Catheter and handle assemblies, systems and methods

Abstract

This invention relates to catheter and handle assemblies for tissue treatment. More specifically, the invention relates to a catheter assembly having an elongated shaft, an ablation component coupled to one end of the shaft, and a handle coupled to the other end of the shaft. The handle facilitates axial and circumferential positioning of the ablation component via the shaft in an airway, tubing, or blood vessel for tissue treatment. Embodiments include using the handle during treatment of lung diseases such as COPD and asthma to facilitate axial and circumferential positioning of the shaft and ablation component through and independently of the working channel of a bronchoscope.

Description

[0001] This application claims the benefit of U.S. Provisional Application No. 61 / 915,282, filed on December 12, 2013, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present invention generally relates to systems, devices and methods for treating tissues, and more particularly, to catheter and handle systems including a catheter positioning handle assembly that facilitates circumferential and axial positioning of the distal end of a catheter in an airway, conduit or vessel. Background Technology

[0003] Lung diseases are among the most common medical conditions, affecting tens of millions of people in the United States alone. Lung diseases are caused by airway problems that interfere with normal breathing. Many of these diseases require medical treatment or intervention to restore normal lung function and improve a patient's overall quality of life. Some of the more common lung diseases include asthma and chronic obstructive pulmonary disease, or COPD. While the symptoms of lung diseases such as COPD and asthma differ, they often include a persistent cough, shortness of breath, wheezing, chest tightness, and shortness of breath. Generally, these symptoms worsen during some level of strenuous activity, such as running, jogging, or brisk walking. However, if the disease is allowed to progress without examination, these symptoms can also be noticed during non-strenuous activities. Over time, especially without seeking medical treatment, a person's daily activities will be significantly impaired, thus reducing their overall quality of life.

[0004] Many lung diseases, whether acute or chronic, often involve pathological conditions associated with airway inflammation. When such inflammation occurs in the airways, infiltrating inflammatory cells damage the bronchial or lung tissue, ultimately leading to the impaired respiratory characteristics of lung disease, such as reduced respiratory flow or oxygen exchange capacity. Over time, this inflammation can cause airway obstruction, airway wall thickening, and alterations in the structures within or around the airway walls. Airway obstruction can significantly reduce the amount of gas exchange in the lungs, leading to shortness of breath. Airway obstruction can be caused by excessive intraluminal mucus, edema fluid, or both. Airway wall thickening can be attributed to excessive contraction of airway smooth muscle, airway smooth muscle hypertrophy, mucous gland hypertrophy, inflammation, edema, or a combination of these. Alterations in the structures surrounding the airways, such as damage to the lung tissue itself, can impair peripheral traction on the airway walls and subsequently narrow the airway. Generally speaking, lung diseases such as COPD and asthma are the result of a complex interaction of local inflammatory cytokines, inhaled irritants (e.g., cold air, smoke, allergens, or other chemicals), systemic hormones (e.g., cortisol and adrenaline), local neural input (i.e., nerve cells completely contained in the airway wall that can produce local reflex stimulation of smooth muscle cells and mucous glands), and central nervous system input (i.e., neural signals transmitted from the brain to smooth muscle cells and mucous glands via the vagus nerve).

[0005] Asthma can also include acute exacerbations or attacks of additional airway narrowing caused by the contraction of hyperresponsive airway smooth muscle, which significantly increases airflow resistance. Asthma symptoms include recurrent episodes of shortness of breath (e.g., shortness of breath or difficulty breathing), wheezing, chest tightness, and cough. Furthermore, COPD (often called emphysema) is characterized by changes in the lung tissue surrounding or adjacent to the airways. Emphysema can involve the destruction of lung tissue (e.g., alveolar sacs), leading to reduced gas exchange and reduced circumferential traction exerted on the airway walls by surrounding lung tissue. The destruction of alveolar tissue restricts the inflow of oxygen-rich air and the normal function of healthier tissue, resulting in significant shortness of breath. Exposure to chemicals or other substances (e.g., tobacco smoke) can significantly accelerate the rate of tissue damage or destruction. Additionally, another type of COPD—chronic bronchitis—is characterized by contraction of airway smooth muscle, smooth muscle hypertrophy, excessive mucus production, hypertrophy of mucous glands, and inflammation of the airway walls. Like asthma, these abnormalities result from a complex interplay of local inflammatory cytokines, inhaled irritants, systemic hormones, and the local and central nervous systems. Unlike asthma, where airway obstruction is largely reversible, airway obstruction in chronic bronchitis is primarily chronic and permanent.

