Shaft Deflection Control Assembly for ENT Guidance Instruments

Abstract

The present invention discloses a device, which includes a main body, a shaft assembly and a deflection actuation assembly. The shaft defines a longitudinal axis and includes a flexible distal portion. The deflection actuation assembly includes a first rotary actuator, a translatable actuation member and an elastic member. The translatable actuation member extends through the shaft assembly and is coupled to the first rotary actuator and the flexible distal portion of the shaft assembly. The first rotary actuator can be rotated by a rotational force to longitudinally drive the translatable actuation member. The elastic member is positioned between the first rotary actuator and the main body and is configured to apply a frictional force between the first rotary actuator and the main body. The frictional force is operable to increase the rotational force required to rotate the first rotary actuator.

Description

[0001] Priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 028,609, filed May 22, 2020, entitled "Shaft Deflection Control Assembly for ENT Guide Instrument", the disclosure of which is hereby incorporated by reference in its entirety. BACKGROUND OF THE INVENTION

[0003] In some cases, it may be desirable to dilate an anatomical passageway within a patient. This can include paranasal sinus ostium dilation (e.g., to treat sinusitis), laryngeal dilation, eustachian tube dilation, dilation of other passageways within the ear, nose, or throat, etc. One method of dilating an anatomical passageway includes positioning an inflatable balloon within the anatomical passageway using a guidewire and catheter, and then inflating the balloon with a fluid (e.g., saline) to dilate the anatomical passageway. For example, an expandable balloon can be positioned within the ostium at the paranasal sinus and then inflated to thereby dilate the ostium by remodeling the bone adjacent to the ostium, without the need to incise the mucosa or remove any bone. The then-dilated ostium can allow for improved drainage and ventilation from the affected paranasal sinus. Systems that can be used to perform such procedures can be provided in accordance with the teachings of U.S. Publication 2011 / 0004057, published Jan. 6, 2011, entitled "Systems and Methods for Transnasal Dilation of Passageways in the Ear, Nose or Throat" (now abandoned), the disclosure of which is hereby incorporated by reference in its entirety. An example of such a system is the Spin Balloon Sinuplasty system provided by Acclarent, Inc. (Irvine, California). Spin Balloon Sinuplasty system.

[0004] In the context of eustachian tube dilation, a dilation catheter or other dilation device can be inserted into the eustachian tube and then inflated or otherwise expanded to dilate the eustachian tube. The dilated eustachian tube can provide improved ventilation from the nasopharynx to the middle ear and further provide improved drainage from the middle ear to the nasopharynx. Methods and devices for dilating the eustachian tube are disclosed in the following U.S. patents: U.S. Patent Publication 2010 / 0274188, entitled "Method and System for Treating Target Tissue within the Et," published on October 28, 2010 (now abandoned), the entire disclosure of which is incorporated herein by reference; and U.S. Patent Publication 2013 / 0274715, entitled "Method and System for Eustachian Tube Dilation," published on October 17, 2013 (now abandoned), the entire disclosure of which is incorporated herein by reference. An example of such a system is the Eustachian tube balloon dilation system provided by Acclarent, Inc. (Irvine, California).

[0005] Although a variable viewing direction endoscope can be used to provide visualization within an anatomical passage, it may also be desirable to provide additional visual confirmation of the correct positioning of the balloon before inflation. This can be achieved using an illuminated guidewire. Such a guidewire can be positioned within the target area and then illuminated by light projected from the distal end of the guidewire. The light can illuminate adjacent tissue (e.g., dermis, subcutaneous tissue, etc.) and can thus be visible to the naked eye from outside the patient through percutaneous illumination. For example, when the distal end is positioned within the maxillary sinus, the light can be visible through the patient's cheek. Using such external visualization to confirm the position of the guidewire, the balloon can then be advanced distally along the guidewire to the position at the dilation site. Such an illuminated guidewire can be provided in accordance with the teachings of U.S. Patent 9,155,492, entitled "Sinus Illumination Lightwire Device," filed on October 13, 2015, the entire disclosure of which is incorporated herein by reference. An example of such an illuminated guidewire is the Relieva Luma provided by Acclarent, Inc. (Irvine, California). Sinus illumination system.

[0006] Image-guided surgery (IGS) is a technique in which a computer is used to obtain real-time correlation between the position of an instrument inserted into a patient and a set of pre-operative images (e.g., CT or MRI scans, 3-D maps, etc.), such that the computer system can overlay the current position of the instrument on the pre-operative images. An example of an electromagnetic IGS navigation system that can be used in IGS surgery is the 3 system. In some IGS surgeries, a digital tomogram of the surgical area (e.g., CT or MRI, 3D map, etc.) is obtained prior to the surgery. The digital tomogram data is then converted into a digital map using a specially programmed computer. During the surgery, special instruments with sensors (e.g., electromagnetic coils that emit electromagnetic fields and / or respond to externally generated electromagnetic fields) are used to perform the procedure while the sensors send data to a computer indicating the current position of each surgical instrument. The computer correlates the data received from the sensors with the digital map generated from the pre-operative tomogram. The tomogram images, along with indicators (e.g., crosshairs or illuminated points, etc.), are shown on a video monitor, thereby showing the real-time position of each surgical instrument relative to the anatomical structures shown in the scan image. Even though the surgeon cannot directly visually inspect the current position of the in-vivo instrument itself, the surgeon can know the exact position of each sensor-equipped instrument by looking at the video monitor.

[0007] An example of an electromagnetic IGS system that can be used in ENT and sinus surgeries is the one provided by Biosense-Webster, Inc., Irvine, California 3 Systems. When applied to functional endoscopic sinus surgery (FESS), sinus balloon dilation, and / or other ENT procedures, the use of the IGS system enables the surgeon to more precisely move and position surgical instruments compared to what can be achieved by endoscopic observation alone. Thus, the IGS system may be particularly useful during the performance of FESS, sinus balloon dilation, and / or other ENT procedures in the absence or difficulty of visually viewing anatomical landmarks from the endoscope. Examples of the use of the IGS system in ENT surgery are described in the following U.S. patents: U.S. Patent Publication 2014 / 0364725, published December 11, 2014, entitled "Systems and Methods for Performing Image - Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses" (now abandoned), the entire disclosure of which is incorporated herein by reference; and U.S. Patent 10,561,370, issued February 18, 2020, entitled "Apparatus to Secure Field Generating Device to Chair", the entire disclosure of which is incorporated herein by reference.

[0008] It may be desirable to easily and controllably place the balloon of the dilation catheter in an anatomical passage (including in surgeries to be performed by a single operator only). Although several systems and methods have been developed and used to position the balloon of a dilation catheter in an anatomical passage, it is believed that no one prior to the present inventors has developed or used the invention described in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Although the claims that particularly point out and distinctly claim the invention follow the description, it is believed that the invention may be better understood from the following description of certain examples in conjunction with the drawings, in which like reference numerals represent like elements, and in which:

[0010] Figure 1A A perspective view of an exemplary dilation instrument is shown, where the guide wire and the dilation catheter are each in their respective proximal positions;

[0011] Figure 1B Shows Figure 1A a perspective view of the instrument, where the guide wire is in the distal position and the dilation catheter is in the proximal position;

[0012] Figure 1C Shows Figure 1A a perspective view of the instrument, where the guide wire and the dilation catheter are each in their respective distal positions, and where the dilator of the dilation catheter is in the non - inflated state;

[0013] Figure 1D Shows a Figure 1A perspective view of an instrument in which a guide wire and a dilation catheter are each in respective distal positions and in which the dilator of the dilation catheter is in an inflated state;

[0014] Figure 2 Shows a perspective view of an exemplary alternative dilation instrument in which a guide wire and a dilation catheter are each in respective proximal positions;

[0015] Figure 3 Shows a Figure 2 disassembled perspective view of the guide shaft assembly of an instrument;

[0016] Figure 4A Shows a Figure 2 side view of the flexible segment of an instrument in which the flexible segment is in an undeflected state;

[0017] Figure 4B Shows a Figure 2 side view of the flexible segment of an instrument in which the flexible segment is in a deflected state;

