DILATION INSTRUMENT WITH TRANSLATABLE AND MALLEABLE SLEEVE
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional Application No. 63/560,152, filed March 1, 2024, the entirety of which is incorporated herein by reference.
BACKGROUND
[0002] 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 CARTO® 3 System by Biosense-Webster, 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, special instruments having sensors (e.g., electromagnetic coils that emit electromagnetic fields and/or are responsive to externally generated electromagnetic fields) are used to perform the procedure while the sensors send data to the computer indicating the current position of each surgical 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.
[0003] In some instances, it may be desirable to dilate an anatomical passageway in a patient. This may include dilation of ostia of paranasal sinuses (e.g., to treat sinusitis), dilation of the larynx, dilation of the Eustachian tube, dilation of other passageways within the ear, nose, or throat, etc. One method of dilating anatomical passageways includes using a guide wire and catheter to position an inflatable balloon within the anatomical passageway, then inflating the balloon with a fluid (e.g., saline) to dilate the anatomical passageway. For instance, the expandable balloon may be positioned within an ostium at a paranasal sinus and then be inflated, to thereby dilate the ostium by remodeling the bone adjacent to the ostium, without requiring incision of the mucosa or removal of any bone. The dilated ostium may then allow for improved drainage from and ventilation of the affected paranasal sinus.
[0004] It may also be desirable to ablate tissue within the ear, nose, or throat of a patient. For instance, such ablation may be desirable to remodel tissue (e.g., to reduce the size of a turbinate), to provide denervation (e.g., to disable the posterior nasal nerve), and/or for other purposes. Some such ablation treatments may include radiofrequency (RF) ablation with alternating current (AC) electrical energy; and/or irreversible electroporation (IRE) via pulsed field direct current (DC) electrical energy. To achieve ablation, an end effector with one or more needle electrodes or other kind(s) of tissue contacting electrodes may be activated with monopolar or bipolar electrical energy. Such ablation procedures may be carried out in conjunction with a dilation procedure or separately from a dilation procedure.
[0005] It may also be desirable to provide easily controlled placement of a dilation catheter, ablation instrument, or other ENT instrument in an anatomical passageway, including in procedures that will be performed only by a single operator. While several systems and methods have been made and used to position an ENT instrument in an anatomical passageway, 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
[0006] 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.
[0007] FIG. 1 depicts a schematic view of an example of a surgery navigation system being used on a patient seated in an example of a medical procedure chair;
[0008] FIG. 2A depicts a schematic side elevational view of an example of an instrument with a slider in a distal position, such that a malleable sleeve of the instrument is extended distally relative to a dilation balloon of the instrument, showing the malleable sleeve in a bent configuration and the dilation balloon in a non-inflated state;
[0009] FIG. 2B depicts a schematic side elevational view of the instrument of FIG. 2A, with the slider in a proximal position, such that the malleable sleeve is retracted proximally relative to the dilation balloon;
[0010] FIG. 2C depicts a schematic side elevational view of the instrument of FIG. 2A, with the slider in the proximal position, showing the dilation balloon in an inflated state;
[0011] FIG. 3 depicts an exploded perspective view of an example of a dilation catheter assembly comprising a dilation catheter and a straight, rigid stylet;
[0012] FIG. 4A depicts an elevational side view of the distal end of the dilation catheter of FIG. 3, where the distal end is in a straight, non-articulated configuration;
[0013] FIG. 4B depicts an elevational side view of the distal end of the dilation catheter of FIG. 3, where the distal end is in a bent, articulated configuration;
[0014] FIG. 5 depicts an exploded perspective view of another example of a dilation catheter assembly comprising a dilation catheter and a malleable stylet configured to transition a distal end of the dilation catheter from a straight, non-articulated configuration to a bent, articulated configuration;
[0015] FIG. 6A depicts an elevational side view of the distal end of the dilation catheter of FIG. 5, where the distal end is in the straight, non-articulated configuration; and
[0016] FIG. 6B depicts an elevational side view of the distal end of the dilation catheter of FIG. 5, where the distal end is in the bent, articulated configuration.
DETAILED DESCRIPTION
[0017] 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.
[0018] 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.
[0019] 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.
[0020] I. Example of an Image Guided Surgery Navigation System
[0021] When performing a medical procedure within a head (H) of a patient (P), it may be desirable to have information regarding the position of an instrument within the head (H) of the patient (P), particularly when the instrument is in a location where it is difficult or impossible to obtain an endoscopic view of a working element of the instrument within the head (H) of the patient (P). FIG. 1 shows an example of a IGS navigation system (50) enabling an ENT procedure to be performed using image guidance. In addition to or in lieu of having the components and operability described herein IGS navigation system (50) may be constructed and operable in accordance with at least some of the teachings of 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; and U.S. Pat. Pub. No. 2014/0364725, entitled “Systems and Methods for Performing Image Guided Procedures within the Ear, Nose, Throat and Paranasal Sinuses,” published December 11, 2014, now abandoned, the disclosure of which is incorporated by reference herein.
[0022] IGS navigation system (50) of the present example comprises a field generator assembly (60), which comprises set of magnetic field generators (64) that are integrated into a horseshoe-shaped frame (62). Field generators (64) are operable to generate alternating magnetic fields of different frequencies around the head (H) of the patient (P). An instrument, such as any of the ablation instruments described below, may be inserted into the head (H) of the patient (P). Such an instrument may be a standalone device or may be positioned on an end effector. In the present example, frame (62) is mounted to a chair (70), with the patient (P) being seated in the chair (70) such that frame (62) is located adjacent to the head (H) of the patient (P). By way of example only, chair (70) and/or field generator assembly (60) may be configured and operable in accordance with at least some of the teachings of 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.
