Dilation instrument with lead screw drive for catheter

Abstract

A dilation catheter of a medical instrument can translate longitudinally relative to a guide of the medical instrument to position the guide relative to a target anatomical passageway before entering the passageway. The medical instrument can have a handle assembly, a guide member extending distally relative to the handle assembly, a dilation catheter slidably disposed relative to the guide member, and a dilation catheter actuation assembly. Optionally, the dilation catheter can translate relative to the handle assembly along a longitudinal axis. The dilation catheter can include an expandable element configured to dilate the passageway. The dilation catheter can include a first rotary member that rotates relative to the handle assembly about a first rotation axis that is substantially parallel to the longitudinal axis to thereby drive translation of the dilation catheter along the longitudinal axis.

Description

DILATION INSTRUMENT WITH LEAD SCREW DRIVE FOR CATHETERCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 563,531, filed March 11, 2024, the entirety of which is incorporated herein by reference.BACKGROUND

[0002] In some instances, it may be desirable to dilate an anatomical passageway in a patient. This may include dilation of ostia of paranasal sinuses (e.g., to treat sinusitis), dilation of the larynx, dilation of the Eustachian tube, dilation of other passageways within the ear, nose, or throat, etc. One method of dilating anatomical passageways includes using a guide wire and catheter to position an inflatable balloon within the anatomical passageway, then inflating the balloon with a fluid (e.g., saline) to dilate the anatomical passageway. For instance, the expandable balloon may be positioned within an ostium at a paranasal sinus and then be inflated, to thereby dilate the ostium by remodeling the bone adjacent to the ostium, without requiring incision of the mucosa or removal of any bone. The dilated ostium may then allow for improved drainage from and ventilation of the affected paranasal sinus. A system that may be used to perform such procedures may be provided in accordance with the teachings of U.S. Pat. No. 11,534,192, entitled “Methods and Apparatus for Treating Disorders of the Sinuses,” issued December 27, 2022; U.S. Pat. No. 9,579,448, entitled “Balloon Dilation Catheter System for Treatment and Irrigation of the Sinuses,” issued February 28, 2017; U.S. Pat. No. 9,155,492, entitled “Sinus Illumination Lightwire Device,” issued October 13, 2015; and U.S. Pub. No. 2021 / 0361912, entitled “Shaft Deflection Control Assembly for ENT Guide Instrument,” published November 25, 2021. The disclosures of U.S. Pat. No. 11,534,192, entitled “Methods and Apparatus for Treating Disorders of the Sinuses,” issued December 27, 2022; U.S. Pat. No. 9,579,448, entitled “Balloon Dilation Catheter System for Treatment and Irrigation of the Sinuses,” issued February 28, 2017; U.S. Pat. No. 9,155,492, entitled “Sinus Illumination Lightwire Device,” issued October 13, 2015; and U.S. Pub. No. 2021 / 0361912, entitled “Shaft Deflection Control Assembly for ENT Guide Instrument,” published November 25, 2021, are incorporated herein, in their entireties.

[0003] In the context of Eustachian tube dilation, a dilation catheter or other dilation instrument may be inserted into the Eustachian tube and then be inflated or otherwise expanded to thereby dilate the Eustachian tube. The dilated Eustachian tube may provide improved ventilation from the nasopharynx to the middle ear and further provide improved drainage fromthe middle ear to the nasopharynx. Methods and devices for dilating the Eustachian tube are disclosed in U.S. Pat. No. 10,206,821, entitled “Eustachian Tube Dilation Balloon with Ventilation Path,” issued February 19, 2019; and U.S. Pat. No. 11,013,896, entitled “Method and System for Eustachian Tube Dilation,” issued May 25, 2021. The disclosures of U.S. Pat. No. 10,206,821, entitled “Eustachian Tube Dilation Balloon with Ventilation Path,” issued February 19, 2019; and U.S. Pat. No. 11,013,896, entitled “Method and System for Eustachian Tube Dilation,” issued May 25, 2021, are incorporated herein, in their entireties.

[0004] Some medical instruments may include an adjustable guide that allows the same medical instrument to readily access different anatomical structures (e.g., Eustachian tubes and different passageways associated with drainage of paranasal sinuses, etc.). Examples of dilation instruments with adjustable guides are described in U.S. Pat. No. 10,137,285, entitled “Balloon Dilation System with Malleable Internal Guide,” issued November 27, 2018; U.S. Pat. No. 11,013,897, entitled “Apparatus for Bending Malleable Guide of Surgical Instrument,” issued May 25, 2021; and U.S. Pat. No. 11,534,192, entitled “Methods and Apparatus for Treating Disorders of the Sinuses,” issued December 27, 2022. The disclosures of U.S. Pat. No. 10, 137,285, entitled “Balloon Dilation System with Malleable Internal Guide,” issued November 27, 2018; U.S. Pat. No. 11,013,897, entitled “Apparatus for Bending Malleable Guide of Surgical Instrument,” issued May 25, 2021; and U.S. Pat. No. 11,534,192, entitled “Methods and Apparatus for Treating Disorders of the Sinuses,” issued December 27, 2022, are incorporated herein, in their entireties.

[0005] In some scenarios, it may be desirable to allow a dilation catheter of a medical instrument to translate longitudinally relative to a guide of the same instrument. This may allow the guide to be initially positioned in relation to a targeted anatomical passageway while the dilation catheter is in a proximal position. The dilation catheter may then be advanced relative to the guide to a distal position to thereby enter the targeted anatomical passageway. While several systems and methods have been made and used to dilate anatomical passageways within a patient, it is believed that no one prior to the inventors has made or used the inventions described in the appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The drawings and detailed description that follow are intended to be merely illustrative and are not intended to limit the scope of the inventions as contemplated by the inventors.

[0007] FIG. 1 depicts a perspective view of an example of a medical instrument,with a dilation catheter in a proximal position, in accordance with some embodiments disclosed herein.

[0008] FIG. 2 depicts a perspective view of first and second actuation assemblies of the medical instrument of FIG. 1, in accordance with some embodiments disclosed herein.

[0009] FIG. 3 depicts an exploded perspective view of the first and second actuation assemblies of FIG. 2, in accordance with some embodiments disclosed herein.

[0010] FIG. 4 depicts an end cross-sectional view of the medical instrument of FIG. 1, taken along line 4-4 of FIG. 1, in accordance with some embodiments disclosed herein.

[0011] FIG. 5 depicts an end cross-sectional view of the medical instrument of FIG. 1, taken along line 5-5 of FIG. 1, in accordance with some embodiments disclosed herein.

[0012] FIG. 6A depicts a side cross-sectional view of the medical instrument of FIG. 1, taken along line 6-6 of FIG. 1, showing a lead nut of the first actuation assembly in a respective proximal position, and further showing a lead nut of the second actuation assembly in a respective proximal position, in accordance with some embodiments disclosed herein.

[0013] FIG. 6B depicts a side cross-sectional view of the medical instrument of FIG. 1, taken along line 6-6 of FIG. 1, showing the lead nut of the second actuation assembly in the respective proximal position, and further showing the lead nut of the first actuation assembly in a respective distal position, in accordance with some embodiments disclosed herein.

[0014] FIG. 7A depicts a side cross-sectional view of the medical instrument of FIG. 1, taken along line 7-7 of FIG. 1, showing the lead nut of the second actuation assembly in the respective proximal position, and further showing the lead nut of the first actuation assembly in the respective distal position, in accordance with some embodiments disclosed herein.