[0018] Figure 5 Shows a Figure 2 perspective view of the guide shaft assembly of an instrument in which a deflection control knob is being rotated and the flexible segment is deflecting away from the longitudinal axis of the guide shaft assembly;

[0019] Figure 6 Shows a Figure 2 perspective view of a portion of an instrument in which a housing portion has been removed from the handle assembly of the instrument to reveal internal components at the distal end of the handle assembly;

[0020] Figure 7 Shows a Figure 5 cross-sectional view taken along line 7-7 of a Figure 2 portion of an instrument;

[0021] Figure 8A Shows a Figure 5 cross-sectional view taken along line 8-8 of a Figure 2 portion of an instrument in which a deflection control knob and a haptic feedback member are in a first position;

[0022] Figure 8B Shows a Figure 5 cross-sectional view taken along line 8-8 of a Figure 2 portion of an instrument in which a deflection control knob and a haptic feedback member are in a second position;

[0023] Figure 8C Shows a Figure 5 cross-sectional view taken along line 8-8 of aFigure 2 A cross-sectional view of a portion of the instrument, where the deflection control knob and the haptic feedback member are in the third position;

[0024] Figure 9A Shows a cross-section taken along Figure 5 line 9-9 of a portion of the instrument, where the deflection control knob and the cam barrel are in the first position; Figure 2 A cross-sectional view of a portion of the instrument, where the deflection control knob and the cam barrel are in the first position;

[0025] Figure 9B Shows a cross-section taken along Figure 5 line 9-9 of a portion of the instrument, where the deflection control knob and the cam barrel are in the second position; Figure 2 A cross-sectional view of a portion of the instrument, where the deflection control knob and the cam barrel are in the second position;

[0026] Figure 10 Shows a perspective view of the guide shaft assembly of the instrument, where the shaft rotation control knob is being rotated and the flexible section is rotating about the longitudinal axis of the guide shaft assembly; Figure 2 A perspective view of the guide shaft assembly of the instrument, where the shaft rotation control knob is being rotated and the flexible section is rotating about the longitudinal axis of the guide shaft assembly;

[0027] Figure 11A Shows a perspective view of a portion of the instrument, where the housing portion is removed from the handle assembly of the instrument to expose the internal components at the distal end of the handle assembly, where the shaft rotation control knob is shown transparent and rotated to the first position; Figure 2 A perspective view of a portion of the instrument, where the housing portion is removed from the handle assembly of the instrument to expose the internal components at the distal end of the handle assembly, where the shaft rotation control knob is shown transparent and rotated to the first position;

[0028] Figure 11B Shows a perspective view of a portion of the instrument, where the housing portion is removed from the handle assembly of the instrument to expose the internal components at the distal end of the handle assembly, where the shaft rotation control knob is shown transparent and rotated to the second position; Figure 2 A perspective view of a portion of the instrument, where the housing portion is removed from the handle assembly of the instrument to expose the internal components at the distal end of the handle assembly, where the shaft rotation control knob is shown transparent and rotated to the second position;

[0029] Figure 12A Shows a cross-section taken along Figure 10 line 12-12 of a portion of the instrument, where the shaft rotation control knob is rotated to the first position; and Figure 2 A cross-sectional view of a portion of the instrument, where the shaft rotation control knob is rotated to the first position; and

[0030] Figure 12B Shows a cross-section taken along Figure 10 line 12-12 of a portion of the instrument, where the shaft rotation control knob is rotated to the second position; Figure 2 A cross-sectional view of a portion of the instrument, where the shaft rotation control knob is rotated to the second position;

[0031] The accompanying drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present invention may be carried out in many other ways, including those not necessarily shown in the accompanying drawings. The drawings incorporated in and forming a part of this specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the present invention; however, it is to be understood that the present invention is not limited to the specific arrangements shown. Detailed Description

[0032] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will be apparent to those skilled in the art from the following description, which is presented by way of example. A best mode is contemplated for carrying out the present invention. As will be recognized, the present invention is capable of other different and obvious aspects, all of which do not depart from the present invention. For example, although various. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0033] It should be understood that the terms "proximal" and "distal" as used herein are relative to a clinician holding the handpiece assembly. Thus, the end effector is distal relative to the nearer handpiece assembly. It should also be understood that, for convenience and clarity, spatial terms such as "top" and "bottom" are also used herein with reference to a clinician holding the handpiece assembly. However, the surgical instrument is used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0034] It should also be understood that any one or more of the teachings, expressions, forms, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, forms, examples, etc. described herein. Accordingly, the following teachings, expressions, forms, examples, etc. should not be regarded as mutually separate. Various suitable ways in which the teachings herein may be combined will be apparent to those of ordinary skill in the art in light of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0035] I. Exemplary Dilatation Devices

[0036] A. Overview

[0037] Figures 1A through 1DAn exemplary dilation device (10) is shown that can be used to dilate the ostium of the paranasal sinuses, another passage associated with the drainage of the paranasal sinuses, the eustachian tube, or another anatomical passage (e.g., an anatomical passage within the ear, nose, or throat, etc.). As will be described in more detail below, the dilation device (10) of this example provides adjustability that enables an operator to use the dilation device (10) in different scenarios without the operator having to switch between different devices. For example, by simply adjusting the structural features of the dilation device (10), the device can be used to dilate various different anatomical passages (e.g., the frontal sinus ostium, frontal recess, maxillary sinus ostium, sphenoid sinus ostium, ethmoid sinus ostium, eustachian tube, etc.).

[0038] The dilation device (10) of this example includes: a handle assembly (500); a guide shaft assembly (100) that extends distally from the handle assembly (500); a guide wire actuation assembly (600) that is slidably coupled to the handle assembly (500); and a dilation catheter actuation assembly (700) that is slidably coupled to the handle assembly (500). A guide wire module (12) is coupled to the guide wire (602) of the dilation device (10) via a connector (604). An inflation fluid source (14) and a flush fluid source (16) are coupled to the dilation catheter (702) of the dilation device (10) via a connector (710). An aspiration source (18) is coupled to the guide shaft assembly (100) of the dilation device (10) via an aspiration port (550) and a catheter (not shown) that traverses the handle assembly (500).

[0039] The handle assembly (500) is sized and configured to be grasped and operated by an operator with one hand. The operator can selectively operate the guide wire actuation assembly (600) and the dilation catheter actuation assembly (700) with the same hand that grasps the handle assembly (500). As shown by the transition from Figures 1A through 1B , the operator can advance the guide wire actuation assembly (600) distally along the handle assembly (500), thereby advancing the guide wire (602) distally such that the distal end (606) of the guide wire (602) is positioned distal to the distal end of the guide shaft assembly (100). As shown by the transition from Figures 1B through 1C , the operator can advance the dilation catheter actuation assembly (700) distally along the handle assembly (500), thereby advancing the dilation catheter (702) distally such that the distal tip (720) of the dilation catheter (702) is positioned distal to the distal end of the guide shaft assembly (100). As the dilation catheter (702) is advanced to the distal position, the operator can then inflate the dilator (722) of the dilation catheter (702) to achieve the inflated state as shown in Figure 1D , thereby dilating the anatomical passage in which the dilator (722) is positioned.

[0040] In this example, the dilation catheter (702) is coaxially disposed within the guide shaft assembly (100), and the guide wire (602) is coaxially disposed within the dilation catheter (702). In some other configurations, the guide shaft assembly (100) is coaxially disposed within the dilation catheter (702), and the guide wire (602) is coaxially disposed within the guide shaft assembly (100). Additionally, in some configurations, the guide wire (602) is omitted.

