ENT ablation instrument with electrode ring

Abstract

An apparatus is provided that includes a shaft assembly and an electrode assembly at a distal end of the shaft assembly. The electrode assembly includes a first electrically conductive segment extending at the distal end of the shaft assembly along a first angular range. The first electrically conductive segment is operable to apply RF energy to tissue at a first polarity. The electrode assembly also includes a second electrically conductive segment angularly spaced from the first electrically conductive segment. The second electrically conductive segment extends at the distal end of the shaft assembly along a second angular range. The second electrically conductive segment is operable to apply RF energy to tissue at a second polarity, such that the first electrically conductive segment and the second electrically conductive segment are operable to apply bipolar RF energy to tissue.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Patent Application 63 / 067,495, filed August 19, 2020, entitled “ENT Ablation Instrument with Electrode Loop,” the disclosure of which is incorporated by reference herein; U.S. Provisional Patent Application 63 / 092,751, filed October 16, 2020, entitled “ENT Instrument with Ablation Loop and Ablation Needles,” the disclosure of which is incorporated by reference herein; and U.S. Provisional Patent Application 63 / 142,098, filed January 27, 2021, entitled “ENT Instrument with Ablation Loop and Ablation Needles,” the disclosure of which is incorporated by reference herein. BACKGROUND

[0003] Rhinitis is a medical condition manifested by pain and inflammation of the mucosa within the nasal cavity. The inflammation results in the production of excess mucus, which can cause nasal discharge, nasal congestion, sneezing, and / or postnasal drip. Allergic rhinitis is an allergic reaction to environmental factors such as airborne allergens, while non-allergic (or “vasomotor”) rhinitis is a chronic condition manifested independent of environmental factors. Conventional treatments for rhinitis include, for example, antihistamines, topical or systemic corticosteroids, and topical anticholinergics.

[0004] For cases of intractable rhinitis in which symptoms are severe and persistent, an additional treatment option is surgical removal of a portion of the vidian (or “pterygopalatine”) nerve, which is a procedure known as vidian neurectomy. The theoretical basis for vidian neurectomy is that rhinitis is caused by an imbalance between parasympathetic and sympathetic innervation of the nasal cavity and the resulting overstimulation of the mucosal mucous glands. Vidian neurectomy aims to disrupt this imbalance and reduce nasal mucus secretion via surgical treatment of the vidian nerve. However, in some cases, vidian neurectomy can cause collateral damage to the lacrimal gland, which is innervated by the vidian nerve. Such damage to the lacrimal gland can result in long-term health complications for the patient, such as chronic dry eye. Surgical removal of the posterior nasal nerve or a portion of the posterior nasal nerve can be an effective alternative to vidian neurectomy for treating intractable rhinitis.

[0005] Figure 1A left sagittal view showing a portion of a patient's head, showing the nasal cavity (10), frontal sinus (12), sphenoid sinus (14), and sphenoid bone (16). The nasal cavity (10) is laterally bounded by the nasal wall (18), which includes the inferior (20), middle (22), and superior (24) concha. The vidian nerve (32) resides within the pterygoid canal (or "pterygopalatine") (30), which is partially defined by the sphenoid bone (16) and lies posterior to the sphenoid sinus (14), in approximate alignment with the middle concha (22). The vidian nerve (32) is formed at its posterior end by the junction of the greater (34) and lesser (36) petrosal nerves; and at its anterior end, it joins the pterygopalatine ganglion (38), which is responsible for regulating blood flow to the nasal mucosa. The posterior nasal nerve (40) joins the pterygopalatine ganglion (38) and extends through the region surrounding the inferior concha (20).

[0006] Although instruments and methods for performing a vidian neurectomy and a posterior nasal neurectomy and a conchotomy are known, it is believed that no one prior to the inventors has made or used the invention described in the appended claims. BRIEF DESCRIPTION OF DRAWINGS

[0007] The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0008] Figure 1 A left sagittal view of a portion of a patient's head is depicted, showing details of certain paranasal sinuses and nerves, including the vidian nerve and the posterior nasal nerve;

[0009] Figure 2 A perspective view of an example of an instrument that can be used to perform an ablation procedure in the nasal cavity is depicted;

[0010] Figure 3 A perspective view of a distal portion of a shaft assembly of the instrument of Figure 2 is depicted, with the distal needle electrode in a retracted position, with the set of angled needle electrodes in a retracted position, and with the sheath in an advanced position;

[0011] Figure 4 A perspective view of a distal portion of a shaft assembly of the instrument of Figure 3 is depicted, with the distal needle electrode in an advanced position, with the set of angled needle electrodes in a retracted position, and with the sheath in an advanced position;

[0012] Figure 5 A perspective view of a distal portion of a shaft assembly of the instrument of Figure 3 is depicted, with the distal needle electrode in a retracted position, with the set of angled needle electrodes in an advanced position, and with the sheath in an advanced position;

[0013] Figure 6 A perspective view of a distal portion of a shaft assembly of the instrument ofFigure 3 A perspective view of the distal portion of the shaft assembly, wherein the distal needle electrode is in the advancing position, wherein the set of inclined needle electrodes is in the advancing position, and wherein the sheath is in the advancing position;

[0014] Figure 7 Depicting Figure 3 A perspective view of the distal portion of the shaft assembly, wherein the distal needle electrode is in the retracted position, wherein the set of tilted needle electrodes is in the retracted position, and wherein the sheath is in the retracted position.

[0015] Figure 8A A perspective view depicting another example of an instrument that can be used to perform ablation surgery in the nasal cavity, wherein the annular electrode is in a retracted position, and wherein the attachment is in a retracted position;

[0016] Figure 8B Depicting Figure 8A A perspective view of the instrument, in which the annular electrode is in the advanced position and the attachment is in the retracted position;

[0017] Figure 8C Depicting Figure 8A A perspective view of the instrument, in which the annular electrode is in the advancing position, and in which the attachment is in the advancing position;

[0018] Figure 9 Depicting Figure 8A A perspective view of the distal portion of the shaft assembly of the instrument, with the annular electrode in the advancing position;

[0019] Figure 10A Depicting Figure 8A A perspective view of the distal portion of the shaft assembly of the device, with the annular electrode in the retracted position.

[0020] Figure 10B depicts Figure 8A A perspective view of the distal portion of the shaft assembly of the device, in which the annular electrode is in a partially advanced position;

[0021] Figure 10C depicts Figure 8A A perspective view of the distal portion of the shaft assembly of the instrument, with the annular electrode in the advancing position;

[0022] Figure 11 Depicting Figure 8A A perspective view of the distal portion of the shaft assembly of the instrument, wherein the annular electrode is in the advanced position, and wherein the cannula-shaped accessory is in the advanced position;

[0023] Figure 12 Depicting Figure 8A A perspective view of the distal portion of the shaft assembly of the instrument, wherein the annular electrode is in the advancing position, and wherein an accessory in the form of a needle electrode is set in the advancing position;

[0024] Figure 13A depicts a perspective view of a distal portion of another example of an instrument usable to perform ablation procedures in a nasal cavity, wherein the instrument has a pair of loop electrodes, and wherein the needle electrodes are in a retracted position;

[0025] Figure 13B depicts a perspective view of a distal portion of the instrument of Figure 13A , wherein the needle electrodes are in an advanced position;

[0026] Figure 14 depicts a top plan view of a distal portion of the instrument of Figure 13A , wherein the needle electrodes are in an advanced position;

[0027] Figure 15 depicts a side elevational view of a distal portion of the instrument of Figure 13A , wherein the needle electrodes are in an advanced position;

[0028] Figure 16A depicts a perspective view of a distal portion of another example of an instrument usable to perform ablation procedures in a nasal cavity, wherein the instrument has a loop electrode, and wherein a pair of needle electrodes are in a retracted position;

[0029] Figure 16B depicts a perspective view of a distal portion of the instrument of Figure 16A , wherein the needle electrodes are in an advanced position;

[0030] Figure 17 depicts a top plan view of a distal portion of the instrument of Figure 16A , wherein the needle electrodes are in an advanced position;

[0031] Figure 18 depicts a side elevational view of a distal portion of the instrument of Figure 16A , wherein the needle electrodes are in an advanced position;

[0032] Figure 19A depicts a perspective view of a distal portion of another example of an instrument usable to perform ablation procedures in a nasal cavity, wherein the instrument has a pair of transverse loop electrodes, and wherein a pair of needle electrodes are in a retracted position;

[0033] Figure 19B depicts a perspective view of a distal portion of the instrument of Figure 19A , wherein the needle electrodes are in an advanced position;

[0034] Figure 20A depicts a perspective view of a distal portion of another example of an instrument usable to perform ablation procedures in a nasal cavity, wherein the instrument has a pair of transverse loop electrodes, and wherein the needle electrodes and the loop electrode are in a retracted position;

[0035] Figure 20B Depicting Figure 20A A perspective view of the distal portion of the device, in which the needle electrode and the annular electrode are in the advanced position;

[0036] Figure 21 A perspective view depicting an example of an instrument that can be used to perform ablation surgery in the nasal cavity, wherein the annular electrode assembly of the instrument is in a proximal retracted position relative to the axial assembly of the instrument, and wherein a pair of needle electrodes of the instrument is in a proximal retracted position relative to the axial assembly.

[0037] Figure 22A Depicting Figure 21 A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a proximal retracted position relative to the shaft assembly, and wherein a pair of needle electrodes is in a proximal retracted position relative to the shaft assembly.

[0038] Figure 22B Depicting Figure 21 A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a proximal retracted position relative to the shaft assembly, and wherein a pair of needle electrodes is in a distal extended position relative to the shaft assembly.

[0039] Figure 22C Depicting Figure 21 A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a distally extending position relative to the shaft assembly, and wherein a pair of needle electrodes is in a distally extending position relative to the shaft assembly.

[0040] Figure 23A A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted, wherein the annular electrode assembly of the instrument is in a proximal retracted position relative to the shaft assembly, and wherein the needle electrode assembly of the instrument is in a proximal retracted position relative to the shaft assembly.

[0041] Figure 23B Depicting Figure 23A A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a proximal retracted position relative to the shaft assembly, and wherein the needle electrode assembly is in a distal extended position relative to the shaft assembly.

[0042] Figure 23C Depicting Figure 23A A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a distally extending position relative to the shaft assembly, and wherein the needle electrode assembly is in a distally extending position relative to the shaft assembly.

[0043] Figure 24AA perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted, wherein the annular electrode assembly of the instrument is in a proximal retracted position relative to the shaft assembly, and wherein the needle electrode assembly of the instrument is in a proximal retracted position relative to the shaft assembly.

[0044] Figure 24B Depicting Figure 24A A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a proximal retracted position relative to the shaft assembly, and wherein the needle electrode assembly is in a distal extended position relative to the shaft assembly.

[0045] Figure 24C Depicting Figure 24A A perspective view of the distal portion of the shaft assembly of the device, wherein the annular electrode assembly is in a distally extending position relative to the shaft assembly, and wherein the needle electrode assembly is in a distally extending position relative to the shaft assembly.

[0046] Figure 25A A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted, the instrument having a pair of distal terminal electrodes, wherein a pair of needle electrodes of the instrument are in a proximal retracted position relative to the shaft assembly.

[0047] Figure 25B Depicting Figure 25A A perspective view of the distal portion of the shaft assembly of the device, wherein a pair of needle electrodes are in a distally extended position relative to the shaft assembly.

[0048] Figure 26 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity;

[0049] Figure 27 Depicting Figure 26 Visualization of the instrument and side view of the rinsing components;

[0050] Figure 28 Depicting Figure 27 A visualization of the front view of the rinsing components;

[0051] Figure 29 Depicting Figure 27 Visualization and breakdown perspective of the flushing components;

[0052] Figure 30 Depicting Figure 26 A perspective view of the distal portion of the shaft assembly of the instrument, in which Figure 27 The visualization and flushing components are positioned proximal to the distal end of the shaft assembly;

[0053] Figure 31 Depicting Figure 26A perspective view of the distal portion of the shaft assembly of the instrument, in which Figure 27 The visualization and flushing components are located at the distal end relative to the shaft assembly;

[0054] Figure 32 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted, the instrument having a pair of distal end electrodes, wherein the non-conductive needle of the instrument is in a distally extended position relative to the distal end of the shaft assembly.

[0055] Figure 33 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted, the instrument having a pair of distal end electrodes, wherein a plurality of conductive needles of the instrument are in a distally extended position relative to the distal end of the shaft assembly.

[0056] Figure 34 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted. The instrument has a pair of distal end electrodes and a visualization and flushing assembly, wherein a plurality of conductive needles of the instrument are in a distally extended position relative to the distal end of the shaft assembly.

[0057] Figure 35 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted. The instrument has a pair of distal terminal electrodes and a visualization and flushing assembly, wherein the inflatable balloon of the instrument is in a distally extended position relative to the distal end of the shaft assembly.

[0058] Figure 36 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted, the instrument having a pair of distal end electrodes, wherein the inflatable balloon of the instrument is in a distally extended position relative to the distal end of the shaft assembly.

[0059] Figure 37 A perspective view of the distal portion of the shaft assembly of another example of an instrument that can be used to perform ablation surgery in the nasal cavity is depicted. The instrument has a pair of distal end electrodes and a visualization and flushing assembly, wherein a pair of distal biopsy forceps of the instrument are in a distally extended position relative to the distal end of the shaft assembly.

[0060] Figure 38A A left sagittal view depicting a portion of the patient's head shows... Figure 21 The distal portion of the device is inserted into the region of the posterior nasal nerve in the patient's nasal cavity, wherein the ring electrode and a pair of needle electrodes are in the corresponding proximal retracted position relative to the axial assembly; and

[0061] Figure 38BA left sagittal view depicting this part of the patient's head is shown, in which... Figure 21 The distal portion of the device is inserted into the region of the posterior nasal nerve in the patient's nasal cavity, wherein a ring electrode and a pair of needle electrodes are in corresponding distal extension positions relative to the axial assembly, such that the needle electrodes pierce the nasal wall to deliver RF energy across the surface of the nasal wall to the posterior nasal nerve for deep intratissue ablation of the posterior nasal nerve, and such that the ring electrode is pressed against the surface of the nasal wall adjacent to the entry point of the needle electrodes to deliver RF energy from the surface of the nasal wall to the posterior nasal nerve for superficial surface ablation of the posterior nasal nerve. Detailed Implementation

[0062] The following description of certain examples of the invention is not intended to limit the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is shown by way of example, and a best mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different and obvious aspects, all of which are not departing from the invention. Therefore, the drawings and descriptions should be regarded as substantially illustrative and not restrictive.

[0063] For clarity of disclosure, the terms "proximal" and "distal" are defined herein relative to a surgeon or other operator holding a surgical instrument with a distal surgical end effector. The term "proximal" refers to a position where the element is positioned closer to the surgeon's placement, and the term "distal" refers to a position where the element is closer to the surgical end effector of the surgical instrument and further away from the surgeon's placement. Furthermore, the use of spatial terms such as "upper," "lower," "vertical," "horizontal," etc., with reference to the accompanying drawings, should be understood as such terms being used for illustrative purposes only and are not intended to be limiting or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions, not limited to those shown and described herein.

[0064] As used herein, the terms “about” and “approximately” for any numerical value or range indicate that a part or collection of parts is permitted to perform appropriate dimensional tolerances as described herein for its intended purpose.

[0065] I. Shallow, Deep, and Volumetric Ablation

[0066] In some clinical scenarios, it may be desirable to apply radiofrequency (RF) energy to tissue to ablate it. This may involve contacting the tissue surface with one or more electrodes, and then activating the electrodes to apply RF energy to the tissue. In cases where a single electrode is used, a grounding pad may be positioned to contact the patient's skin, and the electrode in contact with the target tissue surface may apply unipolar RF energy to the target tissue surface. In cases where two or more electrodes are used, two or more electrodes may be positioned to contact the target tissue surface and may be activated to apply bipolar RF energy to the target tissue surface. In either case, the RF energy ablates the tissue to provide the desired therapeutic effect.

[0067] RF ablation electrodes can also be in the form of needles, which penetrate the tissue and are activated once inserted to apply RF energy. Unlike RF ablation electrodes that contact the tissue surface, needle-shaped electrodes can facilitate ablation far beyond the tissue surface. In some cases, needle-shaped electrodes can avoid ablation of the tissue surface, even though they penetrate the tissue surface, where only subcutaneous tissue is ablated.

[0068] In some ear, nose, and throat (ENT) ablation procedures, it may be desirable to provide relatively shallow radiofrequency ablation, allowing the use of only tissue surface contact electrodes. In other ENT scenarios, it may be desirable to provide relatively deep radiofrequency ablation, allowing the use of tissue-penetrating needle electrodes. In still other ENT scenarios, it may be desirable to provide a combination of shallow and deep ablation through the combined use of tissue surface contact electrodes and tissue-penetrating needle electrodes, resulting in volumetric ablation.

[0069] Referring to the foregoing, it may be desirable to provide an ablation device capable of operating to perform relatively shallow RF ablation, relatively deep RF ablation, or volumetric ablation (i.e., a combination of shallow and deep ablation) without requiring the use of more than one device. In other words, it may be desirable to provide a single RF ablation device capable of operating to switch between shallow, deep, and volumetric ablation modalities at the operator's choice. Several examples of RF ablation devices capable of selecting between these modalities are provided below. Although these examples are described in the context of ENT procedures, it will be apparent to those skilled in the art, in light of the teachings herein, that the devices described below can be used in other procedures in other areas of the patient's anatomy.

[0070] II. Ablation Instruments with Axial and Tilted Needle Electrodes

[0071] Figure 1An example of an instrument (100) is shown that can be used to deliver RF energy to tissue within the nasal cavity or other locations within a patient's head. For example, the instrument (100) can be used to ablate nerves (e.g., the posterior nasal nerve (40)), ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)), or ablate any other type of anatomical structure in the patient's head. The instrument (100) of this example includes a handle assembly (110), a shaft assembly (120), and an end effector (130). The instrument (100) is coupled to an RF generator 102, which is operable to generate RF electrosurgical energy for delivery to tissue via electrodes (140, 150), as will be described in more detail below.

[0072] The handle assembly (110) of this example includes a body (112), a first slider (114), and a second slider (116). The body (112) is sized and configured for single-handed gripping and operation by an operator, such as via a motorized grip, a pencil grip, or any other suitable type of grip. Each slider (114, 116) is operable to translate longitudinally relative to the body (112). In some configurations, the sliders (114, 116) are operable to translate independently of each other. Slider (114) is coupled to an electrode (140) and is therefore operable to translate the electrode (140) longitudinally, as will be described in more detail below. Slider (116) is coupled to an electrode (150) and is therefore operable to translate the electrode (150) longitudinally, as will be described in more detail below.

[0073] While sliders (114, 116) are the form of user input in the handle assembly (110) of this example, the handle assembly (110) may include various other types of user inputs in addition to or in lieu of sliders (114, 116). In some configurations, the handle assembly (110) may also include one or more buttons or other electrode-activated features. Other suitable types of user input features that may be incorporated into the handle assembly (110) will be apparent to those skilled in the art in light of the teachings herein. User input features external to the handle assembly (110) may include, but are not limited to, one or more foot switches, one or more user input structures on the RF generator (102), etc.

[0074] The shaft assembly (120) of this example extends distally from the handle assembly (110) and includes an outer sheath 122 operable to translate longitudinally relative to the handle assembly (110). In some configurations, the handle assembly (110) includes an actuator (e.g., a slider, etc.) operable to drive translation of the outer sheath (122). In some other configurations, a grip or other actuator is attached to the outside of the outer sheath (122) and configured to be manipulated by an operator to translate the outer sheath (122) relative to the handle assembly (110). Figures 2-7 As best seen, the shaft assembly (120) also includes an inner shaft (126) in which a plurality of annular electrodes (128) are positioned around the inner shaft (126) at a distal portion (124) of the shaft assembly (120). An outer sheath (122) is operable to selectively cover or expose the annular electrodes (128) based on the longitudinal position of the outer sheath (122) relative to the shank assembly (110). The annular electrodes (128) are operable to provide RF ablation of tissue, as will be described in more detail below.

[0075] In some forms, the shaft assembly (120) is rigid along its entire length. In other forms, at least a portion of the shaft assembly (120) is flexible. For example, some variations of the shaft assembly (120) may be extendable along the distal portion (124). As another example, some variations of the shaft assembly (120) may provide steering capability along the distal portion (124). For example, one or more traction wires may be actuated to bend the distal portion (124) and thereby laterally deflect the distal portion (124) away from the central longitudinal axis. Various suitable ways in which the shaft assembly (120) may combine ductility, steering capability, or other flexibility will be apparent to those skilled in the art, taking into account the teachings herein. In forms where flexibility, steerability, or other bendability is provided in the distal portion (124) or elsewhere within the shaft assembly (120), the shaft assembly (120) may include features that prevent the bendable segments of the shaft assembly (120) from kinking or otherwise locking the needle electrodes (140, 150), allowing the needle electrodes (140, 150) to translate freely longitudinally along the shaft assembly (120), even when the bendable regions of the shaft assembly (120) are bent. Such anti-kinking features may include a longitudinally spaced array of annular bodies. In some forms, the annular electrode (128), described in more detail below, provides anti-kinking functionality in the shaft assembly (120) in addition to providing RF power delivery capability.

[0076] An end effector (130) is positioned at the distal portion (124) of the shaft assembly (120). The end effector (130) includes a dome-shaped end (132) securely attached to the distal end of the inner shaft (126). The end (132) defines a central opening (134) aligned with the longitudinal axis of the shaft assembly (120). An array of lateral openings (136) is formed at the distal end of the inner shaft (126), just proximal to the end (132). In this example, the inner shaft (126) includes four lateral openings (136) angularly spaced from each other at equal distances around the central longitudinal axis of the shaft assembly (120). In other configurations, more or fewer than four lateral openings (136) may be provided. Although in this example the opening (136) is laterally presented on the outer surface of the inner shaft (126), the inner shaft (126) may include internal guide features (not shown) leading to the opening (136), wherein such internal guide features are obliquely or otherwise non-perpendicularly oriented relative to the central longitudinal axis of the shaft assembly (120). Such internal guide features may facilitate the guidance of the needle electrode (150) through the opening (136) along an oblique exit path, as will be described in more detail below. As used herein, the terms “oblique” and “obliquely” should be understood to include a relationship in which the structural element extends along a curve bent away from the straight axis; furthermore, it also includes a relationship in which the structural element extends along a straight path not parallel to the straight axis.