[0015] FIG. 7B depicts a side cross-sectional view of the medical instrument of FIG. 1, taken along line 7-7 of FIG. 1, showing the lead nut of the first actuation assembly in the respective distal position, and further showing the lead nut of the second actuation assembly in a respective distal position, in accordance with some embodiments disclosed herein.

[0016] FIG. 8A depicts a schematic side cross-sectional view of another example of a medical instrument, with a dilation catheter in a proximal position, in accordance with some embodiments disclosed herein.

[0017] FIG. 8B depicts a schematic side cross-sectional view of the instrument of FIG. 8A, with the dilation catheter in a distal position, with a dilation catheter in a proximal position, in accordance with some embodiments disclosed herein.DETAILED DESCRIPTION

[0018] The following description of certain examples of the inventions should not be used to limit the scope of the present inventions. Other examples, features, aspects, embodiments, and advantages of the inventions will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the inventions. As will be realized, the inventions are capable of other different and obvious aspects, all without departing from the inventions. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0019] For clarity of disclosure, the terms “proximal” and “distal” are defined herein relative to a surgeon, or other operator, grasping a surgical instrument having a distal surgical end effector. The term “proximal” refers to the position of an element arranged closer to the surgeon, and the term “distal” refers to the position of an element arranged closer to the surgical end effector of the surgical instrument and further away from the surgeon. Moreover, to the extent that spatial terms such as “upper,” “lower,” “vertical,” “horizontal,” or the like are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and are not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions not limited to those shown and described herein.

[0020] As used herein, the terms “about” and “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.I, Examples of Dilation Instruments with Translatable Dilation Catheters

[0021] In some scenarios, it may be desirable to advance a dilation catheter into an anatomical passageway in or near the ear, nose, or throat of a patient and expand the dilator to thereby dilate the passageway. For instance, it may be desirable to dilate a paranasal sinus ostium or other passageway associated with drainage of a paranasal sinus cavity, a Eustachian tube, a stenotic region in an airway of a patient, etc. It may also be desirable to incorporate a guide into such an instrument, to assist in guiding the dilation catheter into the targeted anatomical passageway, and to allow the dilation catheter to translate longitudinally relative to the guide. This may allow the guide to be initially positioned in relation to a targeted anatomical passageway while the dilation catheter is in a proximal position. The dilation catheter may then be advanced relative to the guide to a distal position to thereby enter thetargeted anatomical passageway.

[0022] To the extent that some conventional instruments may provide a translating actuator to drive translation of a dilation catheter relative to a guide, some such translating actuators may provide usability difficulties. For instance, if an operator wishes to grasp the handle of the instrument with a single hand and actuate the actuator with the same hand (e.g., leaving their other hand free to manipulate an endoscope or other instrument, etc.), it may be difficult to advance the translating actuator through its full range of motion, particularly if the operator has small hands. It may therefore be desirable to provide a dilation catheter actuator that does not require the operator to move their finger or thumb through full range of longitudinal motion required to drive corresponding longitudinal motion of a dilation catheter. To that end, it may be desirable to provide a dilation instrument that provides a rotary actuator to drive longitudinal motion of a dilation catheter, to facilitate driving the dilation catheter through its full range of longitudinal motion without requiring the operator to move a finger or thumb through a corresponding range of longitudinal motion.

[0023] It may also be desirable to provide a single instrument that is capable of dilating different anatomical passageways in a patient. To facilitate such capabilities, the dilation instrument may include an adjustable guide, such as a malleable guide. To the extent that a malleable guide may facilitate different bend angles in a guide, it may be further desirable to achieve different longitudinal positions in a guide, to thereby further facilitate access to different anatomical passageways.

[0024] Each of the examples of dilation instruments 10, 110 described below may function in such a manner.A, Example of Dilation Instrument with Laterally Offset Rotary Members for Translating Dilation Catheter and Guide Member

[0025] FIGS. 1-7B depict an example of a dilation instrument 10 that may be used to dilate an anatomical passageway in or near an ear, nose, or throat of a patient. The instrument 10 of this example includes a handle 12, a shaft assembly 30 extending distally from the handle 12 along a central longitudinal axis (LA), and first and second actuation assemblies 60a, 60b. The first and second actuation assemblies 60a, 60b are operable to drive longitudinal movement of a dilation catheter 40 and a guide rail 50 along the central longitudinal axis (LA), as described in greater detail below.

[0026] The handle 12 includes a housing 22 having a substantially cylindrical the sidewall 24 extending along the central longitudinal axis (LA) of the shaft assembly 30. Thesidewall 24 at least partially defines an interior 25 (FIGS. 4-7B) of the housing 22. In the example shown, the housing 22 also includes the first and second longitudinal slots 26a, 26b extending through the sidewall 24 to allow visual observation of the interior 25 of the housing 22 and / or components of the actuation assemblies 60a, 60b housed therein from a vantage point that is external of the housing 22. The housing 22 of the present example further includes the first and second apertures 28a, 28b (FIGS. 4 and 5) extending through the sidewall 24 for allowing engagement between components of respective the actuation assemblies 60a, 60b therethrough, as described in greater detail below. In the example shown, the first aperture 28a is distal of the second aperture 28b, though it will be appreciated that the first aperture 28a may alternatively be proximal of the second aperture 28b. Also, in the example shown, the first and second longitudinal slots 26a, 26b are angularly aligned with the first and second apertures 28a, 28b relative to the central longitudinal axis (LA), respectively, while the first longitudinal slot 26a and the first aperture 28a are angularly offset from the second longitudinal slot 26b and the second aperture 28b relative to the central longitudinal axis (LA). For example, the first longitudinal slot 26a and the first aperture 28a may be angularly offset from the second longitudinal slot 26b and the second aperture 28b by about 90° relative to the central longitudinal axis (LA).

[0027] The shaft assembly 30 includes an outer sheath 32, a guide rail 50, and the dilation catheter 40. In the present example, these components are configured to be positioned coaxially with each other along the central longitudinal axis (LA) of the shaft assembly 30, such that the outer sheath 32 is positioned externally, the dilation catheter 40 is positioned internal to the outer sheath 32, and the guide rail 50 is positioned internal to the dilation catheter 40. The outer sheath 32 of the present example is rigid, though other versions may be malleable or otherwise flexible. In the present example, the outer sheath 32 does not enter the head of the patient during operation of the instrument 10, though some scenarios may exist where the outer sheath 32 enters the patient during operation of the instrument 10.

[0028] The guide rail 50 of the present example is malleable and has an atraumatic distal tip 52. In some versions, the distal tip 52 is dome shaped. In some other versions, the distal tip 52 is enlarged (e.g., configured as a ball tip or blueberry tip, etc.). The malleability of the guide rail 50 may allow the guide rail 50 to maintain the bend angle of a bend while the guide rail 50 is disposed in the head of the patient, including while the dilation catheter 40 is advanced distally relative to the guide rail 50. Such operability of the guide rail 50 may promote access by the dilation catheter 40 to various locations within the head of a patient, such as the maxillary sinus ostium, the frontal recess, the sphenoid sinus ostium, the Eustachiantube, etc., based on the selected bend angle. By way of example only, the bending of the guide rail 50 may be performed in accordance with at least some of the teachings of U.S. Pat. No. 11,013,897, entitled “Apparatus for Bending Malleable Guide of Surgical Instrument,” issued May 25, 2021. The disclosure of U.S. Pat. No. 11,013,897, entitled “Apparatus for Bending Malleable Guide of Surgical Instrument,” issued May 25, 2021, is incorporated herein, in its entirety.