[0041] Figure 2 An exemplary alternative dilation instrument (400) is shown that can be used to dilate the ostium of a paranasal sinus, dilate another passage associated with drainage of a paranasal sinus, dilate the eustachian tube, or dilate some other anatomical passage (e.g., an anatomical passage within the ear, nose, or throat, etc.). The dilation instrument (400) of this example is operable to provide substantially the same or similar functionality as the dilation instrument (10), and is constructed and operable to be only like the dilation instrument (10), except for the differences described below. The dilation instrument (400) of this example includes: a handle assembly (402); a guide shaft assembly (404) that extends distally from the handle assembly (402); a guide wire actuation assembly (406) that is slidably coupled to the handle assembly (402); and a dilation catheter actuation assembly (408) that is slidably coupled to the handle assembly (402). A guide wire module (not shown) is coupled to a guide wire (not shown), similar to the guide wire module (12) and guide wire (602) of the dilation instrument (10). An inflation fluid source (410) and a flush fluid source (412) are coupled to the dilation catheter (414) of the dilation instrument (400) via a connector (416). A suction source (418) is coupled to the guide shaft assembly (404) of the dilation instrument (400) via a suction port (420) and a catheter (not shown) that traverses the handle assembly (500).

[0042] Similar to the dilation instrument (10), the operator can advance the guide wire actuation assembly (406) distally along the handle assembly (402), thereby advancing the guide wire distally. The operator can advance the dilation catheter actuation assembly (408) distally along the handle assembly (402), thereby advancing the dilation catheter (414) distally such that the distal end (not shown) of the dilation catheter (414) is positioned distal to the distal end of the guide shaft assembly (404). As the dilation catheter (414) is advanced to a distal position, the operator can then inflate a dilator (such as a dilator similar to the dilator (722) of the instrument (10)) to achieve the Figure 1D inflated state shown, thereby dilating the anatomical passage in which the dilator (722) is positioned.

[0043] In this example, the dilation catheter (414) is coaxially disposed within the guide shaft assembly (404), and the guide wire is coaxially disposed within the dilation catheter (414). In some other configurations, the guide shaft assembly (404) is coaxially disposed within the dilation catheter (414), and the guide wire is coaxially disposed within the guide shaft assembly (404). Additionally, in some configurations, as Figure 2 shown, the guide wire is omitted.

[0044] Examples of the features and functions of the above-described components of the dilation instrument (400) are described in more detail below. These features and functions are merely illustrative examples. By way of example only, the features and functions described herein may be modified in accordance with the teachings of U.S. Patent 10,874,839, entitled "Adjustable Instrument for Dilation of Anatomical Passageway," issued on December 29, 2020, and U.S. Patent Publication 2019 / 0015646, entitled "Adjustable Instrument for Dilation of Anatomical Passageway," published on January 17, 2019, the entire disclosures of which are incorporated herein by reference. With reference to the teachings herein, other variations of the features and functions will be apparent to those skilled in the art.

[0045] B. Exemplary Guide Shaft Assembly and Deflection Actuation Assembly

[0046] Figures 3 through 12B Various components of the guide shaft assembly (404) are shown in more detail. The exemplary guide shaft assembly (404) includes a rigid shaft member (422), a flexible shaft member (424), a push-pull wire (426), a cam barrel (428), a translatable member (such as a pull sleeve (430)), a rotary actuator (such as a deflection control knob (432)), and a shaft rotation assembly (498). In this example, the shaft members (422, 424), the cam barrel (428), the pull sleeve (430), and the deflection control knob (432) are coaxially aligned with each other, wherein the push-pull wire (426) is offset from the longitudinal axis (434) shared by the shaft members (422, 424), the cam barrel (428), the pull sleeve (430), and the deflection control knob (432). As will be described in more detail below, the guide shaft assembly (404) is operable to direct a guide wire (similar to the guide wire (602) of the dilation instrument (10)) and the dilation catheter (414) along an exit angle relative to the central longitudinal axis (434) of the guide shaft assembly (404) selected by the operator.

[0047] In some forms, both shaft members (422, 424) are formed of a metallic material such as stainless steel and / or nitinol. In some forms of this type, the shaft members (422, 424) (and at least some other parts of the instrument (400)) may be reusable, and such reusable components are subjected to cleaning and disinfection between uses on different patients. In some other forms, one or both of the shaft members (422, 424) may be formed of a polymeric material. In some forms of this type, the shaft members (422, 424) may be considered disposable components. The flexible shaft member (424) is fixed to the rigid shaft member (422) and is positioned distally relative to the rigid shaft member (422).

[0048] As Figures 4A through 4B fully shown, the flexible shaft member (424) includes a flexible segment (436) formed by a series of ribs (438) separated by a series of notches (440). The notches (440) are generally V-shaped with a rounded opening at the apex of each "V". The notches (440) also include a protrusion portion (442) that fits into a corresponding sub-notch (444). The top of each "V" includes a set of stop features (446). As Figure 4A shown, when the flexible segment (436) is in a straight configuration, the protrusion portion (442) is disposed in the corresponding sub-notch (444) but is not fully seated in the sub-notch (444). As Figure 4A shown, when the flexible segment (436) is in a straight configuration, the stop features (446) are spaced apart from each other. Figure 4B A flexible segment (436) in a fully bent configuration is shown. In this state, the protrusion portion (442) is fully seated in the sub-notch (444) and the stop features (446) engage each other. During the transition between the states shown in Figures 4A through 4B the protrusion portion (442) and the sub-notch (444) may cooperate to ensure that the flexible segment (436) bends in a consistent manner and has sufficient lateral stability; and the flexible segment (436) provides a consistent and stable bent or straight state.

[0049] By way of example only, the flexible segment (436) can be formed by laser cutting or any other suitable manufacturing process. In some forms, the flexible segment (436) is covered with a flexible wrapper (not shown). Such a flexible wrapper can prevent tissue and other structures from getting caught or pinched in the notch (440) without compromising the flexibility of the flexible segment (436). The flexible wrapper can also ensure that the suction provided by the guide shaft assembly (404) is concentrated at the distal end (448). Various suitable forms that the flexible segment (436) can take will be apparent to those of ordinary skill in the art in light of the teachings herein. By way of further example only, the flexible segment (436) can be constructed and operated in accordance with at least some of the teachings of U.S. Patent Publication 2018 / 0311472, titled "Deflectable Guide for Medical Instrument," published on November 1, 2018, the entire disclosure of which is incorporated herein by reference.

[0050] A push-pull wire (426) is disposed within the shaft members (422, 424) and is operable to provide controlled bending of the flexible segment (436). As Figures 4A through 4B shown, the distal end (450) of the push-pull wire (426) is fixed to the distal end (448) of the flexible shaft member (424) that is distal to the flexible segment (436). The push-pull wire (426) is disposed near the top of the "V" of the notch (440). Thus, when the push-pull wire (426) is pulled proximally, the flexible segment (436) will bend into a deflected configuration. When the push-pull wire (426) is pushed distally, the flexible segment (436) will bend into a straight configuration. The proximal end (452) of the push-pull wire (426) is coupled to a retention holder (454) ( Figure 3 and Figures 11A through 11B ) that is fixed to pull the sleeve (430) via a retention key (456) ( Figure 3 and Figures 11A through 11B ). More specifically, the proximal end (452) is coupled to the retention holder (454); and the retention holder (454) is inserted into the retention key (456) that is formed with a lumen within the pull sleeve (430) having complementary dimensions and shape to mate with the retention holder (454) such that longitudinal movement of the pull sleeve (430) along the axis (434) results in complementary longitudinal movement of the push-pull wire (426) along the axis (434). As Figure 5 shown and will be described in more detail below, rotation of the deflection control knob (432) causes longitudinal translation of the push-pull wire (426), and longitudinal translation of the push-pull wire (426) thereby causes straightening or bending of the flexible segment (436).

