CN117202864A - Flexible sensor assembly for ENT instrument - Google Patents
Flexible sensor assembly for ENT instrument Download PDFInfo
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- CN117202864A CN117202864A CN202280029241.1A CN202280029241A CN117202864A CN 117202864 A CN117202864 A CN 117202864A CN 202280029241 A CN202280029241 A CN 202280029241A CN 117202864 A CN117202864 A CN 117202864A
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- Surgical Instruments (AREA)
Abstract
The present invention provides an ENT surgical instrument that includes 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 in an anatomic passageway in a patient's ear, nose, or throat. The flexible substrate extends along at least a portion of the shaft. 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
Background
Image Guided Surgery (IGS) is one such technique: wherein a computer is used to obtain a real-time correlation of the position of an instrument that has been inserted into the patient's body with a set of preoperatively acquired images (e.g., CT or MRI scans, 3-D maps, etc.), such that the computer system can superimpose the current position of the instrument on the preoperatively acquired images. 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 system. In some IGS protocols, a digital tomographic scan (e.g., CT or MRI, 3D map, etc.) of the surgical field is obtained prior to the surgical procedure. The digital tomographic data is then converted into a digital map using a specially programmed computer. During surgery, a particular instrument having a sensor (e.g., a solenoid that emits an electromagnetic field and/or responds to an externally generated electromagnetic field) is used to perform a procedure while the sensor sends data to a computer indicating the current position of each surgical instrument. The computer correlates the data received from the sensors with digital maps generated by pre-operative tomography. Tomographic images are shown on the video monitor along with indication marks (e.g., crosshairs or luminous points, etc.) to show the real-time position of each surgical instrument relative to the anatomy shown in the scanned images. Thus, even though the surgeon cannot directly visualize the instruments themselves at the current location of the in-vivo instrument, the surgeon is able to see the exact location of each sensor-equipped instrument by looking at the video monitor.
In some cases, it may be desirable to dilate an anatomical passageway in a patient. This may include paranasal sinus dilation (e.g., to treat sinusitis), laryngeal dilation, eustachian tube dilation, dilation of the ear, nose or other passages within the throat, and the like. One method of expanding the anatomic passageway includes positioning an inflatable balloon within the anatomic passageway using a guidewire and catheter, and then inflating the balloon with a fluid (e.g., saline) to expand the anatomic passageway. For example, an inflatable balloon may be positioned within the mouth at the paranasal sinus and then inflated to thereby dilate the mouth by remodelling the bone adjacent to the mouth without the need to incise the mucosa or remove any bone. The dilated mouth may then allow improved drainage and ventilation from the affected paranasal sinus.
In the case of a eustachian tube expansion, an expansion catheter or other expansion instrument may be inserted into the eustachian tube and then inflated or otherwise expanded to expand the eustachian tube. The dilated eustachian tube can provide improved ventilation from the nasopharynx to the middle ear and further provide improved drainage from the middle ear to the nasopharynx.
It may be desirable to easily controllably place a dilation catheter or other ENT instrument in an anatomic passageway, including in procedures that are to be performed by only a single operator. While several systems and methods have been developed and used to position a dilation catheter or other ENT instrument in an anatomical passageway, it is believed that the inventors have not previously developed or used the invention described in the appended claims.
Drawings
The drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention which the inventors contemplate.
FIG. 1 shows a schematic view of an exemplary surgical navigation system for use on a patient seated in an exemplary medical procedure seat;
FIG. 2 illustrates a perspective view of an exemplary instrument having a flexible navigation sensor assembly;
FIG. 3 illustrates a perspective view of a distal portion of the instrument of FIG. 2, showing a flexible navigation sensor assembly extending across an inner diameter of a shaft in a flat configuration;
FIG. 4 illustrates a top plan view of the flexible navigation sensor assembly of FIG. 3;
FIG. 5 illustrates a bottom plan view of the flexible navigation sensor assembly of FIG. 3;
FIG. 6 illustrates a top plan view of a proximal portion of the flexible navigation sensor assembly of FIG. 3;
FIG. 7 illustrates a top plan view of a middle portion of the flexible navigation sensor assembly of FIG. 3;
FIG. 8 illustrates a top plan view of a distal portion of the flexible navigation sensor assembly of FIG. 3;
FIG. 9 illustrates a bottom plan view of a proximal portion of the flexible navigation sensor assembly of FIG. 3;
FIG. 10 illustrates a bottom plan view of a middle portion of the flexible navigation sensor assembly of FIG. 3;
FIG. 11 illustrates a bottom plan view of a distal portion of the flexible navigation sensor assembly of FIG. 3;
FIG. 12 shows a schematic circuit diagram of the flexible navigation sensor assembly of FIG. 3;
FIG. 13 illustrates a perspective view of a distal portion of the instrument of FIG. 2, showing a flexible navigation sensor assembly disposed along an inner cylindrical surface of the shaft in a curved configuration;
FIG. 14 illustrates 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;
FIG. 15 illustrates a top plan view of the flexible navigation sensor assembly of FIG. 14;
FIG. 16 illustrates a bottom plan view of the flexible navigation sensor assembly of FIG. 14;
FIG. 17 illustrates a top plan view of a proximal portion of the flexible navigation sensor assembly of FIG. 14;
FIG. 18 illustrates a top plan view of a middle portion of the flexible navigation sensor assembly of FIG. 14;
FIG. 19 illustrates a top plan view of a distal portion of the flexible navigation sensor assembly of FIG. 14;
FIG. 20 illustrates a bottom plan view of a proximal portion of the flexible navigation sensor assembly of FIG. 14;
FIG. 21 illustrates a bottom plan view of a middle portion of the flexible navigation sensor assembly of FIG. 14;
FIG. 22 illustrates a bottom plan view of a distal portion of the flexible navigation sensor assembly of FIG. 14;
FIG. 23 illustrates a flow chart of an exemplary method for determining position coordinates of a portion of an ENT instrument from signals received from the flexible navigation sensor assembly of FIG. 14;
FIG. 24 illustrates a perspective view of another exemplary instrument having a flexible navigation sensor assembly;
FIG. 25A illustrates a perspective view of the distal portion of the instrument of FIG. 24, showing the flexible distal shaft portion of the instrument in a straight configuration, and further showing the flexible navigation sensor assembly disposed along the inner cylindrical surface of the flexible distal portion in a first curved configuration;
FIG. 25B illustrates a perspective view of the distal portion of the instrument of FIG. 24, showing the flexible distal shaft portion of the instrument in a bent configuration, and further showing the flexible navigation sensor assembly disposed along the inner cylindrical surface of the flexible distal portion in a second bent configuration;
FIG. 26A illustrates a perspective view of the flexible navigation sensor assembly of FIG. 25A in a flat configuration;
FIG. 26B illustrates a side elevational view of the flexible navigation sensor assembly of FIG. 25A in a laterally curved, longitudinally straight configuration;
FIG. 26C illustrates a side elevational view of the flexible navigation sensor assembly of FIG. 25A in a laterally curved, longitudinally curved configuration;
FIG. 27A illustrates a perspective view of a distal portion of an exemplary suction instrument having a flexible navigation sensor assembly, showing an extendable shaft of the suction instrument in a straight configuration, and further illustrating the flexible navigation sensor assembly disposed along an outer cylindrical surface of the extendable shaft in a first curved configuration;
FIG. 27B illustrates a perspective view of the distal portion of the suction instrument of FIG. 27A, showing the malleable shaft of the suction instrument in a bent configuration, and further showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the malleable shaft in a second bent configuration;
FIG. 27C illustrates a perspective view of the distal portion of the suction instrument of FIG. 27A, showing the malleable shaft of the suction instrument in a double curved configuration, and further showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the malleable shaft in a third curved configuration;
FIG. 28 illustrates a perspective view of an exemplary tissue shaving instrument having a flexible navigation sensor assembly;
FIG. 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;
FIG. 30 illustrates a top plan view of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 31 illustrates a bottom plan view of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 32 illustrates a top plan view of a proximal portion of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 33 illustrates a top plan view of a middle portion of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 34 illustrates a top plan view of a distal portion of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 35 illustrates a bottom plan view of a proximal portion of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 36 illustrates a bottom plan view of a middle portion of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 37 illustrates a bottom plan view of the distal portion of the flexible navigation sensor assembly of FIG. 29 in a flat configuration;
FIG. 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;
FIG. 39 illustrates a perspective view of another exemplary tissue shaving instrument with a navigation adapter sheath removably secured to the tissue shaving instrument;
FIG. 40 shows a perspective view of the tissue shaving instrument and navigation adapter sheath of FIG. 39 with the navigation adapter sheath removed from the tissue shaving instrument;
FIG. 41 illustrates an exploded perspective view of the shaft assembly of the navigation adapter sheath of FIG. 39;
FIG. 42 shows a cross-sectional end view of the shaft assembly of FIG. 41 taken along line 42-42 of FIG. 39;
FIG. 43 shows a perspective view of the distal portion of the tissue shaving instrument and navigation adapter sheath of FIG. 39 with the navigation adapter sheath secured to the tissue shaving instrument and the outer shaft of the shaft assembly omitted to reveal the positioning of the flex circuit;
FIG. 44 illustrates a flow chart of an exemplary method for calibrating a flexible navigation sensor assembly;
FIG. 45 shows a photograph of an exemplary geometric measurement taken using the method of FIG. 44;
FIG. 46 illustrates a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a first example of a bonded ablation flex circuit;
FIG. 47 illustrates a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a second example of a bonded ablation flex circuit;
FIG. 48 illustrates a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a third example of a bonded ablation flex circuit; and is also provided with
Fig. 49 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a fourth example of a bonded ablation flex circuit.
Detailed Description
The following description of certain examples of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of example, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
For clarity of disclosure, the terms "proximal" and "distal" are defined herein with respect to the 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 disposed closer to a surgeon, and the term "distal" refers to a location where an element is disposed closer to a surgical end effector of a surgical instrument and farther from the surgeon. Furthermore, to the extent that spatial terms such as "upper," "lower," "vertical," "horizontal," and the like are used herein with reference to the drawings, it is to be understood that such terms are used for illustrative descriptive purposes only and are not intended to be limiting or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions, not limited to those shown and described herein.
As used herein, the terms "about" and "approximately" with respect to any numerical value or range mean a suitable dimensional tolerance that allows a part or collection of parts to perform its intended purpose 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 about the position of the instrument within the head (H) of the patient (P), especially when the instrument is in a position where it is difficult or impossible to obtain an endoscopic view of the working elements of the instrument within the head (H) of the patient (P). FIG. 1 illustrates an exemplary IGS navigation system (50) that enables execution 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 operated in accordance with at least some of the teachings of the following patents: U.S. patent No. 7,720,521, published 5/18/2010 and entitled "Methods and Devices for Performing Procedures within the Ear, nose, throat and Paranasal Sinuses" and "Systems and Methods for Performing Image Guided Procedures within the Ear, nose, throat and Paranasal Sinuses" published 12/11/2014, the now abandoned U.S. patent publication 2014/0364125.
The IGS navigation system (50) of the present example includes a field generator assembly (60) including 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 the instruments 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 the seat (70), and the patient (P) is seated in the seat (70) such that the frame (62) is located near the head (H) of the patient (P). By way of example only, the seat (70) and/or the field generator assembly (60) can be constructed and operated in accordance with at least some of the teachings of U.S. patent 10,561,370, entitled "Apparatus to Secure Field Generating Device to Chair," published 18, 2/2020.
The IGS navigation system (50) of the present 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 processing the signals from the instrument to determine the position of the navigation sensor or position sensor in the instrument within the head (H) of the patient (P). The processor (52) includes a processing unit (e.g., a set of electronic circuits arranged to evaluate and execute software instructions using combinational logic circuits or other similar circuitry) in communication with one or more memories. The processor (52) of the present example is mounted in a console (58) that includes an operational control (54) including a keyboard and/or pointing device, such as a mouse or trackball. In performing a surgical procedure, a physician interacts with the processor (52) using the operational controls (54).
Although not shown, the instrument may include a navigation sensor or position sensor responsive to being positioned 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 coupling unit may provide wired or wireless communication of data and other signals.
In some versions, the navigation sensor or position sensor of the instrument may include at least one coil at or near the distal end of the instrument. When such coils are positioned within an alternating electromagnetic field generated by a field generator (64), the alternating magnetic field may generate an electrical current in the coils, and this current may be conveyed along an electrical conduit in the instrument and further to the processor (52) via the coupling unit. This phenomenon may enable the IGS navigation system (50) to determine the position of the distal end of the instrument in 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 from the position-related signals of the coils in the instrument. Thus, the navigation sensor can be used as a position sensor by generating a signal indicative of the real-time position of the sensor in three-dimensional space.
The processor (52) uses software stored in a 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, the operations may also include monitoring and enforcing one or more security 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 position of the distal end of the instrument relative to a camera image of the patient's head (H), a CT scan image of the patient's head (H), and/or a computer-generated three-dimensional model of anatomy within and near the patient's nasal cavity. The display screen (56) may display such images simultaneously and/or superimposed on one another during a surgical procedure. Such display images may also include a graphical representation of the instrument inserted into the patient's head (H) so that an operator may view in real time a virtual rendering of the instrument in its actual position. 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 10,463,242, entitled "Guidewire Navigation for Sinuplasty," published 11/5/2019. In the case where the operator also uses the endoscope, an endoscopic image may be provided on the display screen (56).
The images provided by the display screen (56) may help guide the operator in maneuvering and otherwise manipulating the instrument within the patient's head (H). It should also be appreciated that other components of the surgical instrument described below, as well as other types of surgical instruments, may incorporate navigation sensors (such as those described above).
Exemplary ENT apparatus with Flexible navigation sensor Assembly
In some instances, it may be desirable to provide a flexible navigation sensor assembly (e.g., a printed circuit board) for ENT instruments as a replacement for conventional coil sensors in order to simplify and/or lower cost sensor manufacture and calibration, reduce sensor size and/or profile, and/or improve sensor integration with a variety of different types of ENT instruments. Each of the exemplary flexible navigation sensor assemblies (110,210,410,510,610) described below may function in this manner. While the examples provided below are discussed in the context of various specific ENT instruments (100,400,500,600,700), flexible navigation sensor assemblies (110,210,410,510,610) may be used to provide navigation capabilities to any other suitable ENT instrument. 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 appreciated that all flexible circuit Printed Circuit Boards (PCBs) and other flexible circuit features described below may include only one single layer or multiple layers.
A. Exemplary Instrument with rectangular, double-layer Flexible navigation sensor Assembly
Fig. 2-13 illustrate examples of instruments (100) that may be used to guide a dilation catheter into an anatomical passageway to thereby dilate the anatomical passageway, guide other instruments into the anatomical passageway, and/or deliver RF energy to tissue in or near the anatomical passageway. For example, the instrument (100) may be used for dilation of the paranasal sinus ostium (e.g., to treat sinusitis), laryngeal dilation, eustachian tube dilation, dilation of other passages in the ear, nose, or throat, and the like. Additionally or alternatively, the instrument (100) may be used to ablate nerves (e.g., the posterior nasal nerve); ablating turbinates; or ablation, electroporation (e.g., to facilitate absorption of a therapeutic agent, etc.), or any other kind of anatomical structure that applies resistive heating to the patient's head.