[0077] In some scenarios, such as Figure 4 As shown, the end effector (130) also includes a distal needle electrode (140). By way of example only, the needle electrode (140) may be coupled to the slider (114) such that as the slider (114) advances distally along the body (112) of the shank assembly (110), the needle electrode (140) advances distally to... Figure 4 The needle electrode (140) is positioned and configured to exit the tip (132) via an opening (134). The needle electrode (140) includes a sharp tip (142) configured to pierce tissue when the needle electrode (140) is advanced distally. In this example, the needle electrode (140) also defines a lumen (144), but in some types the lumen (144) may be omitted. In some types that include a lumen (144), the needle electrode (140) may be used to deliver fluids (e.g., flushing fluids, therapeutic substances, etc.) to tissue.

[0078] The needle electrode (140) is coupled to the RF generator (102) (e.g., via one or more filaments, etc.) so that the needle electrode (140) can be operated to deliver RF energy to tissue. In some scenarios, a grounding pad is placed in contact with the patient's skin, and the needle electrode (140) is activated to apply monopolar RF energy to the tissue. In some other scenarios, the needle electrode (140) cooperates with one or more other electrodes (128, 150) of the device (100) to apply bipolar radiofrequency energy to the tissue.

[0079] As another variation, the tip (132) may be configured to function as an electrode, such that the tip (132) and the needle electrode (140) can cooperate to apply bipolar RF energy to tissue. For example, the needle electrode (140) may function as an active electrode, while the tip (132) may function as a return electrode. In a form in which the tip (132) includes a conductive material that allows the tip (132) to function as an electrode, at least a proximal portion of the needle electrode (140) may include an electrically insulating coating or sheath, etc., to prevent short circuits between the needle electrode (140) and the tip (132). Alternatively, or in an alternative, a portion of the tip (132) may include an electrically insulating coating or sheath, etc., to prevent short circuits between the needle electrode (140) and the tip (132). Other suitable ways in which the needle electrode (140) and / or the tip (132) can be used to apply monopolar or bipolar RF energy to tissue will be apparent to those skilled in the art in light of the teachings herein. In addition to or instead of being used to deliver tissue ablation via RF energy, needle electrodes (140) and / or tips (132) may be used to provide tissue electroporation. Such electroporation may be provided to facilitate the delivery of therapeutic substances, etc., to the tissue.

[0080] In some scenarios, such as Figure 5 As shown, the end effector (130) also includes a plurality of inclined needle electrodes (150). Although four needle electrodes (150) are shown in this example, the instrument (100) may alternatively include more or fewer than four needle electrodes (150). By way of example only, the needle electrodes (150) may be coupled to the slider (116) such that as the slider (116) advances distally along the body (112) of the shank assembly (110), the needle electrodes (150) simultaneously advance distally to... Figure 5The positions are shown. Although in this example all needle electrodes (150) are coupled to the slider (116) such that the needle electrodes (150) advance distally simultaneously as the slider (116) advances distally, other configurations may include separate actuators for the needle electrodes (150) (e.g., such that each needle electrode (150) is configured to advance individually and independently relative to the other needle electrodes (150)). The needle electrodes (150) are positioned and configured to the inner shaft (126) via corresponding openings (136). Each needle electrode (150) includes a sharp tip (152) configured to pierce tissue when the needle electrode (150) is advanced distally. In some configurations, each needle electrode (150) also defines a lumen (not shown), but in some configurations such a lumen may be omitted. In some types in which each needle electrode (150) includes a lumen, the needle electrode (150) can be used to deliver fluid (e.g., flushing fluid, therapeutic substance, etc.) to tissue.

[0081] Each needle electrode (150) is coupled to an RF generator (102) (e.g., via one or more filaments, etc.) such that the needle electrode (150) is operable to deliver RF energy to tissue. In some scenarios, a grounding pad is placed in contact with the patient's skin, and each needle electrode (150) can be activated to apply unipolar RF energy to the tissue. All needle electrodes (150) can therefore have the same polarity. In some other scenarios, the needle electrodes (150) cooperate with each other to apply bipolar RF energy to the tissue. For example, two needle electrodes (150) can be used as active electrodes, while another two needle electrodes (150) can be used as return electrodes. In this type, two active needle electrodes (150) can be angularly spaced 180 degrees apart from each other, or they can be spaced 90 degrees apart from each other. As another example, in a configuration in which the end (132) is configured to function as an RF electrode, one or more of the needle electrodes (150) may cooperate with the end (132) to apply bipolar RF energy to the tissue.

[0082] As the needle electrode (150) exits through the opening (136), the needle electrode (150) in this example is elastically biased to bend outward, as... Figure 5 As shown. As described above, the inner shaft (126) may include an internal guiding feature that guides the needle electrode (150) through an opening (136) as the needle electrode (150) is advanced distally. Such a guiding feature also facilitates the realization of the needle electrode (150) in the distal position. Figure 5 The outward-flaring configuration is shown. By way of example only, the needle electrode (150) may comprise nitinol or any other suitable elastic material to impart a bias voltage to achieve the desired effect. Figure 5 The bending configuration shown.

[0083] In some configurations, the needle electrode (150) is biased to extend along a hyperbola as it is advanced distally. In other configurations, the needle electrode (150) is biased to extend along a single-radius curvature as it is advanced distally. As yet another example, the needle electrode (150) may be elastically biased to present a straight configuration, and an internal guide feature in the inner shaft (126) may push the needle electrode (150) to extend along a straight inclined path as it is advanced distally. Regardless of whether the needle electrode (150) is elastically biased to present a curved or straight configuration, it may be considered to extend outwardly at an angle relative to the longitudinal axis of the shaft assembly (120) as it is advanced distally. Other suitable configurations will be apparent to those skilled in the art in light of the teachings herein. Some designs also allow the needle electrode (150) to stop advancing at any suitable location, allowing the needle electrode (150) to be advanced more distally than... Figure 5 The location shown may be further or less distal, depending on the desired depth of tissue penetration.

[0084] Similar to the needle electrode (140), the needle electrode (150) may include an insulating coating or sheath along at least a portion of the electrode (150) to prevent short circuits with adjacent conductive parts. Also similar to the needle electrode (140), the needle electrode (150) may be used to provide tissue ablation via RF energy, electroporation of tissue, or other electroinduced tissue effects.

[0085] In some scenarios, the operator may wish to construct an end effector (130) in which needle electrodes (140) and needle electrodes (150) are deployed simultaneously, such as Figure 6 As shown. This arrangement can be achieved by advancing the two sliders (114, 116) along the body (112) to the distal side. When the end effector (130) is as Figure 6 When constructed as shown, the needle electrodes (140, 150) can cooperate in any suitable manner, wherein the end (132) is configured to have or not have an end (132) in the form of an electrode to apply RF energy to tissue.

[0086] Figure 7Another example of the operating state of the device (100) is shown. In this state, the sheath (122) is retracted proximally to expose the annular electrodes (128). The sheath (122) may be formed of a non-conductive material. In some configurations, some annular electrodes (128) are configured to function as active electrodes, while others are configured to function as return electrodes, enabling the annular electrodes (128) to operate to apply bipolar RF energy to tissue. In some other configurations, the annular electrodes (128) cooperate with a grounding pad (not shown) that contacts the patient's skin to apply unipolar RF energy to tissue. In configurations where the end (132) is configured to function as an electrode, the annular electrodes (128) cooperate with the end (132) to apply bipolar RF energy to tissue. Although all needle electrodes (140, 150) are in the retracted position in this example, it is possible that one or more needle electrodes (140, 150) are pushed distally while the sheath (122) is in the retracted position. Figure 7 The retracted position is shown in the usage scenario. In such a scenario, the annular electrode (128) can cooperate with one or more advancing needle electrodes (140, 150) to apply bipolar RF energy to the tissue.

[0087] When the needle electrodes (140, 150) are used to deliver RF energy to the tissue, the needle electrodes (140, 150) can be advanced into the tissue, causing the needle electrodes (140, 150) to penetrate the tissue; then, the needle electrodes (140, 150) can be activated to apply RF energy to the penetrated tissue. When the distal end (132) or the annular electrode (128) is used to deliver RF energy to the tissue, the distal end (132) or the annular electrode (128) can be pressed onto the tissue, causing the distal end (132) or the annular electrode (128) to engage the tissue; then, the distal end (132) or the annular electrode (128) can be activated to apply RF energy to the engaged tissue.

[0088] As described above, the device (100) allows the operator to select between applying RF energy to the tissue surface (e.g., via the tip (132) and / or the ring electrode (128)) and / or within the penetrated tissue (e.g., via the needle electrode (140) and / or the needle electrodes (140, 150)). Therefore, the device (100) can be used to perform relatively shallow ablation (e.g., via the tip (132) and / or the ring electrode (128)) and relatively deep ablation (e.g., via the needle electrode (140, 150)). 0) and / or needle electrodes (140, 150) or volumetric ablation (e.g., via a combination of distal (132) and / or ring electrode (128) with needle electrodes (140) and / or needle electrodes (140, 150)). In just another example, the instrument (100) can be used to perform pterygopalatine ganglion resection, posterior nasal nerve resection, turbinate resection, or any other suitable procedure. In some cases, a combination of the distal needle electrode (140) and the distal end (132) can be used to perform turbinate resection.

[0089] In some alternative applications, the shaft assembly (120) may be pressed into the tissue such that the tip (132) penetrates the tissue to a certain depth. For example, the tip (132) may be inserted through an incision formed using another instrument; or the tip (132) may be pressed with sufficient force to provide blunt dissection. In either case, once the tip (132) and at least one annular electrode (128) have penetrated into the tissue, the tip (132) and / or the annular electrode (128) may be activated to apply RF energy to the tissue. Similarly, needle electrodes (140) and / or needle electrodes (150) may be deployed after the tip (132) has penetrated into the tissue; then, the needle electrodes (140) and / or needle electrodes (150) may be activated to apply RF energy to the tissue. Other suitable ways in which the needle electrodes (140, 150), the tip (132), and / or the annular electrode (128) can be used to apply RF energy to tissue will be apparent to those skilled in the art in light of the teachings herein.

[0090] Although not shown, the device (100) may also include one or more position sensors operable to generate signals indicating the position of the end effector (130) in three-dimensional space. Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from these position signals can be processed by a system that provides visual indications to the operator, displaying in real-time the position of the end effector (130) within the patient's body. Such visual indications may be provided as a superposition on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such position sensing and navigation capabilities can be provided based on at least some of the teachings of the following U.S. patents: U.S. Patent Publication 2014 / 0364725 (now obsolete), published December 11, 2014, entitled “Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent 7,720,521, published May 18, 2010, entitled “Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent 10,463,242, published November 5, 2019, entitled “Guidewire Navigation for Sinuplasty,” the disclosure of which is incorporated herein by reference in its entirety; and / or U.S. Patent Publication 2014 / 0364725, published February 18, 2020, entitled “Apparatus to Secure U.S. Patent 10,561,370, entitled "Field Generating Device to Chair", is incorporated herein by reference in its entirety.

[0091] III. Ablation Instruments with Lateral Loop Electrodes and Needle Electrodes

[0092] Figures 8A-12Another example of an instrument (200) for delivering RF energy to tissue is shown. For example, the instrument (200) can be used to ablate nerves (e.g., the posterior nasal nerve (40)), ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)), or ablate any other type of anatomical structure in a patient's head. The instrument (200) of this example includes a handle assembly (210), a shaft assembly (230), a ring electrode assembly (240), and an accessory (250). The instrument (200) is coupled to an RF generator (202) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (242, 244, 270), as described in more detail below. The instrument (200) may also optionally be coupled to an accessory driver (204) that can drive the accessory (250) in a manner based on the accessory (250). Various examples of the forms in which Annex (250) may be taken will be described in more detail below; and examples will be obvious to those skilled in the art in light of the teachings herein.

[0093] The handle assembly (210) of this example includes a body (212), a first slider (220), and a second slider (222). The body (212) is sized and configured for single-handed gripping and operation by an operator, such as via a motorized grip, pencil grip, or any other suitable type of grip. Each slider (220, 222) is operable to translate longitudinally relative to the body (212). In some models, the sliders (220, 222) are operable to translate independently of each other. The slider (220) is coupled to and thus operable to translate the annular electrode assembly (240) longitudinally, as will be described in more detail below. Figures 8A-8B The transition is illustrated by a slider (220) that drives the annular electrode assembly (240) from a proximal position to a distal position. The slider (222) is coupled to the attachment (250) and is therefore operable to longitudinally translate the attachment (250), as will be described in more detail below. Figures 8B-8C The transition is illustrated by the slider (222) that drives the attachment (250) from the proximal position to the distal position.

[0094] The shaft assembly (230) of this example includes a rigid portion (232), a flexible portion (234) distal to the rigid portion (232), and an open distal end (236). A traction wire (not shown) is coupled to the flexible portion (234) and to a deflection control knob (216) of the shank assembly (210). The deflection control knob (216) is rotatable relative to the body (212) about an axis perpendicular to the longitudinal axis of the shaft assembly (230) to selectively retract the traction wire proximally. As the traction wire retracts proximally, the flexible portion (234) bends and thereby laterally deflects the distal end (236) away from the longitudinal axis of the rigid portion (232). The deflection control knob (216), the traction wire, and the flexible portion (234) thus cooperate to give the shaft assembly (230) steerability. By way of example only, such steerability of the shaft assembly (230) may be provided according to at least some of the teachings of the following U.S. patent application: U.S. Patent Application 63 / 028,609, filed May 22, 2020, entitled “Shaft Deflection Control Assembly for ENT Guide Instrument,” the disclosure of which is incorporated herein by reference in its entirety. Other embodiments may provide some other kind of user input features instead of a deflection control knob (216) to drive the steering of the flexible portion (234). In some alternative embodiments, the deflection control knob (216) is omitted, and the flexible portion (234) is extendable. In still other embodiments, the entire length of the shaft assembly (230) is rigid.

[0095] The shaft assembly (230) is also rotatable relative to the handle assembly (210) about the longitudinal axis of the rigid portion (232). Such rotation can be driven via a rotary control knob (214) rotatably coupled to the body (212) of the handle assembly (210). Alternatively, the shaft assembly (230) can be rotated via some other form of user input; or it can be non-rotatable relative to the handle assembly (210).

[0096] like Figure 9As best seen in the image, the annular electrode assembly (240) of this example includes a pair of bow-shaped arms (242, 244). One end of the bow-shaped arm (242) is fixed to the deployment arm (243); while the other end of the bow-shaped arm (242) is fixed to the coupling (246). Similarly, one end of the bow-shaped arm (244) is fixed to the deployment arm (245); while the other end of the bow-shaped arm (244) is fixed to the coupling (246). In some configurations, the bow-shaped arm (242) and the deployment arm (243) are integrally formed from the same first wire; while the bow-shaped arm (244) and the deployment arm (245) are integrally formed from the same second wire. The deployment arms (243, 245) extend along the length of the shaft assembly (230) and are coupled to the first slider (220). Each deployment arm (243, 245) may include an electrically insulating coating or sheath to prevent short circuits within the shaft assembly (230), wherein the bow-shaped arms (242, 244) remain exposed to serve as electrodes. Each bow-shaped arm (242, 244) is coupled to one or more corresponding wires that electrically couple the bow-shaped arm (242, 244) to the RF generator (202). The bow-shaped arm (242) is configured to apply RF energy with a first polarity; while the bow-shaped arm (244) is configured to apply RF energy with a second polarity. The bow-shaped arms (242, 244) thus serve as electrodes operable to apply bipolar RF energy to tissue in contact with the bow-shaped arms (242, 244). A joint (246) is formed of an electrically insulating material that prevents short circuits between the bow-shaped arms (242, 244) while mechanically securing the corresponding ends of the bow-shaped arms (242, 244) together.

[0097] like Figure 9 As shown, when the bow arms (242, 244) are exposed relative to the distal end (236) of the shaft assembly (230), the bow arms (242, 244) are elastically biased to define a bow configuration. By way of example only, the bow arms (242, 244) may be formed of nitinol. In this example, the bow arms (242, 244) extend along a curve defined by a single radius. Thus, the bow arms (242, 244) and the joint (246) cooperate to define a generally circular shape. In some other forms, the bow arms (242, 244) and the joint (246) cooperate to define an elliptical, oval, square, triangular, or other non-circular shape. In this example, the generally circular shape defined by the bow arms (242, 244) and the joint (246) extends along a plane perpendicular to the longitudinal axis of the shaft assembly (230). In some other forms, the generally circular shape (or other non-circular shape) defined by the bow arms (242, 244) and the joint (246) extends along a plane that is obliquely oriented or otherwise transverse to the longitudinal axis of the shaft assembly (230).

[0098] During use of the annular electrode assembly (240), when the annular electrode assembly (240) is fully deployed from the distal end (236) of the shaft assembly (230), as Figure 9 As shown, the operator can use a pressing motion to press the annular electrode assembly (240) against the tissue against which the operator wishes to ablate (or otherwise apply RF energy). With the tissue fully engaged by the bow arms (242, 244), the operator can then activate the RF generator (202), whereby the bow arms (242, 244) act as electrodes to apply bipolar RF energy to the tissue against which the annular electrode assembly (240) is pressed. This can provide a relatively shallow ablation compared to ablation provided via the aforementioned needle electrodes (140, 150) (or the needle electrode (270) described below).

[0099] In some cases, the operator may wish to deploy the annular electrode assembly (240) only partially from the distal end (236) of the shaft assembly (230). For example... Figure 10A As shown, with the first slider (220) in the closest position, the annular electrode assembly (240) can be fully accommodated within the shaft assembly (230). When the first slider (220) is partially advanced distally to the intermediate longitudinal position, the annular electrode assembly (240) can extend distally from the distal end (236) of the shaft assembly (230), as shown in FIG10B. In this state, the elasticity of the annular electrode assembly (240) allows for a certain degree of outward bending of the bow arms (242, 244), which are not limited to a generally circular shape. However, when the annular electrode assembly 240 is in a partially deployed state (e.g., the state shown in FIG10B), the operator can press the bow arms (242, 244) against the tissue and then activate the bow arms (242, 244) to apply RF energy to the tissue. If, when the annular electrode assembly 240 is in the partially deployed state shown in FIG10B, the operator chooses to fully deploy the annular electrode assembly (240) in addition to or instead of applying RF energy to the tissue, the operator may continue to advance the first slider (220) to the distal position. With the first slider (220) in the distal position, the annular electrode assembly (240) can be fully deployed and thereby defines the generally circular shape shown in FIG10C.

[0100] As described above, the device (200) may include an accessory (250) coupled to the second slider (222) and operable to translate relative to the shaft assembly (230) and relative to the annular electrode assembly (240). Figure 11 An example of the form in which the accessory (250) can take is shown. In this example, the accessory (250) includes a cannula (260) having a shaft (262) with an open distal end (264). Figure 11In the example shown, the cannula (260) can be advanced distally to a point where the distal end (264) of the cannula (260) is located at approximately the same longitudinal position as the annular electrode assembly (240). In some other configurations, the cannula (260) can be advanced to a point where the distal end (264) of the cannula (260) is located proximal or distal to the longitudinal position of the annular electrode assembly (240).

[0101] In some embodiments in which the accessory (250) includes a cannula (260), the accessory driver (204) may include a saline source, allowing the cannula (260) to be used to provide flushing at the site of deployment of the ring electrode assembly (240). In some other embodiments in which the accessory (250) includes a cannula (260), the accessory driver (204) may include a therapeutic agent source, allowing the cannula (260) to be used to provide a therapeutic agent at the site of deployment of the ring electrode assembly (240). In embodiments in which the cannula (260) is used to deliver a therapeutic agent, the ring electrode assembly (240) may be used to provide electroporation of tissue, thereby facilitating the delivery of therapeutic substances from the cannula (260) to the tissue. In still other embodiments in which the accessory (250) includes a cannula (260), the accessory driver (204) may include an aspiration source, allowing the cannula (260) to be used to provide aspiration at the site of deployment of the ring electrode assembly (240). As another example, the guidewire or other components may be introduced into the site where the annular electrode assembly (240) is deployed via a cannula (260). Other suitable methods of using the cannula (260) will be apparent to those skilled in the art.

[0102] Figure 12 Another example of the form in which the attachment (250) may take is shown. In this example, the attachment (250) includes a bundle of needle electrodes (270). Although four needle electrodes (270) are shown, any other suitable number of needle electrodes (270) may be provided. Each needle electrode (270) in this example includes an insulated proximal portion (272), an exposed distal portion (274), and a sharp tip (276). Although the needle electrodes (270) in this example do not have lumens, other types of needle electrodes (270) may include lumens that allow the needle electrodes (270) to deliver fluids (e.g., flushing fluids, therapeutic agents, etc.) into tissue. As the second slider (222) is advanced distally, the needle electrodes (270) are driven to extend distally across the transverse plane defined by the annular electrode assembly (240), as Figure 12As shown. The operator can stop the distal advance of the second slider (222) at any suitable location along the length of the body (212) of the handle assembly (210) to achieve penetration of the needle electrode (270) into the tissue to any suitable depth. In the form in which the attachment (250) is in the form of a needle electrode (270), the attachment driver (204) includes an RF generator. The needle electrode (270) is thus operable to apply RF energy to the tissue in which the exposed distal portion (274) is disposed.

[0103] In this example, when the needle electrode (270) is as Figure 12 When positioned distally as shown, the needle electrode (270) is resiliently biased to flare outward relative to the longitudinal axis of the shaft assembly (230). In some configurations, the needle electrode (270) is biased to extend along a hyperbola as it is advanced distally. In other configurations, the needle electrode (270) is biased to extend along a single-radius curvature as it is advanced distally. In addition to or as an alternative to the resilient biasing of the needle electrode (270) to flare outward, the distal portion of the shaft assembly (230) also includes a guide feature that facilitates the flare of the needle electrode (270) as it is advanced distally through the distal end (236).

[0104] In some configurations, all needle electrodes (270) have the same polarity. In this configuration, the needle electrodes (270) may cooperate with an electrode pad in contact with the patient's skin to provide unipolar RF energy. In some other configurations of this type, the needle electrodes (270) may be used as active electrodes (or return electrodes), while the ring electrode assembly (240) may be used as return electrodes (or active electrodes) to provide bipolar RF energy to the tissue. As another variation, the needle electrodes (270) may cooperate with each other to apply bipolar RF energy to the tissue. For example, two needle electrodes (270) may be used as active electrodes, while two other needle electrodes (270) may be used as return electrodes. In this configuration, two active needle electrodes (270) may be angularly spaced 180 degrees apart from each other, or 90 degrees apart.

[0105] When the needle electrode (270) is used to deliver RF energy to tissue, the needle electrode (270) can be advanced into the tissue, causing the needle electrode (270) to penetrate the tissue; then, the needle electrode (270) can be activated to apply RF energy to the penetrated tissue. When the ring electrode assembly (240) is used to deliver RF energy to tissue, the ring electrode assembly (240) can be pressed against the tissue, causing the ring electrode assembly (240) to engage the tissue; then, the ring electrode assembly (240) can be activated to apply RF energy to the engaged tissue.