[0029] The dilation catheter 40 of the present example includes a shaft 42 having an integral balloon 44 and a distal tip 46. The shaft 42 is coaxially positioned with the outer sheath 32 and the guide rail 50. The shaft 42 defines two inner lumens, including a first lumen in which the guide rail 50 is slidably disposed and a second lumen in fluid communication with the balloon 44. The balloon 44 may comprise a non-extensible material and may be sized and configured to fit within a targeted anatomical passageway while in the deflated state and then dilate the targeted anatomical passageway while in the inflated state.

[0030] One or both of the distal tips 46, 52 may comprise an indicator element. Each such indicator element may comprise a position sensor and / or an illuminating feature. In versions where an indicator element includes a position sensor, the position sensor may comprise one or more coils. When such a coil is positioned within an alternating electromagnetic field generated by field generators, the alternating magnetic field may induce electrical current in the coil, and this induced electrical current may be communicated as a position-indicative signal along the electrical conduit(s) in the instrument and further to a processor. This phenomenon may enable an image-guided surgery navigation system to determine the location of the distal tips 46, 52 within a three-dimensional space (i.e., within the head of the patient, etc.). To accomplish this, the processor may execute an algorithm to calculate location coordinates of the distal tip 46, 52 from the position related signals (e.g., from induced currents) of the coil(s) in the distal tip 46, 52. Thus, a navigation sensor may serve as a position sensor by generating signals indicating the real-time position of the sensor within three-dimensional space or by otherwise indicating the real-time position of the sensor within three-dimensional space.

[0031] In versions where an indicator element includes an illuminating feature, the illuminating feature may be operable to project light outwardly from indicator element. Such an illuminating feature may provide transillumination through the skin of the patient. In some such versions, the illuminating feature includes an optically transmissive window that is optically coupled with one or more optical fibers, with such one or more optical fibers being optically coupled with a light source. In some other versions, the illuminating feature includesone or more LEDs or other local sources of light positioned locally at the distal tip 46, 52.

[0032] FIGS. 2-5 show the first and second actuation assemblies 60a, 60b that are operable to independently drive translation of the dilation catheter 40 and the guide rail 50 in greater detail. Each actuation assembly 60a, 60b of the present example includes a respective actuator 61a, 61b that is rotatably supported by the housing 22 of the handle 12 over a corresponding aperture 28a, 28b, such that each actuator 61a, 61b is rotatable about the central longitudinal axis (LA). Each actuator 61a, 61b of the present example is in the form of a dial ring having the inner teeth 62a, 62b, where each actuator 61a, 61b may be independently driven to rotate about the central longitudinal axis (LA) by a finger or thumb of the same hand that grasps the handle 12 for one-handed operation of the instrument 10. It should therefore be understood that, in some cases, each actuator 61a, 61b may be operated as a thumbwheel. In the example shown, the first actuator 61a is distal of the second actuator 61b, though it will be appreciated that the first actuator 61a may alternatively be proximal of the second actuator 61b.

[0033] The first and second leadscrews 64a, 64b are also rotatably supported by the housing 22 within the interior 25, such that each leadscrew 64a, 64b is configured to rotate about a respective offset rotation axis (RAI, RA2) that is laterally offset from (e.g., radially outward of) and substantially parallel to the central longitudinal axis (LA). First and second rotary members in the form of the first and second pinions 70a, 70b are fixedly secured to the first and second leadscrews 64a, 64b, respectively, and have respective outer teeth 72a, 72b that mesh with the inner teeth 62a, 62b of the respective actuator 61a, 61b via the corresponding aperture 28a, 28b, such that each pinion 70a, 70b rotates together with the respective leadscrew 64a, 64b about the respective offset rotation axis (RAI, RA2) in response to rotation of the respective actuator 61a, 61b about the central longitudinal axis (LA). In the example shown, the first pinion 70a is distal of the second pinion 70b, though it will be appreciated that the first pinion 70a may alternatively be proximal of the second pinion 70b.

[0034] The first and second lead nuts 80a, 80b are slidably supported within the interior 25 of the housing 22 and have respective threaded, substantially C-shaped channels 82a, 82b that are angularly aligned with the respective leadscrew 64a, 64b relative to the central longitudinal axis (LA) and threadably engage with the respective leadscrew 64a, 64b, such that each lead nut 80a, 80b translates along the central longitudinal axis (LA) in response to rotation of the respective leadscrew 64a, 64b about the respective offset rotation axis (RAI, RA2). While substantially C-shaped channels 82a, 82b are shown in the present example, any other suitable threaded features may be provided in place of substantially C-shaped channels 82a, 82b, such as threaded, substantially cylindrical bores. In the example shown, the first lead nut80a is distal of the second lead nut 80b, though it will be appreciated that the first lead nut 80a may alternatively be proximal of the second lead nut 80b.

[0035] The first and second guide pins 84a, 84b are fixedly supported by the housing 22 within the interior 25, such that each guide pin 84a, 84b is laterally offset from (e.g., radially outward of) and substantially parallel to the central longitudinal axis (LA), and the lead nuts 80a, 80b have respective substantially cylindrical bores 86a, 86b that are angularly aligned with the respective guide pin 84a, 84b relative to the central longitudinal axis (LA) and slidably receive the respective guide pin 84a, 84b, such that movement of each lead nut 80a, 80b relative to the housing 22 is substantially constrained to translation of each lead nut 80a, 80b along the central longitudinal axis (LA). In the example shown, first and second guide pins 84a, 84b are angularly offset from the first and second leadscrews 64a, 64b by about 180° relative to the central longitudinal axis (LA), respectively. While guide pins 84a, 84b are shown in the present example, any other suitable guide features may be provided in place of guide pins 84a, 84b, such as boss rails extending longitudinally along an inner surface of the sidewall 24 of the housing 22.

[0036] Thus, when the first actuator 61a is rotated in a first direction (e.g., clockwise or counterclockwise) about the central longitudinal axis (LA), the first lead nut 80a translates distally from the proximal position shown in FIG. 6A to the distal position shown in FIGS. 6B-7B. When the first actuator 61a is rotated in a second direction (e.g., counterclockwise or clockwise) about the central longitudinal axis (LA), the first lead nut 80a translates proximally from the distal position shown in FIGS. 6B-7B to the proximal position shown in FIG. 6A. Similarly, when the second actuator 61b is rotated in a first direction about the central longitudinal axis (LA), the second lead nut 80b translates distally from the proximal position shown in FIGS. 6A-7A to the distal position shown in FIG. 7B. When the second actuator 61b is rotated in a second direction about the central longitudinal axis (LA), the second lead nut 80b translates proximally from the distal position shown in FIG. 7B to the proximal position shown in FIGS. 6A-7A.

