CN117202864A - Flexible sensor assembly for ENT instrument - Google Patents

Abstract

The present invention provides an ENT surgical instrument including a shaft assembly, a flexible substrate, and at least one conductive sensor trace formed on the flexible substrate. The shaft assembly has a distal end sized and configured to fit within an anatomical passage in the patient's ear, nose, or throat. The flexible substrate extends along at least a portion of the axis. The at least one sensor trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor.

Description

Flexible sensor components for ENT devices

Background technique

Image-guided surgery (IGS) is a technique in which a computer is used to obtain the position of an instrument that has been inserted into the patient's body in conjunction with a set of images obtained prior to surgery (e.g., CT or MRI scans, 3-D mapping, etc. ) allows the computer system to superimpose the current position of the instrument on the image obtained before surgery. An example of an electromagnetic IGS navigation system that may be used in the IGS protocol is provided by Biosense-Webster, Inc. (Irvine, California) 3 systems. In some IGS procedures, a digital tomogram of the surgical field (eg, CT or MRI, 3D mapping, etc.) is obtained prior to the surgical procedure. The digital tomography data are then converted into digital maps using specially programmed computers. During surgical procedures, special instruments with sensors (eg, electromagnetic coils that emit electromagnetic fields and/or respond to externally generated electromagnetic fields) are used to perform the procedure, while the sensors send data to the computer indicating the current location of each surgical instrument. The computer correlates data received from the sensors with digital maps generated from pre-operative tomography scans. The tomographic scan images are shown on a video monitor along with indicators (eg, crosshairs, glowing dots, etc.) showing the real-time position of each surgical instrument relative to the anatomy shown in the scanned image. Therefore, even though the surgeon cannot directly visually view the instrument itself at its current position within the body, the surgeon is able to understand the exact location of each sensor-equipped instrument by viewing the video monitor.

In some cases, it may be desirable to dilate anatomical passages within the patient's body. This may include dilation of paranasal sinus ostia (eg, to treat sinusitis), laryngeal dilatation, Eustachian tube dilation, ear, nose, or other passages within the throat, etc. One method of dilating an anatomical channel involves using a guidewire and catheter to position an inflatable balloon within the anatomical channel and then inflating the balloon with a fluid (eg, saline) to dilate the anatomical channel. For example, an inflatable balloon can be positioned within the mouth at the paranasal sinus and then inflated to thereby expand the mouth by reshaping the bone adjacent to the mouth without the need to incise the mucosa or remove any bone. The dilated orifice may then allow improved drainage and ventilation from the affected paranasal sinuses.

In the case of Eustachian tube dilation, a dilation catheter or other dilation device may be inserted into the Eustachian tube and then inflated or otherwise expanded to dilate the Eustachian tube. A dilated Eustachian tube provides improved ventilation from the nasopharynx to the middle ear and further provides improved drainage from the middle ear to the nasopharynx.

It may be desirable to easily controllable placement of dilation catheters or other ENT devices in an anatomical passage, including in procedures that will be performed by only a single operator. Although several systems and methods have been developed and used to position dilation catheters or other ENT devices within anatomical passages, it is believed that no one has before made or used the invention described in the appended claims.

Description of the drawings

The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention contemplated by the inventors.

1 shows a schematic diagram of an exemplary surgical navigation system used on a patient seated in an exemplary medical procedure chair;

Figure 2 shows a perspective view of an exemplary instrument with a flexible navigation sensor assembly;

3 illustrates a perspective view of a distal portion of the instrument of FIG. 2 showing a flexible navigation sensor assembly extending across the inner diameter of the shaft in a flat configuration;

Figure 4 shows a top plan view of the flexible navigation sensor assembly of Figure 3;

Figure 5 shows a bottom plan view of the flexible navigation sensor assembly of Figure 3;

Figure 6 shows a top plan view of the proximal portion of the flexible navigation sensor assembly of Figure 3;

Figure 7 shows a top plan view of the middle portion of the flexible navigation sensor assembly of Figure 3;

Figure 8 shows a top plan view of a distal portion of the flexible navigation sensor assembly of Figure 3;

Figure 9 shows a bottom plan view of the proximal portion of the flexible navigation sensor assembly of Figure 3;

Figure 10 shows a bottom plan view of the middle portion of the flexible navigation sensor assembly of Figure 3;

Figure 11 shows a bottom plan view of a distal portion of the flexible navigation sensor assembly of Figure 3;

Figure 12 shows a schematic circuit diagram of the flexible navigation sensor assembly of Figure 3;

13 illustrates a perspective view of the distal portion of the instrument of FIG. 2 showing the flexible navigation sensor assembly disposed along the inner cylindrical surface of the shaft in a curved configuration;

14 shows a perspective view of a distal portion of the visualization and irrigation assembly of the instrument of FIG. 2 coupled to another exemplary flexible navigation sensor assembly;

Figure 15 shows a top plan view of the flexible navigation sensor assembly of Figure 14;

Figure 16 shows a bottom plan view of the flexible navigation sensor assembly of Figure 14;

Figure 17 shows a top plan view of the proximal portion of the flexible navigation sensor assembly of Figure 14;

Figure 18 shows a top plan view of the middle portion of the flexible navigation sensor assembly of Figure 14;

Figure 19 shows a top plan view of the distal portion of the flexible navigation sensor assembly of Figure 14;

Figure 20 shows a bottom plan view of the proximal portion of the flexible navigation sensor assembly of Figure 14;

Figure 21 shows a bottom plan view of the middle portion of the flexible navigation sensor assembly of Figure 14;

Figure 22 shows a bottom plan view of a distal portion of the flexible navigation sensor assembly of Figure 14;

23 illustrates a flowchart of an exemplary method for determining position coordinates of a portion of an ENT instrument based on signals received from the flexible navigation sensor assembly of FIG. 14;

Figure 24 shows a perspective view of another exemplary instrument with a flexible navigation sensor assembly;

Figure 25A shows a perspective view of the distal portion of the instrument of Figure 24, showing the flexible distal shaft portion of the instrument in a straight configuration, and further showing the flexible distal portion along the first curved configuration. A flexible navigation sensor assembly provided on the inner cylindrical surface;

Figure 25B illustrates a perspective view of the distal portion of the instrument of Figure 24, showing the flexible distal shaft portion of the instrument in a curved configuration, and further illustrating the flexible distal portion along the flexible distal portion in a second curved configuration. A flexible navigation sensor assembly provided on the inner cylindrical surface;

Figure 26A shows a perspective view of the flexible navigation sensor assembly of Figure 25A in a flat configuration;

Figure 26B shows a side elevation view of the flexible navigation sensor assembly of Figure 25A in a laterally curved, longitudinally straight configuration;

Figure 26C shows a side elevation view of the flexible navigation sensor assembly of Figure 25A in a laterally bent, longitudinally bent configuration;

27A illustrates a perspective view of a distal portion of an exemplary suction instrument with a flexible navigation sensor assembly, showing the extensible shaft of the suction instrument in a linear configuration, and further illustrating a first curved configuration. A flexible navigation sensor assembly arranged along the outer cylindrical surface of the extendable shaft;

Figure 27B shows a perspective view of a distal portion of the suction instrument of Figure 27A, showing the extensible shaft of the suction instrument in a curved configuration, and further illustrating the extensible shaft along the suction instrument in a second curved configuration. a flexible navigation sensor assembly provided on the outer cylindrical surface of the shaft;

Figure 27C shows a perspective view of the distal portion of the suction instrument of Figure 27A, showing the extensible shaft of the suction instrument in a double curved configuration, and further illustrating the extensible shaft in a third curved configuration. a flexible navigation sensor assembly provided on the outer cylindrical surface of the extension shaft;

Figure 28 shows a perspective view of an exemplary tissue shaving instrument with a flexible navigation sensor assembly;

29 illustrates a perspective view of the outer tube of the tissue shaving instrument of FIG. 28 showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the outer tube in a first curved configuration;

Figure 30 shows a top plan view of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 31 shows a bottom plan view of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 32 shows a top plan view of the proximal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 33 shows a top plan view of the middle portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 34 shows a top plan view of the distal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 35 shows a bottom plan view of the proximal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 36 shows a bottom plan view of the middle portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

Figure 37 shows a bottom plan view of the distal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

38 illustrates a perspective view of another exemplary tissue shaving instrument having the flexible navigation sensor assembly of FIG. 29, showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the outer tube in a second curved configuration. ;

39 shows a perspective view of another exemplary tissue shaving instrument with a navigation adapter sheath removably secured to the tissue shaving instrument;

Figure 40 shows a perspective view of the tissue shaving instrument and navigation adapter sheath of Figure 39 with the navigation adapter sheath removed from the tissue shaving instrument;

Figure 41 shows an exploded perspective view of the shaft assembly of the navigation adapter boot of Figure 39;

Figure 42 shows a cross-sectional end view of the shaft assembly of Figure 41 taken along line 42-42 of Figure 39;

Figure 43 shows a perspective view of the distal portion of the tissue shaving instrument and navigation adapter sheath of Figure 39, with the navigation adapter sheath secured to the tissue shaving instrument and with the outer shaft of the shaft assembly omitted to reveal the flexible circuitry. position;

44 illustrates a flow diagram of an exemplary method for calibrating a flexible navigation sensor assembly;

Figure 45 shows a photograph of an exemplary geometric measurement obtained using the method of Figure 44;

46 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a first example of an incorporated ablation flex circuit;

47 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a second example of an incorporated ablation flex circuit;

48 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a third example of an incorporated ablation flex circuit; and

49 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a fourth example of an incorporated ablation flex circuit.

Detailed ways

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

For clarity of disclosure, the terms "proximal" and "distal" are defined herein with respect to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to a location where an element is closer to a surgeon's placement, and the term "distal" refers to a location where an element is closer to a surgical end effector of a surgical instrument and further away from a surgeon's placement. Furthermore, to the extent that spatial terms such as "upper," "lower," "vertical," "horizontal," etc. are used herein with reference to the drawings, it is to be understood that such terms are for illustrative purposes only and are not intended to is restrictive 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 that are not limited to those shown and described herein.

As used herein, the terms "about" and "approximately" with respect to any numerical value or range mean suitable dimensional tolerances that allow a part or collection of components to perform its intended use as described herein.

I. Exemplary Image-Guided Surgical Navigation System

When performing a medical procedure within the head (H) of a patient (P), it may be desirable to obtain information regarding the position of an instrument within the head (H) of the patient (P), especially when the instrument is in a position where it is difficult or impossible to An endoscopic view is obtained of the position of the working element of the instrument within the head (H) of the patient (P). Figure 1 illustrates an exemplary IGS navigation system (50) that enables performance of ENT procedures using image guidance. In addition to or in lieu of the components and operability described herein, the IGS navigation system (50) may be constructed and operative in accordance with the teachings of at least some of the following patents: 2010 U.S. Patent No. 7,720,521 titled "Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses" published on May 18, 2014 and "Systems and Methods for Performing ImageGuided Procedures" published on December 11, 2014 Now-abandoned U.S. Patent Publication 2014/0364725 of "within the Ear, Nose, Throat and Paranasal Sinuses".

The IGS navigation system (50) of this example includes a field generator assembly (60) that includes a set of magnetic field generators (64) integrated into a horseshoe frame (62). The field generator (64) is operable to generate alternating magnetic fields of different frequencies around the head (H) of the patient (P). An instrument such as any of those described below may be inserted into the head (H) of the patient (P). Such instruments may be stand-alone devices or may be positioned on the end effector. In this example, the frame (62) is mounted to a seat (70) in which the patient (P) sits such that the frame (62) is located near the patient's (P) head (H). By way of example only, the seat (70) and/or the field generator assembly (60) can be configured in accordance with the teachings of U.S. Patent No. 10,561,370 entitled "Apparatus to Secure Field Generating Device to Chair" published on February 18, 2020 At least some of the content teaches how to construct and operate.

The IGS navigation system (50) of this example also includes a processor (52) that controls the field generator (64) and other elements 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 the instrument to determine the position of a navigation sensor or position sensor in the instrument on the head (H) of the patient (P) location within. The processor (52) includes a processing unit (eg, a set of electronic circuits arranged to evaluate and execute software instructions using combinational logic circuits or other similar circuits) in communication with one or more memories. The processor (52) of this example is mounted in a console (58) that includes operational controls (54) including a keyboard and/or pointing device, such as a mouse or trackball. The physician interacts with processor (52) using operating controls (54) while performing a surgical procedure.

Although not shown, the instrument may include a navigation sensor or a position sensor responsive to positioning within the alternating magnetic field generated by the field generator (64). A coupling unit (not shown) may be secured to the proximal end of the instrument and may be configured to provide communication of data and other signals between the console (58) and the instrument. The connection unit provides wired or wireless communication of data and other signals.

In some versions, the instrument's navigation sensor or position sensor may include 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 the field generator (64), the alternating magnetic field can generate an electric current in the coil, and this electric current can be transmitted along the electrical conduits in the instrument and further via the coupling unit to processor(52). This phenomenon may enable the IGS navigation system (50) to determine the position of the distal end of the instrument within three-dimensional space (i.e., within the head (H) of the patient (P), etc.). To achieve this, the processor (52) executes an algorithm to calculate the position coordinates of the distal end of the instrument based on the position-related signals of the coils in the instrument. Navigation sensors can therefore function as position sensors by generating signals that indicate the sensor's real-time position within three-dimensional space.

The processor (52) uses software stored in the memory of the processor (52) to calibrate and operate the IGS navigation system (50). Such operations include driving the field generator (64), processing data from the instrument, processing data from the operating controls (54), and driving the display screen (56). In some implementations, operations may also include monitoring and enforcing one or more safety features or functions of the IGS navigation system (50). The processor (52) is further operable to provide real-time video via the display screen (56) showing a 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 the location of a computer-generated three-dimensional model of the anatomy within and adjacent to the patient's nasal cavity. The display screen (56) may display such images simultaneously and/or superimposed on each other during the surgical procedure. Such display images may also include graphical representations of instruments 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, the display screen (56) may provide images in accordance with at least some of the teachings of U.S. Patent No. 10,463,242, "Guidewire Navigation for Sinuplasty," issued on November 5, 2019. In situations where the operator is also using an endoscope, the endoscopic image may also be provided on the display screen (56).

The images provided through the display screen (56) can help guide the operator to maneuver and otherwise manipulate the instrument within the patient's head (H). It will also be appreciated that other components of surgical instruments as described below, as well as other types of surgical instruments, may incorporate navigation sensors such as those described above.

II. Exemplary ENT Device with Flexible Navigation Sensor Assembly

In some cases, it may be desirable to provide flexible navigation sensor assemblies (e.g., printed circuit boards) for ENT devices as an alternative to traditional coil sensors to facilitate simplified and/or lower cost sensor manufacturing and calibration, sensor reduction size and/or contour, and/or improve sensor integration with various types of ENT devices. Each of the exemplary flexible navigation sensor assemblies (110, 210, 410, 510, 610) described below may function in this manner. Although the examples provided below are discussed in the context of various specific ENT devices (100, 400, 500, 600, 700), the flexible navigation sensor assembly (110, 210, 410, 510, 610) may be used to provide navigation capabilities to any other suitable ENT device. Other suitable ways in which the flexible navigation sensor assembly (110, 210, 410, 510, 610) may be used will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that all flexible circuit printed circuit boards (PCBs) and other flexible circuit features described below may include only a single layer or multiple layers.

A. Exemplary instrument with rectangular, dual-layer flexible navigation sensor assembly

Figures 2-13 illustrate an example of an instrument (100) that can be used to guide a dilation catheter into an anatomical channel to thereby dilate an anatomical channel, guide other instruments into an anatomical channel, and/or deliver RF energy to Tissues in or near dissection channels. For example, the device (100) may be used for dilation of paranasal sinus ostia (eg, to treat sinusitis), laryngeal dilation, Eustachian tube dilation, ear, nose, or other passages within the larynx, and the like. Additionally or alternatively, the instrument (100) may be used to ablate a nerve (e.g., posterior nasal nerve); ablate turbinates; or ablate, electroporate (e.g., to facilitate absorption of therapeutic agents, etc.), or apply resistive heating to the patient's head any other kind of anatomical structure in the body.

The example instrument (100) includes a handle assembly (102), a shaft assembly (104), and a navigation, visualization, and irrigation assembly (106) having a visualization and irrigation assembly (108) and a navigation sensor assembly (110). Instrument (100) may be coupled with a source of inflation fluid (not shown) operable to selectively supply inflation fluid to a dilation catheter (not shown) disposed in instrument (100) The balloon is used to inflate the balloon to expand the anatomical passage. Additionally or alternatively, the instrument (100) may be coupled with an RF generator (101) operable to generate electricity for delivery via the electrodes (121, 122) located at the distal end of the shaft assembly (104). RF electrosurgical energy is delivered to tissue to ablate, electroporate, or apply resistive heating to the tissue.

The handle assembly (102) of this example includes a body (112) and at least one slider (114). The body (112) is sized and configured to be grasped and operated with one hand of an operator, such as via an electric grip, pencil grip, or any other suitable kind of grip. The slider (114) is operable to translate longitudinally relative to the body (112). The slider (114) is coupled to at least one of a guidewire or catheter (eg, a dilation catheter or an energy catheter) (not shown) and is therefore operable to longitudinally translate such guidewire or catheter. In some versions, another slider (not shown) may be operable to longitudinally translate the other of the guidewire or catheter.

The shaft assembly (104) of this example includes a rigid portion (116), a flexible portion (118) distal to the rigid portion (116), and an open distal end (120). A pull wire (not shown) is coupled to the flexible portion (118) and the deflection control knob (122) of the handle assembly (102). Deflection control knob (122) is rotatable relative to body (112) about an axis perpendicular to the longitudinal axis of shaft assembly (104) to selectively retract the pull wire proximally. As the pull wire is retracted proximally, the flexible portion (118) bends and thereby deflects the distal end (120) laterally away from the longitudinal axis of the rigid portion (116). The deflection control knob (122), pull wire, and flexible portion (118) thus cooperate to impart steerability to the shaft assembly (104). By way of example only, such steerability of the shaft assembly (104) may be provided in accordance with at least some of the teachings of the following U.S. patent application, entitled "Shaft Deflection Control Assembly" filed on May 22, 2020 forENT Guide Instrument” U.S. Patent Application No. 63/028,609. Other versions may provide some other kind of user input feature other than the deflection control knob (122) to drive the steering of the flexible portion (118). In some alternatives, the deflection control knob (122) is omitted and the flexible portion (118) is extensible. In still other versions, the shaft assembly (104) is rigid throughout its length.

The shaft assembly (104) is also rotatable relative to the handle assembly (102) about the longitudinal axis of the rigid portion (116). Such rotation may be driven via a rotary control knob (124) that is rotatably coupled to the body (112) of the handle assembly (102). Alternatively, shaft assembly (104) may be rotatable via some other form of user input; or may be non-rotatable relative to handle assembly (102). It should also be understood that the examples of handle assembly (102) described herein are illustrative examples only. The shaft assembly (104) may alternatively be coupled with any other suitable kind of handle assembly or other support body.

As best shown in Figure 3, the navigation, visualization and irrigation assembly (106) is disposed within the shaft assembly (104) and is operable to provide navigation capabilities to the shaft assembly (104) and is located distally of the shaft assembly (104). Visualization and irrigation are provided at the target tissue site distal to tip 120.

In this regard, the navigation sensor assembly (110) of the navigation, visualization and flushing assembly (106) is disposed within the shaft assembly (104) and is operable to provide navigation capabilities to the shaft assembly (104). More specifically, the navigation sensor assembly (110) extends generally horizontally through its center across the inner diameter of the flexible portion (118) of the shaft assembly (104) and has a generally flat (eg, planar) configuration.

Referring now to FIGS. 4-11 , the navigation sensor assembly (110) of this example is provided in the form of a flexible printed circuit board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (126) on which Forming (eg, printed and/or embedded) a plurality of traces (130, 132, 134, 136), a plurality of corresponding trace leads (eg, pads) (138a, 138b, 138c, 138d), and a plurality of ground leads (139a, 139b ,139c,139d). As shown, the base plate (126) extends longitudinally between the proximal and distal ends (140, 141), laterally between the first and second sides (142, 143), and between the top surface and the bottom surface. Extend vertically between surfaces (144,145). The substrate (126) of this example includes a pair of through holes (146) extending between top and bottom surfaces (144, 145). The through hole (146) may be configured to receive a corresponding pin (not shown) or other suitable fastener to secure the navigation sensor assembly (110) to the flexible portion (118) of the shaft assembly (104) and/or Any other components of the instrument (100), such as visualization and irrigation components (108). In the version shown, the base plate (126) also includes a proximal ramp (148) extending between the proximal end (140) and the second side (143). The proximal ramp (148) may be configured to facilitate positioning the proximal end (140) relative to the flexible portion (118) of the shaft assembly (104) and/or relative to any other components of the instrument (100) such as Visualize and rinse component (108)) at the desired location.