[0051] As Figure 3and Figures 6 through 7 As shown, the deflection control knob (432) includes a finger wheel (458), a shaft (460), and a notched gear (462). As Figures 6 through 7 shown, the deflection control knob (432) is fixed to the housing (464) of the handle assembly (402) such that the finger wheel (458) is above the housing (464) and the shaft (460) is captured between the housings (464). The finger wheel (458) is positioned such that an operator can rotate the finger wheel (458) relative to the housing (464) using the thumb of the hand grasping the handle assembly (402). An elastic member, such as a spring (468), is positioned along the exterior of the shaft (460) to engage the housing (464). Specifically, the spring (468) is positioned between the lower surface (470) of the finger wheel (458) and the upper surface (472) of the flange (466) of the housing (464). In some configurations, the spring (468) is a compression spring formed in an annular shape. In an alternative form, the ends of the spring (468) are joined in an annular shape to form a toroidal coil spring. The spring (468) is positioned between the lower surface (470) of the finger wheel (458) and the upper surface (472) of the flange (466) of the housing (464) such that the spring (468) is radially compressed to form an oval shape. Accordingly, the spring (468) exerts a constant frictional resistance against rotational movement of the deflection control knob (432) relative to the housing (464). Accordingly, the spring (468) increases the minimum force required for an operator to rotate the deflection control knob (432), and the deflection control knob (432) is thus less likely to permit inadvertent or, in other words, unwanted rotational movement, which could cause an error during operation of the dilation instrument (400). Further, although the spring (468) increases the force required to rotate the deflection control knob (432), the spring (468) does not limit the degree of rotation by which the deflection control knob (432) can be rotated. Accordingly, the deflection control knob (432) is capable of rotating infinitely about any number of rotational positions as needed.

[0052] As will be described in more detail below, the flexible segment (436) of the flexible shaft member (424) is configured to deflect away from the longitudinal axis (434) of the guide shaft assembly (404) when the deflection control knob (432) is rotated about an axis (476) perpendicular to the longitudinal axis (434) of the guide shaft assembly (404). When the deflection control knob (432) is rotated, the notched gear (462) of the deflection control knob (432) is positioned to engage a feedback member (474) that is configured to provide tactile and audible feedback to the operator. This feature may optionally be included in the dilation instrument (400) for some procedures, such as those performed in dimming illumination, to allow for better viewing of an image-guided monitor or better viewing of an illuminated guidewire. Requiring the operator to shift her eyes from the monitor to the dilation instrument (400) to verify the rotational position of the deflection control knob (432) can result in problems such as loss of endoscope position, mispositioning of a sinus balloon dilation device, or other issues. Accordingly, the feedback member (474) may be included to provide tactile feedback to the operator, such as an audible noise or vibration, indicating the rotational position of the deflection control knob (432). The feedback member (474) may comprise any material operable to bend and provide acoustic or vibrational feedback when released from a bent position. For example, the feedback member (474) may comprise a material of any device such as polyester, nylon, polyetheretherketone film, stainless steel spring, annular stainless steel wire, nitinol wire, spring-applied linear plunger, rigid plastic strip, and / or other suitable materials.

[0053] As Figures 8A through 8C shown, the feedback member (474) may be coupled to the housing (464) and positioned adjacent the notched gear (462) of the deflection control knob (432). The feedback member (474) may be configured to cooperate with a feedback portion of the notched gear (462) when the deflection control knob (432) is rotated, where the cooperation is operable to generate a tactile and audible feedback indication to the user. The feedback portion of the notched gear (462) is defined by one or more pawl portions (478) separated by one or more protrusion portions (480). In Figure 8A the first position shown, the feedback member (474) may extend into the pawl portion (478). As Figure 8B shown, when the deflection control knob (432) (and thus the notched gear (462)) is rotated, the feedback member (474) is configured to bend when it contacts the protrusion portion (480). As Figure 8CAs shown, once the feedback member (474) reaches the detent portion (478), it moves or "snaps" back to the straightened configuration. When the feedback member (474) moves back to the straightened configuration, an audible noise, such as a click or vibration, occurs to indicate to the operator that the desired rotational position of the deflection control knob (432) has been reached and, thus, the desired deflection angle (θ) of the flexible segment (436) has been achieved ( Figure 5 ). Thus, the detent portion (478) can be predefined on the notched gear (462) to correspond to one or more desired degrees of deflection of the flexible segment (436) away from the longitudinal axis (434). For example, the notched gear (462) can include detents that provide three tactile feedbacks to the operator. These three exemplary detent portions (478) can be configured to correspond to deflection angles (θ) of 55 degrees, 70 degrees, and 110 degrees of the flexible segment (436) relative to the longitudinal axis (434). These three exemplary angles (θ) can be specifically configured to allow the guide shaft assembly (404) to be inserted into any one of three or more different paranasal sinus ostia or other channels (e.g., eustachian tube, etc.).

[0054] Once the operator achieves the desired deflection angle of the flexible segment (436), the detent portion (478) can provide a self-locking function such that the flexible segment (436) can maintain the selected deflection angle during subsequent normal use of the instrument (400) until the operator rotates the deflection control knob (432) relative to the rigid shaft member (422) again to further adjust the deflection angle. Since the guide wire and the dilation catheter (414) can be slidably positioned within the guide shaft assembly (404), the guide wire and the dilation catheter (414) will exit the distal end of the guide shaft assembly (404) at any deflection angle selected by the operator. In view of the above, the operator can easily obtain various exit angles of the guide wire and the dilation catheter (414) by rotating the deflection control knob (432) relative to the rigid shaft member (422). Thus, the operator can easily dilate various anatomical channels without exchanging instruments; and without replacing multiple instruments (400).

[0055] As Figures 9A through 9BAs shown, the deflection of the flexible segment (436) of the guide shaft assembly (404) can be operated using the push-pull wire (426), the cam barrel (428), the traction sleeve (430), and the deflection control knob (432). In addition, the deflection control knob (432) includes a pin (482) to longitudinally (distally and proximally) translate the cam barrel (428) along the longitudinal axis (434). The pin (482) is sized and shaped to fit into a cam groove (484) which, in some configurations, may include a linear recess perpendicular to the longitudinal axis (434) formed in the top surface of the cam barrel (428). The pin (482) is laterally offset relative to the axis (460) and the axis of rotation of the deflection control knob (432). As Figure 7 and Figure 9A shown, the pin (482) is centered within the cam groove (484) and is operable to rotate about the axis of rotation of the deflection control knob (432) along a track path as the user deflects the control knob (432). When the pin (482) traverses this track path, the motion of the pin (482) has both a longitudinal direction component and a lateral direction component. Thus, the lateral direction component perpendicular to the longitudinal axis (434) translates the pin (482) through the cam groove (484), while the longitudinal direction component pushes and pulls the cam barrel (428) distally and proximally. As Figure 9B shown, the deflection control knob (434), and thus the pin (482), are shown rotating counterclockwise by a quarter turn, causing the cam barrel (428) to translate proximally relative to the housing (464) of the handle assembly (402). When the deflection control knob (434) is rotated another quarter turn, the cam barrel (428) is pulled proximally to the furthest extent it can be pulled. After another quarter turn, the cam barrel (428) translates distally back to a similar position, as Figure 9B shown. Finally, after the fourth quarter turn, the cam barrel (428) returns to its furthest distal position, as Figure 9A shown.

[0056] The cam barrel (428) includes additional features to allow longitudinal translation relative to the housing (464) of the handle assembly (402). For example, the cam barrel (428) includes a longitudinal recess (486) sized and shaped to allow the shaft (460) of the deflection control knob (432) to pass through during longitudinal translation. In addition, as Figure 7 shown, the cam barrel (428) is coupled to a rigid track (488) formed by the inner region of the housing (464) such that the cam barrel (428) is allowed to slide longitudinally along the track (488); this also prevents the cam barrel (428) from shifting or rotating about the longitudinal axis (434). As Figure 7As shown, one or more protrusions (490) project laterally and integrally from the cam barrel (428) and are configured to mate with the track (488). Accordingly, the cam barrel (428) is slidably disposed within the housing (464) of the handle assembly (402) and is positioned relative to the housing. Other suitable structures may be used to achieve this relationship between the track (488) and the cam barrel (428).

