WO2025193875A1

WO2025193875A1 - Dilation instrument with cable drive for catheter

Info

Publication number: WO2025193875A1
Application number: PCT/US2025/019638
Authority: WO
Inventors: Alex GONZALEZ; Cesar FUENTES-ORTEGA; Henry F. SALAZAR; Brittanie Chu
Original assignee: Acclarent Inc
Current assignee: Acclarent Inc
Priority date: 2024-03-13
Filing date: 2025-03-12
Publication date: 2025-09-18
Anticipated expiration: 2026-09-13

Abstract

A dilation apparatus can include a body, a guide member, a dilation catheter, and a dilation catheter actuation assembly. The dilation catheter is slidably disposed relative to the guide member between a proximal position and a distal position. The dilation catheter actuation assembly is configured to drive the dilation catheter relative to the guide member between the proximal position and the distal position. The dilation catheter actuation assembly includes a first cable and a first pulley. The first cable includes an anchor attached to the proximal shaft of the dilation catheter. The first pulley is rotatably coupled to the body via a first axle. The first pulley is configured to rotate relative to the body via the first axle in a first angular direction to simultaneously gather a portion of the first cable and actuate the dilation catheter toward the distal position.

Description

DILATION INSTRUMENT WITH CABLE DRIVE FOR CATHETER

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/564,582, filed March 13, 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 guidewire 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, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 9,579,448, entitled “Balloon Dilation Catheter System for Treatment and Irrigation of the Sinuses,” issued February 28, 2017, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 9,155,492, entitled “Sinus Illumination Lightwire Device,” issued October 13, 2015, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pub. No. 2021/0361912, entitled “Shaft Deflection Control Assembly for ENT Guide Instrument,” published November 25, 2021, the disclosure of which is incorporated by reference herein, in its entirety.

[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 from the 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, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pat. No. 11,013,896, entitled “Method and System for Eustachian Tube Dilation,” issued May 25, 2021, the disclosure of which is incorporated by reference herein, in its entirety.

[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, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 11,013,897, entitled “Apparatus for Bending Malleable Guide of Surgical Instrument,” issued May 25, 2021, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pat. No. 11,534,192, entitled “Methods and Apparatus for Treating Disorders of the Sinuses,” issued December 27, 2022, the disclosure of which is incorporated by reference herein, in its entirety.

[0005] Image-guided surgery (IGS) is a technique where a computer is used to obtain a real-time correlation of the location of an instrument that has been inserted into a patient's body to a set of preoperatively obtained images (e.g., a CT or MRI scan, 3-D map, etc.), such that the computer system may superimpose the current location of the instrument on the preoperatively obtained images. An example of an electromagnetic IGS navigation system that may be used in IGS procedures is the TRUDI® Navigation System by Acclarent, Inc., of Irvine, California. In some IGS procedures, a digital tomographic scan (e.g., CT or MRI, 3-D map, etc.) of the operative field is obtained prior to surgery. A specially programmed computer is then used to convert the digital tomographic scan data into a digital map. During surgery, some instruments can include sensors (e.g., electromagnetic coils that emit electromagnetic fields and/or are responsive to externally generated electromagnetic fields), which can be used to perform the procedure while the sensors send data to the computer indicating the current position of each sensor-equipped instrument. The computer correlates the data it receives from the sensors with the digital map that was created from the preoperative tomographic scan. The tomographic scan images are displayed on a video monitor along with an indicator (e.g., crosshairs or an illuminated dot, etc.) showing the real-time position of each surgical instrument relative to the anatomical structures shown in the scan images. The surgeon is thus able to know the precise position of each sensor-equipped instrument by viewing the video monitor even if the surgeon is unable to directly visualize the instrument itself at its current location within the body. Examples of IGS systems that may be used in the ENT context are described in U.S. Pat. No. 7,720,521, entitled “Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” issued May 18, 2010, the disclosure of which is incorporated by reference herein, in its entirety; and U.S. Pat. No. 10,561,370, entitled “Apparatus to Secure Field Generating Device to Chair,” issued February 18, 2020, the disclosure of which is incorporated by reference herein, in its entirety.

[0006] 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 invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

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

[0008] FIG. 1 A depicts a perspective view of an example of a medical instrument, with a dilation catheter in a retracted position;

[0009] FIG. IB depicts a perspective view of the medical instrument of claim 1 A, with the dilation catheter in an extended position;

[0010] FIG. 2A depicts a schematic cross-sectional side view of an alternative medical instrument, with a dilation catheter in a retracted position;

[0011] FIG. 2B depicts a schematic cross-sectional side view of the medical instrument of FIG. 2A, with a dilation catheter drive assembly actuating the dilation catheter into an extended position;

[0012] FIG. 2C depicts a schematic cross-sectional side view of the medical instrument of FIG. 2 A, with the dilation catheter drive assembly actuating the dilation catheter from the extended position back into the retracted position;

[0013] FIG. 3 A depicts a schematic cross-sectional side view of another alternative medical instrument, with a dilation catheter in a retracted position;

[0014] FIG. 3B depicts a schematic cross-sectional side view of the medical instrument of FIG. 2A, with a dilation catheter drive assembly actuating the dilation catheter into an extended position;

[0015] FIG. 3C depicts a schematic cross-sectional side view of the medical instrument of FIG. 2 A, with the dilation catheter drive assembly actuating the dilation catheter from the extended position back into the retracted position;

[0016] FIG. 4A depicts a schematic cross-sectional side view of another alternative medical instrument, with a dilation catheter in a retracted position;

[0017] FIG. 4B depicts a schematic cross-sectional side view of the medical instrument of FIG. 2A, with a dilation catheter drive assembly actuating the dilation catheter into an extended position; and

[0018] FIG. 4C depicts a schematic cross-sectional side view of the medical instrument of FIG. 2 A, with the dilation catheter drive assembly actuating the dilation catheter from the extended position back into the retracted position.

DETAILED DESCRIPTION

[0019] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

[0020] 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.

[0021] 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.

[0022] I. Illustrative Dilation Instrument with Translatable Dilation Catheter

[0023] 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 the targeted anatomical passageway.