[0037] The first and second lead nuts 80a, 80b of the present example also have respective unthreaded, substantially C-shaped channels 88a, 88b that are angularly aligned with the second and first leadscrews 64b, 64a relative to the central longitudinal axis (LA), respectively, and that each have a cross dimension (e.g., diameter) that is sufficiently large such that each unthreaded channel 88a, 88b accommodates the leadscrew 64b, 64a of the other actuation assembly 60b, 60a without threadably engaging the leadscrew 64b, 64a of the other actuation assembly 60b, 60a. While the substantially C-shaped channels 88a, 88b are shownin the present example, any other suitable unthreaded features may be provided in place of the substantially C-shaped channels 88a, 88b, such as unthreaded, substantially cylindrical bores. Thus, the longitudinal position of the lead nut 80a, 80b of one actuation assembly 60a, 60b may be unaffected by rotation of the leadscrew 64b, 64a of the other actuation assembly 60b, 60a about the respective offset rotation axis (RA2, RAI). For example, rotation of the leadscrew 64a of the first actuation assembly 60a about the first offset rotation axis (RAI) may not cause translation of the lead nut 80b of the second actuation assembly 60b along the central longitudinal axis (LA), and rotation of the leadscrew 64b of the second actuation assembly 60b about the second offset rotation axis (RA2) may not cause translation of the lead nut 80a of the first actuation assembly 60a along the central longitudinal axis (LA).

[0038] The first and second lead nuts 80a, 80b of the present example further have respective openings 89a, 89b that are angularly aligned with second and first guide pins 84b, 84a relative to the central longitudinal axis (LA), respectively, and that each have a cross dimension that is sufficiently large such that each opening 89a, 89b accommodates the guide pin 84b, 84a of the other actuation assembly 60b, 60a without necessarily slidably engaging the guide pin 84b, 84a of the other actuation assembly 60b, 60a. Thus, the openings 89a, 89b may accommodate passage of other components therethrough in addition to the guide pin 84b, 84a of the other actuation assembly 60b, 60a, such as tubing (e.g., for providing inflation fluid to the balloon 44) and / or one or more electrically conductive elements (e.g., wires extending to the indicator element of either the distal tip 46 or the distal tip 52). In some other versions, each opening 89a, 89b may slidably engage the guide pin 84b, 84a of the other actuation assembly 60b, 60a. For example, each opening 89a, 89b may be formed as a substantially cylindrical bore that slidably receives the guide pin 84b, 84a of the other actuation assembly 60b, 60a.

[0039] First and second lead nuts 80a, 80b are fixedly secured to respective ones of the shaft 42 of the dilation catheter 40 or the guide rail 50, such that the dilation catheter 40 translates unitarily with one lead nut 80a, 80b and such that the guide rail 50 translates unitarily with the other lead nut 80b, 80a. In this regard, the first and second lead nuts 80a, 80b of the present example have respective central, substantially cylindrical bores 90a, 90b that extend along the central longitudinal axis (LA) and that are configured to facilitate fixedly securing the lead nuts 80a, 80b to the respective ones of the shaft 42 of the dilation catheter 40 or the guide rail 50.

[0040] In some versions, the first lead nut 80a may be fixedly secured to the guide rail 50, while the second lead nut 80b may be fixedly secured to the shaft 42 of the dilationcatheter 40. For example, the central bore 90a of the first lead nut 80a may fixedly retain a proximal end of the guide rail 50, such that the guide rail 50 translates unitarily with the first lead nut 80a, while the central bore 90b of the second lead nut 80b may fixedly retain a proximal end of a drive rod (not shown), such that the drive rod translates unitarily with the second lead nut 80b. A distal portion of the drive rod may be fixedly coupled with the shaft 42 of the dilation catheter 40, such that the dilation catheter 40 translates unitarily with the drive rod. To that end, the drive rod may be routed through the opening 89a of the first lead nut 80a to reach the shaft 42 of the dilation catheter 40, which may be disposed on a distal side of the first lead nut 80a. Thus, when the first actuator 61a is rotated in the first direction about the central longitudinal axis (LA), the guide rail 50 translates distally in response to the distal translation of the first lead nut 80a from the proximal position shown in FIG. 6A to the distal position shown in FIG. 6B. Then, when the second actuator 61b is rotated in the first direction about the central longitudinal axis (LA), the dilation catheter 40 translates distally in response to the distal translation of the second lead nut 80b from the proximal position shown in FIG. 7A to the distal position shown in FIG. 7B. Conversely, when the second actuator 61b is rotated in the second direction about the central longitudinal axis (LA), the dilation catheter 40 translates proximally in response to the proximal translation of the second lead nut 80b from the distal position shown in FIG. 7B to the proximal position shown in FIG. 7A. Then, when the first actuator 61a is rotated in the second direction about the central longitudinal axis (LA), the guide rail 50 translates proximally in response to the proximal translation of the first lead nut 80a from the distal position shown in FIG. 6B to the proximal position shown in FIG. 6A.

[0041] In some other versions, the first lead nut 80a may be fixedly secured to the shaft 42 of the dilation catheter 40, while the second lead nut 80b may be fixedly secured to the guide rail 50. For example, the central bore 90a of the first lead nut 80a may fixedly retain a proximal end of the shaft 42 of the dilation catheter 40, such that the dilation catheter 40 translates unitarily with the first lead nut 80a, while the central bore 90b of the second lead nut 80b may fixedly retain a proximal end of the guide rail 50, such that the guide rail 50 translates unitarily with the second lead nut 80b. In some such cases, the proximal position of the first lead nut 80a may be shifted distally of that shown in FIG. 6A, and / or the distal position of the second lead nut 80b may be shifted proximally of that shown in FIG. 7B. Optionally, this provides sufficient longitudinal clearance between lead nuts 80a, 80b when in the respective proximal positions to permit translation of the second lead nut 80b (together with the guide rail 50) from the respective proximal position to the respective distal position prior to translation of the first lead nut 80a (together with the dilation catheter 40) from the respective proximalposition to the respective distal position. Optionally, this provides sufficient longitudinal clearance between lead nuts 80a, 80b when in the respective distal positions to permit translation of the first lead nut 80a (together with the dilation catheter 40) from the respective distal position to the respective proximal position prior to translation of the second lead nut 80b (together with the guide rail 50) from the respective distal position to the respective proximal position.

[0042] In the example shown, the first and second leadscrews 64a, 64b are angularly aligned with the first and second longitudinal slots 26a, 26b relative to the central longitudinal axis (LA), respectively, such that leadscrews 64a, 64b and / or the corresponding lead nuts 80a, 80b may be visually observed by the operator through the respective longitudinal slots 26a, 26b. For example, the operator may visually observe a longitudinal position of the first or second lead nut 80a, 80b along the respective leadscrew 64a, 64b and may determine a longitudinal position of the dilation catheter 40 or the guide rail 50 based on the observed longitudinal position of the first or second lead nut 80a, 80b, respectively.

[0043] While the actuators 61a, 61b and the corresponding apertures 28a, 28b and the corresponding pinions 70a, 70b of the example shown are positioned at or near a distal end of the handle 12, one or both of the actuators 61a, 61b and the corresponding apertures 28a, 28b and pinions 70a, 70b may alternatively be positioned at or near a proximal end of the handle 12 and / or at any other suitable location along the length of the handle 12. While the actuators 61a, 61b are each rotatable about the central longitudinal axis (LA), one or both of the actuators 61a, 61b may alternatively be rotatable about a respective rotation axis that is perpendicular to the central longitudinal axis (LA). In some such cases, a bevel gear assembly (not shown) may be interposed between the actuator 61a, 61b and the corresponding leadscrew 64a, 64b for converting rotation of the actuator 61a, 61b about the rotation axis that is perpendicular to the central longitudinal axis (LA) into rotation of the corresponding leadscrew 64a, 64b about the central longitudinal axis (LA).