Substrate (126) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (126), the substrate (126) may be formed from polyimide because such a substrate (126) formed from polyimide may be resilient toward a naturally flat configuration. Ground offset. Alternatively, where more complex geometries and/or increased flexibility of substrate (126) are desired, substrate (126) may be formed from LCP, as substrate (126) formed from LCP may be thermoformed to accommodate this. class complex geometries and/or provide increased flexibility, as discussed below. In any case, traces (130, 132, 134, 136), leads (138a, 138b, 138c, 138d), and ground leads (139a, 139b, 139c, 139d) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (110) is appropriately sized to fit within the shaft assembly (104) while still allowing for a working channel (149) to extend along the shaft assembly (104) (e.g., within the navigation sensor assembly (110) above), thereby permitting additional instrumentation (eg, dilation catheters and/or energy catheters), suction, fluids, etc. to pass through the open distal end (120) adjacent the navigation sensor assembly (110). In this regard, the navigation sensor assembly (110) may have a relatively low profile, at least compared to conventional coil sensors. In some versions, navigation sensor assembly (110) may have a thickness of approximately 50 microns.

As shown in FIGS. 4 and 5 , traces ( 130 , 132 , 134 , 136 ) include proximal top traces ( 130 ) and distal top traces ( 132 ), each formed on a top surface ( 144 ) of substrate ( 126 ), and respective Proximal bottom traces (134) and distal bottom traces (136) are formed on the bottom surface (145) of the substrate (126) opposite and/or parallel to corresponding top traces (130, 132). Similarly, leads (138a, 138b, 138c, 138d) include first and second top leads (138a, 138b) each formed on the top surface (144) of the substrate (126), and each formed on the substrate (126). First and second bottom leads (138c, 138d) on the bottom surface (145) of 126) that are opposite and/or parallel to the corresponding top leads (138a, 138b). Ground leads (139a, 139b, 139c, 139d) include first and second top ground leads (139a, 139b) each formed on the top surface (144) of the substrate (126), and each formed on the substrate (126). First bottom ground lead and second bottom ground lead (139c, 139d) on the bottom surface (145) of 126). Top traces (130,132), top leads (138a, 138b), and top ground leads (139a, 139b) collectively define the top flex circuit layer of the navigation sensor assembly (110), while bottom traces (134,136), bottom leads (138c, 138d) and bottom ground leads (139c, 139d) together define the bottom flexible circuit layer of the navigation sensor assembly (110).

Referring now to Figures 6-11, traces (130, 132, 134, 136) each include respective first longitudinal portions (130a, 132a, 134a, 136a), concentric ring portions (130b, 132b, 134b, 136b) and second longitudinal portions (130c ,132c,134c,136c). As shown, the concentric ring portions (132b, 136b) of the distal traces (132, 136) are positioned distally relative to the concentric ring portions (130b, 134b) of the corresponding proximal traces (130, 134).

The first top lead (138a) is electrically coupled to the proximal end of the first longitudinal portion (130a) of the proximal top trace (130). A first longitudinal portion (130a) of the proximal top trace (130) extends distally from its proximal end and is electrically coupled at its distal end to the proximal bottom trace (130a) through a corresponding via hole. The distal end of the first longitudinal portion (134a) of 134). A first longitudinal portion (134a) of the proximal bottom trace (134) extends proximally from its distal end toward the first bottom lead (138c) and is electrically coupled to the proximal bottom at its proximal end The proximal end of the second longitudinal portion (134c) of the trace (134). A second longitudinal portion (134c) of the proximal bottom trace (134) extends distally from a proximal end thereof and is electrically coupled at its distal end to the concentric ring of proximal bottom trace (134) Radially outer end of portion (134b). The concentric ring portion (134b) of the proximal bottom trace (134) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the proximal top trace (134b) through corresponding vias. The radially inner end of the concentric ring portion (130b) of 130). The concentric ring portion (130b) of the proximal top trace (130) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (130b) of the proximal top trace (130). The distal end of the longitudinal portion (130c). A second longitudinal portion (130c) of the proximal top trace (130) extends proximally from its distal end toward the first top lead (138b) and is electrically coupled at its proximal end by a corresponding via Connect to the first bottom lead (138c).

The second top lead (138b) is electrically coupled to the proximal end of the first longitudinal portion (132a) of the distal top trace (132). A first longitudinal portion (132a) of the distal top trace (132) extends distally from its proximal end and is electrically coupled at its distal end to the distal bottom trace (132a) through a corresponding via hole. The distal end of the first longitudinal portion (136a) of 136). A first longitudinal portion (136a) of the distal bottom trace (136) extends proximally from a distal end thereof toward a second bottom lead (138d) and is electrically coupled to the distal bottom at a proximal end thereof The proximal end of the second longitudinal portion (136c) of the trace (136). A second longitudinal portion (136c) of the distal bottom trace (136) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of the distal bottom trace (136) Radially outer end of portion (136b). The concentric ring portion (136b) of the distal bottom trace (136) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the distal top trace (136b) through corresponding vias. The radially inner end of the concentric ring portion (132b) of 132). The concentric ring portion (132b) of the distal top trace (132) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second longitudinal direction of the distal top trace (132) The distal end of portion (132c). A second longitudinal portion (132c) of the distal top trace (132) extends proximally from its distal end toward the second top lead (138b) and is electrically coupled at its proximal end by a corresponding via Connect to second bottom lead (138d).

Accordingly, current may flow generally along first top lead (138a) to first longitudinal portion (130a) of proximal top trace (130), to first longitudinal portion (134a) of proximal bottom trace (134), to Second longitudinal portion (134c) of proximal bottom trace (134), concentric ring portion (134b) flowing to proximal bottom trace (134), concentric ring portion (130b) flowing to proximal top trace (130) , to the second longitudinal portion (130c) of the proximal top trace (130), to the first bottom lead (138c). Alternatively, current may flow generally along the first bottom lead (138c) to the second longitudinal portion (130c) of the proximal top trace (130), to the concentric ring portion (130b) of the proximal top trace (130), Concentric ring portion (134b) flowing to the proximal bottom trace (134), second longitudinal portion (134c) flowing to the proximal bottom trace (134), first longitudinal portion (134) flowing to the proximal bottom trace (134) 134a), to the first longitudinal portion (130a) of the proximal top trace (130), to the first top lead (138a).

Likewise, current may flow generally along second top lead (138b) to first longitudinal portion (132a) of distal top trace (132), to first longitudinal portion (136a) of distal bottom trace (136), to Second longitudinal portion (136c) of distal bottom trace (136), concentric ring portion (136b) flowing to distal bottom trace (136), concentric ring portion (132b) flowing to distal top trace (132) , to the second longitudinal portion (132c) of the distal top trace (132), to the second bottom lead (138d). Alternatively, current may flow generally along the second bottom lead (138d) to the second longitudinal portion (132c) of the distal top trace (132), to the concentric ring portion (132b) of the distal top trace (132), Concentric ring portion (136b) flowing to the distal bottom trace (136), second longitudinal portion (136c) flowing to the distal bottom trace (136), first longitudinal portion (136) flowing to the distal bottom trace (136) 136a), to the first longitudinal portion (132a) of the distal top trace (132), to the second top lead (138b).

When the concentric ring portions (130b, 132b, 134b, 136b) are positioned within the alternating electromagnetic field generated by the field generator (64), the alternating magnetic field can generate electrical current in the concentric ring portions (130b, 132b, 134b, 136b) , and this current can flow along the respective longitudinal portions (130a, 132a, 134a, 136a, 130c, 132c, 134c, 136c) such as via coupling units (not shown) electrically coupled to the leads (138a, 138b, 138c, 138d) ) is sent to the processor (52). Thus, each concentric ring portion (130b, 132b, 134b, 136b) defines a respective navigation sensor (150, 152, 154, 156) operable to generate an indication of the position of the respective navigation sensor (150, 152, 154, 156) and thereby the instrument (100) A signal indicating the position in three-dimensional space of at least a portion of the shaft assembly (104), such as the flexible portion (118) of the shaft assembly (104). Position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to the operator to show the operator in real time where the shaft assembly (104) of the instrument (100) is located within the patient (P). Located in the location. Such visual indications may be provided as an overlay on one or more preoperatively acquired images (eg, CT scans) of the patient's anatomy.

In the example shown, the distal navigation sensors (152, 156) are positioned at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120), while the proximal navigation sensors (150, 154 ) may be positioned at or near the proximal end of flexible portion (118) to aid in identifying, for example, the direction and/or orientation of flexible portion (118). By way of further example only, distal navigation sensors (152, 156) may be positioned in a distal region of flexible portion (118) such that when distal end (120) deflects laterally away from the longitudinal axis of rigid portion (116) , the distal navigation sensors (152, 156) are deflected laterally away from the longitudinal axis of the rigid portion (116). Conversely, the proximal navigation sensor (150, 154) may be positioned proximal to the flexible portion (118) such that when the distal end (120) deflects laterally away from the longitudinal axis of the rigid portion (116), the proximal navigation sensor (154) 150, 154) will not deflect laterally away from the longitudinal axis of the rigid portion (116). In such scenarios, position data from the nearside navigation sensors (150, 154) can be compared to position data from the far side navigation sensors (152, 156) to accurately determine the distal end (120) relative to the IGS navigation system The degree of lateral deflection of the reference frame of (50). Of course, the navigation sensors (150, 152, 154, 156) may be positioned at any other suitable location relative to the components of the instrument (100) requiring navigation; and may be used in any other suitable manner.

In some versions, the length of the navigation sensor assembly (110) defined between the proximal and distal ends (140, 141) of the base plate (126) may be large enough to position the distal navigation sensors (152, 156) on-axis. at or near the distal end (120) of the assembly (104) to facilitate navigation of the distal end (120) while also positioning the leads (138a, 138b, 138c, 138d) at a location sufficiently proximal to At this location the leads (138a, 138b, 138c, 138d) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). In this regard, the length of the navigation sensor assembly (110) can be substantially equal to or greater than the length of the shaft assembly (104) such that the leads (138a, 138b, 138c, 138d) can be positioned on the body of the handle assembly (110) (112) or even positioned proximally relative to the body of the handle assembly. For example, navigation sensor assembly (110) may be on the order of several meters in length. In this way, the navigation sensor assembly (110) can both generate and transmit position-related signals to the coupling unit without the need to run wires or cables between the coupling units.

It will be appreciated that the navigation sensors (150, 152, 154, 156) may each be configured in any other suitable manner for generating electrical current when positioned within an alternating electromagnetic field. For example, the number of concentric rings defining each concentric ring portion (130b, 132b, 134b, 136b) of the navigation sensor (150, 152, 154, 156) may be greater or less than the number shown. Additionally or alternatively, any one or more dimensions (eg, height, width, length, and/or thickness) of each concentric ring portion (130b, 132b, 134b, 136b) may be larger or smaller than the dimensions shown. Although the concentric ring portions (130b, 132b, 134b, 136b) are shown as being generally rectangular, the concentric ring portions (130b, 132b, 134b, 136b) may have any other suitable shape. For example, the concentric ring portions (130b, 132b, 134b, 136b) may each be generally circular and may have any suitable diameter.

It will be appreciated that the top traces (130, 132) or the bottom traces (134, 136) alone may be capable of carrying position-related signals to the processor (52), and the bottom traces (134, 136) may carry position-related signals to the processor (52) There may therefore be redundancy for those position related signals carried via the top traces (130, 132). Such redundancy may increase the reliability of the position-related signals provided by the top traces (130, 132) by validating the position data generated by the position-related signals carried by the top traces (130, 132). Additionally or alternatively, position-related signals conveyed by top traces (130, 132) and bottom traces (134, 136) may be used to determine the orientation of the flexible portion (118) of the shaft assembly (104).

In some versions, the relative arrangement of top traces (130, 132) relative to corresponding bottom traces (134, 136) may help to substantially reduce or eliminate electromagnetic interference or "noise" (which may otherwise be caused by leads (138a, 138b) , 138c, 138d) caused by the current flowing in the traces (130, 132, 134, 136) without the twisted pairs typically present in conventional coil sensor arrangements, to thereby increase the accuracy of the position-related signals transmitted to the processor (52) performance and reliability. As schematically shown in Figure 12, current may flow in a first direction in the top traces (130, 132) and in a second direction opposite and parallel to the first direction in the corresponding bottom traces (134, 136). For example, current may flow in a first direction (eg, one of clockwise or counterclockwise) in the top concentric ring portions (130b, 132b) and in the corresponding bottom concentric ring portions (134b, 136b). A second direction (eg, the other of clockwise or counterclockwise) flows opposite and parallel to the first direction. Likewise, current may flow in a first direction (eg, one of proximal or distal) in the top longitudinal portions (130a, 132a, 130c, 132c) and may flow in the corresponding bottom longitudinal portions (134a, 136a, 134c, 136c) in a second direction (eg, the other of proximal or distal) that is opposite and parallel to the first direction. The current flowing in the first direction in the top traces (130, 132) and the current flowing in the second direction in the corresponding bottom traces (134, 136) may be of substantially the same magnitude as each other. Therefore, the magnetic field noise caused by the current in the top traces (130, 132) and the magnetic field noise caused by the current in the corresponding bottom traces (134, 136) may be substantially equal and opposite to each other, such that the magnetic field noise cancels each other and thus both have been largely reduced or eliminated. Therefore, while the top flex circuit layer or the bottom flex circuit layer alone may be able to provide position-dependent signals, having the redundancy of both layers may provide noise reduction benefits. In some versions, more or fewer flexible circuit layers may be provided. For example, the top flexible circuit layer or the bottom flexible circuit layer may be omitted.

In some other versions, the relative arrangement of top leads (138a, 138b) relative to corresponding bottom leads (138c, 138d) may help to substantially reduce or eliminate electromagnetic fields picked up at proximal terminals of traces (130, 132, 134, 136) noise. For example, the polarity of the first top lead (138a) may be opposite to the polarity of the first bottom lead (138c) such that any pickup noise from the proximal terminals of the proximal top trace (130) and from the proximal bottom trace Any pickup noise from the proximal terminals of line (134) cancels each other out and thereby both are substantially reduced or eliminated. Likewise, the polarity of the second top lead (138b) may be opposite to the polarity of the second bottom lead (138d) such that any pickup noise from the proximal terminals of the far top trace (132) and from the far bottom trace (132) Any pickup noise of the proximal terminals of line (136) cancels each other out and thereby both are substantially reduced or eliminated.

While the navigation sensor assembly (110) of this example includes a single distal top navigation sensor (152) and a single distal bottom navigation sensor (156), the navigation sensor assembly (110) may alternatively include multiple distal top navigation sensors. (152) and/or the distal bottom navigation sensor (156). For example, navigation sensor assembly (110) may include a pair of laterally adjacent distal top navigation sensors (152) and/or a pair of laterally adjacent distal bottom navigation sensors (156). Such a pair of distal top navigation sensors and/or distal bottom navigation sensors (152, 156) may assist in increasing the flexibility of the shaft assembly (104) calculated by the processor (52) based on position-related signals from the navigation sensors (150, 152, 154, 156) The accuracy of the position coordinates of part (118). In some cases, navigation sensor assembly (110) may be disposed along a generally cylindrical surface of flexible portion (118) of shaft assembly (104) as described below such that one distal top navigation sensor and/or of such a pair Or the distal bottom navigation sensor (152, 156) may be disposed on a first lateral side of the flexible portion (118) of the shaft assembly (104), and the other distal top navigation sensor and/or distal of such a pair Bottom navigation sensors (152, 156) may be disposed on the second lateral side of the flexible portion (118) of the shaft assembly (104). In this manner, a pair of distal top navigation sensors and/or distal bottom navigation sensors (152, 156) may provide position-related signals indicative of the position of the two lateral sides of the flexible portion (118), which may enhance the processing by the processor (52) Accuracy of calculated position coordinates, such as when the flexible portion (118) is in a curved configuration.

Although the navigation sensor assembly (110) of this example is disposed within the shaft assembly (104) such that the navigation sensors (150, 152, 154, 156) are operable to generate signals indicative of the position of the shaft assembly (104), the navigation sensor assembly (110) may alternatively Positioning on any other component of the instrument (100) to generate a signal indicative of the location of such other component. Additionally, while the navigation sensor assembly (110) of this example extends generally horizontally through its center across the inner diameter of the flexible portion (118) of the shaft assembly (104) and has a generally flat configuration, the navigation sensor assembly (110 ) may alternatively be disposed at any other suitable location on or within the shaft assembly (104) and may have any other suitable configuration. For example, navigation sensor assembly (110) may extend across any suitable chord of flexible portion (118) of shaft assembly (104).

As shown in Figure 13, the navigation sensor assembly (110) may be disposed beneath the visualization and irrigation assembly (108) along a generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) and may have a generally curved configuration such that The navigation sensor assembly (110) is curved about a longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface to thereby conform to the inner circumference of the flexible portion (118) . In this configuration, the navigation sensor assembly (110) may permit relatively more space for the larger working channel (149a) to extend along the shaft assembly (104) (eg, above the visualization and flushing assembly 108). Alternatively, the navigation sensor assembly (110) may be disposed along a generally cylindrical outer surface of the flexible portion (118) of the shaft assembly (104) and may have a generally curved configuration such that the navigation sensor assembly (110) surrounds the shaft assembly (104 ) The longitudinal axis of the flexible portion (118) is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface to thereby conform to the outer circumference of the flexible portion (118).

In any event, the navigation sensor assembly (110) may permit space for the working channels (149, 149a) to extend along the shaft assembly (104) as described above, such that the navigation sensor assembly (110) may be used in the catheter (e.g., dilation catheter or energy catheter) distally through the working channel (149, 149a) and/or while such catheter remains positioned within the working channel (149, 149a) (such as during balloon inflation of the dilation catheter to dilate the anatomical channel) and/or continuously transmits position-related signals to the processor (52) during delivery of RF energy to the tissue via the electrodes of the energy conduit). In other words, navigation of the flexible portion (118) can occur simultaneously with expansion of the anatomical passage and/or with delivery of RF energy to the tissue without interfering with each other.

As mentioned above, the navigation, visualization and flushing assembly (106) of this example also includes a visualization and flushing assembly (108) disposed within the shaft assembly (104) directly below the navigation sensor assembly (110). The visualization and irrigation assembly (108) is operable to provide visualization and irrigation at a target tissue site distal to the distal end (120) of the shaft assembly (104). Referring again to Figure 3, the visualization and irrigation assembly (108) of this example includes a plate member (160), a camera (161), a pair of lighting elements (162, 163), and a pair of fluid conduits (164, 165). The camera (161) may be of a form that is appropriately sized to fit within the shaft assembly (104) while still allowing space for the working channel (149) to extend along the shaft assembly (104), thereby allowing Additional instruments, suction, fluids, etc. pass through the open distal end (120) adjacent the camera (161).

Lighting elements (162, 163) are configured and operable to illuminate the field of view of the camera (161). The lighting element (162) is positioned at one lateral side of the camera (161) and the lighting element (163) is positioned at the other lateral side of the camera (161). Although two lighting elements (162,163) are used in this example, other versions may employ only one lighting element (162,163) or more than two lighting elements (162,163). In this example, the lighting elements (162, 163) include LEDs. In some other versions, the lighting elements (162, 163) include fiber optic components. For example, each lighting element (162, 163) may include a lens optically coupled to one or more corresponding optical fibers or fiber bundles. Such optical fibers or fiber bundles may extend along the shaft assembly (104) and be optically coupled to a light source integrated into the handle assembly (110) (or some other body from which the shaft assembly (104) extends) or otherwise provided. coupling.