[0024] FIGS. 1A-1B shows an illustrative handheld dilation instrument (100). Dilation instrument (100) includes a handle assembly (110), an outer sheath (120) extending distally from handle assembly (110), a dilation catheter (130) slidably disposed within outer sheath (120), and a guide rail (140) disposed within a lumen (138) defined by dilation catheter (130). Handle assembly (110) includes an elongate body (112) defining a slot (114), and an actuator (116). Actuator (116) is slidably disposed relative to elongate body (112) along a longitudinal path. Actuator (116) may be slidably attached to elongate body (112) using any suitable features as would be apparent to one skilled in the art in view of the teachings herein. For example, actuator (116) may be attached to at least one longitudinally extending rail protruding outwardly from the exterior surface of elongate body (112). As another example, actuator (116) may include a portion slidably contained within a slot defined by elongate body (112), such that a portion of actuator (116) is housed within the internal confines of elongate body (112).

[0025] An operator may grasp elongate body (112) with a single handle to control the placement of dilation instrument (100) and use a finger/thumb of the same hand to control the placement of actuator (116) relative to elongate body (112). In the current example, the user may translate actuator (116) longitudinally along elongate body (112). As best shown between FIGS. 1A-1B, actuator (116) is operatively attached to dilation catheter (130) such that translation of actuator (116) relative to elongate body (112) drives translation of dilation catheter (130) relative to elongate body (112), outer sheath (120), and guide rail (140). Instrument (100) may include any suitable dilation catheter drive assembly interposed between actuator (116) and dilation catheter (130) that may be utilized to convert movement of actuator (116) relative to elongate body (120) into corresponding movement of dilation catheter (130) in accordance with the description herein.

[0026] Outer sheath (120) includes a rigid tube (122) defining a lumen that terminates into an open distal end (124). Guide rail (140) extends distally from open distal end (124) of rigid tube (122). In some instances, guide rail (140) is fixed to rigid tube (122). In some instances, guide rail (140) and/or rigid tube (122) may be configured to rotate and/or translate relative to handle assembly (110) to achieve various spatial configurations suitable for accessing different anatomical passageways (e.g., suitable configurations for the maxillary sinus ostium, the frontal recess, the sphenoid sinus ostium, the eustachian tube, etc.). In some instances, guide rail (140) terminates proximally within rigid tube (122) at a location distal relative to elongate body (112). In other instances, guide rail (140) extends within the confines of handle assembly (110).

[0027] Guide rail (140) of the present example is malleable and has an atraumatic distal tip (142). In some versions, distal tip (142) is dome shaped. In some other versions, distal tip (142) is enlarged (e.g., configured as a ball tip or blueberry tip, etc.). The malleability of guide rail (140) allows guide rail (140) to be bent to a desired bend angle before being inserted into the head of the patient. The malleability of guide rail (140) may allow guide rail (140) to maintain the bend angle while guide rail (140) is disposed in the head of the patient, including while dilation catheter (130) is advanced distally relative to guide rail (140) in accordance with the description herein. Such operability of guide rail (140) may promote access by dilation catheter (130) to various locations within the head of a patient, such as the maxillary sinus ostium, the frontal recess, the sphenoid sinus ostium, the eustachian tube, etc., based on the selected bend angle.

[0028] By way of example only, the bending of guide rail (140) 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 which is incorporated by reference herein, in its entirety. By way of example only, malleable guide rail may be provided in accordance with at least some of the teachings ofU.S. Pat. No. 10,137,285, entitled “Balloon Dilation System with Malleable Internal Guide,” issued November 27, 2018, the disclosure of which is incorporated by reference herein, in its entirety; U.S. Pat. No. 11,013,897, entitled “Apparatus for Bending Malleable Guide of Surgical Instrument,” issued May 25, 2021, the disclosure of which is incorporated by reference herein, in its entirety; and/or U.S. Pat. No. 11,534,192, entitled “Methods and Apparatus for Treating Disorders of the Sinuses,” issued December 27, 2022, the disclosure of which is incorporated by reference herein, in its entirety.

[0029] In some instances, guide rail (140) may define a lumen (not shown). Such a lumen (now shown) may be configured to slidably receive a guide wire (not shown) such that the distal tip of guide wire (not shown) may acuate distal and proximal relative to distal tip (142) of guide rail (140). Alternatively, any other suitable kind(s) of element may be disposed in lumen (not shown) of guide rail (140). In some instances, such a lumen (not shown) defined by guide rail (140) may be utilized for aspiration and/or delivery of suitable fluids/medicants as would be apparent to one skilled in the art in view of the teachings herein. In some other variations, guide rail (140) may be solid such that lumen (785) is omitted.

[0030] In some instances, in addition to or in lieu of providing guide rail (140), rigid tube (122) may be configured to promote advancement of open distal end (124) within a suitable opening of a patient (e.g., transnasally, orally, etc.) to thereby promote access by dilation catheter (130) to various locations within the head of a patient. In such instances, open distal end (124) of outer sheath (120) is dimensioned to be inserted within a patient to position open distal end (124) adjacent to a targeted anatomical passageway to be dilated. In some instances, a distal portion of rigid tube (122) near open distal end (124) may be curved/bent to promote suitable access to a targeted anatomical passageway to be dilated. In some instances, a distal portion of outer sheath (120) near open distal end (124) may be configured to selectively bend relative to the longitudinal axis of instrument (100) to better position open end (124) into alignment of the targeted anatomical passageway to be dilated. For instance, the distal portion of outer sheath (120) may be malleable, may be steerable (e.g., via one or more pull-wires, etc.), or may otherwise be selectively bent. In some other versions, the distal portion of outer sheath (120) includes a rigid, pre-formed bend.

[0031] A lumen defined by rigid tube (122) is in communication with an interior of elongate body (112). As mentioned above, dilation catheter (130) is slidably disposed within outer sheath (120). Dilation catheter (130) includes an elongate shaft (132) and a dilator in the form of a balloon (134). Balloon (134) is attached to a distal end of elongate shaft (132). A proximal portion of elongate shaft (132) extends proximally past the lumen defined by rigid tube (122) into the interior of elongate body (112). The portion of elongate shaft (132) extending within the interior of elongate body (112) is operatively coupled to actuator (116) such that translation of actuator (116) relative to elongate body (112) drives translation of dilation catheter (130) relative to elongate body (112), outer sheath (120), and guide rail (140). As mentioned above, instrument (100) may include any suitable drive assembly interposed between actuator (116) and dilation catheter (130) that may be utilized to convert movement of actuator (116) relative to elongate body (120) into corresponding movement of dilation catheter (130) in accordance with the description herein. Therefore, a user may actuate dilation catheter (130) relative to outer sheath (120) and/or guide rail (140), thereby translating dilation catheter (130) distally relative to outer sheath (120) and/or guide rail (140), by translating actuator (116) relative to elongate body (112).