[0106] As described above, the instrument (200) allows the operator to choose between applying RF energy to the tissue surface (e.g., via the ring electrode assembly 240) and / or within the penetrated tissue (e.g., via the needle electrode (270)). Thus, the instrument (200) can be used to perform relatively shallow ablation (e.g., via the ring electrode assembly 240), relatively deep ablation (e.g., via the needle electrode (270)), or volumetric ablation (e.g., a combination of the ring electrode assembly (240) and the needle electrode (270)). In just another example, the instrument (200) can be used to perform pterygopalatine ganglion resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the ring electrode assembly (240) and the needle electrode (270) can be used to perform turbinate resection. Other suitable ways in which the needle electrode (270) and / or the ring electrode assembly (240) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0107] Although not shown, the instrument (200) may also include one or more position sensors operable to generate signals indicating the position of the distal end (236) or some other component of the instrument (200) in three-dimensional space. Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides visual indications to the operator in real time, showing the operator the position of the distal end (236) or some other component of the instrument (200) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such position sensing and navigation capabilities may be provided based on at least some of the teachings of the various references cited herein.

[0108] IV. Ablation Instruments with Dual Axial Loop Electrode Assemblies and Single Needle Electrode

[0109] Figure 13 to Figure 15 The distal portion of another example of a device (300) that can be used to deliver RF energy to tissue is shown. For example, the device (300) can be used to ablate nerves (e.g., the posterior nasal nerve (40)), ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)), or ablate any other type of anatomical structure in a patient's head. This example device (300) includes a shaft (310), a first annular electrode assembly (320), a second annular electrode assembly (340), and a needle electrode (360). These features of the device (300) can be readily incorporated into device (100) or device (200) with reference to the teachings herein, as will be apparent to those skilled in the art.

[0110] The annular electrode assemblies (320, 340) are coplanar with each other and extend along a plane that extends along a dimension aligned with and perpendicular to the longitudinal axis of the shaft (310). The first annular electrode assembly (320) is larger than and surrounds the second annular electrode assembly (340). The first annular electrode assembly (320) includes a first longitudinal extension segment (322) extending distally from the distal end of the shaft (310), a second longitudinal extension segment (324) extending distally from the first longitudinal extension segment (322) and laterally offset from the first longitudinal extension segment (322), a lateral extension segment (326) positioned distally, a third longitudinal extension segment (328) extending proximally from the lateral extension segment (326), and a fourth longitudinal extension segment (330) extending from the third longitudinal extension segment (328) into the shaft (310) and laterally offset from the third longitudinal extension segment (328).

[0111] In this example, the first annular electrode assembly (320) defines a generally rectangular shape, wherein the segments (324, 326, 328) are substantially straight. Alternatively, the first annular electrode assembly (320) may define different shapes in other forms. Furthermore, although the first annular electrode assembly (320) is symmetrical about the longitudinal axis of the axis (310), it may be asymmetrical if desired. The first annular electrode assembly (320) of this example is also formed of an elastic material (e.g., nitinol, etc.) such that the first annular electrode assembly (320) is elastically biased to form a generally rectangular shape, although the first annular electrode assembly (320) is configured to deform laterally, inwardly, and otherwise. For example, the first annular electrode assembly (320) may deform when pressed against tissue, when the first annular electrode assembly (320) is contained within a sheath, etc.

[0112] The second annular electrode assembly (340) is nested within the perimeter defined by the first electrode assembly (320). The second electrode assembly (340) includes a first longitudinal extension segment (342) extending distally from the distal end of the shaft (310), a second longitudinal extension segment (344) extending distally from the first longitudinal extension segment (342) and laterally offset from the first longitudinal extension segment (342), a lateral extension segment (346) positioned distally, a third longitudinal extension segment (348) extending proximally from the lateral extension segment (346), and a fourth longitudinal extension segment (350) extending from the third longitudinal extension segment (348) into the shaft (310) and laterally offset from the third longitudinal extension segment (348).

[0113] In this example, the second annular electrode assembly (340) defines a generally rectangular shape, wherein the segments (344, 346, 348) are substantially straight. Alternatively, the second annular electrode assembly (340) may define different shapes in other forms. Furthermore, although the second annular electrode assembly (340) is symmetrical about the longitudinal axis of the axis (310), it may be asymmetrical if desired. The second annular electrode assembly (340) of this example is also formed of an elastic material (e.g., nitinol, etc.) such that the second annular electrode assembly (340) is elastically biased to form a generally rectangular shape, although the second annular electrode assembly (340) is configured to deform laterally, inwardly, and otherwise. For example, the second annular electrode assembly (340) may deform when pressed against tissue, when the second annular electrode assembly (340) is contained within a sheath, etc.

[0114] A needle electrode (360) is nested within a perimeter defined by a second electrode assembly (340). The needle electrode (360) includes a straight proximal portion (362), a curved distal portion (364), and a sharp distal end (366). The needle electrode (360) is configured to penetrate tissue. In some embodiments, the needle electrode (360) also includes a lumen and an opening at the distal end (366), allowing the needle electrode (360) to be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) to tissue. In this example, the needle electrode (360) is formed of an elastic material (e.g., nitinol, etc.), such that the needle electrode (360) is elastically biased to form a curve at the curved distal portion (364).

[0115] like Figures 13A-13BAs shown, the needle electrode (360) can be selectively advanced and retracted relative to the shaft (310). Such advancement and retraction can be controlled by a sliding actuator similar to the sliders (114, 116, 220, 222) described above or via any other suitable user input feature. In some variations, one or both of the annular electrode assemblies (320, 340) can also be selectively advanced and retracted relative to the shaft (310) by an actuator. Alternatively, the needle electrode (360) and / or the annular electrode assembly (320, 340) can be longitudinally fixed relative to the shaft (310). In this type, the needle electrode (360) and / or the annular electrode assembly (320, 340) can be selectively housed within or exposed by an outer sheath (not shown) slidably disposed relative to the shaft (310). For example, the shaft (310) may slide longitudinally relative to such an outer sheath, or the outer sheath may slide longitudinally relative to the shaft (310) to selectively accommodate or expose the needle electrode (360) and / or the annular electrode assembly (320, 340). Regardless of how the needle electrode (360) and / or the annular electrode assembly (320, 340) are advanced, retracted, accommodated, or exposed, the degree of advancement, retraction, accommodation, or exposure may be similar to that described above. Figures 10A-1 The methods described in 0C can be selected and adjusted to change the degree of tissue contact.

[0116] The annular electrode assembly (320, 340) and the needle electrode (360) are operable to apply bipolar RF energy to tissue. In some configurations, the first annular electrode assembly (320) provides RF energy of a first polarity, while the second annular electrode assembly (340) provides RF energy of a second polarity. The needle electrode (360) may also provide either RF energy of the first polarity or RF energy of the second polarity. As another example, the first annular electrode assembly (320) itself may be configured to apply bipolar RF energy to tissue. For example, segments (324, 328) may be configured to provide RF energy of the first polarity, while segment (326) may be configured to provide RF energy of the second polarity. In this configuration, the first annular electrode assembly (320) may include an electrically insulating material providing electrical isolation between segments (324, 326, 328). Similarly, the second annular electrode assembly (340) itself may be configured to apply bipolar RF energy to tissue. For example, segments (344, 348) may be configured to provide RF energy of a first polarity, while segment (346) may be configured to provide RF energy of a second polarity. In this type, the second annular electrode assembly (340) may include an electrically insulating material providing electrical isolation between segments (344, 346, 348). In some types in which the annular electrode assemblies (320, 340) are each operable to apply bipolar RF energy to tissue, segments (324, 328, 346) are operable to apply RF energy of a first polarity, while segments (326, 344, 348) are operable to apply RF energy of a second polarity.

[0117] Some types of needle electrodes (360) can also be configured to apply bipolar RF energy to tissue. For example, different regions of the needle electrode (360) can be electrically isolated from each other and can be operable to provide RF energy of different polarities. Other suitable ways of allocating polarity between the annular electrode assembly (320, 340) and the needle electrode (360) will be apparent to those skilled in the art, taking into account the teachings herein.

[0118] like Figure 15As shown, a needle electrode (360) protrudes into a first region (370) above the annular electrode assembly (320, 340). A second region (380) is defined on the opposite side of the annular electrode assembly (320, 340). In some configurations, the portions of the annular electrode assembly (320, 340) and the needle electrode (360) facing the second region (380) are covered with an electrically insulating material; while the portions of the annular electrode assembly (320, 340) and the needle electrode (360) facing the first region (370) remain exposed. In this configuration, the annular electrode assembly (320, 340) and the needle electrode (360) can apply RF energy only to tissue located within the first region (370). By way of example only, approximately 30% to approximately 60% of the surface area of ​​the annular electrode assembly (320, 340) and the needle electrode (360) facing the second region (380) may be covered with an insulating material. In other configurations, the portions of the annular electrode assembly (320, 340) and the needle electrode (360) facing the second region (380) remain exposed, allowing the annular electrode assembly (320, 340) and the needle electrode (360) to apply RF energy to tissue located within the second region (380).

[0119] During use of the instrument (300), the operator can press the annular electrode assembly (320, 340) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is adequately engaged by the annular electrode assembly (320, 340), the operator can then activate the RF generator (202), whereby the annular electrode assembly (320, 340) serves as an electrode to apply bipolar RF energy to the tissue against which the annular electrode assembly (320, 340) is pressed. This provides relatively shallow ablation. In scenarios where the operator wishes to provide relatively deep ablation, the operator can advance a needle electrode (360) into the tissue and activate the needle electrode (360) to apply RF energy to the tissue in which the needle electrode (360) is disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator can simultaneously activate the needle electrode (360) and at least one annular electrode assembly (320, 340). By way of just another example, the instrument (300) can be used to perform pterygopalatine canal nerve resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the ring electrode assembly (320, 340) and the needle electrode (360) can be used to perform turbinate resection. Other suitable ways in which the ring electrode (320, 340) and / or the needle electrode (360) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0120] Although not shown, the device (300) may also include one or more position sensors operable to generate signals indicating the position in three-dimensional space of the annular electrode assembly (320, 340) and / or the needle electrode (360) or some other component of the device (300). Such position sensors may also indicate the orientation of the needle electrode (360), thereby assisting the operator in determining the position of the region (370, 380) relative to the annular electrode assembly (320, 340) and the needle electrode (360). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the annular electrode assembly (320, 340) and / or the needle electrode (360) or some other component of the device (300) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such location sensing and navigation capabilities can be provided based on at least some of the teachings in the various references cited in this article.

[0121] V. Ablation Instruments with Single Axial Loop Electrode Assembly and Dual Needle Electrodes

[0122] Figures 16A-18 The distal portion of another example of a device (400) that can be used to deliver RF energy to tissue is shown. For example, the device (400) can be used to ablate nerves (e.g., the posterior nasal nerve (40)), ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)), or ablate any other type of anatomical structure in the patient's head. This example device (400) includes a shaft (410), a ring electrode assembly (420), a first needle electrode (460), and a second needle electrode (470). These features of the device (400) can be readily incorporated into device (100) or device (200) with reference to the teachings herein, as will be apparent to those skilled in the art.

[0123] The annular electrode assembly (420) extends along a plane that is aligned with and perpendicular to the longitudinal axis of the shaft (410). The annular electrode assembly (420) includes a first longitudinally extending segment (422) extending distally from a distal end of the shaft (410), a first arcuate segment (424) extending distally from the first longitudinally extending segment (422), a laterally positioned transversely extending segment (426), a second arcuate segment (428) extending proximally from the transversely extending segment (426), and a fourth longitudinally extending segment (430) extending from the second arcuate segment (428) into the shaft (410).

[0124] In this example, the annular electrode assembly (420) is defined as generally elliptical. Alternatively, the annular electrode assembly (420) may be defined as different shapes in other types. Furthermore, although the annular electrode assembly (420) is symmetrical about the longitudinal axis of the axis (410), it may be asymmetrical if desired. The annular electrode assembly (420) of this example is also formed of an elastic material (e.g., nitinol, etc.) such that the annular electrode assembly (420) is elastically biased to form a generally elliptical shape, although the annular electrode assembly (420) is configured to deform laterally, inwardly, and otherwise. For example, the annular electrode assembly (420) may deform when pressed against tissue, when the annular electrode assembly (420) is contained within a sheath, etc.

[0125] Needle electrodes (460, 470) are nested within a perimeter defined by an annular electrode assembly (420). The first needle electrode (460) includes a straight proximal portion (462), a curved distal portion (464), and a sharp distal end (466). The first needle electrode (460) is configured to penetrate tissue. In some embodiments, the first needle electrode (460) further includes a lumen and an opening at the distal end (466), allowing the first needle electrode (460) to be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) to tissue. In this example, the first needle electrode (460) is formed of an elastic material (e.g., nitinol, etc.), such that the first needle electrode (460) is elastically biased to form a curve at the curved distal portion (464).

[0126] The second needle electrode (470) includes a straight proximal portion (472), a curved distal portion (474), and a sharp distal end (476). In some embodiments, the straight proximal portion (472) extends integrally from either the straight proximal portion (462) or the curved distal portion (464) of the first needle electrode (460). In some other embodiments, the straight proximal portion (472) extends directly from the distal end of the shaft (410). As another variation, a tubular element or other frame member may extend from the distal end of the shaft (410) and may support the needle electrodes (460, 470). Such a tubular element or other frame member may have lateral openings or other passages from which the needle electrodes (460, 470) may protrude laterally relative to the longitudinal axis of the shaft (410). Other ways of supporting, guiding, or otherwise engaging the needle electrodes (460, 470) will be apparent to those skilled in the art, taking into account the teachings herein.

[0127] Similar to the first needle electrode (460), the second needle electrode (470) is configured to penetrate tissue. In some configurations, the second needle electrode (470) also includes a lumen and an opening at a distal end (476), allowing the second needle electrode (470) to be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) into the tissue. In this example, the second needle electrode (470) is formed of an elastic material (e.g., nitinol, etc.), such that the first needle electrode (470) is elastically biased to form a curve at the curved distal portion (474).

[0128] like Figures 16A-16B As shown, the needle electrodes (460, 470) can be selectively advanced and retracted relative to the shaft (410) via a passage (412) formed in the shaft (410). Such advancement and retraction can be controlled by a sliding actuator similar to the sliders (114, 116, 220, 222) described above, or via any other suitable user input feature. In some variations, the annular electrode assembly (420) can also be selectively advanced and retracted relative to the shaft (410) via an actuator. Alternatively, the needle electrodes (460, 470) and / or the annular electrode assembly (420) can be longitudinally fixed relative to the shaft (410). In this type, the needle electrodes (460, 470) and / or the annular electrode assembly (420) can be selectively housed within or exposed by an outer sheath (not shown) slidably disposed relative to the shaft (410). For example, the shaft (410) may slide longitudinally relative to such an outer sheath, or the outer sheath may slide longitudinally relative to the shaft (410) to selectively accommodate or expose the needle electrodes (460, 470) and / or the annular electrode assembly (420). Regardless of how the needle electrodes (460, 470) and / or the annular electrode assembly (420) are advanced, retracted, accommodated, or exposed, the degree of advancement, retraction, accommodation, or exposure may be similar to that described above. Figures 10A-1 The methods described in 0C can be selected and adjusted to change the degree of tissue contact.

[0129] The annular electrode assembly (420) and needle electrodes (460, 470) are operable to apply bipolar RF energy to tissue. In some configurations, a first arcuate segment (424) provides RF energy of a first polarity, while an arcuate segment (428) provides RF energy of a second polarity. In this configuration, a laterally extending segment (426) may include an electrically insulating material such that the laterally extending segment (426) provides structural support between the arcuate segments (424, 428) without providing a path for short-circuiting between the arcuate segments (424, 428). The needle electrode (460) may also provide either RF energy of the first polarity or RF energy of the second polarity; while the needle electrode (470) may provide either RF energy of the first polarity or RF energy of the second polarity. As another example, the first arcuate segment (424) and the first needle electrode (460) may provide RF energy of the first polarity, while the second arcuate segment (428) and the second needle electrode (470) may provide RF energy of the second polarity. Other suitable ways of allocating polarity between the annular electrode assembly (420) and the needle electrode assembly (460, 470) will be apparent to those skilled in the art, taking into account the teachings herein.

[0130] like Figure 18 As shown, needle electrodes (460, 470) protrude into a first region (480) above the annular electrode assembly (420). A second region (490) is defined on the opposite side of the annular electrode assembly (420). In some configurations, the portions of the annular electrode assembly (420) and needle electrodes (460, 470) facing the second region (490) are covered with an electrically insulating material; while the portions of the annular electrode assembly (420) and needle electrodes (460, 470) facing the first region (480) remain exposed. In this configuration, the annular electrode assembly (420) and needle electrodes (460, 470) can apply RF energy only to tissue located within the first region (480). By way of example only, approximately 30% to approximately 60% of the surface area of ​​the annular electrode assembly (420) and needle electrodes (460, 470) facing the second region (490) may be covered with an insulating material. In other configurations, the portions of the annular electrode assembly (420) and the needle electrodes (460, 470) facing the second region (490) remain exposed, allowing the annular electrode assembly (420) and the needle electrodes (460, 470) to apply RF energy to tissue located within the second region (490).

[0131] During use of the instrument (400), the operator can press the annular electrode assembly (420) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy) using a punching motion. Once the tissue is adequately engaged by the annular electrode assembly (420), the operator can then activate the RF generator (202), where the arcuate segments (424, 428) serve as electrodes to apply bipolar RF energy to the tissue against which the arcuate segments (424, 428) are pressed. This provides relatively shallow ablation. In scenarios where the operator wishes to provide relatively deep ablation, the operator can advance the needle electrodes (460, 470) into the tissue and activate the needle electrodes (460, 470) to apply RF energy to the tissue in which the needle electrodes (460, 470) are disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator can simultaneously activate the needle electrodes (460, 470) and the annular electrode assembly (420). By way of just another example, the instrument (400) can be used to perform pterygopalatine canal nerve resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of needle electrodes (460, 470) and a ring electrode assembly (420) can be used to perform turbinate resection. Other suitable ways in which the ring electrode assembly (420) and / or needle electrodes (460, 470) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0132] Although not shown, the device (400) may also include one or more position sensors operable to generate signals indicating the position in three-dimensional space of the annular electrode assembly (420) and / or the needle electrodes (460, 470) or some other components of the device (300). Such position sensors may also indicate the orientation of the needle electrodes (460, 470), thereby assisting the operator in determining the position of the region (480, 490) relative to the annular electrode assembly (420) and the needle electrodes (460, 470). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the annular electrode assembly (420) and / or the needle electrodes (460, 470) or some other components of the device (400) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such location sensing and navigation capabilities can be provided based on at least some of the teachings in the various references cited in this article.

[0133] VI. Ablation Instruments with Lateral Loop Electrodes and Lateral Offset Needle Electrodes

[0134] Figures 19A-19BThe distal portion of another example of a device (500) that can be used to deliver RF energy to tissue is shown. For example, the device (500) can be used to ablate nerves (e.g., the posterior nasal nerve (40)), ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)), or ablate any other type of anatomical structure in a patient's head. This example device (500) includes an outer sheath (512), an inner shaft (514), a first annular electrode segment (520), a second annular electrode segment (530), a first needle electrode (540), and a second needle electrode (550). These features of the device (500) can be readily incorporated into a device (100) or a device (200) with reference to the teachings herein, as will be apparent to those skilled in the art.

[0135] The annular electrode segments (520, 530) are coplanar with each other and extend along a plane perpendicular to the longitudinal axis shared by the sheath (512) and the shaft (514). The annular electrode segment (520) includes a deployment arm (522), an arcuate arm (524), and a sharp end (526). The deployment arm (522) extends along the space between the sheath (512) and the shaft (514). The arcuate arm (524) extends along a plane distal to the distal end of the shaft (514), such that the arcuate arm (524) is effectively spaced distally relative to the distal end of the shaft (514). Similarly, the annular electrode segment (530) includes a deployment arm (532), an arcuate arm (534), and a sharp end (536). The deployment arm (532) extends along the space between the sheath (512) and the shaft (514). The bow-shaped arm (534) extends along the plane at the distal end of the shaft (514) such that the bow-shaped arm (534) is effectively spaced distally relative to the distal end of the shaft (514).

[0136] In this example, the annular electrode segments (520, 530) together define a generally circular shape, although the annular electrode segments (520, 530) do not contact each other. In other words, there are minute gaps between the end (526) and the bow-shaped arm (534) and between the end (536) and the bow-shaped arm (524). Alternatively, the annular electrode segments (520, 530) may define any other suitable shape. Furthermore, while the annular electrode segments (520, 530) are symmetrical to each other in this example, in other types the annular electrode segments (520, 530) may be asymmetrical. Each annular electrode segment (520, 530) in this example is formed of an elastic material (e.g., nitinol, etc.) such that the bow-shaped arms (524, 534) are elastically biased to form a generally circular shape. However, the bow arms (524, 534) are configured to deform and fit within the space between the sheath (512) and the shaft (514) when the sheath (512) is positioned distally relative to the shaft (514) (e.g., during transport through the nasal cavity toward the target ablation site). Furthermore, the bow arms (524, 534) are deformable when pressed against tissue.

[0137] In some configurations, each annular electrode segment (520, 530) is further defined with an open lumen at its distal end (526, 536), allowing the annular electrode segment (520, 530) to be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) to tissue. While the distal ends (526, 536) are sharp in this example, they may alternatively be blunt or otherwise non-invasive in other configurations.

[0138] The needle electrode (540) includes a shaft (542) and a sharp distal end (544). For example... Figures 19A-19BAs shown, the needle electrode (540) is operable to retract proximally into a passage (518) within the shaft (514) or to advance distally relative to that passage. The needle electrode (550) includes a shaft (552) and a sharp distal end (554). The needle electrode (550) is operable to retract proximally into a passage (518) within the shaft (516) or to advance distally relative to that passage. When the needle electrodes (540, 550) are fully advanced distally, the ends (544, 554) are positioned distally relative to a transverse plane (i.e., a circular shape) defined by the arcuate arms (524, 534). In some configurations, each needle electrode (540, 550) also defines a lumen with an opening at the end (544, 554), allowing the needle electrodes (540, 550) to be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) to tissue. Although the needle electrodes (540, 550) are shown as straight in this example, some types of needle electrodes (540, 550) can be elastically biased to flare out or provide any other suitable configuration.

[0139] As described above, some versions of the device (500) provide longitudinal advance and retraction of the sheath (512) relative to the shaft (514). Alternatively, the shaft (514) is operable to longitudinally advance and retract relative to the sheath (512). In either case, such longitudinal movement can be driven by a sliding actuator similar to the sliders (114, 116, 220, 222) described above or via any other suitable user input feature. Similarly, the longitudinal movement of the needle electrodes (540, 550) relative to the shaft (514) can be driven by a sliding actuator similar to the sliders (114, 116, 220, 222) described above or via any other suitable user input feature. In some versions, the needle electrodes (540, 550) translate simultaneously relative to the shaft (514); while in other embodiments, the needle electrodes (540, 550) translate independently of each other relative to the shaft (514). As another variation, some types of the device (500) can provide a fixed longitudinal position of the needle electrodes (540, 550) relative to the axis (514).