In this example, the conduits (164, 165) are located laterally to the side of the camera (161). Specifically, the conduit (164) is positioned outside relative to the camera (161) while being positioned medially relative to the lighting element (162). The conduit (165) is positioned externally relative to the camera (161) and internally relative to the lighting element (163). In some versions, both conduits (164, 165) are in fluid communication with a source of liquid (eg, saline, etc.). In some other versions, both conduits (164, 165) are in fluid communication with the suction source. In some other versions, one conduit (164 or 165) is in fluid communication with the liquid source and the other conduit (165 or 164) is in fluid communication with the suction source. In still other versions, one or both of the conduits (164, 165) may be in fluid communication with a valve assembly coupled with a source of liquid and a source of suction. In this type of version, a valve assembly may be used to selectively couple one or both of the conduits (164, 165) with a source of liquid or suction. Various suitable ways in which either or both conduits (164, 165) may be coupled with a source of liquid and/or suction will be apparent to those skilled in the art in view of the teachings herein. In versions where at least one of the conduits (164, 165) is in communication with a source of liquid, such conduits (164, 165) may be used to deliver such liquid to the distal end of the camera (161). By flushing the distal end of the camera (161) with liquid, the catheters (164, 165) can be used to keep the distal end of the camera (161) free of debris and thereby maintain proper visualization through the camera (161). In versions where at least one of the conduits (164, 165) is in communication with a suction source, such conduits (164, 165) may be used to suck away excess liquid (eg, liquid drained via another conduit (164), etc.).

The plate member (160) of this example includes a plate (166) and a pair of laterally extending tabs (167,168). The plate (166) is positioned above the camera (161) and can therefore serve to shield the camera (161) from being snagged and possibly damaged by other instruments advancing along the working channel (149). In the embodiment shown, the navigation sensor assembly (110) is further positioned above the plate (166), and thus can also be used to shield the camera (161) from being snagged by such instruments. Tabs (167, 168) are positioned to correspond with the location of respective distal ends of catheters (164, 165). Specifically, tab (167) is positioned just distal to the distal end of catheter (164); and tab (168) is positioned just distal to the distal end of catheter (165). Tab (167) may further be positioned with a gap (not shown) between the proximal side of tab (167) and the distal end of catheter (164), and with a gap (not shown) between the proximal side of tab (168) and the distal end of catheter (164). A similar gap may be left between the distal ends of the catheter (165). These gaps may be sized to allow liquid to escape from the distal ends of the catheters (164, 165); and to allow suction to be applied via the distal ends of the catheters (164, 165). However, the presence of tabs (167, 168) may assist in redirecting liquid drained via the distal end of catheter (164, 165) toward the distal end of camera (161). In other words, as liquid is conveyed along either or both conduits (164, 165) and such liquid exits the distal end of such conduits (164, 165), the corresponding tabs (167, 168) may cause the expelled liquid to Turning towards the distal end of the camera (161) and thereby assists in flushing debris away from the camera (161). In some other versions, the tabs (167,168) are omitted. The plate member (160) is only optional.

In addition to the foregoing, at least a portion of the visualization and irrigation assembly (108) and/or other components of the instrument (100) may be constructed and operated in accordance with at least some of the teachings of the following U.S. Patent Application: June 2020 The U.S. Provisional Patent Application No. 63/037,640 titled "ENT Guide with Advanceable Instrument and AdvanceableEndoscope Shaft" was filed on the 11th and the U.S. Provisional Patent Application titled "ENTInstrument with Ablation Loop and Ablation Needles" was filed on January 27, 2021. No. 63/142,098.

In some versions, the visualization and flushing assembly (108) may be omitted such that the navigation sensor assembly (110) is in a flat configuration extending across the inner diameter or other chord of the flexible portion (118) of the shaft assembly (104). 3), a second working channel (not shown) may be positioned opposite the working channel (149) relative to the navigation sensor assembly (110) (e.g., below the navigation sensor assembly (110)), or Such that with the navigation sensor assembly (110) in its curved configuration disposed along the cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) (see Figure 13), the internal cross-section of the working channel (149) Size can be enlarged.

Although instrument (100) has been described for use in dilating anatomical passages within a patient's ear, nose, or throat and/or for delivering RF energy to tissue, it should be understood that instrument (100) may be adapted to perform other surgical procedures. Functionality, including, for example, diagnostic procedures, electrophysiological mapping, electrophysiologically guided catheter-guided surgery, and/or cardiac ablation procedures.

B. Exemplary Navigation,Visualization with Camera Circuitry and Temperature Sensor Integrated on the Navigation Sensor Assembly and flush components

In some cases, it may be desirable to provide a navigation, visualization, and irrigation assembly with circuitry for the camera (161) of the visualization and irrigation assembly (108) integrated onto its navigation sensor assembly, such as with This eliminates the need to route wires or cables along the axis assembly (104) to the camera (161). Integrating the circuitry for the camera (161) into a flex circuit already used for other purposes (e.g., for navigation sensor assembly circuitry, etc.) increases flexibility and/or compared to the navigation, visualization, and flushing assembly (106) or reduce size. Accordingly, the internal cross-sectional dimensions of the working channel (149) may be enlarged, and/or the external cross-sectional dimensions of the shaft assembly (104) may be reduced. Additionally or alternatively, it may be desirable to monitor the temperature associated with such navigation sensor assemblies, such as to improve the accuracy of position coordinates determined via the navigation sensor assembly, which position coordinates may otherwise be adversely affected by temperature changes. Figures 14-23 illustrate examples of navigation, visualization and irrigation components (206) having such functionality and which may be incorporated into the instrument (100) in place of the navigation, visualization and irrigation component (106) middle. The navigation, visualization and flushing component (206) has a navigation sensor component (210) and a visualization and flushing component (108) disposed directly below the navigation sensor component (210) and may be similar to the navigation, visualization and flushing component (106), Unless otherwise described.

Referring now to Figures 15-22, the example navigation sensor assembly (210) is provided in the form of a flexible printed circuit board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (226) on which Formed (e.g., printed and/or embedded) with a plurality of thermocouples (227a, 227b, 227c, 227d), camera traces (228a, 228b, 228c, 228d), corresponding camera trace leads (229a, 229b, 229c , 229d, 229e, 229f, 229g, 229h), sensor traces (230, 232, 234, 236), corresponding sensor trace leads (238a, 238, 238c, 238d) and ground leads (239a, 239b). As shown, the base plate (226) extends longitudinally between the proximal and distal ends (240, 241), laterally between the first and second sides (242, 243), and between the top surface and the bottom surface. Extend vertically between surfaces (244,245). The substrate (226) of this example includes a via (246) extending between the top and bottom surfaces (244, 245). The through hole (246) may be configured to receive a pin (not shown) or other suitable fastener to secure the navigation sensor assembly (210) to the flexible portion (118) of the shaft assembly (104) and/or the instrument ( Any other components of 100), such as visualization and flushing components (108). In the version shown, the base plate (226) also includes a proximal ramp (248) extending between the proximal end (240) and the first side (242). The proximal ramp (248) may be configured to facilitate positioning the proximal end (240) relative to the flexible portion (118) of the shaft assembly (104) and/or relative to any other components of the instrument (100) such as Visualize and rinse component (108)) at the desired location.

Substrate (226) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (226), the substrate (226) may be formed from polyimide because such a substrate (226) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (226) are desired, substrate (226) may be formed from LCP, as substrate (226) formed from LCP may be thermoformed to accommodate this. class complex geometries and/or provide increased flexibility, as discussed below. In any case, sensor traces (230, 232, 234, 236), sensor leads (238a, 238b, 238c, 238d), camera traces (228a, 228b, 228c, 228d) and camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h) may each be formed of a conductive metal material such as copper. The navigation sensor assembly (210) is appropriately sized to fit within the shaft assembly (104) while still permitting for the working channel (149) to extend along the shaft assembly (104) (e.g., within the navigation sensor assembly (210) above), thereby permitting additional instrumentation (eg, dilation catheters and/or energy catheters), suction, fluids, etc. to pass through the open distal end (120) adjacent the navigation sensor assembly (210). In this regard, the navigation sensor assembly (210) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (210) may have a thickness of approximately 50 microns.

As shown in Figures 15 and 16, sensor traces (230, 232, 234, 236) include a proximal top sensor trace (230) and a distal top sensor trace (232) each formed on the top surface (244) of the substrate (226) , as well as proximal bottom sensor traces (234) and distal bottom sensor traces ( 236). The sensor leads (238a, 238b, 238c, 238d) include first and second outer sensor leads (238a, 238b) each formed on a top surface (244) of the substrate (226) and a first inner sensor lead and Second internal sensor leads (238c, 238d). Camera traces (228a, 228b, 228c, 228d) include first and second external camera traces (228a, 228b) each formed on a top surface (244) of the substrate (226) and a first internal Camera trace and second internal camera trace (228c, 228d). Camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h) include first and second proximal external camera leads each formed on a top surface (244) of the substrate (226) (229a, 229b), first and second near-side internal camera leads (229c, 229d), first and second far-side external camera leads (229e, 229f) and first A far-side internal camera lead and a second far-side internal camera lead (229g, 229h). Ground leads (239a, 239b) include first and second proximal ground leads (239a, 239b) each formed on the top surface (244) of the substrate (226). Thermocouples (227a, 227b, 227c, 227d) include first and second proximal thermocouples (227a, 227b) each formed on the top surface (244) of the substrate (226) and a first distal Thermocouple and second distal thermocouple (227c, 227d). Top sensor traces (230,232), sensor leads (238a, 238b, 238c, 238d), camera traces (228a, 228b, 228c, 228d), camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h), ground leads (239a, 239b), and thermocouples (227a, 227b, 227c, 227d) collectively define the top flex circuit layer of the navigation sensor assembly (210), while the bottom sensor traces (234, 236) collectively define the navigation sensor assembly ( 210) bottom flexible circuit layer.

Referring now to Figures 17-22, sensor traces (230, 232, 234, 236) each include respective first longitudinal portions (230a, 232a, 234a, 236a), concentric ring portions (230b, 232b, 234b, 236b) and second longitudinal portions ( 230c,232c,234c,236c). As shown, the concentric ring portions (232b, 236b) of the distal traces (232, 236) are positioned distally relative to the concentric ring portions (230b, 234b) of the corresponding proximal traces (230, 234). Additionally, concentric ring portions (230b, 232b, 234b, 236b) are each located laterally to the side of the camera traces (228a, 228b, 228c, 228d).

The first outer sensor lead (238a) is electrically coupled to the proximal end of the first longitudinal portion (232a) of the distal top trace (232). A first longitudinal portion (232a) of the distal top trace (232) extends distally from a proximal end thereof and is electrically coupled at its distal end to a first portion of the distal bottom trace (236). The distal end of the longitudinal portion (236a). A first longitudinal portion (236a) of the distal bottom trace (236) extends proximally from its distal end toward a location on the bottom surface (245) opposite the first outer sensor lead (238a) and is The proximal end is electrically coupled to the proximal end of the second longitudinal portion (236c) of the distal bottom trace (236). A second longitudinal portion (236c) of the distal bottom trace (236) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of the distal bottom trace (236) Radially outer end of portion (236b). The concentric ring portion (236b) of the distal bottom trace (236) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the concentric ring of the distal top trace (232) Radially inner end of portion (232b). The concentric ring portion (232b) of the distal top trace (232) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (232b) of the distal top trace (232). The distal end of the longitudinal portion (232c). A second longitudinal portion (232c) of the distal top trace (232) extends proximally from its distal end to the first inner sensor lead (238c) and is electrically coupled at its proximal end to the first inner sensor lead (238c). An internal sensor lead.

A second outer sensor lead (238b) is electrically coupled to the proximal end of the first longitudinal portion (230a) of the proximal top trace (230). A first longitudinal portion (230a) of the proximal top trace (230) extends distally from a proximal end thereof and is electrically coupled at its distal end to a first portion of the proximal bottom trace (234). The distal end of the longitudinal portion (234a). A first longitudinal portion (234a) of the proximal bottom trace (234) extends proximally from its distal end toward a location on the bottom surface (245) opposite the second outer sensor lead (238b) and is The proximal end is electrically coupled to the proximal end of the second longitudinal portion (234c) of the proximal bottom trace (234). A second longitudinal portion (234c) of the proximal bottom trace (234) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of proximal bottom trace (234) Radially outer end of portion (234b). The concentric ring portion (234b) of the proximal bottom trace (234) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the concentric ring of the proximal top trace (230) Radially inner end of portion (230b). The concentric ring portion (230b) of the proximal top trace (230) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (230b) of the proximal top trace (230). The distal end of the longitudinal portion (230c). A second longitudinal portion (230c) of the proximal top trace (230) extends proximally from its distal end to a second inner sensor lead (238d) and is electrically coupled at its proximal end to the second inner sensor lead (238d). Two internal sensor leads.

In a manner similar to that described above, each concentric ring portion (230, 232, 234, 236) defines a respective navigation sensor (250, 252, 254, 256) operable to generate an indication of the position of the respective navigation sensor (250, 252, 254, 256) and thereby indicate A signal of the position of at least a portion of the instrument (100) (eg, the flexible portion (118) of the shaft assembly (104)) in three-dimensional space. Position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to the operator to show the operator, in real time, that the shaft assembly (104) of the instrument (100) is within the patient (P) location. Such visual indications may be provided as an overlay on one or more preoperatively acquired images (eg, CT scans) of the patient's anatomy.

A first proximal external camera lead (229a) is electrically coupled to a proximal end of a first external camera trace (228a) that extends distally from its proximal end to a first distal side external camera lead (229e) and is electrically coupled at its distal end to the first distal external camera lead. A second proximal external camera lead (229b) is electrically coupled to a proximal end of a second external camera trace (228b) that extends distally from its proximal end to a second distal side external camera lead (229f) and is electrically coupled at its distal end to the second distal external camera lead. A first proximal internal camera lead (229c) is electrically coupled to a proximal end of a first internal camera trace (228c) that extends distally from its proximal end to a first distal A side inner camera lead (229g) is electrically coupled at its distal end to the first distal inner camera lead. A second proximal internal camera lead (229d) is electrically coupled to a proximal end of a second internal camera trace (228d) that extends distally from its proximal end to a second distal side inner camera lead (229h) and is electrically coupled at its distal end to the second distal inner camera lead.

Accordingly, current signals and/or image signals may generally flow between the first proximal external camera lead and the first distal external camera lead (229a, 229e) via the first external camera trace (228a), via the second external camera trace (228a). The camera trace (228b) flows between the second nearside outer camera lead and the second farside outer camera lead (229b, 229f) via the first inner camera trace (228c) between the first nearside inner camera lead and Flow between the first far-side internal camera leads (229e, 229g) and/or between the second near-side internal camera lead and the second far-side internal camera lead (229d, 229h) via the second internal camera trace (228d) flow between. In this way, camera traces (228a, 228b, 228c, 228d) and camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h) can be used to visualize and flush the camera (161) operation of the assembly (108) is coupled to the processor (52) to transmit image signals from the camera (161) to the processor (52) (which may thereby provide video in real time via the display screen (56)), and/or the camera (161 ) is operatively coupled to a power source (not shown) to supply power to the camera (161).

In some versions, the length of the navigation sensor assembly (210) defined between the proximal and distal ends (240, 241) of the base plate (226) may be large enough to position the distal navigation sensors (252, 256) on-axis. at or near the distal end (120) of the assembly (104) to facilitate navigation of the distal end (120) while also positioning the sensor leads (238a, 238b, 238c, 238d) at a sufficiently proximal location, At this location the sensor leads (238a, 238b, 238c, 238d) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). Likewise, the length of the navigation sensor assembly (210) may be large enough to position the far-side camera leads (229e, 229f, 229g, 229h) at a sufficiently distal location where the far-side camera leads (229e, 229f , 229g, 229h) may be electrically coupled directly to the camera (161) (e.g., without the need to insert wires or cables) while also positioning the proximal camera leads (229a, 229b, 229c, 229d) proximally enough to In this position, the near-side camera leads (229a, 229b, 229c, 229d) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). In this regard, the length of the navigation sensor assembly (210) may be substantially equal to or greater than the length of the shaft assembly (104) such that the sensor leads (238a, 238b, 238c, 238d) and/or the proximal camera leads (229a, 229b, 229c, 229d) may be positioned within the body (112) of the handle assembly (110) or even proximally relative to the body of the handle assembly. For example, navigation sensor assembly (210) may be on the order of several meters in length. In this way, the navigation sensor assembly (210) can both generate and transmit position-related signals to the coupling unit without the need to run wires or cables between the coupling units; and can also both generate and transmit position-related signals to the camera (161) The power supply in turn transmits image signals from the camera to the coupling unit without the need to run wires or cables between the coupling units.

As mentioned above, the navigation sensor assembly (210) of this example also includes a plurality of temperature sensors in the form of thermocouples (227a, 227b, 227c, 227d) positioned on the top surface (244) of the substrate (226). Referring again to Figure 15, the proximal thermocouples (227a, 227b) are each positioned relatively proximate the proximal top navigation sensor (250), and the distal thermocouples (227c, 227d) are each positioned relatively proximate the distal top navigation sensor (252). ). Accordingly, the proximal thermocouples (227a, 227b) are operable to sense the temperature of the substrate (226) and/or the surrounding environment at or near the proximal top navigation sensor (252), and the distal thermocouples (227c, 227d) Operable to sense the temperature of the substrate (226) and/or the surrounding environment at or near the distal top navigation sensor (250). Each thermocouple (227a, 227b, 227c, 227d) is operable to generate a signal indicative of a respective detected temperature and thereby the temperature of a respective navigation sensor (250, 252). Temperature data generated from such temperature-related signals may be processed by the processor (52) to improve the accuracy of position coordinates calculated by the processor (52) based on the position-related signals of the navigation sensors (250, 252, 254, 256).

In this regard, it should be understood that changes (eg, increases) in the temperature of the navigation sensors (250, 252, 254, 256) can lead to corresponding changes in the resistance of the corresponding concentric ring portions (230b, 232b, 234b, 236b), which in turn can lead to The accuracy of the position coordinates calculated by the processor (52) based on the resulting position-related signals may be adversely affected by corresponding changes in the induced current generated by the varying electromagnetic field in the concentric ring portion. Such temperature changes can be directly correlated with their corresponding resistance changes, such that the processor (52) can adjust the calculation of position coordinates based on the temperature data to correct for any resistance changes caused by the temperature changes.

Referring now to Figure 23, a method is provided for position-related signals received by a processor (52) from navigation sensors (250, 252, 254, 256) and further based on position-related signals received by a processor (52) from thermocouples (227a, 227b, 227c, 227d). Method (301) of determining position coordinates based on received temperature-related signals. The method (301) begins with step (303), where the temperature-related signal indicates that the first temperature of the navigation sensor (250, 252, 254, 256) is equal to the ambient temperature, such that there is no temperature change-induced resistance in the navigation sensor (250, 252, 254, 256) to be considered changes, and the processor (52) calculates accurate location coordinates based on location-related signals received from the navigation sensors (250, 252, 254, 256).

The method (301) proceeds from step (303) to step (305) where the temperature-related signal indicates that the second temperature of the navigation sensor (250,252,254,256) is greater than the ambient temperature such that the temperature in the navigation sensor (250,252,254,256) may need to be considered The resistance change caused by the change; and the processor (52) calculates the position coordinates of the resistance change shift based on the position-related signals received from the navigation sensor (250, 252, 254, 256). For example, such temperature increases may be caused by operating powered instruments (eg, energy catheters, surgical razors, etc.) within the working channel (149). In any case, the method (301) proceeds from step (305) to step (307) where the processor (52) calculates the temperature change from the first temperature to the second temperature (eg, the first temperature and the difference between the second temperatures).

The method (301) proceeds from step (307) to step (309) where the processor (52) determines a correction factor based on the temperature change via a stored navigation displacement model that converts the temperature change into Corresponding correction factors are associated to account for changes in resistance caused by such temperature changes. The method (301) proceeds from step (309) to step (311), where the processor (52) applies a correction factor to the position coordinates shifted by the resistance change to thereby determine the difference between the first temperature and the first temperature. The temperature change between the two temperatures causes the exact position coordinates of the resistance change.