[0057] As described above, the proximal end (452) of the push-pull wire (426) is fixed to the pull sleeve (430) such that the push-pull wire (426) translates relative to the rigid shaft member (422) together with the pull sleeve (430) in response to rotation of the deflection control knob (432) relative to the rigid shaft member (422). As Figures 9A through 9B shown, one side of the proximal portion of the pull sleeve (430) includes a slot (492). The slot (492) is configured to mate with a rib (494) of the cam barrel (428). Accordingly, when the deflection control knob (432) rotates, with the push-pull wire (426) coupled to the pull sleeve (430) and the pull sleeve (430) effectively fixed to the cam barrel (428), the pull sleeve (430) and the push-pull wire (426) translate distally and proximally relative to the rigid shaft member (422). As Figure 9B can be seen, translating the push-pull wire (426), the pull sleeve (430), and the cam barrel (428) in the proximal direction results in the formation of an air gap (496) between the pull sleeve (430) and the shaft rotation assembly (498). Also as described above, translation of the push-pull wire (426) relative to the rigid shaft member (422) causes lateral deflection of the flexible segment (436). The operator can thus selectively deflect the flexible segment (436) by rotating the deflection control knob (432) relative to the rigid shaft member (422).

[0058] C. Exemplary Shaft Rotation Assembly

[0059] In addition to providing control of the deflection of the flexible segment (436) to facilitate access to various anatomical passageways, it may be desirable to enable the guide shaft assembly (404) to rotate about the longitudinal axis (434) of the guide shaft assembly (434) to further facilitate access to various anatomical passageways. To this end, as Figure 10 shown, the instrument (400) includes a shaft rotation assembly (498) for rotating the guide shaft assembly (404) about the longitudinal axis (434). If desired, rotation of the guide shaft assembly (404) can be performed simultaneously with the deflection control knob (432). For example, the operator may need to perform a series of guide shaft assembly (404) adjustments, including both rotation of the rigid shaft member (422) and deflection of the flexible shaft member (424) to reach a desired anatomical passageway.

[0060] As Figures 9A through 9B shown, the slotted connection between the slot (492) of the traction sleeve (430) and the rib (494) of the cam barrel (428) allows the traction sleeve (430) to operate similar to a sliding connection, thus allowing the traction sleeve (430) to rotate infinitely relative to the cam barrel (428), and the cam barrel is fixed in place via the track (488). More specifically, the traction sleeve (430) and the push-pull wire (426) can rotate 360 degrees around the longitudinal axis (434) without limitation.

[0061] As Figures 11A through 12B shown, and additionally referring to Figure 3 , the shaft rotation assembly (498) consists of a shaft rotation knob (650) and a slotted guide (652). The shaft rotation knob (650) is fixed to the slotted guide (652) through a slot (654) formed on the outer surface of the slotted guide (652). The slot (654) is configured to receive a protrusion (656) on the inner surface of the shaft rotation knob (650), such that when the shaft rotation knob (650) rotates, the protrusion (656) corresponds to the slot (654) to cause the slotted guide (652) to rotate around the longitudinal axis (434). Additionally, the shaft rotation knob (650) is held in place by a pin (658) ( Figures 9A through 9B ) that fixes it to a corresponding rib slot (660) formed around the circumference of the housing (464). When the shaft rotation knob (650) rotates, the relationship between the pin (658) and the rib slot (660) is formed such that the pin (658) rotates and translates through the rib slot (660), thereby fixing the shaft rotation knob (650) relative to the housing (464) in place while allowing 360-degree rotation of the shaft rotation knob (650). Other suitable structures can be used to achieve this relationship between the housing (464) and the shaft rotation knob (650).

[0062] The slotted guide (652) is fixed to the rigid shaft member (422) and the traction sleeve (430), as Figures 9A through 9B shown. As described above, the traction sleeve (430) and the push-pull wire (426) can rotate 360 degrees around the longitudinal axis (434) without limitation. Therefore, when the shaft rotation knob (650) rotates, the slotted guide (652) rotates around the longitudinal axis (434), thereby causing each of the traction sleeve (430), the push-pull wire (426), and the rigid shaft member (422) to rotate similarly around the longitudinal axis (434).

[0063] Figure 11A and Figure 12A show the shaft rotation knob (650) in a first rotational position, and thus show the guide shaft assembly (404). As Figure 11B andFigure 12B As shown, when the shaft rotation knob (650) rotates about the longitudinal axis (434), the rigid shaft member (422), the traction sleeve (430), and the push-pull wire (426) rotate together about the longitudinal axis (434).

[0064] II. Exemplary Combinations

[0065] The following embodiments relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following embodiments are not intended to limit the scope of any claims that may be provided at any time in this patent application or in subsequent filings of this patent application. There is no intention to disclaim. The following embodiments are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in many other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Accordingly, none of the aspects or features mentioned below should be considered decisive, unless otherwise expressly so indicated, for example, by the inventor or the successor in interest of the inventor, at a later date. If any claims presented in this patent application or in subsequent filings related to this patent application include additional features other than those mentioned below, such additional features should not be assumed to have been added for any reason related to patentability.

[0066] Example 1

[0067] A device, comprising: (a) a body; (b) a shaft assembly that extends distally from the body and defines a longitudinal axis, wherein the shaft assembly includes a flexible distal portion; and (c) a deflection actuation assembly, the deflection actuation assembly comprising: (i) a first rotary actuator, (ii) a translatable actuation member that extends through the shaft assembly, wherein the translatable actuation member is operatively coupled to the first rotary actuator and the flexible distal portion of the shaft assembly, wherein the first rotary actuator is capable of being rotated by a rotational force to longitudinally drive the translatable actuation member, wherein the flexible distal portion is configured to deflect away from the longitudinal axis in response to longitudinal translation of the translatable actuation member, and (iii) an elastic member positioned between the first rotary actuator and the body, wherein the elastic member is configured to apply a frictional force between the first rotary actuator and the body, wherein the frictional force is capable of operating to increase the rotational force required to rotate the first rotary actuator.

[0068] Example 2

[0069] The device according to embodiment 1, wherein the elastic member comprises a compression spring.

[0070] Example 3

[0071] The device according to Embodiment 2, wherein the compression spring is formed in an annular shape.

[0072] Example 4

[0073] The device according to Embodiment 1, wherein the elastic member includes an annular helical spring.

[0074] Example 5

[0075] The device according to any one of Embodiments 1 to 4, wherein the elastic member is configured to be radially compressed between the first rotary actuator and the body such that the frictional force applied between the first rotary actuator and the body is constant.

[0076] Example 6

[0077] The device according to any one of Embodiments 1 to 5, wherein the first rotary actuator further includes a plurality of predetermined rotational positions.

[0078] Example 7

[0079] The device according to any one of Embodiments 1 to 6, further comprising a feedback member coupled to the body and positioned adjacent to the first rotary actuator, wherein the feedback member is configured to cooperate with a feedback portion of the first rotary actuator when the first rotary actuator rotates, and wherein the cooperation is operable to generate a feedback indication to the user.

[0080] Example 8

[0081] The device according to Embodiment 7, wherein the feedback indication includes an audible noise.

[0082] Example 9

[0083] The device according to any one of Embodiments 7 to 8, wherein the feedback indication includes a tactile response.

[0084] Example 10

[0085] The device according to Embodiment 9, wherein the tactile response includes vibration.

[0086] Example 11

[0087] The device according to any one of embodiments 7 to 10, wherein the feedback portion of the first rotary actuator includes one or more pawls, and the feedback member is configured to contact the one or more pawls when the first rotary actuator rotates.

[0088] Example 12

[0089] The device according to embodiment 11, wherein each of the one or more pawls in the feedback portion of the first rotary actuator is positioned to correspond to a rotational position of the first rotary actuator, and the rotational position of the first rotary actuator is configured to correspond to a degree of deflection of the flexible distal portion away from the longitudinal axis.

[0090] Example 13

[0091] The device according to embodiment 12, wherein the one or more pawls include three pawls, and the three pawls are configured to correspond to deflection angles of 55 degrees, 70 degrees, and 110 degrees of the flexible distal portion relative to the longitudinal axis.

[0092] Example 14

[0093] The device according to any one of embodiments 1 to 13, further comprising a dilation catheter, wherein the dilation catheter is slidable relative to the shaft assembly, and the dilation catheter includes an inflatable dilator.

[0094] Example 15

[0095] The device according to embodiment 14, further comprising a guide wire, wherein the guide wire is slidably disposed in the dilation catheter.

