 11

[0083] According to the device of embodiment 10, the at least one distal lead is positioned distal to the distal navigation sensor.

[0084] Example 12

[0085] The device according to any one of embodiments 10 to 11 further includes at least one of an image sensor or an illumination element, wherein the at least one distal lead is electrically coupled to the at least one of the image sensor or the illumination element.

[0086] Example 13

[0087] According to the device of embodiment 12, the at least one distal lead is aligned at an angle with the at least one of the image sensor or illumination element relative to the longitudinal axis.

[0088] Example 14

[0089] According to any one of embodiments 12 to 13, the at least one of the image sensor or the lighting element includes an image sensor and a lighting element.

[0090] Example 15

[0091] According to the device of embodiment 14, the at least one distal lead includes at least one first distal lead and at least one second distal lead, the at least one first distal lead being electrically coupled to the image sensor and the at least one second distal lead being electrically coupled to the illumination element.

[0092] Example 16

[0093] According to any one of embodiments 1 to 15, the proximal portion of the shaft assembly is rigid.

[0094] Example 17

[0095] In any one of the embodiments 1 to 16, the distal portion of the shaft assembly is flexible.

[0096] Example 18

[0097] The device according to any one of embodiments 1 to 17 has a distal end portion whose size and configuration are set to fit into an anatomical passage in the patient's ear, nose, or throat.

[0098] Example 19

[0099] According to any one of embodiments 1 to 18, the remote navigation sensor is configured to indicate the position of the remote end of the remote portion in the three-dimensional space by generating a signal indicating the position of the remote end of the remote portion in the three-dimensional space.

[0100] Example 20

[0101] According to any one of embodiments 1 to 19, the pair of proximal navigation sensors are configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis by generating a signal indicating the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

[0102] Example 21

[0103] An apparatus comprising: (a) a shaft assembly including a proximal portion and a flexible distal portion, the distal portion being configured such that a distal end can be laterally deflected away from or toward a longitudinal axis defined by the proximal portion; and (b) a navigation sensor assembly extending along the distal portion, the navigation sensor assembly including: (i) a flexible substrate having a proximal portion, a distal portion, and an intermediate portion extending between the proximal portion and the distal portion; and (ii) a pair of laterally adjacent proximal navigation sensors. (iii) A laterally adjacent proximal navigation sensor is disposed on the proximal portion of the flexible substrate, (iv) a distal navigation sensor is disposed on the distal portion of the flexible substrate, (v) at least one distal lead is configured to be electrically coupled to at least one of an image sensor or an illumination element, and (v) at least one conductive element extends along the intermediate portion and is electrically coupled to at least one of the distal navigation sensor or the at least one distal lead.

[0104] Example 22

[0105] According to the device of embodiment 21, the distal portion includes a linear array of articulated ribs.

[0106] Example 23

[0107] According to the device of embodiment 22, the distal navigation sensor is positioned distal to the linear array of the joint motion ribs, and the pair of proximal navigation sensors are positioned proximal to the linear array of the joint motion ribs.

[0108] Example 24

[0109] According to any one of embodiments 22 to 23, in the device, the articulated ribs are connected to each other by elastic ridges, and the middle portion of the flexible substrate extends along the elastic ridges.

[0110] Example 25

[0111] According to any one of embodiments 21 to 24, the proximal portion of the shaft assembly is rigid.

[0112] Example 26

[0113] According to any one of embodiments 21 to 25, the distal portion of the shaft assembly is flexible.

[0114] Example 27

[0115] The device according to any one of embodiments 21 to 26 has a distal end portion whose size and configuration are set to fit into an anatomical passage in the patient's ear, nose, or throat.

[0116] Example 28

[0117] According to any one of embodiments 21 to 27, the remote navigation sensor is configured to indicate the position of the remote end of the remote portion in three-dimensional space.

[0118] Example 29

[0119] According to the device of embodiment 28, the remote navigation sensor is configured to indicate the position of the remote end of the remote portion in the three-dimensional space by generating a signal indicating the position of the remote end of the remote portion in the three-dimensional space.

[0120] Example 30

[0121] According to any one of embodiments 21 to 29, the pair of proximal navigation sensors are configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

[0122] Example 31

[0123] According to any one of embodiments 21 to 30, the pair of proximal navigation sensors are configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis by generating a signal indicating the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

[0124] Example 32

[0125] An apparatus comprising: (a) a shaft assembly including a proximal portion and a distal portion, the distal portion being configured such that a distal end can be laterally deflected away from or toward a longitudinal axis defined by the proximal portion; (b) an image sensor attached to the distal end of the shaft assembly for visualizing anatomical structures; (c) an illumination element attached to the distal end of the shaft assembly for illuminating the field of view of the image sensor; and (d) a navigation sensor assembly extending along the distal portion, the navigation sensor assembly including: (i) at least one navigation sensor; and (ii) at least one distal lead configured to be electrically coupled to at least one of the image sensor or the illumination element, the at least one distal lead being angularly aligned with the at least one of the image sensor or the illumination element relative to the longitudinal axis.

[0126] Example 33

[0127] According to the device of embodiment 32, the proximal portion of the shaft assembly is rigid.