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). The instrument (100) may be coupled to an inflation fluid source (not shown) operable to selectively supply inflation fluid to a balloon of an inflation catheter (not shown) disposed in the instrument (100) for inflating the balloon to dilate the anatomical passageway. Additionally or alternatively, the instrument (100) may be coupled with an RF generator (101) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (121, 122) located at the distal end of the shaft assembly (104) 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 gripped and operated by a single hand of an operator, such as via a motorized 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 with at least one of a guidewire or catheter (e.g., an inflation catheter or an energy catheter) (not shown), and is thus operable to longitudinally translate such a 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 the present example includes a rigid portion (116), a flexible portion (118) distal to the rigid portion (116), and an open distal end (120). A traction wire (not shown) is coupled with the flexible portion (118) and a deflection control knob (122) of the handle assembly (102). The yaw control knob (122) is rotatable relative to the body (112) about an axis perpendicular to the longitudinal axis of the shaft assembly (104) to selectively retract the pull wire proximally. When the traction wire is retracted proximally, the flexible portion (118) flexes and thereby deflects the distal end (120) laterally away from the longitudinal axis of the rigid portion (116). The yaw control knob (122), the traction wire, and the flexible portion (118) thus cooperate to impart a steerable characteristic to the shaft assembly (104). By way of example only, such rotational orientation of the shaft assembly (104) may be provided in accordance with at least some of the teachings of the following U.S. patent applications: U.S. patent application No. 63/028,609, entitled "Shaft Deflection Control Assembly for ENT Guide Instrument", filed on 5/22/2020. Other versions may provide some other type of user input feature instead of deflecting the control knob (122) to drive the steering of the flexible portion (118). In some alternative versions, the deflection control knob (122) is omitted and the flexible portion (118) is malleable. In still other versions, the entire length of the shaft assembly (104) is rigid.
The shaft assembly (104) is also rotatable relative to the handle assembly (102) about a longitudinal axis of the rigid portion (116). Such rotation may be driven via a rotary control knob (124) rotatably coupled with the body (112) of the handle assembly (102). Alternatively, the shaft assembly (104) may be rotated via some other form of user input; or may be non-rotatable relative to the handle assembly (102). It should also be appreciated that the examples of handle assemblies (102) described herein are merely illustrative examples. The shaft assembly (104) may alternatively be coupled with any other suitable kind of handle assembly or other support body.
As best shown in fig. 3, a 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 visualization and irrigation at a target tissue site distal to the distal end 120 of the shaft assembly (104).
In this regard, a navigation sensor assembly (110) of 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). More specifically, the navigation sensor assembly (110) extends generally horizontally across an inner diameter of a flexible portion (118) of the shaft assembly (104) through a center thereof and has a generally flat (e.g., planar) configuration.
Referring now to fig. 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) having a plurality of traces (130, 132,134, 136) formed thereon (e.g., printed and/or embedded), a plurality of corresponding trace leads (e.g., pads) (138 a,138b,138c,138 d), and a plurality of ground leads (139 a,139b,139c,139 d). As shown, the base plate (126) extends longitudinally between proximal and distal ends (140, 141), laterally between first and second sides (142, 143), and vertically between top and bottom surfaces (144, 145). The substrate (126) of the present example includes a pair of through holes (146) extending between the top and bottom surfaces (144, 145). The through holes (146) may be configured to receive corresponding pins (not shown) or other suitable fasteners to secure the navigation sensor assembly (110) to the flexible portion (118) of the shaft assembly (104) and/or any other component of the instrument (100), such as the visualization and irrigation assembly (108). In the illustrated version, the base plate (126) further 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) at a desired location relative to the flexible portion (118) of the shaft assembly (104) and/or relative to any other component of the instrument (100), such as the visualization and irrigation assembly (108).
The substrate (126) may be formed of 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 of polyimide, as such a substrate (126) formed of polyimide may be resiliently biased toward a natural flat configuration. Alternatively, where a more complex geometry and/or increased flexibility of the substrate (126) is desired, the substrate (126) may be formed from LCP, as the substrate (126) formed from LCP may be thermoformed to accommodate such complex geometry and/or provide increased flexibility, as described below. In any event, the traces (130, 132,134, 136), leads (138 a,138b,138c,138 d), and ground leads (139 a,139b,139c,139 d) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (110) is suitably sized to fit within the shaft assembly (104) while still permitting space for the working channel (149) to extend along the shaft assembly (104) (e.g., over the navigation sensor assembly (110)) permitting additional instruments (e.g., dilation catheter and/or energy catheter), aspiration, fluid, 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 as compared to conventional coil sensors. In some versions, the navigation sensor assembly (110) may have a thickness of approximately 50 microns.
As shown in fig. 4 and 5, the traces (130, 132,134, 136) include a proximal top trace (130) and a distal top trace (132) each formed on a top surface (144) of the substrate (126), and a proximal bottom trace (134) and a distal bottom trace (136) each formed on a bottom surface (145) of the substrate (126) opposite and/or parallel to the corresponding top trace (130, 132). Similarly, the leads (138 a,138b,138c,138 d) include first and second top leads (138 a,138 b) each formed on the top surface (144) of the substrate (126), and first and second bottom leads (138 c,138 d) each formed on the bottom surface (145) of the substrate (126) opposite and/or parallel to the corresponding top leads (138 a,138 b). The ground leads (139 a,139b,139c,139 d) include first and second top ground leads (139 a,139 b) each formed on a top surface (144) of the substrate (126), and first and second bottom ground leads (139 c,139 d) each formed on a bottom surface (145) of the substrate (126). The top traces (130, 132), top leads (138 a,138 b), and top ground leads (139 a,139 b) collectively define a top flex circuit layer of the navigation sensor assembly (110), while the bottom traces (134, 136), bottom leads (138 c,138 d), and bottom ground leads (139 c,139 d) collectively define a bottom flex circuit layer of the navigation sensor assembly (110).
Referring now to fig. 6-11, the traces (130, 132,134, 136) each include a respective first longitudinal portion (130 a,132a,134a,136 a), concentric ring portions (130 b,132b,134b,136 b), and a second longitudinal portion (130 c,132c,134c,136 c). As shown, the concentric ring portions (132 b,136 b) of the distal traces (132, 136) are positioned distally relative to the concentric ring portions (130 b,134 b) of the respective proximal traces (130, 134).
The first top lead (138 a) is electrically coupled to a proximal end of the first longitudinal portion (130 a) of the proximal top trace (130). The first longitudinal portion (130 a) of the proximal top trace (130) extends distally from its proximal end and is electrically coupled at its distal end to the distal end of the first longitudinal portion (134 a) of the proximal bottom trace (134) by a corresponding through hole. A first longitudinal portion (134 a) of the proximal bottom trace (134) extends proximally from a distal end thereof toward the first bottom lead (138 c) and is electrically coupled at a proximal end thereof to a proximal end of a second longitudinal portion (134 c) of the proximal bottom trace (134). The second longitudinal portion (134 c) of the proximal bottom trace (134) extends distally from its proximal end and is electrically coupled at its distal end to a radially outer end of the concentric ring portion (134 b) of the proximal bottom trace (134). The concentric ring portion (134 b) 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 radially inner end of the concentric ring portion (130 b) of the proximal top trace (130) by a corresponding via. The concentric ring portion (130 b) of the proximal top trace (130) spirals radially outward from its radially inner end and is electrically coupled to the distal end of the second longitudinal portion (130 c) of the proximal top trace (130) at its radially outer end. The second longitudinal portion (130 c) of the proximal top trace (130) extends proximally from its distal end toward the first top lead (138 b) and is electrically coupled to the first bottom lead (138 c) at its proximal end by a corresponding through hole.
The second top lead (138 b) is electrically coupled to a proximal end of the first longitudinal portion (132 a) of the distal top trace (132). The first longitudinal portion (132 a) of the distal top trace (132) extends distally from its proximal end and is electrically coupled at its distal end to the distal end of the first longitudinal portion (136 a) of the distal bottom trace (136) by a corresponding through hole. A first longitudinal portion (136 a) of the distal bottom trace (136) extends proximally from a distal end thereof toward the second bottom lead (138 d) and is electrically coupled at a proximal end thereof to a proximal end of a second longitudinal portion (136 c) of the distal bottom trace (136). A second longitudinal portion (136 c) of the distal bottom trace (136) extends distally from a proximal end thereof and is electrically coupled to a radially outer end of the concentric ring portion (136 b) of the distal bottom trace (136) at a distal end thereof. The concentric ring portion (136 b) 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 radially inner end of the concentric ring portion (132 b) of the distal top trace (132) by a corresponding via. The concentric ring portion (132 b) of the distal top trace (132) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to the distal end of the second longitudinal portion (132 c) of the distal top trace (132). A second longitudinal portion (132 c) of the distal top trace (132) extends proximally from its distal end toward the second top lead (138 b) and is electrically coupled at its proximal end to the second bottom lead (138 d) through a corresponding through hole.
Thus, current may flow generally along the first top lead (138 a) to the first longitudinal portion (130 a) of the proximal top trace (130), to the first longitudinal portion (134 a) of the proximal bottom trace (134), to the second longitudinal portion (134 c) of the proximal bottom trace (134), to the concentric ring portion (134 b) of the proximal bottom trace (134), to the concentric ring portion (130 b) of the proximal top trace (130), to the second longitudinal portion (130 c) of the proximal top trace (130), to the first bottom lead (138 c). Alternatively, the current may flow generally along the first bottom lead (138 c) to the second longitudinal portion (130 c) of the proximal top trace (130), to the concentric ring portion (130 b) of the proximal top trace (130), to the concentric ring portion (134 b) of the proximal bottom trace (134), to the second longitudinal portion (134 c) of the proximal bottom trace (134), to the first longitudinal portion (134 a) of the proximal bottom trace (134), to the first longitudinal portion (130 a) of the proximal top trace (130), to the first top lead (138 a).
Likewise, current may flow generally along the second top lead (138 b) to the first longitudinal portion (132 a) of the distal top trace (132), to the first longitudinal portion (136 a) of the distal bottom trace (136), to the second longitudinal portion (136 c) of the distal bottom trace (136), to the concentric ring portions (136 b) of the distal bottom trace (136), to the concentric ring portions (132 b) of the distal top trace (132), to the second longitudinal portion (132 c) of the distal top trace (132), to the second bottom lead (138 d). Alternatively, the current may flow generally along the second bottom lead (138 d) to the second longitudinal portion (132 c) of the distal top trace (132), to the concentric ring portion (132 b) of the distal top trace (132), to the concentric ring portion (136 b) of the distal bottom trace (136), to the second longitudinal portion (136 c) of the distal bottom trace (136), to the first longitudinal portion (136 a) of the distal bottom trace (136), to the first longitudinal portion (132 a) of the distal top trace (132), to the second top lead (138 b).
When the concentric ring portions (130 b,132b,134b,136 b) are positioned within the alternating electromagnetic field generated by the field generator (64), the alternating magnetic field may generate a current in the concentric ring portions (130 b,132b,134b,136 b), and this current may be transferred to the processor (52) along the respective longitudinal portions (130 a,132a,134a,136a, 130c,132c,134c,136 c), such as via a coupling unit (not shown) electrically coupled to the leads (138 a,138b,138c,138 d). As such, each concentric ring portion (130 b,132b,134b,136 b) defines a respective navigation sensor (150, 152,154, 156) operable to generate a signal indicative of a position of the respective navigation sensor (150, 152,154, 156) and thereby indicative of a position of at least a portion of the instrument (100) (e.g., the flexible portion (118) of the shaft assembly (104)) in three-dimensional space. The position data generated from such position-related signals may be processed by the processor (52) for providing visual indications to an operator to display to the operator in real time where the shaft assembly (104) of the instrument (100) is located within the patient (P). Such visual indications may be provided as a superposition over one or more preoperatively acquired images (e.g., CT scans) of the patient's anatomy.
In the illustrated example, a distal navigation sensor (152, 156) is positioned at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120), while a proximal navigation sensor (150, 154) may be positioned at or near the proximal end of the flexible portion (118) to facilitate identification of, for example, a direction and/or orientation of the flexible portion (118). By way of further example only, the distal navigation sensor (152, 156) may be positioned in a distal region of the flexible portion (118) such that when the distal end (120) is deflected laterally away from the longitudinal axis of the rigid portion (116), the distal navigation sensor (152, 156) is 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) is deflected laterally away from the longitudinal axis of the rigid portion (116), the proximal navigation sensor (150, 154) does not deflect laterally away from the longitudinal axis of the rigid portion (116). In such a scenario, the position data from the proximal navigation sensors (150, 154) may be compared to the position data from the distal navigation sensors (152, 156) to accurately determine the degree of lateral deflection of the distal end (120) relative to the frame of reference of the IGS navigation system (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) that need to be navigated; 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 sufficiently large to position the distal navigation sensor (152, 156) at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120), while also positioning the leads (138 a,138b,138c,138 d) at a sufficiently proximal location where the leads (138 a,138b,138c,138 d) may be directly electrically coupled to the coupling unit (e.g., without the need for an intervening wire or cable). In this regard, the length of the navigation sensor assembly (110) may be substantially equal to or greater than the length of the shaft assembly (104) such that the leads (138 a,138b,138c,138 d) 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, the navigation sensor assembly (110) may have a length on the order of meters. In this way, the navigation sensor assembly (110) can both generate and transmit position-related signals to the coupling units without the need to route wires or cables between the coupling units.
It should be appreciated that the navigation sensors (150, 152,154, 156) may each be configured in any other suitable manner for generating an electrical current when positioned within an alternating electromagnetic field. For example, the number of concentric rings defining each concentric ring portion (130 b,132b,134b,136 b) 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 (e.g., height, width, length, and/or thickness) of each concentric ring portion (130 b,132b,134b,136 b) may be greater than or less than the illustrated dimensions. While the concentric ring portions (130 b,132b,134b,136 b) are each shown as being generally rectangular, the concentric ring portions (130 b,132b,134b,136 b) may each have any other suitable shape. For example, the concentric ring portions (130 b,132b,134b,136 b) may each be generally circular and may have any suitable diameter.
It should be appreciated that either the top trace (130, 132) or the bottom trace (134, 136) alone may be capable of transmitting position-related signals to the processor (52), and that the position-related signals transmitted to the processor (52) through the bottom trace (134, 136) may therefore be redundant to those transmitted through the top trace (130, 132). Such redundancy may improve the reliability of the position-related signals provided by the top traces (130, 132) by verifying the position data generated by the position-related signals transmitted by the top traces (130, 132). Additionally or alternatively, the position-related signals transmitted by the top trace (130, 132) and the bottom trace (134, 136) may be used to determine an orientation of the flexible portion (118) of the shaft assembly (104).
In some versions, the relative arrangement of the top traces (130, 132) with respect to the corresponding bottom traces (134, 136) may help substantially reduce or eliminate electromagnetic interference or "noise" (which may otherwise be caused by current flowing in the traces (130, 132,134, 136) due to the absence of twisted pairs of wires (138 a,138b,138c,138 d) typically present in conventional coil sensor arrangements) to thereby improve the accuracy and reliability of the position-related signals transmitted to the processor (52). As schematically shown in fig. 12, current may flow in a first direction in the top trace (130, 132) and may flow in a second direction opposite and parallel to the first direction in the corresponding bottom trace (134, 136). For example, current may flow in a first direction (e.g., one of clockwise or counterclockwise) in the top concentric ring portion (130 b, 132 b) and may flow in a second direction (e.g., the other of clockwise or counterclockwise) opposite and parallel to the first direction in the corresponding bottom concentric ring portion (134 b,136 b). Likewise, current may flow in a first direction (e.g., one of proximal or distal) in the top longitudinal portion (130 a,132a,130c,132 c) and may flow in a second direction (e.g., the other of proximal or distal) opposite and parallel to the first direction in the corresponding bottom longitudinal portion (134 a,136a,134c,136 c). The current flowing in the first direction in the top trace (130, 132) and the current flowing in the second direction in the corresponding bottom trace (134, 136) may have substantially the same magnitude as each other. Thus, the magnetic field noise caused by the current in the top trace (130, 132) and the magnetic field noise caused by the current in the corresponding bottom trace (134, 136) may be substantially equal and opposite to each other such that the magnetic field noise cancel each other and thus both are substantially reduced or eliminated. Thus, while either the top flex circuit layer or the bottom flex circuit layer alone may be capable of providing a position-dependent signal, redundancy with two layers may provide noise reduction benefits. In some versions, more or fewer flexible circuit layers may be provided. For example, the top flex circuit layer or the bottom flex circuit layer may be omitted.