Although temperature sensors in the form of thermocouples (227a, 227b, 227c, 227d) are shown, any other suitable type of temperature sensor may be used, such as a thermistor. In some versions, thermocouples (227a, 227b, 227c, 227d) may be omitted, such as where temperature changes are not typical (eg, when operating unpowered instruments within working channel (149)). In other versions, temperature changes of the navigation sensors (250, 252, 254, 256) may be determined by detecting changes in impedance of corresponding concentric ring portions (230b, 232b, 234b, 236b). For example, it should be understood that copper has a relatively large coefficient of thermal expansion such that impedance changes can be directly related to its corresponding temperature changes. Accordingly, the processor (52) may adjust the calculation of the position coordinates based on the impedance data to correct for any changes in resistance caused by temperature changes in a manner similar to that described above.

C. Exemplary Instrument with Snake-Shaped Flexible Navigation Sensor Assembly

Figures 24-26C illustrate another example of an instrument (400) that can be used to dilate anatomical channels and/or deliver RF energy to tissue. For example, the device (400) may be used for dilation of paranasal sinus ostia (eg, to treat sinusitis), laryngeal dilation, Eustachian tube dilation, ear, nose, or other passages within the throat, and the like. Additionally or alternatively, instrument (400) may be used to ablate nerves (e.g., posterior nasal nerve); ablate turbinates; or ablate, electroporate (e.g., to facilitate absorption of therapeutic agents, etc.), or apply resistive heating to the patient's head any other kind of anatomical structure in the body. The example instrument (400) includes a handle assembly (102), a shaft assembly (104), and a navigation sensor assembly (410), which may be similar to the navigation sensor assembly (110) unless otherwise described.

Instrument (400) may be coupled with a source of inflation fluid (not shown) operable to selectively supply inflation fluid to a balloon of a dilation catheter (not shown) of instrument (400) , used to inflate the balloon to expand the anatomical passage. Additionally or alternatively, instrument (400) may be coupled with an RF generator (101) operable to generate electricity for delivery via electrodes (121, 122) located at the distal end of shaft assembly (104). RF electrosurgical energy is delivered to tissue to ablate, electroporate, or apply resistive heating to the tissue. The transition from Figure 25A to Figure 25B shows the flexible portion (118) of the shaft assembly (104) bending from a straight configuration (Figure 25A) to a curved configuration (Figure 25B), and thereby causing the distal end (120 ) deflects laterally away from the longitudinal axis of the rigid portion (116).

As best shown in Figures 25A and 25B, a navigation sensor assembly (410) is disposed within the shaft assembly (104) and is operable to provide navigation capabilities to the shaft assembly (104). More specifically, the navigation sensor assembly (410) is disposed along a generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) in at least one generally curved configuration in which the navigation sensor assembly (410) Curve about the longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface of the flexible portion (118) to thereby conform to the flexible portion (118) the inner circumference.

Referring now to Figures 26A-26C, the example navigation sensor assembly (410) is provided in the form of a flexible printed circuit board (PCB) and includes a serpentine flexible circuit substrate (426) having a pair of sides positioned thereon Sensors (452, 453) and corresponding leads (not shown) are navigated distally adjacent. As shown, the base plate (426) extends longitudinally between the proximal and distal ends (440, 441), laterally between the first and second sides (442, 443), and between the top surface and the bottom surface. Extend vertically between surfaces (444,445).

Substrate (426) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (426), the substrate (426) may be formed from polyimide because such a substrate (426) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (426) are desired, substrate (426) may be formed from LCP, as substrate (426) formed from LCP may be thermoformed to accommodate this. qua complex geometric configurations and/or provide increased flexibility, such as to allow the navigation sensor assembly (410) together with the flexible portion (118) of the shaft assembly (104) to flex between a straight configuration and a curved configuration. In any event, the distal navigation sensors (452, 453) may be partially defined by concentric rings of corresponding conductive traces (not shown) formed on the top surface (444) of the substrate (426) and be operable to generate an indication as described above. signals of the position of the corresponding navigation sensors (452, 453) described above. The navigation sensor assembly (410) is appropriately sized to fit within the shaft assembly (104) while still allowing for a working channel (449) to extend along the shaft assembly (104) (e.g., within the navigation sensor assembly (410) above), thereby permitting additional instrumentation (eg, dilation catheters and/or energy catheters), suction, fluids, etc. to pass through the open distal end (120) adjacent the navigation sensor assembly (410). In this regard, the navigation sensor assembly (410) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (410) may have a thickness of approximately 50 microns.

It will be appreciated that the serpentine configuration of the base plate (426) of the navigation sensor assembly (110) may provide the navigation sensor assembly (410) with reduced geometric constraints and increased flexibility compared to the generally rectangular configuration of the base plate (126) of the navigation sensor assembly (110). sex. Accordingly, base plate (426) may be used in situations where more complex geometries and/or increased flexibility of base plate (426) are desired, such as for use in flexible portions of a malleable or orientable device such as shaft assembly (104) (118)).

As best seen in Figure 26A, navigation sensor assembly (410) may initially have a generally flat configuration, such as when substrate (426) is initially formed and/or during initial positioning of distal navigation sensors (452, 453) on the substrate. As shown, a longitudinal centerline (C) extends along the base plate (426). As best seen in Figure 26B, the navigation sensor assembly (410) may assume a laterally curved, longitudinally straight configuration in which the sides (442, 443) of the base plate (426) curve upward from the longitudinal centerline (C), The navigation sensor assembly (410) extends in the longitudinal direction. Accordingly, when disposed within the flexible portion (118), the navigation sensor assembly (410) can be arranged about the longitudinal axis of the flexible portion (118) of the shaft assembly (104) to correspond to the curvature of the cylindrical inner surface of the flexible portion (118). The radius of curvature is curved to thereby conform to the inner circumference of the flexible portion (118). As best seen in Figure 26C, the navigation sensor assembly (410) can assume a laterally curved, longitudinally curved configuration in which the sides (442, 443) of the base plate (426) curve upward from the longitudinal centerline (C), The navigation sensor assembly (410) is at least partially deflected from the longitudinal direction. The navigation sensor assembly (410) may be in its laterally curved, longitudinally straight configuration when the flexible portion (118) of the shaft assembly (104) is in its straight configuration, and when the flexible portion (118) of the shaft assembly (104) When in its curved configuration, the navigation sensor assembly (410) may be in its laterally curved, longitudinally curved configurations. In this manner, the navigation sensor assembly (410) can accommodate bending of the flexible portion (118) between its straight configuration and its curved configuration, such that the flexure can be performed regardless of whether the flexible portion (118) is in its straight configuration or its curved configuration. Navigation of section (118).

In the example shown, distal navigation sensors (452, 453) are positioned at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120). However, it should be appreciated that the navigation sensors (452, 453) may be positioned at any other suitable location relative to the components of the instrument (400) over which navigation is desired. It will also be appreciated that one distal navigation sensor (452, 453) can be disposed on the first lateral side of the flexible portion (118) of the shaft assembly (104) and another distal navigation sensor (452, 453) can be disposed on the shaft assembly ( 104) on the second lateral side of the flexible portion (118). In this manner, the distal navigation sensors (452, 453) may provide position-related signals indicative of the positions of the two lateral sides of the flexible portion (118), which may improve the accuracy of the position coordinates calculated by the processor (52), such as when the flexure Section (118) is in a curved configuration. In some versions, only a single far side navigation sensor (452, 453) may be provided. In other versions, one or more proximal top navigation sensors (not shown) may be provided. In still other versions, a distal bottom navigation sensor and/or a proximal bottom navigation sensor (not shown) may be disposed on a bottom surface (445) of the base plate (426) opposite a corresponding top navigation sensor (452, 453), Such as for reducing or eliminating electromagnetic noise as described above. Some variations may also provide a combination of one or more navigation sensors (452, 453) located distal to the flexible portion (118) with another one or more navigation sensors (452, 453) located proximal to the flexible portion (118).

While the navigation sensor assembly (410) of this example is disposed along the generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104), the navigation sensor assembly (410) may alternatively be in at least one generally curved configuration along the shaft. The generally cylindrical outer surface of the flexible portion (118) of the assembly (104) is disposed, and in the at least one generally curved configuration, the navigation sensor assembly (110) is arranged about a longitudinal axis of the flexible portion (118) of the shaft assembly (104). The radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the flexible portion (118) is curved to thereby conform to the outer circumference of the flexible portion (118). In any event, the navigation sensor assembly (410) may permit space for the working channel (449) to extend along the shaft assembly (104) as described above, such that the navigation sensor assembly (410) may be used in a catheter (e.g., a dilation catheter). or energy catheter) distally through the working channel (449) and/or while such catheter remains positioned within the working channel (449), such as during balloon inflation of the dilation catheter to dilate the anatomical channel and/or Position-related signals are continuously transmitted to the processor (52) during delivery of RF energy to the tissue via the electrodes of the energy catheter. In other words, navigation of the flexible portion (118) can occur simultaneously with expansion of the anatomical passage and/or with delivery of RF energy to the tissue without interfering with each other.

D. Exemplary suction device with snake-shaped flexible navigation sensor assembly

Figures 27A-27C illustrate an example of an instrument (500) that may be used to provide suction during a surgical procedure to facilitate removal of foreign and/or undesirable materials (e.g., fluids and /or debris). For example, instrument (500) may be used to clear fluid from the paranasal sinuses, larynx, Eustachian tube, ear, nose, or other passages within the throat, etc., during a FESS procedure, a sinuplasty procedure, and/or during various other ENT procedures. and/or debris. The instrument (500) of this example includes an elongate extendable shaft (516) that extends distally from a handle (not shown) to an open distal aspiration tip (510) and a navigation sensor assembly (510). 520), which navigation sensor assembly may be similar to navigation sensor assembly (410) unless otherwise described. Instrument (500) may be coupled with a suction source (not shown) operable to selectively provide sufficient suction at the surgical site to draw excess fluid and/or debris proximally. By instrument (500). The transition from Figure 27A to Figure 27C shows the extensible shaft (516) bending from a straight configuration (Figure 27A) to a curved configuration and a double curved configuration (Figures 27B and 27C, respectively), and thereby allowing the remote The side suction tip (520) deflects laterally away from the proximal longitudinal axis of the extensible shaft (516).

As shown, a navigation sensor assembly (510) is disposed on the exterior of the extendable shaft (516) and is operable to provide navigation capabilities to the extendable shaft (516). More specifically, the navigation sensor assembly (510) is disposed along the generally cylindrical outer surface of the extensible shaft (516) in at least one generally curved configuration in which the navigation sensor assembly (510) surrounds the extensible shaft (516). The longitudinal axis of the extendable shaft (516) is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the extendable shaft (516) to thereby conform to the outer circumference of the extendable shaft (516).

The navigation sensor assembly (510) of this example is provided in the form of a flexible printed circuit board (PCB) and includes a serpentine flexible circuit substrate (526) on which a pair of laterally adjacent distal navigation sensors are positioned. Sensors (552, 553) and corresponding leads (not shown). As shown, base plate (526) extends longitudinally between proximal and distal ends (540,541), laterally between first and second sides (542,543), and on top surface (544 ) and the bottom surface (not shown) extending vertically.

Substrate (526) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (526), the substrate (526) may be formed from polyimide because such a substrate (526) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (526) are desired, substrate (526) may be formed from LCP, as substrate (526) formed from LCP may be thermoformed to accommodate this. qua complex geometric configurations and/or provide increased flexibility, such as to allow the navigation sensor assembly (510) with the extensible shaft (516) to flex between straight configurations, curved configurations, and double curved configurations. In any case, the distal navigation sensors (552, 553) may be partially defined by concentric rings of corresponding conductive traces (not shown) formed on the top surface (544) of the substrate (526) and be operable to generate an indication as described above. signals of the position of the corresponding navigation sensors (552, 553) described above. The navigation sensor assembly (510) is appropriately sized to fit over the exterior of the extendable shaft (516) without blocking the working channel (549) extending along the extendable shaft (516), thereby permitting additional instrumentation, extraction Suction, fluid, etc. is passed through the open distal suction tip (520) while still remaining generally flush with the exterior of the extendable shaft (516) to minimize the risk of snagging tissue. In this regard, the navigation sensor assembly (510) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (510) may have a thickness of approximately 50 microns.

In some versions, navigation sensor assembly (510) may initially have a generally flat configuration (not shown) similar to the configuration of navigation sensor assembly (410), such as when substrate (526) is initially formed and/or at a remote location. During initial positioning of side navigation sensors (552,553) on the substrate. As best seen in Figure 27A, the navigation sensor assembly (510) may assume a laterally curved, longitudinally straight configuration in which the sides (542, 543) of the base plate (526) extend from the longitudinal centerline (526) of the base plate (526). (not shown) is bent downward, and the navigation sensor assembly (510) extends in the longitudinal direction. Accordingly, when disposed on the exterior of extensible shaft (516), navigation sensor assembly (510) may be arranged about the longitudinal axis of extensible shaft (516) with a radius of curvature corresponding to the cylindrical outer surface of extensible shaft (516) with a radius of curvature to thereby conform to the outer circumference of the extensible shaft (516).

As best seen in Figure 27B, the navigation sensor assembly (510) can assume a laterally curved, longitudinally curved configuration in which the sides (542, 543) of the base plate (526) extend from the longitudinal centerline of the base plate (526) to the longitudinal centerline of the base plate (526). Curved downward, the navigation sensor assembly (510) is at least partially deflected from the longitudinal direction at a first location along its length.

As best seen in Figure 27C, the navigation sensor assembly (510) can assume a laterally curved, longitudinally double curved configuration in which the sides (542, 543) of the base plate (526) extend from the longitudinal centerline of the base plate (526) Curved downward, the navigation sensor assembly (510) is at least partially deflected from the longitudinal direction at first and second positions along its length. The navigation sensor assembly (510) may be in its laterally curved, longitudinally straight configuration when the extensible shaft (516) is in its straight configuration, and when the extensible shaft (516) is in its curved configuration, the navigation sensor assembly (510) may be in its laterally curved, longitudinally straight configuration. 510) may be in its laterally bent, longitudinally bent configuration, and the navigation sensor assembly (510) may be in its laterally bent, longitudinally bent configuration when the extensible shaft (516) is in its double bent configuration. In this way, the navigation sensor assembly (510) can accommodate bending of the extensible shaft (516) between its straight configuration, a curved configuration, and a double-bent configuration, such that whether the extensible shaft (516) is in its straight configuration, Navigation of the extensible shaft (516) may be performed in either a curved configuration or a double curved configuration.

In the example shown, distal navigation sensors (552, 553) are positioned at or near the distal suction tip (520) of the extensible shaft (516) to facilitate navigation of the distal suction tip (520). However, it should be appreciated that the navigation sensors (552, 553) may be positioned at any other suitable location relative to the components of the instrument (500) over which navigation is desired. It should also be appreciated that one distal navigation sensor (552,553) may be disposed on a first lateral side of the extensible shaft (516) and another distal navigation sensor (552,553) may be disposed on a first lateral side of the extensible shaft (516). Two sides to the side. In this manner, the distal navigation sensors (552, 553) may provide position-related signals indicative of the positions of the two lateral sides of the extensible axis (516), which may improve the accuracy of the position coordinates calculated by the processor (52), such as when The extensible shaft (516) is in a curved configuration and/or a dual-bent configuration. In some versions, only a single far side navigation sensor (552,553) may be provided. In other versions, one or more proximal top navigation sensors (not shown) may be provided. In still other versions, a distal bottom navigation sensor and/or a proximal bottom navigation sensor (not shown) may be disposed on the bottom surface (545) of the base plate (526) opposite the corresponding top navigation sensor (552,553), Such as for reducing or eliminating electromagnetic noise as described above. Some versions may also provide a number of navigation sensors (552, 553) located at various longitudinal positions along the length of the extendable axis (516). Such positioning may enable the IGS navigation system (50) to determine the position and orientation of the extensible shaft (516) throughout the length of the patient (P), regardless of the specific bending configuration that the operator has applied to the extensible shaft. (516).

While the navigation sensor assembly (510) of this example is disposed along the generally cylindrical outer surface of the extensible axis (516), the navigation sensor assembly (510) may alternatively be in at least one generally curved configuration along the extensible axis (516). In the at least one generally curved configuration, the navigation sensor assembly (510) is disposed about the longitudinal axis of the extensible shaft (516) with a curvature corresponding to the curvature of the cylindrical inner surface of the extensible shaft (516). The radius of curvature is curved to thereby conform to the inner circumference of the extensible shaft (516). In any event, the navigation sensor assembly (510) may permit space for the working channel (549) to extend along the extensible axis (516) as described above, such that the navigation sensor assembly (510) may pass through the working channel (549). Position-related signals are continuously transmitted to the processor (52) during proximal aspiration of fluid and/or debris to clear such fluid and/or debris from within or adjacent the anatomical passage. In other words, removal of fluid and/or debris from the anatomical passage and navigation of the extensible shaft (516) can occur simultaneously without interfering with each other.

Although navigation sensor assembly (510) is shown incorporated into instrument (500) to provide suction, it should be understood that navigation sensor assembly (510) may be incorporated into any other suitable surgical instrument, such as for use during ENT procedures. Instruments that perform other functions during the operation, including, for example, probing instruments or curette instruments with extensible shafts.

E. Exemplary shaving instrument with straight flexible navigation sensor assembly

Figures 28-37 illustrate examples of instruments (600) that can be used to sever and remove tissue, such as bone tissue, from an anatomical passage. For example, instrument (600) may be used to sever and remove bone tissue and adjacent mucosal tissue from the nasal cavity, as well as from any other suitable location. The example instrument (600) includes a handle assembly (602), a hub (603), a shaft assembly (604), and a navigation sensor assembly (610), which may be similar to the navigation sensor assembly (110) unless otherwise described. . Instrument (600) may be coupled with a suction source (not shown) operable to selectively provide sufficient suction at the surgical site to draw severed tissue proximally through instrument (600) ).

The handle assembly (602) of this example includes a body (612) sized and configured to be grasped and manipulated by one hand of an operator, such as via a power grip, pencil grip, or any other suitable kind grip. The handle assembly (602) may include controls for operating the instrument (600), or the controls may be remotely located. The instrument (600) also includes a suction port (613) operably connected to the suction source and configured to aspirate tissue, such as bone tissue, from the surgical site. Rotational motion may be delivered to shaft assembly (604) by a motorized drive assembly (not shown) in handle assembly (602), although any suitable source of rotational or oscillatory motion may be utilized. For example, this source of motion may be contained within the handle assembly (602), or may be external and connectable to the handle assembly (602). A power source (not shown) can be connected to the motorized drive assembly to power the instrument (600) for use. Additionally or alternatively, the handle assembly (602) may accommodate a battery (not shown).

Shaft assembly (604) generally includes a longitudinally straight rigid outer shaft (616) and an inner cutting member (618) that are collectively configured to receive and remove tissue from a surgical site. A cutting member (618), which may include a tube, is disposed within a longitudinally extending lumen of the outer shaft (616) and is configured to rotate about the longitudinal axis of the shaft assembly (604) at the distal portion. The cutting member (618) defines a lumen and extends proximally to the handle assembly (612) and is connected to a motorized drive assembly that rotatably drives the cutting member (618) relative to the outer shaft (616). The outer shaft (616) includes a lateral shaft window opening (621) configured to cooperate with a cutting window opening (not shown) of the inner cutting member (618). Such configurations can be constructed and operated according to any of the teachings in US Publication No. 2019/0388117 titled "Surgical Shaver with Feature to Detect Window State" published on December 26, 2019.

The shaft assembly (604) is also rotatable relative to the handle assembly (610) about the longitudinal axis of the shaft assembly (604). Such rotation may be driven via a rotary control knob (614) that is rotatably coupled to the body (612) of the handle assembly (610). Alternatively, shaft assembly (604) may be rotatable via some other form of user input; or may be non-rotatable relative to handle assembly (610). It should also be understood that the examples of handle assembly (610) described herein are illustrative examples only. The shaft assembly (604) may alternatively be coupled with any other suitable kind of handle assembly or other support body.

As best shown in Figure 29, navigation sensor assembly (610) is disposed on the exterior of outer shaft (616) and is operable to provide navigation capabilities to outer shaft (616). More specifically, the navigation sensor assembly (610) is disposed along the generally cylindrical outer surface of the outer shaft (616) in a generally curved configuration in which the navigation sensor assembly (610) surrounds the outer shaft (616). The longitudinal axis is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the outer shaft (616) to thereby conform to the outer circumference of the outer shaft (616). In some versions, the instrument (600) may include a sheath (not shown) coaxially positioned about at least a portion of the radially outward outer shaft (616) of the navigation sensor assembly (610) such that the navigation sensor assembly (610) Can be sandwiched between the sheath and the outer shaft (616).