[0044] It should be understood from the foregoing that an operator may grasp the handle 12 with a single hand, and readily manipulate either of the actuators 61a, 61b with a single finger or thumb of that same hand to independently drive the dilation catheter 40 and the guide rail 50 distally and proximally along a full range of longitudinal motion. Moreover, the operator may achieve this full range of longitudinal motion of the dilation catheter 40 and the guide rail 50 without having to move the finger or thumb on the respective actuator 61a, 61b along the same full range of longitudinal motion. In some cases, the operator may achieve the full range of longitudinal motion of the dilation catheter 40 or the guide rail 50 by urging therespective actuator 61a, 61b to rotate via one stroke with the finger or thumb of the hand grasping the handle 12. In some other cases, the operator may drive the respective actuator 61a, 61b with two or more strokes of the finger or thumb to drive the dilation catheter 40 or the guide rail 50 along the full range of longitudinal motion. In either scenario, this interaction with the respective actuator 61a, 61b may be easier for some operators than manipulation of a dilation catheter actuator that must travel longitudinally along the same full range of longitudinal motion of the dilation catheter 40 or the guide rail 50, particularly operators with small hands.

[0045] While the first and second actuation assemblies 60a, 60b are shown in the present example for independently driving translation of the dilation catheter 40 and the guide rail 50, some other versions of the instrument 10 may include only a single actuation assembly 60a, 60b. For example, the first actuation assembly 60a may be configured to drive translation of the dilation catheter 40, and the guide rail 50 may be omitted such that the second actuation assembly 60b may likewise be omitted. As another example, the first actuation assembly 60a may be operable to drive staged longitudinal translation of the guide rail 50 and the dilation catheter 40 in accordance with at least some of the teachings of U.S. Pat. App. No. 63 / 611,229, entitled “Balloon Dilation Instrument with Dilation Catheter Actuator,” filed December 18, 2023. The disclosure of U.S. Pat. App. No. 63 / 611,229, entitled “Balloon Dilation Instrument with Dilation Catheter Actuator,” filed December 18, 2023, is incorporated herein, in its entirety.

[0046] It will be appreciated that the dilation catheter 40 may be advanced distally along a straight guide rail 50 or along a guide rail 50 having a bend formed therein, with the guide rail 50 maintaining the formed bend as the dilation catheter 40 traverses the formed bend to reach the targeted anatomical passageway. Regardless of whether the guide rail 50 is bent or straight, after the dilation catheter 40 reaches the distal position, the balloon 44 may be inflated to dilate the targeted anatomical passageway.

[0047] While the instrument 10 provides translation of the dilation catheter 40 relative to an internal guide in the form of the guide rail 50, some variations of the instrument 10 may provide translation of the dilation catheter 40 relative to any other suitable type of internal guide, such as a guidewire, and / or relative to an external guide, such as a guide catheter or other kind of external guide. Such external guides may be rigid, malleable, or steerable. Versions of the instrument 10 that include an external guide may omit the guide rail 50 and the respective actuation assembly 60a, 60b. It should therefore be understood that the presence of the guide rail 50 is not necessary for proper performance of the actuation assembly 60a, 60bthat drives the dilation catheter 40 in the instrument 10.

[0048] In some variations of the instrument 10 that include a guidewire, that guidewire may be secured to the first lead nut 80a rather than the guide rail 50 being secured to the first lead nut 80a. In such versions, the guidewire may thus translate longitudinally with the first lead nut 80a in response to rotation of the actuator 61a about rotation axis (RAI). In some such versions, the guidewire may be slidably disposed within a lumen or channel in the guide rail 50, such that the guidewire may be extended longitudinally relative to the guide rail 50 to position the distal tip of the guidewire distally in relation to the distal tip of the guide rail 50. In some such versions, the guide rail 50 may be longitudinally fixed relative to the housing 22. In some other versions, the guide rail 50 is movable relative to the housing 22 via actuation of some component other than one of the actuators 61a, 61b. In versions that include a guidewire, the guidewire may further include an illuminating element at or near the distal tip of the guidewire. Such an illuminating element may include an LED, an optical fiber, or some other feature that is capable of providing emission of light at or near the distal tip of the guidewire. In addition, or in the alternative, the guidewire may include a position sensor (e.g., coil, etc.) that provides a signal indicating a position of the distal tip of the guidewire in three- dimensional space (e.g., in response to an externally applied alternating electromagnetic field, etc.). Alternatively, a guidewire may have any other suitable features and may take any other suitable forms.B, Example of Dilation Instrument with Laterally Offset Rotary Member for Translating Dilation Catheter

[0049] FIGS. 8A-8B depict another example of a dilation instrument 110 that may be used to dilate an anatomical passageway in or near an ear, nose, or throat of a patient. The instrument 110 may be similar to the instrument 10 described above, except as otherwise described below. In this regard, the instrument 110 of this example includes a handle 112, a shaft assembly 130 extending distally from the handle 112 along a central longitudinal axis (LA), and a single actuation assembly 160. The actuation assembly 160 is operable to drive longitudinal movement of a dilation catheter 140 along the central longitudinal axis (LA), as described in greater detail below. The handle 112 of the present example includes a housing 122 that may be similar to the housing 22 described above, while the shaft assembly 130 of the present example includes the dilation catheter 140, which may be similar to the dilation catheter 40 described above. In this regard, the dilation catheter 140 of the present example includes a shaft 142 having an integral balloon (not shown) and a distal tip 146. While not shown, theshaft assembly 130 may also include an outer sheath similar to the outer sheath 32 and / or a guide rail similar to the guide rail 50.

[0050] The actuation assembly 160 is operable to drive translation of the dilation catheter 140. The actuation assembly 160 of the present example includes an actuator 161 that is rotatably supported within an interior of the housing 122. The actuator 161 of the present example is in the form of a thumbwheel that is exposed relative to the housing 122 (e.g., via a corresponding aperture extending through a sidewall of the housing 122), where the actuator 161 may be driven to rotate about an offset rotation axis (RA) that is laterally offset from (e.g., radially outward of) and substantially parallel to the central longitudinal axis (LA) by a finger or thumb of the same hand that grasps the handle 112 for one-handed operation of the instrument 110. In some versions, the actuation assembly 160 may further include a dial ring having inner teeth that mesh with outer teeth (not shown) of the actuator 161 in a manner similar to actuators 61a, 61b described above.

[0051] A leadscrew 164 is also rotatably supported by the housing 122 within the interior of the housing 122, such that the leadscrew 164 is configured to rotate about the offset rotation axis (RA). The actuator 161 is fixedly secured to the leadscrew 164, such that the leadscrew 164 rotates about the offset rotation axis (RA) together with the actuator 161. A lead nut 180 is slidably supported within the interior of the housing 122 and has a threaded bore (not shown) that is angularly aligned with the leadscrew 164 relative to the central longitudinal axis (LA) and threadably engages with the leadscrew 164, such that the lead nut 180 translates along the central longitudinal axis (LA) in response to rotation of the leadscrew 164 about the offset rotation axis (RA). A pair of guide pins 184 is fixedly supported by the housing 122 within the interior of the housing 122, such that each guide pin 184 is laterally offset from (e.g., radially outward of) and substantially parallel to the central longitudinal axis (LA). Moreover, the lead nut 180 has two substantially cylindrical bores (not shown) that are angularly aligned with the guide pins 184 relative to the central longitudinal axis (LA) and slidably receive the guide pins 184, such that movement of the lead nut 180 relative to the housing 122 is substantially constrained to translation of the lead nut 180 along the central longitudinal axis (LA).