[0006] Treatment for lung diseases includes reducing exposure to harmful agents, administering medications (e.g., bronchodilators, steroids, phosphodiesterase inhibitors, theophylline, antibiotics, etc.), applying lung therapy (e.g., oxygen therapy, pulmonary rehabilitation), and surgical interventions such as bronchial thermoplasty. Unfortunately, medication requires patient adherence, often causes harmful side effects, and does not necessarily treat the underlying cause of the disease. Similarly, surgical interventions can lead to disruption of smooth muscle tone and neurological function, preventing patients from responding effectively to inhaled irritants, systemic hormones, and both local and central nervous system inputs.

[0007] Alternative approaches to treating lung diseases are known as targeted lung denervation. This method utilizes ablation (e.g., RF ablation) to selectively treat target areas within the airway wall (e.g., anatomical features of the matrix) via an ablation component, while protecting surface tissues such as the airway wall surface. For example, if desired or desired, mucous glands can be damaged to reduce mucus production to a level sufficient to prevent mucus accumulation that leads to increased airflow resistance, while preserving adequate mucus production to maintain effective mucociliary transport. Nerve branches / fibers passing through the airway wall or other anatomical features within the airway wall can also be disrupted.

[0008] A specially designed catheter allows for the introduction of an ablation component into a patient's airway via a delivery device. This ablation component typically comprises one or more foldable electrodes or energy emitters connected to an expandable component (e.g., a balloon). The delivery device can be a guide tube, delivery sheath, bronchoscope, or endoscope, and may include one or more observation devices, such as optical observation devices (e.g., a camera), optical trains (e.g., a set of lenses), optical fibers, a CCD chip, etc. Once positioned in the desired area of ​​the airway, such as the left and / or right main bronchi, the expandable component extends to bring one or more electrodes into contact with the tracheal wall.

[0009] Energy (e.g., RF energy) is supplied to an energy emitter to ablate target tissue, resulting in lesions that temporarily or permanently damage the target tissue, thereby affecting (e.g., attenuating) neural signals arriving at or from the lung portion associated with the target tissue. Simultaneously, a coolant is supplied via a conduit and directed to one or more electrodes and into an expandable member or balloon. This cools the surface tissue in contact with the electrodes, as well as adjacent tissue. The size, shape, and depth of the lesion are determined by the flow rate and temperature of the coolant and the energy supplied to the energy emitter. Apparatus, systems, and methods of such procedures can be found in one or more of the following documents: for example, U.S. Patent No. 8,088,127 entitled “Systems, Assemblies, and Methods for Treating a Bronchial Tree,” and U.S. Patent Application Publication No. 2011 / 0152855 entitled “Delivery Devices with Coolable Energy Emitting Assemblies,” both of which are incorporated herein by reference in their entirety.

[0010] To ensure that most or all of the target nerves extending along the airway are treated, it is generally desirable to create a peripheral lesion around all or most of the airway wall. Due to design constraints or preferences, the electrode or energy emitter may not extend along the entire periphery of the airway wall. Therefore, a peripheral lesion can be created by ablating tissue while slowly rotating the ablation assembly, or by positioning the ablation assembly in a series of rotational positions and delivering energy for a desired duration at each of these positions. Adjacent lesions then become contiguous, forming a peripheral band around the airway wall from beginning to end. Alternatively, the catheter may be axially repositioned within the distal or proximal portion of the first treatment site in the airway to treat other locations.