Referring now to FIGS. 30-37 , the navigation sensor assembly (610) of this example is provided in the form of a flexible printed circuit board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (626) on which Formed (eg, printed and/or embedded) are a plurality of traces (630, 632, 633, 634, 636, 637), a plurality of corresponding trace leads (638a, 638b, 638c, 638d, 638e, 638f), and a plurality of ground leads (639a, 639b). As shown, the base plate (626) extends longitudinally between the proximal and distal ends (640, 641), laterally between the first and second sides (642, 643), and between the top surface and the bottom surface. Extend vertically between surfaces (644,645). The substrate (626) of this example includes a plurality of vias (646) extending between top and bottom surfaces (644, 645). Through-hole (646) may be configured to receive corresponding pins (not shown) or other suitable fasteners to secure navigation sensor assembly (610) to flexible outer shaft (616) and/or to the instrument (600) any other parts. In the version shown, the base plate (626) also includes a proximal ramp (648) extending between the proximal end (640) and the first side (642). Proximal ramp (648) may be configured to facilitate positioning proximal end (640) at a desired location relative to outer shaft (616) and/or relative to any other components of instrument (600).

Substrate (626) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (626), the substrate (626) may be formed from polyimide because such a substrate (626) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (626) are desired, substrate (626) may be formed from LCP, as substrate (626) formed from LCP may be thermoformed to accommodate this. resemble complex geometries and/or provide increased flexibility. In any case, traces (630, 632, 633, 634, 636, 637) and leads (638a, 638b, 638c, 638d, 638e, 638f) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (610) is appropriately sized to fit over the exterior of the outer shaft (616) without blocking the lumen of the outer shaft (616), thereby allowing the inner cutting member (618) to be rotatably disposed thereon. in the lumen while also remaining generally flush with the exterior of the outer shaft (616) to minimize the risk of snagging tissue. In this regard, the navigation sensor assembly (610) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (610) may have a thickness of approximately 50 microns.

As shown in Figures 30 and 31, traces (630, 632, 633, 634, 636, 637) include a proximal top trace (630), a first distal top trace (632), and A second distal top trace (633), and a proximal bottom trace (634) each formed on the bottom surface (645) of the substrate (626) opposite and/or parallel to the corresponding top trace (630, 632, 633) , a first distal bottom trace (636) and a second distal bottom trace (637). Similarly, leads (638a, 638b, 638c, 638d, 638e, 638f) include a proximal top lead (638a) and first and second distal top leads, each formed on a top surface (644) of the substrate (626). distal top leads (638b, 638c); and proximal bottom leads (638d) each formed on the bottom surface (645) of the substrate (626) opposite and/or parallel to the corresponding top lead (638a, 638b, 638c) ) and the first and second distal bottom leads (638e, 638f). Ground leads (639a, 639b) include first and second ground leads (639a, 639b) each formed on the top surface (644) of the substrate (626). Top traces (630,632,633), top leads (638a, 638b, 638c), and ground leads (639a, 639b) collectively define the top flex circuit layer of the navigation sensor assembly (610), while bottom traces (634,636,637) and bottom leads (638d , 638e, 638f) together define the bottom flexible circuit layer of the navigation sensor assembly (610).

Referring now to Figures 32-37, traces (630, 632, 633, 634, 636, 637) each include corresponding first longitudinal portions (630a, 632a, 633a, 634a, 636a, 637a), concentric ring portions (630b, 632b, 633b, 634b, 636b, 637b ) and the second longitudinal portion (630c, 632c, 633c, 634c, 636c, 637c). As shown, the concentric ring portions (632b, 633b, 636b, 637b) of the distal traces (632, 633, 636, 637) are positioned distally relative to the concentric ring portions (630b, 634b) of the corresponding proximal traces (630, 634).

The proximal top lead (638a) is electrically coupled to the proximal end of the first longitudinal portion (630a) of the proximal top trace (630). A first longitudinal portion (630a) of the proximal top trace (630) extends distally from a proximal end thereof and is electrically coupled at a distal end thereof to a first longitudinal portion (630a) of the proximal bottom trace (634) The distal end of portion (634a). A first longitudinal portion (634a) of the proximal bottom trace (634) extends proximally from its distal end toward the proximal bottom lead (638d) and is electrically coupled to the proximal bottom at its proximal end The proximal end of the second longitudinal portion (634c) of the trace (634). A second longitudinal portion (634c) of the proximal bottom trace (634) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of proximal bottom trace (634) Radially outer end of portion (634b). The concentric ring portion (634b) of the proximal bottom trace (634) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the concentric ring of the proximal top trace (630) Radially inner end of portion (630b). The concentric ring portion (630b) of the proximal top trace (630) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (630b) of the proximal top trace (630). The distal end of the longitudinal portion (630c). A second longitudinal portion (630c) of the proximal top trace (630) extends proximally from its distal end toward the proximal top lead (638a) and is electrically coupled to the proximal bottom at its proximal end Lead (638d).

The first distal top lead (638b) is electrically coupled to the proximal end of the first longitudinal portion (632a) of the first distal top trace (632). A first longitudinal portion (632a) of the first distal top trace (632) extends distally from its proximal end and is electrically coupled at its distal end to the first distal bottom trace (636 ) distal end of the first longitudinal portion (636a). A first longitudinal portion (636a) of the first distal bottom trace (636) extends proximally from its distal end toward the first distal bottom lead (638e) and is electrically coupled at its proximal end To the proximal end of the second longitudinal portion (636c) of the first distal bottom trace (636). A second longitudinal portion (636c) of the first distal bottom trace (636) extends distally from its proximal end and is electrically coupled at its distal end to the first distal bottom trace (636 ) of the radially outer end of the concentric ring portion (636b). The concentric ring portion (636b) of the first distal bottom trace (636) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the first distal top trace (632 ) of the radially inner end of the concentric ring portion (632b). The concentric ring portion (632b) of the first distal top trace (632) spirals radially outward from its radially inner end and is electrically coupled to the first distal top trace (632) at its radially outer end ) the distal end of the second longitudinal portion (632c). A second longitudinal portion (632c) of the first distal top trace (632) extends proximally from its distal end toward the first distal top lead (638b) and is electrically coupled at its proximal end to the first distal bottom lead (638e).

The second distal top lead (638c) is electrically coupled to the proximal end of the first longitudinal portion (633a) of the second distal top trace (633). A first longitudinal portion (633a) of the second distal top trace (633) extends distally from its proximal end and is electrically coupled at its distal end to the second distal bottom trace (637 ) distal end of the first longitudinal portion (637a). A first longitudinal portion (637a) of the second distal bottom trace (637) extends proximally from its distal end toward the second distal bottom lead (638f) and is electrically coupled at its proximal end To the proximal end of the second longitudinal portion (637c) of the second distal bottom trace (637). A second longitudinal portion (637c) of the second distal bottom trace (637) extends distally from its proximal end and is electrically coupled at its distal end to the second distal bottom trace (637 ) of the radially outer end of the concentric ring portion (637b). The concentric ring portion (637b) of the second distal bottom trace (637) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the second distal top trace (633 ) of the radially inner end of the concentric ring portion (633b). The concentric ring portion (633b) of the second distal top trace (633) spirals radially outward from its radially inner end and is electrically coupled to the second distal top trace (633) at its radially outer end. ) of the distal end of the second longitudinal portion (633c). A second longitudinal portion (633c) of the second distal top trace (633) extends proximally from its distal end toward the second distal top lead (638c) and is electrically coupled at its proximal end to the second distal bottom lead (638f).

In a manner similar to that described above, each concentric ring portion (630b, 632b, 633b, 634b, 636b, 637b) defines a corresponding navigation sensor (650, 652, 653, 654, 656, 657) operable to generate an indication of the corresponding navigation The position of the sensor (650, 652, 653, 654, 656, 657) and thereby the signal indicating the position of at least a portion of the instrument (500) (eg, the outer shaft (616)) in three-dimensional space. Position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to the operator to show the operator in real time where the outer shaft (616) of the instrument (600) is within the patient (P). Located in the location. Such visual indications may be provided as an overlay on one or more preoperatively acquired images (eg, CT scans) of the patient's anatomy.

In the example shown, the distal navigation sensors (652, 653, 656, 657) are positioned at or near the lateral axis window (621) of the outer axis (616) to facilitate navigation of the lateral axis window (621), while the proximal navigation sensors (650,654 ) may be positioned at any suitable location along outer axis (616) to facilitate identification of, for example, the direction and/or orientation of outer axis (616)). However, it should be appreciated that the navigation sensors (650, 652, 653, 654, 656, 657) may be positioned at any other suitable location relative to the components of the instrument (600) over which navigation is desired. Also in the example shown, the navigation sensor assembly (610) includes a pair of laterally adjacent distal top navigation sensors (652, 653) and a pair of laterally adjacent distal bottom navigation sensors (656, 657). Such a pair of distal top navigation sensors (652,653) and distal bottom navigation sensors (656,657) may help improve the outer axis (616) calculated by the processor (52) based on position-related signals from the navigation sensors (650,652,653,654,656,657) The accuracy of the location coordinates. In this regard, the present version of the navigation sensor assembly (610) is disposed along the generally cylindrical outer surface of the outer axis (616) such that a distal top navigation sensor (652, 653) and a distal bottom navigation sensor (656, 657) can disposed on a first lateral side of the outer shaft (616), and another distal top navigation sensor (652, 653) and another distal bottom navigation sensor (656, 657) may be disposed on a second lateral side of the outer shaft (616) . In this manner, a pair of distal top navigation sensors and distal bottom navigation sensors (652, 653, 656, 657) may provide position-related signals indicative of the position of the two lateral sides of the outer shaft (616), which may improve the calculation by the processor (52) Accuracy of location coordinates.

In some versions, the length of the navigation sensor assembly (610) defined between the proximal and distal ends (640, 641) of the base plate (626) may be large enough to position the distal navigation sensors (652, 653, 656, 657) on the outer axis (616) at or near the lateral axis window (621) to facilitate navigation of the lateral axis window (621) while also positioning the leads (638a, 638b, 638c, 638d, 638e, 638f) sufficiently proximally at which the leads (638a, 638b, 638c, 638d, 638e, 638f) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). In this regard, the length of the navigation sensor assembly (610) can be substantially equal to or greater than the length of the shaft assembly (604) such that the leads (638a, 638b, 638c, 638d, 638e, 638f) can be positioned on the handle assembly (638a, 638b, 638c, 638f) 610) within or even proximally positioned relative to the body (612) of the handle assembly. For example, navigation sensor assembly (610) may be on the order of several meters in length. In this way, the navigation sensor assembly (610) can both generate and transmit position-related signals to the coupling unit without the need to run wires or cables between the coupling units.

While the navigation sensor assembly (610) of this example is disposed along the generally cylindrical outer surface of the outer shaft (616), the navigation sensor assembly (610) may alternatively be in a generally curved configuration along the generally cylindrical shape of the outer shaft (616). The inner surface is configured in the generally curved configuration in which the navigation sensor assembly (610) is curved about the longitudinal axis of the outer shaft (616) with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface of the outer shaft (616) to be formed by This conforms to the inner circumference of the outer shaft (616). In any event, the navigation sensor assembly (610) may permit space for the lumen to extend along the outer axis (616) as described above, such that the navigation sensor assembly (610) may be used during dissection and/or aspiration of tissue. Position-related signals are continuously communicated to the processor (52). In other words, tissue severing/aspiration and navigation of the outer shaft (616) can occur simultaneously without interfering with each other.

Although not shown, the navigation sensor assembly (610) may include at least one temperature sensor formed (eg, printed and/or embedded) on the substrate (626) for sensing the substrate (626) and/or at least one Navigate the temperature of the surrounding environment at or near the sensor (650, 652, 653, 654, 656, 657) and generate a signal indicative of the detected temperature, which signal may be processed by the processor (52) for use in a manner similar to that described above. Accuracy of position coordinates calculated by the processor (52) based on position-related signals from the navigation sensor (650, 652, 653, 654, 656, 657). In this regard, it should be understood that operation of the motorized drive assembly to rotatably drive the cutting member (618) relative to the outer shaft (616) can cause an increase in the temperature of the shaft assembly (604), which in turn can cause the navigation sensor (650,652,653,654,656,657 ) changes in resistance caused by temperature changes. In other versions, temperature changes of the navigation sensors (650, 652, 653, 654, 656, 657) may be determined by detecting changes in impedance of corresponding concentric ring portions (630b, 632b, 633b, 634b, 636b, 637b). In any case, the processor (52) may adjust the calculation of the position coordinates based on the temperature data to correct for any resistance changes caused by temperature changes.

F. Exemplary Shaving Instrument with Curved Flexible Navigation Sensor Assembly

Figure 38 shows another example of an instrument (700) that can be used to sever and remove tissue, such as bone tissue, from an anatomical passage. For example, instrument (700) may be used to sever and remove bone tissue from the nasal cavity, as well as from any other suitable location. Instrument (700) of this example includes a handle assembly (not shown), hub (703), shaft assembly (704), and navigation sensor assembly (610), and may be similar to instrument (600) unless otherwise described. Instrument (700) may be coupled with a suction source (not shown) operable to selectively provide sufficient suction at the surgical site to draw severed tissue proximally through instrument (700) ).

Shaft assembly (704) generally includes a longitudinally curved rigid outer shaft (716) and an inner cutting member (not shown) that are jointly configured to receive and remove tissue from a surgical site. In some versions, the distal portion of outer shaft (716) may be oriented at an angle of approximately 60° relative to the proximal portion of outer shaft (716). In any case, the outer shaft (716) includes a lateral shaft window opening (not shown) configured to cooperate with a cutting window opening (not shown) of the inner cutting member.

As shown, a navigation sensor assembly (610) is disposed on the exterior of the outer shaft (716) and is operable to provide navigation capabilities to the outer shaft (716). More specifically, the navigation sensor assembly (610) is disposed along the generally cylindrical outer surface of the outer shaft (716) in a generally curved configuration in which the navigation sensor assembly (610) surrounds the outer shaft (716). The longitudinal axis is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the outer shaft (716) to thereby conform to the outer circumference of the outer shaft (716). The navigation sensor assembly (610) also bends longitudinally to conform to the longitudinal bending of the outer shaft (716).

III. Exemplary Navigation Adapter Sheath

As mentioned above, it may be desirable to provide an instrument with a flexible circuit having integrated navigation sensors. It may also be desirable to provide an adapter with a flexible circuit having one or more integrated navigation sensors, where such an adapter can be easily coupled to instruments that otherwise lack any navigation sensors. In such scenarios, the adapter can provide navigation capabilities to the device. Similarly, it may be desirable to use an adapter with a flexible circuit that has one or more integrated navigation sensors in conjunction with an instrument that already has one or more navigation sensors, where the position of the one or more navigation sensors from the adapter The data may be supplemented with position data from one or more navigation sensors of the instrument. In such scenarios, adapters can enhance the instrument's navigation capabilities. In either scenario, the adapter can be configured to avoid adding bulk to the instrument; and to be easily assembled with instruments in the surgical field.

Figures 39-43 illustrate an example of an adapter in the form of an adapter boot (1100) that can provide the benefits and functionality described above. In this example, adapter sheath (1100) is coupled to tissue shaving instrument (1000). The example tissue shaving instrument (1000) includes a body (1002), a suction port (1004), a rotary control knob (1006), a power source connector (1008), a hub (1010), and a shaft assembly (1020). The main body (1002) is configured to be held by an operator. Suction port (1004) is configured to couple with a suction source such that suction can be applied to aspirate tissue and fluid during operation of tissue shaving instrument (1000). The rotary control knob (1006) is rotatable relative to the body (1002) to reorient the shaft assembly (1020) about its longitudinal axis. Power source connector (1008) is configured to couple with a power source to provide power to a motor (not shown) in body (1002). The motor is operable to drive a cutting shaft (not shown) of shaft assembly (1020) as is known in the art.

In addition to including the cutting shaft, shaft assembly (1020) also includes an outer shaft (1030) and an end effector (1022). An end effector (1022) is located at the distal end of shaft assembly (1020). As best seen in Figure 43, end effector (1022) includes a transverse opening (1040) formed at the distal end of outer shaft (1030) with a serrated cutting edge (1042) extending along the perimeter of the opening (1040). The cutting shaft is positioned inside the outer shaft (1030) and includes similar transverse openings (1040) and cutting edges (1042) complementary to the transverse openings (1040) and cutting edges (1042). A motor in body (1002) drives the cutting shaft to rotate relative to outer shaft (1030) about the longitudinal axis of shaft assembly (1020). During such rotation, suction is applied through the lumen defined by the cutting shaft to draw tissue into the opening (1040), the cutting edge of the cutting shaft cooperating with the cutting edge (1042) of the outer shaft (1030) to shear tissue , and the sheared tissue is sucked proximally through the lumen of the cutting shaft under the influence of suction. One of ordinary skill in the art will appreciate that it may be beneficial to have data from navigation sensors indicating the real-time position of the end effector (1022) within the patient's body during operation of the tissue shaving instrument (1000).

As shown in Figures 39-40, the adapter housing (1100) of this example includes a hub (1110), a shaft assembly (1120) extending distally from the hub (1110), a cable (1102), and a connector (1104) . As best seen in Figure 41, shaft assembly (1120) includes a hollow outer shaft (1130), a flex circuit (1140), and a hollow inner shaft (1150). Hub (1110) is fixedly secured to the proximal end of outer shaft (1130). Flexible circuit (1140) includes a flexible substrate (1142), a pair of navigation sensors (1144, 1146) and traces (not shown). The flexible substrate (1142), navigation sensors (1144, 1146), and traces may be configured to be operable, such as any of the various flexible substrates, navigation sensors, and traces described above. Flexible circuit (1140) may have only a single layer or multiple layers.

As shown in Figure 42, the shaft assembly (1120) is configured such that the inner shaft (1150) is coaxially nested within the outer shaft (1130) and the flex circuit (1140) is radially interposed externally of the inner shaft (1150). and the inside of the outer shaft (1130). In some versions, shaft assembly (1120) is configured such that flex circuit (1140) is embedded within or otherwise coupled to inner shaft (1150) and/or outer shaft (1130). In some versions, the distal end (1132) of the outer shaft (1130) is welded to or otherwise secured to the distal end (1152) of the inner shaft (1150). Additionally or alternatively, the proximal portions of the shafts (1130, 1150) may be welded or otherwise secured together. The relationship between the shafts (1130, 1150) and the flexible circuit (1140) can provide protection for the flexible circuit (1140) such that the shaft assembly (1120) can withstand different types of sterilization procedures, otherwise if one or more of the flexible circuits (1140) If multiple features are exposed, these disinfection procedures may damage the features. Although in this example the flexible circuit (1140) is interposed between the shafts (1130, 1150), the flexible circuit (1140) may be interposed between any other suitable kind of tubular members, or otherwise relative to any other Positioning of tubular members of the appropriate kind.

The inner shaft (1150) defines an inner diameter (ID) that corresponds to the outer diameter of the outer shaft (1030) of the tissue shaving instrument (1000) such that the shaft assembly (1020) can be easily inserted into the shaft assembly (1120). 1120) corresponds closely to shaft assembly (1020). With such close correspondence, shaft assembly (1120) may not substantially increase the outer diameter of shaft assembly (1020) such that the addition of adapter sheath (1100) may not undesirably enlarge the tissue shaving instrument (1000) outline. In other words, the presence of adapter sheath (1100) may not undesirably interfere with normal use of tissue shaving instrument (1000).

The hub (1110) of the adapter sheath (1100) is configured to engage the hub (1010) of the tissue shaving instrument (1000) to thereby removably secure the adapter sheath (1110) relative to the tissue shaving instrument (1000). 1100). By way of example only, hub (1110) may provide a snap fit, interference fit, or any other suitable kind of relationship with hub (1010). As shown in Figures 39 and 43, the length of the shaft assembly (1120) is such that when the adapter sheath (1100) is fully seated on the tissue shaving instrument (1000), the distal ends (1132, 1152) are just near side of the actuator (1022). As also shown in Figure 43, where the outer shaft (1130) is omitted, the distal navigation sensor (1146) of the adapter sheath (1100) is positioned adjacent the end effector (1022). Such position of the distal navigation sensor (1146) may thus allow the distal navigation sensor (1146) to readily indicate the real-time position of the end effector (1022). The proximal navigation sensor (1146) of the adapter sheath (1100) is positioned more proximally from the end effector (1022) such that the proximal navigation sensor (1146) can readily indicate the corresponding proximal side of the shaft assembly (1020) Part of the real-time location. In some versions, the nearside navigation sensor (1146) is omitted.