[0052] Thus, when the actuator 161 is rotated in a first direction (e.g., clockwise or counterclockwise) about the offset rotation axis (RA), the lead nut 180 translates distally from the proximal position shown in FIG. 8 A to the distal position shown in FIG. 8B. When the actuator 161 is rotated in a second direction (e.g., counterclockwise or clockwise) about the offset rotation axis (RA), the lead nut 180 translates proximally from the distal position shownin FIG. 8B to the proximal position shown in FIG. 8 A. The lead nut 180 is fixedly secured to the shaft 142 of the dilation catheter 140, such that the dilation catheter 140 translates unitarily with the lead nut 180. In this regard, the lead nut 180 may have a central, substantially cylindrical bore (not shown) that extends along the central longitudinal axis (LA) and that may fixedly retain a proximal end of the shaft 142 of the dilation catheter 140. Thus, when the actuator 161 is rotated in the first direction about the offset rotation axis (RA), the dilation catheter 140 translates distally from the proximal position shown in FIG. 8A to the distal position shown in FIG. 8B. Conversely, when the actuator 161 is rotated in the second direction about the offset rotation axis (RA), the dilation catheter 140 translates proximally from the distal position shown in FIG. 8B to the proximal position shown in FIG. 8A.II. Examples of Combinations

[0053] The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to restrict the coverage of any claims that may be presented at any time in this application or in subsequent filings of this application. No disclaimer is intended. The following examples are being provided for nothing more than merely illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in numerous other ways. It is also contemplated that some variations may omit certain features referred to in the below examples. Therefore, none of the aspects or features referred to below should be deemed critical unless otherwise explicitly indicated as such at a later date by the inventors or by a successor in interest to the inventors. If any claims are presented in this application or in subsequent filings related to this application that include additional features beyond those referred to below, those additional features shall not be presumed to have been added for any reason relating to patentability.

[0054] Example 1 : An apparatus, comprising: (a) a handle assembly; (b) a guide member extending distally relative to the handle assembly; (c) a dilation catheter slidably disposed relative to the guide member, the dilation catheter being operable to translate relative to the handle assembly along a longitudinal axis through a range of motion from a proximal- most position to a distal-most position, the dilation catheter including: (i) an expandable element configured to dilate a passageway within a head of a patient, and (ii) a distal end; and (d) a dilation catheter actuation assembly, the dilation catheter actuation assembly comprising a first rotary member operable to rotate relative to the handle assembly about a first rotation axis to thereby drive translation of the dilation catheter along the longitudinal axis through therange of motion, the first rotation axis being substantially parallel to the longitudinal axis.

[0055] Example 2: The apparatus of Example 1, the first rotary member comprising a thumbwheel.

[0056] Example 3 : The apparatus of any of Examples 1 through 2, the first rotary member comprising a pinion.

[0057] Example 4: The apparatus of any of Examples 1 through 3, the dilation catheter actuation assembly further comprising a first lead nut slidably disposed in the handle assembly, the first rotary member being operatively coupled with the first lead nut such that the first rotary member is rotatable about the first rotation axis to drive translation of the first lead nut along the longitudinal axis, the first lead nut being configured to drive translation of the dilation catheter along the longitudinal axis.

[0058] Example 5: The apparatus of Example 4, the dilation catheter actuation assembly further comprising a first guide pin fixedly supported by the handle assembly, the first lead nut being slidable along the first guide pin.

[0059] Example 6: The apparatus of any of Examples 4 through 5, the dilation catheter actuation assembly further comprising a first leadscrew rotatably supported by the handle assembly, the first rotary member being operatively coupled with the first lead nut via the first leadscrew.

[0060] Example 7: The apparatus of Example 6, the first leadscrew being operable to rotate relative to the handle assembly about the first rotation axis.

[0061] Example 8: The apparatus of any of Examples 6 through 7, the first rotary member being fixedly secured to the first leadscrew.

[0062] Example 9: The apparatus of any of Examples 1 through 8, a first portion of the first rotary member being exposed relative to the handle assembly, a second portion of the first rotary member being positioned in an interior region of the handle assembly.

[0063] Example 10: The apparatus of any of Examples 1 through 9, the guide member comprising at least one of a guide rail or a guidewire.

[0064] Example 11 : The apparatus of any of Examples 1 through 10, the guide member being slidably positioned within a lumen of the dilation catheter.

[0065] Example 12: The apparatus of any of Examples 1 through 11, the guide member and the dilation catheter being configured such that a distal end of the guide member is distal to the distal end of the dilation catheter when the dilation catheter is in the proximal- most position, the guide member and the dilation catheter being further configured such that the distal end of the guide member is proximal to the distal end of the dilation catheter whenthe dilation catheter is in the distal-most position.

[0066] Example 13: The apparatus of any of Examples 1 through 12, the dilation catheter actuation assembly further comprising a first dial ring operable to rotate relative to the handle assembly about the longitudinal axis to thereby drive rotation of the first rotary member about the first rotation axis.

[0067] Example 14: The apparatus of any of Examples 1 through 13, the guide member being operable to translate relative to the handle assembly along the longitudinal axis.

[0068] Example 15: The apparatus of Example 14, further comprising a guide member actuation assembly, the guide member actuation assembly comprising a second rotary member operable to rotate relative to the handle assembly about a second rotation axis to thereby drive translation of the guide member along the longitudinal axis, the second rotation axis being substantially parallel to the longitudinal axis.

[0069] Example 16: The apparatus of Example 15, the guide member actuation assembly further comprising a second lead nut slidably disposed in the handle assembly, the second rotary member being operatively coupled with the second lead nut such that the second rotary member is rotatable about the second rotation axis to drive translation of the second lead nut along the longitudinal axis, the second lead nut being configured to drive translation of the guide member along the longitudinal axis.

[0070] Example 17: The apparatus of Example 16, the guide member actuation assembly further comprising a second leadscrew rotatably supported by the handle assembly, the second rotary member being operatively coupled with the second lead nut via the second leadscrew.

[0071] Example 18: The apparatus of any of Examples 15 through 17, the guide member actuation assembly further comprising a second dial ring operable to rotate relative to the handle assembly about the longitudinal axis to thereby drive rotation of the second rotary member about the second rotation axis.

[0072] Example 19: The apparatus of any of Examples 1 through 18, the expandable element comprising a balloon.

[0073] Example 20: The apparatus of any of Examples 1 through 19, the first rotary member being configured for rotation via a plurality of strokes to thereby drive translation of the dilation catheter along the longitudinal axis through the range of motion.