[0140] The annular electrode segments (520, 530) and needle electrodes (540, 550) are operable to apply bipolar RF energy to tissue. In some configurations, the first annular electrode segment (520) provides RF energy of a first polarity, while the second annular electrode segment (530) provides RF energy of a second polarity. The needle electrode (540) may also provide either RF energy of the first polarity or RF energy of the second polarity; while the needle electrode (550) may provide either RF energy of the first polarity or RF energy of the second polarity. As another example, the first annular electrode segment (520) and the needle electrode (550) may provide RF energy of the first polarity, while the second electrode segment (530) and the needle electrode (540) may provide RF energy of the second polarity. Other suitable ways of allocating polarity between the annular electrode segments (520, 530) and the needle electrodes (540, 550) will be apparent to those skilled in the art in light of the teachings herein.

[0141] During use of the instrument (500), the operator can use a pressing motion to press the bow arms (524, 534) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is fully engaged by the bow arms (524, 534), the operator can then activate the RF generator (202), whereby the bow arms (524, 534) serve as electrodes to apply bipolar RF energy to the tissue against which the bow arms (524, 534) are pressed. This provides relatively shallow ablation. In scenarios where the operator wishes to provide relatively deep ablation, the operator can advance the needle electrodes (540, 550) into the tissue and activate the needle electrodes (540, 550) to apply RF energy to the tissue in which the needle electrodes (540, 550) are disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator may simultaneously activate the needle electrode (540, 550) and at least one bow arm (524, 534). By way of just another example, the instrument (500) can be used to perform pterygopalatine ganglion resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the bow arms (524, 534) and the needle electrode (540, 550) can be used to perform turbinate resection. Other suitable ways in which the bow arms (524, 534) and / or the needle electrode (540, 550) can be used to apply RF energy to tissue will be apparent to those skilled in the art, referring to the teachings herein.

[0142] Although not shown, the instrument (500) may also include one or more position sensors operable to generate signals indicating the position of the bow arms (524, 534) and / or needle electrodes (540, 550) or some other components of the instrument (500) in three-dimensional space. Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides visual indications to the operator in real time, showing the operator the position of the bow arms (524, 534) and / or needle electrodes (540, 550) or some other components of the instrument (500) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such position sensing and navigation capabilities may be provided based on at least some of the teachings of the various references cited herein.

[0143] VII. Ablation Instruments with Lateral Loop Electrodes and Longitudinal Offset Needle Electrodes

[0144] Figures 20A-20B The distal portion of another example of a device (600) that can be used to deliver RF energy to tissue is shown. For example, the device (600) can be used to ablate nerves (e.g., the posterior nasal nerve (40)), ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)), or ablate any other type of anatomical structure in a patient's head. This example device (600) includes an outer sheath (612), an inner shaft (614), a first annular electrode segment (620), a second annular electrode segment (630), and a needle electrode assembly (640). These features of the device (300) can be readily incorporated into either device (100) or device (200) with reference to the teachings herein, as will be apparent to those skilled in the art.

[0145] The annular electrode segments (620, 630) are coplanar with each other and extend along a plane perpendicular to the longitudinal axis shared by the sheath (612) and the shaft (614). The annular electrode segment (620) includes a deployment arm (622), an arcuate arm (624), and a sharp end (626). The deployment arm (622) extends along the space between the sheath (612) and the shaft (614). The arcuate arm (624) extends along a plane distal to the distal end of the shaft (614), such that the arcuate arm (624) is effectively spaced distally relative to the distal end of the shaft (614). Similarly, the annular electrode segment (630) includes a deployment arm (632), an arcuate arm (634), and a sharp end (636). The deployment arm (632) extends along the space between the sheath (612) and the shaft (614). The bow-shaped arm (634) extends along the plane at the distal end of the shaft (614) such that the bow-shaped arm (634) is effectively spaced distally relative to the distal end of the shaft (614).

[0146] In this example, the annular electrode segments (620, 630) together define a generally circular shape, although the annular electrode segments (620, 630) do not contact each other. In other words, there are minute gaps between the end (626) and the bow arm (634) and between the end (636) and the bow arm (624). Alternatively, the annular electrode segments (620, 630) may define any other suitable shape. Furthermore, while the annular electrode segments (620, 630) are symmetrical to each other in this example, in other types the annular electrode segments (620, 630) may be asymmetrical. Each annular electrode segment (620, 630) in this example is formed of an elastic material (e.g., nitinol, etc.) such that the bow arms (624, 634) are elastically biased to form a generally circular shape. However, the bow-shaped arms (624, 634) are configured to deform and fit within the space between the sheath (612) and the shaft (614) when the sheath (612) is positioned distally relative to the shaft (614) (e.g., during transport through the nasal cavity toward the target ablation site). Furthermore, the bow-shaped arms (624, 634) are deformable when pressed against tissue.

[0147] In some configurations, each annular electrode segment (620, 630) is further defined with an open lumen at its distal end (626, 636), allowing the annular electrode segment (620, 630) to be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) to tissue. While the distal ends (626, 636) are sharp in this example, they may alternatively be blunt or otherwise non-invasive in other configurations.

[0148] The needle electrode assembly (640) includes a shaft (642) to which an annular electrode (644) is coaxially fixed; and a needle electrode (650) extending distally from the shaft (642). The needle electrode (650) includes a needle shaft (652) having a sharp distal end (654) and a lumen (656) extending to an opening at the end (654). The needle electrode (650) can be used to deliver fluids (e.g., irrigation fluids, therapeutic substances, etc.) to tissues via the lumen (656). Alternatively, in some embodiments, the lumen (656) may be omitted entirely. Figures 20A-20B As shown, the needle electrode assembly (640) is operable to retract proximally into a passage (616) within the shaft (614) or advance distally relative to that passage. When the needle electrode assembly (640) is fully advanced distally, the electrodes (644, 650) are positioned distally relative to the lateral plane (i.e., circular shape) defined by the arcuate arms (624, 634). Although the needle electrode assembly (640) is shown as straight in this example, some configurations of the needle electrode assembly (640) can be resiliently biased to laterally deflect outwards or to provide any other suitable configuration.

[0149] As described above, some versions of the device (600) provide longitudinal advance and retraction of the sheath (612) relative to the shaft (614). Alternatively, the shaft (614) is operable to longitudinally advance and retract relative to the sheath (612). In either case, such longitudinal movement can be driven by a sliding actuator similar to the sliders (114, 116, 220, 222) described above or via any other suitable user input feature. Similarly, longitudinal movement of the needle electrode assembly (640) relative to the shaft (614) can be driven by a sliding actuator similar to the sliders (114, 116, 220, 222) described above or via any other suitable user input feature. In some versions, the shafts (642, 652) translate simultaneously relative to the shaft (614); while in other embodiments, the shafts (642, 652) translate independently of each other relative to the shaft (614). As another variation, some types of the device (600) can provide a fixed longitudinal positioning of the needle electrode assembly (640) relative to the axis (614).

[0150] The annular electrode segments (620, 630) and electrodes (644, 650) are operable to apply bipolar RF energy to tissue. In some configurations, the first annular electrode segment (620) provides RF energy of a first polarity, while the second annular electrode segment (630) provides RF energy of a second polarity. The annular electrode (644) may also provide either RF energy of the first or second polarity; while the needle electrode (650) may provide either RF energy of the first or second polarity. As another example, the first annular electrode segment (620) and the annular electrode (644) may provide RF energy of the first polarity, while the second electrode segment (630) and the needle electrode (650) may provide RF energy of the second polarity. Other suitable ways of allocating polarity between the annular electrode segments (620, 630) and the electrodes (644, 650) will be apparent to those skilled in the art in light of the teachings herein.

[0151] During use of the instrument (600), the operator can press the bow arms (624, 634) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is fully engaged by the bow arms (624, 634), the operator can then activate the RF generator (202), whereby the bow arms (624, 634) serve as electrodes to apply bipolar RF energy to the tissue against which the bow arms (624, 634) are pressed. This provides relatively shallow ablation. In scenarios where the operator wishes to provide relatively deep ablation, the operator can advance the needle electrode assembly (640) into the tissue and activate the electrodes (644, 650) to apply RF energy to the tissue in which the needle electrode assembly (640) is disposed. In scenarios where the operator wishes to perform volumetric ablation, the operator can simultaneously activate the electrodes (644, 650) and at least one bow arm (624, 634). By way of just another example, the instrument (600) can be used to perform pterygopalatine canal nerve resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the bow arms (624, 634) and electrodes (644, 650) can be used to perform turbinate resection. Other suitable ways in which the bow arms (624, 634) and / or needle electrode assemblies (640) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0152] Although not shown, the device (600) may also include one or more position sensors operable to generate signals indicating the position of the bow arm (624, 634) and / or the needle electrode assembly (640) or some other component of the device (600) in three-dimensional space. Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides visual indications to the operator in real time, showing the operator the position of the bow arm (624, 634) and / or the needle electrode assembly (640) or some other component of the device (600) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such position sensing and navigation capabilities may be provided based on at least some of the teachings of the various references cited herein.

[0153] VIII. Examples of RF Ablation Instruments with Loop Electrode Assemblies and Needle Electrodes

[0154] Figures 21-22C An example of an instrument (1100) for delivering RF energy to tissue is shown. For example, the instrument (1100) can be used to ablate nerves (e.g., the posterior nasal nerve (40)); ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)); or ablate, electroporate (e.g., to facilitate the absorption of therapeutic agents, etc.), or apply resistive heating to any other type of anatomical structure in a patient's head. The example instrument (1100) includes a handle assembly (1110), a shaft assembly (1130), a ring electrode assembly (1140), and a needle electrode assembly (1150). The instrument (1100) is coupled to an RF generator (1102) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (1142, 1144, 1170, 1172), as will be described in more detail below.

[0155] The handle assembly (1110) of this example includes a body (1112), a first slider (1120), and a second slider (1122). The body (1112) is sized and configured for single-handed gripping and operation by an operator, such as via a motorized grip, pencil grip, or any other suitable type of grip. Each slider (1120, 1122) is operable to translate longitudinally relative to the body (1112). In some models, the sliders (1120, 1122) are operable to translate independently of each other. The slider (1120) is coupled to and thus operable to translate the annular electrode assembly (1140) longitudinally, as will be described in more detail below. Figures 22B-22CThe transition is illustrated by the annular electrode assembly (1140) being driven from a proximal position to a distal position by a slider (1120). The slider (1122) is coupled to and thus operable to longitudinally translate the needle electrode assembly (1150), as will be described in more detail below. Figures 22A-22B The transition illustrates the needle electrode assembly (1150) driven from a proximal position to a distal position by a slider (1122).

[0156] The shaft assembly (1130) of this example includes a rigid portion (1132), a flexible portion (1134) distal to the rigid portion (1132), and an open distal end (1136). A traction wire (not shown) is coupled to the flexible portion (1134) and to a deflection control knob (1116) of the shank assembly (1110). The deflection control knob (1116) is rotatable relative to the body (1112) about an axis perpendicular to the longitudinal axis of the shaft assembly (1130) to selectively retract the traction wire proximally. As the traction wire retracts proximally, the flexible portion (1134) bends and thereby laterally deflects the distal end (1136) away from the longitudinal axis of the rigid portion (1132). The deflection control knob (1116), the traction wire, and the flexible portion (1134) thus cooperate to give the shaft assembly (1130) steerability. By way of example only, such steerability of the shaft assembly (1130) may be provided according to at least some of the teachings of the following U.S. patent application: U.S. Patent Application 63 / 028,609, filed May 22, 2020, entitled “Shaft Deflection Control Assembly for ENT Guide Instrument,” the disclosure of which is incorporated herein by reference in its entirety. Other embodiments may provide some other kind of user input features instead of a deflection control knob (1116) to drive the steering of the flexible portion (1134). In some alternative embodiments, the deflection control knob (1116) is omitted, and the flexible portion (1134) is extendable. In still other embodiments, the entire length of the shaft assembly (1130) is rigid.

[0157] The shaft assembly (1130) is also rotatable relative to the handle assembly (1110) about the longitudinal axis of the rigid portion (1132). Such rotation can be driven via a rotary control knob (1114) rotatably coupled to the body (1112) of the handle assembly (1110). Alternatively, the shaft assembly (1130) can be rotated via some other form of user input; or it can be non-rotatable relative to the handle assembly (1110). It should also be understood that the examples of the handle assembly (1110) described herein are merely illustrative. The shaft assembly (1130) can alternatively be coupled to any other suitable type of handle assembly or other support body.

[0158] like Figure 22C As best seen in the image, the annular electrode assembly (1140) of this example includes a pair of bow-shaped arms (1142, 1144). One end of the bow-shaped arm (1142) is fixed to the deployment arm (1143); while the other end of the bow-shaped arm (1142) is fixed to the coupling (1146). Similarly, one end of the bow-shaped arm (1144) is fixed to the deployment arm (1145); while the other end of the bow-shaped arm (1144) is fixed to the coupling (1146). In some configurations, the bow-shaped arm (1142) and the deployment arm (1143) are integrally formed from the same first metal wire; while the bow-shaped arm (1144) and the deployment arm (1145) are integrally formed from the same second metal wire. The deployment arms (1143, 1145) extend along the length of the shaft assembly (1130) and are coupled to the first slider (1120). Each deployment arm (1143, 1145) may include an electrically insulating coating or sheath to prevent short circuits within the shaft assembly (1130), wherein the bow-shaped arms (1142, 1144) remain exposed to function as electrodes. Each bow-shaped arm (1142, 1144) is coupled to one or more corresponding filaments, traces, and / or other conductive elements that electrically couple the bow-shaped arm (1142, 1144) to the RF generator (1102). The bow-shaped arm (1142) is configured to apply RF energy with a first polarity; while the bow-shaped arm (1144) is configured to apply RF energy with a second polarity. The bow-shaped arms (1142, 1144) thus function as electrodes operable to apply bipolar RF energy to tissue in contact with the bow-shaped arms (1142, 1144). The joint (1146) is formed of an electrically insulating material that prevents short circuits between the bow arms (1142, 1144) while mechanically fixing the corresponding ends of the bow arms (1142, 1144) together.

[0159] like Figure 22CAs shown, when the bow arms (1142, 1144) are exposed relative to the distal end (1136) of the shaft assembly (1130), the bow arms (1142, 1144) are elastically biased to define a bow configuration. By way of example only, the bow arms (1142, 1144) may be formed of nitinol. In this example, the bow arms (1142, 1144) extend along a curve defined by a single radius. Thus, the bow arms (1142, 1144) and the joint (1146) cooperate to define a generally circular shape. In some other forms, the bow arms (1142, 1144) and the joint (1146) cooperate to define an elliptical, oval, square, triangular, or other non-circular shape. In this example, the generally circular shape defined by the bow arms (1142, 1144) and the joint (1146) extends along a plane perpendicular to the longitudinal axis of the shaft assembly (1130). In some other forms, the generally circular shape (or other non-circular shape) defined by the bow arms (1142, 1144) and the joint (1146) extends along a plane that is obliquely oriented or otherwise transverse to the longitudinal axis of the shaft assembly (1130).

[0160] During use of the annular electrode assembly (1140), when the annular electrode assembly (1140) is fully deployed from the distal end (1136) of the shaft assembly (1130), as Figure 22C As shown, the operator can use a pressing motion to press the annular electrode assembly (1140) onto the tissue to which the operator wishes to ablate (or otherwise apply RF energy). With the tissue fully engaged by the bow arms (1142, 1144), the operator can then activate the RF generator (1102), where the bow arms (1142, 1144) act as electrodes to apply bipolar RF energy to the tissue pressed against by the annular electrode assembly (1140). This provides a relatively shallow ablation compared to ablation provided via the needle electrodes (1170, 1172) described below. In some cases, saline or other flushing fluids can be drained via the shaft assembly (1130) while RF energy is applied to the tissue via the electrode assembly (1140), thereby promoting electrical continuity. Alternatively, or in an alternative, aspiration can be applied via the shaft assembly (1130) to remove fumes, vapors, etc., generated during the ablation procedure.

[0161] In some cases, the operator may wish to deploy the annular electrode assembly (1140) only partially from the distal end (1136) of the shaft assembly (1130). For example... Figure 22BAs shown, with the first slider (1120) in the closest position, the annular electrode assembly (1140) can be fully accommodated within the shaft assembly (1130). When the first slider (1120) is partially advanced distally to the intermediate longitudinal position (not shown), the annular electrode assembly (1140) can extend distally from the distal end (1136) of the shaft assembly (1130) (not shown). In this state, the elasticity of the annular electrode assembly (1140) allows for a certain degree of outward bending of the bow arms (1142, 1144), which are not limited to a generally circular shape. However, when the annular electrode assembly (1140) is in the partially deployed state, the operator can press the bow arms (1142, 1144) against the tissue and then activate the bow arms (1142, 1144) to apply RF energy to the tissue. If, while the annular electrode assembly (1140) is in a partially deployed state, the operator chooses to fully deploy the annular electrode assembly (1140) in addition to applying RF energy to the tissue, or instead of applying RF energy to the tissue, the operator may continue to advance the first slider (1120) to the distal position. With the first slider (1120) in the distal position, the annular electrode assembly (1140) can be fully deployed and thus defined. Figure 22C The generally circular shape is shown. By way of example only, such portions and / or the complete deployment of the ring electrode assembly (1140) may be provided in accordance with at least some of the teachings of the following U.S. patent application: U.S. Provisional Patent Application 63 / 067,495, filed August 19, 2020, entitled “ENTAblation Instrument with Electrode Loop,” the disclosure of which is incorporated herein by reference in its entirety.

[0162] like Figure 22B and Figure 22C As best seen, the needle electrode assembly (1150) of this example includes a pair of needle electrodes (1170, 1172) longitudinally fixed relative to each other by a barrier (1173). Although two needle electrodes (1170, 1172) are shown, any other suitable number of needle electrodes (1170, 1172) may be provided. Each needle electrode (1170, 1172) of this example includes a needle shaft (1174) having a sharp distal end (1176) and a lumen (1178) extending to an opening at the end (1176). The needle electrodes (1170, 1172) can be used to deliver fluids (e.g., irrigation fluids, therapeutic agents, etc.) to tissues via the lumen (1178). Alternatively, in some types, the lumen (1178) may be omitted entirely.

[0163] As the second slider (1122) advances distally, the needle electrodes (1170, 1172) are driven to extend distally across the transverse plane defined by the annular electrode assembly (1140), as... Figure 22C As shown. The operator can prevent distal advancement of the second slider (1122) at any suitable location along the length of the body (1112) of the shank assembly (1110) to allow the needle electrodes (1170, 1172) to penetrate into the tissue to any suitable depth. Each needle electrode (1170, 1172) may include an electrically insulating coating or sheath to prevent short circuits within the shaft assembly (1130), with the distal portion of the corresponding needle shaft (1174) remaining exposed for use as an electrode. Each needle shaft (1174) is coupled to one or more corresponding filaments, traces, and / or other conductive elements electrically coupling the needle shaft (1174) to the RF generator (1102). The needle electrodes (1170, 1172) are thus operable to apply RF energy to the tissue in which the needle electrode assembly (1150) is disposed. The barrier (1173) is formed of an electrically insulating material (e.g., plastic, etc.) that prevents short circuits between the needle shafts (1174) (e.g., in cases where the needle shafts (1174) are configured to apply RF energy with different polarities, as described below); while mechanically securing the corresponding sides of the needle shafts (1174) together. In some forms, the barrier (1173) is formed of a flexible material to accommodate bending or other deflections of the needle electrodes (1170, 1172), such as laterally away from the longitudinal axis of the rigid portion (1132). The barrier (1173) may also include a heat-resistant material to prevent melting or other deformation of the barrier (1173) when the needle electrodes (1170, 1172) are heated while RF energy is applied.

[0164] In this example, the needle electrodes (1170, 1172) are straight and configured such that when the needle electrodes (1170, 1172) are as Figure 22B The distally positioned pins extend along or parallel to the longitudinal axis of the shaft assembly (1130). In some configurations, the pin electrodes (1170, 1172) may be resiliently biased to flare outward relative to the longitudinal axis of the shaft assembly (1130) when the pin electrodes (1170, 1172) are positioned distally. Such biasing and / or flaring of the pin electrodes (1170, 1172) may be provided, by way of example only, according to at least some of the teachings of U.S. Patent Application 63 / 067,495, filed August 19, 2020, entitled “ENT Ablation Instrument with Electrode Loop”.

[0165] In some configurations, the two needle electrodes (1170, 1172) have the same polarity. In this configuration, the needle electrodes (1170, 1172) can cooperate with an electrode pad in contact with the patient's skin to provide unipolar RF energy. In some other configurations of this type, the needle electrodes (1170, 1172) can be used as active electrodes (or return electrodes), while the ring electrode assembly (1140) serves as a return electrode (or active electrode) to provide bipolar RF energy to the tissue. As another variation, the needle electrodes (1170, 1172) can cooperate with each other to apply bipolar RF energy to the tissue. For example, the needle electrode (1170) can be used as an active electrode, while the needle electrode (1172) can be used as a return electrode. In this configuration, the bow arm (1142) can be used as a return electrode, while the bow arm (1144) can be used as an active electrode. Thus, the needle electrode (1170) and the bow arm (1142) can cooperate to provide bipolar RF energy to the tissue between the needle electrode (1170) and the bow arm (1142), which are typically positioned on a first lateral side relative to the barrier (1173). Similarly, the needle electrode (1172) and the bow arm (1144) can cooperate to provide bipolar RF energy to the tissue between the needle electrode (1172) and the bow arm (1144), which are typically positioned on a second lateral side relative to the barrier (1173).

[0166] When the needle electrodes (1170, 1172) are used to deliver RF energy to the tissue, the needle electrodes (1170, 1172) can be advanced into the tissue, causing the needle electrodes (1170, 1172) to penetrate the tissue; then, the needle electrodes (1170, 1172) can be activated to apply RF energy to the penetrated tissue. When the ring electrode assembly (1140) is used to deliver RF energy to the tissue, the ring electrode assembly (1140) can be pressed against the tissue, causing the ring electrode assembly (1140) to engage the tissue; then, the ring electrode assembly (1140) can be activated to apply RF energy to the engaged tissue.