In some other versions, the relative arrangement of the top leads (138 a,138 b) with respect to the corresponding bottom leads (138 c,138 d) may help substantially reduce or eliminate electromagnetic noise picked up at the proximal terminals of the traces (130, 132,134, 136). For example, the polarity of the first top lead (138 a) may be opposite to the polarity of the first bottom lead (138 c) such that any pick-up noise from the proximal terminal of the proximal top trace (130) and any pick-up noise from the proximal terminal of the proximal bottom trace (134) cancel each other out and thereby both are substantially reduced or eliminated. Likewise, the polarity of the second top lead (138 b) may be opposite to the polarity of the second bottom lead (138 d) such that any pick-up noise from the proximal terminal of the distal top trace (132) and any pick-up noise from the proximal terminal of the distal bottom trace (136) cancel each other out and thereby both are substantially reduced or eliminated.
Although the navigation sensor assembly (110) of the present 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 distal bottom navigation sensors (156). For example, the 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 and/or bottom navigation sensors (152, 156) may help to improve the accuracy of the position coordinates of the flexible portion (118) of the shaft assembly (104) calculated by the processor (52) from the position-related signals of the navigation sensors (150, 152,154, 156). In some cases, the navigation sensor assembly (110) may be disposed along a generally cylindrical surface of the flexible portion (118) of the shaft assembly (104) as described below such that one distal top navigation sensor and/or distal bottom navigation sensor (152, 156) of such a pair 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 bottom navigation sensor (152, 156) of such a pair may be disposed on a second lateral side of the flexible portion (118) of the shaft assembly (104). In this way, a pair of distal top and/or bottom navigation sensors (152, 156) may provide position-related signals indicative of the position of both lateral sides of the flexible portion (118), which may improve the accuracy of position coordinates calculated by the processor (52), such as when the flexible portion (118) is in a curved configuration.
While the navigation sensor assembly (110) of the present 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 be positioned on any other component of the instrument (100) to generate signals indicative of the position of such other component. Further, while the navigation sensor assembly (110) of the present example extends generally horizontally across the inner diameter of the flexible portion (118) of the shaft assembly (104) through its center 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, the navigation sensor assembly (110) may extend across any suitable chord of the flexible portion (118) of the shaft assembly (104).
As shown in fig. 13, the navigation sensor assembly (110) may be disposed below 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) curves about a longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to a radius of curvature of the cylindrical inner surface to thereby conform to an inner circumference of the flexible portion (118). In this configuration, the navigation sensor assembly (110) may permit relatively more space for a larger working channel (149 a) to extend along the shaft assembly (104) (e.g., over the visualization and irrigation 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) curves around a longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to a radius of curvature of the cylindrical outer surface to thereby conform to an outer circumference of the flexible portion (118).
In any event, the navigation sensor assembly (110) may permit space for the working channel (149, 149 a) to extend along the shaft assembly (104) as described above such that the navigation sensor assembly (110) may continuously transmit position-related signals to the processor (52) during distal advancement of a catheter (e.g., a dilation catheter or an energy catheter) through the working channel (149, 149 a) and/or while such a catheter remains positioned within the working channel (149, 149 a), such as during inflation of a balloon of the dilation catheter to dilate an anatomical channel and/or during delivery of RF energy to tissue via an electrode of the energy catheter. In other words, navigation of the flexible portion (118) may be concurrent with expansion of the anatomic passageway and/or concurrent with delivery of RF energy to the tissue without interfering with one another.
As described above, the navigation, visualization and irrigation assembly (106) of the present example also includes a visualization and irrigation 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 FIG. 3, the example visualization and irrigation assembly (108) includes a plate member (160), a camera (161), a pair of illumination elements (162, 163), and a pair of fluid conduits (164, 165). The camera (161) may be in the form of a camera suitably sized to fit within the shaft assembly (104) while still permitting space for the working channel (149) to extend along the shaft assembly (104), permitting additional instruments, suction, fluids, etc. to pass through the open distal end (120) adjacent the camera (161).
The illumination element (162, 163) is configured and operable to illuminate a field of view of the camera (161). The lighting element (162) is positioned at one lateral side of the camera (161), while 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 element (162, 163) includes a fiber optic component. For example, each illumination element (162, 163) may include a lens optically coupled to one or more respective optical fibers or bundles. Such optical fibers or bundles of optical fibers may extend along the shaft assembly (104) and be optically coupled with a light source integrated into the handle assembly (110) (or some other body from which the shaft assembly (104) extends) or otherwise provided.
In this example, the conduits (164, 165) are laterally located to the sides of the camera (161). In particular, the conduit (164) is positioned outside with respect to the camera (161) and inside with respect to the lighting element (162). The conduit (165) is positioned outside with respect to the camera (161) and inside with respect to the illumination element (163). In some versions, both conduits (164, 165) are in fluid communication with a liquid source (e.g., saline, etc.). In some other versions, both conduits (164, 165) are in fluid communication with a suction source. In some other versions, one conduit (164 or 165) is in fluid communication with a liquid source, while the other conduit (165 or 164) is in fluid communication with a suction source. In still other versions, one or both of the conduits (164, 165) may be in fluid communication with a valve assembly, wherein the valve assembly is coupled with a liquid source and a suction source. In such versions, a valve assembly may be used to selectively couple one or both of the conduits (164, 165) with a liquid source or a suction source. Various suitable ways in which either or both of the conduits (164, 165) may be coupled with a liquid source and/or a suction source will be apparent to those skilled in the art in view of the teachings herein. In versions in which at least one of the conduits (164, 165) is in communication with a liquid source, 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 conduits (164, 165) may be used to keep the distal end of the camera (161) clear 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 conduit (164, 165) may be used to suck away excess liquid (e.g., liquid discharged via another conduit (164), etc.).
The example plate member (160) includes a plate (166) and a pair of laterally extending tabs (167,168). The plate (166) is positioned above the camera (161) and thus may be used to shield the camera (161) from being hooked and possibly damaged by other instruments advancing along the working channel (149). In the illustrated embodiment, the navigation sensor assembly (110) is further positioned above the plate (166) and thus may likewise be used to shield the camera (161) from being hooked by such instruments. The tabs (167,168) are positioned to correspond to the position of the respective distal ends of the catheters (164, 165). Specifically, the tab (167) is positioned just distal of the distal end of the catheter (164); while the tab (168) is positioned just distal to the distal end of the catheter (165). The tab (167) may be further positioned to leave a gap (not shown) between the proximal side of the tab (167) and the distal end of the catheter (164), and a similar gap may be left between the proximal side of the tab (168) and the distal end of the catheter (165). These gaps may be sized to allow liquid to escape from the distal end of the catheter (164, 165); and allowing suction to be applied via the distal end of the catheter (164, 165). However, the presence of the tab (167,168) may help to divert liquid discharged via the distal end of the catheter (164, 165) toward the distal end of the camera (161). In other words, when liquid is conveyed along either or both of the conduits (164, 165) and such liquid exits the distal end of such conduits (164, 165), the corresponding tabs (167,168) may divert the expelled liquid toward the distal end of the camera (161) and thereby help flush debris away from the camera (161). In some other versions, the tab (167,168) is omitted. The plate member (160) is merely 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 applications: U.S. provisional patent application 63/037,640 entitled "ENT Guide with Advanceable Instrument and Advanceable Endoscope Shaft" filed on day 6 and 11 in 2020 and U.S. provisional patent application 63/142,098 entitled "ENT Instrument with Ablation Loop and Ablation Needles" filed on day 1 and 27 in 2021.
In some versions, the visualization and irrigation assembly (108) may be omitted such that the second working channel (not shown) may be disposed opposite the working channel (149) relative to the navigation sensor assembly (110) (e.g., below the navigation sensor assembly (110)) in a flat configuration where the navigation sensor assembly (110) is disposed across an inner diameter or other chord of the flexible portion (118) of the shaft assembly (104) (see fig. 3), or such that the internal cross-sectional dimension of the working channel (149) may be enlarged in a curved configuration where the navigation sensor assembly (110) is disposed along a cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) (see fig. 13).
While the instrument (100) has been described as being used to dilate an anatomical passageway within a patient's ear, nose, or throat and/or to deliver RF energy to tissue, it should be appreciated that the instrument (100) may be adapted to perform other surgical functions including, for example, diagnostic procedures, electrophysiological mapping, electrophysiologically guided catheter-guided surgery, and/or cardiac ablation procedures.
B. Exemplary navigation and visualization with Camera Circuit and temperature sensor integrated onto navigation sensor Assembly
And a flushing assembly
In some cases, it may be desirable to provide a navigation, visualization, and irrigation assembly having circuitry integrated into its navigation sensor assembly for the camera (161) of the visualization and irrigation assembly (108), such as to eliminate the need to route wires or cables to the camera (161) along the shaft assembly (104). Integrating the circuitry for the camera (161) into a flexible circuit that has been used for other purposes (e.g., for navigation sensor assembly circuitry, etc.) may increase flexibility and/or reduce size compared to the navigation, visualization, and irrigation assembly (106). Thus, the inner cross-sectional dimension of the working channel (149) may be enlarged and/or the outer cross-sectional dimension of the shaft assembly (104) may be reduced. Additionally or alternatively, it may be desirable to monitor temperatures associated with such navigation sensor assemblies, such as to increase the accuracy of position coordinates determined via the navigation sensor assemblies, which might otherwise be adversely affected by temperature variations. Fig. 14-23 illustrate examples of navigation, visualization and irrigation assemblies (206) having such functionality, and which may be incorporated into the instrument (100) in place of the navigation, visualization and irrigation assembly (106). The navigation, visualization, and irrigation assembly (206) has a navigation sensor assembly (210) and a visualization and irrigation assembly (108) disposed directly below the navigation sensor assembly (210), and may be similar to the navigation, visualization, and irrigation assembly (106), unless otherwise described.
Referring now to fig. 15-22, the navigation sensor assembly (210) of this example is provided in the form of a flexible Printed Circuit Board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (226) having a plurality of thermocouples (227 a,227b,227c,227 d), camera traces (228 a,228b,228c,228 d), corresponding camera trace leads (229 a,229b,229c,229d,229e,229f,229g,229 h), sensor traces (230, 232,234, 236), corresponding sensor trace leads (238 a,238 c,238 d), and ground leads (238 a,238 b) formed (e.g., printed and/or embedded) thereon. As shown, the base plate (226) extends longitudinally between proximal and distal ends (240, 241), laterally between first and second sides (242, 243), and vertically between top and bottom surfaces (244, 245). The substrate (226) of the present example includes a through-hole (246) extending between the top and bottom surfaces (244, 245). The through-holes (246) may be configured to receive pins (not shown) or other suitable fasteners to secure the navigation sensor assembly (210) to the flexible portion (118) of the shaft assembly (104) and/or any other component of the instrument (100), such as the visualization and irrigation assembly (108). In the illustrated version, the base plate (226) further includes a proximal bevel (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) at a desired location relative to the flexible portion (118) of the shaft assembly (104) and/or relative to any other component of the instrument (100), such as the visualization and irrigation assembly (108).
The substrate (226) may be formed of 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 of polyimide, as such a substrate (226) formed of polyimide may be resiliently biased toward a natural flat configuration. Alternatively, where a more complex geometry and/or increased flexibility of the substrate (226) is desired, the substrate (226) may be formed from LCP, as the substrate (226) formed from LCP may be thermoformed to accommodate such complex geometry and/or provide increased flexibility, as described below. In any event, the sensor traces (230, 232,234, 236), the sensor leads (238 a,238b,238c,238 d), the camera traces (228 a,228b,228c,228 d), and the camera leads (229 a,229b,229c,229d,229e,229f,229g,229 h) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (210) is suitably sized to fit within the shaft assembly (104) while still permitting space for the working channel (149) to extend along the shaft assembly (104) (e.g., over the navigation sensor assembly (210)) permitting additional instruments (e.g., dilation catheter and/or energy catheter), aspiration, fluid, 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 as compared to conventional coil sensors. In some versions, the navigation sensor assembly (210) may have a thickness of approximately 50 microns.
As shown in fig. 15 and 16, the sensor traces (230, 232,234, 236) include a proximal top sensor trace (230) and a distal top sensor trace (232) each formed on a top surface (244) of the substrate (226), and a proximal bottom sensor trace (234) and a distal bottom sensor trace (236) each formed on a bottom surface (245) of the substrate (226) opposite and/or parallel to the corresponding top sensor trace (230, 232). The sensor leads (238 a,238b,238c,238 d) include first and second outer sensor leads (238 a,238 b) and first and second inner sensor leads (238 c,238 d) that are each formed on the top surface (244) of the substrate (226). The camera traces (228 a,228b,228c,228 d) include first and second external camera traces (228 a,228 b) and first and second internal camera traces (228 c,228 d) each formed on a top surface (244) of the substrate (226). The camera leads (229 a,229b,229c,229d,229e,229f,229g,229 h) include first and second proximal outer camera leads (229 a,229 b), first and second proximal inner camera leads (229 c,229 d), first and second distal outer camera leads (229 e,229 f), and first and second distal inner camera leads (229 g,229 h) each formed on a top surface (244) of the substrate (226). The ground leads (239 a,239 b) include first and second proximal ground leads (239 a,239 b) each formed on a top surface (244) of the substrate (226). The thermocouples (227 a,227b,227c,227 d) include first and second proximal thermocouples (227 a,227 b) each formed on a top surface (244) of the substrate (226), and first and second distal thermocouples (227 c,227 d). The top sensor trace (230, 232), the sensor lead (238 a,238b,238c,238 d), the camera trace (228 a,228b,228c,228 d), the camera lead (229 a,229b,229c,229d,229e,229f,229g,229 h), the ground lead (239 a,229 b), and the thermocouple (227 a,227b,227c,227 d) collectively define a top flex circuit layer of the navigation sensor assembly (210), and the bottom sensor trace (234, 236) collectively define a bottom flex circuit layer of the navigation sensor assembly (210).
Referring now to fig. 17-22, the sensor traces (230, 232,234, 236) each include respective first longitudinal portions (230 a,232a,234a,236 a), concentric ring portions (230 b,232b, 236 b), and second longitudinal portions (230 c,232c,234c,236 c). As shown, the concentric ring portions (232 b,236 b) of the distal trace (232, 236) are positioned distally relative to the concentric ring portions (230 b,234 b) of the respective proximal trace (230, 234). Furthermore, the concentric ring portions (230 b,232b,234b,236 b) are each laterally located to a side of the camera track (228 a,228b,228c,228 d).