[0023] IGS navigation system (50) of the present example further comprises a processor (52), which controls field generators (64) and other elements of IGS navigation system (50). For instance, processor (52) is operable to drive field generators (64) to generate alternating electromagnetic fields; and process signals from the instrument to determine the location of a navigation sensor in the instrument within the head (H) of the patient (P). Processor (52) comprises a processing unit (e.g., a set of electronic circuits arranged to evaluate and execute software instructions using combinational logic circuitry or other similar circuitry) communicating with one or more memories. Processor (52) of the present example is mounted in a console (58), which comprises operating controls (54) that include a keypad and/or a pointing device such as a mouse or trackball. A physician uses operating controls (54) to interact with processor (52) while performing the surgical procedure.
[0024] While not shown, the instrument may include a navigation sensor that is responsive to positioning within the alternating magnetic fields generated by field generators (64). A coupling unit (not shown) may be secured to the proximal end of the instrument and may be configured to provide communication of data and other signals between console (58) and the instrument. The coupling unit may provide wired or wireless communication of data and other signals.
[0025] In some versions, the navigation sensor of the instrument may comprise at least one coil at or near the distal end of the instrument. When such a coil is positioned within an alternating electromagnetic field generated by field generators (64), the alternating magnetic field may generate electrical current in the coil, and this electrical current may be communicated along the electrical conduit(s) in the instrument and further to processor (52) via the coupling unit. This phenomenon may enable IGS navigation system (50) to determine the location of the distal end of the instrument within a three-dimensional space (i.e., within the head (H) of the patient (P), etc.). To accomplish this, processor (52) executes an algorithm to calculate location coordinates of the distal end of the instrument from the position related signals of the coil(s) in the instrument.
[0026] Processor (52) uses software stored in a memory of processor (52) to calibrate and operate IGS navigation system (50). Such operation includes driving field generators (64), processing data from the instrument, processing data from operating controls (54), and driving display screen (56). In some implementations, operation may also include monitoring and enforcement of one or more safety features or functions of IGS navigation system (50). Processor (52) is further operable to provide video in real time via display screen (56), showing the position of the distal end of the instrument in relation to a video camera image of the patient’s head (H), a CT scan image of the patient’s head (H), and/or a computergenerated three-dimensional model of the anatomy within and adjacent to the patient’s nasal cavity. Display screen (56) may display such images simultaneously and/or superimposed on each other during the surgical procedure. Such displayed images may also include graphical representations of instruments that are inserted in the patient’s head (H), such that the operator may view the virtual rendering of the instrument at its actual location in real time. By way of example only, display screen (56) may provide images in accordance with at least some of the teachings of U.S. Pat. No. 10,463,242, entitled “Guidewire Navigation for Sinuplasty,” issued November 5, 2019, the disclosure of which is incorporated by reference herein. In the event that the operator is also using an endoscope, the endoscopic image may also be provided on display screen (56).
[0027] The images provided through display screen (56) may help guide the operator in maneuvering and otherwise manipulating instruments within the patient’s head (H). It should also be understood that other components of a surgical instrument and other kinds of surgical instruments, as described below, may incorporate a navigation sensor like the navigation sensor described above.
[0028] II. Example of Dilation Instrument with Translatable and Malleable Sleeve
[0029] In some instances, it may be desirable to provide a cover feature that may be selectively positioned over a dilation balloon of a dilation instrument, such as to protect the dilation balloon while the dilation instrument is being used to probe about (or otherwise traverse) small, tortuous anatomical passageways within the patient’s head (H). It may also be desirable to provide a guide feature that may be used to deflect the dilation balloon relative to a longitudinal axis of the dilation instrument, such as to facilitate positioning of the dilation balloon within a targeted anatomical passageway of the patient’s head (H), so that the dilation instrument may be configured to be used in multiple types of procedures. For example, it may be desirable to have a malleable guide feature that may be selectively bent to various angles prior to being inserted in the patient’s head (H). Therefore, if an operator desires to access a particular anatomical passageway within a patient, the operator may bend the malleable guide feature (e.g., prior to inserting the malleable guide feature into the patient’s head (H)) to a suitable bend angle for accessing that particular anatomical passageway. Moreover, it may be desirable to consolidate such a malleable guide feature and such a cover feature into a single multi-purpose feature. For example, such consolidation may provide the benefits and functionalities of both features while minimizing the number of components of the dilation instrument, thereby minimizing the cost of constructing the dilation instrument and/or the complexity of the dilation instrument.
[0030] FIGS. 2A-2C show an example of a dilation instrument (100) that may function in such a manner. Instrument (100) of the present example includes a handle assembly (110), a dilation catheter (112) extending distally from the handle assembly (110), and a malleable sleeve (114) that is configured to translate longitudinally relative to dilation catheter (112) as will be described in greater detail below. [0031] Handle assembly (110) of this example includes a body (120) and a slider (122). Body (120) is sized and configured to be grasped and operated by a single hand of an operator, such as via a power grip, a pencil grip, or any other suitable kind of grip. Slider (122) is operable to translate longitudinally relative to body (120). Slider (122) is coupled with sleeve (114) and is thus operable to translate sleeve (114) longitudinally as will be described in greater detail below. While slider (122) is the form of user input in handle assembly (110) of the present example, handle assembly (110) may include various other kinds of user inputs in addition to, or in lieu of, slider (122).
[0032] Dilation catheter (112) of the present example includes a flexible shaft (130) extending distally from handle assembly (110) to a distal tip (132). Dilation catheter (112) further includes a dilator in the form of a balloon (134). Shaft (130) may define an inflation lumen (not shown) which terminates distally into communication with the interior of balloon (134). The inflation lumen may be coupled with an inflation fluid source (not shown), which may be operable to selectively supply an inflation fluid to balloon (134) via the inflation lumen for transitioning balloon (134) from a non-inflated state to an inflated state, to thereby dilate an anatomical passageway. While balloon (134) is shown, it will be appreciated that any other suitable type of dilator may be used in lieu of balloon (134).