[0167] As described above, the instrument (1100) allows the operator to choose between applying RF energy to the tissue surface (e.g., via the ring electrode assembly 1140) and / or within the penetrated tissue (e.g., via needle electrodes (1170, 1172)). Thus, the instrument (1100) can be used to perform relatively shallow ablation (e.g., via the ring electrode assembly (1140)), relatively deep ablation (e.g., via needle electrodes (1170, 1172)), or volumetric ablation (e.g., via a combination of the ring electrode assembly (1140) and needle electrodes (1170, 1172)). By way of just another example, the instrument (1100) can be used to perform pterygopalatine ganglion resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the ring electrode assembly (1140) and needle electrodes (1170, 1172) can be used to perform turbinate resection. Other suitable ways in which needle electrodes (1170, 1172) and / or ring electrode assemblies (1140) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0168] Although not shown, the instrument (1100) may also include one or more position sensors operable to generate signals indicating the position of the distal end (1136) or some other component of the instrument (1100) in three-dimensional space. Such position sensors may be directly integrated into the shaft assembly (1130) or otherwise integrated into the instrument. Alternatively, or alternatively, such position sensors may be integrated into a guidewire or other component disposed within the shaft assembly (1130). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. Position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the distal end (1136) or some other component of the instrument (1100) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such position sensing and navigation capabilities may be provided based on at least some of the teachings of the various references cited herein.

[0169] like Figures 22A-22CAs shown, the annular electrode assembly (1140) and the needle electrode assembly (1150) can be selectively advanced and retracted relative to the shaft assembly (1130) via sliders (1120, 1122). Alternatively, the annular electrode assembly (1140) and / or the needle electrode assembly (1150) can be longitudinally fixed relative to the shaft assembly (1130). In this type, the annular electrode assembly (1140) and / or the needle electrode assembly (1150) can be selectively housed within or exposed by an outer sheath (not shown) slidably disposed relative to the shaft assembly (1130). For example, the shaft assembly (1130) can slide longitudinally relative to such an outer sheath, or the outer sheath can slide longitudinally relative to the shaft assembly (1130) to selectively house or expose the annular electrode assembly (1140) and / or the needle electrode assembly (1150). Regardless of how the annular electrode assembly (1140) and the needle electrode assembly (1150) are advanced, retracted, contained, or exposed, the degree of advancement, retraction, containment, or exposure can be selected and adjusted in a manner similar to that described above, thereby altering the degree of tissue contact.

[0170] IX. Examples of RF Ablation Instruments with Loop Electrode Assemblies and Needle Electrode Assemblies of Multiple Polarities

[0171] Figures 23A-23C The distal portion of another example of a device (1200) that can be used to deliver RF energy to tissue is shown. For example, the device (1200) can be used to ablate nerves (e.g., the posterior nasal nerve (40)); ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)); or ablate, electroporate (e.g., to facilitate the absorption of therapeutic agents, etc.), or apply resistive heating to any other type of anatomical structure in a patient's head. Unless otherwise stated herein, the device (1200) is substantially similar to the device (1100). This example device (1200) includes a handle assembly (1110), a shaft assembly (1130), a ring electrode assembly (1140), and a needle electrode assembly (1270). The instrument (1200) is coupled to an RF generator (1102) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (1142, 1144, 1282, 1286), as will be described in more detail below. Figures 23A-23B The transition is illustrated by the needle electrode assembly (1270) being driven from a proximal position to a distal position by a slider (1122). From Figures 23B-23C The transition illustrates the annular electrode assembly (1140) driven from a proximal position to a distal position by the slider (1120). Of course, the shank assembly (1110) is merely an illustrative example; and the sliders (1120, 1122) can be replaced by any other suitable type of structure to drive the translation of the annular electrode assembly (1140) and the needle electrode assembly (1270).

[0172] likeFigure 23B and Figure 23C As best shown, the needle electrode assembly (1270) of this example includes a needle shaft (1274) having a sharp distal end (1276) and a lumen (1278) extending to an opening at the end (1276). The needle electrode assembly (1270) can be used to deliver fluid (e.g., irrigation fluid, therapeutic agent, etc.) to tissue via the lumen (1278). Alternatively, in some types, the lumen (1278) may be omitted entirely. When the second slider (1122) is advanced distally, the needle electrode assembly (1270) is driven to extend distally through the transverse plane defined by the annular electrode assembly (1140), as... Figure 23C As shown. The operator can stop the distal advance of the second slider (1122) at any suitable location along the length of the body (1112) of the handle assembly (1110) to allow the needle electrode assembly (1270) to penetrate into the tissue to any suitable depth.

[0173] The needle shaft (1274) includes a proximal insulating segment (1280), a proximal conductive segment (1282) located distal to the proximal insulating segment (1280), a distal insulating segment (1284) located distal to the proximal conductive segment (1282), and a distal conductive segment (1286) located distal to the distal insulating segment (1284). Although two conductive segments (1282, 1286) are shown, any other suitable number of conductive segments (1282, 1286) may be provided. In some configurations, the proximal and distal insulating segments (1280, 1284) are integrally formed from the same first insulating body (e.g., a cylindrical tube), and the proximal conductive segment (1282) may have a larger diameter than the proximal and distal insulating segments (1280 and 1284) to allow the distal insulating segment (1284) to electrically isolate the proximal conductive segment (1282) from the distal conductive segment (1286). Each conductive segment (1282, 1286) is coupled to one or more corresponding filaments, traces, and / or other conductive elements that electrically couple the conductive segment (1282, 1286) to the RF generator (1102), enabling the conductive segment (1282, 1286) to operate as a corresponding RF electrode. The needle electrode assembly (1270) is thus operable to apply RF energy to tissue in which the needle electrode assembly (1270) is disposed. The distal insulating segment (1284) is formed of an electrically insulating material that prevents short circuits between the conductive segments (1282, 1286) (e.g., in the case where the conductive segments (1282, 1286) are configured to apply RF energy with different polarities from each other, as described below).

[0174] The ring electrode assembly (1140) and the needle electrode assembly (1270) are operable to apply bipolar RF energy to tissue. In some configurations, the ring electrode assembly (1140) provides RF energy of a first polarity, while the needle electrode assembly (1270) provides RF energy of a second polarity. As another example, the ring electrode assembly (1140) itself may be configured to apply bipolar RF energy to tissue. For example, the bow arm (1142) may be configured to provide RF energy of the first polarity, while the bow arm (1144) may be configured to provide RF energy of the second polarity. Some configurations of the needle electrode assembly (1270) may also be configured to apply bipolar RF energy to tissue. For example, the proximal conductive segment (1282) may be configured to provide RF energy of the first polarity, while the distal conductive segment (1286) may be configured to provide RF energy of the second polarity. In some configurations, the distal conductive segment (1286) may be used as the active electrode, while the proximal conductive segment (1282) may be used as the return electrode. In other configurations, the proximal conductive segment (1282) may be used as the active electrode, while the distal conductive segment (1286) may be used as the return electrode. Other suitable methods for allocating polarity between the annular electrode assembly (1140) and the needle electrode assembly (1270) will be apparent to those skilled in the art, taking into account the teachings herein.

[0175] During use of the instrument (1200), the operator can use a pressing motion to press the annular electrode assembly (1140) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is adequately engaged by the annular electrode assembly (1140), the operator can then activate the RF generator (1102), where the arcuate arms (1142, 1144) of the annular electrode assembly (1140) serve as electrodes to apply bipolar RF energy to the tissue against which the annular electrode assembly (1140) is pressed. This provides relatively shallow ablation. In scenarios where the operator desires relatively deep ablation, the operator can advance the needle electrode assembly (1270) into the tissue and activate the needle electrode assembly (1270) to apply RF energy to the tissue in which the needle electrode assembly (1270) is disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator may simultaneously activate at least one conductive segment (1282, 1286) of the needle electrode assembly (1270) and at least one bow-shaped arm (1142, 1144) of the ring electrode assembly (1140). By way of only one other example, the instrument (1200) can be used to perform pterygopalatine canal resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the ring electrode assembly (1140) and the needle electrode assembly (1270) can be used to perform turbinate resection. Other suitable ways in which the ring electrode assembly (1140) and / or the needle electrode assembly (1270) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0176] Although not shown, the device (1200) may also include one or more position sensors operable to generate signals indicating the position in three-dimensional space of the annular electrode assembly (1140) and / or the needle electrode assembly (1270) or some other component of the device (1200). Such position sensors may be directly integrated into the shaft assembly (1130) or otherwise integrated into the device. Alternatively, such position sensors may be integrated into a guidewire or other component disposed within the shaft assembly (1130). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the annular electrode assembly (1140) and / or the needle electrode assembly (1270) or some other component of the device (1200) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such location sensing and navigation capabilities can be provided based on at least some of the teachings in the various references cited in this article.

[0177] X. Examples of RF Ablation Instruments with Loop Electrode Assemblies and Needle Electrode Assemblies with Insulated Needle Shafts and Conductive Rings Figures 24A-24C

[0178] Figures 24A-24B The distal portion of another example of a device (1300) that can be used to deliver RF energy to tissue is shown. For example, the device (1300) can be used to ablate nerves (e.g., the posterior nasal nerve (40)); ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)); or ablate, electroporate (e.g., to facilitate the absorption of therapeutic agents, etc.), or apply resistive heating to any other type of anatomical structure in a patient's head. Unless otherwise stated herein, the device (1300) is substantially similar to the device (1100). This example device (1300) includes a handle assembly (1110), a shaft assembly (1130), a ring electrode assembly (1140), and a needle electrode assembly (1370). The instrument (1300) is coupled to an RF generator (1102) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (1142, 1144, 1380, 1382, 1384, 1386), as will be described in more detail below. Figures 24B-24C The transition is illustrated by the needle electrode assembly (1370) being driven from a proximal position to a distal position by a slider (1122). From Figure 24B The transition illustrates the annular electrode assembly (1140) driven from a proximal position to a distal position by the slider (1120). Of course, the shank assembly (1110) is merely an illustrative example; and the sliders (1120, 1122) can be replaced by any other suitable type of structure to drive the translation of the annular electrode assembly (1140) and the needle electrode assembly (1370).

[0179] like Figure 24C and Figure 24C As best shown, the needle electrode assembly (1370) of this example includes a needle shaft (1374) having a sharp distal end (1376) and a lumen (1378) extending to an opening at the end (1376). The needle electrode assembly (1370) can be used to deliver fluid (e.g., irrigation fluid, therapeutic agent, etc.) to tissue via the lumen (1278). Alternatively, in some types, the lumen (1378) may be omitted entirely. When the second slider (1122) is advanced distally, the needle electrode assembly (1370) is driven to extend distally through the transverse plane defined by the annular electrode assembly (1140), as... XI. Examples of RF Ablation Instruments with Blunt Distal Tip Electrodes and Needle ElectrodesAs shown. The operator can prevent distal advancement of the second slider (1122) at any suitable location along the length of the body (1112) of the handle assembly (1110) to allow the needle electrode assembly (1370) to penetrate into the tissue to any suitable depth. The needle electrode assembly (1370) of this example also includes a plurality of conductive rings (1380, 1382, 1384, 1386) circumferentially positioned about an axis (1374) and axially spaced apart from each other. More specifically, the needle electrode assembly (1370) includes a first conductive ring (1380), a second conductive ring (1382) positioned distal to the first conductive ring (1380), a third conductive ring (1384) positioned distal to the second conductive ring (1382), and a fourth conductive ring (1386) positioned distal to the third conductive ring (1384). Although four conductive rings (1380, 1382, 1384, 1386) are shown, any other suitable number of conductive rings (1380, 1382, 1384, 1386) may be provided. Each conductive ring (1380, 1382, 1384, 1386) is coupled to one or more corresponding filaments, traces, and / or other conductive elements that electrically couple the conductive ring (1380, 1382, 1384, 1386) to the RF generator (1102), such that the conductive ring (1380, 1382, 1384, 1386) can be operated as a corresponding RF electrode. The needle electrode assembly (1370) is thus operable to apply RF energy to tissue in which the needle electrode assembly (1370) is disposed. The needle shaft (1374) may be formed of an electrically insulating material that prevents short circuits between the conductive rings (1380, 1382, 1384, 1386) (e.g., in the case where the conductive rings (1380, 1382, 1384, 1386) are configured to apply RF energy with different polarities from each other, as described below).

[0180] The annular electrode assembly (1140) and the needle electrode assembly (1370) are operable to apply bipolar RF energy to tissue. In some configurations, the annular electrode assembly (1140) provides RF energy of a first polarity, while the needle electrode assembly (1370) provides RF energy of a second polarity. As another example, the annular electrode assembly (1140) itself may be configured to apply bipolar RF energy to tissue. For example, the bow arm (1142) may be configured to provide RF energy of the first polarity, while the bow arm (1144) may be configured to provide RF energy of the second polarity. Some configurations of the needle electrode assembly (1370) may also be configured to apply bipolar RF energy to tissue. For example, the first and third conductive rings (1380, 1384) may be configured to provide RF energy of the first polarity, while the second and fourth conductive rings (1382, 1386) may be configured to provide RF energy of the second polarity, to provide alternating polarity in the axial direction along the needle axis (1374). In some configurations, the second and fourth conductive rings (1382, 1386) may be used as active electrodes, while the first and third conductive rings (1380, 1384) may be used as return electrodes. Other suitable methods for allocating polarity between the annular electrode assembly (1140) and the needle electrode assembly (1370) will be apparent to those skilled in the art, taking into account the teachings herein.

[0181] During use of the instrument (1300), the operator can use a pressing motion to press the annular electrode assembly (1140) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is adequately engaged by the annular electrode assembly (1140), the operator can then activate the RF generator (1102), where the arcuate arms (1142, 1144) of the annular electrode assembly (1140) serve as electrodes to apply bipolar RF energy to the tissue against which the annular electrode assembly (1140) is pressed. This provides relatively shallow ablation. In scenarios where the operator desires relatively deep ablation, the operator can advance the needle electrode assembly (1370) into the tissue and activate at least two conductive rings (1380, 1382, 1384, 1386) of the needle electrode assembly (1370) to apply RF energy to the tissue in which the needle electrode assembly (1370) is disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator may simultaneously activate at least one conductive ring (1380, 1382, 1384, 1386) of the needle electrode assembly (1370) and at least one bow-shaped arm (1142, 1144) of the ring electrode assembly (1140). By way of only one other example, the instrument (1300) can be used to perform pterygopalatine canal resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the ring electrode assembly (1140) and the needle electrode assembly (1370) can be used to perform turbinate resection. Other suitable ways in which the ring electrode assembly (1140) and / or the needle electrode assembly (1370) can be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0182] Although not shown, the device (1300) may also include one or more position sensors operable to generate signals indicating the position in three-dimensional space of the annular electrode assembly (1140) and / or the needle electrode assembly (1370) or some other component of the device (1300). Such position sensors may be directly integrated into the shaft assembly (1130) or otherwise integrated into the device. Alternatively, or in an alternative, such position sensors may be integrated into a guidewire or other component disposed within the shaft assembly (1130). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the annular electrode assembly (1140) and / or the needle electrode assembly (1370) or some other component of the device (1300) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such location sensing and navigation capabilities can be provided based on at least some of the teachings in the various references cited in this article.

[0183] Figures 25A-25B

[0184] Figures 25A-25B The distal portion of another example of a device (1400) that can be used to deliver RF energy to tissue is shown. For example, the device (1400) can be used to ablate nerves (e.g., the posterior nasal nerve (40)); ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)); or ablate, electroporate (e.g., to facilitate the absorption of therapeutic agents, etc.), or apply resistive heating to any other type of anatomical structure in a patient's head. Unless otherwise stated herein, the device (1400) is substantially similar to the device (1100). The device (1400) of this example includes a handle assembly (1110), a shaft assembly (1430), and a needle electrode assembly (1150). While the needle electrode assembly (1150) is shown in this example, the device (1400) may alternatively include any other suitable type of needle electrode or needle electrode assembly, such as the needle electrode assembly (1270) or needle electrode assembly (1370) discussed above. The instrument (1400) is coupled to an RF generator (1102) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (1170, 1172, 1464, 1466), as will be described in more detail below. XII. Examples of RF Ablation Instruments with Blunt Distal Tip Electrodes and Needle Electrodes and Visualization and Irrigation AssembliesThe transition illustrates the needle electrode assembly (1150) being driven from a proximal position to a distal position by the slider (1122). Of course, the shank assembly (1110) is merely an illustrative example; and the slider (1122) can be replaced by any other suitable type of structure to drive the translation of the needle electrode assembly (1150).

[0185] The shaft assembly (1430) of this example includes a rigid portion (1432), a flexible portion (1434) distal to the rigid portion (1432), and an open distal end (1436). A traction wire (not shown) is coupled to the flexible portion (1434) and to a deflection control knob (1116) of the shank assembly (1110) to impart longitudinal versatility to the shaft assembly (1430) as described above with respect to the shaft assembly (1130). The shaft assembly (1430) is also rotatable relative to the shank assembly (1110) about the longitudinal axis of the rigid portion (1432), as described above with respect to the shaft assembly (1130).

[0186] The shaft assembly (1430) of this example also includes a generally annular, blunt distal end electrode assembly (1460) positioned at the distal end (1436) of the opening. The distal end electrode assembly (1460) includes a wheel-shaped end body (1462) securely attached at the distal end (1436) of the opening to a flexible portion (1434). In some forms, the end body (1462) comprises plastic and / or some other electrically insulating material, while the flexible portion (1434) comprises a metallic material. The distal end electrode assembly (1460) of this example also includes a pair of arcuate conductive elements (1464, 1466) spaced at an angle to each other on the distally facing surface of the end body (1462). In this example, the conductive elements (1464, 1466) extend along a curve defined by a single radius. Thus, the conductive elements (1464, 1466) and the end body (1462) cooperate to define a generally circular shape. In some other forms, the conductive elements (1464, 1466) and the end body (1462) cooperate to define an elliptical, oval, square, triangular, or other non-circular shape. In this example, the generally circular shape defined by the conductive elements (1464, 1466) and the end body (1462) extends along a plane perpendicular to the longitudinal axis of the shaft assembly (1430). In some other forms, the generally circular shape (or other non-circular shape) defined by the conductive elements (1464, 1466) and the end body (1462) extends along a plane that is obliquely oriented or otherwise transverse to the longitudinal axis of the shaft assembly (1430).

[0187] In some configurations, the conductive elements (1464, 1466) may each comprise any one or more of conductive filaments, conductive plates, conductive films, and / or conductive coatings, and may be formed of any suitable material or combination of materials, including but not limited to metallic conductive materials such as copper, gold, steel, aluminum, silver, nitinol, etc., and / or non-metallic conductive materials such as conductive polymers, silicides, graphite, etc. The conductive elements (1464, 1466) may be attached to the end body (1462) in any suitable manner, including but not limited to attachment via adhesives, via vapor deposition, or other methods. Although two conductive elements (1464, 1466) are shown, any other suitable number of conductive elements (1464, 1466) may be provided. Each conductive element (1464, 1466) is coupled to one or more corresponding filaments, traces, and / or other conductive elements that electrically couple the conductive element (1464, 1466) to the RF generator (1102).

[0188] In this example, the conductive element (1464) is configured to apply RF energy with a first polarity; while the conductive element (1466) is configured to apply RF energy with a second polarity. The conductive elements (1464, 1466) thus function as electrodes operable to apply bipolar RF energy to tissue in contact with the conductive elements (1464, 1466). The end body (1462) may be formed of an electrically insulating material, such as a plastic material, which prevents short circuits between the conductive elements (1464, 1466) while mechanically fixing the conductive elements (1464, 1466) relative to each other in a spaced-apart relationship.

[0189] The distal end electrode assembly (1460) and the needle electrode assembly (1150) are operable to apply bipolar RF energy to tissue. For example, a conductive element (1466) can be used as an active electrode, while a conductive element (1464) can be used as a return electrode. In this type, a needle electrode (1172) can be used as a return electrode, while a needle electrode (1170) can be used as an active electrode. Thus, the needle electrode (1170) and the conductive element (1464) can cooperate with each other to provide bipolar RF energy to the tissue between the needle electrode (1170) and the conductive element (1464), which are typically positioned on a first lateral side relative to a barrier (1173). Similarly, the needle electrode (1172) and the conductive element (1466) can cooperate with each other to provide bipolar RF energy to the tissue between the needle electrode (1172) and the conductive element (1466), which are typically positioned on a second lateral side relative to the barrier (1173).

[0190] During use of the instrument (1400), the operator can press the distal end electrode assembly (1460) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is adequately engaged by the distal end electrode assembly (1460), the operator can then activate the RF generator (1102), where the conductive elements (1464, 1466) of the distal end electrode assembly (1460) serve as electrodes to apply bipolar RF energy to the tissue against which the distal end electrode assembly (1460) is pressed. This provides relatively shallow ablation. In scenarios where the operator desires relatively deep ablation, the operator can advance the needle electrode assembly (1150) into the tissue and activate the needle electrode assembly (1150) to apply RF energy to the tissue in which the needle electrode assembly (1150) is disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator may simultaneously activate at least one needle electrode (1170, 1172) of the needle electrode assembly (1150) and at least one conductive element (1464, 1466) of the distal terminal electrode assembly (1460). By way of only one other example, the instrument (1400) may be used to perform pterygopalatine canal resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the distal terminal electrode assembly (1460) and the needle electrode assembly (1150) may be used to perform turbinate resection. Other suitable ways in which the distal terminal electrode assembly (1460) and / or the needle electrode assembly (1150) may be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0191] Although not shown, the device (1400) may also include one or more position sensors operable to generate signals indicating the position in three-dimensional space of the distal end electrode assembly (1460) and / or the needle electrode assembly (1150) or some other component of the device (1400). Such position sensors may be directly integrated into the shaft assembly (1130) or otherwise integrated into the device. Alternatively, or in an alternative, such position sensors may be integrated into a guidewire or other component disposed within the shaft assembly (1130). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the distal end electrode assembly (1460) and / or the needle electrode assembly (1150) or some other component of the device (1400) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such location sensing and navigation capabilities can be provided based on at least some of the teachings in the various references cited in this article.

[0192] Figures 26-31 Figures 27-29

[0193] Figure 28 The distal portion of another example of an instrument (1500) for delivering RF energy to tissue is shown. For example, the instrument (1500) can be used to ablate nerves (e.g., the posterior nasal nerve (40)); ablate turbinate bones (e.g., any one of the turbinate bones (20, 22, 24)); or ablate, electroporate (e.g., to facilitate the absorption of therapeutic agents, etc.), or apply resistive heating to any other type of anatomical structure in the patient's head. Unless otherwise stated herein, the instrument (1500) is substantially similar to the instrument (1100). This example instrument (1500) includes a handle assembly (1110), a shaft assembly (1510), a distal electrode assembly (1530), and a visualization and flushing assembly (1700). The instrument (1500) is coupled to an RF generator (1102) operable to generate RF electrosurgical energy for delivery to tissue via electrodes (1540, 1550), as will be described in more detail below. Although the instrument (1500) is described in this example as including a handle assembly (1110), the handle assembly (1110) is merely an illustrative example; and the shaft assembly (1510) may be extended from any other suitable type of body.