Although only one navigation sensor (1144) is shown at the distal end of flexible circuit (1140) in this example, some variations may provide two or more at the distal end of flexible circuit (1140) Navigation sensors (1144). Similarly, although only one navigation sensor (1146) is shown on the flex circuit (1140) proximal to the navigation sensor (1144), two or more navigation sensors may be provided proximal to the navigation sensor (1144). (1146).

Traces of the flex circuit (1140) are configured to carry position indicating signals from the navigation sensors (1144, 1146) to the cable (1102). Cable (1102) is configured to carry these position indicating signals to connector (1104). Connector (1104) is configured to couple with IGS navigation system (50) and thereby transmit a position indicating signal to IGS navigation system (50). In some versions, connector (1104) is configured to plug into a corresponding receptacle on IGS navigation system (50). In some other versions, the connector (1104) includes a wireless transmitter operable to wirelessly transmit a position indicating signal to the IGS navigation system (50). In still other versions, cable (1102) and connector (1104) are omitted, and some other component of adapter housing (1100) is configured to wirelessly transmit a position indicating signal to the IGS navigation system (50). By way of example only, one or more wireless transmitters may be integrated into hub (1110). Alternatively, the position indication signal may be transmitted to the IGS navigation system (50) in any other suitable manner.

In some versions, outer shaft (1130) and inner shaft (1150) each comprise metallic material. In some other versions, outer shaft (1130) and inner shaft (1150) each comprise a polymer material. In some other versions, the outer shaft (1130) includes a metallic material and the inner shaft (1150) includes a polymeric material. In some other versions, the outer shaft (1130) includes a polymeric material and the inner shaft (1150) includes a metallic material. Regardless of the material or materials used to form shafts (1130, 1150), one or both of shafts (1130, 1150) may be rigid, malleable, flexible, and/or have any other suitable characteristics. Thus, while the axes (1130, 1150) are shown as straight in this example, the axes (1130, 1150) may alternatively be curved or have any other kind of non-linear configuration. In versions where the shafts (1130, 1150) are curved or have any other kind of non-linear configuration, the shafts (1130, 1150) may be rigidly constructed in such a manner; or in versions where the shafts (1130, 1150) are malleable or flexible case that can be bent by the operator to achieve this configuration.

Although adapter sheath (1100) is shown and described in the context of a tissue shaving instrument (1000), adapter sheath (1100) may readily be used with any other suitable kind of instrument. Adapter sheath (1100) need not be limited to tissue shaving instruments such as tissue shaving instrument (1000). By way of example only, the adapter sheath (1100) may be configured to fit an endoscope, different kinds of ENT instruments, and/or any other kind that will be apparent to one skilled in the art in light of the teachings herein. above the instrument. The length of adapter sheath (1100) may vary based on the type of instrument to which adapter sheath (1100) will be coupled. Regardless of the type of instrument to which adapter sheath (1100) is coupled, adapter sheath (1100) can be easily coupled to the instrument prior to a medical procedure in which the instrument is to be used with adapter sheath (1100). After the medical procedure is completed, the adapter sheath (1100) can be removed from the instrument. The removed adapter sheath (1100) can be discarded or sterilized for subsequent reuse.

IV. Exemplary Methods for Calibrating Navigation Sensors

In some cases, it may be desirable to provide one or more methods for accurately and reliably calibrating navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) that may include based on navigation sensors (150,152,1 54,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and corresponding devices ( 100,400,500,600,700,1000) to calibrate the distance between the far side ends of each navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) location and/or orientation. Additionally or alternatively, calibrating the navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) may include calibrating each navigation sensor (150,152,154,156,250,252 ,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) sensitivity to the electromagnetic field generated by the field generator (64).

The calibration of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) can be at least partially directly integrated into the corresponding navigation sensor assembly (110,210,410,510,610,11 00) and/or applying the corresponding navigation sensor assembly (110, 210, 410, 510, 610, 1100) to the corresponding device (100, 400, 500, 600, 700) superior. For example, once the sensitivity of a navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) is determined, repeatable manufacturing techniques can be used to accurately and reliably recreate the same navigation sensor (150,152, 154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146). For example, the navigation sensor assembly (110,210,410,510,610,1 144,1146) formed into flexible printed circuit boards (PCBs) can help ensure that accurate and reliable Recreate the same navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) with the same sensitivity. Similarly, once the distance between the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and the corresponding instrument (100,400,500,600,700,1000) is determined The same navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) Accurately and reliably positioned at the same distance from the distal tip of the corresponding identical instrument (100, 400, 500, 600, 700, 1000). For example, through holes (146,246,646) and/or bevels (148,248,648) of corresponding navigation sensor assemblies (110,210,410,510,610,1100) may help ensure that the same navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553, 650,652,653,654,656,657,1144,1146) accurately and reliably positioned at the same distance from the corresponding at a predetermined distance from the distal tip of the instrument (100, 400, 500, 600, 700, 1000).

Figures 44 and 45 show that the navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and the corresponding instruments (100,400,500,600,700,1 Example of optical calibration method (801) for distance between distal tips of 000). Referring to Figure 44, the method (801) begins with step (803) at which an instrument (803) having at least one navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) applied thereto 100, 400, 500, 600, 700) positioned within the optical measurement device. The method (801) proceeds from step (803) to step (805) where the optical measurement device measures the center point or other of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) Reference features and instruments (100, 400, 500, 600, 700, 1000) The distance between the distal ends. The method (801) proceeds from step (805) to step (807) where the optical measurement device communicates the measured distance to the processor. Method (801) proceeds from step (807) to step (809) where the optical measurement device measures the geometry of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146). The method (801) proceeds from step (809) to step (811) where the optical measurement device communicates the measured geometry to the processor. It will be appreciated that the geometry of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) can be directly related to its sensitivity, allowing the processor in some versions to determine the navigation sensor (150,15 2,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) sensitivity. In some versions, one or more of steps (809, 811) may be performed before and/or concurrently with one or more of steps (805, 807). In any case, method (801) proceeds to step (813) where the processor stores calibration data (eg, measured distance, measured geometry, and/or determined sensitivity) in a memory device (eg, , EPROM), the memory device is operatively coupled to the instrument (100, 400, 500, 600, 700, 1000) to facilitate subsequent retrieval of calibration data.

Referring to Figure 45, photographs of exemplary geometric measurements of navigation sensors (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146) using method (801) are shown. Geometric measurements may include measuring corresponding traces (130,132,134,136,230,232,2 34,236,630,632,633,634,636,637) and/or measure the thickness of each segment forming the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1 146) corresponding traces (130,132,134,136,230,232,234,236,630,632,633,634,636,637) the distance between adjacent segments.

V. Exemplary Flexible Circuit with Ablation Electrodes

In some scenarios, it may be desirable to provide RF ablation or cauterization functionality to an instrument, such as a tissue shaving instrument. Such RF ablation or cauterization can be used to stop tissue bleeding, provide other therapeutic effects, and/or provide other kinds of tissue effects. It may further be desirable to utilize flexible circuit technology to provide such RF ablation or cauterization functionality to devices. The use of such flexible circuit technology can facilitate device manufacturing. For example, the device could otherwise be manufactured according to prior practice, where the device would lack RF ablation or cautery functionality, and the flex circuit could be readily applied to the shaft assembly of an otherwise conventional device. Additionally or alternatively, the flexible circuit may provide structurally robust support for the RF ablation or cauterization functionality and allow the instrument's shaft assembly to maintain a small profile despite the addition of the RF ablation or cautery functionality. Several examples of how flexible circuit assemblies can be integrated into tissue shaving instruments to impart RF ablation or cauterization functionality are described in more detail below. In the context of this disclosure, the terms "ablation" and "cauterization" should be understood interchangeably, such that reference to ablation alone should not be understood to exclude cauterization; and reference to cautery alone should not be understood to exclude ablation.

Figure 46 shows an example of a shaft assembly (1200) for a razor instrument incorporating an ablation flex circuit (1230). Only the shaft assembly (1200) of the razor instrument is shown in Figure 46. Shaft assembly (1200) includes an outer shaft (1202) and an inner cutting shaft (1220). Shaft assembly (1200) defines an end effector (1210) formed by a lateral opening (1206) formed at a distal end (1204) of outer shaft (1202), a serrated cutting edge (1208) Extends along the perimeter of opening (1206). Cutting shaft (1220) is positioned within outer shaft (1202) and includes similar lateral openings and cutting edges (1222) complementary to lateral openings (1206) and cutting edges (1208). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1220) relative to the outer shaft (1202) about a longitudinal axis defined by the shaft assembly (1200). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1220) to thereby draw tissue into the lateral opening (1206). As the cutting shaft (1220) rotates relative to the outer shaft (1202), the cutting edges (1208, 1222) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

The flexible circuit (1230) of this example includes a flexible substrate (1232) and a plurality of electrodes (1234). Flexible circuit (1230) may have only a single layer or multiple layers. The flexible substrate (1232) may be formed from an electrically insulating flexible plastic material, such as polyimide or LCP. The flexible substrate (1232) of this example extends longitudinally along the length of the shaft assembly (1200) and wraps at least partially around the distal end (1204) of the outer shaft (1202). In some versions, flexible substrate (1232) is secured to the outer surface of outer shaft (1202) via adhesive. Alternatively, flexible substrate (1232) may be secured to outer shaft (1202) in any other suitable manner.

The electrode (1234) is positioned along a region of the flexible substrate (1232) that at least partially wraps around the distal end (1204) of the outer shaft (1202) such that the electrode (1234) is positioned at the distal end (1202) of the outer shaft (1202). 1204). Electrode (1234) may be vapor deposited on substrate (1232) or may be applied to substrate (1232) in any other suitable manner. Flexible substrate (1232) provides electrical insulation between electrode (1234) and outer shaft (1202) such that flexible substrate (1232) prevents electrode (1234) from energizing outer shaft (1202). Electrode (1234) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1232). In some versions, electrode (1234) is operable to apply bipolar RF energy to tissue in contact with electrode (1234). In some other versions, electrode (1234) is operable to apply monopolar RF energy to tissue in contact with electrode (1234). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1220) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position the electrode (1234) at the distal end (1204) of the outer shaft (1202) since this location will be close to the tissue shaving site.

Although not shown in Figure 46, the flex circuit (1230) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1230) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1210) within the patient's body. Flexible circuit (1230) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1234) and/or tissue adjacent electrode (1234). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1230) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1234) can be integrated into shaft assembly (1200) without the use of flex circuit (1230) such that a flexible substrate (1232) is not necessarily required to integrate electrode (1234) into the shaft. in component(1200).

Figure 47 shows an example of a shaft assembly (1300) for a razor instrument incorporating an ablation flex circuit (1330). Only the shaft assembly (1300) of the razor instrument is shown in Figure 47. Shaft assembly (1300) includes an outer shaft (1302) and an inner cutting shaft (1320) driven for rotation relative to outer shaft (1302) about a longitudinal axis defined by shaft assembly (1300). Shaft assembly (1300) defines an end effector (1310) formed by a lateral opening (1306) formed at a distal end (1304) of outer shaft (1302), a serrated cutting edge (1308) Extends along the perimeter of opening (1306). Cutting shaft (1320) is positioned within outer shaft (1302) and includes similar lateral openings and cutting edges (1322) complementary to lateral openings (1306) and cutting edges (1308). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1320) relative to the outer shaft (1302) about a longitudinal axis defined by the shaft assembly (1300). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1320) to thereby draw tissue into the lateral opening (1306). As the cutting shaft (1320) rotates relative to the outer shaft (1302), the cutting edges (1308, 1322) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

The flexible circuit (1330) of this example includes a flexible substrate (1332) and a plurality of electrodes (1334). Flexible circuit (1330) may have only a single layer or multiple layers. The flexible substrate (1332) may be formed from an electrically insulating flexible plastic material, such as polyimide or LCP. The flexible substrate (1332) of this example extends longitudinally along the length of the shaft assembly (1300), terminating distally at the distal end (1304) of the outer shaft (1302). In some versions, flexible substrate (1332) is secured to the outer surface of outer shaft (1302) via adhesive. Alternatively, flexible substrate (1332) may be secured to outer shaft (1302) in any other suitable manner. Although flexible substrate (1332) is shown extending along only one side of outer shaft (1302), another flexible substrate (1332) may extend along the other side of outer shaft (1302). Additionally, some form of flexible substrate (1332) may be wrapped around the distal end (1304) of outer shaft (1302).

The electrode (1334) is positioned along an area of the flexible substrate (1332) extending beside the longitudinal extension of the lateral opening (1306) of the outer axis (1302) such that the electrode (1334) is positioned beside the lateral opening (1306). Although electrode (1334) is shown positioned adjacent only one longitudinal extension of transverse opening (1306), some versions may also provide electrode (1334) adjacent another longitudinal extension of transverse opening (1306). Additionally or alternatively, in addition to providing electrodes (1334) adjacent either or both of the longitudinal extensions of the transverse opening (1306), some versions may also provide electrodes (1334) along the distal end (1304) ) (eg, similar to electrode (1234)).

Electrode (1334) may be vapor deposited on substrate (1332) or may be applied to substrate (1332) in any other suitable manner. Flexible substrate (1332) provides electrical isolation between electrode (1334) and outer shaft (1302) such that flexible substrate (1332) prevents electrode (1334) from energizing outer shaft (1302). Electrode (1334) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1332). In some versions, electrode (1334) is operable to apply bipolar RF energy to tissue in contact with electrode (1334). In some other versions, electrode (1334) is operable to apply monopolar RF energy to tissue in contact with electrode (1334). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1320) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position electrodes (1334) next to either or both of the longitudinal extensions of transverse openings (1306) since this/these locations will be close to the tissue shaving site.

Although not shown in Figure 47, the flex circuit (1330) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1330) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1310) within the patient's body. Flex circuit (1330) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1334) and/or tissue adjacent electrode (1334). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1330) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1334) can be integrated into shaft assembly (1300) without the use of flex circuit (1330) such that a flexible substrate (1332) is not necessarily required to integrate electrode (1334) into the shaft. in component(1300).

Figure 48 shows an example of a shaft assembly (1400) for a razor instrument incorporating an ablation flex circuit (1430). Only the shaft assembly (1400) of the razor instrument is shown in Figure 48. Shaft assembly (1400) includes an outer shaft (1402) and an inner cutting shaft (1420) driven for rotation relative to outer shaft (1402) about a longitudinal axis defined by shaft assembly (1400). Shaft assembly (1400) defines an end effector (1410) formed by a lateral opening (1406) formed at a distal end (1404) of outer shaft (1402), a serrated cutting edge (1408) Extends along the perimeter of opening (1406). Cutting shaft (1420) is positioned within outer shaft (1402) and includes similar lateral openings and cutting edges (1422) complementary to lateral openings (1406) and cutting edges (1408). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1420) relative to the outer shaft (1402) about a longitudinal axis defined by the shaft assembly (1400). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1420) to thereby draw tissue into the lateral opening (1406). As the cutting shaft (1420) rotates relative to the outer shaft (1402), the cutting edges (1408, 1422) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

The flexible circuit (1430) of this example includes a longitudinally extending flexible substrate portion (1432), a circumferentially extending flexible substrate portion (1434), and a plurality of electrodes (1436). Flexible circuit (1430) may have only a single layer or multiple layers. The flexible substrate portions (1432, 1434) are integrally formed together, with the circumferentially extending flexible substrate portion (1434) positioned just proximal of the transverse opening (1406). The flexible substrate portions (1432, 1434) are each formed from an electrically insulating flexible plastic material, such as polyimide or LCP. In some versions, base plate portions (1432, 1434) are secured to the outer surface of outer shaft (1402) via adhesive. Alternatively, the flexible substrate portions (1432, 1434) may be secured to the outer shaft (1402) in any other suitable manner. Although one longitudinally extending flexible substrate portion (1432) is shown extending along only one side of the outer axis (1402), another longitudinally extending flexible substrate portion (1432) may extend along the other side of the outer axis (1402) . Additionally, some versions of flexible circuit (1430) may include a flexible substrate portion wrapped around the distal end (1404) of outer shaft (1402).

The electrode (1436) is positioned along the circumferentially extending flexible substrate portion (1434) such that the electrode (1436) is positioned just proximal of the lateral opening (1406). In this example, the electrodes (1436) are formed as discrete squares or rectangles arranged in an array spanning the entire circumference about the outer axis (1402). In some variations, in addition to the circumferential array of electrodes (1436), the flexible circuit (1430) includes one or more electrodes extending longitudinally alongside one or both longitudinally extending regions of the lateral opening (1406) (e.g., Similar to electrode 1336)). Additionally or alternatively, in addition to the circumferential array of electrodes (1436), some variations of the flexible circuit (1430) may include one or more electrodes at the distal end (1404) of the outer shaft (1402) (e.g., , similar to electrode 1236)).

Electrode (1434) may be vapor deposited on substrate (1432) or may be applied to substrate (1432) in any other suitable manner. Flexible substrate (1432) provides electrical isolation between electrode (1434) and outer shaft (1402) such that flexible substrate (1432) prevents electrode (1434) from energizing outer shaft (1402). Electrode (1434) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1432). In some versions, electrode (1434) is operable to apply bipolar RF energy to tissue in contact with electrode (1434). In some other versions, electrode (1434) is operable to apply monopolar RF energy to tissue in contact with electrode (1434). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1420) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position the electrode (1434) just proximal of the transverse opening (1406) since this location will be close to the tissue shaving site.

Although not shown in Figure 48, the flex circuit (1430) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1430) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1410) within the patient's body. Flexible circuit (1430) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1434) and/or tissue adjacent electrode (1434). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1430) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1434) may be integrated into shaft assembly (1400) without the use of flex circuit (1430) such that a flexible substrate (1432) is not necessarily required to integrate electrode (1434) into the shaft. in component(1400).

Figure 49 shows an example of a shaft assembly (1500) for a razor instrument incorporating an ablation flex circuit (1530). Only the shaft assembly (1500) of the razor instrument is shown in Figure 49. Shaft assembly (1500) includes an outer shaft (1502) and an inner cutting shaft (1520) driven for rotation relative to outer shaft (1502) about a longitudinal axis defined by shaft assembly (1500). Shaft assembly (1500) defines an end effector (1510) formed by a lateral opening (1506) formed at a distal end (1504) of outer shaft (1502), a serrated cutting edge (1508) Extends along the perimeter of opening (1506). Cutting shaft (1520) is positioned within outer shaft (1502) and includes similar lateral openings and cutting edges (1522) complementary to lateral openings (1506) and cutting edges (1508). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1520) relative to the outer shaft (1502) about a longitudinal axis defined by the shaft assembly (1500). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1520) to thereby draw tissue into the lateral opening (1506). As the cutting shaft (1520) rotates relative to the outer shaft (1502), the cutting edges (1508, 1522) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

The flexible circuit (1530) of this example includes a longitudinally extending flexible substrate portion (1532), a circumferentially extending flexible substrate portion (1534), and a pair of electrodes (1536). Flexible circuit (1530) may have only a single layer or multiple layers. The flexible substrate portions (1532, 1534) are integrally formed together, with the circumferentially extending flexible substrate portion (1534) positioned just proximal of the transverse opening (1506). The flexible substrate portions (1532, 1534) are each formed from an electrically insulating flexible plastic material, such as polyimide or LCP. In some versions, base plate portions (1532, 1534) are secured to the outer surface of outer shaft (1502) via adhesive. Alternatively, the flexible substrate portions (1532, 1534) may be secured to the outer shaft (1502) in any other suitable manner. Although one longitudinally extending flexible substrate portion (1532) is shown extending along only one side of the outer axis (1502), another longitudinally extending flexible substrate portion (1532) may extend along the other side of the outer axis (1502) . Additionally, some versions of flexible circuit (1530) may include a flexible substrate portion wrapped around the distal end (1504) of outer shaft (1502).