[0033] In the example shown, a proximal region of shaft (130) is fixedly secured to body (120) of handle assembly (110), and defines a longitudinal axis of instrument (100). As noted above, shaft (130) is flexible, such that at least a distal region of shaft (130) is configured to bend to form a bent distal portion (136) and thereby deflect distal tip (132) and balloon (134) laterally away from the longitudinal axis. In some versions, shaft (130) may be flexible but not malleable. For example, shaft (130) may be resiliently biased toward a substantially straight configuration. In this regard, shaft (130) may be configured to bend in response to application of one or more laterally directed threshold forces to shaft (130), and may be configured to automatically assume a substantially straight configuration in the absence of such forces.
[0034] Sleeve (114) of the present example defines a lumen (not shown) that extends between an open proximal end (140) of sleeve (114) and an open distal end (142) of sleeve (114). Proximal end (140) is fixedly secured to slider (122) via a flange (144), such that sleeve (114) is configured to translate longitudinally relative to body (120) together with slider (122). Both ends (140, 142) and the lumen extending therebetween are sized and configured to slidably receive dilation catheter (112), at least when balloon (134) is in the non-inflated state. For example, each end (140, 142) and the lumen extending therebetween may have a respective cross dimension (e.g., diameter) that is at least slightly greater than an external cross dimension (e.g., diameter) of shaft (130) and/or balloon (134) when balloon (134) is in the noninflated state. Thus, sleeve (114) may be translatable over dilation catheter (112) between at least one distal position in which sleeve (114) is extended distally relative to balloon (134) such that balloon (134) is substantially covered by sleeve (114) (e.g., in a radial direction), as shown in FIG. 2A; and at least one proximal position in which sleeve (114) is retracted proximally relative to balloon (134) such that balloon (134) is substantially uncovered by sleeve (114), as shown in FIGS. 2B and 2C. In this regard, body (120) of handle assembly (110) may include an elongate receptacle (not shown) that is sized and configured to receive at least a proximal region of sleeve (114) when sleeve (114) is retracted proximally relative to balloon (134).
[0035] As shown, sleeve (114) may be selectively bent by an operator to a desired access angle relative to the longitudinal axis, such that instrument (100) may be used to access multiple sinus drainage passageways and/or other anatomical passageways. FIG. 2A shows instrument (100) where sleeve (114) has been bent to form a bent distal portion (146) defining an access angle of around 80 degrees relative to the longitudinal axis. It should be understood that a bent distal portion (146) having any suitable access angle may be formed as would be apparent to one having ordinary skill in the art in view of the teachings herein.
[0036] Due to the malleability of sleeve (114) and the flexibility of shaft (130), sleeve (114) may be configured to impart a bend (e.g., a curvature) to shaft (130), at least when sleeve (114) is extended distally relative to balloon (134). For example, the selective bending of sleeve (114) by the operator may cause corresponding bending of shaft (130) within sleeve (114). In other words, shaft (130) may conform to the bending of sleeve (114). More particularly, the bending of sleeve (114) to form bent distal portion (146) may cause corresponding bending of shaft (130) to form bent distal portion (136). Thus, bent distal portion (136) of shaft (130) may define the same access angle relative to the longitudinal axis as that defined by bent distal portion (146) of sleeve (114).
[0037] Sleeve (114) is sufficiently rigid such that sleeve (114) may be suitably inserted into the patient’s head (H) at or near a desired anatomical passageway, with sleeve (114) in a bent or unbent state, without deviating from the chosen bend angle. In particular, once inserted into a patient’s head (H), bent distal portion (146) of sleeve (114) remains fixed in the chosen bend angle, at least until being proximally retracted. In other words, once inserted into a patient’s head (H), an operator may not bend sleeve (114) relative to the longitudinal axis, at least as long at sleeve (114) is distally extended relative to balloon (134); and instrument (100) will maintain the selected bend angle at bent distal portions (136, 146) as instrument (100) probes within the patient’s head (H) or otherwise moves within the patient’s head (H). However, sleeve (114) is sufficiently malleable such that an operator may utilize a bending tool or the strength of their own hand in order to manipulate sleeve (114) to form various access angles as shown in FIGS. 2A-2C. Therefore, sleeve (114) may be bent relative to the longitudinal axis such that instrument (100) may be utilized to access a frontal recess, a sphenoid sinus ostium, a maxillary sinus ostium, a Eustachian tube, etc. Of course, sleeve (114) may be utilized to access any other anatomical passageway as would be apparent to one having ordinary skill in the art in view of the teachings herein.
[0038] Sleeve (114) may be formed of shape memory nitinol, stainless steel that is annealed for malleability, a flexible polymer supported by shape memory nitinol wires, or any other suitable material that would be apparent to one having ordinary skill in the art in view of the teachings herein. Additionally, open distal end (142) may also include an olive shaped tip or other bulbous shaped tip (e.g., as described herein) for atraumatic insertion.
[0039] In the example shown, instrument (100) further includes a navigation sensor (150) fixedly secured to sleeve (114) near open distal end (142) and configured to provide navigation capabilities to sleeve (114). In some cases, navigation sensor (150) may be substantially aligned with a portion of balloon (134) (e.g., in a radial direction), at least when sleeve (114) is extended distally. Navigation sensor (150) includes at least one electromagnetic coil (not shown) operable to generate signals indicative of the position of the respective coil and thereby indicative of the position of sleeve (114) and/or balloon (134) in three-dimensional space when positioned within an alternating electromagnetic field generated by field generators (64). The position data generated by such position related signals may be processed by processor (52) for providing a visual indication to the operator to show the operator where sleeve (114) and/or balloon (134) of instrument (100) is located within the patient (P) in real time. Such a visual indication may be provided as an overlay on one or more preop eratively obtained images (e.g., CT scans) of the patient’s anatomy. Navigation sensor (150) may be configured as a single-axis sensor (SAS) (e.g., having a single electromagnetic coil wound about a single axis), as a dual -axis sensor (DAS) (e.g., having two electromagnetic coils wound about respective axes), or as a triple-axis sensor (TAS) (e.g., having three electromagnetic coils wound about respective axes). In addition, or alternatively, navigation sensor (150) may be configured as a flexible printed circuit board (PCB). By way of example only, navigation sensor (150) may be configured and operable in accordance with at least some of the teachings of U.S. Pat. Pub. No. 2022/0257093, entitled “Flexible Sensor Assembly for ENT Instrument,” published August 18, 2022, the disclosure of which is incorporated by reference herein, in its entirety.