The first external sensor lead (238 a) is electrically coupled to a proximal end of the first longitudinal portion (232 a) of the distal top trace (232). The first longitudinal portion (232 a) of the distal top trace (232) extends distally from a proximal end thereof and is electrically coupled to a distal end of the first longitudinal portion (236 a) of the distal bottom trace (236) at a distal end thereof. A first longitudinal portion (236 a) of the distal bottom trace (236) extends proximally from a distal end thereof toward a location on the bottom surface (245) opposite the first external sensor lead (238 a) and is electrically coupled to a proximal end of a second longitudinal portion (236 c) of the distal bottom trace (236) at a proximal end thereof. A second longitudinal portion (236 c) of the distal bottom trace (236) extends distally from a proximal end thereof and is electrically coupled to a radially outer end of the concentric ring portion (236 b) of the distal bottom trace (236) at a distal end thereof. The concentric ring portion (236 b) of the distal bottom trace (236) spirals radially inward from its radially outer end and is electrically coupled to the radially inner end of the concentric ring portion (232 b) of the distal top trace (232) at its radially inner end. The concentric ring portion (232 b) of the distal top trace (232) spirals radially outward from its radially inner end and is electrically coupled to the distal end of the second longitudinal portion (232 c) of the distal top trace (232) at its radially outer end. A second longitudinal portion (232 c) of the distal top trace (232) extends proximally from a distal end thereof to a first internal sensor lead (238 c) and is electrically coupled thereto at a proximal end thereof.
The second external sensor lead (238 b) is electrically coupled to a proximal end of the first longitudinal portion (230 a) of the proximal top trace (230). The first longitudinal portion (230 a) of the proximal top trace (230) extends distally from a proximal end thereof and is electrically coupled to a distal end of the first longitudinal portion (234 a) of the proximal bottom trace (234) at a distal end thereof. A first longitudinal portion (234 a) of the proximal bottom trace (234) extends proximally from a distal end thereof toward a location on the bottom surface (245) opposite the second external sensor lead (238 b) and is electrically coupled to a proximal end of a second longitudinal portion (234 c) of the proximal bottom trace (234) at a proximal end thereof. A second longitudinal portion (234 c) of the proximal bottom trace (234) extends distally from a proximal end thereof and is electrically coupled to a radially outer end of the concentric ring portion (234 b) of the proximal bottom trace (234) at a distal end thereof. The concentric ring portion (234 b) of the proximal bottom trace (234) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the radially inner end of the concentric ring portion (230 b) of the proximal top trace (230). The concentric ring portion (230 b) of the proximal top trace (230) spirals radially outward from its radially inner end and is electrically coupled to the distal end of the second longitudinal portion (230 c) of the proximal top trace (230) at its radially outer end. A second longitudinal portion (230 c) of the proximal top trace (230) extends proximally from a distal end thereof to a second internal sensor lead (238 d) and is electrically coupled thereto at a proximal end thereof.
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 a signal indicative of the position of the respective navigation sensor (250, 252,254, 256) and thereby of at least a portion of the instrument (100) (e.g., the flexible portion (118) of the shaft assembly (104)) in three-dimensional space. The position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to an operator to display to the operator in real time where the shaft assembly (104) of the instrument (100) is located within the patient (P). Such visual indications may be provided as a superposition over one or more preoperatively acquired images (e.g., CT scans) of the patient's anatomy.
A first proximal external camera lead (229 a) is electrically coupled to a proximal end of a first external camera trace (228 a) extending distally from its proximal end to and electrically coupled to a first distal external camera lead (229 e) at its distal end. A second proximal external camera lead (229 b) is electrically coupled to a proximal end of a second external camera trace (228 b) extending distally from its proximal end to and electrically coupled to a second distal external camera lead (229 f) at its distal end. A first proximal inner camera lead (229 c) is electrically coupled to a proximal end of the first inner camera trace (228 c) extending distally from its proximal end to and electrically coupled to the first distal inner camera lead (229 g) at its distal end. A second proximal inner camera lead (229 d) is electrically coupled to a proximal end of a second inner camera trace (228 d) extending distally from its proximal end to and electrically coupled to a second distal inner camera lead (229 h) at its distal end.
Thus, current signals and/or image signals may generally flow between the first proximal and distal external camera leads (229 a,229 e) via the first external camera trace (228 a), between the second proximal and distal external camera leads (229 b,229 f) via the second external camera trace (228 b), between the first proximal and distal internal camera leads (229 e,229 g) via the first internal camera trace (228 c), and/or between the second proximal and distal internal camera leads (229 d,229 h) via the second internal camera trace (228 d). As such, the camera traces (228 a,228b,228c,228 d) and the camera leads (229 a,229b,229c,229d,229e,229f,229g,229 h) may be used to operatively couple the camera (161) of the visualization and flushing assembly (108) 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 may operatively couple the camera (161) to a power source (not shown) to supply power to the camera (161).
In some versions, a length of the navigation sensor assembly (210) defined between the proximal and distal ends (240, 241) of the base plate (226) may be sufficiently large to position the distal navigation sensor (252, 256) at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120), while also positioning the sensor leads (238 a,238b,238c,238 d) at a sufficiently proximal position where the sensor leads (238 a,238b,238c,238 d) may be directly electrically coupled to the coupling unit (e.g., without the need for inserting wires or cables). Also, the length of the navigation sensor assembly (210) may be large enough to position the distal camera lead (229 e,229f,229g,229 h) at a sufficiently distal location where the distal camera lead (229 e,229f,229g,229 h) may be directly electrically coupled to the camera (161) (e.g., without inserting wires or cables), while also positioning the proximal camera lead (229 a,229b,229c,229 d) at a sufficiently proximal location where the proximal camera lead (229 a,229b,229c,229 d) may be directly electrically coupled to the coupling unit (e.g., without inserting 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 (238 a,238b,238c,238 d) and/or the proximal camera leads (229 a,229b,229c,229 d) may be positioned within or even proximally relative to the body (112) of the handle assembly (110). For example, the navigation sensor assembly (210) may have a length on the order of meters. In this way, the navigation sensor assembly (210) can both generate and transmit position-related signals to the coupling units without the need to route wires or cables between the coupling units; and also can both supply power to the camera (161) and transmit image signals from the camera to the coupling units without the need to route wires or cables between the coupling units.
As described above, the navigation sensor assembly (210) of the present example also includes a plurality of temperature sensors in the form of thermocouples (227 a,227b,227c,227 d) positioned on the top surface (244) of the substrate (226). Referring again to fig. 15, the proximal thermocouples (227 a,227 b) are each positioned relatively close to the proximal top navigation sensor (250), and the distal thermocouples (227 c,227 d) are each positioned relatively close to the distal top navigation sensor (252). Thus, the proximal thermocouples (227 a,227 b) are operable to detect the temperature of the substrate (226) and/or the ambient environment at or near the proximal top navigation sensor (252), and the distal thermocouples (227 c,227 d) are operable to detect the temperature of the substrate (226) and/or the ambient environment at or near the distal top navigation sensor (250). Each thermocouple (227 a,227b,227c,227 d) is operable to generate a signal indicative of the respective detected temperature and thereby indicative of the temperature of the 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) from the position-related signals of the navigation sensors (250, 252,254, 256).
In this regard, it should be appreciated that a change (e.g., an increase) in the temperature of the navigation sensor (250, 252,254, 256) may result in a corresponding change in the resistance of the corresponding concentric ring portion (230 b,232b,234b,236 b), which in turn may result in a corresponding change in the induced current generated in the concentric ring portion by the alternating electromagnetic field, such that the accuracy of the position coordinates calculated by the processor (52) from the resulting position-related signals may be adversely affected. Such temperature changes may be directly associated with their corresponding resistance changes such that the processor (52) may adjust the calculation of the position coordinates based on the temperature data to correct for any resistance changes caused by the temperature changes.
Referring now to FIG. 23, a method (301) is provided for determining position coordinates based on position related signals received by a processor (52) from navigation sensors (250, 252,254, 256) and further based on temperature related signals received by the processor (52) from thermocouples (227 a,227b,227c,227 d). The method (301) starts at step (303) where the temperature related signal indicates that a first temperature of the navigation sensor (250, 252,254, 256) is equal to an ambient temperature such that there is no resistance change in the navigation sensor (250, 252,254, 256) caused by a temperature change to be considered, and the processor (52) calculates accurate position coordinates based on the position related signal received from the navigation sensor (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 ambient temperature such that a change in resistance due to a change in temperature in the navigation sensor (250, 252,254, 256) may need to be considered; and the processor (52) calculates position coordinates of the resistance change shift based on the position-related signals received from the navigation sensors (250, 252,254, 256). For example, such temperature increases may be caused by operating a powered instrument (e.g., an energy catheter, a surgical razor, etc.) within the working channel (149). In any event, the method (301) proceeds from step (305) to step (307) where the processor (52) calculates a temperature change (e.g., a difference between the first temperature and the second temperature) from the first temperature to the second temperature.
From step (307), the method (301) proceeds to step (309) where the processor (52) determines correction factors based on the temperature changes via a stored navigation shift model that correlates the temperature changes with the respective correction factors to account for resistance changes caused by such temperature changes. From step (309), the method (301) proceeds to step (311) where the processor (52) applies a correction factor to the shifted position coordinates of the resistance change to thereby determine accurate position coordinates taking into account the resistance change caused by the temperature change between the first temperature and the second temperature.
Although temperature sensors in the form of thermocouples (227 a,227b,227c,227 d) are shown, any other suitable type of temperature sensor may be used, such as thermistors. In some versions, thermocouples (227 a,227b,227c,227 d) may be omitted, such as in situations where temperature changes are not typical (e.g., when operating an unpowered instrument within the working channel (149)). In other versions, the temperature change of the navigation sensor (250, 252,254, 256) may be determined by detecting a change in the impedance of the respective concentric ring portions (230 b,232b,234b,236 b). For example, it should be appreciated that copper has a relatively large coefficient of thermal expansion such that the change in resistance can be directly related to its corresponding change in temperature. Thus, the processor (52) may adjust the calculation of the position coordinates based on the impedance data to correct for any resistance changes caused by temperature changes in a manner similar to that described above.
C. Exemplary Instrument with serpentine Flexible navigation sensor Assembly
Fig. 24-26C illustrate another example of an instrument (400) that may be used to dilate an anatomic passageway and/or deliver RF energy to tissue. For example, the instrument (400) may be used for dilation of the paranasal sinus ostium (e.g., to treat sinusitis), laryngeal dilation, eustachian tube dilation, dilation of other passages in the ear, nose, or throat, and the like. Additionally or alternatively, the instrument (400) may be used to ablate nerves (e.g., the posterior nasal nerve); ablating turbinates; or ablation, electroporation (e.g., to facilitate absorption of a therapeutic agent, etc.), or any other kind of anatomical structure that applies resistive heating to the patient's head. 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.
The instrument (400) may be coupled to a source of inflation fluid (not shown) operable to selectively supply inflation fluid to a balloon of an inflation catheter (not shown) of the instrument (400) for inflating the balloon to dilate the anatomical passageway. Additionally or alternatively, the instrument (400) may be coupled with an RF generator (101) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (121, 122) located at the distal end of the shaft assembly (104) to ablate, electroporate, or apply resistive heating to the tissue. The transition from fig. 25A to 25B shows the flexible portion (118) of the shaft assembly (104) bending from a straight configuration (fig. 25A) to a bent configuration (fig. 25B) and thereby deflecting the distal end (120) laterally away from the longitudinal axis of the rigid portion (116).
As best shown in fig. 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) is curved about a longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to a radius of curvature of the cylindrical inner surface of the flexible portion (118) to thereby conform to the inner circumference of the flexible portion (118).
26A-26C, the navigation sensor assembly (410) of this example is provided in the form of a flexible Printed Circuit Board (PCB) and includes a serpentine flexible circuit substrate (426) having a pair of laterally adjacent distal navigation sensors (452, 453) and corresponding leads (not shown) positioned thereon. 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 vertically between the top and bottom surfaces (444,445).
The substrate (426) may be formed of 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 of polyimide, as such a substrate (426) formed of polyimide may be resiliently biased toward a natural flat configuration. Alternatively, where a more complex geometry and/or increased flexibility of the substrate (426) is desired, the substrate (426) may be formed of LCP, as the substrate (426) formed of LCP may be thermoformed to accommodate such complex geometry and/or provide increased flexibility, such as for allowing the navigation sensor assembly (410) to flex with the flexible portion (118) of the shaft assembly (104) between a straight configuration and a curved configuration. In any event, the distal navigation sensors (452, 453) may be defined by concentric ring portions of respective conductive traces (not shown) formed on the top surface (444) of the substrate (426) and operable to generate signals indicative of the position of the respective navigation sensors (452, 453) as described above. The navigation sensor assembly (410) is suitably sized to fit within the shaft assembly (104) while still permitting space for the working channel (449) to extend along the shaft assembly (104) (e.g., over the navigation sensor assembly (410)) permitting additional instruments (e.g., dilation catheter and/or energy catheter), aspiration, fluid, 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 as compared to conventional coil sensors. In some versions, the navigation sensor assembly (410) may have a thickness of approximately 50 microns.
It should be appreciated that the serpentine configuration of the base plate (426) may provide the navigation sensor assembly (410) with reduced geometric constraints and increased flexibility as compared to a generally rectangular configuration of the base plate (126) of the navigation sensor assembly (110). Thus, the substrate (426) may be used in situations where more complex geometries and/or increased flexibility of the substrate (426) are desired, such as for malleable or orientable devices (e.g., the flexible portion (118) of the shaft assembly (104)).
As best seen in fig. 26A, the navigation sensor assembly (410) may initially have a generally flat configuration, such as when the base plate (426) is initially formed and/or during initial positioning of the distal navigation sensors (452, 453) on the base plate. As shown, the longitudinal centerline (C) extends along the substrate (426). As best seen in fig. 26B, the navigation sensor assembly (410) may assume a laterally curved, longitudinally straight configuration in which sides (442, 443) of the base plate (426) are curved upward from a longitudinal centerline (C), the navigation sensor assembly (410) extending in a longitudinal direction. Thus, when disposed within the flexible portion (118), the navigation sensor assembly (410) may be bent about a longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to a radius of curvature of a cylindrical inner surface of the flexible portion (118) to thereby conform to an inner circumference of the flexible portion (118). As best seen in fig. 26C, the navigation sensor assembly (410) may assume a laterally curved, longitudinally curved configuration in which sides (442, 443) of the base plate (426) are curved upward from a longitudinal centerline (C), the navigation sensor assembly (410) being 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 the navigation sensor assembly (410) may be in its laterally curved, longitudinally curved configuration when the flexible portion (118) of the shaft assembly (104) is in its curved configuration. In this way, the navigation sensor assembly (410) can accommodate bending of the flexible portion (118) between its straight and bent configurations such that navigation of the flexible portion (118) can be performed regardless of whether the flexible portion (118) is in its straight or bent configuration.
In the illustrated example, a distal navigation sensor (452, 453) is 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) for which navigation is desired. It should also be appreciated that one distal navigation sensor (452, 453) may be disposed on a first lateral side of the flexible portion (118) of the shaft assembly (104) and the other distal navigation sensor (452, 453) may be disposed on a second lateral side of the flexible portion (118) of the shaft assembly (104). In this way, the distal navigation sensors (452, 453) may provide position-related signals indicative of the position 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 flexible portion (118) is in a curved configuration. In some versions, only a single distal 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 the corresponding top navigation sensor (452, 453), such as to reduce or eliminate 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 the present example is disposed along a generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104), the navigation sensor assembly (410) may alternatively be disposed along a generally cylindrical outer surface of the flexible portion (118) of the shaft assembly (104) in at least one generally curved configuration in which 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 a radius of curvature of the cylindrical outer surface of the flexible portion (118) to thereby conform to an 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 continuously transmit position-related signals to the processor (52) during distal advancement of a catheter (e.g., an inflation catheter or an energy catheter) through the working channel (449) and/or while such a catheter remains positioned within the working channel (449), such as during inflation of a balloon of the inflation catheter to expand an anatomical channel and/or during delivery of RF energy to tissue via an electrode of the energy catheter. In other words, navigation of the flexible portion (118) may be concurrent with expansion of the anatomic passageway and/or concurrent with delivery of RF energy to the tissue without interfering with one another.