[0194] The shaft assembly (1510) of this example includes a rigid proximal portion (1512), a flexible portion (1514) distal to the rigid proximal portion (1512), a rigid distal portion (1516) distal to the flexible portion (1514), and an open distal end (1518). A traction wire (not shown) is coupled to the flexible portion (1514) and to a deflection control knob (1116) of the shank assembly (1110) to impart longitudinal versatility to the shaft assembly (1510) as described above with respect to the shaft assembly (1130). The shaft assembly (1510) is also rotatable relative to the shank assembly (1110) about the longitudinal axis of the rigid proximal portion (1512), as described above with respect to the shaft assembly (1130).

[0195] The shaft assembly (1510) of this example also includes a generally annular, blunt distal end electrode assembly (1530) positioned at the distal end (1518) of the opening. The distal end electrode assembly (1530) includes a wheel-shaped end body (1520) securely attached at the distal end (1518) of the opening to a rigid distal portion (1516). In some forms, the end body (1520) comprises plastic and / or some other electrically insulating material, while the rigid distal portion (1516) comprises a metallic material. The distal end electrode assembly (1530) of this example also includes a pair of arcuate conductive elements (1540, 1550) spaced at an angle to each other on the distally facing surface of the end body (1520). In this example, the conductive elements (1540, 1550) extend along a curve defined by a single radius. Thus, the conductive elements (1540, 1550) and the end body (1520) cooperate to define a generally circular shape. In some other forms, the conductive elements (1540, 1550) and the end body (1520) cooperate to define an elliptical, oval, square, triangular, or other non-circular shape. In this example, the generally circular shape defined by the conductive elements (1540, 1550) and the end body (1520) extends along a plane perpendicular to the longitudinal axis of the shaft assembly (1510). In some other forms, the generally circular (or other non-circular) shape defined by the conductive elements (1540, 1550) and the end body (1520) extends along a plane that is obliquely oriented or otherwise transverse to the longitudinal axis of the shaft assembly (1510).

[0196] In some forms, the conductive elements (1540, 1550) may each comprise any one or more of conductive wires, conductive plates, conductive films, and / or conductive coatings, and may be formed of any suitable material or combination of materials, including but not limited to metallic conductive materials such as copper, gold, steel, aluminum, silver, nitinol, etc., and / or non-metallic conductive materials such as conductive polymers, silicides, graphite, etc. The conductive elements (1540, 1550) may be attached to the end body (1520) in any suitable manner, including but not limited to attachment via adhesives, via vapor deposition, or other methods. The conductive element (1540) of this example includes a distally facing circumferential extension (1542), an inwardly facing circumferential extension (1544), and an outwardly facing circumferential extension (1546). Similarly, the conductive element (1550) of this example includes a distally facing circumferential extension (1552), an inwardly facing circumferential extension (1554), and an outwardly facing circumferential extension (1556). Although two conductive elements (1540, 1550) are shown, any other suitable number of conductive elements (1540, 1550) may be provided. Each conductive element (1540, 1550) is coupled to one or more corresponding wires, traces and / or other conductive elements that electrically couple the conductive element (1540, 1550) to the RF generator (1102).

[0197] In some designs, the conductive elements (1540, 1550) are substantially flush with the outer surface of the end body (1520). In other designs, the conductive elements (1540, 1550) protrude from the outer surface of the end body (1520). In still other designs, the conductive elements (1540, 1550) are recessed from the outer surface of the end body (1520).

[0198] In this example, the conductive element (1540) is configured to apply RF energy with a first polarity; while the conductive element (1550) is configured to apply RF energy with a second polarity. The conductive elements (1540, 1550) thus function as electrodes capable of applying bipolar RF energy to tissue in contact with the conductive elements (1540, 1550). By way of example only, the conductive element (1540) can be used as an active electrode, and the conductive element (1550) can be used as a return electrode. The end body (1520) can be formed of an electrically insulating material such as a plastic material, which prevents short circuits between the conductive elements (1540, 1550) while mechanically fixing the conductive elements (1540, 1550) relative to each other in a spaced-out relationship. With this interval maintained by the end body (1520), a first angular gap (1532) is defined between the respective first free ends of the conductive elements (1540, 1550); while a second angular gap (1534) is defined between the respective second free ends of the conductive elements (1540, 1550). In this example, the gaps (1532, 1534) are offset from each other at an angle of approximately 180 degrees.

[0199] While the distal end electrode assembly (1530) in this example is operable to apply bipolar RF energy to tissue, other instruments can be used in conjunction with the device (1500) to ablate tissue. By way of example only, any of the various needle electrodes and / or other electrode assemblies described herein can be advanced along the working channel (1560) defined by the shaft assembly (1510) to ablate tissue. Such auxiliary ablation instruments can be used in conjunction with or in place of the distal end electrode assembly (1530).

[0200] During use of the instrument (1500), the operator can press the distal end electrode assembly (1530) against the tissue to which the operator wishes to ablate (or otherwise apply RF energy). Once the tissue is adequately engaged by the distal end electrode assembly (1530), the operator can then activate the RF generator (1102), where the conductive elements (1540, 1550) of the distal end electrode assembly (1530) serve as electrodes to apply bipolar RF energy to the tissue against which the distal end electrode assembly (1530) is pressed. This provides relatively shallow ablation. In scenarios where the operator desires relatively deep ablation, the operator can advance the needle electrode assembly into the tissue via the working channel (1560) and activate the needle electrode assembly to apply RF energy to the tissue in which the needle electrode assembly is disposed. In scenarios where the operator wishes to apply volumetric ablation, the operator may simultaneously activate at least one needle electrode (e.g., at least one needle electrode extending distally from the working channel (1560)) and at least one conductive element (1540, 1550) of the distal terminal electrode assembly (1530). By way of only one other example, the instrument (1500) may be used to perform pterygopalatine ganglion resection, posterior nasal nerve resection, turbinate resection, or any other suitable surgical procedure. In some cases, a combination of the distal terminal electrode assembly (1530) and other electrode assemblies (e.g., electrode assemblies disposed in the working channel (1560)) may be used to perform turbinate resection. Other suitable ways in which the distal terminal electrode assembly (1530) may be used to apply RF energy to tissue will be apparent to those skilled in the art, taking into account the teachings herein.

[0201] As described above, the instrument (1500) of this example also includes a visualization and flushing assembly (1700) disposed within the shaft assembly (1510). The visualization and flushing assembly (1700) is operable to provide visualization and flushing at a target tissue site distal to the distal end (1518) of the shaft assembly (1510). Figure 28 As best seen in the example, the visualization and flushing assembly (1700) includes a plate member (1710), a camera (1740), a pair of illumination elements (1720, 1722), and a pair of fluid conduits (1730, 1750). The camera (1740) may be in the form of a camera sized to fit within the shaft assembly (1510) while still allowing space for a working channel (1560) to extend along the shaft assembly (1510), thereby allowing additional instruments, suction, fluid, etc., to pass through the distal end (1518) of the opening adjacent to the camera (1740).

[0202] Illumination elements (1720, 1722) were constructed and operable to illuminate the field of view of the camera (1740). For example... Figure 27As best viewed, illumination element (1720) is positioned on one side of camera (1740), while illumination element (1722) is positioned on the other side of camera (1740). Although two illumination elements (1720, 1722) are used in this example, other types may employ only one illumination element (1720, 1722) or more than two illumination elements (1720, 1722). In this example, illumination elements (1720, 1722) include LEDs. In some other types, illumination elements (1720, 1722) include fiber optic components. For example, each illumination element (1720, 1722) may include a lens optically coupled to one or more corresponding optical fibers or fiber bundles. Such optical fibers or fiber bundles may extend along the shaft assembly (1510) and be optically coupled to a light source integrated into or otherwise provided in the shank assembly (1110) (or some other body from which the shaft assembly (1510) extends).

[0203] Regardless of the form the illumination elements (1720, 1722) take, in some types, the illumination elements (1720, 1722) are driven to emit light of one or more wavelengths selected to facilitate visualization of tissue state. For example, one or both of the illumination elements (1720, 1722) may be driven to emit light of a wavelength associated with the color of the tissue that has been adequately ablated. In some of this types, the light may provide visual emphasis to the operator to help the operator visually confirm the completion of ablation. Alternatively, or in an alternative, one or both of the illumination elements (1720, 1722) may be driven to emit light of a wavelength associated with the color of the tissue that should be ablated. As another example, some types offer selectable variations in the wavelength of the light emitted by one or both of the illumination elements (1720, 1722), such that the wavelength can be varied based on operator selection and / or based on the stage of the procedure. For example, one or more sensors (e.g., tissue impedance detectors, thermistors, etc.) can provide real-time feedback on the state of the target tissue; and this feedback can be used to automatically change the wavelength of the light emitted by one or both of the illumination elements (1720, 1722). Alternatively, the light emitted by one or both of the illumination elements (1720, 1722) may have any other suitable characteristics.

[0204] In this example, the conduits (1730, 1750) are laterally positioned to the side of the camera (1740). Specifically, conduit (1730) is positioned outward relative to the camera (1740) and inward relative to the illumination element (1720). Conduit (1750) is positioned outward relative to the camera (1740) and inward relative to the illumination element (1722). In some configurations, both conduits (1730, 1750) are in fluid communication with a liquid source (e.g., saline solution). In some other configurations, both conduits (1730, 1750) are in fluid communication with a suction source. In some other configurations, one conduit (1730 or 1750) is in fluid communication with a liquid source, while the other conduit (1750 or 1730) is in fluid communication with a suction source. In other configurations, one or both of the conduits (1730, 1750) may be in fluid communication with a valve assembly, wherein the valve assembly is coupled to a liquid source and a suction source. In this configuration, the valve assembly may be used to selectively couple one or both of the conduits (1730, 1750) to a liquid source or a suction source. Various suitable methods in which either or both of the conduits (1730, 1750) may be coupled to a liquid source and / or a suction source will be apparent to those skilled in the art in light of the teachings herein.

[0205] In a configuration where at least one of the catheters (1730, 1750) is in communication with a liquid source, such catheters (1730, 1750) can be used to deliver such liquid to the distal end (1742) of the camera (1740). By flushing the distal end (1742) with liquid, the catheters (1730, 1750) can be used to keep the distal end (1742) free of debris, thereby maintaining proper visualization via the camera (1740). When the distal electrode assembly (1530) is used to apply RF energy to tissue, the liquid discharged through one or both of the catheters (1730, 1750) can also help promote electrical continuity and reduce impedance at the target ablation site, thereby promoting proper ablation. Therefore, the liquid discharged through one or both of the catheters (1730, 1750) can simultaneously or sequentially promote visualization and ablation.

[0206] In a configuration where at least one of the catheters (1730, 1750) is in communication with an aspiration source, such catheters (1730, 1750) can be used to aspirate excess fluid (e.g., fluid drained via another catheter (1730)). Alternatively, aspiration may be applied via one or both of the catheters (1730, 1750) to aspirate fumes, vapors, and / or other inhalable results from the tissue ablation process. Such aspiration can further facilitate visualization during and after the ablation process by helping to clear the field of view of the camera (1740).

[0207] The plate member (1710) of this example includes a plate (1712) and a pair of laterally extending tabs (1714, 1718). The plate (1712) is positioned above the camera (1740) and thus serves to shield the camera (1740) from being snagged and potentially damaged by other instruments advancing along the working channel (1560). The tabs (1714, 1718) are positioned to correspond to the positions of the corresponding distal ends (1732, 1752) of the conduits (1730, 1750). Specifically, as in Figure 26 In optimal visibility, the tab (1714) is positioned precisely distal to the distal end (1732) of the catheter (1730); while the tab (1718) is positioned precisely distal to the distal end (1752) of the catheter (1750). Figure 30 As best seen, the tab (1714) is also positioned to leave a gap (1716) between the proximal side of the tab (1714) and the distal end (1732) of the conduit (1730). Although not shown, a similar gap may be left between the proximal side of the tab (1718) and the distal end (1752) of the conduit (1750). The size of these gaps (1716) may be set to allow fluid to escape from the distal end (1732, 1752); and to allow suction to be applied via the distal end (1732, 1752). However, the presence of the tabs (1714, 1718) may help to deflect the fluid discharged via the distal end (1732, 1752) toward the distal end (1742) of the camera (1740). In other words, when liquid is transported along either or both of the conduits (1730, 1750) and such liquid exits the distal ends (1732, 1752) of such conduits (1730, 1750), the corresponding tabs (1714, 1718) deflect the discharged liquid toward the distal end (1742) of the camera (1740) and thereby help flush debris away from the camera (1740). In some other forms, the tabs (1714, 1718) are omitted. The plate member (1710) is merely optional.

[0208] In addition to the foregoing, at least a portion of the visualization and rinsing assembly (1700) and / or other components of the instrument (1500) may be constructed and operated in accordance with at least some of the teachings of the following U.S. patent application: priority to U.S. Provisional Patent Application 63 / 037,640, filed June 11, 2020, entitled “ENT Guide with Advanceable Instrument and Advanceable Endoscope Shaft,” the disclosure of which is incorporated herein by reference in its entirety.

[0209] In some configurations, the instrument (1500) is operable to provide relative translation between the distal end (1518) of the shaft assembly (1510) and the visualization and rinsing assembly (1700). In some configurations of this type, the distal end (1518) of the shaft assembly (1510) is operable to translate longitudinally relative to the handle assembly (1110) or some other body extending therefrom from the shaft assembly (1510); while the visualization and rinsing assembly (1700) remains longitudinally stationary relative to the handle assembly (1110) or some other body extending therefrom from the shaft assembly (1510). In some configurations of this type, the visualization and rinsing assembly (1700) is operable to translate longitudinally relative to the handle assembly (1110) or some other body extending therefrom from the shaft assembly (1510); while the distal end (1518) of the shaft assembly (1510) remains longitudinally stationary relative to the handle assembly (1110) or some other body extending therefrom from the shaft assembly (1510). In either case, the relative longitudinal movement between the distal end (1518) of the shaft assembly (1510) and the visualization and flushing assembly (1700) allows the operator to more easily visualize the tissue area as the ablation target before ablation occurs, visualize the target tissue area during ablation, and / or visualize the target tissue area after ablation.

[0210] In a configuration where relative longitudinal movement is permitted between the distal end (1518) of the shaft assembly (1510) and the visualization and rinsing assembly (1700), the operator may wish to position the distal end (1518) of the shaft assembly (1510) and the visualization and rinsing assembly (1700) at approximately the same longitudinal position, such as... Figure 31 As shown, the operator simultaneously manipulates the distal end (1518) toward the target tissue area. Once the operator reaches the target tissue area and presses the distal end electrode assembly (1530) against the target tissue, the operator may wish to retract the visualization and flushing assembly (1700) proximally relative to the distal end (1518) of the shaft assembly (1510), as... ​ As shown, RF energy is simultaneously applied to the tissue via the distal end electrode assembly (1530). Once the operator deems ablation complete, the operator may wish to advance the visualization and flushing assembly (1700) distally relative to the distal end (1518) of the shaft assembly (1510), as... ​As shown, to better visualize the ablated tissue and confirm their satisfaction with the ablation. Referring to the teachings herein, other suitable methods by which an operator may wish to utilize the instrument (1500) with the visualization and flushing assembly (1700) at different longitudinal positions relative to the distal end (1518) of the shaft assembly (1510) will be apparent to those skilled in the art. Similarly, referring to the teachings herein, various suitable actuators and mechanisms, etc., that can be used to provide relative longitudinal movement between the distal end (1518) of the shaft assembly (1510) and the visualization and flushing assembly (1700) will be apparent to those skilled in the art.

[0211] As another example only, the device (1500) may be constructed and operable such that the conductive elements (1540, 1550) are operable to translate longitudinally relative to the end body (1520).

[0212] In a configuration where the visualization and rinsing assembly (1700) provides longitudinal movement relative to the handle assembly (1110) (or relative to any body from which the shaft assembly (1510) extends), it may be necessary to consider such movement in or relative to the filaments, traces, or other conductive paths that couple the camera (1740) to the image processor that is also coupled to the handle assembly (1110) (or some other body from which the shaft assembly (1510) extends). Similarly, in a configuration where the illumination elements (1720, 1722) include LEDs, it may also be necessary to consider longitudinal movement in or relative to the filaments, traces, or other conductive paths that couple the LEDs of the illumination elements (1720, 1722) to the power supply that is also coupled to the handle assembly (1110) (or some other body from which the shaft assembly (1510) extends). Even in scenarios where the visualization and rinsing assembly (1700) is longitudinally fixed within the shaft assembly (1510), it may still be necessary to consider longitudinal movement in or relative to the filaments, traces, or other conductive paths that couple the electrical components of the visualization and rinsing assembly (1700) to other components coupled to the handle assembly (1110) (or some other body from which the shaft assembly (1510) extends). For example, such longitudinal movement can occur when the flexible portion (1514) is laterally deflected relative to the longitudinal axis of the rigid portion (1512), as this deflection can lengthen or shorten the effective length between the visualization and rinsing assembly (1700) and the handle assembly (1110) (or some other body from which the shaft assembly (1510) extends). By way of example only, the electrical path between the electrical components of the visualization and rinsing assembly (1700) and other components coupled to the handle assembly (1110) (or some other body from which the shaft assembly (1510) extends) may include a sliding contact, a maintenance ring, a stretchable feature, or other features configured to maintain electrical continuity while allowing relative longitudinal movement between components of the circuit. By way of another example only, a stretchable circuit component may include a stretchable flexible circuit board on which one or more traces are formed, wherein one or more traces have a zigzag or wave shape, which allows the traces to extend effectively when the stretchable flexible circuit board is stretched longitudinally.

[0213] Although not shown, the device (1500) may also include one or more position sensors operable to generate signals indicating the position in three-dimensional space of the distal end electrode assembly (1530) and / or the visualization and flushing assembly (1700) or some other component of the device (1500). Such position sensors may be directly integrated into the shaft assembly (1510) or otherwise integrated into the device. Alternatively, or in an alternative, such position sensors may be integrated into a guidewire or other component disposed within the shaft assembly (1510). Such position sensors may take the form of one or more coils that generate signals in response to the presence of an alternating magnetic field. The position data generated from such position signals can be processed by a system that provides the operator with visual indications to display in real time the position of the distal end electrode assembly (1530) and / or the visualization and flushing assembly (1700) or some other component of the device (1500) within the patient's body. Such visual indications may be provided as an overlay on one or more preoperative images (e.g., CT scans) of the patient's anatomy. Such location sensing and navigation capabilities can be provided based on at least some of the teachings in the various references cited in this article.

[0214] XIII. Example of an RF ablation instrument with a blunt distal tip electrode and a non-conducting needle

[0215] FIG. 32 The distal portion of another example of a device (1800) that can be used to deliver RF energy to tissue is shown. Unless otherwise stated herein, the device (1800) is substantially similar to the device (1100). The device (1800) of this example includes a shank assembly (1110), a shaft assembly (1830), and a non-conductive (e.g., insulating) needle (1870). FIG. 32 A needle (1870) is shown driven from a proximal position to a distal position by a slider (1122). By way of example only, and with reference to the teachings herein, the needle (1870) may be used to perform a core biopsy, deliver a therapeutic agent, or perform any other suitable function, as will be apparent to those skilled in the art. The needle (1870) may include a sharp distal end (e.g., a wheel-shaped blade) (1872) to facilitate penetration of the needle (1870) into tissue.

[0216] The shaft assembly (1830) of this example includes a rigid portion (1832), a flexible portion (1834) distal to the rigid portion (1832), and an open distal end (1836). The shaft assembly (1830) of this example also includes a generally annular, blunt distal end electrode assembly (1860) positioned at the open distal end (1836). The distal end electrode assembly (1860) includes a wheel-shaped end body (1862) securely attached to the flexible portion (1834) at the open distal end (1836). The distal end electrode assembly (1860) of this example also includes a pair of arcuate conductive elements (1864, 1866) spaced at an angle to each other on the distally facing surface of the end body (1862). In some configurations, the conductive elements (1864, 1866) are configured to apply RF energy with a first polarity and a second polarity, respectively, to act as electrodes operable to apply bipolar RF energy to tissue in contact with the conductive elements (1864, 1866).

[0217] XIV. Example of an RF ablation instrument with a blunt distal tip electrode and a splayed needle electrode

[0218] FIG. 33 The distal portion of another example of a device (1900) that can be used to deliver RF energy to tissue is shown. Unless otherwise stated herein, the device (1900) is substantially similar to the device (1100). The device (1900) of this example includes a shank assembly (1110), a shaft assembly (1830), and a needle-shaped electrode assembly (1950) that can extend from and retract into a non-conductive needle (1870). FIG. 33 A needle electrode assembly (1950) driven from a proximal position to a distal position by a slider (1122) is shown. The needle electrode assembly (1950) of this example includes a pair of straight needle electrodes (1970, 1972), which are longitudinally fixed relative to each other by a barrier (1973) and configured such that when the straight needle electrodes (1970, 1972) are as FIG. 33 As shown, when positioned distally, it extends along or parallel to the longitudinal axis of the shaft assembly (1830). The needle electrode assembly (1950) of this example also includes a plurality of tilted needle electrodes (1981, 1983, 1985, 1987), when the tilted needle electrodes (1981, 1983, 1985, 1987) are positioned as follows: FIG. 33When positioned distally as shown, these tilted needle electrodes are resiliently biased to flare outward relative to the longitudinal axis of the shaft assembly (1830). Such biasing and / or flaring of the tilted needle electrodes (1981, 1983, 1985, 1987) may be provided, by way of example only, according to at least some of the teachings of the following U.S. patent application: U.S. Provisional Patent Application 63 / 067,495, filed August 19, 2020, entitled “ENT Ablation Instrument with Electrode Loop,” the disclosure of which is incorporated herein by reference in its entirety.

[0219] In the example shown, the proximal portions of the needle electrodes (1970, 1972, 1981, 1983, 1985, 1987) are fixed to each other within a collar (1989). In some configurations, the needle electrodes (1970, 1981, 1983) are configured to apply RF energy with a first polarity, and the needle electrodes (1972, 1985, 1987) are configured to apply RF energy with a second polarity, serving as electrodes operable to apply bipolar RF energy to tissue penetrated by the needle electrodes (1970, 1972, 1981, 1983, 1985, 1987) (e.g., by cooperating with each other and / or with conductive elements (1864, 1866)).