The electrode (1536) is positioned along the circumferentially extending flexible substrate portion (1534) such that the electrode (1536) is positioned just proximal to the lateral opening (1506). In this example, the electrodes (1536) are formed as two discrete strips that span together around the circumference of the outer axis (1502), defining a small gap between the free ends of the electrodes (1536). The electrode (1536) is therefore generally semicircular. In some variations, in addition to the circumferential arrangement of electrodes (1536), flexible circuit (1530) includes one or more electrodes extending longitudinally alongside one or both longitudinally extending regions of lateral opening (1506) (e.g., Similar to electrode 1336)). Additionally or alternatively, in addition to the circumferential arrangement of electrodes (1536), some variations of the flexible circuit (1530) may include one or more electrodes (e.g., , similar to electrode 1236)).

Electrode (1534) may be vapor deposited on substrate (1532) or may be applied to substrate (1532) in any other suitable manner. Flexible substrate (1532) provides electrical insulation between electrode (1534) and outer shaft (1502) such that flexible substrate (1532) prevents electrode (1534) from energizing outer shaft (1502). Electrode (1534) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1532). In some versions, electrode (1534) is operable to apply bipolar RF energy to tissue in contact with electrode (1534). In some other versions, electrode (1534) is operable to apply monopolar RF energy to tissue in contact with electrode (1534). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1520) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position the electrode (1534) just proximal to the lateral opening (1506) since this location will be close to the tissue shaving site.

Although not shown in Figure 49, the flex circuit (1530) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1530) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1510) within the patient's body. Flex circuit (1530) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1534) and/or tissue adjacent electrode (1534). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1530) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1534) may be integrated into shaft assembly (1400) without the use of flex circuit (1530) such that a flexible substrate (1532) is not necessarily required to integrate electrode (1534) into the shaft. in component(1500).

Although the flexible circuit (1230, 1330, 1430, 1530) is shown and described in the context of the tissue shaving instrument shaft assembly (1200, 1300, 1400, 1500), the flexible circuit assembly (e.g., the flexible circuit (1230, 1330, 1430,1530)) can be easily used with any other suitable kind of instrument. Flexible circuit components, such as flexible circuits (1230, 1330, 1430, 1530), need not be limited to the context of tissue shaving devices. By way of example only, flexible circuit assemblies such as flexible circuits (1230, 1330, 1430, 1530) may be used with endoscopes, different types of ENT devices, and/or as will become apparent to those skilled in the art in light of the teachings herein. Any other kind of instrument integration is obvious.

VI.Exemplary combinations

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 limit the coverage of any claims that may be presented at any time in this patent application or in a subsequent filing of this patent application. No disclaimer is intended. The following examples are provided for illustrative purposes only. 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 embodiments. Accordingly, none of the aspects or features mentioned below should be considered decisive unless otherwise expressly stated so, for example by the inventor or a successor interested in the inventor at a later date. If any claim set forth in this patent application or in subsequent filings related to this patent application includes additional features beyond those mentioned below, these additional features shall not be assumed for any reason relevant to patentability And was added.

Example 1

An ENT surgical instrument comprising: (a) a shaft assembly having a distal end sized and configured to fit within the ear, nose, or throat of a patient; in the anatomical channel; (b) a flexible substrate extending along at least a portion of the shaft; and (c) at least one conductive sensor trace formed on the flexible substrate, wherein said at least one sensor trace includes at least one concentric ring portion, wherein said at least one concentric ring portion defines at least one navigation sensor.

Example 2

The ENT surgical instrument of embodiment 1, wherein the at least one navigation sensor includes a proximal navigation sensor and at least one distal navigation sensor.

Example 3

The ENT surgical instrument of embodiment 2, wherein the at least one distal navigation sensor includes a pair of laterally adjacent distal navigation sensors.

Example 4

The ENT surgical instrument of any one of embodiments 2-3, wherein the proximal navigation sensor and the distal navigation sensor are electrically isolated from each other.

Example 5

The ENT surgical instrument of any one of embodiments 1 to 4, wherein the flexible substrate includes a top surface and a bottom surface, and wherein the at least one navigation sensor includes a top navigation sensor positioned on the top surface and a positioning A bottom navigation sensor on the bottom surface opposite the top navigation sensor.

Example 6

The ENT surgical instrument of embodiment 5, wherein the top navigation sensor and the bottom navigation sensor are electrically coupled to each other.

Example 7

The ENT surgical instrument of any one of embodiments 1-6, further comprising at least one sensor lead electrically coupled to a proximal end of the at least one sensor trace, wherein the at least one sensor lead is configured operatively coupled to the processor.

Example 8

The ENT surgical instrument of embodiment 7, wherein the at least one sensor lead is positioned proximally relative to the at least one navigation sensor.

Example 9

The ENT surgical instrument according to any one of embodiments 1 to 8, wherein the flexible substrate is at least one of a rectangular shape or a serpentine shape.

Example 10

The ENT surgical instrument of any one of embodiments 1-9, wherein the flexible substrate is configured to transition between a flat configuration and at least one curved configuration.

Example 11

The ENT surgical instrument of any one of embodiments 1 to 10, the shaft assembly includes a shaft member, wherein the flexible base plate is secured to the shaft member.

Example 12

The ENT surgical instrument of embodiment 11, wherein the shaft member includes an inner chord, and wherein the flexible substrate is disposed along the inner chord in a flat configuration.

Example 13

The ENT surgical instrument of embodiment 11, wherein the shaft member includes a cylindrical inner surface, and wherein the flexible substrate is disposed along the cylindrical inner surface in at least one curved configuration.

Example 14

The ENT surgical instrument of embodiment 11, wherein the shaft member includes a cylindrical outer surface, and wherein the flexible substrate is disposed along the cylindrical outer surface in at least one curved configuration.

Example 15

The ENT surgical instrument of any one of embodiments 1 to 14, wherein the shaft assembly includes a flexible portion, and wherein the flexible base plate extends along the flexible portion.

Example 16

An ENT surgical instrument comprising: (a) a shaft assembly having a distal end sized and configured to fit within the ear, nose, or throat of a patient; in the anatomical channel; (b) a flexible substrate extending along at least a portion of the shaft, the flexible substrate having a top surface and a bottom surface; (c) a proximal top conductive sensor trace, the proximal top A conductive sensor trace is formed on the top surface, wherein the proximal top sensor trace includes a proximal top concentric ring portion, wherein the proximal top concentric ring portion defines a proximal top navigation sensor; (d) at least one a distal top conductive sensor trace, the at least one distal top conductive sensor trace being formed on the top surface, wherein the at least one distal top sensor trace includes at least one distal top concentric ring portion, wherein the at least one distal top conductive sensor trace the at least one distal top concentric ring portion defines at least one distal top navigation sensor; (e) a proximal bottom conductive sensor trace formed on the bottom surface, wherein the proximal bottom conductive sensor trace is formed on the bottom surface, wherein the proximal bottom conductive sensor trace is formed on the bottom surface; a side bottom sensor trace including a proximal bottom concentric ring portion, wherein the proximal bottom concentric ring portion defines a proximal bottom navigation sensor; (f) at least one distal bottom conductive sensor trace, the at least one distal bottom conductive A sensor trace is formed on the bottom surface, wherein the at least one distal bottom sensor trace includes at least one distal bottom concentric ring portion, wherein the at least one distal bottom concentric ring portion defines at least one distal bottom navigation sensor.

Example 17

The ENT surgical instrument of embodiment 16, wherein the proximal bottom sensor trace is positioned opposite the proximal top sensor trace, wherein the at least one distal bottom sensor trace is positioned opposite the at least one A far side top sensor trace is opposite.

Example 18

The ENT surgical instrument of any one of embodiments 16-17, wherein the at least one distal top sensor trace includes a pair of laterally adjacent distal top sensor traces, wherein the at least one distal top sensor trace The bottom sensor traces include a pair of laterally adjacent distal bottom sensor traces.

Example 19

A method of using an ENT surgical instrument having (i) a flexible substrate and (ii) at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace includes at least one Concentric ring portions, wherein the at least one concentric ring portion defines at least one navigation sensor, the method comprising: (a) inserting the flexible substrate into an anatomical passage within at least one of the patient's ear, nose, or throat; (b) exposing the at least one navigation sensor to an electromagnetic field; (c) generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field; (d) based on the generated signals to navigate a distal portion of the ENT surgical instrument through the anatomical passage; and (e) treat the anatomical passage via the ENT surgical instrument.

Example 20

The method of embodiment 19, wherein treating the anatomical passage via the ENT surgical instrument includes dilating the anatomical passage, applying RF energy to tissue within the anatomical passage, severing tissue within the anatomical passage or removing at least one of the debris from the anatomical passage.

Example 21

An apparatus comprising: (a) a shaft assembly having a distal end sized and configured to fit an anatomical passage in the ear, nose, or throat of a patient in; (b) a flexible substrate extending along at least a portion of the axis; (c) at least one navigation sensor positioned on the flexible substrate; and (d) at least one electrically conductive A camera trace, the at least one conductive camera trace is formed on the flexible substrate, wherein the at least one camera trace is configured to operatively couple a camera to at least one of a processor or a power source.

Example 22

The apparatus of embodiment 21, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.

Example 23

The apparatus of any one of embodiments 21 to 22, wherein the at least one navigation sensor includes a proximal navigation sensor and a distal navigation sensor.

Example 24

The apparatus of any one of embodiments 21 to 23, wherein the flexible substrate includes a top surface and a bottom surface, and wherein the at least one navigation sensor includes a top navigation sensor positioned on the top surface and a top navigation sensor positioned on the top surface. a bottom navigation sensor on the bottom surface opposite the top navigation sensor.

Example 25

The apparatus of any one of embodiments 21 to 24, wherein the flexible substrate includes a surface, wherein the at least one navigation sensor is positioned on the surface, and wherein the at least one camera trace is formed on the surface superior.

Example 26

The apparatus of any one of embodiments 21-25, further comprising at least one proximal camera lead electrically coupled to a proximal end of the at least one camera trace, wherein the at least one proximal camera lead Configured to be operatively coupled to at least one of a processor or a power source.

Example 27

The device of embodiment 26, wherein the at least one proximal camera lead is positioned proximally relative to the at least one navigation sensor.

Example 28

The apparatus of any one of embodiments 21-27, further comprising at least one distal camera lead electrically coupled to a distal end of the at least one camera trace, wherein the at least one distal camera lead configured to be operatively coupled to the camera.

Example 29

The device of embodiment 28, wherein the at least one distal camera lead is positioned distally relative to the at least one navigation sensor.

Example 30

The apparatus of any one of embodiments 21 to 29, wherein the at least one camera trace includes a plurality of camera traces.

Example 31

The apparatus of embodiment 30, wherein the plurality of camera traces are located laterally to the side of the at least one navigation sensor.

Example 32

The apparatus of any one of embodiments 21-31, further comprising the camera, wherein the at least one camera trace is operatively coupled to the camera.

Example 33

The apparatus of any one of embodiments 21-32, further comprising at least one of the processor or the power source, wherein the at least one camera trace is operatively coupled to the processor or the power source. The at least one of the power sources.

Example 34

The apparatus of any one of embodiments 21 to 33, the shaft assembly including a flexible portion, the flexible base plate being secured to the flexible portion, the flexible base plate being further configured to flex with the flexible portion.

Example 35

The device of any one of embodiments 21 to 34, the shaft assembly includes one or more electrodes operable to apply RF energy to tissue.

Example 36

A device comprising: (a) a camera; (b) a processor; (c) a power source; (d) a flexible substrate; (e) at least one navigation sensor positioned on the flexible substrate ; and (f) a first conductive camera trace and a second conductive camera trace formed on the flexible substrate, wherein the first camera trace and the second conductive camera trace are formed on the flexible substrate. A trace operatively couples the camera to the processor, wherein the second camera trace operatively couples the camera to the power source.

Example 37

The apparatus of embodiment 36, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.

Example 38

A method of using a device having (i) a flexible substrate, (ii) at least one navigation sensor positioned on the flexible substrate, and (iii) at least one conductive camera trace formed on the flexible substrate , the method includes: (a) operatively coupling a camera to at least one of a processor or a power source via the at least one camera trace; (b) inserting the flexible substrate into an anatomical passage of a patient; (c) exposing the at least one navigation sensor to an electromagnetic field; (d) generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field; (e) based on the generated signals to navigate the distal portion of the device through the anatomical channel; and (f) visualizing, via the camera, a portion of the anatomical channel distal to the distal portion of the device.

Example 39

The method of embodiment 38, wherein navigating the distal portion of the device through the anatomical passage includes bending the flexible base plate.

Example 40

The method of any one of embodiments 38-39, further comprising applying RF energy to tissue within the anatomical channel.

Example 41

An apparatus comprising: (a) a shaft assembly having a distal end sized and configured to fit an anatomical passage in the ear, nose, or throat of a patient in; (b) a substrate positioned along at least a portion of the axis; (c) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor The trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and (d) at least one temperature sensor positioned on the substrate.

Example 42

The apparatus of embodiment 41, wherein the at least one temperature sensor is configured to detect the temperature of the at least one sensor trace.

Example 43

The apparatus of embodiment 42, wherein the at least one temperature sensor includes at least one of a thermocouple or a thermistor.

Example 44

The apparatus of any one of embodiments 42-43, further comprising a processor, wherein the processor is operatively coupled to the at least one navigation sensor and the at least one temperature sensor such that the at least one navigation sensor A sensor is operable to transmit a position signal to the processor, and the at least one temperature sensor is operable to transmit a temperature signal to the processor.

Example 45

The apparatus of embodiment 44, wherein the processor is configured to process based on the position signal transmitted to the processor by the at least one navigation sensor and based on the position signal transmitted to the processor by the at least one temperature sensor The temperature signal of the device is used to determine the position coordinates.

Example 46

The apparatus of embodiment 45, wherein the processor is configured to apply a correction factor to the location coordinates in response to the temperature signal indicating a change in the detected temperature.

Example 47

The apparatus of any one of embodiments 45 to 46, wherein the processor is configured to correlate changes in the detected temperature with changes in resistance of the at least one sensor trace.

Example 48

The apparatus of any one of embodiments 41 to 47, wherein the substrate includes a surface, wherein the at least one navigation sensor is positioned on the surface, and wherein the at least one temperature sensor is positioned on the surface.

Example 49

The device of any one of embodiments 41 to 48, wherein the substrate is flexible.

Example 50

The apparatus of any one of embodiments 41 to 49, wherein the at least one navigation sensor includes a proximal navigation sensor and a distal navigation sensor.

Example 51

The apparatus of embodiment 50, wherein the at least one temperature sensor includes at least one proximal temperature sensor positioned adjacent the proximal navigation sensor, and at least one distal temperature sensor positioned adjacent the distal navigation sensor sensor.

Example 52

The apparatus of embodiment 51, wherein the at least one proximal temperature sensor is positioned proximally relative to the proximal navigation sensor, and wherein the at least one distal temperature sensor is positioned proximally relative to the distal navigation sensor. proximal and positioned distally relative to the proximal navigation sensor.

Example 53

The apparatus of any one of embodiments 41 to 52, wherein the at least one temperature sensor includes a pair of laterally adjacent temperature sensors.

Example 54

An ENT surgical instrument comprising: (a) a powered component configured to generate heat; and (b) the device of any one of embodiments 41 to 53, wherein the at least one navigation sensor Exposure to heat generated by the power components.

Example 55

The ENT surgical instrument of embodiment 54, wherein the powered component includes (i) an electrode configured to deliver RF energy to tissue, or (ii) a motor configured to drive a cutting member for severing tissue. At least one.

Example 56

An apparatus comprising: (a) a shaft assembly having a distal end sized and configured to fit an anatomical passage in the ear, nose, or throat of a patient in; (b) a substrate extending along at least a portion of the axis; (c) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor The trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and (d) a processor, wherein the processor is operatively coupled to the at least one navigation sensor, wherein the The processor is configured to monitor the temperature of the at least one sensor trace.

Example 57

A method of using a device having (i) a substrate and (ii) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace includes at least one concentric ring portion, wherein the The at least one concentric ring portion defines at least one navigation sensor, and the method includes: (a) inserting the flexible substrate into an anatomical passage of the patient; (b) exposing the at least one navigation sensor to an electromagnetic field; (c) responding generating a signal via the at least one navigation sensor upon the act of exposing the at least one navigation sensor to the electromagnetic field; (d) determining position coordinates based on the generated signal; (e) detecting the at least one sensor trace and (f) adjusting the position coordinates in response to detecting a temperature change of the at least one sensor trace.

Example 58

The method of embodiment 57, wherein the act of adjusting the location coordinates includes applying a correction factor to the location coordinates, wherein the correction factor corresponds to the detected temperature change.

Example 59

A method as in any one of embodiments 57 to 58, wherein said act of detecting temperature changes of said at least one sensor trace is performed via a temperature sensor.

Example 60

A method as in any one of embodiments 57-58, wherein the act of detecting a change in temperature of the at least one sensor trace includes detecting a change in electrical impedance of the at least one sensor trace.

Example 61

An apparatus comprising: (a) an inner shaft defining a lumen sized to receive an instrument; (b) an outer shaft securely positioned relative to the inner shaft fixed, the outer shaft and the inner shaft are arranged coaxially; and (c) a first navigation sensor, the first navigation sensor is radially inserted between the inner shaft and the outer shaft, so The first navigation sensor is operable to generate a signal indicative of a position of the first navigation sensor in three-dimensional space.

Example 62

According to the device of embodiment 61, the inner cavity is sized to receive a shaft assembly of a tissue shaving instrument.

Example 63

The apparatus of embodiment 62, further comprising a tissue shaving instrument having a shaft assembly, the lumen being sized to receive the shaft assembly of the tissue shaving instrument.

Example 64

The apparatus of embodiment 63, the shaft assembly of the tissue shaving instrument having a transverse opening configured to receive tissue, the inner shaft and the outer shaft each having a length, the length being Arranged to provide exposure of the transverse opening when the shaft assembly of the tissue shaving instrument is fully inserted within the lumen.

Example 65

The apparatus of embodiment 64, the first navigation sensor configured for positioning adjacent and proximal to the lateral opening when the shaft assembly of the tissue shaving instrument is fully inserted into the lumen. .

Example 66

The apparatus of any one of embodiments 61 to 65, further comprising a flexible substrate radially interposed between the inner shaft and the outer shaft, the first navigation sensor positioned on the flexible substrate as part of a flexible circuit.

Example 67

The apparatus of embodiment 66, the flexible substrate extends along the length of the inner shaft and along the length of the outer shaft.

Example 68

The apparatus of embodiment 67, the flexible substrate having a distal end, the first navigation sensor being positioned at the distal end of the flexible substrate.

Example 69

The apparatus of any one of embodiments 61 to 68, further comprising a second navigation sensor radially interposed between the inner shaft and the outer shaft, the second navigation sensor operable to generate A signal indicating the position of the second navigation sensor in three-dimensional space.

Example 70

The apparatus of embodiment 69, the second navigation sensor is positioned proximal to the first navigation sensor.

Example 71

The apparatus of any one of embodiments 69 to 70, further comprising a flexible substrate radially interposed between the inner shaft and the outer shaft, the first navigation sensor and the second navigation sensor Sensors are each positioned on the flexible substrate as part of a flexible circuit.

Example 72

The device of any one of embodiments 61-71, further comprising a hub positioned at a proximal end of one or both of the inner shaft or the outer shaft.

Example 73

The device of embodiment 72, the hub is configured to removably couple with an instrument received in the lumen.

Example 74

The device of any one of embodiments 61 to 73, the inner shaft having an open distal end and an open proximal end.

Example 75

The device of any one of embodiments 61 to 74, the outer shaft having an open distal end and an open proximal end.

Example 76

An apparatus comprising: (a) a shaft assembly including an outer shaft having an outer surface, a length and a distal end; (b) a flexible circuit including: (i) a flexible substrate secured to the outer surface of the outer shaft, at least a portion of the flexible substrate extending along the length of the outer shaft, and (ii) a plurality of electrodes, the plurality of electrodes Secured to the flexible substrate, the electrode is positioned at or near the distal end of the outer shaft, the electrode operable to apply RF energy to tissue to ablate the tissue.

Example 77

The device of embodiment 76, the electrodes are arranged in an array extending along the distal end of the outer shaft.

Example 78

The apparatus of any one of embodiments 76 to 77, said electrode being arranged to extend along a portion of said length of said outer shaft along a region proximal to said distal end of said outer shaft array.