D. Exemplary suction apparatus with serpentine Flexible navigation sensor Assembly
27A-27C illustrate examples of instruments (500) that may be used to provide suction during a surgical procedure to facilitate removal of foreign and/or undesired substances (e.g., fluids and/or debris) within or near an anatomical passageway. For example, the instrument (500) may be used to clear fluids and/or debris from paranasal sinuses, larynx, eustachian tube, ear, nose or other passages within the larynx, etc. during a FESS procedure, a sinuroplasty procedure, and/or in various other ENT procedures. The instrument (500) of this example includes an elongate malleable shaft (516) extending distally from a handle (not shown) to an open distal suction tip (520) and a navigation sensor assembly (510), which may be similar to the navigation sensor assembly (410) unless otherwise described. The 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 through the instrument (500). The transition from fig. 27A to 27C shows the malleable shaft (516) bending from a straight configuration (fig. 27A) to a bent configuration and a double bent configuration (fig. 27B and 27C, respectively), and thereby deflecting the distal suction tip (520) laterally away from the proximal longitudinal axis of the malleable shaft (516).
As shown, the navigation sensor assembly (510) is disposed on an exterior of the malleable shaft (516) and is operable to provide navigation capabilities to the malleable shaft (516). More specifically, the navigation sensor assembly (510) is disposed along a generally cylindrical outer surface of the malleable shaft (516) in at least one generally curved configuration in which the navigation sensor assembly (510) is curved about a longitudinal axis of the malleable shaft (516) with a radius of curvature corresponding to a radius of curvature of the cylindrical outer surface of the malleable shaft (516) to thereby conform to an outer circumference of the malleable 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 (552,553) and corresponding leads (not shown) are positioned. As shown, the base plate (526) extends longitudinally between the proximal and distal ends (540,541), laterally between the first and second sides (542,543), and vertically between the top and bottom surfaces (544, not shown).
The substrate (526) may be formed of 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 of polyimide, as such substrate (526) formed of polyimide may be resiliently biased toward a natural flat configuration. Alternatively, where a more complex geometry and/or increased flexibility of the substrate (526) is desired, the substrate (526) may be formed of LCP, as the substrate (526) formed of LCP may be thermoformed to accommodate such complex geometry and/or provide increased flexibility, such as for allowing the navigation sensor assembly (510) to bend with the malleable shaft (516) between a straight configuration, a bent configuration, and a double bent configuration. In any event, the distal navigation sensor (552,553) may be defined by concentric ring portions of respective conductive traces (not shown) formed on the top surface (544) of the base plate (526) and operable to generate signals indicative of the position of the respective navigation sensor (552,553) as described above. The navigation sensor assembly (510) is suitably sized to fit over the exterior of the malleable shaft (516) without obstructing a working channel (549) extending along the malleable shaft (516), thereby permitting additional instruments, suction, fluids, etc. to pass through the open distal suction tip (520) while also remaining substantially flush with the exterior of the malleable 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 as compared to conventional coil sensors. In some versions, the navigation sensor assembly (510) may have a thickness of approximately 50 microns.
In some versions, the navigation sensor assembly (510) may initially have a substantially flat configuration (not shown) similar to the configuration of the navigation sensor assembly (410), such as when the base plate (526) is initially formed and/or during initial positioning of the distal navigation sensor (552,553) on the base plate. As best seen in fig. 27A, the navigation sensor assembly (510) may assume a laterally curved, longitudinally straight configuration in which the side (542,543) of the base plate (526) is curved downwardly from a longitudinal centerline (not shown) of the base plate (526), the navigation sensor assembly (510) extending in a longitudinal direction. Thus, when disposed on the exterior of the malleable shaft (516), the navigation sensor assembly (510) may be bent about the longitudinal axis of the malleable shaft (516) with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the malleable shaft (516) to thereby conform to the outer circumference of the malleable shaft (516).
As best seen in fig. 27B, the navigation sensor assembly (510) may assume a laterally curved, longitudinally curved configuration in which a side (542,543) of the base plate (526) is curved downwardly from a longitudinal centerline of the base plate (526), the navigation sensor assembly (510) being at least partially deflected from the longitudinal direction at a first location along its length.
As best seen in fig. 27C, the navigation sensor assembly (510) may assume a laterally curved, longitudinally double-curved configuration in which the side (542,543) of the base plate (526) is curved downwardly from the longitudinal centerline of the base plate (526), the navigation sensor assembly (510) being at least partially deflected from the longitudinal direction at a first position and a second position along its length. The navigation sensor assembly (510) may be in its laterally curved, longitudinally straight configuration when the malleable shaft (516) is in its straight configuration, the navigation sensor assembly (510) may be in its laterally curved, longitudinally curved configuration when the malleable shaft (516) is in its curved configuration, and the navigation sensor assembly (510) may be in its laterally curved, longitudinally double curved configuration when the malleable shaft (516) is in its double curved configuration. In this way, the navigation sensor assembly (510) can accommodate bending of the malleable shaft (516) between its straight, bent, and double-bent configurations such that navigation of the malleable shaft (516) can be performed regardless of whether the malleable shaft (516) is in its straight, bent, or double-bent configuration.
In the illustrated example, a distal navigation sensor (552,553) is positioned at or near the distal suction tip (520) of the malleable shaft (516) to facilitate navigation of the distal suction tip (520). However, it should be appreciated that the navigation sensor (552,553) may be positioned at any other suitable location relative to the components of the instrument (500) for 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 malleable shaft (516) and the other distal navigation sensor (552,553) may be disposed on a second lateral side of the malleable shaft (516). In this way, the distal navigation sensor (552,553) may provide a position-related signal indicative of the position of both lateral sides of the malleable shaft (516), which may improve the accuracy of the position coordinates calculated by the processor (52), such as when the malleable shaft (516) is in a bent and/or doubly-bent configuration. In some versions, only a single distal 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 a bottom surface (545) of the base plate (526) opposite the corresponding top navigation sensor (552,553), such as to reduce or eliminate 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 malleable shaft (516). Such positioning may enable the IGS navigation system (50) to determine the position and orientation of the malleable shaft (516) throughout the length within the patient (P), regardless of what particular bending configuration the operator has applied to the malleable shaft (516).
While the navigation sensor assembly (510) of the present example is disposed along a generally cylindrical outer surface of the malleable shaft (516), the navigation sensor assembly (510) may alternatively be disposed along a generally cylindrical inner surface of the malleable shaft (516) in at least one generally curved configuration in which the navigation sensor assembly (510) is curved about a longitudinal axis of the malleable shaft (516) with a radius of curvature corresponding to a radius of curvature of the cylindrical inner surface of the malleable shaft (516) to thereby conform to the inner circumference of the malleable shaft (516). In any event, the navigation sensor assembly (510) may permit space for the working channel (549) to extend along the malleable shaft (516) as described above such that the navigation sensor assembly (510) may continuously communicate position-related signals to the processor (52) during proximal aspiration of fluids and/or debris through the working channel (549) to clear such fluids and/or debris from within or near the anatomical channel. In other words, the removal of fluid and/or debris from the anatomic passageways and navigation of the malleable shaft (516) may be performed simultaneously without interfering with one another.
While the navigation sensor assembly (510) is shown incorporated into the instrument (500) to provide aspiration, it should be appreciated that the navigation sensor assembly (510) may be incorporated into any other suitable surgical instrument, such as instruments for performing other functions during ENT procedures, including, for example, a probe instrument or a curette instrument having a malleable shaft.
E. Exemplary shaving machine with straight flexible navigation sensor Assembly
Fig. 28-37 illustrate examples of instruments (600) that may be used to sever and remove tissue, such as bone tissue, from an anatomic passageway. For example, the 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. The instrument (600) may be coupled with a suction source (not shown) that is operable to selectively provide sufficient suction at the surgical site to pull severed tissue proximally through the instrument (600).
The handle assembly (602) of this example includes a body (612) sized and configured to be gripped and operated by a single hand of an operator, such as via a motorized grip, a pencil grip, or any other suitable kind of grip. The handle assembly (602) may include controls for operating the instrument (600), or the controls may be remotely located. The instrument (600) further includes a suction port (613) operatively connected to the suction source and configured to aspirate tissue (such as bone tissue) from the surgical site. The rotational motion may be delivered to the shaft assembly (604) by a motorized drive assembly (not shown) in the handle assembly (602), although any suitable source of rotational or oscillating motion may be utilized. For example, this source of motion may be housed within the handle assembly (602), or may be external and connectable to the handle assembly (602). A power source (not shown) may be connected to the motorized drive assembly to power the instrument (600) for use. Additionally or alternatively, the handle assembly (602) may house a battery (not shown).
The 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 comprise a tube, is disposed within the longitudinally extending lumen of the outer shaft (616) and is configured to rotate about a longitudinal axis of the shaft assembly (604) at the distal portion. The cutting member (618) defines an inner 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 a configuration can be constructed and operated in accordance with any of the teachings of U.S. publication No. 2019/0388117, entitled "Surgical Shaver with Feature to Detect Window State," published 12, 26, 2019.
The shaft assembly (604) is also rotatable relative to the handle assembly (610) about a longitudinal axis of the shaft assembly (604). Such rotation may be driven via a rotary control knob (614) rotatably coupled with a body (612) of the handle assembly (610). Alternatively, the shaft assembly (604) may be rotated via some other form of user input; or may be non-rotatable relative to the handle assembly (610). It should also be understood that the examples of handle assemblies (610) described herein are merely illustrative examples. The shaft assembly (604) may alternatively be coupled with any other suitable kind of handle assembly or other support body.
As best shown in fig. 29, the navigation sensor assembly (610) is disposed on an exterior of the outer shaft (616) and is operable to provide navigation capabilities to the outer shaft (616). More specifically, the navigation sensor assembly (610) is disposed along a generally cylindrical outer surface of the outer shaft (616) in a generally curved configuration in which the navigation sensor assembly (610) is curved about a longitudinal axis of the outer shaft (616) with a radius of curvature corresponding to a radius of curvature of the cylindrical outer surface of the outer shaft (616) to thereby conform to an outer circumference of the outer shaft (616). In some versions, the instrument (600) may include a sheath (not shown) coaxially positioned around at least a portion of the outer shaft (616) radially outward of the navigation sensor assembly (610) such that the navigation sensor assembly (610) may be sandwiched between the sheath and the outer shaft (616).
Referring now to fig. 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) having a plurality of traces (630,632,633,634,636,637) formed (e.g., printed and/or embedded) thereon, a plurality of corresponding trace leads (428 a, 618 b, 618 c, 618 d, 618 e, 618 f), and a plurality of ground leads (639 a,639 b). 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 vertically between the top and bottom surfaces (644,645). The substrate (626) of the present example includes a plurality of through holes (646) extending between a top surface and a bottom surface (644,645). The through holes (646) may be configured to receive corresponding pins (not shown) or other suitable fasteners to secure the navigation sensor assembly (610) to the flexible outer shaft (616) and/or any other component of the instrument (600). In the illustrated version, the base plate (626) further includes a proximal ramp (648) extending between the proximal end (640) and the first side (642). The proximal ramp (648) may be configured to facilitate positioning of the proximal end (640) at a desired location relative to the outer shaft (616) and/or relative to any other component of the instrument (600).
The substrate (626) may be formed of 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, as such substrate (626) formed from polyimide may be resiliently biased toward a natural flat configuration. Alternatively, where a more complex geometry and/or increased flexibility of the substrate (626) is desired, the substrate (626) may be formed from LCP, as the substrate (626) formed from LCP may be thermoformed to accommodate such complex geometry and/or provide increased flexibility. In any event, the traces (630,632,633,634,636,637) and leads (428 a, 428 b, 428 c, 428 d, 428 e, 428 f) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (610) is suitably sized to fit over the exterior of the outer shaft (616) without blocking the lumen of the outer shaft (616), thereby permitting the inner cutting member (618) to be rotatably disposed within the lumen while also remaining substantially 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 as compared to conventional coil sensors. In some versions, the navigation sensor assembly (610) may have a thickness of approximately 50 microns.
As shown in fig. 30 and 31, the 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) each formed on a top surface (644) of the substrate (626), and a proximal bottom trace (634), a first distal bottom trace (636), and a second distal bottom trace (637) each formed on a bottom surface (645) of the substrate (626) opposite and/or parallel to the corresponding top trace (630,632,633). Similarly, the leads (638 a, 428 b, 428 c, 428 d, 428 e, 428 f) include proximal top leads (638 a) and first and second distal top leads (428 b, 428 c) each formed on the top surface (644) of the substrate (626); and proximal bottom leads (638 d) and first and second distal bottom leads (428 e, 428 f) each formed on a bottom surface (645) of the substrate (626) opposite and/or parallel to the corresponding top leads (638 a, 428 b, 428 c). The ground leads (639 a,639 b) include first and second ground leads (639 a,639 b) each formed on a top surface (644) of the substrate (626). The top trace (630,632,633), the top lead (428 a, 428 b, 428 c), and the ground lead (639 a,639 b) collectively define a top flex circuit layer of the navigation sensor assembly (610), while the bottom trace (634,636,637) and the bottom lead (428 d, 428 e, 328 f) collectively define a bottom flex circuit layer of the navigation sensor assembly (610).
Referring now to figures 32 to 37 of the drawings, the traces (630,632,633,634,636,637) each include respective first longitudinal portions (630 a, 63a, 637 a), concentric ring portions (630 b, 63b, 636b,637 b) and second longitudinal portions (630 c,633c,634c,636c,637 c). As shown, the concentric ring portions (630 b,633b,636b,637 b) of the distal trace (632,633,636,637) are positioned distally relative to the concentric ring portions (630 b ) of the respective proximal trace (630,634).
The proximal top lead (638 a) is electrically coupled to a proximal end of the first longitudinal portion (630 a) of the proximal top trace (630). The first longitudinal portion (630 a) of the proximal top trace (630) extends distally from its proximal end and is electrically coupled at its distal end to the distal end of the first longitudinal portion (634 a) of the proximal bottom trace (634). A first longitudinal portion (634 a) of the proximal base trace (634) extends proximally from a distal end thereof toward the proximal base lead (638 d) and is electrically coupled at a proximal end thereof to a proximal end of a second longitudinal portion (634 c) of the proximal base trace (634). A second longitudinal portion (634 c) of the proximal base trace (634) extends distally from a proximal end thereof and is electrically coupled at a distal end thereof to a radially outer end of the concentric ring portion (634 b) of the proximal base trace (634). The concentric ring portion (634 b) of the proximal bottom trace (634) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the radially inner end of the concentric ring portion (630 b) of the proximal top trace (630). The concentric ring portion (630 b) of the proximal top trace (630) spirals radially outward from its radially inner end and is electrically coupled to the distal end of the second longitudinal portion (630 c) of the proximal top trace (630) at its radially outer end. The second longitudinal portion (630 c) of the proximal top trace (630) extends proximally from its distal end toward the proximal top lead (638 a) and is electrically coupled to the proximal bottom lead (638 d) at its proximal end.