[0096] Example 16

[0097] The device according to embodiment 15, further comprising a guide wire actuation assembly, wherein the guide wire actuation assembly is operable to translate the guide wire relative to the body, and the guide wire actuation assembly is further operable to rotate the guide wire about the longitudinal axis.

[0098] Example 17

[0099] The device according to any one of embodiments 1 to 16, further comprising a shaft rotation assembly, wherein the shaft rotation assembly is operable to rotate the shaft assembly about the longitudinal axis.

[0100] Example 18

[0101] The device according to embodiment 17, wherein the shaft rotation assembly includes a second rotation actuator positioned at a distal portion of the body, and the second rotation actuator is capable of rotating about an axis perpendicular to the longitudinal axis.

[0102] Example 19

[0103] The device according to any one of embodiments 1 to 18, wherein the translatable actuating member includes a pull wire.

[0104] Example 20

[0105] The device according to any one of embodiments 1 to 19, further comprising a pin coupled to the rotation actuator, wherein the rotation actuator is operatively coupled to the translatable actuating member via the pin to longitudinally drive the translatable actuating member.

[0106] Example 21

[0107] The device according to embodiment 20, wherein the rotation actuator is configured to rotate about a rotation axis, and the pin is laterally offset from the rotation axis.

[0108] Example 22

[0109] The device according to any one of embodiments 20 to 21, further comprising a slot defined in a surface of the translatable actuating member, and the pin is configured to cooperate with the slot to longitudinally drive the translatable actuating member.

[0110] Example 23

[0111] A device, comprising: (a) a body; (b) a shaft assembly that extends distally from the body and defines a longitudinal axis, wherein a portion of the shaft assembly is configured to be inserted into a patient's anatomical passage, and the shaft assembly includes a flexible distal portion; and (c) a deflection actuating assembly, the deflection actuating assembly comprising: (i) a translatable actuating member extending through the shaft assembly, wherein the translatable actuating member is operatively coupled to the flexible distal portion, (ii) a rotation actuator that is capable of rotating about a rotation axis to actuate the translatable actuating member to deflect the flexible distal portion away from the longitudinal axis, and (iii) a pin coupled to the rotation actuator, wherein the pin is laterally offset from the rotation axis, and the rotation actuator is operatively coupled to the translatable actuating member via the pin to actuate the translatable actuating member.

[0112] Example 24

[0113] The device according to embodiment 23, wherein the axis of rotation is oriented transversely to the longitudinal axis.

[0114] Example 25

[0115] The device according to any one of embodiments 23 to 24, further comprising an elastic member positioned between the rotary actuator and the body, wherein the elastic member is configured to cause a frictional force to partially limit the rotation of the rotary actuator.

[0116] Example 26

[0117] The device according to embodiment 25, wherein the elastic member comprises a compression spring.

[0118] Example 27

[0119] The device according to embodiment 26, wherein the compression spring is formed in an annular shape.

[0120] Example 28

[0121] The device according to any one of embodiments 23 to 24, wherein the elastic member comprises an annular helical spring.

[0122] Example 29

[0123] The device according to any one of embodiments 23 to 28, wherein the elastic member is configured to be radially compressed between the rotary actuator and the body such that the frictional force applied between the rotary actuator and the body is constant.

[0124] Example 30

[0125] The device according to any one of embodiments 23 to 29, further comprising a feedback member coupled to the body and positioned adjacent to the rotary actuator, wherein the feedback member is configured to cooperate with a feedback portion of the rotary actuator when the rotary actuator rotates, wherein the cooperation is operable to generate a tactile feedback indication to the user.

[0126] Example 31

[0127] The device according to embodiment 30, wherein the feedback indication comprises an audible noise.

[0128] Example 32

[0129] The device according to any one of embodiments 30 to 31, wherein the feedback indication includes a haptic response.

[0130] Example 33

[0131] The device according to any one of embodiments 30 to 32, wherein the feedback portion of the rotary actuator includes one or more ratchets, and the feedback member is configured to contact the one or more ratchets when the rotary actuator rotates.

[0132] Example 34

[0133] The device according to embodiment 33, wherein each of the one or more ratchets in the feedback portion of the rotary actuator is positioned to correspond to a rotational position of the rotary actuator, and the rotational position of the rotary actuator is configured to correspond to a degree of deflection of the flexible distal portion away from the longitudinal axis.

[0134] Example 35

[0135] The device according to any one of embodiments 33 to 34, wherein the one or more ratchets include three ratchets, and the three ratchets are configured to correspond to deflection angles of 55 degrees, 70 degrees, and 110 degrees of the flexible distal portion relative to the longitudinal axis.

[0136] Example 36

[0137] A device comprising: (a) a body; (b) a shaft assembly that extends distally from the body and defines a longitudinal axis, wherein a portion of the shaft assembly is configured to be inserted into a patient's anatomical passage, and the shaft assembly includes a flexible distal portion; (c) a deflection actuation assembly that is operatively coupled to the flexible distal portion of the shaft assembly, wherein a rotary actuator is capable of rotating about a rotational axis to deflect the flexible distal portion away from the longitudinal axis, and the rotational axis is transverse to the longitudinal axis of the shaft assembly; and (d) a feedback member that is coupled to the body and positioned adjacent to the rotary actuator, wherein the feedback member is configured to cooperate with a feedback portion of the rotary actuator when the rotary actuator rotates, and the cooperation is operable to generate a feedback indication to a user.

[0138] Example 37

[0139] The device according to embodiment 36, wherein the rotational axis is perpendicular to the longitudinal axis of the shaft assembly.

[0140] Example 38

[0141] The device according to any one of embodiments 36 to 37, wherein the feedback indication includes an audible noise.

[0142] Example 39

[0143] The device according to any one of embodiments 36 to 38, wherein the feedback indication includes a tactile response.

[0144] Example 40

[0145] The device according to embodiment 39, wherein the tactile response includes vibration.

[0146] Example 41

[0147] The device according to any one of embodiments 36 to 40, wherein the feedback portion of the rotary actuator includes one or more pawls, and the feedback member is configured to contact the one or more pawls when the rotary actuator rotates.

[0148] Example 42

[0149] The device according to embodiment 41, wherein each of the one or more pawls in the feedback portion of the first rotary actuator is positioned to correspond to a rotational position of the first rotary actuator, and the rotational position of the first rotary actuator is configured to correspond to a degree of deflection of the flexible distal portion away from the longitudinal axis.

[0150] Example 43

[0151] The device according to embodiment 42, wherein the one or more pawls include three pawls, and the three pawls are configured to correspond to deflection angles of 55 degrees, 70 degrees, and 110 degrees of the flexible distal portion relative to the longitudinal axis.

[0152] Example 44

[0153] The device according to any one of embodiments 36 to 43, further comprising an elastic member positioned between the rotary actuator and the body, wherein the elastic member is configured to be radially compressed between the rotary actuator and the body, and the elastic member is operable to induce a constant frictional force to partially limit the rotation of the rotary actuator.

[0154] Example 45

[0155] The device according to embodiment 44, wherein the elastic member comprises a compression spring.

[0156] Example 46

[0157] The device according to embodiment 45, wherein the compression spring is formed in an annular shape.

[0158] Example 47

[0159] The device according to embodiment 44, wherein the elastic member comprises an annular helical spring.

[0160] Example 48

[0161] The device according to any one of embodiments 44 to 47, wherein the elastic member is configured to be radially compressed between the first rotary actuator and the body such that the frictional force applied between the first rotary actuator and the body is constant.

[0162] Example 49

[0163] The device according to any one of embodiments 36 to 48, further comprising a pin coupled to the rotary actuator, wherein the rotary actuator is operatively coupled to the translatable actuating member via the pin to longitudinally drive the translatable actuating member.

[0164] Example 50

[0165] The device according to embodiment 49, wherein the rotary actuator is configured to rotate about a rotational axis, and wherein the pin is laterally offset from the rotational axis.