Example 79

The apparatus of any one of embodiments 76 to 78, the outer shaft defining a circumference, the electrodes being arranged in an array extending around the circumference of the outer shaft.

Example 80

The device of embodiment 79, the electrodes include two electrodes, each of the two electrodes having a generally semicircular shape.

Example 81

According to the device of embodiment 79, the electrodes include a plurality of square or rectangular shaped electrodes.

Example 82

The apparatus of any one of embodiments 76 to 81, the outer shaft defining a circumference, the flexible substrate including a longitudinally extending portion and a circumferentially extending portion, the longitudinally extending portion along the length of the outer shaft Extending, the circumferential extension extends around the circumference of the outer shaft.

Example 83

The apparatus of embodiment 82, the longitudinally extending portion having a distal end, the circumferentially extending portion being located at the distal end of the longitudinally extending portion.

Example 84

The apparatus of any one of embodiments 82 to 83, at least some of the electrodes being positioned along the circumferentially extending portion in a circumferentially extending array.

Example 85

The device of any one of embodiments 76-84, the outer shaft further defining an opening configured to receive tissue, the shaft assembly further comprising a cutting shaft configured to sever tissue received in the opening. .

Example 86

The apparatus of embodiment 85, the opening having a transverse orientation on the outer axis such that at least a portion of the opening extends longitudinally along the axis.

Example 87

The apparatus of embodiment 86, at least some of the electrodes extend longitudinally in an array beside the opening.

Example 88

The device of any one of embodiments 85 to 86, at least some of the electrodes are positioned proximal of the opening.

Example 89

The device of any one of embodiments 85 to 88, at least some of the electrodes are positioned distally of the opening.

VII.Miscellaneous

It is to be understood that any of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any of the other teachings, expressions, embodiments, examples, etc. described herein . Accordingly, the above teachings, expressions, implementations, examples, etc. should not be considered in isolation from each other. Various suitable ways in which the teachings herein may be combined will be 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.

Devices of the type described above may be designed for single use and then discarded, or they may be designed for multiple uses. In either or both cases, these versions can be repaired for reuse after at least one use. Restoration can include any combination of the following steps: disassembly of the unit, followed by cleaning or replacement of specific parts and subsequent reassembly. In particular, some types of devices may be disassembled, and any number of specific parts or portions of the device may be selectively replaced or removed in any combination. When certain parts are cleaned and/or replaced, some types of devices may be reassembled at a reconditioning facility or by the user immediately prior to the procedure for subsequent use. Those skilled in the art will appreciate that device repair may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting repair devices are within the scope of this application.

By way of example only, the versions described herein may be sterilized before and/or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or TYVEK bag. The container and device can then be placed in a radiation field that penetrates the container, such as gamma radiation, x-rays, or high-energy electrons. Radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. The 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.

Having shown and described various embodiments of the invention, further improvements in the methods and systems described herein may be effected by those of ordinary skill in the art with appropriate modifications without departing from the scope of the invention. Several such possible modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, implementations, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the invention should be considered in light of the following claims, and should be understood not to be limited to the details of construction and operation shown and described in the specification and drawings.

Claims (89)

1. An ENT surgical instrument, comprising:

(a) A shaft assembly having a distal end sized and configured to fit in an anatomic passageway in a patient's ear, nose, or throat;

(b) A flexible substrate extending along at least a portion of the shaft; and

(c) At least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor.

2. The ENT surgical instrument of claim 1, wherein the at least one navigation sensor comprises a proximal navigation sensor and at least one distal navigation sensor.

3. The ENT surgical instrument of claim 2, wherein the at least one distal navigation sensor comprises a pair of laterally adjacent distal navigation sensors.

4. The ENT surgical instrument of any one of claims 2-3, wherein the proximal and distal navigation sensors are electrically isolated from each other.

5. The ENT surgical instrument of any one of claims 1-4, wherein the flexible substrate comprises a top surface and a bottom surface, wherein the at least one navigation sensor comprises a top navigation sensor positioned on the top surface and a bottom navigation sensor positioned on the bottom surface opposite the top navigation sensor.

6. The ENT surgical instrument of claim 5, wherein the top navigation sensor and the bottom navigation sensor are electrically coupled to each other.

7. The ENT surgical instrument of any one of claims 1-6, further comprising at least one sensor lead electrically coupled to a proximal end of the at least one sensor trace, wherein the at least one sensor lead is configured to be operatively coupled to a processor.

8. The ENT surgical instrument of claim 7, wherein the at least one sensor lead is positioned proximally relative to the at least one navigation sensor.

9. The ENT surgical instrument of any one of claims 1-8, wherein the flexible substrate is at least one of rectangular or serpentine.

10. The ENT surgical instrument of any one of claims 1-9, wherein the flexible substrate is configured to transition between a flat configuration and at least one curved configuration.

11. The ENT surgical instrument of any one of claims 1-10, the shaft assembly comprising a shaft member, wherein the flexible substrate is secured to the shaft member.

12. The ENT surgical instrument of claim 11, wherein the shaft member comprises an inner chord, wherein the flexible substrate is disposed along the inner chord in a flat configuration.

13. The ENT surgical instrument of claim 11, wherein the shaft member comprises a cylindrical inner surface, wherein the flexible substrate is disposed along the cylindrical inner surface in at least one curved configuration.

14. The ENT surgical instrument of claim 11, wherein the shaft member comprises a cylindrical outer surface, wherein the flexible substrate is disposed along the cylindrical outer surface in at least one curved configuration.

15. The ENT surgical instrument of any one of claims 1-14, wherein the shaft assembly comprises a flexible portion, wherein the flexible substrate extends along the flexible portion.

16. An ENT surgical instrument, comprising:

(a) A shaft assembly having a distal end sized and configured to fit in an anatomic passageway in a patient's ear, nose, or throat;

(b) A flexible substrate extending along at least a portion of the shaft, the flexible substrate having a top surface and a bottom surface;

(c) A proximal top conductive sensor trace formed on the top surface, wherein the proximal top sensor trace comprises a proximal top concentric ring portion, wherein the proximal top concentric ring portion defines a proximal top navigation sensor;

(d) At least one distal top conductive sensor trace formed on the top surface, wherein the at least one distal top sensor trace comprises at least one distal top concentric ring portion, wherein the at least one distal top concentric ring portion defines at least one distal top navigation sensor;

(e) A proximal bottom conductive sensor trace formed on the bottom surface, wherein the proximal bottom sensor trace comprises a proximal bottom concentric ring portion, wherein the proximal bottom concentric ring portion defines a proximal bottom navigation sensor; and

(f) At least one distal bottom conductive sensor trace formed on the bottom surface, wherein the at least one distal bottom sensor trace comprises at least one distal bottom concentric ring portion, wherein the at least one distal bottom concentric ring portion defines at least one distal bottom navigation sensor.

17. The ENT surgical instrument of claim 16, wherein the proximal bottom sensor trace is positioned opposite the proximal top sensor trace, wherein the at least one distal bottom sensor trace is positioned opposite the at least one distal top sensor trace.

18. The ENT surgical instrument of any one of claims 16-17, wherein the at least one distal top sensor trace comprises a pair of laterally adjacent distal top sensor traces, wherein the at least one distal bottom sensor trace comprises a pair of laterally adjacent distal bottom sensor traces.

19. A method of using an ENT surgical instrument having (i) a flexible substrate and (ii) at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor, the method comprising:

(a) Inserting the flexible substrate into an anatomical passageway within at least one of an ear, nose, or throat of a patient;

(b) Exposing the at least one navigation sensor to an electromagnetic field;

(c) Generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field;

(d) Navigating a distal portion of the ENT surgical instrument through the anatomic passageway based on the generated signals; and

(e) The anatomic passageway is treated via the ENT surgical instrument.

20. The method of claim 19, wherein the act of treating the anatomical passageway via the ENT surgical instrument comprises at least one of: expanding the anatomic passageways, applying RF energy to tissue within the anatomic passageways, severing tissue within the anatomic passageways, or removing debris from the anatomic passageways.

21. An apparatus, comprising:

(a) A shaft assembly having a distal end sized and configured to fit in an anatomic passageway in a patient's ear, nose, or throat;

(b) A flexible substrate extending along at least a portion of the shaft;

(c) At least one navigation sensor positioned on the flexible substrate; and

(d) At least one conductive camera trace formed on the flexible substrate, wherein the at least one camera trace is configured to operatively couple a camera to at least one of a processor or a power source.

22. The apparatus of claim 21, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.

23. The apparatus of any one of claims 21 to 22, wherein the at least one navigation sensor comprises a proximal navigation sensor and a distal navigation sensor.

24. The apparatus of any of claims 21-23, wherein the flexible substrate comprises a top surface and a bottom surface, wherein the at least one navigation sensor comprises a top navigation sensor positioned on the top surface and a bottom navigation sensor positioned on the bottom surface opposite the top navigation sensor.

25. The apparatus of any of claims 21-24, wherein the flexible substrate comprises a surface, wherein the at least one navigation sensor is positioned on the surface, wherein the at least one camera trace is formed on the surface.

26. The apparatus of any of claims 21-25, further comprising at least one proximal camera lead electrically coupled to a proximal end of the at least one camera trace, wherein the at least one proximal camera lead is configured to be operatively coupled to at least one of a processor or a power source.

27. The apparatus of claim 26, wherein the at least one proximal camera lead is positioned proximally relative to the at least one navigation sensor.

28. The device of any of claims 21-27, further comprising at least one distal camera lead electrically coupled to a distal end of the at least one camera trace, wherein the at least one distal camera lead is configured to be operatively coupled to the camera.

29. The apparatus of claim 28, wherein the at least one distal camera lead is positioned distally relative to the at least one navigation sensor.

30. The apparatus of any of claims 21 to 29, wherein the at least one camera trace comprises a plurality of camera traces.

31. The apparatus of claim 30, wherein the plurality of camera traces are laterally located to a side of the at least one navigation sensor.

32. The device of any of claims 21 to 31, further comprising the camera, wherein the at least one camera trace is operatively coupled to the camera.

33. The apparatus of any one of claims 21 to 32, further comprising at least one of the processor or the power source, wherein the at least one camera trace is operatively coupled to the at least one of the processor or the power source.

34. The apparatus of any one of claims 21 to 33, the shaft assembly comprising a flexible portion, the flexible substrate being secured to the flexible portion, the flexible substrate being further configured to flex with the flexible portion.

35. The apparatus of any one of claims 21 to 34, the shaft assembly comprising one or more electrodes operable to apply RF energy to tissue.

36. An apparatus, comprising:

(a) A camera;

(b) A processor;

(c) A power source;

(d) A flexible substrate;

(e) At least one navigation sensor positioned on the flexible substrate; and

(f) A first conductive camera trace and a second conductive camera trace, the first conductive camera trace and the second conductive camera trace being formed on the flexible substrate,

wherein the first camera trace operatively couples the camera to the processor, wherein the second camera trace operatively couples the camera to the power source.

37. The apparatus of claim 36, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.

38. A method of using a device having (i) a flexible substrate, (ii) at least one navigation sensor positioned on the flexible substrate, and (iii) at least one conductive camera trace formed on the flexible substrate, the method comprising:

(a) Operatively coupling a camera to at least one of a processor or a power source via the at least one camera trace;

(b) Inserting the flexible substrate into an anatomic passageway of a patient;

(c) Exposing the at least one navigation sensor to an electromagnetic field;

(d) Generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field;

(e) Navigating a distal portion of the device through the anatomic passageway based on the generated signals; and

(f) A portion of the anatomic passageway distal to the distal portion of the device is visualized via the camera.

39. The method of claim 38, wherein the act of navigating the distal portion of the device through the anatomic passageway comprises bending the flexible substrate.

40. The method of any one of claims 38 to 39, further comprising applying RF energy to tissue within the anatomic passageway.

41. An apparatus, comprising:

(a) A shaft assembly having a distal end sized and configured to fit within a patient's ear _、 In an anatomic passageway in the nose or throat;

(b) A base plate positioned along at least a portion of the axis;

(c) At least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and

(d) At least one temperature sensor positioned on the substrate.

42. The apparatus of claim 41, wherein the at least one temperature sensor is configured to detect a temperature of the at least one sensor trace.

43. The apparatus of claim 42, wherein the at least one temperature sensor comprises at least one of a thermocouple or a thermistor.

44. The device of any one of claims 42 to 43, further comprising a processor, wherein the processor is operatively coupled to the at least one navigation sensor and the at least one temperature sensor such that the at least one navigation sensor is operable to communicate a position signal to the processor and such that the at least one temperature sensor is operable to communicate a temperature signal to the processor.

45. The apparatus of claim 44, wherein the processor is configured to determine location coordinates based on the location signals transmitted to the processor by the at least one navigation sensor and based on the temperature signals transmitted to the processor by the at least one temperature sensor.

46. The apparatus of claim 45, wherein the processor is configured to apply a correction factor to the position coordinates in response to the temperature signal indicating a change in the detected temperature.

47. The device of any one of claims 45 to 46, wherein the processor is configured to correlate the detected change in temperature with a change in resistance of the at least one sensor trace.

48. The apparatus of any one of claims 41-47, wherein the substrate comprises a surface, wherein the at least one navigation sensor is positioned on the surface, wherein the at least one temperature sensor is positioned on the surface.

49. The apparatus of any one of claims 41-48, wherein the substrate is flexible.

50. The device of any one of claims 41-49, wherein the at least one navigation sensor comprises a proximal navigation sensor and a distal navigation sensor.

51. The apparatus of claim 50, wherein the at least one temperature sensor comprises at least one proximal temperature sensor positioned near the proximal navigation sensor and at least one distal temperature sensor positioned near the distal navigation sensor.

52. The apparatus of claim 51, wherein the at least one proximal temperature sensor is positioned proximally relative to the proximal navigation sensor, wherein the at least one distal temperature sensor is positioned proximally relative to the distal navigation sensor and distally relative to the proximal navigation sensor.

53. The apparatus of any one of claims 41-52, wherein the at least one temperature sensor comprises a pair of laterally adjacent temperature sensors.

54. An ENT surgical instrument, comprising:

(a) A power component configured to generate heat; and

(b) The apparatus of any one of claims 41-53, wherein the at least one navigation sensor is exposed to heat generated by the power component.

55. The ENT surgical instrument of claim 54, wherein the power component comprises at least one of (i) an electrode configured to deliver RF energy to tissue, or (ii) a motor configured to drive a cutting member for severing tissue.

56. An apparatus, comprising:

(a) A shaft assembly having a distal end sized and configured to fit within a patient's ear _、 In an anatomic passageway in the nose or throat;

(b) A substrate extending along at least a portion of the axis;

(c) At least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and

(d) The processor may be configured to perform the steps of,

wherein the processor is operatively coupled to the at least one navigation sensor, wherein the processor is configured to monitor a temperature of the at least one sensor trace.

57. A method of using a device having (i) a substrate and (ii) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor, the method comprising:

(a) Inserting the flexible substrate into an anatomic passageway of a patient;

(b) Exposing the at least one navigation sensor to an electromagnetic field;

(c) Generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field;

(d) Determining location coordinates based on the generated signals;

(e) Detecting a temperature change of the at least one sensor trace; and

(f) The position coordinates are adjusted in response to a behavior of detecting a temperature change of the at least one sensor trace.

58. The method of claim 57, wherein the act of adjusting the position coordinates comprises applying a correction factor to the position coordinates, wherein the correction factor corresponds to the detected temperature change.

59. The method of any of claims 57-58, wherein the act of detecting a temperature change of the at least one sensor trace is performed via a temperature sensor.

60. The method of any of claims 57-58 wherein the act of detecting a temperature change of the at least one sensor trace includes detecting a change in electrical impedance of the at least one sensor trace.

61. An apparatus, comprising:

(a) An inner shaft defining a lumen sized to receive an instrument;

(b) An outer shaft fixedly secured relative to the inner shaft, the outer shaft being coaxially disposed with the inner shaft; and

(c) A first navigation sensor interposed radially between the inner shaft and the outer shaft, the first navigation sensor operable to generate a signal indicative of a position of the first navigation sensor in three-dimensional space.

62. The apparatus of claim 61, the lumen sized to receive a shaft assembly of a tissue shaving instrument.

63. The apparatus of claim 62, further comprising a tissue shaving instrument having a shaft assembly, the lumen sized to receive the shaft assembly of the tissue shaving instrument.

64. The apparatus of claim 63, the shaft assembly of the tissue shaving instrument having a transverse opening configured to receive tissue, the inner shaft and the outer shaft each having a length sized to provide exposure of the transverse opening when the shaft assembly of the tissue shaving instrument is fully inserted in the lumen.

65. The apparatus of claim 64, the first navigation sensor configured for positioning near and proximal to the lateral opening when the shaft assembly of the tissue shaving instrument is fully inserted into the lumen.

66. The apparatus of any one of claims 61-65, further comprising a flexible substrate radially interposed between the inner shaft and the outer shaft, the first navigation sensor positioned on the flexible substrate as part of a flexible circuit.

67. The apparatus of claim 66, the flexible substrate extending along a length of the inner shaft and along a length of the outer shaft.

68. The apparatus of claim 67, the flexible substrate having a distal end, the first navigation sensor positioned at the distal end of the flexible substrate.

69. The apparatus of any one of claims 61-68, further comprising a second navigation sensor radially interposed between the inner shaft and the outer shaft, the second navigation sensor operable to generate a signal indicative of a position of the second navigation sensor in three-dimensional space.

70. The apparatus of claim 69, the second navigation sensor positioned proximal to the first navigation sensor.

71. The apparatus of any one of claims 69-70, further comprising a flexible substrate interposed radially between the inner shaft and the outer shaft, the first and second navigation sensors each positioned on the flexible substrate as part of a flexible circuit.

72. The apparatus of any one of claims 61-71, further comprising a hub positioned at a proximal end of one or both of the inner shaft or the outer shaft.

73. The apparatus of claim 72, the hub configured to be removably coupled with an instrument received in the lumen.

74. The device of any one of claims 61-73, the inner shaft having an open distal end and an open proximal end.

75. The device of any one of claims 61-74, the outer shaft having an open distal end and an open proximal end.

76. An apparatus, comprising:

(a) A shaft assembly including an outer shaft having an outer surface _、 A length and a distal end; and

(b) A flexible circuit, the flexible circuit comprising:

(i) A flexible substrate secured to the outer surface of the outer shaft, at least a portion of the flexible substrate extending along the length of the outer shaft, and

(ii) A plurality of electrodes secured to the flexible substrate, the electrodes positioned at or near the distal end of the outer shaft, the electrodes operable to apply RF energy to tissue to ablate the tissue.

77. The apparatus of claim 76, the electrodes arranged in an array extending along the distal end of the outer shaft.

78. The device of any one of claims 76-77, the electrodes arranged in an array extending along a portion of the length of the outer shaft along a region proximal to the distal end of the outer shaft.

79. The device of any one of claims 76-78, the outer shaft defining a circumference, the electrodes being arranged in an array extending around the circumference of the outer shaft.

80. The apparatus of claim 79, the electrode comprising two electrodes, each of the two electrodes having a generally semi-circular shape.

81. The apparatus of claim 79, the electrode comprising a plurality of square or rectangular shaped electrodes.

82. The apparatus of any one of claims 76-81, the outer shaft defining a circumference, the flexible substrate including a longitudinally extending portion extending along the length of the outer shaft and a circumferentially extending portion extending around the circumference of the outer shaft.

83. The apparatus of claim 82, the longitudinally extending portion having a distal end, the circumferentially extending portion being located at the distal end of the longitudinally extending portion.

84. The apparatus of any one of claims 82-83, at least some of the electrodes being positioned along the circumferentially extending portion in a circumferentially extending array.

85. The device of any one of claims 76-84, the outer shaft further defining an opening configured to receive tissue, the shaft assembly further comprising a cutting shaft configured to sever tissue received in the opening.

86. The apparatus of claim 85, the opening having a transverse orientation on the outer shaft such that at least a portion of the opening extends longitudinally along the shaft.

87. The apparatus of claim 86, at least some of the electrodes extending longitudinally in an array alongside the opening.

88. The device of any one of claims 85-86, at least some of the electrodes being positioned proximal to the opening.

89. The device of any one of claims 85-88, at least some of the electrodes being positioned distal to the opening.