[0220] XV. Example of an RF ablation instrument with a blunt distal tip electrode, a splayed needle electrode, and a visualization and irrigation assembly FIG. 34

[0221] FIG. 34 The distal portion of another example of a device (2000) that can be used to deliver RF energy to tissue is shown. Unless otherwise stated herein, the device (2000) is substantially similar to the device (1100). This example device (2000) includes a shank assembly (1110), a shaft assembly (1830), a needle electrode assembly (1950) that can extend from and retract into a non-conductive needle (1870), and a visualization and flushing assembly (1700). FIG. 34 The needle electrode assembly (1950) is shown being driven from the proximal position to the distal position by the slider (1122). FIG. 33 The needle electrode assembly shown (1950) can be as follows FIG. 34 It is constructed and operated in the same manner as the needle electrode assembly (1950) described above. FIG. 26 to FIG. 31 The visualization and rinsing components (1700) shown can be used as follows XVI. Example of an RF ablation instrument with a blunt distal tip electrode, a dilating assembly, and a visualization and irrigation assemblyThe visualization and rinsing assembly (1700) is constructed and operated as shown above. In a form in which the visualization and rinsing assembly (1700) is translatable relative to the rest of the shaft assembly (1830), the visualization and rinsing assembly (1700) may be translatable independently of the needle electrode assembly (1950) relative to the rest of the shaft assembly (1830).

[0222] FIG. 35 FIG. 35

[0223] XVII. Example of an RF ablation instrument with a blunt distal tip electrode and a dilating assembly The distal portion of another example of a device (2100) that can be used to deliver RF energy to tissue is shown. Unless otherwise stated herein, the device (2100) is substantially similar to the device (1100). The device (2100) of this example includes a handle assembly (1110), a shaft assembly (1830), an expansion assembly (2200), and a visualization and flushing assembly (1700). FIG. 36 An expansion assembly (2200) driven from a proximal position to a distal position by a slider (1122) is shown. The expansion assembly (2200) of this example includes an elongated shaft (2202), an inflatable dilator in the form of an inflatable balloon (2204), and a blunt distal end electrode (2206). The balloon (2204) is depicted as being in a contracted state, but the balloon (2204) can be inflated to dilate various anatomical passages within the ear, nose, or pharynx (e.g., the Eustachian tube, paranasal sinus ostia, etc.). In some configurations, the distal end electrode (2206) is configured to apply RF energy in a first polarity to act as an electrode operable to apply monopolar RF energy to tissue in contact with the distal end electrode (2206) and / or operable to apply bipolar RF energy to tissue in contact with the distal end electrode (2206) (e.g., through cooperation with conductive elements (1864, 1866)). In a form in which the visualization and rinsing component (1700) is able to translate relative to the rest of the shaft assembly (1830), the visualization and rinsing component (1700) may be able to translate independently of the expansion component (2200) relative to the rest of the shaft assembly (1830).

[0224] FIG. 36

[0225] FIG. 36 The distal portion of another example of a device (2300) that can be used to deliver RF energy to tissue is shown. Unless otherwise stated herein, the device (1300) is substantially similar to the device (1100). The device (2300) of this example includes a handle assembly (1110), a shaft assembly (1830), and an expansion assembly (2200). FIG. 35An expansion assembly (2200) is shown that has been driven from a proximal position to a distal position by a slider (1122). FIG. 36 The device (2300) shown may be able to, as XVIII. Example of an RF ablation instrument with a blunt distal tip electrode, a biopsy assembly, and a visualization and irrigation assembly The device shown is constructed and operated in the same manner as the instrument (2100) described above, except that it is constructed and operated in the same manner as the one described above. FIG. 37 The visualization and rinsing components (1700) are omitted from the instrument (2300).

[0226] FIG. 37 XIX. Example method of ablating the posterior nasal nerve

[0227] FIG. 38A to FIG. 38B The distal portion of another example of a device (2400) that can be used to deliver RF energy to tissue is shown. Unless otherwise stated herein, the device (2400) is substantially similar to the device (1100). The device (2400) of this example includes a handle assembly (1110), a shaft assembly (1830), a biopsy assembly (2500), and a visualization and flushing assembly (1700). FIG. 38A A biopsy assembly (2500) driven from a proximal position to a distal position by a slider (1122) is shown. The biopsy assembly (2500) of this example includes an elongated shaft (2502) and a pair of opposing distal biopsy forceps (2504, 2506) pivotally coupled to the shaft (2502) for selectively clamping and capturing tissue therebetween. In a form in which the visualization and flushing assembly (1700) is translatable relative to the remainder of the shaft assembly (1830), the visualization and flushing assembly (1700) may be translatable independently of the biopsy assembly (2500) relative to the remainder of the shaft assembly (1830).

[0228] FIG. 38B

[0229] The exemplary features of the instrument (1100, 1200, 1300, 1400, 1500, 1800, 1900, 2000, 2100, 2300, 2400) have been described above. Now, in conjunction with... XX. Example combinationsAn exemplary method for performing ablation on the posterior nasal nerve (40) of a patient using an instrument (1100) is described. While the exemplary method is shown to be performed using the instrument (1100), it should be understood that similar methods can be performed using instruments (1200, 1300, 1400, 1500, 1800, 1900, 2000, 2100, 2300, 2400). Additionally, while the instrument (1100) for treating the posterior nasal nerve is shown and described, it should be understood that the instrument (1100) can be used in a variety of other surgical applications for ablation of other nerves or anatomical structures within the nasal cavity (10), or for ablation of tissue in a variety of other anatomical regions of the patient. For example, the teachings herein may be combined with at least some of the teachings in U.S. Patent Publication 2019 / 0374280 entitled “Apparatus and Method for Performing Vidian Neurectomy Procedure”, published on December 12, 2019, the disclosure of which is incorporated herein by reference in its entirety; and / or with at least some of the teachings in U.S. Patent Application 63 / 080,066 entitled “ENT Instrument with Expandable Ablation Feature”, published on September 18, 2020, the disclosure of which is incorporated herein by reference in its entirety.

[0230] like Example 1 As shown, the distal end of the instrument (1100) is inserted into the nasal cavity (10) and toward the posterior ends of the inferior and middle turbinates (20, 22), which can be performed, for example, under visualization provided by an endoscope (not shown). Upon reaching the target site on the nasal wall (18) where the target portion of the posterior nasal nerve (40) is located, the operator advances the sliders (1120, 1122) distally, thereby extending the annular electrode assembly (1140) and the needle electrode assembly (1150), as shown. Example 2 As shown, the bow-shaped arms (1142, 1144) are pushed against the surface of the nasal wall (18) and the needle electrodes (1170, 1172) are inserted through the contact points of the bow-shaped arms (1142, 1144) to position the bow-shaped arms (1142, 1144) and the needle electrodes (1170, 1172) in electrical contact with the target portion of the posterior nasal nerve (40). Then, the ring electrode assembly (1140) and the needle electrode assembly (1150) are energized individually or together with bipolar RF energy to ablate the target portion of the posterior nasal nerve (40) via superficial, deep and / or volumetric ablation.

[0231] Example 3

[0232] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0233] Example 4

[0234] An apparatus comprising: (a) a shaft having a distal end and defining a longitudinal axis; (b) a first electrode assembly located at the distal end of the shaft, the first electrode assembly including a first member forming an annular shape, the first member of the first electrode assembly being operable to apply RF energy to tissue; and (c) a second electrode assembly located at the distal end of the shaft, the second electrode assembly including a first needle having a sharp tip operable to penetrate tissue, the first needle being further operable to apply RF energy to tissue, the first needle being further configured to project distally through or laterally relative to the first member of the first electrode assembly.

[0235] Example 5

[0236] According to the device described in Embodiment 1, the first component and the first needle of the first electrode assembly are operable to cooperatively apply bipolar RF energy to tissue.

[0237] Example 6

[0238] According to any one or more of the devices described in Embodiments 1 to 2, the first electrode assembly further includes a second member forming an annular shape, the second member of the first electrode assembly being operable to apply RF energy to tissue.

[0239] Example 7

[0240] According to the device described in Embodiment 3, the first and second components of the first electrode assembly are operable to cooperatively apply bipolar RF energy to tissue.

[0241] Example 8

[0242] According to any one or more of the devices described in Embodiments 1 to 4, the second electrode assembly further includes a second needle having a sharp tip, the second needle being operable to penetrate tissue, the second needle being further operable to apply RF energy to tissue, and the second needle being further configured to project distally through or laterally relative to the first member of the first electrode assembly.

[0243] Example 9

[0244] According to the device described in Embodiment 5, the first and second needles of the second electrode assembly are operable to cooperatively apply bipolar RF energy to the tissue.

[0245] Example 10

[0246] According to the device described in any one or more of Embodiments 5 to 6, the first needle includes a straight needle aligned with the longitudinal axis of the shaft, and the second needle extends obliquely relative to the longitudinal axis of the shaft.

[0247] Example 11

[0248] According to the device of embodiment 7, the second needle extends on a curve diverging from the longitudinal axis away from the axis.

[0249] Example 12

[0250] According to the device described in Embodiment 8, the second needle is elastically biased to extend along the curve.

[0251] Example 13

[0252] According to the device of any one or more of embodiments 7 to 9, the second electrode assembly further includes a plurality of tilting needles extending obliquely relative to the longitudinal axis of the shaft, the plurality of tilting needles being angularly spaced from each other about the longitudinal axis of the shaft.

[0253] Example 14

[0254] According to the device of embodiment 10, the shaft defines a distal opening and a plurality of lateral openings, the first needle being configured to pass through the distal opening and the plurality of needles being configured to pass through the lateral openings.

[0255] Example 15

[0256] According to any one or more of the devices described in Embodiments 1 to 9, the second electrode assembly further includes a plurality of tilting needles extending obliquely relative to the longitudinal axis of the shaft, the plurality of tilting needles being angularly spaced from each other about the longitudinal axis of the shaft, the shaft defining a distal opening, the first needle and the plurality of tilting needles being configured to pass through the distal opening.

[0257] Example 16

[0258] The device according to any one or more of embodiments 1 to 12 further includes a sleeve operable to translate relative to the axis.

[0259] Example 17

[0260] According to the device of embodiment 13, the sheath is operable to selectively cover or expose at least a portion of the first electrode assembly.

[0261] Example 18

[0262] According to the device described in any one of Embodiments 11 to 14, the sheath is operable to selectively cover or expose at least a portion of the second electrode assembly.

[0263] Example 19

[0264] According to any one or more of the devices described in Embodiments 1 to 15, the first pin is slidably disposed relative to the shaft.

[0265] Example 20

[0266] According to the device of embodiment 16, the first needle is operable to selectively switch between a proximal position and a distal position, wherein the first needle is retracted in the shaft in the proximal position and the first needle is advanced distally relative to the shaft in the distal position.

[0267] Example 21

[0268] The device according to any one or more of embodiments 14 to 17 further includes a shank assembly including a needle actuator operable to drive translation of the first needle relative to the axis.

[0269] Example 22

[0270] According to any one or more of the devices described in Embodiments 1 to 18, the shaft includes a bendable segment.

[0271] Example 23 .

[0272] According to the device described in Embodiment 19, the flexible segment is extendable.

[0273] Example 24

[0274] According to the device described in Embodiment 19, the flexible segment is capable of steering.

[0275] Example 25

[0276] The device according to embodiment 21 further includes a handle assembly, the handle assembly including a steering actuator operable to drive steering of the bendable segment of the shaft.

[0277] Example 26

[0278] According to any one or more of the devices described in Embodiments 1 to 22, the first member of the first electrode assembly is coaxially aligned with the longitudinal axis of the shaft.

[0279] Example 27

[0280] According to the device of embodiment 23, the first component of the first electrode assembly includes an annular electrode coaxially disposed around the longitudinal axis of the shaft.

[0281] Example 28

[0282] According to the device of embodiment 24, the first electrode assembly further includes a plurality of annular electrodes coaxially disposed around the longitudinal axis of the shaft.

[0283] Example 29

[0284] According to the device described in Example 25, the annular electrode is operable to cooperatively apply bipolar RF energy to tissue.

[0285] Example 30

[0286] According to any one or more of the devices described in Embodiments 1 to 26, the second electrode assembly further includes a second needle.

[0287] Example 31

[0288] The device according to any one or more of embodiments 1 to 27 further includes a blunt end electrode at the distal end of the shaft.

[0289] Example 32

[0290] According to the device of embodiment 28, the blunt end electrode and the first component of the first electrode assembly are operable to cooperatively apply bipolar RF energy to the tissue.

[0291] Example 33

[0292] According to any one or more of the devices described in Examples 28 to 29, the blunt end electrode and the first needle are operable to cooperatively apply bipolar RF energy to the tissue.

[0293] Example 34

[0294] According to any one or more of the devices described in Embodiments 28 to 30, the blunt end electrode defines an opening, and the first needle is configured to pass through the opening of the blunt end electrode.

[0295] Example 35

[0296] According to any one or more of the devices described in Embodiments 1 to 31, the shaft terminates at a distal end, and the first member of the first electrode assembly is positioned proximal to the distal end of the shaft.

[0297] Example 36

[0298] According to any one or more of the devices described in Embodiments 1 to 31, the shaft terminates at a distal end, and the first member of the first electrode assembly is positioned distal to the distal end of the shaft.

[0299] Example 37

[0300] According to any one or more of the devices described in Embodiments 1 to 33, the annular shape extends along a plane, and the plane of the annular shape is laterally oriented relative to the longitudinal axis of the shaft.

[0301] Example 38

[0302] According to the device of embodiment 34, the plane of the annular shape is oriented perpendicularly to the longitudinal axis of the shaft.

[0303] Example 39

[0304] According to any one or more of the devices described in Embodiments 1 to 33, the annular shape extends along a plane, and the plane of the annular shape is oriented parallel to the longitudinal axis of the shaft.

[0305] Example 40

[0306] According to any one or more of the devices described in Embodiments 1 to 36, the first member of the first electrode assembly is elastically biased to form the annular shape.

[0307] Example 41

[0308] According to any one or more of the devices described in Embodiments 1 to 37, the first component of the first electrode assembly includes: (i) a first arcuate segment and (ii) a second arcuate segment, the second arcuate segment being angularly spaced from the first arcuate segment.

[0309] Example 42

[0310] According to the device of embodiment 38, the first component of the first electrode assembly further includes an insulating component angledly inserted between the first arcuate segment and the second arcuate segment.

[0311] Example 43

[0312] According to the device described in any one or more of Embodiments 38 to 39, the first arcuate segment and the second arcuate segment are operable to cooperatively apply bipolar RF energy to the tissue.

[0313] Example 44

[0314] According to any one or more of the devices described in Embodiments 1 to 40, the annular shape defines a generally circular ring.

[0315] Example 45

[0316] According to any one or more of the devices described in Embodiments 1 to 40, the annular shape defines a generally rectangular ring.

[0317] Example 46

[0318] According to any one or more of the devices described in Embodiments 1 to 40, the annular shape defines a generally elliptical ring.

[0319] Example 47

[0320] According to any one or more of the devices described in Embodiments 1 to 43, the first electrode assembly further includes a second component forming an annular shape.

[0321] Example 48

[0322] According to the device of embodiment 44, the ring shape of the second component is smaller than the ring shape of the first component.

[0323] Example 49

[0324] According to the device of embodiment 45, the annular shape of the second component is nested within the annular shape of the first component.

[0325] Example 50

[0326] According to any one or more of the devices described in Examples 44 to 46, the first and second components of the first electrode assembly are operable to cooperatively apply bipolar RF energy to tissue.

[0327] Example 51

[0328] According to any one or more of the devices described in embodiments 44 to 47, the first needle extends obliquely outward from within the annular shape of the second member relative to the longitudinal axis of the shaft.

[0329] Example 52

[0330] According to the device of embodiment 48, the first needle extends obliquely into a first region laterally positioned relative to the first electrode assembly, a second region is defined on the side of the first electrode assembly opposite to the first region, and a portion of the first electrode assembly facing the second region comprises an electrically insulating material.

[0331] Example 53

[0332] According to any one or more of embodiments 1 to 49, the annular shape extends along a plane parallel to the longitudinal axis of the shaft, and the first needle extends obliquely relative to the plane of the annular shape.

[0333] Example 54

[0334] According to the device of embodiment 50, the first needle extends obliquely from the inner region defined by the annular shape.

[0335] Example 55

[0336] According to the device of embodiment 51, the second electrode assembly further includes a second needle that extends obliquely from an inner region defined by the annular shape.

[0337] Example 56

[0338] According to the device of embodiment 52, the second needle is positioned distally relative to the first needle.

[0339] Example 57

[0340] According to any one or more of the devices described in Examples 52 to 53, the first needle and the second needle are operable to cooperatively apply bipolar RF energy to tissue.

[0341] Example 58

[0342] According to any one or more of embodiments 1 to 54, in the device, the annular shape of the first member of the first electrode assembly extends along a plane laterally oriented relative to the longitudinal axis of the shaft, and the first needle passes through the plane.

[0343] Example 59

[0344] According to the device of embodiment 55, the second electrode assembly further includes a second needle that passes through the plane.

[0345] Example 60

[0346] According to the device of embodiment 56, the first needle and the second needle are laterally spaced apart from each other.

[0347] Example 61

[0348] According to any one or more of the devices described in Examples 55 to 57, the first needle and the second needle are operable to cooperatively apply bipolar RF energy to tissue.

[0349] Example 62

[0350] According to any one or more of the devices described in Embodiments 1 to 58, the second electrode assembly further includes: (i) an electrode shaft coaxially disposed around the first needle, and (ii) an annular electrode positioned on the electrode shaft, the annular electrode being positioned distally relative to the distal end of the shaft.

[0351] Example 63

[0352] According to the device of embodiment 59, the annular electrode is further positioned distally relative to the first electrode assembly.

[0353] Example 64

[0354] According to any one or more of the devices described in Examples 59 to 60, the first needle and the annular electrode are operable to cooperatively apply bipolar RF energy to the tissue.

[0355] Example 65

[0356] According to any one or more of the devices described in Embodiments 1 to 61, the first needle defines a lumen and is operable to dispense fluid distally via the lumen.

[0357] Example 66

[0358] The device according to any one or more of Embodiments 1 to 62 further includes a position sensor configured to generate a signal indicating the position of one or both of the first electrode assembly or the second electrode assembly in three-dimensional space.

[0359] Example 67

[0360] According to any one or more of the devices described in Embodiments 1 to 63, the shaft, the first electrode assembly, and the second electrode assembly are configured to be fitted into the nasal cavity of a patient.

[0361] Example 68

[0362] An apparatus comprising: (a) a shaft having a distal end and defining a longitudinal axis; (b) a first annular electrode positioned on the shaft, the first annular electrode being coaxially positioned about the longitudinal axis and proximal to the distal end of the shaft; and (c) a first needle-shaped electrode located at the distal end of the shaft, the first needle-shaped electrode having a sharp tip, the first needle-shaped electrode being operable to penetrate tissue, and the first annular electrode and the first needle-shaped electrode being operable to cooperatively apply bipolar RF energy to tissue.

[0363] Example 69

[0364] According to the device of embodiment 65, the first needle electrode extends distally along the longitudinal axis.

[0365] Example 70

[0366] The device according to any one or more of embodiments 65 to 66 further includes a second annular electrode, the second annular electrode being coaxially positioned about the longitudinal axis, the second annular electrode being proximal to the distal end of the axis.

[0367] Example 71

[0368] According to the device described in Embodiment 67, the first annular electrode and the second annular electrode are operable to cooperatively apply bipolar RF energy to tissue.

[0369] Example 72

[0370] According to any one or more of the devices described in Embodiments 65 to 68, the first needle electrode extends obliquely relative to the longitudinal axis.

[0371] Example 73

[0372] The device according to any one or more of embodiments 65 to 69 further includes a second needle electrode that extends obliquely relative to the longitudinal axis.

[0373] Example 74

[0374] The device according to any one or more of embodiments 65 to 70 further includes a sheath slidably disposed around the axis.

[0375] Example 75

[0376] According to the device of embodiment 71, the sheath is operable to selectively cover and expose the first annular electrode.

[0377] Example 76

[0378] According to any one or more of the devices described in embodiments 65 to 72, the first needle electrode is slidably disposed relative to the axis.

[0379] Example 77

[0380] The device according to embodiment 73 further includes an actuator operable to drive the first needle electrode to translate relative to the axis.

[0381] Example 78

[0382] The device according to any one or more of embodiments 65 to 72 further includes an end electrode located at the distal end of the shaft.

[0383] Example 79

[0384] According to the device of embodiment 75, the first annular electrode and the terminal electrode are operable to cooperatively apply bipolar RF energy to the tissue.

[0385] Example 80

[0386] According to any one or more of the devices described in Examples 75 to 76, the first needle electrode and the terminal electrode are operable to cooperatively apply bipolar RF energy to the tissue.

[0387] Example 81

[0388] An apparatus comprising: (a) a shaft having a distal end and defining a longitudinal axis, the distal end terminating at a distal terminal; (b) an annular electrode assembly located at the distal end of the shaft, the annular electrode forming an annular shape extending along a plane laterally oriented relative to the longitudinal axis of the shaft, the annular electrode assembly being positioned distally relative to the distal terminal of the shaft; and (c) a first needle electrode located at the distal end of the shaft, the first needle electrode having a sharp tip, the first needle electrode being operable to penetrate tissue, the annular electrode assembly and the first needle electrode each being operable to apply RF energy to tissue.

[0389] Example 82

[0390] According to the device of embodiment 78, the annular electrode assembly and the first needle electrode are operable to cooperatively apply bipolar RF energy to the tissue.

[0391] Example 83

[0392] According to any one or more of the devices described in Embodiments 78 to 79, the annular electrode assembly includes: (i) a first arcuate segment and (ii) a second arcuate segment, the second arcuate segment being angularly spaced from the first arcuate segment.

[0393] Example 84

[0394] According to the device of embodiment 80, the annular electrode assembly further includes an insulating member angled between the first arcuate segment and the second arcuate segment.

[0395] Example 85

[0396] According to the device described in any one or more of Embodiments 80 to 81, the first arcuate segment and the second arcuate segment are operable to cooperatively apply bipolar RF energy to the tissue.

[0397] Example 86

[0398] According to any one or more of the devices described in embodiments 78 to 82, the annular shape defines a generally circular ring.

[0399] Example 87

[0400] According to the device described in any one of embodiments 78 to 83, the first needle electrode is configured to pass through the plane of the annular shape such that the sharp end is positioned distally relative to the annular shape.

[0401] Example 88

[0402] The device according to any one or more of embodiments 78 to 84 further includes a plurality of needle electrodes at the distal end of the shaft, the plurality of needle electrodes being operable to cooperatively apply bipolar RF energy to the tissue.

[0403] Example 89

[0404] According to the device of embodiment 85, at least some of the plurality of needle electrodes are configured to extend obliquely relative to the longitudinal axis of the shaft.

[0405] Example 90

[0406] The device according to any one or more of embodiments 78 to 86 further includes a second needle-shaped electrode at the distal end of the shaft, the second needle having a sharp tip, the second needle-shaped electrode being operable to penetrate tissue.

[0407] Example 91

[0408] According to the device described in Example 87, the first needle electrode and the second needle electrode are operable to cooperatively apply bipolar RF energy to tissue.

[0409] Example 92

[0410] According to the device described in any one or more of Embodiments 87 to 88, the first needle electrode and the second needle electrode are laterally spaced apart from each other.