[0166] Example 51

[0167] The device according to any one of embodiments 49 to 50, further comprising a slot defined in a surface of the translatable actuating member, wherein the pin is configured to cooperate with the slot to longitudinally drive the translatable actuating member.

[0168] Example 52

[0169] An apparatus, comprising: (a) a body; (b) a shaft assembly that extends distally from the body and defines a longitudinal axis, wherein the shaft assembly includes a flexible distal portion; and (c) a deflection actuation assembly, comprising: (i) a first rotary actuator, (ii) a cam member, wherein the first rotary actuator is rotatable to longitudinally translate the cam member along the longitudinal axis relative to the body; (iii) a traction member that is slidably coupled to the cam member, wherein the cam member is longitudinally translatable to longitudinally translate the traction member, wherein the traction member is configured to rotate about the longitudinal axis relative to the body and relative to the cam member, and (iv) a translatable actuation member that is coupled to the traction member and the flexible distal portion of the shaft assembly, wherein the flexible distal portion is configured to deflect away from the longitudinal axis in response to longitudinal translation of the translatable actuation member.

[0170] Example 53

[0171] The apparatus according to embodiment 52, further comprising a pin coupled to the first rotary actuator, wherein the first rotary actuator is operatively coupled to the translatable actuation member via the pin to longitudinally drive the translatable actuation member.

[0172] Example 54

[0173] The apparatus according to embodiment 53, wherein the first rotary actuator is configured to rotate about a rotational axis, wherein the pin is laterally offset from the rotational axis.

[0174] Example 55

[0175] The apparatus according to any one of embodiments 53 to 54, further comprising a slot defined in a surface of the translatable actuation member, wherein the pin is configured to cooperate with the slot to longitudinally drive the translatable actuation member.

[0176] Example 56

[0177] The apparatus according to embodiment 55, wherein the slot has a linear configuration.

[0178] Example 57

[0179] The apparatus according to any one of embodiments 52 to 56, wherein the traction member and the cam member are coupled together via a rib-slot coupling.

[0180] Example 58

[0181] The device according to any one of embodiments 52 to 57, wherein the pulling member is rotatable about the longitudinal axis to rotate the shaft assembly about the longitudinal axis.

[0182] Example 59

[0183] The device according to any one of embodiments 52 to 58, wherein the translatable actuator is disposed coaxially and slidably about the shaft assembly.

[0184] Example 60

[0185] The device according to any one of embodiments 52 to 59, wherein the cam member and the body include complementary features to allow the cam member to translate longitudinally relative to the body while preventing the cam member from rotating about the longitudinal axis.

[0186] Example 61

[0187] The device according to any one of embodiments 52 to 60, further comprising a shaft rotation assembly, wherein the shaft rotation assembly is operable to rotate the shaft assembly about the longitudinal axis.

[0188] Example 62

[0189] The device according to embodiment 61, wherein the shaft rotation assembly includes a second rotary actuator positioned at a distal portion of the body, wherein the second rotary actuator is rotatable about the longitudinal axis.

[0190] Example 63

[0191] The device according to embodiment 62, wherein each of the first rotary actuator and the second rotary actuator is actuable by a hand of a user grasping the body without the user having to reposition the hand.

[0192] Example 64

[0193] The device according to any one of embodiments 52 to 63, wherein the translatable actuator includes a pulling wire.

[0194] Example 65

[0195] The device according to any one of embodiments 52 to 64, further comprising an expansion catheter, wherein the expansion catheter is slidable relative to the shaft assembly, and wherein the expansion catheter includes an inflatable expander.

[0196] Example 66

[0197] The device according to any one of claims 52 to 65, further comprising a guide wire, wherein the guide wire is slidably disposed in the dilation catheter.

[0198] Example 67

[0199] The device according to any one of embodiments 52 to 66, wherein the flexible distal portion of the shaft assembly is simultaneously operable to deflect away from the longitudinal axis when the shaft assembly rotates about the longitudinal axis.

[0200] Example 68

[0201] The device according to any one of embodiments 52 to 67, further comprising a feedback member coupled to the body and positioned adjacent the first rotary actuator, wherein the feedback member is configured to cooperate with a feedback portion of the first rotary actuator when the first rotary actuator rotates, and wherein the cooperation is operable to generate a feedback indication to the user.

[0202] Example 69

[0203] The device according to embodiment 68, wherein the feedback indication includes at least one of an audible noise and a tactile response.

[0204] Example 70

[0205] The device according to any one of embodiments 68 to 69, wherein the feedback portion of the first rotary actuator includes one or more pawls, and wherein the feedback member is configured to contact the one or more pawls when the first rotary actuator rotates.

[0206] Example 71

[0207] The device according to any one of embodiments 52 to 70, wherein the translatable actuator member is laterally offset from the longitudinal axis.

[0208] Example 72

[0209] An apparatus, comprising: (a) a body; (b) a shaft assembly that extends distally from the body and defines a longitudinal axis, wherein the shaft assembly includes a flexible distal portion; (c) a deflection actuation assembly that includes: (i) a first rotary actuator, (ii) a cam member, wherein the first rotary actuator is rotatable to translate the cam member distally and proximally relative to the body, (iii) a pull member coupled to the cam member, wherein the cam member is longitudinally translatable to translate the pull member distally and proximally, wherein the pull member is configured to rotate about the longitudinal axis, and (iv) a translatable actuation member coupled to the pull member and the flexible distal portion of the shaft assembly; and (d) a shaft rotation assembly, wherein the shaft rotation assembly is operable to rotate the shaft assembly and the pull member about the longitudinal axis.

[0210] Example 73

[0211] The apparatus according to embodiment 72, further comprising a pin coupled to the first rotary actuator, wherein the first rotary actuator is operatively coupled to the translatable actuation member via the pin to longitudinally drive the translatable actuation member.

[0212] Example 74

[0213] The apparatus according to embodiment 73, wherein the first rotary actuator is configured to rotate about a rotational axis, and wherein the pin is laterally offset from the rotational axis.

[0214] Example 75

[0215] The apparatus according to any one of embodiments 73 to 74, further comprising a slot defined in a surface of the translatable actuation member, wherein the pin is configured to cooperate with the slot to longitudinally drive the translatable actuation member.

[0216] Example 76

[0217] The apparatus according to any one of embodiment 75, wherein the slot has a linear configuration.

[0218] Example 77

[0219] The apparatus according to any one of embodiments 72 to 76, wherein the pull member and the cam member are coupled together using a rib and groove coupling.

[0220] Example 78

[0221] Embodiment 72 includes an apparatus as described in any one of embodiments 72 to 77 wherein rotation of the puller member about the longitudinal axis is operable to rotate the shaft assembly about the longitudinal axis.

[0222] Example 79

[0223] A device according to any one of embodiments 72 to 78, wherein the cam member and the body include complementary features to allow the cam member to translate longitudinally relative to the body while preventing the cam member from rotating about the longitudinal axis.

[0224] Example 80

[0225]

[00136] The apparatus of any one of embodiments 72 to 79 further comprises a shaft rotation assembly, wherein the shaft rotation assembly is operable to rotate the shaft assembly about the longitudinal axis.

[0226] Example 81

[0227]

[0113] The apparatus of embodiment 80, wherein the shaft rotation assembly includes a second rotation actuator positioned at a distal portion of the body, wherein the second rotation actuator is rotatable about an axis perpendicular to the longitudinal axis.

[0228] Example 82

[0229] A device according to embodiment 81, wherein the first rotary actuator and the second rotary actuator are each capable of being actuated by a user's hand without requiring the user to reposition the hand.

[0230] Example 83

[0231]

[00136] The apparatus of any one of embodiments 72 to 82, wherein the translatable actuation member comprises a pull wire.

[0232] Example 84

[0233]

[00136] The apparatus of any one of Examples 72-83, further comprising a dilation catheter, wherein the dilation catheter is slidable relative to the shaft assembly, wherein the dilation catheter comprises an expandable dilator.

[0234] Example 85

[0235]

[00136] The apparatus of any one of Examples 72 to 84, wherein the flexible distal portion of the shaft assembly is simultaneously operable to deflect away from the longitudinal axis when the shaft assembly is rotated about the longitudinal axis.