The first distal top lead (638 b) is electrically coupled to a proximal end of a first longitudinal portion (632 a) of the first distal top trace (632). A first longitudinal portion (632 a) of the first distal top trace (632) extends distally from a proximal end thereof and is electrically coupled to a distal end of the first longitudinal portion (636 a) of the first distal bottom trace (636) at a distal end thereof. A first longitudinal portion (636 a) of the first distal bottom trace (636) extends proximally from a distal end thereof toward the first distal bottom lead (638 e) and is electrically coupled at a proximal end thereof to a proximal end of a second longitudinal portion (636 c) of the first distal bottom trace (636). A second longitudinal portion (636 c) of the first distal bottom trace (636) extends distally from a proximal end thereof and is electrically coupled to a radially outer end of the concentric ring portion (636 b) of the first distal bottom trace (636) at a distal end thereof. The concentric ring portion (636 b) of the first distal bottom trace (636) spirals radially inward from its radially outer end and is electrically coupled to the radially inner end of the concentric ring portion (632 b) of the first distal top trace (632) at its radially inner end. The concentric ring portion (632 b) of the first distal top trace (632) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to the distal end of the second longitudinal portion (632 c) of the first distal top trace (632). A second longitudinal portion (632 c) of the first distal top trace (632) extends proximally from a distal end thereof toward the first distal top lead (638 b) and is electrically coupled to the first distal bottom lead (638 e) at a proximal end thereof.
The second distal top lead (638 c) is electrically coupled to a proximal end of the first longitudinal portion (633 a) of the second distal top trace (633). The first longitudinal portion (633 a) of the second distal top trace (633) extends distally from a proximal end thereof and is electrically coupled to a distal end of the first longitudinal portion (637 a) of the second distal bottom trace (637) at a distal end thereof. The first longitudinal portion (637 a) of the second distal bottom trace (637) extends proximally from its distal end toward the second distal bottom lead (638 f) and is electrically coupled at its proximal end to a proximal end of the second longitudinal portion (637 c) of the second distal bottom trace (637). A second longitudinal portion (637 c) of the second distal bottom trace (637) extends distally from a proximal end thereof and is electrically coupled at a distal end thereof to a radially outer end of the concentric ring portion (637 b) of the second distal bottom trace (637). The concentric ring portion (637 b) of the second distal bottom trace (637) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the radially inner end of the concentric ring portion (633 b) of the second distal top trace (633). The concentric ring portion (633 b) of the second distal top trace (633) spirals radially outward from its radially inner end and is electrically coupled to the distal end of the second longitudinal portion (633 c) of the second distal top trace (633) at its radially outer end. A second longitudinal portion (633 c) of the second distal top trace (633) extends proximally from its distal end toward the second distal top lead (638 c) and is electrically coupled to the second distal bottom lead (638 f) at its proximal end.
In a similar manner as described above, each concentric ring portion (630 b,633b, 630b, 636b,637 b) defines a respective navigation sensor (650,652,653,654,656,657) operable to generate a signal indicative of the position of the respective navigation sensor (650,652,653,654,656,657) and thereby of at least a portion (e.g., outer shaft (616)) of the instrument (500) in three-dimensional space. The position data generated from such position-related signals may be processed by the processor (52) for providing visual indications to an operator to display to the operator in real time where the outer shaft (616) of the instrument (600) is located within the patient (P). Such visual indications may be provided as a superposition over one or more preoperatively acquired images (e.g., CT scans) of the patient's anatomy.
In the illustrated example, the distal navigation sensor (652,653,656,657) is positioned at or near a lateral shaft window (621) of the outer shaft (616) to facilitate navigation of the lateral shaft window (621), while the proximal navigation sensors (650, 654) may be positioned at any suitable location along the outer shaft (616) to facilitate identifying a direction and/or orientation of the outer shaft (616), for example. However, it should be appreciated that the navigation sensor (650,652,653,654,656,657) may be positioned at any other suitable location relative to the components of the instrument (600) for which navigation is desired. Also in the illustrated example, 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 sensor (652,653) and distal bottom navigation sensor (656,657) may help to improve the accuracy of the position coordinates of the outer shaft (616)) calculated by the processor (52) from the position related signals of the navigation sensors (650,652,653,654,656,657). In this regard, the present version of the navigation sensor assembly (610) is disposed along a generally cylindrical outer surface of the outer shaft (616) such that one distal top navigation sensor (652,653) and one distal bottom navigation sensor (656,657) may be disposed on a first lateral side of the outer shaft (616) and the other distal top navigation sensor (652,653) and the other distal bottom navigation sensor (656,657) may be disposed on a second lateral side of the outer shaft (616). In this way, a pair of distal top and bottom navigation sensors (652,653,656,657) can provide position-related signals indicative of the position of both lateral sides of the outer shaft (616), which can improve the accuracy of the position coordinates calculated by the processor (52).
In some versions, a length of the navigation sensor assembly (610) defined between the proximal and distal ends (640, 641) of the base plate (626) may be sufficiently large to position the distal navigation sensor (652,653,656,657) at or near the lateral shaft window (621) of the outer shaft (616) to facilitate navigation of the lateral shaft window (621), while also positioning the leads (618 a, 618 b, 618 c, 618 d, 618 e, 618 f) at a sufficiently proximal location where the leads (618 a, 618 b, 618 c, 618 d, 618 e, 618 f) may be directly electrically coupled to the coupling unit (e.g., without the insertion of wires or cables). In this regard, the length of the navigation sensor assembly (610) may be substantially equal to or greater than the length of the shaft assembly (604) such that the leads (428 a, 428 b, 428 c, 428 d, 428 e, 428 f) may be positioned within the body (612) of the handle assembly (610) or even proximally relative to the body of the handle assembly. For example, the navigation sensor assembly (610) may have a length on the order of meters. In this way, the navigation sensor assembly (610) can both generate and transmit position-related signals to the coupling units without the need to route wires or cables between the coupling units.
While the navigation sensor assembly (610) of the present example is disposed along a generally cylindrical outer surface of the outer shaft (616), the navigation sensor assembly (610) may alternatively be disposed along a generally cylindrical inner surface of the outer shaft (616) in a generally curved configuration in which the navigation sensor assembly (610) is curved about a longitudinal axis of the outer shaft (616) with a radius of curvature corresponding to a radius of curvature of the cylindrical inner surface of the outer shaft (616) to thereby conform to an inner circumference of the outer shaft (616). In any event, the navigation sensor assembly (610) can permit space for the lumen to extend along the outer shaft (616) as described above such that the navigation sensor assembly (610) can continuously communicate position-related signals to the processor (52) during severing and/or aspiration of tissue. In other words, the severing/aspiration of tissue and navigation of the outer shaft (616) may be performed simultaneously without interfering with one another.
Although not shown, the navigation sensor assembly (610) may include at least one temperature sensor formed (e.g., printed and/or embedded) on the substrate (626) for detecting a temperature of the substrate (626) and/or an ambient environment at or near the at least one navigation sensor (650,652,653,654,656,657), and generating a signal indicative of the detected temperature that may be processed by the processor (52) for improving accuracy of position coordinates calculated by the processor (52) from position-related signals of the navigation sensor (650,652,653,654,656,657) in a manner similar to that described above. In this regard, it should be appreciated that operation of the motorized drive assembly to rotatably drive the cutting member (618) relative to the outer shaft (616) may result in an increase in temperature of the shaft assembly (604), which in turn may result in a change in resistance caused by a change in temperature in the navigation sensor (650,652,653,654,656,657). In other versions, the temperature change of the navigation sensor (650,652,653,654,656,657) may be determined by detecting a change in the impedance of the respective concentric ring portions (630 b,633b,634b,636b,637 b). In any event, the processor (52) may adjust the calculation of the position coordinates based on the temperature data to correct for any resistance changes caused by the temperature changes.
F. Exemplary shaving machine with curved Flexible navigation sensor Assembly
Fig. 38 illustrates another example of an instrument (700) that may be used to sever and remove tissue, such as bone tissue, from an anatomic passageway. For example, the instrument (700) may be used to sever and remove bone tissue from the nasal cavity, as well as from any other suitable location. The instrument (700) of this example includes a handle assembly (not shown), a hub (703), a shaft assembly (704), and a navigation sensor assembly (610), and may be similar to the instrument (600) unless otherwise described. The instrument (700) may be coupled with a suction source (not shown) that is operable to selectively provide sufficient suction at the surgical site to pull severed tissue proximally through the instrument (700).
The shaft assembly (704) generally includes a longitudinally curved rigid outer shaft (716) and an inner cutting member (not shown) that are collectively configured to receive and remove tissue from a surgical site. In some versions, the distal portion of the outer shaft (716) may be oriented at an angle of approximately 60 ° relative to the proximal portion of the outer shaft (716). In any event, 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, the navigation sensor assembly (610) is disposed on an 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 a generally cylindrical outer surface of the outer shaft (716) in a generally curved configuration in which the navigation sensor assembly (610) is curved about a longitudinal axis of the outer shaft (716) with a radius of curvature corresponding to a radius of curvature of the cylindrical outer surface of the outer shaft (716) to thereby conform to an outer circumference of the outer shaft (716). The navigation sensor assembly (610) also flexes longitudinally to conform to the longitudinal curvature of the outer shaft (716).
Exemplary navigation adapter sheath
As noted above, it may be desirable to provide an instrument with a flexible circuit having an integrated navigation sensor. It may also be desirable to provide an adapter with a flexible circuit having one or more integrated navigation sensors, wherein such an adapter may be easily coupled with an instrument that otherwise lacks any navigation sensors. In such scenarios, the adapter may impart navigational capabilities to the instrument. Similarly, it may be desirable to use an adapter with a flexible circuit having one or more integrated navigation sensors in combination with an instrument that already has one or more navigation sensors, wherein position data from the one or more navigation sensors of the adapter may supplement position data from the one or more navigation sensors of the instrument. In such scenarios, the adapter may enhance the navigational capabilities of the instrument. In either of the above two scenarios, the adapter may be configured to avoid increasing the volume of the instrument; and are easily assembled with instruments in the surgical field.
Fig. 39-43 illustrate examples of adapters in the form of adapter jackets (1100) that may provide the benefits and functions described above. In this example, the adapter sheath (1100) is coupled with a tissue shaving instrument (1000). The tissue shaving instrument (1000) of this example 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 body (1002) is configured to be held by an operator. The suction port (1004) is configured to be coupled with a suction source such that suction can be applied to aspirate tissue and fluid during operation of the tissue shaving instrument (1000). The rotary control knob (1006) is rotatable relative to the body (1002) to reorient the shaft assembly (1020) about a longitudinal axis of the shaft assembly (1020). The power source connector (1008) is configured to couple with a power source to provide power to a motor (not shown) in the body (1002). The motor is operable to drive a cutting shaft (not shown) of the shaft assembly (1020) in a manner as known in the art.
In addition to including a cutting shaft, the shaft assembly (1020) includes an outer shaft (1030) and an end effector (1022). An end effector (1022) is located at a distal end of the shaft assembly (1020). As best seen in fig. 43, the end effector (1022) includes a transverse opening (1040) formed at the distal end of the outer shaft (1030), and a serrated cutting edge (1042) extends along the periphery of the opening (1040). The cutting shaft is positioned inside the outer shaft (1030) and includes similar transverse openings and cutting edges that are complementary to the transverse openings (1040) and cutting edges (1042). A motor in the body (1002) drives rotation of the cutting shaft relative to the outer shaft (1030) about a longitudinal axis of the shaft assembly (1020). During such rotation, suction is applied via a lumen defined by the cutting shaft to draw tissue into the opening (1040), a cutting edge of the cutting shaft cooperates with a cutting edge (1042) of the outer shaft (1030) to shear the tissue, and the sheared tissue is drawn proximally through the lumen of the cutting shaft under the influence of the suction. It will be appreciated by those of ordinary skill in the art that it may be beneficial to have data from the navigation sensor indicating the real-time position of the end effector (1022) within the patient during operation of the tissue shaving machine (1000).
As shown in fig. 39-40, the adapter sheath (1100) of the present 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 fig. 41, the shaft assembly (1120) includes a hollow outer shaft (1130), a flexible circuit (1140), and a hollow inner shaft (1150). The hub (1110) is fixedly secured to a proximal end of the outer shaft (1130). The flex circuit (1140) includes a flexible substrate (1142), a pair of navigation sensors (1144,1146), and traces (not shown). The flexible substrate (1142), navigation sensor (1144,1146), and trace may be configured to be operable, such as any of the various flexible substrates, navigation sensors, and traces described above. The flexible circuit (1140) may have only one single layer or multiple layers.
As shown in fig. 42, the shaft assembly (1120) is configured such that the inner shaft (1150) is coaxially nested within the outer shaft (1130), with the flexible circuit (1140) interposed radially between the exterior of the inner shaft (1150) and the interior of the outer shaft (1130). In some versions, the shaft assembly (1120) is configured such that the flexible circuit (1140) is embedded within or otherwise coupled to the inner shaft (1150) and/or the 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 shaft (1130,1150) can be welded or otherwise secured together. The relationship between the shaft (1130,1150) and the flexible circuit (1140) may provide protection for the flexible circuit (1140) such that the shaft assembly (1120) may be subjected to different kinds of sterilization procedures that might otherwise damage one or more features of the flexible circuit (1140) if such features were exposed. Although in this example the flex circuit (1140) is interposed between the shafts (1130,1150), the flex circuit (1140) may be interposed between or otherwise positioned relative to any other suitable type of tubular member.
The inner shaft (1150) defines an Inner Diameter (ID) corresponding to an outer diameter of an outer shaft (1030) of the tissue shaving instrument (1000) such that the shaft assembly (1020) may be easily inserted into the shaft assembly (1120), the shaft assembly (1120) closely corresponding to the shaft assembly (1020). In such close correspondence, the shaft assembly (1120) may not substantially increase the outer diameter of the shaft assembly (1020) such that the addition of the adapter sheath (1100) may not undesirably increase the profile of the tissue shaving instrument (1000). In other words, the presence of the adapter sheath (1100) may not undesirably interfere with the normal use of the tissue shaving instrument (1000).
The hub (1110) of the adapter sheath (1100) is configured to engage with the hub (1010) of the tissue shaving instrument (1000) to thereby removably secure the adapter sheath (1100) relative to the tissue shaving instrument (1000). By way of example only, the hub (1110) may provide a snap fit, interference fit, or any other suitable kind of relationship with the hub (1010). As shown in fig. 39 and 43, the length of the shaft assembly (1120) is such that the distal end (1132,1152) is just proximal of the end effector (1022) when the adapter sheath (1100) is fully seated on the tissue shaving instrument (1000). As also shown in fig. 43, wherein the outer shaft (1130) is omitted, the distal navigation sensor (1146) of the adapter sheath (1100) is positioned adjacent to the end effector (1022). Such a position of the distal navigation sensor (1146) may thus allow the distal navigation sensor (1146) to easily indicate the real-time position of the end effector (1022). The proximal navigation sensor (1146) of the adapter sheath (1100) is positioned more proximal than the end effector (1022) such that the proximal navigation sensor (1146) can readily indicate the real-time position of the corresponding proximal portion of the shaft assembly (1020). In some versions, the proximal navigation sensor (1146) is omitted.
Although only one navigation sensor (1144) is shown at the distal end of the flexible circuit (1140) in this example, some variations may provide two or more navigation sensors (1144) at the distal end of the flexible circuit (1140). Similarly, although only one navigation sensor (1146) is shown on the flex circuit (1140) located proximal to the navigation sensor (1144), two or more navigation sensors (1146) may be provided proximal to the navigation sensor (1144).
Traces of the flex circuit (1140) are configured to transmit the position indication signal from the navigation sensor (1144,1146) to the cable (1102). The cable (1102) is configured to transmit the position indication signals to the connector (1104). The connector (1104) is configured to couple with the IGS navigation system (50) and thereby transmit a position indication signal to the IGS navigation system (50). In some versions, the connector (1104) is configured to plug into a corresponding receptacle of the IGS navigation system (50). In some other versions, the connector (1104) includes a wireless transmitter operable to wirelessly transmit the position indication signal to the IGS navigation system (50). In still other versions, the cable (1102) and connector (1104) are omitted, and some other components of the adapter sheath (1100) are configured to wirelessly transmit the position indication signal to the IGS navigation system (50). By way of example only, one or more wireless transmitters may be integrated into the hub (1110). Alternatively, the position indication signal may be transmitted to the IGS navigation system (50) in any other suitable manner.