[0032] Elongate shaft (132) defines two lumens in the current example. A first lumen of elongate shaft (132) is in fluid communication with an interior of balloon (134). The first lumen of elongate shaft (132) is also configured to selectively couple with a fluid source (10). Therefore, a user may communicate fluid (e.g., saline, etc.) from fluid source (10), through the first lumen defined by elongate shaft (132), and into the interior of balloon (134) to selectively expand and contract balloon (134) between an inflated and deflated configuration. A second lumen (138) defined by elongate shaft (132) extends into an open distal end (136). Guide rail (140) is disposed within second lumen (138) such that dilation catheter (130) may actuate relative to guide rail (140) along a path defined by guide rail (140). Therefore, dilation catheter (130) is slidably disposed over guide rail (140). Therefore, guide catheter (130) may actuate relative to guide rail (140) between a proximal position (see FIG. 1 A) and a distal position (see FIG. IB).

[0033] During illustrative use, dilation catheter (130) may be initially in the proximal position relative to guide rail (140) as shown in FIG. 1A (i.e., a preloaded configuration). It should be undersotod that while balloon (134) is in the preloaded configuration, balloon (134) may be in the deflated configuration. With dilation catheter (130) in the proximal position, a user may grasp handle assembly (110) to advance distal tip (142) of guide rail (140) within a patient until open distal tip (142) is suitably positioned relative to a targeted anatomical passageway.

[0034] Once guide rail (140) is suitably positioned, a user may advance actuator (116) distally relative to elongate body (112) to advance balloon catheter (130) distally along the path defined by guide rial (140), thereby advancing balloon (134) within the targeted anatomical passageway to be dilated. Once balloon (134) is suitably disposed within the targeted anatomical passageway, a user may inflate balloon (134) via fluid source (10) and the first lumen defined by elongate shaft (132) such that balloon (134) expands into the inflated configuration. Balloon (134) may remain in the inflated configuration until the anatomical passageway is suitably dilated. In some instances, balloon (134) may transition between the inflated and deflated configuration multiple times to suitably dilate the targeted anatomical passage. Once the targeted anatomical passageway is suitably dilated, a user may deflate balloon (134), proximally retract balloon (134) and guide rail (140) toward the preloaded configuration, and then remove outer sheath (120) from the patient.

[0035] II. Illustrative Dilation Catheter Drive Assemblies

[0036] As noted above, instrument (100) includes an actuator (116) operatively attached to dilation catheter (130) via a dilation catheter drive assembly such that movement of actuator (116) relative to elongate body (112) drives actuation of dilation catheter (130) relative to guide rail (140). FIGS. 2A-4C show illustrative instruments (200, 300, 400) having various dilation catheter drive assemblies (250, 350, 400) configured to actuate a respective dilation catheter (230, 330, 430) along a respective guide rail (240, 340, 440) in accordance with the description herein. Therefore, it should be understood that each dilation catheter drive assembly (250, 350, 450) may be readily incorporated into instrument (100), either in replacement of actuator (116) or in conjunction with actuator (116), to actuate dilation catheter (130) along guide rail (140).

[0037] FIGS. 2A-2C show an illustrative handheld dilation instrument (200) that may be used in replacement of instrument (100) described above. Therefore, handheld dilation instrument (200) may be substantially similar to instrument (100) described above, with differences elaborated herein. Instrument (200) includes handle assembly (210) having an elongate body (212), an outer sheath (220) having a rigid tube (222), an open distal end (224), a dilation catheter (230), an elongate shaft (232), a balloon (234), an open distal end (236), and a guide rail (240) terminating into a distal tip (242); which may be substantially similair to handle assembly (110), elongate body (112), outer sheath (120), rigid tube (122), open distal end (124), dilation catheter (130), elongate shaft (132), balloon (134), open distal end (136), guide rail (140), and distal tip (142) described above, respectively, with differences elaborated below.

[0038] Dilation catheter (230) is configured to actuate along guide rail (240) between a proximal position (see FIGS. 2A and 2C) and a distal position (see FIG. 2B) to suitably access and dilate a targeted anatomical passageway in accordance with the description herein. Dilation catheter (230) is slidably supported by other suitable components of instrument (200) such that a proximal portion of dilation catheter (230) actuates along a predetermined path when actuated in accordance with the description herein. Dilation catheter (230) may be slidably supported by handle assembly (210), shaft assembly (220), guide rail (240), and/or any other suitable components as would be apparent to one skilled in the art in view of the teachings herein. Dilation catheter (230) and/or handle assembly (210) is configured to suitably attach to fluid source (10) in substantially similar manner to dilation catheter (130) and/or handle assembly (110) described above.

[0039] As will be described in greater detail below, instrument (200) includes dilation catheter drive assembly (250) that may be utilized to acuate a dilation catheter (230) along guide rail (240) between the proximal position (see FIGS. 2A and 2C) and the distal position (see FIG. 2B). Dilation catheter drive assembly (250) includes a distal actuation assembly (252) and a proximal actuation assembly (262); which are configured to distally advance dilation catheter (230) along guide rail (240) (see FIG. 2B) and proximally retract dilation catheter (230) along guide rail (240) (see FIG. 2C), respectively.

[0040] Distal actuation assembly (252) includes a thumbwheel (254), a pulley (256), and a cable (258) having a catheter anchor end (255) and a pulley section (257). In the current example, thumbwheel (254) and pulley (256) are substantially fixed to each other such that thumbwheel (254) and pulley (256) move together relative to elongated body (212) in accordance with the description herein. Thumbwheel (254) and pulley (256) are rotationally coupled to elongate body (212) of handle assembly (210) via axle (259), which extends along an axis into and out of the view shown in FIGS. 2A-2C. Thumbwheel (254) and pulley (256) may be rotatably coupled to handle assembly (210) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein.