[0411] Example 93

[0412] According to any one or more of the devices described in embodiments 87 to 89, the first needle electrode and the second needle electrode are parallel to each other.

[0413] Example 94

[0414] According to the device of embodiment 90, the first needle electrode and the second needle electrode are parallel to the longitudinal axis of the shaft.

[0415] Example 95

[0416] The device according to any one or more of embodiments 78 to 91 further includes: (i) an electrode shaft coaxially disposed around the first needle electrode, and (ii) an annular electrode positioned on the electrode shaft, the annular electrode being positioned distally relative to the distal end of the shaft.

[0417] Example 96

[0418] According to the device of embodiment 92, the annular electrode is further positioned distally relative to the annular electrode assembly.

[0419] Example 97

[0420] According to any one or more of the devices described in Examples 92 to 93, the first needle electrode and the ring electrode are operable to cooperatively apply bipolar RF energy to the tissue.

[0421] Example 98

[0422] An apparatus comprising: (a) a shaft having a distal end and defining a longitudinal axis, the distal end terminating at a distal terminal; (b) an annular electrode assembly located at the distal end of the shaft, the annular electrode assembly including a first member forming a first annular shape extending along a plane parallel to the longitudinal axis of the shaft, the annular electrode assembly being positioned distally relative to the distal terminal of the shaft; and (c) a first needle-shaped electrode located at the distal end of the shaft, the first needle having a sharp tip, the first needle being operable to penetrate tissue, the annular electrode assembly and the first needle-shaped electrode each being operable to apply RF energy to tissue.

[0423] Example 99

[0424] According to the device described in Embodiment 95, the annular electrode assembly and the first needle electrode are operable to collaboratively apply bipolar RF energy to the tissue.

[0425] Example 100

[0426] According to any one or more of the devices described in Embodiments 95 to 96, the annular electrode assembly includes a second member that forms a second annular shape extending along a plane parallel to the longitudinal axis of the shaft.

[0427] Example 101

[0428] According to the device of embodiment 97, the second annular shape is nested within the first annular shape.

[0429] Example 102

[0430] According to any one or more of the devices described in Embodiments 89 to 90, the first component and the second component are operable to cooperatively apply bipolar RF energy to the tissue.

[0431] Example 103

[0432] According to one or more of the devices described in Embodiments 95 to 96, the first needle electrode extends obliquely relative to the plane associated with the first annular shape.

[0433] Example 104

[0434] According to the device of embodiment 100, the first needle electrode extends obliquely along a curved path.

[0435] Example 105

[0436] According to any one or more of the devices described in Embodiments 95 to 101, the first annular shape is generally rectangular.

[0437] Example 106

[0438] According to any one or more of the devices described in embodiments 95 to 101, the first annular shape is generally elliptical.

[0439] Example 107

[0440] According to any one or more of the devices described in Embodiments 95 to 103, the first component includes a first segment and a second segment, the first segment and the second segment of the first component being operable to cooperatively apply bipolar RF energy to tissue.

[0441] Example 108

[0442] According to any one or more of the devices described in Embodiments 95 to 103, the first needle electrode is positioned within the inner region defined by the first annular shape.

[0443] Example 109

[0444] The device according to any one or more of embodiments 95 to 105 further includes a second needle electrode positioned within the inner region defined by the first annular shape.

[0445] Example 110

[0446] According to the device of embodiment 106, the second needle electrode is positioned distally relative to the first needle electrode.

[0447] Example 111

[0448] According to any one or more of the devices described in Examples 106 to 107, the first needle electrode and the second needle electrode are operable to cooperatively apply bipolar RF energy to tissue.

[0449] Example 112

[0450] According to any one or more of the devices described in Embodiments 98 to 108, the second needle electrode extends obliquely relative to the plane associated with the first annular shape.

[0451] Example 113

[0452] According to any one or more of embodiments 95 to 109, the first needle electrode extends obliquely into a first region laterally positioned relative to the annular electrode assembly, a second region is defined on the side of the annular electrode assembly opposite to the first region, and a portion of the annular electrode assembly facing the second region comprises an electrically insulating material.

[0453] Example 114

[0454] A method includes: (a) pressing a ring electrode assembly against tissue within a patient's nasal cavity; (b) driving a needle electrode through the tissue within the patient's nasal cavity; and (c) applying bipolar RF energy to the tissue within the patient's nasal cavity via the ring electrode assembly and the needle electrode.

[0455] Example 115

[0456] An apparatus comprising: (a) a shaft having a distal end and defining a longitudinal axis; (b) a first electrode assembly located at the distal end of the shaft, the first electrode assembly including a member operable to apply RF energy to tissue; and (c) a second electrode assembly located at the distal end of the shaft, the second electrode assembly including a first needle having a sharp tip operable to penetrate tissue, the first needle being further operable to apply RF energy to tissue, the first needle being selectively longitudinally translatable relative to the shaft between a proximal retracted position and a distal extended position, in the distal extended position being distally protruding through the member of the first electrode assembly.

[0457] Example 116

[0458] According to the device of embodiment 112, the components of the first electrode assembly and the first needle are operable to cooperatively apply bipolar RF energy to tissue.

[0459] Example 117

[0460] According to any one or more of embodiments 112 to 113, the components of the first electrode assembly include: (i) a first arcuate segment and (ii) a second arcuate segment, the second arcuate segment being angularly spaced from the first arcuate segment.

[0461] Example 118

[0462] According to the device of embodiment 114, the component of the first electrode assembly further includes an insulating component angled between the first arcuate segment and the second arcuate segment.

[0463] Example 119

[0464] The device according to any one or more of Embodiments 114 to 115, wherein the first arcuate segment and the second arcuate segment are operable to cooperatively apply bipolar RF energy to tissue.

[0465] Example 120

[0466] The device according to any one or more of embodiments 112 to 116, wherein the component of the first electrode assembly includes a blunt end electrode that is securely fixed to the distal end of the shaft.

[0467] Example 121

[0468] According to the device of embodiment 117, wherein the blunt end electrode forms an annular shape and defines an opening, and the first needle is configured to pass through the opening of the blunt end electrode.

[0469] Example 122

[0470] According to the device of embodiment 118, the annular shape extends along a plane, and the plane of the annular shape is laterally oriented relative to the longitudinal axis of the shaft.

[0471] Example 123

[0472] According to the device of embodiment 119, the annular plane is oriented perpendicularly to the longitudinal axis of the shaft.

[0473] Example 124

[0474] According to one or more of the devices described in embodiments 112 to 116, the member of the first electrode assembly is capable of selective longitudinal translation relative to the axis.

[0475] Example 125

[0476] According to the device of embodiment 121, the components of the first electrode assembly are formed in an annular shape.

[0477] Example 126

[0478] According to the device of embodiment 122, the annular shape extends along a plane, and the plane of the annular shape is laterally oriented relative to the longitudinal axis of the shaft.

[0479] Example 127

[0480] According to the device of embodiment 123, the annular plane is oriented perpendicularly to the longitudinal axis of the shaft.

[0481] Example 128

[0482] The device according to any one or more of embodiments 122 to 124, wherein the member of the first electrode assembly is elastically biased to form the annular shape.

[0483] Example 129

[0484] The device according to any one or more of embodiments 122 to 125, wherein the annular shape defines a generally circular ring.

[0485] Example 130

[0486] The device according to any one or more of Embodiments 112 to 126, wherein the second electrode assembly further includes a second needle having a sharp tip, the second needle being operable to penetrate tissue, the second needle being further operable to apply RF energy to tissue, the second needle being selectively longitudinally translatable relative to the axis between a proximal retracted position and a distal extended position, in the distal extended position, the second needle protruding distally through the member of the first electrode assembly.

[0487] ​

[0488] According to the device of embodiment 127, the first needle and the second needle are laterally spaced apart from each other.

[0489] ​

[0490] According to the device of embodiment 128, the second electrode assembly further includes an insulating member laterally inserted between the first needle and the second needle.

[0491] ​

[0492] According to any one or more of the devices described in Embodiments 127 to 129, the first and second needles of the second electrode assembly are operable to cooperatively apply bipolar RF energy to tissue.

[0493] Example 131

[0494] According to any one or more of embodiments 112 to 126, the first needle further includes a needle shaft comprising a first insulating segment and a first conductive segment operable to apply RF energy to tissue.

[0495] Example 132

[0496] According to the device of embodiment 131, the needle shaft further includes a second conductive segment operable to apply RF energy to tissue and axially spaced from the first conductive segment, wherein the first insulating segment is axially inserted between the first conductive segment and the second conductive segment.

[0497] Example 133

[0498] According to the device of embodiment 132, the first conductive segment and the second conductive segment of the needle shaft are operable to cooperatively apply bipolar RF energy to the tissue.

[0499] Example 134

[0500] The device according to any one or more of embodiments 131 to 133, wherein the first conductive segment is configured to protrude distally through the member of the first electrode assembly when the first needle is in the distal extension position.

[0501] Example 135

[0502] The device according to any one or more of embodiments 131 to 134, wherein the first conductive segment includes the sharp end of the first needle.

[0503] Example 136

[0504] The device according to any one or more of embodiments 112 to 126, wherein the first needle further includes an insulating needle shaft and at least one conductive ring positioned around the insulating needle shaft.

[0505] Example 137

[0506] According to the device of embodiment 136, the at least one conductive ring includes a first conductive ring and a second conductive ring axially spaced apart from each other along the insulating needle shaft.

[0507] Example 138

[0508] According to the device of embodiment 137, the first conductive ring and the second conductive ring of the first needle are operable to cooperatively apply bipolar RF energy to the tissue.

[0509] Example 139

[0510] The device according to any one or more of embodiments 136 to 138, wherein the at least one conductive ring is configured to protrude distally through the member of the first electrode assembly when the first needle is in the distal extension position.

[0511] Example 140

[0512] The device according to any one or more of embodiments 112 to 139, wherein the first needle defines a lumen and is operable to dispense fluid distally via the lumen.

[0513] Example 141

[0514] The device according to any one or more of embodiments 112 to 140 further includes a position sensor configured to generate a signal indicating the position of one or both of the first electrode assembly or the second electrode assembly in three-dimensional space.

[0515] Example 142

[0516] A device includes: (a) a shaft having a distal end and defining a longitudinal axis; (b) a first electrode assembly located at the distal end of the shaft, the first electrode assembly including: (i) a first conductive segment operable to apply RF energy to tissue with a first polarity; and (ii) a second conductive segment angularly spaced from the first conductive segment, wherein the second conductive segment is operable to apply RF energy to tissue with a second polarity; and (c) a second electrode assembly located at the distal end of the shaft, the second electrode assembly including: (i) a first needle having a sharp tip operable to penetrate tissue; and (ii)... (iii) A first conductive portion, the first conductive portion being presented by the first needle, wherein the first conductive portion is operable to apply RF energy to tissue in the second polarity, and (iii) a second conductive portion, wherein the second conductive portion is operable to apply RF energy to tissue in the first polarity, wherein the first conductive segment and the second conductive segment are operable to cooperatively apply bipolar RF energy to tissue, wherein the first conductive portion and the second conductive portion are operable to cooperatively apply bipolar RF energy to tissue, wherein the first conductive segment and the first conductive portion are operable to cooperatively apply bipolar RF energy to tissue, and wherein the second conductive segment and the second conductive portion are operable to cooperatively apply bipolar RF energy to tissue.

[0517] Example 143

[0518] The device according to embodiment 142, wherein the second conductive portion is presented by the first needle.

[0519] Example 144

[0520] According to the device of embodiment 143, the first needle includes a needle shaft, wherein the first conductive portion and the second conductive portion are each present free from the needle shaft, wherein the needle shaft includes an insulating portion between the first conductive portion and the second conductive portion.

[0521] Example 145

[0522] According to the device of embodiment 143, the first needle includes an insulating needle shaft, and the first conductive portion and the second conductive portion respectively include a first conductive ring and a second conductive ring positioned around the insulating needle shaft.

[0523] Example 146

[0524] The device according to embodiment 142 further includes a second needle having a sharp end operable to penetrate tissue, wherein the second conductive portion is presented by the second needle.

[0525] Example 147

[0526] The device according to any one or more of embodiments 142 to 146, wherein the first conductive segment is positioned on a first lateral side relative to the longitudinal axis of the shaft, and wherein the second conductive segment is positioned on a second lateral side relative to the longitudinal axis of the shaft.

[0527] Example 148

[0528] According to the device of embodiment 147, wherein the first conductive portion is positioned on the first lateral side relative to the longitudinal axis of the shaft, and wherein the second conductive portion is positioned on the second lateral side relative to the longitudinal axis of the shaft.

[0529] Example 149

[0530] According to any one or more of embodiments 142 to 148, the first needle is selectively longitudinally translatable relative to the axis between a proximal retracted position and a distal extended position, in which the first needle protrudes distally through the first conductive segment and the second conductive segment of the first electrode assembly.

[0531] Example 150

[0532] According to any one or more of embodiments 142 to 149, the first conductive segment and the second conductive segment of the first electrode assembly are securely fixed to the distal end of the shaft.

[0533] Example 151

[0534] According to one or more of the devices described in embodiments 142 to 149, the first conductive segment and the second conductive segment of the first electrode assembly are capable of selective longitudinal translation relative to the axis.

[0535] Example 152

[0536] According to the device of embodiment 151, wherein the first electrode assembly is formed in an annular shape extending in a plane laterally oriented relative to the longitudinal axis of the shaft.

[0537] Example 153

[0538] According to the device of embodiment 152, the annular shape defines a generally circular ring.

[0539] Example 154

[0540] The device according to any one or more of embodiments 152 to 153, wherein the first electrode assembly is elastically biased to form the annular shape.

[0541] Example 155

[0542] The device according to any one or more of embodiments 142 to 154, wherein the first electrode assembly defines an opening, and the first needle is configured to pass through the opening of the first electrode assembly.

[0543] Example 156

[0544] A method includes: (a) pressing an electrode assembly against tissue within a patient's nasal cavity; (b) driving a needle electrode through the tissue within the patient's nasal cavity; (c) selecting a bipolar RF energy application mode from a plurality of bipolar RF energy application modes, wherein the plurality of bipolar RF energy application modes include a shallow bipolar RF energy application mode, a deep bipolar RF energy application mode, and a volumetric bipolar RF energy application mode; and (d) applying bipolar RF energy to the tissue within the patient's nasal cavity via at least one of the electrode assembly or the needle electrode in the selected bipolar RF energy application mode.

[0545] Example 157

[0546] An apparatus comprising: (a) a shaft assembly having a distal end; and (b) an electrode assembly located at the distal end of the shaft assembly, the electrode assembly comprising: (i) a first conductive segment extending at the distal end of the shaft assembly along a first angular range, wherein the first conductive segment is operable to apply RF energy to tissue with a first polarity; and (ii) a second conductive segment angularly spaced from the first conductive segment, extending at the distal end of the shaft assembly along a second angular range, wherein the second conductive segment is operable to apply RF energy to tissue with a second polarity, such that the first conductive segment and the second conductive segment are operable to apply bipolar RF energy to tissue.

[0547] Example 158

[0548] The device according to embodiment 157 further includes a visualization component at the distal end of the shaft, the visualization component including a camera.

[0549] Example 159

[0550] According to the device of embodiment 158, the visualization component is longitudinally fixed relative to the axis assembly.

[0551] Example 160

[0552] According to the device of embodiment 158, the visualization component and the axis component are configured to enable relative longitudinal translation between the visualization component and the axis component.

[0553] Example 161

[0554] According to any one or more of the devices described in Embodiments 158 to 160, the visualization component and the electrode component are configured to enable relative longitudinal translation between the visualization component and the electrode component.

[0555] Example 162

[0556] The device according to any one or more of Embodiments 158 to 161 further includes a fluid conduit positioned and configured to discharge for one or both of the following: (i) flushing debris from the camera, or (ii) promoting continuity between the first conductive segment and the second conductive segment and the tissue.

[0557] Example 163

[0558] According to the device of embodiment 162, the visualization component further includes a liquid steering member positioned and configured to steer liquid discharged via the fluid conduit toward the camera.

[0559] Example 164

[0560] According to the device described in any one or more of Embodiments 162 to 163, the fluid conduit is further configured to apply suction at the distal end of the shaft assembly.

[0561] Example 165

[0562] The device according to any one or more of embodiments 158 to 164 further includes an illumination element configured to illuminate the field of view of the camera.

[0563] Example 166

[0564] According to the device of embodiment 165, the lighting element includes an LED.

[0565] Example 167

[0566] According to any one or more of embodiments 157 to 166, the shaft assembly includes a rigid proximal portion and a flexible distal portion, the flexible distal portion being configured such that the distal end can be laterally deflected away from or toward a longitudinal axis defined by the rigid proximal portion.

[0567] Example 168

[0568] According to the device of embodiment 167, the shaft assembly further includes a rigid distal portion defining the distal end, the flexible distal portion being longitudinally inserted between the rigid proximal portion and the rigid distal portion.

[0569] Example 169

[0570] According to any one or more of embodiments 157 to 168, the electrode assembly further includes a distal end member fixed to the distal end of the shaft assembly, wherein the first conductive segment and the second conductive segment are fixed to the distal end member.

[0571] Example 170

[0572] According to the device of embodiment 169, the distal end member comprises a non-conductive material.

[0573] Example 171

[0574] According to any one or more of embodiments 157 to 170, the first conductive segment has an arcuate shape, and the second conductive segment has an arcuate shape.

[0575] Example 172

[0576] According to the device of embodiment 171, the first conductive segment and the second conductive segment together define a generally circular shape.

[0577] Example 173

[0578] According to any one or more of the devices described in Embodiments 157 to 172, the electrode assembly defines a first angular gap between the first conductive segment and the second conductive segment.

[0579] Example 174

[0580] According to the device of embodiment 173, the electrode assembly further defines a second angular gap between the first conductive segment and the second conductive segment.

[0581] Example 175

[0582] According to the device described in Embodiment 174, the second corner gap is 180 degrees apart from the first corner gap.

[0583] Example 176

[0584] According to any one or more of embodiments 157 to 175, in the device, the distal end of the shaft assembly defines a distally facing circular edge, the first conductive segment extends along the distally facing circular edge through the first angular range, and the second conductive segment extends along the distally facing circular edge through the second angular range.

[0585] Example 177

[0586] According to any one or more of embodiments 157 to 176, the first conductive segment includes a first distally facing portion, and the second conductive segment includes a second distally facing portion.

[0587] Example 178

[0588] According to any one or more of embodiments 157 to 177, the first conductive segment includes a first radially outward portion, and the second conductive segment includes a second radially outward portion.

[0589] Example 179

[0590] According to any one or more of embodiments 157 to 178, the first conductive segment includes a first radially inward portion, and the second conductive segment includes a second radially inward portion.

[0591] Example 180

[0592] According to any one or more of the devices described in Embodiments 157 to 179, the shaft assembly defines a working channel.

[0593] Example 181

[0594] According to the device of embodiment 180, the size and configuration of the working channel are configured such that the working element can be advanced distally through the distal end of the shaft assembly and distally through the electrode assembly.

[0595] XXI. Miscellaneous

[0596] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the foregoing teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0597] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.

[0598] Devices of the types described above may be designed for single-use and disposal, or they may be designed for multiple uses. In either or both cases, these types may be repaired for reuse after at least one use. Repair may include any combination of the following steps: disassembling the device, then cleaning or replacing specific parts, and subsequently reassembling. Specifically, some types of devices may be disassembled, and any combination may be used to selectively replace or remove any number of specific parts or portions of the device. While cleaning and / or replacing specific components, some types of devices may be reassembled at a repair facility or by the user prior to surgery for subsequent use. Those skilled in the art will appreciate that device repair can utilize a variety of techniques for disassembly, cleaning / replacement, and reassembly. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0599] By way of example only, the types described herein can be sterilized before and / or after surgery. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, or vapor.

[0600] Various embodiments of the invention have been shown and described, and further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the embodiments, implementations, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. An ENT ablation device, comprising: (a) A shaft assembly having a distal end, the distal end including a hollow wheel-shaped end portion, the hollow wheel-shaped end portion comprising: (i) Inner surface, (ii) outer surface, and (iii) A surface extending distally between the inner surface and the outer surface; and (b) An electrode assembly located at the hollow wheel-shaped end portion, the electrode assembly comprising: (i) A first conductive segment disposed on at least one of the inner surface, the outer surface, and the distally facing surface, the first conductive segment being operable to apply RF energy to the tissue in a first polarity, and (ii) A second conductive segment, which is angularly spaced from the first conductive segment, is disposed on at least one of the inner surface, the outer surface, and the distally facing surface, and is operable to apply RF energy to the tissue in a second polarity, such that the first and second conductive segments are operable to apply bipolar RF energy to the tissue.

2. The device of claim 1, further comprising a visualization component at the distal end of the shaft assembly, the visualization component comprising a camera.

3. The device of claim 2, wherein the visualization component and the axis component are configured to enable relative longitudinal translation between the visualization component and the axis component.

4. The device of claim 2, wherein the visualization component and the electrode component are configured to enable relative longitudinal translation between the visualization component and the electrode component.

5. The device of claim 2, further comprising a fluid conduit positioned and configured to discharge liquid for one or both of the following: (i) Rinse the debris from the camera, or (ii) Promote the continuity between the first conductive segment and the second conductive segment and the tissue.

6. The device of claim 5, wherein the visualization component further comprises a liquid deflector positioned and configured to deflect liquid discharged via the fluid conduit toward the camera.

7. The device of claim 5, wherein the fluid conduit is further configured to apply suction at the distal end of the shaft assembly.

8. The device of claim 2, wherein the visualization component further comprises an illumination element configured to illuminate the field of view of the camera.

9. The device of claim 1, wherein the shaft assembly includes a rigid proximal portion and a flexible distal portion, the flexible distal portion being configured such that the distal end can be laterally deflected away from or toward a longitudinal axis defined by the rigid proximal portion.

10. The device according to claim 1, wherein the hollow wheel-shaped end portion comprises a non-conductive material.

11. The device according to claim 1, wherein the first conductive segment has an arcuate shape, and the second conductive segment has an arcuate shape.

12. The device of claim 1, wherein the electrode assembly defines a first angular gap between the first conductive segment and the second conductive segment.

13. The device of claim 1, wherein the first conductive segment includes a first distally facing portion extending along the distally facing surface, and the second conductive segment includes a second distally facing portion extending along the distally facing surface.

14. The device of claim 1, wherein the first conductive segment includes a first radially outward portion extending along the outer surface, and the second conductive segment includes a second radially outward portion extending along the outer surface.

15. The device of claim 1, wherein the first conductive segment includes a first radially inward portion extending along the inner surface, and the second conductive segment includes a second radially inward portion extending along the inner surface.

16. The device of claim 1, wherein the shaft assembly defines a working channel, the size and configuration of which are configured such that a working element can be advanced distally through the distal end of the shaft assembly and distally through the electrode assembly.

Images