[0236] Example 86

[0237] An apparatus, comprising: (a) a body; (b) a shaft assembly that extends distally from the body and defines a longitudinal axis, (c) a shaft rotation assembly, wherein the shaft rotation assembly is operable to rotate the shaft assembly about the longitudinal axis, (d) a deflection actuation assembly, the deflection actuation assembly comprising: (i) a rotary actuator, (ii) a cam member, wherein rotation of the rotary actuator is operable to translate the cam member distally and proximally relative to the body, (iii) a pull member that is in sliding coupling with the cam member, wherein the rotary actuator is rotatable to longitudinally translate the pull member, wherein the pull member is configured to rotate about the longitudinal axis relative to the cam member in response to rotation of the shaft rotation assembly about the longitudinal axis, and (iv) a translatable actuation member that is coupled to the pull member, wherein the translatable actuation member is configured to deflect a portion of the shaft assembly away from the longitudinal axis in response to longitudinal translation of the translatable actuation member.

[0238] III. Miscellaneous

[0239] It should be understood that any example described herein may also include various other features in addition to or instead of those described above. By way of example only, any example described herein may also include one or more of the various features disclosed in any one of the various references incorporated herein by reference.

[0240] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc. described herein. Accordingly, the above teachings, expressions, embodiments, examples, etc. should not be regarded as being in isolation from one another. In light of the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those of ordinary skill in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0241] It should be understood that any patent, patent publication, or other published material that is purported to be incorporated herein by reference, whether in its entirety or in part, is incorporated herein only to the extent that the incorporated material does not conflict with the existing definitions, statements, or other published material set forth in this disclosure. Accordingly, and to the extent necessary, the explicit disclosure set forth herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof that is purported to be incorporated herein by reference but conflicts with the existing definitions, statements, or other published material set forth herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing published material.

[0242] The forms of the devices disclosed herein can be designed to be discarded after single use or designed for multiple uses. In either case or both cases, these forms can be repaired for reuse after at least one use. The repair can include any combination of the following steps: disassembling the device and then cleaning or replacing specific parts and subsequently reassembling. Specifically, the form of the device can be disassembled, and any number of specific components or parts of the device can be replaced or removed selectively in any combination. When cleaning and / or replacing specific parts, the form of the device can be reassembled in a repair facility for subsequent use or reassembled by the surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the repair of the device can be carried out for disassembly, cleaning / replacement, and reassembly using a variety of techniques. The use of such techniques and the resulting repaired devices are within the scope of this application.

[0243] By way of example only, the forms described herein can be processed prior to a surgical procedure. First, new or used instruments can be obtained and cleaned as needed. Then, the instruments can be sterilized. In one sterilization technique, the instrument is placed in a sealed and airtight container (such as a plastic or TYVEK bag). The container and the instrument can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation can kill bacteria on the instrument and in the container. The sterilized instrument can then be stored in a sterile container. The sealed container can keep the instrument sterile until the container is opened in a surgical facility. Any other techniques known in the art can also be used to sterilize the device, including but not limited to beta radiation or gamma radiation, ethylene oxide, or steam.

[0244] Having shown and described various forms of the present invention, further improvements to the methods and systems described herein are achieved by appropriate modifications by those of ordinary skill in the art without departing from the scope of the present invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, forms, geometries, materials, dimensions, ratios, steps, etc. discussed above are exemplary and not essential. Therefore, the scope of the present invention should be considered in light of the following claims and should be understood to be not limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A guiding shaft device for a medical dilatation instrument, comprising: (a) a main body; (b) a shaft assembly that extends distally from the main body and defines a longitudinal axis, wherein the shaft assembly includes a flexible distal portion; and (c) a deflection actuation assembly, the deflection actuation assembly comprising: (i) a first rotary actuator, (ii) a translatable actuation member that extends through the shaft assembly, wherein the translatable actuation member is operatively coupled to the first rotary actuator and the flexible distal portion of the shaft assembly, wherein the first rotary actuator is rotatable by a rotational force to longitudinally drive the translatable actuation member, wherein the flexible distal portion is configured to deflect away from the longitudinal axis in response to longitudinal translation of the translatable actuation member, and (iii) an elastic member positioned between the first rotary actuator and the main body, wherein the elastic member is configured to apply a frictional force between the first rotary actuator and the main body, wherein the frictional force can operate to increase the rotational force required to rotate the first rotary actuator; wherein the elastic member is configured to be radially compressed between the first rotary actuator and the main body such that the frictional force applied between the first rotary actuator and the main body is constant.

2. The device according to claim 1, wherein The elastic member includes a compression spring.

3. The device according to claim 2, wherein The compression spring is formed in an annular shape.

4. The device according to claim 1, wherein, The elastic member includes an annular helical spring.

5. The device according to claim 1, wherein the first rotary actuator further includes a plurality of predetermined rotational positions.

6. The device according to claim 1, further comprising a feedback member that is coupled to the main body and positioned adjacent to the first rotary actuator, wherein the feedback member is configured to cooperate with a feedback portion of the first rotary actuator when the first rotary actuator rotates, wherein the cooperation can operate to generate a feedback indication to the user.

7. The device according to claim 6, wherein The feedback indication includes an audible noise.

8. The device according to claim 6, wherein, The feedback indication includes a tactile response.

9. The device according to claim 6, wherein, The feedback portion of the first rotary actuator includes one or more pawls, wherein the feedback member is configured to contact the one or more pawls when the first rotary actuator rotates.

10. The device according to claim 9, wherein, Each of the one or more pawls in the feedback portion of the first rotary actuator is positioned to correspond to a rotational position of the first rotary actuator, wherein the rotational position of the first rotary actuator is configured to correspond to a degree of deflection of the flexible distal portion away from the longitudinal axis.

11. The device according to claim 1, further comprising a dilatation catheter, wherein the dilatation catheter is slidable relative to the shaft assembly, wherein the dilatation catheter includes an inflatable dilator.

12. The device according to claim 11, further comprising a guide wire, wherein the guide wire is slidably disposed in the dilatation catheter.

13. The device according to claim 1 further includes a shaft rotation assembly, wherein the shaft rotation assembly is operable to rotate the shaft assembly about the longitudinal axis, wherein the shaft rotation assembly includes a second rotation actuator positioned at a distal portion of the body, and wherein the second rotation actuator is capable of rotating about an axis perpendicular to the longitudinal axis.

14. The device according to claim 1 further includes a pin coupled to the rotation actuator, wherein the rotation actuator is operatively coupled to the translatable actuator member via the pin to longitudinally drive the translatable actuator member, wherein the rotation actuator is configured to rotate about a rotation axis, and wherein the pin is laterally offset from the rotation axis.

15. The device according to claim 1 includes: wherein a portion of the shaft assembly is configured to be inserted into an anatomical passage of a patient, and wherein the shaft assembly includes a flexible distal portion; wherein the deflection actuator assembly is operatively coupled to the flexible distal portion of the shaft assembly, and wherein the rotation actuator is capable of rotating about a rotation axis to deflect the flexible distal portion away from the longitudinal axis, and wherein the rotation axis is transverse to the longitudinal axis of the shaft assembly; and further includes: a feedback member coupled to the body and positioned adjacent to the rotation actuator, wherein the feedback member is configured to cooperate with a feedback portion of the rotation actuator when the rotation actuator rotates, and wherein the cooperation is operable to generate a feedback indication to a user.

16. The device according to claim 15, wherein, The rotation axis is perpendicular to the longitudinal axis of the shaft assembly.

17. The device according to claim 15, wherein The feedback portion of the rotation actuator includes one or more pawls, and wherein the feedback member is configured to contact the one or more pawls when the first rotation actuator rotates.

18. The device according to claim 17, wherein Each of the one or more pawls in the feedback portion of the first rotation actuator is positioned to correspond to a rotational position of the first rotation actuator, and wherein the rotational position of the first rotation actuator is configured to correspond to a degree of deflection of the flexible distal portion away from the longitudinal axis.

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