In some versions, the outer shaft (1130) and the inner shaft (1150) each comprise a metallic material. In some other versions, the outer shaft (1130) and the inner shaft (1150) each comprise a polymeric material. In some other versions, the outer shaft (1130) comprises a metallic material and the inner shaft (1150) comprises a polymeric material. In some other versions, the outer shaft (1130) comprises a polymeric material and the inner shaft (1150) comprises a metallic material. One or both of the shafts (1130,1150) may be rigid, malleable, flexible, and/or have any other suitable characteristics, regardless of the material or materials used to form the shafts (1130,1150). Thus, while the shaft (1130,1150) is shown as being straight in this example, the shaft (1130,1150) alternatively may be curved or have any other kind of non-linear configuration. In versions where the shaft (1130,1150) is curved or has any other kind of non-linear configuration, the shaft (1130,1150) may be rigidly configured in such a manner; or may be bent by an operator to achieve this configuration where the shafts (1130, 1150) are malleable or flexible.
Although the adapter sheath (1100) is shown and described in the context of a tissue shaving instrument (1000), the adapter sheath (1100) may be readily used with any other suitable type of instrument. The adapter sheath (1100) need not be limited to the context of a tissue shaving instrument, such as the tissue shaving instrument (1000). By way of example only, the adapter sheath (1100) may be configured to fit over an endoscope, different types of ENT instruments, and/or any other type of instrument that would be apparent to one of ordinary skill in the art in view of the teachings herein. The length of the adapter sheath (1100) may vary based on the type of instrument to be coupled with the adapter sheath (1100). Regardless of the type of instrument coupled with the adapter sheath (1100), the adapter sheath (1100) can be easily coupled with the instrument prior to a medical procedure in which the instrument is to be used with the adapter sheath (1100). After the medical procedure is completed, the adapter sheath (1100) may be removed from the instrument. The removed adapter sheath (1100) may be discarded or sterilized for subsequent reuse.
Exemplary methods for calibrating navigation Sensors
In some cases, it may be desirable to provide one or more methods for accurately and reliably calibrating the navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146), which may include calibrating the position and/or orientation of each navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) based on 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 distal tip of the respective instrument (100,400,500,600,700,1000). 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 the sensitivity of each navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) to an electromagnetic field generated by the field generator (64).
Calibration of the navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) may be at least partially integrated directly into the manufacture of the respective navigation sensor assembly (110,210,410,510,610,1100) and/or application of the respective navigation sensor assembly (110,210,410,510,610,1100) to the corresponding instrument (100,400,500,600,700). 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) with the same sensitivity. For example, forming the navigation sensor assembly (110,210,410,510,610,1144,1146) as a flexible Printed Circuit Board (PCB) by printing corresponding traces (130,132,134,136,230,232,234,236,630,632,633,634,636,637) on a corresponding substrate (126,226,426,526,626,1142) can 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) having the same sensitivity can be accurately and reliably recreated. 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 distal tip of the respective 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) can be accurately and reliably positioned at the same distance from the distal tip of the respective same instrument (100,400,500,600,700,1000) using a repeatable application of techniques. For example, the through holes (146,246,646) and/or the beveled surfaces (148,248,648) of the corresponding navigation sensor assemblies (110,210,410,510,610,1100) can 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) is accurately and reliably positioned at a predetermined distance from the distal tip of the respective same instrument (100,400,500,600,700,1000).
Fig. 44 and 45 illustrate examples of optical calibration methods (801) that may be used to determine the distance between a navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and the distal tip of a corresponding instrument (100,400,500,600,700,1000). Referring to fig. 44, the method (801) begins at step (803) where an instrument (100,400,500,600,700) 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 is positioned within an optical measurement device. The method (801) proceeds from step (803) to step (805) where an optical measurement device measures a distance between a center point or other reference feature of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and a distal tip of the instrument (100,400,500,600,700,1000). The method (801) proceeds from step (805) to step (807) where the optical measurement device communicates the measured distance to the processor. The method (801) proceeds from step (807) to step (809) where an 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). From step (809), the method (801) proceeds to step (811) where the optical measurement device communicates the measured geometry to the processor. It should 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) may be directly related to its sensitivity such that the processor may determine the sensitivity of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) based on the measured geometry in some versions. In some versions, one or more of steps (809,811) may be performed prior to and/or concurrently with one or more of steps (805, 807). In any event, the method (801) proceeds to step (813) where the processor stores the calibration data (e.g., measured distance, measured geometry, and/or determined sensitivity) on a memory device (e.g., EPROM) operatively coupled to the instrument (100,400,500,600,700,1000) to facilitate subsequent retrieval of the calibration data.
Referring to fig. 45, a photograph of an exemplary geometric measurement of a navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) using the method (801) is shown. The geometric measurements may include measuring a thickness of each segment forming a respective trace (130,132,134,136,230,232,234,236,630,632,633,634,636,637) of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and/or measuring a distance between adjacent segments forming a respective trace (130,132,134,136,230,232,234,236,630,632,633,634,636,637) of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146).
V. exemplary Flexible Circuit with ablation electrode
In some scenarios, it may be desirable to provide an RF ablation or cauterization function to an instrument, such as a tissue shaving instrument. Such RF ablation or cauterization may be used to prevent tissue bleeding, provide other therapeutic effects, and/or provide other types of tissue effects. It may further be desirable to utilize flex circuit technology to provide such RF ablation or cauterization functionality to the instrument. The use of such flexible circuit technology may facilitate the manufacture of the instrument. For example, the instrument may additionally be manufactured according to previous practices, wherein the instrument would lack RF ablation or cauterization functionality, and the flexible circuit may be readily applied to shaft assemblies of otherwise conventional instruments. Additionally or alternatively, the flexible circuit may provide structurally sound support for the RF ablation or cauterization function and allow the shaft assembly of the instrument to maintain a low profile despite the addition of the RF ablation or cauterization function. Several examples of how the flex circuit assembly may be integrated into a tissue shaving instrument to impart RF ablation or cauterization functionality will be described in more detail below. In the context of the present disclosure, the terms "ablation" and "cautery" should be understood interchangeably, such that reference to ablation alone should not be construed as excluding cautery; and references to cautery alone should not be construed to exclude ablation.
Fig. 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 fig. 46. The shaft assembly (1200) includes an outer shaft (1202) and an inner cutting shaft (1220). The shaft assembly (1200) defines an end effector (1210) formed by a transverse opening (1206) formed at a distal end (1204) of the outer shaft (1202), with a serrated cutting edge (1208) extending along a periphery of the opening (1206). The cutting shaft (1220) is positioned inside the outer shaft (1202) and includes similar transverse openings and cutting edges (1222) complementary to the transverse 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 transverse opening (1206). When the cutting shaft (1220) is rotated relative to the outer shaft (1202), the cutting edges (1208,1222) cooperate to shear tissue, and the sheared tissue is drawn proximally through the lumen of the cutting shaft under the influence of suction.
The flexible circuit (1230) of the present example includes a flexible substrate (1232) and a plurality of electrodes (1234). The flexible circuit (1230) may have only one single layer or multiple layers. The flexible substrate (1232) may be formed of an electrically insulating flexible plastic material, such as polyimide or LCP. The flexible substrate (1232) of the present example extends longitudinally along a length of the shaft assembly (1200) and wraps at least partially around the distal end (1204) of the outer shaft (1202). In some versions, the flexible substrate (1232) is secured to an outer surface of the outer shaft (1202) via an adhesive. Alternatively, the flexible substrate (1232) may be secured to the outer shaft (1202) in any other suitable manner.
The electrode (1234) is positioned along a region of the flexible substrate (1232) that is at least partially wrapped around the distal end (1204) of the outer shaft (1202) such that the electrode (1234) is positioned at the distal end (1204) of the outer shaft (1202). The electrode (1234) may be vapor deposited on the substrate (1232) or may be applied to the substrate (1232) in any other suitable manner. The flexible substrate (1232) provides electrical insulation between the electrode (1234) and the outer shaft (1202) such that the flexible substrate (1232) prevents the electrode (1234) from energizing the outer shaft (1202). The electrode (1234) is coupled to an RF generator (e.g., similar to the RF generator (101) described above) via traces (not shown) formed along the 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 such versions, a ground pad (not shown) may contact the patient at any suitable location. Regardless of whether bipolar RF energy or monopolar RF energy is used, the RF energy may ablate tissue during a tissue shaving operation. Such RF energy may be applied concurrently with 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) because this location will be close to the tissue shaving site.
Although not shown in fig. 46, the flexible circuit (1230) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the other various navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) described herein. The version of the flex circuit (1230) that includes one or more integrated navigation sensors may thus facilitate determining the real-time position of the end effector (1210) within the patient. The flexible circuit (1230) may also include one or more integrated temperature sensors (e.g., thermocouples, etc.). Such temperature sensors may sense the temperature of the electrode (1234) and/or tissue adjacent to the electrode (1234). The temperature data may be used as real-time feedback to adjust RF delivery to the tissue (e.g., to avoid overheating the tissue). The flexible circuit (1230) may include any other suitable features in addition to or instead of the features described above. As yet another example of a variation, the electrode (1234) may be integrated into the shaft assembly (1200) without the use of a flexible circuit (1230), such that a flexible substrate (1232) is not necessarily required to integrate the electrode (1234) into the shaft assembly (1200).
Fig. 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 fig. 47. The shaft assembly (1300) includes an outer shaft (1302) and an inner cutting shaft (1320) that is driven to rotate relative to the outer shaft (1302) about a longitudinal axis defined by the shaft assembly (1300). The shaft assembly (1300) defines an end effector (1310) formed by a transverse opening (1306) formed at a distal end (1304) of the outer shaft (1302), with a serrated cutting edge (1308) extending along a periphery of the opening (1306). A cutting shaft (1320) is positioned inside the outer shaft (1302) and includes similar transverse openings and cutting edges (1322) that are complementary to the transverse 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 a lumen formed by the cutting shaft (1320) to thereby draw tissue into the transverse opening (1306). When 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 lumen of the cutting shaft under the influence of suction.
The flexible circuit (1330) of the present example includes a flexible substrate (1332) and a plurality of electrodes (1334). The flexible circuit (1330) may have only one single layer or multiple layers. The flexible substrate (1332) may be formed of an electrically insulating flexible plastic material, such as polyimide or LCP. The flexible substrate (1332) of the present example extends longitudinally along the length of the shaft assembly (1300), terminating distally at a distal end (1304) of the outer shaft (1302). In some versions, the flexible substrate (1332) is secured to an outer surface of the outer shaft (1302) via an adhesive. Alternatively, the flexible substrate (1332) may be secured to the outer shaft (1302) in any other suitable manner. While the flexible substrate (1332) is shown extending along only one side of the outer shaft (1302), another flexible substrate (1332) may extend along the other side of the outer shaft (1302). In addition, some versions of the flexible substrate (1332) may be wrapped around the distal end (1304) of the outer shaft (1302).
The electrode (1334) is positioned along a region of the flexible substrate (1332) that extends alongside a longitudinally extending region of the lateral opening (1306) of the outer shaft (1302), such that the electrode (1334) is positioned alongside the lateral opening (1306). Although the electrode (1334) is shown positioned alongside only one longitudinally extending region of the transverse opening (1306), some versions may provide the electrode (1334) alongside another longitudinally extending region of the transverse opening (1306). Additionally or alternatively, some versions may provide an electrode (1334) along the distal end (1304) (e.g., similar to electrode (1234)) in addition to providing an electrode (1334) alongside either or both of the longitudinally extending regions of the lateral opening (1306).
The electrode (1334) may be vapor deposited on the substrate (1332) or may be applied to the substrate (1332) in any other suitable manner. The flexible substrate (1332) provides electrical insulation between the electrode (1334) and the outer shaft (1302) such that the flexible substrate (1332) prevents the electrode (1334) from energizing the outer shaft (1302). The electrode (1334) is coupled to an RF generator (e.g., similar to the RF generator (101) described above) via traces (not shown) formed along the 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 such versions, a ground pad (not shown) may contact the patient at any suitable location. Regardless of whether bipolar RF energy or monopolar RF energy is used, the RF energy may ablate tissue during a tissue shaving operation. Such RF energy may be applied concurrently with 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 the electrode (1334) alongside either or both of the longitudinally extending regions of the transverse opening (1306), as this/these location(s) will be close to the tissue shaving site.
Although not shown in fig. 47, the flexible circuit (1330) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the other various navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) described herein. The version of the flex circuit (1330) that includes one or more integrated navigation sensors may thus facilitate determining the real-time position of the end effector (1310) within the patient. The flexible circuit (1330) may also include one or more integrated temperature sensors (e.g., thermocouples, etc.). Such temperature sensors may sense the temperature of the electrode (1334) and/or tissue adjacent to the electrode (1334). The temperature data may be used as real-time feedback to adjust RF delivery to the tissue (e.g., to avoid overheating the tissue). The flexible circuit (1330) may include any other suitable features in addition to or instead of the features described above. As yet another example of a variation, the electrode (1334) may be integrated into the shaft assembly (1300) without the use of a flexible circuit (1330), such that a flexible substrate (1332) is not necessarily required to integrate the electrode (1334) into the shaft assembly (1300).
Fig. 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 fig. 48. The shaft assembly (1400) includes an outer shaft (1402) and an inner cutting shaft (1420) that is driven to rotate relative to the outer shaft (1402) about a longitudinal axis defined by the shaft assembly (1400). The shaft assembly (1400) defines an end effector (1410) formed by a transverse opening (1406) formed at a distal end (1404) of the outer shaft (1402), with a serrated cutting edge (1408) extending along a periphery of the opening (1406). The cutting shaft (1420) is positioned inside the outer shaft (1402) and includes similar transverse openings and cutting edges (1422) that are complementary to the transverse 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 transverse opening (1406). When 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 lumen of the cutting shaft under the influence of suction.
The flexible circuit (1430) of the present example includes a longitudinally extending flexible substrate portion (1432), a circumferentially extending flexible substrate portion (1434), and a plurality of electrodes (1436). The flexible circuit (1430) may have only one single layer or multiple layers. The flexible substrate portions (1432,1434) are integrally formed together, with the circumferentially extending flexible substrate portions (1434) being positioned just proximal to the lateral openings (1406). The flexible substrate portions (1432,1434) are each formed of an electrically insulating flexible plastic material, such as polyimide or LCP. In some versions, the base plate portion (1432,1434) is secured to an outer surface of the outer shaft (1402) via an adhesive. Alternatively, the flexible substrate portion (1432,1434) can be secured to the outer shaft (1402) in any other suitable manner. While the longitudinally extending flexible substrate portion (1432) is shown extending along only one side of the outer shaft (1402), another longitudinally extending flexible substrate portion (1432) may extend along the other side of the outer shaft (1402). Additionally, some versions of the flexible circuit (1430) may include a flexible substrate portion wrapped around the distal end (1404) of the 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 to the lateral opening (1406). In this example, the electrodes (1436) are formed as discrete squares or rectangles arranged in an array spanning around the entire circumference of the outer shaft (1402). In some variations, the flexible circuit (1430) includes one or more electrodes (e.g., similar to electrode 1336)) extending longitudinally alongside one or both longitudinally extending regions of the transverse opening (1406) in addition to the circumferential array of electrodes (1436). 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 (e.g., similar to electrode 1236) at the distal end (1404) of the outer shaft (1402).