[0041] Thumbwheel (254) and pulley (256) are located within an interior (218) defined by elongated body (212). Additionally, a portion of thumbwheel (254) extends out of an exterior surface of elongated body (212) via an opening (214) defined by the exterior surface of elongated body (212). Therefore, a portion of thumbwheel (254) is accessible by an operator holding handle assembly (210) in accordance with the description herein. In particular, an operator may rotate thumbwheel (254) about axle (259) with a finger/thumb of the hand holding handle assembly (210) to distally advance dilation catheter (230) along guide rail (240) in accordance with the description herein. Opening (214) may have any suitable dimension as would be apparent to one skilled in the art in view of the teaching herein. For example, opening (214) may be big enough just to allow thumbwheel (254) to rotate about axle (259) relative to elongate body (212). As another example, opening (214) may comprise a longitudinally extending slot that extends along a substantial length of elongate body (212).

[0042] Pulley (256) is operatively coupled with pulley section (257) of cable (258) such that rotation of pulley (256) about axle (259) in a first rotational direction causes cable (258) to be gathered by pulley (256). Conversely, rotation of pulley (256) about axle (259) in a second, opposite, rotational direction causes cable (258) to be released by pulley (256).

[0043] Cable (258) is housed within interior (218) of elongate body (212). Cable (258) is configured to move along a predetermined path within interior (218) to drive catheter (230) distally along guide rail (240) and also allow for proximal actuation assembly (262) to proximally retract catheter (230) in accordance with the description herein. In some instances, handle assembly (210) may include features configured to guide cable (258) along the predetermined path. For example, elongate body (212) may define a channel configured to guide cable (258); and/or may include bosses or other projections configured to guide cable (258).

[0044] Catheter anchor end (255) of cable (258) is suitably attached/fixed to dilation catheter (230) such that when pulley (256) is rotated to gather pulley section (257) of cable (258), such movement drives dilation catheter (230) distally along guide rail (240). Therefore, as shown in FIG. 2B, an operator may rotate thumbwheel (254) in the first rotational direction to thereby actuate dilation catheter (230) distally along guide rail (240) in accordance with the description herein. Additionally, as also shown in FIG. 2B, when thumbwheel (254) and pulley (256) drive dilation catheter (230) distally along guide rail, a thumbwheel (264) and a pulley (266) of proximal actuation assembly (262) rotate freely relative to elongate body (212) to thereby release suitable portions of a respective cable (268).

[0045] In some instances, an actuator (substantially similar to actuators (116) described above) may be slidably coupled to elongate body (212) and engaged with thumbwheel (254) such that translation of actuator (not shown) causes rotation of thumbwheel (254). Such an actuator (not shown) may be slidably attached to elongate body (212) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein. For example, elongate body (212) may define an elongate slot that slidably houses a portion of such an actuator (not shown). As another example, elongate body (212) may have rails

-I l protruding from its exterior surface that slidably support such an actuator (now shown).

[0046] As will be described in greater detail below, and as shown in FIG. 2C, when proximal actuation assembly (262) drives dilation catheter (230) proximally along guide rail (240) in accordance with the description herein, thumbwheel (254) and pulley (256) are configured to rotate in the second, opposite, rotational direction to thereby release suitable portions of pulley section (257) of cable (258).

[0047] Proximal actuation assembly (262) includes thumbwheel (264), pulley (266), and cable (268) having a catheter anchor end (265) and a pulley section (267). In the current example, thumbwheel (264) and pulley (266) are substantially fixed to each other such that thumbwheel (264) and pulley (266) move together relative to elongated body (212) in accordance with the description herein. Thumbwheel (264) and pulley (266) are rotationally coupled to elongated body (212) of handle assembly (210) via axle (269), which extends along an axis into and out of the views of FIGS. 2A-2C. Thumbwheel (264) and pulley (266) may be rotationally coupled to handle assembly (210) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein.

[0048] Thumbwheel (264) and pulley (266) are located within an interior (218) defined by elongated body (212). Additionally, a portion of thumbwheel (264) extends out of an exterior surface of elongated body (212) via an opening (216) defined by the exterior surface of elongated body (212).

[0049] Therefore, a portion of thumbwheel (264) is accessible by an operator holding handle assembly (210) in accordance with the description herein. In particular, an operator may rotate thumbwheel (264) about axle (269) with a finger/thumb of the hand holding handle assembly (210) to proximally retract dilation catheter (230) along guide rail (240) in accordance with the description herein. Opening (216) may have any suitable dimension as would be apparent to one skilled in the art in view of the teaching herein. For example, opening (216) may be big enough just to allow thumbwheel (264) to rotate about axle (269) relative to elongated body (212). As another example, opening (216) may comprise a longitudinally extending slot that extends along a substantial length of elongate body (212).

[0050] Pulley (266) is operatively coupled with pulley section (267) of cable (268) such that rotation of pulley (266) about axle (269) in a rotational direction causes cable (268) to be gathered by pulley (266). Conversely, rotation of pulley (266) about axle (269) in the opposite rotational direction causes cable (268) to be released by pulley (266).

[0051] Cable (268) is housed within interior (218) of elongate body (212). Cable (268) is configured to move along a predetermined path within interior (218) to drive catheter (230) proximally along guide rail (240) and also allow for distal actuation assembly (252) to distally drive catheter (230) in accordance with the description herein. In some instances, handle assembly (210) may include features configured to guide cable (268) along the predetermined path. For example, elongate body (212) may define a channel configured to guide cable (268); and/or may include bosses or other projections configured to guide cable (268).

[0052] Catheter anchor end (265) of cable (268) is suitably attached/fixed to dilation catheter (230) such that when pulley (266) is rotated to gather pulley section (267) of cable (258), such movement drives dilation catheter (230) proximally along guide rail (240). Therefore, as shown in FIG. 2C, an operator may rotate thumbwheel (264) in a rotational direction about axle (269) to thereby actuate dilation catheter (230) proximally along guide rail (240) in accordance with the description herein. Additionally, as also shown in FIG. 2C, when thumbwheel (264) and pulley (266) drive dilation catheter (230) proximally along guide rail, thumbwheel (254) and pulley (256) of distal actuation assembly (252) rotate freely relative to elongate body (212) to thereby release suitable portions of a respective cable (258).

[0053] In some instances, an actuator (substantially similar to actuators (116) described above) may be slidably coupled to elongate body (212) and engaged with thumbwheel (264) such that translation of actuator (not shown) causes rotation of thumbwheel (264). Such an actuator (not shown) may be slidably attached to elongate body (212) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein. For example, elongate body (212) may define an elongate slot that slidably houses a portion of such an actuator (not shown). As another example, elongate body (212) may have rails protruding from its exterior surface that slidably support such an actuator (now shown).