[0040] In use, sleeve (114) may initially be distally extended to cover balloon (134), and may be selectively bent relative to the longitudinal axis by the operator from a substantially straight configuration (not shown) to form bent distal portion (146) of sleeve (114) and corresponding bent distal portion (136) of shaft (130), as shown in FIG. 2A. As a result, balloon (134) may be deflected laterally away from the longitudinal axis at the desired access angle. Bent distal portion (146) of sleeve (114), with bent distal portion (136) of shaft (130) housed therein, may then be inserted into the patient’s head (H) and advanced toward the targeted anatomical passageway of the patient’s head (H) until balloon (134) is disposed within the targeted anatomical passageway. It will be appreciated that balloon (134) may be safely protected by sleeve (114) from damage that might otherwise occur during probing or other movement of instrument (100) within the patient’s head (H) prior to reaching the targeted anatomical passageway.
[0041] Once balloon (134) is disposed within the targeted anatomical passageway, slider (122) may be proximally retracted relative to body (120) to proximally retract sleeve (114) relative to both body (120) and dilation catheter (112), thereby uncovering balloon (134), as shown in FIG. 2B. In some cases, the targeted anatomical passageway in which balloon (134) is disposed may be sufficiently tight to prevent shaft (130) from resiliently returning to a substantially straight configuration and thereby substantially maintain balloon (134) at the desired access angle when sleeve (114) is proximally retracted. In other words, bent distal portion (136) of shaft (130) may be maintained via spatial constraints imposed by the targeted anatomical passageway. In addition, or alternatively, bent distal portion (146) of sleeve (114) may assist with maintaining balloon (134) at the desired access angle even when sleeve (114) is proximally retracted. In some versions, sleeve (114) may be proximally retracted sufficiently to cause body (120) to urge sleeve (114) toward the substantially straight configuration and thereby at least partially straighten out bent distal portion (146). For example, proximal retraction of bent distal portion (146) into the elongate receptacle of body (120) may cause bent distal portion (146) to substantially conform to the elongate shape of the receptacle. Alternatively, sleeve (114) may be sufficiently rigid to prevent such proximal retraction of bent distal portion (146) into the elongate receptacle of bent distal portion (146). As shown, handle assembly (110) may be manipulated (e.g., reoriented) to accommodate the proximal retraction of sleeve (114) in some cases.
[0042] After sleeve (114) has been proximally retracted to uncover balloon (134), and while balloon (134) is disposed within the targeted anatomical passageway, balloon (134) may be transitioned from the non-inflated state to the inflated state to thereby dilate the targeted anatomical passageway, as shown in FIG. 2C. Balloon (134) may be subsequently returned to the non-inflated state. In some cases, slider (122) may be distally advanced relative to body (120) to distally extend sleeve (114) relative to both body (120) and dilation catheter (112), thereby re-covering balloon (134), such as to resume protecting balloon (134) during further probing or other movement of instrument (100) within the patient’s head (H) after balloon (134) has been returned to the non-inflated state.
[0043] In some cases, instrument (100) may be configured to deliver irrigation fluid to the targeted anatomical passageway via sleeve (114) and/or dilation catheter (112). For example, irrigation fluid may be directed through the lumen of sleeve (114) (e.g., around dilation catheter (112)) and may exit sleeve (114) via open distal end (142). In addition, or alternatively, shaft (130) may define an irrigation lumen (not shown) which terminates distally at an open distal end (not shown) provided in distal tip (132).
[0044] III. Examples of Dilation Catheter Assemblies with Stylets
[0045] In some instances, it may be desirable to provide a stylet that may be selectively received within a flexible shaft of a dilation instrument, such as to deflect the dilation balloon relative to a longitudinal axis of the dilation instrument and/or to impart rigidity to the flexible shaft while the dilation instrument is being used to probe about (or otherwise traverse) small, tortuous anatomical passageways within the patient’s head (H). Each of the examples of dilation catheter assemblies (204, 304) described below may provide one or more such functionalities.
[0046] A. Example of Dilation Catheter Assembly with Straight, Rigid Stylet
[0047] FIGS. 3-4B show an example of a deflectable dilation catheter (200) in combination with a straight, rigid stylet (202), such that deflectable dilation catheter (200) and stylet (202) collectively define a dilation catheter assembly (204). Deflectable dilation catheter (200) is configured to be selectively deflected between a substantially straight configuration (see FIG. 4A) and a bent configuration (see FIG. 4B). Deflectable dilation catheter (200) includes a handle assembly (210), a shaft assembly (250), a dilator in the form of a balloon (260), and a navigation system connector (280) extending proximally from handle assembly (210). Handle assembly (210) includes a body (212) defining an elongated slot (214), and an actuator (216) slidably coupled to body (212) via elongated slot (214). Body (212) is dimensioned to be grasped by a single hand of a clinician or other operator such that the clinician may also control actuator (216) with the same hand. Body (212) defines a distal recess (218) dimensioned to house a portion of rotation knob (255) of shaft assembly (250). Distal recess (218) may house a portion of rotation knob (255) at multiple, discrete, angular positions; thereby locking shaft assembly (250) into a corresponding angular position relative to handle assembly (210). Engagement between distal recess (218) and rotation knob (255) allows a clinician to control the orientation of balloon (260) about its own long axis relative to body (212).
[0048] Actuator (216) is configured to slide relative to body (212) along a path defined by elongated slot (214). As will be described in greater detail below, actuator (216) is attached to a pull wire (270) such that movement of actuator (216) relative to body (212) is configured to bend shaft assembly (250) and balloon (260) between the substantially straight configuration (see FIG. 4A) and the bent configuration (see FIG. 4B).