The electrode (1434) may be vapor deposited on the substrate (1432) or may be applied to the substrate (1432) in any other suitable manner. The flexible substrate (1432) provides electrical insulation between the electrode (1434) and the outer shaft (1402) such that the flexible substrate (1432) prevents the electrode (1434) from energizing the outer shaft (1402). The electrode (1434) is coupled to an RF generator (e.g., similar to the RF generator (101) described above) via traces (not shown) formed along the 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, the electrode (1434) is operable to apply monopolar RF energy to tissue in contact with the electrode (1434). In such versions, a ground pad (not shown) may contact the patient at any suitable location. Regardless of whether bipolar RF energy or monopolar RF energy is used, the RF energy may ablate tissue during a tissue shaving operation. Such RF energy may be applied concurrently with 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 to the transverse opening (1406) because this location will be close to the tissue shaving site.
Although not shown in fig. 48, the flexible circuit (1430) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the other various navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) described herein. The version of the flexible circuit (1430) that includes one or more integrated navigation sensors can thus facilitate determining the real-time position of the end effector (1410) within the patient. The flexible circuit (1430) may also include one or more integrated temperature sensors (e.g., thermocouples, etc.). Such temperature sensors may sense the temperature of the electrode (1434) and/or tissue adjacent to the electrode (1434). The temperature data may be used as real-time feedback to adjust RF delivery to the tissue (e.g., to avoid overheating the tissue). The flexible circuit (1430) may include any other suitable features in addition to or instead of the features described above. As yet another example of a variation, the electrode (1434) may be integrated into the shaft assembly (1400) without using the flexible circuit (1430) such that the flexible substrate (1432) is not necessarily required to integrate the electrode (1434) into the shaft assembly (1400).
Fig. 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 fig. 49. The shaft assembly (1500) includes an outer shaft (1502) and an inner cutting shaft (1520) that is driven to rotate relative to the outer shaft (1502) about a longitudinal axis defined by the shaft assembly (1500). The shaft assembly (1500) defines an end effector (1510) formed by a transverse opening (1506) formed at a distal end (1504) of the outer shaft (1502), a serrated cutting edge (1508) extending along a periphery of the opening (1506). The cutting shaft (1520) is positioned inside the outer shaft (1502) and includes similar transverse openings and cutting edges (1522) that are complementary to the transverse 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 a lumen formed through the cutting shaft (1520) to thereby draw tissue into the transverse 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 lumen of the cutting shaft under the influence of suction.
The flex circuit (1530) of this example includes a longitudinally extending flex substrate portion (1532), a circumferentially extending flex substrate portion (1534), and a pair of electrodes (1536). The flex 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 portions (1534) being positioned just proximal to the lateral openings (1506). The flexible substrate portions (1532,1534) are each formed of an electrically insulating flexible plastic material, such as polyimide or LCP. In some versions, the base plate portion (1532,1534) is secured to an outer surface of the outer shaft (1502) via an adhesive. Alternatively, the flexible substrate portion (1532,1534) can be secured to the outer shaft (1502) in any other suitable manner. While the longitudinally extending flexible substrate portion (1532) is shown extending along only one side of the outer shaft (1502), another longitudinally extending flexible substrate portion (1532) may extend along the other side of the outer shaft (1502). In addition, some versions of the flexible circuit (1530) may include a flexible substrate portion wrapped around the distal end (1504) of the 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 transverse opening (1506). In this example, the electrode (1536) is formed as two discrete strips that together span around the circumference of the outer shaft (1502), defining a small gap between the free ends of the electrode (1536). The electrode (1536) is thus substantially semicircular. In some variations, in addition to the circumferential arrangement of electrodes (1536), the flexible circuit (1530) also includes one or more electrodes (e.g., similar to electrode 1336) that extend longitudinally alongside one or both longitudinally extending regions of the transverse opening (1506). 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) at the distal end (1504) of the outer shaft (1502).
The electrode (1534) may be vapor deposited on the substrate (1532) or may be applied to the substrate (1532) in any other suitable manner. The flexible substrate (1532) provides electrical insulation between the electrode (1534) and the outer shaft (1502) such that the flexible substrate (1532) prevents the electrode (1534) from energizing the outer shaft (1502). The electrode (1534) is coupled with an RF generator (e.g., similar to the RF generator (101) described above) via traces (not shown) formed along the flexible substrate (1532). In some versions, the electrode (1534) is operable to apply bipolar RF energy to tissue in contact with the electrode (1534). In some other versions, the electrode (1534) is operable to apply monopolar RF energy to tissue in contact with the electrode (1534). In such versions, a ground pad (not shown) may contact the patient at any suitable location. Regardless of whether bipolar RF energy or monopolar RF energy is used, the RF energy may ablate tissue during a tissue shaving operation. Such RF energy may be applied concurrently with 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 transverse opening (1506) because this location will be close to the tissue shaving site.
Although not shown in fig. 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 other various navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) described herein. The version of the flex circuit (1530) that includes one or more integrated navigation sensors can thus facilitate determining the real-time position of the end effector (1510) within the patient. The flexible circuit (1530) may also include one or more integrated temperature sensors (e.g., thermocouples, etc.). Such temperature sensors may sense the temperature of the electrode (1534) and/or tissue adjacent to the electrode (1534). The temperature data may be used as real-time feedback to adjust RF delivery to the tissue (e.g., to avoid overheating the tissue). The flex circuit 1530 may include any other suitable features in addition to or instead of the features described above. As yet another example of a variation, the electrode (1534) may be integrated into the shaft assembly (1400) without the use of the flexible circuit (1530), such that the flexible substrate (1532) is not necessarily required to integrate the electrode (1534) into the shaft assembly (1500).
Although the flex circuit (1230,1330,1430,1530) is shown and described in the context of a tissue shaving instrument shaft assembly (1200,1300,1400,1500), a flex circuit assembly, such as flex circuit (1230,1330,1430,1530), may be readily used with any other suitable type of instrument. The flexible circuit assembly, such as the flexible circuit (1230,1330,1430,1530), need not be limited to the context of a tissue shaving instrument. By way of example only, a flex circuit assembly, such as flex circuit (1230,1330,1430,1530), may be integrated with an endoscope, a different type of ENT instrument, and/or any other type of instrument that will be apparent to those of skill in the art in view of the teachings herein.
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 scope of coverage of any claim that may be provided at any time in this patent application or in a later filed 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 embodiments below. Thus, none of the aspects or features mentioned below should be considered decisive unless explicitly indicated at a later date, e.g. by the inventors or by an inheritor of interest to the inventors. If any claim set forth in the present patent application or in a later-filed document related to the present patent application includes additional features beyond those mentioned below, such additional features should not be assumed to be added for any reason related to patentability.
Example 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.
Example 2
The ENT surgical instrument of embodiment 1, wherein the at least one navigation sensor comprises 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 comprises a pair of laterally adjacent distal navigation sensors.
Example 4
The ENT surgical instrument of any one of embodiments 2-3, wherein the proximal and distal navigation sensors are electrically isolated from each other.
Examples5
The ENT surgical instrument of any of embodiments 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.
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 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 to be operatively coupled to a 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 of any one of embodiments 1-8, wherein the flexible substrate is at least one of rectangular or serpentine.
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 1-10, the shaft assembly comprising a shaft member, wherein the flexible substrate is secured to the shaft member.
Example 12
The ENT surgical instrument of embodiment 11, wherein the shaft member comprises an inner chord, 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 comprises a cylindrical inner surface, 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 comprises a cylindrical outer surface, 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 1-14, wherein the shaft assembly comprises a flexible portion, wherein the flexible substrate 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 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; (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.
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 distal top sensor trace.
Example 18
The ENT surgical instrument of any one of embodiments 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.
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 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) treating the anatomic passageway via the ENT surgical instrument.
Example 20
The method of embodiment 19, wherein the act of treating the anatomical passageway via the ENT surgical instrument comprises at least one of expanding the anatomical passageway, applying RF energy to tissue within the anatomical passageway, cutting tissue within the anatomical passageway, or removing debris from the anatomical passageway.
Example 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.
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 comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.
Example 23
The device of any one of embodiments 21-22, wherein the at least one navigation sensor comprises a proximal navigation sensor and a distal navigation sensor.
Example 24
The apparatus of any of embodiments 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.
Example 25
The apparatus of any of embodiments 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.
Example 26
The apparatus of any 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 is configured to be operatively coupled to at least one of a processor or a power source.
Example 27
The apparatus 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 device of any 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 is configured to be operatively coupled to the camera.
Example 29
The apparatus 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 comprises a plurality of camera traces.
Example 31
The apparatus of embodiment 30, wherein the plurality of camera traces are laterally located to a side of the at least one navigation sensor.
Example 32
The device of any 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 at least one of the processor or the power source.
Example 34
The apparatus of any one of embodiments 21-33, the shaft assembly comprising a flexible portion to which the flexible substrate is secured, the flexible substrate further configured to flex with the flexible portion.
Example 35
The apparatus of any one of embodiments 21-34, the shaft assembly comprising one or more electrodes operable to apply RF energy to tissue.
Example 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) first and second conductive camera traces 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.
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 comprises 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 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) visualizing a portion of the anatomic passageway distal to the distal portion of the device via the camera.
Example 39
The method of embodiment 38, wherein the act of navigating the distal portion of the device through the anatomic passageway comprises bending the flexible substrate.
Example 40
The method of any one of embodiments 38-39, further comprising applying RF energy to tissue within the anatomic passageway.
Example 41
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 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.
Example 42
The device of embodiment 41, wherein the at least one temperature sensor is configured to detect a temperature of the at least one sensor trace.
Example 43
The apparatus of embodiment 42, wherein the at least one temperature sensor comprises at least one of a thermocouple or a thermistor.
Example 44
The device of any 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 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.
Example 45
The device of embodiment 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.
Example 46
The apparatus of embodiment 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.
Example 47
The device of any of embodiments 45-46, wherein the processor is configured to correlate the detected change in temperature with a change in resistance of the at least one sensor trace.
Example 48
The apparatus of any of embodiments 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.
Example 49
The apparatus of any one of embodiments 41-48, wherein the substrate is flexible.
Example 50
The device of any one of embodiments 41-49, wherein the at least one navigation sensor comprises a proximal navigation sensor and a distal navigation sensor.
Example 51
The apparatus of embodiment 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.
Example 52
The apparatus of embodiment 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.
Example 53
The apparatus of any one of embodiments 41-52, wherein the at least one temperature sensor comprises a pair of laterally adjacent temperature sensors.
Example 54
An ENT surgical instrument, comprising: (a) A power component configured to generate heat; and (b) the apparatus of any one of embodiments 41-53, wherein the at least one navigation sensor is exposed to heat generated by the power component.
Example 55
The ENT surgical instrument of embodiment 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.
Example 56
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 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) a processor, 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.
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 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) adjusting the position coordinates in response to the act of detecting a temperature change of the at least one sensor trace.
Example 58
The method of embodiment 57 wherein the act of adjusting the position coordinates includes applying a correction factor to the position coordinates, wherein the correction factor corresponds to the detected temperature change.
Example 59
The method of any one of embodiments 57-58, wherein the act of detecting a temperature change of the at least one sensor trace is performed via a temperature sensor.
Example 60
The method according to any one of embodiments 57-58, wherein the act of detecting a temperature change of the at least one sensor trace comprises 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 fixedly secured relative to the inner shaft, the outer shaft being coaxially disposed with the inner shaft; and (c) a first navigation sensor radially interposed 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.
Example 62
The device of embodiment 61, the lumen sized to receive a shaft assembly of a tissue shaving instrument.
Example 63
The device of embodiment 62, further comprising a tissue shaving instrument having a shaft assembly, the lumen 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 sized to provide exposure of the transverse opening when the shaft assembly of the tissue shaving instrument is fully inserted in the lumen.
Example 65
The apparatus of embodiment 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.
Example 66
The apparatus of any one of embodiments 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.
Example 67
The apparatus of embodiment 66, the flexible substrate extending along a length of the inner shaft and along a length of the outer shaft.
Example 68
The apparatus of embodiment 67, the flexible substrate having a distal end, the first navigation sensor positioned at the distal end of the flexible substrate.
Example 69
The device of any one of embodiments 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.
Example 70
The apparatus of embodiment 69, the second navigation sensor positioned proximal to the first navigation sensor.
Example 71
The apparatus of any one of embodiments 69-70 further comprising a flexible substrate radially interposed 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.
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 apparatus of embodiment 72, the hub configured to be removably coupled with an instrument received in the lumen.
Example 74
The device of any one of embodiments 61-73, the inner shaft having an open distal end and an open proximal end.
Example 75
The device of any one of embodiments 61-74, 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, 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.
Example 77
The apparatus of embodiment 76, the electrodes are arranged in an array extending along the distal end of the outer shaft.
Example 78
The device of any one of embodiments 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.
Example 79
The device of any one of embodiments 76-78, the outer shaft defining a circumference, the electrodes being arranged in an array extending around the circumference of the outer shaft.
Example 80
The apparatus of embodiment 79, the electrode comprising two electrodes, each of the two electrodes having a generally semi-circular shape.
Example 81
The apparatus of embodiment 79, the electrode comprising a plurality of square or rectangular shaped electrodes.
Example 82
The apparatus of any one of embodiments 76-81, the outer shaft defining a circumference, the flexible substrate comprising 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.
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 82-83, at least some of the electrodes being positioned along the circumferentially extending portion in a circumferentially extending array.
Example 85
The device of any 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 shaft such that at least a portion of the opening extends longitudinally along the shaft.
Example 87
The apparatus of embodiment 86, at least some of the electrodes extending longitudinally in an array alongside the opening.
Example 88
The device of any one of embodiments 85-86, at least some of the electrodes positioned proximal to the opening.
Example 89
The device of any of embodiments 85-88, at least some of the electrodes being positioned distal to the opening.
VII miscellaneous items
It should be understood that any of the teachings, expressions, embodiments, examples, etc. described herein can be combined with any of the other teachings, expressions, embodiments, examples, etc. described herein. Thus, the above teachings, expressions, embodiments, examples, etc. should not be considered as being 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 appended claims.
Devices of the type described above may be designed to be disposed of after a single use, or they may be designed to be used multiple times. In either or both cases, these versions may be reconditioned for reuse after at least one use. Repair may include any combination of the following steps: the device is disassembled, then the particular piece is cleaned or replaced and then reassembled. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility, or by a user immediately prior to a procedure. Those skilled in the art will appreciate that repair of the device may be accomplished using a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting prosthetic devices are within the scope of the 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 or TYVEK bag. The container and device may then be placed in a radiation field that is transparent to the container, such as gamma radiation, x-rays, or energetic electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. 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.
Various embodiments of the present invention have been shown and described, and further modifications of the methods and systems described herein may be made by those of ordinary skill in the art without departing from the scope of the invention. Several such possible modifications have been mentioned and other modifications will be apparent to persons skilled in the art. For example, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and not required. The scope of the invention should, therefore, be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.
Claims (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.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US63/150776 | 2021-02-18 | ||
| US63/288014 | 2021-12-10 | ||
| US17/584,693 US20220257093A1 (en) | 2021-02-18 | 2022-01-26 | Flexible sensor assembly for ent instrument |
| US17/584693 | 2022-01-26 | ||
| PCT/IB2022/051442 WO2022175877A2 (en) | 2021-02-18 | 2022-02-18 | Flexible sensor assembly for ent instrument |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117202864A true CN117202864A (en) | 2023-12-08 |
Family
ID=88985516
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280029241.1A Pending CN117202864A (en) | 2021-02-18 | 2022-02-18 | Flexible sensor assembly for ENT instrument |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117202864A (en) |
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2022
- 2022-02-18 CN CN202280029241.1A patent/CN117202864A/en active Pending
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