[0074] Example 21 : An apparatus, comprising: (a) a handle assembly; (b) a guide member extending distally relative to the handle assembly; (c) a dilation catheter slidably disposed relative to the guide member, the dilation catheter being operable to translate relativeto the handle assembly along a longitudinal axis through a range of motion from a proximal- most position to a distal-most position, the dilation catheter including: (i) an expandable element configured to dilate a passageway within a head of a patient, and (ii) a distal end; and (d) a dilation catheter actuation assembly, the dilation catheter actuation assembly comprising: (i) a first rotary member operable to rotate relative to the handle assembly about a first rotation axis, the first rotation axis being parallel to the longitudinal axis, (ii) a first leadscrew operable to rotate relative to the handle assembly about the first rotation axis in response to rotation of the first rotary member relative to the handle assembly about the first rotation axis, and (iii) a first lead nut operable to translate relative to the handle assembly along the longitudinal axis in response to rotation of the first leadscrew relative to the handle assembly about the first rotation axis, the first lead nut being configured to drive translation of the dilation catheter along the longitudinal axis through the range of motion.

[0075] Example 22: The apparatus of Example 21, further comprising a second rotary member operable to rotate relative to the handle assembly about the longitudinal axis to thereby drive rotation of the first rotary member about the first rotation axis.

[0076] Example 23: The apparatus of any of Examples 21 through 22, the guide member being operable to translate relative to the handle assembly along the longitudinal axis.

[0077] Example 24: The apparatus of Example 23, further comprising a guide member actuation assembly, the guide member actuation assembly comprising: (i) a second rotary member operable to rotate relative to the handle assembly about a second rotation axis, the second rotation axis being parallel to the longitudinal axis, (ii) a second leadscrew operable to rotate relative to the handle assembly about the second rotation axis in response to rotation of the second rotary member relative to the handle assembly about the second rotation axis, and (iii) a second lead nut operable to translate relative to the handle assembly along the longitudinal axis in response to rotation of the second leadscrew relative to the handle assembly about the second rotation axis, the second lead nut being configured to drive translation of the guide member along the longitudinal axis.

[0078] Example 25: The apparatus of Example 24, the first and second lead nuts being configured to drive translation of the dilation catheter and the guide member, respectively, independently of each other.

[0079] Example 26: The apparatus of any of Examples 24 through 25, the first lead nut having a first unthreaded feature configured to accommodate the second leadscrew.

[0080] Example 27: The apparatus of Example 26, the second lead nut having a second unthreaded feature configured to accommodate the first leadscrew.

[0081] Example 28: The apparatus of Example 27, each of the first and second unthreaded features including at least one of a channel or a bore.

[0082] Example 29: The apparatus of any of Examples 24 through 28, the dilation catheter actuation assembly further comprising a first guide pin fixedly supported by the handle assembly, the first lead nut being slidable along the first guide pin, the guide member actuation assembly further comprising a second guide pin fixedly supported by the handle assembly, the second lead nut being slidable along the second guide pin.

[0083] Example 30: The apparatus of Example 29, the first lead nut having a first opening configured to accommodate the second guide pin, the second lead nut having a second opening configured to accommodate the first guide pin.

[0084] Example 31 : An apparatus, comprising: (a) a handle assembly; (b) a dilation catheter operable to translate relative to the handle assembly along a longitudinal axis through a range of motion from a proximal-most position to a distal-most position, the dilation catheter including: (i) an expandable element configured to dilate a passageway within a head of a patient, and (ii) a distal end; and (c) a first actuation assembly, the first actuation assembly comprising a rotary member operable to rotate relative to the handle assembly about a rotation axis to thereby drive translation of the dilation catheter along the longitudinal axis through the range of motion, the rotation axis being substantially parallel to the longitudinal axis.

[0085] Example 32: The apparatus of Example 31, further comprising a guide element slidably disposed relative to the dilation catheter, the guide element having a distal end.

[0086] Example 33: The apparatus of Example 32, at least one of the dilation catheter or the guide element including an indicator element, the indicator element being configured to indicate a position of the distal end of the at least one of the dilation catheter or the guide element in three-dimensional space.

[0087] Example 34: The apparatus of Example 33, the indicator element comprising one or more of a position sensor coil or an illuminating element.

[0088] Example 35: The apparatus of any of Examples 31 through 34, the guide element being operable to translate relative to the handle assembly along the longitudinal axis.

[0089] Example 36: The apparatus of Example 35, further comprising a second actuation assembly configured to drive translation of the guide element along the longitudinal axis.

[0090] Example 37: The apparatus of any of Examples 32 through 36, the guide element comprising at least one of a guide rail or a guidewire.

[0091] Example 38: The apparatus of any of Examples 32 through 37, the guide element being malleable.

[0092] Example 39: The apparatus of any of Examples 32 through 38, the guide element being slidably positioned within a lumen of the dilation catheter.

[0093] Example 40: The apparatus of any of Examples 31 through 39, the expandable element comprising a balloon.III. Miscellaneous

[0094] It should be understood that any of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any of the other teachings, expressions, embodiments, examples, etc. that are described herein. The abovedescribed teachings, expressions, embodiments, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0095] It should be appreciated that any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

[0096] Versions of the devices described above may be designed to be disposed of after a single use, or they can be designed to be used multiple times. Versions may, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning may include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, some versions of the device may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, some versions of the device may be reassembled for subsequent use either at a reconditioning facility or by a user immediately prior to a procedure. Those skilled in the art will appreciate that reconditioning of a device may utilize a variety of techniques fordisassembly, cleaning / replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0097] By way of example only, versions described herein may be sterilized before and / or after a procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK bag. The container and device may then be placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation may kill bacteria on the device and in the container. The sterilized device may then be stored in the sterile container for later use. A device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

[0098] Having shown and described various embodiments of the present inventions, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one skilled in the art without departing from the scope of the present inventions. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present inventions should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

WHAT IS CLAIMED IS:

1. A dilation instrument, comprising: a handle assembly; a guide member extending distally relative to the handle assembly; a dilation catheter slidably disposed relative to the guide member, the dilation catheter being operable to translate relative to the handle assembly along a longitudinal axis through a range of motion from a proximal-most position to a distal-most position, the dilation catheter comprising: an expandable element configured to dilate a passageway within a head of a patient, and a distal end; and a dilation catheter actuation assembly, the dilation catheter actuation assembly comprising a first rotary member operable to rotate relative to the handle assembly about a first rotation axis to thereby drive translation of the dilation catheter along the longitudinal axis through the range of motion, the first rotation axis being substantially parallel to the longitudinal axis.

2. The dilation instrument of Claim 1, wherein the first rotary member comprises a thumbwheel.

3. The dilation instrument of any of the preceding Claims, wherein the first rotary member comprises a pinion.

4. The dilation instrument of any of the preceding Claims, wherein the dilation catheter actuation assembly further comprises a first lead nut slidably disposed in the handle assembly and configured to drive translation of the dilation catheter along the longitudinal axis, and the first rotary member is operatively coupled with the first lead nut such that the first rotary member is rotatable about the first rotation axis to drive translation of the first lead nut along the longitudinal axis.

5. The dilation instrument of Claim 4, wherein the dilation catheter actuation assembly further comprises a first guide pin fixedly supported by the handle assembly, the first lead nut being slidable along the first guide pin.

6. The dilation instrument of any of Claims 4 through 5, wherein the dilation catheter actuation assembly further comprises a first leadscrew rotatably supported by the handle assembly, the first rotary member being operatively coupled with the first lead nut via the first leadscrew.

7. The dilation instrument of Claim 6, wherein the first leadscrew is operable to rotate relative to the handle assembly about the first rotation axis.