[0049] A luer fitting (220) extends from body (212). Luer fitting (220) is configured to selectively couple with a suitable source of fluid (i.e., saline, air, etc.). Luer fitting (220) is in fluid communication with an inflation lumen (not shown) of shaft assembly (250), which terminates distally into communication with the interior of balloon (260). Therefore, luer fitting (220) and the inflation lumen are configured to provide fluid commutation between a suitable source of fluid and the interior of balloon (260) in order to selectively inflate and deflate balloon (260) in accordance with the description herein.
[0050] Shaft assembly (250) includes a flexible elongated shaft (252) extending distally from handle assembly (210) into a distal tip (262), and rotation knob (255) fixed to elongated shaft (252). In some instances, distal tip (262) may have a position sensor configured to be used with a suitable navigation system in order to track and display the position of distal tip (262). The position sensor may be integrated into distal tip (262) itself; or may be fixed relative to distal tip. By way of example only, a position sensor at distal tip (262) may take the form of one or more coils that generate signals in response to an alternating electromagnetic field, where those signals indicate the real-time location of the position sensor in three- dimensional space.
[0051] Elongated shaft (252) may define one or more lumens, such as the inflation lumen, a pull wire lumen (not shown), and/or a working lumen (258). The pull wire lumen may slidably receive pull wire (270), which extends from a distal potion of balloon (260) all the way to actuator (216) of handle assembly (210). Pull wire (270) is fixed to the distal portion of balloon (260) as well as actuator (216). Therefore, a clinician may slide actuator (216) along the path defined by elongated slot (214) in order to acuate pull wire (270) within the pull wire lumen, thereby deflecting balloon (260) between the substantially straight configuration (see FIG. 4A) and the bent configuration (see FIG. 4B). Balloon (260) may be resiliently biased toward the straight configuration such that once tension from pull wire (270) is relieved, balloon (260) may bend itself back toward the straight configuration. Working lumen (258) extends through elongated shaft (252) all the way to an open distal tip (262). In some versions, body (212) of handle assembly (210) includes a proximal opening (not shown) that is axially aligned with working lumen (258) for facilitating insertion of one or more tools, such as stylet (202), into working lumen (258) from a proximal side of body (212).
[0052] By way of further example only, deflectable dilation catheter (200) may be configured and operable in accordance with at least some of the teachings of U.S. Pat. App. No. 63/539,363, entitled “Medical Instrument with Translating Actuator to Steer Shaft,” filed September 20, 2023, the disclosure of which is incorporated by reference herein.
[0053] In the example shown, stylet (202) includes a proximal base (290) and a rail (292) extending distally from base (290) to a distal tip (294). Rail (292) of the present example is both straight and substantially fully rigid, and is sized and configured to be selectively received within a lumen of deflectable dilation catheter (200), such as working lumen (258). When received within working lumen (258), rail (292) may impart rigidity to shaft assembly (250) and thereby inhibit bending of shaft assembly (250) from the substantially straight configuration toward the bent configuration. Thus, the presence of rail (292) within working lumen (258) may facilitate probing or other movement of deflectable dilation catheter (200) within the patient’s head (H) (e.g., prior to reaching a targeted anatomical passageway).
[0054] In some versions, base (290) of stylet (202) may be sized and configured to inhibit insertion of base (290) into working lumen (258) and thereby limit the extent to which rail (292) may be inserted into working lumen (258). For example, base (290) may be sized and configured to abut a proximal surface of body (212) of handle assembly (210) when distal tip (294) of rail (292) is disposed at or near a distal end of working lumen (258), so as to prevent distal tip (294) from extending distally beyond distal tip (262).
[0055] As shown in FIG. 4A, shaft assembly (250) may initially be in the substantially straight configuration, with rail (292) received within working lumen (258) such that the operator may use deflectable dilation catheter (200) for probing or otherwise moving within the patient’s head (H) without causing inadvertent bending of shaft assembly (250). If the operator subsequently desires to bend shaft assembly (250) (e.g., to access a targeted anatomical passageway), the operator may retract rail (292) from working lumen (258) and then slide actuator (216) along the path defined by elongated slot (214) in order to acuate pull wire (270), thereby bending shaft assembly (250) as shown in FIG. 4B. In some instances, the operator may then return shaft assembly (250) to the substantially straight configuration and, if desired, may reinsert rail (292) into working lumen (258).
[0056] While rail (292) has been described as being selectively received within working lumen (258), it will be appreciated that rail (292) may be configured to be selectively received within any other suitable lumen of deflectable dilation catheter (200). For example, rail (292) may be configured to be selectively received within a lumen of deflectable dilation catheter (200) having a closed distal end (not shown).
[0057] In some cases, deflectable dilation catheter (200) may be configured to deliver irrigation fluid to the targeted anatomical passageway. For example, irrigation fluid may be directed through working lumen (258) or any other suitable lumen of deflectable dilation catheter (200).
[0058] B. Example of Dilation Catheter Assembly with Malleable Stylet
[0059] FIGS. 5-6B show another example of a deflectable dilation catheter (300) in combination with a malleable stylet (302), such that deflectable dilation catheter (300) and stylet (302) collectively define a dilation catheter assembly (304). Deflectable dilation catheter (300) is similar to deflectable dilation catheter (200) described above, except as otherwise described below. In this regard, deflectable dilation catheter (300) is configured to be selectively deflected between a substantially straight configuration (see FIG. 6A) and a bent configuration (see FIG. 6B). Deflectable dilation catheter (300) includes a handle assembly (310), a shaft assembly (350), a dilator in the form of a balloon (360), and a navigation system connector (380). Handle assembly (310) includes a body (312) that defines a distal recess (318) dimensioned to house a portion of rotation knob (355) of shaft assembly (350). A luer fitting (320) extends from body (312) and is in fluid communication with an inflation lumen (not shown) of shaft assembly (350) to provide fluid commutation between a suitable source of fluid and the interior of balloon (360). Shaft assembly (350) includes a flexible elongated shaft (352) extending distally from handle assembly (310) into a distal tip (362), and rotation knob (355) fixed to elongated shaft (352).