[0054] In the current example, thumbwheels (254, 264) are longitudinally offset from each other and located on top and bottom portions of handle assembly (210), respectively. However, this is merely optional. Thumbwheels (254, 264) may be located at any suitable location along handle assembly (210) as would be apparent to one skilled in the art in view of the teachings herein. For example, thumbwheels (254, 264) may be located on the same top or bottom portion of handle assembly (210). In such instances, a suitable cable (258, 268) may be guided along a predetermined path within interior (218) of handle assembly (210) such that rotation of thumbwheels (254, 264) in a common rotational direction about their respective rotational axles (259, 269) achieves the desired functionality as described herein. In such instances, a single actuator (not shown) may be slidably attached to handle assembly (210) and configured to rotate both thumbwheels (254, 264) simultaneously to thereby actuate catheter (230) both distally and proximally in response to sliding along handle assembly (210).

[0055] FIGS. 3A-3C show another illustrative handheld dilation instrument (300) that may be used in replacement of instrument (100) described above. Therefore, handheld dilation instrument (300) may be substantially similar to instrument (100) described above, with differences elaborated herein. Instrument (300) includes handle assembly (310) having an elongate body (312), an outer sheath (320) having a rigid tube (322), an open distal end (324), a dilation catheter (330), an elongate shaft (332), a balloon (334), an open distal end (336), and a guide rail (340) terminating into a distal tip (342); which may be substantially similar to handle assembly (110), elongate body (112), outer sheath (120), rigid tube (122), open distal end (124), dilation catheter (130), elongate shaft (132), balloon (134), open distal end (136), guide rail (140), and distal tip (142) described above, respectively, with differences elaborated below.

[0056] Dilation catheter (330) is configured to actuate along guide rail (340) between a proximal position (see FIGS. 3A and 3C) and a distal position (see FIG. 3B) to suitably access and dilate a targeted anatomical passageway in accordance with the description herein. Dilation catheter (330) is slidably supported by other suitable components of instrument (300) such that a proximal portion of dilation catheter (330) actuates along a predetermined path when actuated in accordance with the description herein. Dilation catheter (330) may be slidably supported by handle assembly (310), shaft assembly (320), guide rail (340), and/or any other suitable components as would be apparent to one skilled in the art in view of the teachings herein. Dilation catheter (330) and/or handle assembly (310) is configured to suitably attach to fluid source (10) in substantially similar manner to dilation catheter (130) and/or handle assembly (110) described above.

[0057] As will be described in greater detail below, instrument (300) includes a dilation catheter drive assembly (350) that may be utilized to acuate a dilation catheter (330) along guide rail (340) between a proximal position (see FIGS. 3 A and 3C) and a distal position (see FIG. 3B). Dilation catheter drive assembly (350) includes a thumbwheel (354), a pulley (356), a cable (358), a proximal post (360), and a distal post (362).

[0058] In the current example, thumbwheel (354) and pulley (356) are substantially fixed to each other such that thumbwheel (354) and pulley (356) move together relative to elongated body (312) in accordance with the description herein. Thumbwheel (354) and pulley (356) are rotationally coupled to elongate body (312) of handle assembly (310) via axle (359), which extends along an axis into and out of the view shown in FIGS. 3A-3C. Thumbwheel (354) and pulley (356) may be rotationally coupled to handle assembly (310) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein.

[0059] Thumbwheel (354) and pulley (356) are located within an interior (318) defined by elongated body (312). Additionally, a portion of thumbwheel (354) extends out of an exterior surface of elongated body (312) via an opening (314) defined by the exterior surface of elongated body (312). Therefore, a portion of thumbwheel (354) is accessible by an operator holding handle assembly (310) in accordance with the description herein. In particular, an operator may rotate thumbwheel (354) about axle (359) with a finger/thumb of the hand holding handle assembly (310) to distally advance and proximally retract dilation catheter (330) along guide rail (340) in accordance with the description herein. Opening (314) may have any suitable dimension as would be apparent to one skilled in the art in view of the teaching herein. For example, opening (314) may be big enough just to allow thumbwheel (354) to rotate about axle (359) relative to elongate body (312). As another example, opening (314) may be a longitudinally extending slot that extends along a substantial length of elongate body (312).

[0060] Proximal post (360) and distal post (362) are each fixed to elongate shaft (332) of dilation catheter (330). Additionally, cable (358) is fixed to each post (360, 362) via a proximal anchor (355) and a distal anchor (357), respectively. In other words, one end of cable (358) is secured to post (360) while the other end of cable (358) is secured to post (368), with an intermediate region of cable (358) being wrapped around pulley (356). In some versions, cable (358) is wrapped around pulley (356) once. In some other versions, cable (358) is wrapped around pulley (356) two or more times. Cable (358) and posts (360, 362) are configured to acuate with elongate shaft (332) of dilation catheter (330) relative to handle assembly (310) and guide rail (340) in accordance with the description herein. Therefore, cable (358) and posts (360, 362) are also configured to actuate relative to axle (359), with which thumbwheel (354) and pulley (356) are coupled.

[0061] As shown in FIG. 3B, pulley (356) is operatively coupled with cable (358) with sufficient tension such that rotation of pulley (356) about axle (359) in a first rotational direction causes a proximal portion of cable (358) (i.e. the portion of cable interposed between pulley (356) and proximal post (360)) to be gathered by pulley (356) while a distal potion of cable (358) (i.e., the portion of cable interposed between pulley (356) and distal post (362)) is simultaneously released by pulley (356). Such simultaneous feeding and releasing of cable (358) drives cable (358) distally relative to pulley (356), thumbwheel (354), and handle assembly (310). Since cable (358) is also attached to dilation catheter (330) via posts (360, 362), distal movement of cable (358) relative to handle assembly (310) drives distal movement of dilation catheter (330) relative to guide rail (340).