[0011] Typically, targeted lung denervation is performed under bronchoscopic visualization. A bronchoscope can be introduced into the target airway, and the treatment catheter can then be delivered along the bronchoscope, or more preferably, through the working channel of the bronchoscope. However, placement through the working channel presents challenges in catheter manipulation due to the small size of the working channel, friction between the catheter and the working channel wall, and the bending or twisting of the working channel in the case of a flexible bronchoscope. Furthermore, if the electrodes and camera are independently rotatable, they are prone to losing their relative position because the camera will always protrude in the upper right of the airway, regardless of the bronchoscope's position.

[0012] During treatment, misalignment of the electrodes at the treatment site and / or unintended movement of the catheter relative to the bronchoscope can lead to inaccurate treatment, resulting in axial or circumferential misalignment of the lesions, undesirable gaps between lesions, or excessive overlap between lesions.

[0013] To address these and other challenges, there remains a need for systems, devices, or equipment that allow for precise placement and manipulation of lung treatment catheters (e.g., targeted lung denervation catheters) while easily maintaining electrode orientation when placed in the lung airway via a delivery device (e.g., the working channel of a bronchoscope). Summary of the Invention

[0014] Embodiments of the present invention relate to a lung processing catheter and handle system, the lung processing catheter and handle system including a catheter assembly, a handle assembly, and an endoscope coupling assembly for connecting the handle assembly and the catheter assembly to a delivery device, such as a bronchoscope. Embodiments also relate to a kit including a catheter assembly and a handle assembly connected to a delivery device via the endoscope coupling assembly, and instructions for using the same, such as a bronchoscope. The catheter assembly is also fluidly and electrically connected to a system control console via the handle assembly, the system control console including a coolant supply and a return reservoir, and a power supply such as an RF generator.

[0015] The catheter assembly, handle assembly, and endoscope coupling assembly work together to facilitate circumferential and axial positioning of the catheter electrode at the treatment site for tissue treatment, while maintaining the known rotational and axial orientation of portions of the catheter assembly (e.g., the ablation component) within the treatment site, such as an airway, conduit, or blood vessel, and the ablation component including an energy emitter or electrode. The system also facilitates optical connection between the ablation component of the catheter assembly and an observation device (e.g., a fiber optic camera) at the working end of the bronchoscope, while maintaining independent movement of the observation device relative to the ablation component to achieve maximum observational flexibility of the treatment site and the ablation component. This allows for complete observation of the ablation component's electrodes within the treatment site, regardless of their orientation or positioning within the treatment site.

[0016] In some embodiments, the catheter assembly includes a targeted lung denervation RF, microwave, or ultrasound catheter, and generally includes an elongated shaft and an ablation assembly coupled to a distal portion of the shaft. The ablation assembly includes an expandable member (e.g., a balloon or basket section) and one or more electrodes or energy emitters coupled to the expandable member. The catheter assembly also includes a cooling circuit comprising coolant inlet and outlet chambers within the elongated shaft for circulating coolant to the expandable member and energy emitter, as well as coolant inlet and return paths (e.g., cooling conduits), one or more wires for powering the energy emitter, and optional thermocouples and associated wires for measuring and sensing temperature at proximal electrode locations, and optional cooling circuit pressure sensor associated wires and / or pressure relief valves for measuring and sensing pressure in the cooling circuit.

[0017] In some embodiments, the handle assembly is coupled to the proximal portion of the shaft. The handle assembly may include a housing and spindle tube or handle frame fixedly coupled to the proximal end of the shaft, the spindle tube and handle frame coupled to the housing to allow the spindle tube to be rotatably and axially movable relative to the housing and the conduit assembly. The handle assembly may also include an umbilical cable with strain release for coupling the handle assembly and ultimately the conduit assembly to a system console, which includes a heat exchanger, a coolant pump, an energy generator (e.g., an RF, microwave, or ultrasonic generator), and a system controller. The umbilical cable may facilitate coupling, for example, inlet and return fluid lines (coolant) from the system console for fluidly coupling the handle assembly to the console's heat exchanger and pump, cables / connectors for electrically coupling the electrodes of the conduit assembly to the energy source, thermocouples for monitoring the temperature of surface tissue at the treatment site, and electrodes and / or pressure sensors, or both, for monitoring high-pressure coolant inlet flow and low-pressure return flow.