[0060] Elongated shaft (352) may define one or more lumens, such as the inflation lumen and/or a working lumen (358). Working lumen (358) extends through elongated shaft (352) all the way to an open distal tip (362). In some versions, body (312) of handle assembly (310) includes a proximal opening (not shown) that is axially aligned with working lumen (358) for facilitating insertion of one or more tools, such as stylet (302), into working lumen (358) from a proximal side of body (312).
[0061] Unlike deflectable dilation catheter (200) described above, deflectable dilation catheter (300) of the present example does not include an actuation assembly (e.g., actuator (216) and pull wire (270)) forbending shaft assembly (350) and balloon (360) between the substantially straight configuration (see FIG. 4A) and the bent configuration (see FIG. 4B). Rather, stylet (302) of the present example is configured to bend shaft assembly (350) and balloon (360) between the substantially straight configuration and the bent configuration.
[0062] In the example shown, stylet (302) includes a proximal base (390) and a rail (392) extending distally from base (390) to a distal tip (394). Rail (392) of the present example is malleable, and is sized and configured to be selectively received within a lumen of deflectable dilation catheter (300), such as working lumen (358). As shown, rail (392) may be selectively bent by an operator to a desired access angle. FIG. 5 shows stylet (302) where rail (392) has been bent to form a bent distal portion (396) defining an access angle of around 80 degrees. It should be understood that a bent distal portion (396) having any suitable access angle may be formed as would be apparent to one having ordinary skill in the art in view of the teachings herein.
[0063] Due to the malleability of rail (392) and the flexibility of shaft assembly (350), rail (392) may be configured to impart a bend (e.g., a curvature) to shaft assembly (350) when rail (392) is received within working lumen (358). For example, the selective bending of rail (392) by the operator may cause corresponding bending of shaft assembly (350) external to rail (392). In other words, shaft assembly (350) may conform to the bending of rail (392). More particularly, the bending of rail (392) to form bent distal portion (396) may cause corresponding bending of shaft assembly (350) to form a bent distal portion. Thus, the bent distal portion of shaft assembly (350) may define the same access angle as that defined by bent distal portion (396) of rail (392).
[0064] Rail (392) is sufficiently rigid such that shaft assembly (350) may be suitably inserted into the patient’s head (H) at or near a desired anatomical passageway, with rail (392) received within working lumen (358) in a bent or unbent state, without deviating from the chosen bend angle. In particular, once inserted into a patient’s head (H), bent distal portion (396) of rail (392) remains fixed in the chosen bend angle. In other words, once inserted into a patient’s head (H), an operator may not bend rail (392); and deflectable dilation catheter (300) will maintain the selected bend angle at bent distal portion (396) as deflectable dilation catheter (300) probes or otherwise moves within the patient’s head (H). However, rail (392) is sufficiently malleable such that an operator may utilize a bending tool or the strength of their own hand in order to manipulate rail (392) to form various access angles. Therefore, rail (392) may be bent such that deflectable dilation catheter (300) may be utilized to access a frontal recess, a sphenoid sinus ostium, a maxillary sinus ostium, a Eustachian tube, etc. Of course, rail (392) may be utilized to access any other anatomical passageway as would be apparent to one having ordinary skill in the art in view of the teachings herein.
[0065] Rail (392) may be formed of shape memory nitinol, stainless steel that is annealed for malleability, a flexible polymer supported by shape memory nitinol wires, or any other suitable material that would be apparent to one having ordinary skill in the art in view of the teachings herein.
[0066] When received within working lumen (358), rail (392) may cause shaft assembly (350) to assume the bent configuration. In addition, or alternatively, rail (392) may impart rigidity to shaft assembly (350) and thereby inhibit bending of shaft assembly (350) from the bent configuration (e.g., toward another bent configuration and/or toward the substantially straight configuration). Thus, the presence of rail (392) within working lumen (358) may facilitate transitioning of shaft assembly (350) to the bent configuration, and/or may facilitate probing or other movement of deflectable dilation catheter (300) within the patient’s head (H).
[0067] In some versions, base (390) of stylet (302) may be sized and configured to inhibit insertion of base (390) into working lumen (358) and thereby limit the extent to which rail (392) may be inserted into working lumen (358). For example, base (390) may be sized and configured to abut a proximal surface of body (312) of handle assembly (310) when distal tip (394) of rail (392) is disposed at or near a distal end of working lumen (358), so as to prevent distal tip (394) from extending distally beyond distal tip (362).
[0068] As shown in FIG. 4 A, shaft assembly (350) may initially be in the substantially straight configuration, with rail (392) disposed outside of working lumen (358). If the operator subsequently desires to use deflectable dilation catheter (300) for probing or otherwise moving within the patient’s head (H) and/or to bend shaft assembly (350) (e.g., to access a targeted anatomical passageway), the operator may insert rail (392) into working lumen (358), thereby bending shaft assembly (350) as shown in FIG. 4B. In some cases, rail (392) may be inserted into working lumen (358) after being bent to form bent distal portion (396). In some other cases, rail (392) may be inserted into working lumen (358) prior to being bent to form bent distal portion (396).
[0069] While rail (392) has been described as being selectively received within working lumen (358), it will be appreciated that rail (392) may be configured to be selectively received within any other suitable lumen of deflectable dilation catheter (300). For example, rail (392) may be configured to be selectively received within a lumen of deflectable dilation catheter (300) having a closed distal end (not shown). While rail (392) has been described as being malleable, rail (392) may alternatively be substantially fully rigid. For example, rail (392) may be formed with a permanent bent distal portion (396) defining a fixed bend angle. In some cases, a plurality of stylets (302) may be provided, each having a permanent bent distal portion (396) defining a different fixed bend angle, such that the operator may select a particular stylet (302) based on the desired access angle.
[0070] In some cases, deflectable dilation catheter (300) may be configured to deliver irrigation fluid to the targeted anatomical passageway. For example, irrigation fluid may be directed through working lumen (358) or any other suitable lumen of deflectable dilation catheter (300).