[0062] Conversely, as shown in FIG. 3C, pulley (356) is operatively coupled with cable (358) with sufficient tension such that rotation of pulley (356) about axle (359) in a second, opposite, rotational direction causes the proximal portion of cable (358) to be released by pulley (356) while the distal portion of cable (358) is simultaneously gathered by pulley (356). Such simultaneous releasing and feeding of cable (358) drives cable (358) proximal relative to pulley (356), thumbwheel (354), and handle assembly (310). Since cable (358) is also attached to dilation catheter (330) via posts (360, 362), proximal movement of cable (358) relative to handle assembly (310) drives proximal movement of dilation catheter (330) relative to guide rail (340).

[0063] Therefore, an operator may suitably control the position of dilation catheter (330) relative to guide rail (340) by rotating thumbwheel (354) in a first rotational direction about axle (359), and a second, opposite, rotational direction about axle (359).

[0064] In some instances, an actuator (substantially similar to actuators (116) described above) may be slidably coupled to elongate body (312) and engaged with thumbwheel (354) such that translation of actuator (not shown) causes rotation of thumbwheel (354). Such an actuator (not shown) may be slidably attached to elongate body (312) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein. For example, elongate body (312) may define an elongate slot that slidably houses a portion of such an actuator (not shown). As another example, elongate body (312) may have rails protruding from its exterior surface that slidably support such an actuator (now shown).

[0065] FIGS. 4A-4C show another illustrative handheld dilation instrument (400) that may be used in replacement of instrument (100) described above. Therefore, handheld dilation instrument (400) may be substantially similar to instrument (100) described above, with differences elaborated herein. Instrument (400) includes handle assembly (410) having an elongate body (412), an outer sheath (420) having a rigid tube (422), an open distal end (424), a dilation catheter (430), an elongate shaft (432), a balloon (434), an open distal end (436), and a guide rail (440) terminating into a distal tip (442); which may be substantially similar to handle assembly (110), elongate body (112), outer sheath (120), rigid tube (122), open distal end (124), dilation catheter (130), elongate shaft (132), balloon (134), open distal end (136), guide rail (140), and distal tip (142) described above, respectively, with differences elaborated below.

[0066] Dilation catheter (430) is configured to actuate along guide rail (440) between a proximal position (see FIGS. 4A and 4C) and a distal position (see FIG. 4B) to suitably access and dilate a targeted anatomical passageway in accordance with the description herein. Dilation catheter (430) is slidably supported by other suitable components of instrument (400) such that a proximal portion of dilation catheter (430) actuates along a predetermined path when actuated in accordance with the description herein. Dilation catheter (430) may be slidably supported by handle assembly (410), shaft assembly (420), guide rail (440), and/or any other suitable components as would be apparent to one skilled in the art in view of the teachings herein. Dilation catheter (430) and/or handle assembly (410) is configured to suitably attach to fluid source (10) in substantially similar manner to dilation catheter (130) and/or handle assembly (110) described above.

[0067] As will be described in greater detail below, instrument (400) includes a dilation catheter drive assembly (450) that may be utilized to acuate a dilation catheter (430) along guide rail (440) between a proximal position (see FIGS. 4A and 4C) and a distal position (see FIG. 4B). Dilation catheter drive assembly (450) includes a thumbwheel (454), a pulley (456), a cable (458), a proximal post (460), and a bias spring (462).

[0068] In the current example, thumbwheel (454) and pulley (456) are substantially fixed to each other such that thumbwheel (454) and pulley (456) move together relative to elongated body (412) in accordance with the description herein. Thumbwheel (454) and pulley (456) are rotationally coupled to elongate body (412) of handle assembly (410) via axle (459), which extends along an axis into and out of the view shown in FIGS. 4A-4C. Thumbwheel (454) and pulley (456) may be rotationally coupled to handle assembly (410) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein.

[0069] Thumbwheel (454) and pulley (456) are located within an interior (418) defined by elongated body (412). Additionally, a portion of thumbwheel (454) extends out of an exterior surface of elongated body (412) via an opening (414) defined by the exterior surface of elongated body (412). Therefore, a portion of thumbwheel (454) is accessible by an operator holding handle assembly (410) in accordance with the description herein. In particular, an operator may rotate thumbwheel (454) about axle (459) with a finger/thumb of the hand holding handle assembly (410) to distally advance and proximally retract dilation catheter (430) along guide rail (440) in accordance with the description herein. Opening (414) may have any suitable dimension as would be apparent to one skilled in the art in view of the teaching herein. For example, opening (414) may be big enough just to allow thumbwheel (454) to rotate about axle (459) relative to elongate body (412). As another example, opening (414) may comprise a longitudinally extending slot that extends along a substantial length of elongate body (412).

[0070] Pulley (456) is operatively coupled with pulley section (457) of cable (458) such that rotation of pulley (456) about axle (459) in a first rotational direction causes cable (458) to be gathered by pulley (456). Conversely, rotation of pulley (456) about axle (459) in a second, opposite, rotational direction causes cable (458) to be released by pulley (456).

[0071] Post (460) is fixed to elongate shaft (432) of dilation catheter (430). Anchor

(455) of cable (458) is suitably attached/fixed to post (460) and/or dilation catheter (430) such that when pulley (456) is rotated to gather pulley section (457) of cable (458), such movement drives dilation catheter (430) distally along guide rail (440). Therefore, as shown in FIG. 4B, an operator may rotate thumbwheel (454) in the first rotational direction to thereby actuate dilation catheter (430) distally along guide rail (440) in accordance with the description herein.

[0072] Bias spring (462) is coupled to dilation catheter (430) and a suitable portion of handle assembly (410), such as a portion of elongate body (412) defining interior (418). Bias spring (462) urges dilation catheter (430) toward the proximal position shown in FIGS. 4A and 4C. Therefore, in instances where pulley section (457) is gathered by pulley (456) to distally actuate dilation catheter (430), spring (462) may be utilized to actuate dilation catheter (430) proximally to thereby cause pulley section (457) of cable (458) to be released by pulley

(456) such that pulley (456) and thumbwheel (454) rotate in the second, opposite, rotation direction (see. FIG. 4C). Spring (462) may have any suitable characteristics as would be apparent to one skilled in the art in view of the teachings herein. For example, spring (462) comprise be a coil spring interposed between handle (410) and dilation catheter (420). As another example, spring (462) may comprise a torsional spring interposed between thumbwheel (454) and elongate body (412), where the torsion spring (462) biases thumbwheel (454) toward the second, opposite rotational direction. Alternatively, any other suitable form of resilient member may be used to effectively resiliently bias dilation catheter (430) toward the proximal position shown in FIGS. 4 A and 4C.