[0128] Example 34

[0129] According to any one of embodiments 32 to 33, the distal portion of the shaft assembly is flexible.

[0130] Example 35

[0131] According to any one of embodiments 32 to 34, the distal portion has a distal end whose size and configuration are set to fit into an anatomical passage in the patient's ear, nose, or throat.

[0132] Example 36

[0133] According to any one of embodiments 32 to 35, the at least one navigation sensor includes a remote navigation sensor and at least two proximal navigation sensors.

[0134] Example 37

[0135] According to the device of embodiment 36, the remote navigation sensor is configured to indicate the position of the remote end of the remote portion in three-dimensional space.

[0136] Example 38

[0137] According to the device of embodiment 37, the remote navigation sensor is configured to indicate the position of the remote end of the remote portion in the three-dimensional space by generating a signal indicating the position of the remote end of the remote portion in the three-dimensional space.

[0138] Example 39

[0139] According to any one of embodiments 36 to 38, the at least two proximal navigation sensors are configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

[0140] Example 40

[0141] According to the device of embodiment 39, the at least two proximal navigation sensors are configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis by generating a signal indicating the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

[0142] V. Miscellaneous

[0143] It should be understood that any or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with any or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0144] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with the existing definitions, statements, or other public materials listed in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference but conflicting with the existing definitions, statements, or other public materials listed herein, will be incorporated only to the extent that the incorporated material does not conflict with the existing public materials.

[0145] Devices of the types described above may be designed for single-use disposal or they may be designed for multiple uses. In either or both cases, these types may be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts, and subsequently reassembling. Specifically, some types of devices may be disassembled, and any combination may be used to selectively replace or remove any number of specific parts or portions of the device. While cleaning and / or replacing specific components, some types of devices may be reassembled at a repair facility or by the user prior to the procedure for subsequent use. Those skilled in the art will appreciate that device repair can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0146] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field capable of penetrating the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0147] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An apparatus comprising: A shaft assembly including a proximal portion and a distal portion, the distal portion being configured such that a distal end can be laterally deflected away from or toward a longitudinal axis defined by the proximal portion; A remote navigation sensor, located at or near the remote end of the remote portion, the remote navigation sensor being configured to indicate the position of the remote end of the remote portion in three-dimensional space; and A pair of proximal navigation sensors, located at or near the proximal end of the distal portion, are configured to indicate the yaw orientation of the proximal end of the distal portion about the longitudinal axis.

2. The device of claim 1, wherein the distal portion comprises a linear array of articulated ribs.

3. The device of claim 2, wherein the distal navigation sensor is positioned distal to the linear array of the joint motion ribs.

4. The device of claim 2, wherein the pair of proximal navigation sensors are positioned proximal to the linear array of the articular motion ribs.

5. The device of claim 2, wherein the articulated ribs are connected to each other by elastic ridges.

6. The device according to claim 5, further comprising at least one conductive element extending along the elastic ridge.

7. The device of claim 6, wherein the at least one conductive element is electrically coupled to the remote navigation sensor.

8. The device of claim 1, further comprising a flexible substrate fixed to the distal portion, wherein each of the proximal navigation sensor and the distal navigation sensor is disposed on the flexible substrate to define a navigation sensor assembly.

9. The device according to claim 8, wherein: The navigation sensor assembly includes multiple proximal leads, and Each of the near-side navigation sensor and the far-side navigation sensor is electrically coupled to a corresponding near-side lead in the plurality of near-side leads.

10. The device of claim 8, wherein the navigation sensor assembly includes at least one distal lead configured to be electrically coupled to at least one of an image sensor or an illumination element.

11. The device of claim 10, wherein the at least one distal lead is positioned distal to the distal navigation sensor.

12. The device of claim 10, further comprising at least one of an image sensor or an illumination element, wherein the at least one distal lead is electrically coupled to the at least one of the image sensor or the illumination element.

13. The device of claim 12, wherein the at least one distal lead is angularly aligned with the at least one of the image sensor or illumination element relative to the longitudinal axis.

14. The device of claim 12, wherein at least one of the image sensor or the illumination element comprises an image sensor and an illumination element.

15. The device of claim 14, wherein the at least one distal lead comprises at least one first distal lead and at least one second distal lead, the at least one first distal lead being electrically coupled to the image sensor and the at least one second distal lead being electrically coupled to the illumination element.

16. The device of claim 1, wherein the proximal portion of the shaft assembly is rigid.

17. The device of claim 1, wherein the distal portion of the shaft assembly is flexible.

18. The device of claim 1, wherein the distal portion has a distal end portion, the size and configuration of which are adapted to fit within an anatomical passage in the patient's ear, nose, or throat.

19. The device of claim 1, wherein the remote navigation sensor is configured to indicate the position of the remote end of the remote portion in the three-dimensional space by generating a signal indicating the position of the remote end of the remote portion in the three-dimensional space.

20. The device of claim 1, wherein the pair of proximal navigation sensors are configured to indicate the roll orientation of the proximal end of the distal portion about the longitudinal axis by generating a signal indicating the roll orientation of the proximal end of the distal portion about the longitudinal axis.

Images