[0071] III. Examples of Combinations
[0072] 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.
[0073] Example 1 : A method comprising: (a) positioning a dilation catheter within a malleable sleeve such that a dilator of the dilation catheter is housed within the malleable sleeve; (b) inserting a bent distal portion of the malleable sleeve into an ear, nose, or throat of a patient; (c) advancing the bent distal portion of the malleable sleeve toward a targeted anatomical passageway of the patient until the dilator is disposed within the targeted anatomical passageway; (d) while the dilator is disposed within the targeted anatomical passageway, retracting the malleable sleeve relative to the dilator to thereby expose the dilator within the targeted anatomical passageway; and (e) transitioning the dilator from a non-expanded state to an expanded state within the targeted anatomical passageway to thereby dilate the targeted anatomical passageway.
[0074] Example 2: The method of Example 1, further comprising bending the malleable sleeve to form the bent distal portion.
[0075] Example 3 : The method of Example 2, bending the malleable sleeve being performed prior to positioning the dilation catheter within the malleable sleeve.
[0076] Example 4: The method of Example 3, positioning the dilation catheter within the malleable sleeve causing a flexible shaft of the dilation catheter to conform to the bent distal portion of the malleable sleeve.
[0077] Example 5: The method of Example 2, bending the malleable sleeve being performed after positioning the dilation catheter within the malleable sleeve.
[0078] Example 6: The method of Example 5, bending the malleable sleeve causing a flexible shaft of the dilation catheter to conform to the bent distal portion of the malleable sleeve.
[0079] Example 7: The method of any of Examples 1 through 6, the dilator being in the non-expanded state while the dilator is housed within the malleable sleeve.
[0080] Example 8: The method of any of Examples 1 through 7, further comprising transitioning the dilator from the expanded state to the non-expanded state after dilating the targeted anatomical passageway.
[0081] Example 9: The method of Example 8, further comprising extending the malleable sleeve relative to the dilator to thereby resuming housing the dilator within the malleable sleeve after transitioning the dilator from the expanded state to the non-expanded state.
[0082] Example 10: The method of any of Examples 1 through 9, the dilator comprising a balloon.
[0083] Example 11 : The method of any of Examples 1 through 10, the dilation catheter extending distally from a body of a handle assembly, the malleable sleeve being translatably coupled to the body of the handle assembly.
[0084] Example 12: The method of Example 11, retracting the malleable sleeve relative to the dilator being performed via proximal translation of the malleable sleeve relative to the body of the handle assembly.
[0085] Example 13: The method of any of Examples 11 through 12, a proximal region of a flexible shaft of the dilation catheter being fixedly secured to the body of the handle assembly.
[0086] Example 14: The method of any of Examples 1 through 13, further comprising navigating the bent distal portion of the malleable sleeve based on signals generated by a navigation sensor fixedly secured to the malleable sleeve. [0087] Example 15: The method of any of Examples 1 through 14, further comprising delivering irrigation fluid to the targeted anatomical passageway via at least one of the malleable sleeve or the dilation catheter.
[0088] Example 16: A method comprising: (a) positioning a dilation catheter within a malleable sleeve such that a dilator of the dilation catheter is proximal of an open distal end of the malleable sleeve; (b) inserting a bent distal portion of the malleable sleeve into an ear, nose, or throat of a patient; (c) advancing the bent distal portion of the malleable sleeve toward a targeted anatomical passageway of the patient until the dilator is disposed within the targeted anatomical passageway; (d) while the dilator is disposed within the targeted anatomical passageway, retracting the malleable sleeve relative to the dilator such that the open distal end of the malleable sleeve is proximal of the dilator; and (e) transitioning the dilator from a nonexpanded state to an expanded state within the targeted anatomical passageway to thereby dilate the targeted anatomical passageway.
[0089] Example 17: The method of Example 16, further comprising bending the malleable sleeve to form the bent distal portion.
[0090] Example 18: The method of any of Examples 16 through 17, further comprising delivering irrigation fluid to the targeted anatomical passageway via at least one of the malleable sleeve or the dilation catheter.
[0091] Example 19: A method comprising: (a) inserting a bent distal portion of a malleable sleeve into an ear, nose, or throat of a patient while a dilator of a dilation catheter is housed within the malleable sleeve; (b) advancing the bent distal portion of the malleable sleeve toward a targeted anatomical passageway of the patient until the dilator is disposed within the targeted anatomical passageway; (c) while the dilator is disposed within the targeted anatomical passageway, retracting the malleable sleeve relative to the dilator to thereby expose the dilator within the targeted anatomical passageway; and (d) transitioning the dilator from a non-expanded state to an expanded state within the targeted anatomical passageway to thereby dilate the targeted anatomical passageway.
[0092] Example 20: The method of Example 19, further comprising bending the malleable sleeve to form the bent distal portion.
[0093] Example 21 : A method comprising: (a) inserting a deflectable distal portion of a dilation catheter into an ear, nose, or throat of a patient while a straight stylet is disposed within the deflectable distal portion to maintain the deflectable distal portion in a straight configuration; (b) retracting the straight stylet out of the deflectable distal portion; (c) transitioning the deflectable distal portion from the straight configuration to a deflected configuration such that a distal end of the dilation catheter is oriented toward a targeted anatomical passageway of the patient; (d) advancing the dilation catheter to position a dilator of the dilation catheter within the targeted anatomical passageway; and (e) transitioning the dilator from a non-expanded state to an expanded state within the targeted anatomical passageway to thereby dilate the targeted anatomical passageway.
[0094] Example 22: The method of Example 21, transitioning the deflectable distal portion from the straight configuration to the deflected configuration being performed by actuating an actuator of the dilation catheter.
[0095] Example 23 : The method of Example 21, transitioning the deflectable distal portion from the straight configuration to the deflected configuration being performed by inserting a bent distal portion of a rail into the deflectable distal portion.