[0073] In some instances, while guide catheter (430) is in a distal position (e.g., the position shown in FIG. 4B), thumbwheel (454), pulley (456), cable (458), and or other suitable components, may contain a suitable amount of static and/or dynamic frictional braking force that overcomes the proximal bias urged by spring (462). Such a frictional braking force may inhibit spring (462) from actuating dilation catheter (430) back into the proximal position when an operator releases thumbwheel (454) after distally advancing dilation catheter (430) along guide rail (440). Therefore, in such instances, an operator would have to rotate thumbwheel (454) in the second, opposite direction, to allow spring (462) to suitably retract dilation catheter (430) into the proximal position. As another example, dilation catheter drive assembly (450) may include a manually actuated and/or manually released braking feature, such that the operator may manipulate such a braking feature to maintain dilation catheter (430) in the distal position and/or release dilation catheter (430) from the distal position. By way of further example only, a ratcheting assembly may prevent spring (462) from pulling a distally positioned dilation catheter (430) back to the proximal position until the operator releases a pawl of the ratcheting assembly. Alternatively, instrument (400) may have any other suitable features that inhibit spring (462) from inadvertently actuating dilation catheter (430) toward the proximal position while dilation catheter (430) is in the distal position shown in FIG. 4B.

[0074] Cable (458) is housed within interior (418) of elongate body (412). Cable (458) is configured to move along a predetermined path within interior (418) to drive catheter (430) distally along guide rail (440) and also allow for proximal actuation assembly (462) to proximally retract catheter (430) in accordance with the description herein. In some instances, handle assembly (410) may include features configured to guide cable (458) along the predetermined path. For example, elongate body (412) may define a channel configured to guide cable (458); and/or may include bosses or other projections configured to guide cable (458).

[0075] In some instances, an actuator (substantially similar to actuators (116) described above) may be slidably coupled to elongate body (412) and engaged with thumbwheel (454) such that translation of actuator (not shown) causes rotation of thumbwheel (454). Such an actuator (not shown) may be slidably attached to elongate body (412) via any suitable means as would be apparent to one skilled in the art in view of the teachings herein. For example, elongate body (412) may define an elongate slot that slidably houses a portion of such an actuator (not shown). As another example, elongate body (412) may have rails protruding from its exterior surface that slidably support such an actuator (now shown).

[0076] III. Examples of Combinations

[0077] 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.

[0078] Example 1 : A dilation apparatus, comprising: (a) a body; (b) a guide member extending distally relative to the body; (c) a dilation catheter slidably disposed relative to the guide member between a proximal position and a distal position, the dilation catheter comprising: (i) an expandable element configured to dilate an anatomical passageway within a patient, and (ii) a proximal shaft; and (d) a dilation catheter actuation assembly configured to drive the dilation catheter relative to the guide member between the proximal position and the distal position, the dilation catheter actuation assembly comprising: (i) a first cable comprising an anchor attached to the proximal shaft of the dilation catheter, and (ii) a first pulley rotatably coupled to the body via a first axle, the first pulley being configured to rotate relative to the body via the first axle in a first angular direction to simultaneously gather a portion of the first cable and actuate the dilation catheter toward the distal position.

[0079] Example 2: The dilation apparatus of Example 1, the body comprising a handle defining an interior.

[0080] Example 3 : The dilation apparatus of Example 2, the first cable and the first pulley being housed within the interior of the handle.

[0081] Example 4: The dilation apparatus of any of Examples 1 through 3, further comprising a thumbwheel fixed to the first pulley.

[0082] Example 5: The dilation apparatus of Example 4, a portion of the thumbwheel extending exteriorly to the body.

[0083] Example 6: The dilation apparatus of any of Examples 1 through 5, the dilation catheter actuation assembly further comprising a second cable and a second pulley.

[0084] Example 7: The dilation apparatus of Example 6, the second cable comprising a second anchor attached to the proximal shaft of the dilation catheter.

[0085] Example 8: The dilation apparatus of Example 7, the second pulley being rotatably coupled to the body via a second axle, the second pulley being configured to rotate relative to the body via the second axle to simultaneously gather a portion of the second cable and acuate the dilation catheter toward the proximal position.

[0086] Example 9: The dilation apparatus of Example 8, the second pulley being positioned proximally relative to the first pulley.

[0087] Example 10: The dilation apparatus of any of Examples 7 through 8, the second pulley being located on a bottom side of the body, the first pulley being located on a top side of the body.

[0088] Example 11 : The dilation apparatus of any of Examples 1 through 5, the dilation catheter actuation assembly further comprising a proximal post fixed to the proximal shaft of the dilation catheter.

[0089] Example 12: The dilation apparatus of Example 11, the anchor being fixed to the proximal post.

[0090] Example 13: The dilation apparatus of any of Examples 11 through 12, the dilation catheter actuation assembly further comprising a distal post fixed to the proximal shaft of the dilation catheter, the first cable having a second anchor fixed to the distal post to the shaft.

[0091] Example 14: The dilation apparatus of Example 13, the first pulley being configured to rotate relative to the body via the first axle in a second angular direction to simultaneously gather a portion of the cable and actuate the dilation catheter toward the proximal position.

[0092] Example 15: The dilation apparatus of any of Examples 11 through 12, the dilation catheter actuation assembly further comprising a resilient member biasing the dilation catheter toward the proximal position.

[0093] Example 16: The dilation apparatus of Example 15, the first pulley being configured to rotate relative to the body via the first axle in a second angular direction to simultaneously release a portion of the cable and actuate the dilation catheter toward the proximal position.

[0094] Example 17: A dilation apparatus, comprising: (a) a handle defining an interior, the handle comprising an exterior surface defining an opening in communication with the interior; (b) a guide member extending distally relative to the handle; (c) a dilation catheter slidably disposed relative to the guide member between a proximal position and a distal position, (i) a ballon configured to dilate an anatomical passageway within a patient, and (ii) a proximal shaft; and (d) a dilation catheter actuation assembly configured to drive the dilation catheter relative to the guide member between the proximal position and the distal position, the dilation catheter actuation assembly comprising: (i) a cable housed within the interior of the handle, the cable comprising a first end fixed relative to a proximal end of the proximal shaft, (ii) a pulley rotatably coupled to the handle about an axle, the pulley being configured to rotate relative to the handle in a first angular direction to simultaneously gather a portion of the cable and actuate the dilation catheter toward the distal position, and (iii) a thumbwheel partially housed within the interior of the handle, the thumbwheel being fixed to the pulley, the thumbwheel having a portion extending out of the interior of the handle via the opening.