8. The dilation instrument of any of Claims 6 through 7, wherein the first rotary member is fixedly secured to the first leadscrew.

9. The dilation instrument of any of the preceding Claims, wherein a first portion of the first rotary member is exposed relative to the handle assembly, and a second portion of the first rotary member is positioned in an interior region of the handle assembly.

10. The dilation instrument of any of the preceding Claims, wherein the guide member comprises at least one of a guide rail or a guidewire.

11. The dilation instrument of any of the preceding Claims, wherein the guide member is slidably positioned within a lumen of the dilation catheter.

12. The dilation instrument of any of the preceding Claims, wherein the guide member and the dilation catheter are configured such that a distal end of the guide member is distal to the distal end of the dilation catheter when the dilation catheter is in the proximal-most position, and the guide member and the dilation catheter are further configured such that the distal end of the guide member is proximal to the distal end of the dilation catheter when the dilation catheter is in the distal-most position.

13. The dilation instrument of any of the preceding Claims, wherein the dilation catheter actuation assembly further comprises a first dial ring operable to rotate relative to the handle assembly about the longitudinal axis to thereby drive rotation of the first rotary member about the first rotation axis.

14. The dilation instrument of any of the preceding Claims, wherein the guide member is operable to translate relative to the handle assembly along the longitudinal axis.

15. The dilation instrument of Claim 14, further comprising a guide member actuation assembly that comprises a second rotary member operable to rotate relative to the handle assembly about a second rotation axis to thereby drive translation of the guide member along the longitudinal axis, the second rotation axis being substantially parallel to the longitudinal axis.

16. The dilation instrument of Claim 15, wherein the guide member actuation assembly further comprises a second lead nut slidably disposed in the handle assembly and configured to drive translation of the guide member along the longitudinal axis, and the second rotary member is operatively coupled with the second lead nut such that the second rotary member is rotatable about the second rotation axis to drive translation of the second lead nut along the longitudinal axis.

17. The dilation instrument of Claim 16, wherein the guide member actuation assembly further comprises a second leadscrew rotatably supported by the handle assembly, and the second rotary member is operatively coupled with the second lead nut via the second leadscrew.

18. The dilation instrument of any of Claims 15 through 17, wherein the guide member actuation assembly further comprises a second dial ring operable to rotate relative to the handle assembly about the longitudinal axis to thereby drive rotation of the second rotary member about the second rotation axis.

19. The dilation instrument of any of the preceding Claims, wherein the expandable element comprises a balloon.

20. The dilation instrument of any of the preceding Claims, wherein the first rotary member is configured to rotate via a plurality of strokes to thereby drive translation of the dilation catheter along the longitudinal axis through the range of motion.

21. A dilation instrument, comprising: a handle assembly; a guide member extending distally relative to the handle assembly; a dilation catheter slidably disposed relative to the guide member, the dilation catheter being operable to translate relative to the handle assembly along a longitudinal axis through a range of motion from a proximal-most position to a distal-most position, the dilation catheter comprising: an expandable element configured to dilate a passageway within a head of a patient, and a distal end; and a dilation catheter actuation assembly, the dilation catheter actuation assembly comprising: a first rotary member operable to rotate relative to the handle assembly about a first rotation axis, the first rotation axis being parallel to the longitudinal axis, a first leadscrew operable to rotate relative to the handle assembly about the first rotation axis in response to rotation of the first rotary member relative to the handle assembly about the first rotation axis, and a first lead nut operable to translate relative to the handle assembly along the longitudinal axis in response to rotation of the first leadscrew relative to the handle assembly about the first rotation axis, the first lead nut being configuredto drive translation of the dilation catheter along the longitudinal axis through the range of motion.

22. The dilation instrument of Claim 21 , further comprising a second rotary member operable to rotate relative to the handle assembly about the longitudinal axis to thereby drive rotation of the first rotary member about the first rotation axis.

23. The dilation instrument of any of Claims 21 through 22, wherein the guide member is operable to translate relative to the handle assembly along the longitudinal axis.

24. The dilation instrument of Claim 23, further comprising a guide member actuation assembly, the guide member actuation assembly comprising: a second rotary member operable to rotate relative to the handle assembly about a second rotation axis, the second rotation axis being parallel to the longitudinal axis; a second leadscrew operable to rotate relative to the handle assembly about the second rotation axis in response to rotation of the second rotary member relative to the handle assembly about the second rotation axis; and a second lead nut operable to translate relative to the handle assembly along the longitudinal axis in response to rotation of the second leadscrew relative to the handle assembly about the second rotation axis, the second lead nut being configured to drive translation of the guide member along the longitudinal axis.

25. The dilation instrument of Claim 24, wherein the first and second lead nuts are configured to drive translation of the dilation catheter and the guide member, respectively, independently of each other.

26. The dilation instrument of any of Claims 24 through 25, wherein the first lead nut comprises a first unthreaded feature configured to accommodate the second leadscrew.

27. The dilation instrument of Claim 26, wherein the second lead nut comprises a second unthreaded feature configured to accommodate the first leadscrew.

28. The dilation instrument of Claim 27, wherein each of the first and second unthreaded features comprises at least one of a channel or a bore.

29. The dilation instrument of any of Claims 24 through 28, wherein the dilation catheter actuation assembly further comprises a first guide pin fixedly supported by the handle assembly and slidable along the first guide pin, and the guide member actuation assembly further comprises a second guide pin fixedly supported by the handle assembly and slidable along the second guide pin.

30. The dilation instrument of Claim 29, wherein the first lead nut comprises a first opening configured to accommodate the second guide pin, and the second lead nut comprises a second opening configured to accommodate the first guide pin.

31. A dilation instrument, comprising: a handle assembly; a dilation catheter operable to translate relative to the handle assembly along a longitudinal axis through a range of motion from a proximal-most position to a distal- most position, the dilation catheter comprising: an expandable element configured to dilate a passageway within a head of a patient, and a distal end; and a first actuation assembly comprising a rotary member operable to rotate relative to the handle assembly about a rotation axis to thereby drive translation of the dilation catheter along the longitudinal axis through the range of motion, the rotation axis being substantially parallel to the longitudinal axis.

32. The dilation instrument of Claim 31, further comprising a guide element slidably disposed relative to the dilation catheter and comprising a distal end.

33. The dilation instrument of Claim 32, wherein at least one of the dilation catheter or the guide element comprises an indicator element configured to indicate a position of the distal end of the at least one of the dilation catheter or the guide element in three-dimensional space.

34. The dilation instrument of Claim 33, wherein the indicator element comprises one or more of a position sensor coil or an illuminating element.

35. The dilation instrument of any of Claims 32 through 34, wherein the guide element is operable to translate relative to the handle assembly along the longitudinal axis.

36. The dilation instrument of Claim 35, further comprising a second actuation assembly configured to drive translation of the guide element along the longitudinal axis.

37. The dilation instrument of any of Claims 32 through 36, wherein the guide element comprises at least one of a guide rail or a guidewire.

38. The dilation instrument of any of Claims 32 through 37, wherein the guide element is malleable.

39. The dilation instrument of any of Claims 32 through 38, wherein the guide element is slidably positioned within a lumen of the dilation catheter.

40. The dilation instrument of any of Claims 31 through 39, wherein the expandable element comprises a balloon.

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