[0096] Example 24: The method of Example 23, the rail being malleable, the method further comprising bending the rail to form the bent distal portion.
[0097] Example 25: The method of any of Examples 21 through 24, further comprising delivering irrigation fluid to the targeted anatomical passageway via the dilation catheter.
[0098] Example 26: A method comprising: (a) inserting a deflectable distal portion of a dilation catheter into an ear, nose, or throat of a patient; (b) inserting a bent distal portion of a rail into a deflectable distal portion of the dilation catheter to thereby transition the deflectable distal portion from the straight configuration to a deflected configuration; (c) orienting a distal end of the dilation catheter toward a targeted anatomical passageway of the patient; (d) advancing the dilation catheter to position a dilator of the dilation catheter within the targeted anatomical passageway; and (e) transitioning the dilator from a non-expanded state to an expanded state within the targeted anatomical passageway to thereby dilate the targeted anatomical passageway.
[0099] Example 27: The method of Example 26, the rail being malleable, the method further comprising bending the rail to form the bent distal portion.
[0100] Example 28: The method of Example 26, the rail being substantially fully rigid.
[0101] Example 29: The method of any of Examples 26 through 28, inserting the bent distal portion of the rail into the deflectable distal portion of the dilation catheter being performed prior to inserting the deflectable distal portion of the dilation catheter into the ear, nose, or throat of the patient.
[0102] Example 30: The method of any of Examples 26 through 29, further comprising delivering irrigation fluid to the targeted anatomical passageway via the dilation catheter.
[0103] Example 31 : An apparatus comprising: (a) a handle assembly comprising a body; (b) a dilation catheter comprising: (i) a flexible shaft extending distally from the body along a longitudinal axis, the flexible shaft having a proximal region fixedly secured to the body, and (ii) a dilator coupled to the flexible shaft, the dilator being configured to transition from a non-expanded state to an expanded state; and (c) a malleable sleeve translatably coupled relative to the body such that the malleable sleeve is configured to translate longitudinally relative to the body, the malleable sleeve defining a lumen, at least a portion of the dilation catheter being slidably received within the lumen.
[0104] Example 32: The apparatus of Example 31, the handle assembly further comprising an actuator coupled to the malleable sleeve, the actuator being configured to move relative to the body to thereby translate the malleable sleeve longitudinally relative to the body.
[0105] Example 33: The apparatus of Example 32, the actuator comprising a slider configured to translate longitudinally relative to the body to thereby translate the malleable sleeve longitudinally relative to the body.
[0106] Example 34: The apparatus of any of Examples 31 through 33, the dilator comprising a balloon.
[0107] Example 35: The apparatus of any of Examples 31 through 34, the dilator being slidably received within the lumen when the dilator is in the non-expanded state.
[0108] Example 36: The apparatus of any of Examples 31 through 35, the flexible shaft having a distal region configured to bend to thereby deflect the dilator laterally away from the longitudinal axis.
[0109] Example 37: The apparatus of any of Examples 31 through 36, the flexible shaft being resiliently biased toward a substantially straight configuration.
[0110] Example 38: The apparatus of any of Examples 31 through 37, the malleable sleeve having an open proximal end.
[0111] Example 39: The apparatus of any of Examples 31 through 38, the malleable sleeve having an open distal end.
[0112] Example 40: The apparatus of any of Examples 31 through 39, the malleable sleeve being configured to translate longitudinally relative to the body between a distally extended position in which the dilator is housed within the lumen, and a proximally retracted position in which the dilator is exposed outside of the lumen.
[0113] Example 41 : The apparatus of any of Examples 31 through 40, the malleable sleeve being configured to impart a bend to the flexible shaft when the flexible shaft is slidably received within the lumen.
[0114] Example 42: The apparatus of any of Examples 31 through 41, the malleable sleeve comprising shape memory ni tinol.
[0115] Example 43 : The apparatus of any of Examples 31 through 41 , the malleable sleeve comprising stainless steel annealed for malleability.
[0116] Example 44: The apparatus of any of Examples 31 through 41, the malleable sleeve comprising a flexible polymer supported by shape memory nitinol wires.
[0117] Example 45: The apparatus of any of Examples 31 through 44, further comprising a navigation sensor fixedly secured to the malleable sleeve.
[0118] Example 46: An apparatus comprising: (a) a body; (b) a dilation catheter comprising: (i) a flexible shaft extending distally from the body along a longitudinal axis, the flexible shaft having a proximal region fixedly secured to the body, and (ii) a dilator coupled to the flexible shaft, the dilator being configured to transition from a non-expanded state to an expanded state; and (c) a malleable sleeve translatably coupled relative to the body such that the malleable sleeve is configured to translate longitudinally relative to the body between a distally extended position in which the dilator is housed within the sleeve, and a proximally retracted position in which the dilator is exposed outside of the sleeve.
[0119] Example 47: The apparatus of Example 46, further comprising an actuator coupled to the malleable sleeve, the actuator being configured to move relative to the body to thereby translate the malleable sleeve longitudinally relative to the body.
[0120] Example 48: The apparatus of any of Examples 46 through 47, the flexible shaft having a distal region configured to bend to thereby deflect the dilator laterally away from the longitudinal axis.
[0121] Example 49: An apparatus comprising: (a) a body; (b) a dilation catheter extending distally from the body, the dilation catheter being fixedly secured to the body; and (c) a malleable sleeve translatably coupled relative to the body such that the malleable sleeve is configured to translate longitudinally relative to the body about an exterior of the dilation catheter.
[0122] Example 50: The apparatus of Example 50, the dilation catheter comprising: (i) a flexible shaft extending distally from the body along a longitudinal axis, the flexible shaft having a proximal region fixedly secured to the body, and (ii) a dilator coupled to the flexible shaft, the dilator being configured to transition from a non-expanded state to an expanded state.
[0123] IV. Miscellaneous [0124] 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. that are described herein. The above-described 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.
[0125] 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.
[0126] 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.
[0127] 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.
[0128] 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 of ordinary skill 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.