[0095] Example 18: The dilation apparatus of Example 17, the dilation catheter actuation assembly further comprising an actuator configured to slide along the exterior surface of the handle to thereby rotate the thumbwheel.

[0096] Example 19: The dilation apparatus of Example 18, the actuator being slidably disposed within the opening.

[0097] Example 20: A dilation apparatus, comprising: (a) a handle assembly comprising an elongate body defining an interior; (b) a guide rail extending distally relative to the body; (c) a dilation catheter slidably disposed relative to the guide rail between a proximal position and a distal position; and (d) a dilation catheter actuation assembly configured to drive the dilation catheter relative to the guide rail between the proximal position and the distal position, the dilation catheter actuation assembly comprising: (i) a cable affixed to a portion of the dilation catheter housed within the interior of the handle, and (ii) a pulley housed within the interior of the handle, the pulley being configured to rotate in a first angular direction to simultaneously gather a portion of the cable and actuate the dilation catheter toward the distal position.

[0098] IV. Miscellaneous

[0099] 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.

[0100] 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.

[0101] 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 for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0102] 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.

[0103] Having shown and described various embodiments of the present invention, 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 invention. 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 invention 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

I/We claim:

1. A dilation apparatus, comprising:

(a) a body;

(b) a guide member extending distally relative to the body;

(c) a dilation catheter slidably disposed relative to the guide member between a proximal position and a distal position, the dilation catheter comprising:

(i) an expandable element configured to dilate an anatomical passageway within a patient, and

(ii) a proximal shaft; and

(d) a dilation catheter actuation assembly configured to drive the dilation catheter relative to the guide member between the proximal position and the distal position, the dilation catheter actuation assembly comprising:

(i) a first cable comprising an anchor attached to the proximal shaft of the dilation catheter, and

(ii) a first pulley rotatably coupled to the body via a first axle, the first pulley being configured to rotate relative to the body via the first axle in a first angular direction to simultaneously gather a portion of the first cable and actuate the dilation catheter toward the distal position.

2. The dilation apparatus of Claim 1, the body comprising a handle defining an interior.

3. The dilation apparatus of Claim 2, the first cable and the first pulley being housed within the interior of the handle.

4. The dilation apparatus of Claim 1, further comprising a thumbwheel fixed to the first pulley.

5. The dilation apparatus of Claim 4, a portion of the thumbwheel extending exteriorly to the body.

6. The dilation apparatus of Claim 1, the dilation catheter actuation assembly further comprising a second cable and a second pulley.

7. The dilation apparatus of Claim 6, the second cable comprising a second anchor attached to the proximal shaft of the dilation catheter.

8. The dilation apparatus of Claim 7, the second pulley being rotatably coupled to the body via a second axle, the second pulley being configured to rotate relative to the body via the second axle to simultaneously gather a portion of the second cable and acuate the dilation catheter toward the proximal position.

9. The dilation apparatus of Claim 8, the second pulley being positioned proximally relative to the first pulley.

10. The dilation apparatus of Claim 7, the second pulley being located on a bottom side of the body, the first pulley being located on a top side of the body.

11. The dilation apparatus of Claim 1, the dilation catheter actuation assembly further comprising a proximal post fixed to the proximal shaft of the dilation catheter.

12. The dilation apparatus of Claim 11, the anchor being fixed to the proximal post.

13. The dilation apparatus of Claim 11, the dilation catheter actuation assembly further comprising a distal post fixed to the proximal shaft of the dilation catheter, the first cable having a second anchor fixed to the distal post to the shaft.

14. The dilation apparatus of Claim 13, the first pulley being configured to rotate relative to the body via the first axle in a second angular direction to simultaneously gather a portion of the cable and actuate the dilation catheter toward the proximal position.

15. The dilation apparatus of Claim 11, the dilation catheter actuation assembly further comprising a resilient member biasing the dilation catheter toward the proximal position.

16. The dilation apparatus of Claim 15, the first pulley being configured to rotate relative to the body via the first axle in a second angular direction to simultaneously release a portion of the cable and actuate the dilation catheter toward the proximal position.

17. A dilation apparatus, comprising:

(a) a handle defining an interior, the handle comprising an exterior surface defining an opening in communication with the interior;

(b) a guide member extending distally relative to the handle;

(c) a dilation catheter slidably disposed relative to the guide member between a proximal position and a distal position,

(i) a ballon configured to dilate an anatomical passageway within a patient, and

(ii) a proximal shaft; and (d) a dilation catheter actuation assembly configured to drive the dilation catheter relative to the guide member between the proximal position and the distal position, the dilation catheter actuation assembly comprising:

(i) a cable housed within the interior of the handle, the cable comprising a first end fixed relative to a proximal end of the proximal shaft,

(ii) a pulley rotatably coupled to the handle about an axle, the pulley being configured to rotate relative to the handle in a first angular direction to simultaneously gather a portion of the cable and actuate the dilation catheter toward the distal position, and

(iii) a thumbwheel partially housed within the interior of the handle, the thumbwheel being fixed to the pulley, the thumbwheel having a portion extending out of the interior of the handle via the opening.

18. The dilation apparatus of Claim 17, the dilation catheter actuation assembly further comprising an actuator configured to slide along the exterior surface of the handle to thereby rotate the thumbwheel.

19. The dilation apparatus of Claim 18, the actuator being slidably disposed within the opening.

20. A dilation apparatus, comprising:

(a) a handle assembly comprising an elongate body defining an interior;

(b) a guide rail extending distally relative to the body;

(c) a dilation catheter slidably disposed relative to the guide rail between a proximal position and a distal position; and

(d) a dilation catheter actuation assembly configured to drive the dilation catheter relative to the guide rail between the proximal position and the distal position, the dilation catheter actuation assembly comprising:

(i) a cable affixed to a portion of the dilation catheter housed within the interior of the handle, and

(ii) a pulley housed within the interior of the handle, the pulley being configured to rotate in a first angular direction to simultaneously gather a portion of the cable and actuate the dilation catheter toward the distal position.