[0018] In some embodiments, the endoscope coupling assembly detachably connects the handle assembly and the catheter assembly to the working channel of a delivery device (e.g., a bronchoscope) in a unique or single orientation, such that the initial rotation and axial orientation of the catheter assembly relative to the working end or distal end of the bronchoscope are known. The coupling assembly is fixedly connected to the spindle tube, allowing the handle housing and the catheter assembly to be rotatably and axially movable relative to the working channel.

[0019] In some embodiments, the handle assembly is configured to manipulate, in both axial and circumferential directions, the distal portion of the catheter shaft with the ablation component relative to the delivery device and airway wall during or in preparation for the application of lung disease treatment. In some aspects, the delivery device is a bronchoscope, which includes an elongated shaft of the catheter and a working channel or port through which the ablation component can be inserted, and the handle assembly can be fixed to the bronchoscope in a manner that functionally moves the handle assembly together with the bronchoscope and the ablation component of the catheter assembly. For example, the handle assembly can be fixed to the bronchoscope such that the shaft of the catheter assembly, and thus the ablation component, rotates and translates together with the corresponding rotation and axial translation of the bronchoscope used for coarse adjustment of the ablation component in the airway. The handle assembly may also include one or more control or manipulation mechanisms functionally coupled to the shaft and / or ablation assembly for rotatably and / or axially translating the shaft and / or ablation assembly relative to the mirror for coarse or fine circumferential adjustment, while other portions of the handle assembly remain engaged with and fixed relative to the bronchoscope.

[0020] In a specific implementation, the length of the elongated shaft of the catheter assembly and the length of the operating mechanism of the handle assembly are configured to allow the stroke length of the ablation assembly to be equal to or greater than the longitudinal length of the ablation assembly, such that the axial stroke of the handle assembly (from full retraction to full extension) allows the ablation assembly to switch between being fully extended out of the working end or distal end of the bronchoscope (with or without gaps outside the working end) and being fully retracted within the working end of the bronchoscope (with or without gaps inside the working end).

[0021] In some embodiments, once engaged with a bronchoscope, the user can manipulate the bronchoscope, its elongated shaft, and the ablation assembly to a position advantageous for performing lung disease treatment (e.g., targeted lung denervation). In some embodiments, the handle assembly may include controls for adjusting the distal portion of the catheter elongated shaft and / or the ablation assembly independently of the bronchoscope. In yet another embodiment, the handle assembly may include a separate control mechanism for axial translation of the catheter assembly relative to the working channel of the bronchoscope and for rotational movement of the catheter assembly relative to the working channel of the bronchoscope.

[0022] In use, the handle is permanently or temporarily coupled to the catheter assembly, the distal portion of the catheter shaft and the ablation assembly are inserted into the working channel or port of the delivery device, such as a bronchoscope. The handle assembly is then oriented to the bronchoscope via a coupling assembly. In some embodiments, the distal portion of the delivery device may include a visualization device, a camera and / or a suction chamber or vacuum. In some embodiments, the distal end of the catheter shaft and the ablation assembly can be positioned using axial and circumferential controls of the handle assembly, allowing specific portions of airway tissue to be targeted (e.g., radiofrequency energy emission from the electrodes). In some embodiments, the working end of the bronchoscope can be manipulated independently of the catheter shaft and the ablation assembly. For example, the handle assembly can be used to more precisely position the electrodes of the ablation assembly based on visual cues from the camera of the delivery device, without moving the delivery device and the camera.

[0023] In some embodiments, the distal end of the catheter assembly includes a longitudinal indicator band or strip. When the catheter assembly and handle assembly are coupled to the working end of the bronchoscope, the indicator band is aligned with the center point of the bronchoscope camera. This band provides visual confirmation of the orientation of the ablation assembly at the treatment site, regardless of the rotational orientation of the bronchoscope at the treatment site, the position of the ablation assembly relative to the working end of the bronchoscope is known. Furthermore, the band provides visual confirmation of the axial position of the ablation assembly relative to the working end of the bronchoscope to provide optimal optical alignment between the bronchoscope camera and the ablation assembly.

[0024] The systems according to various embodiments allow for one-handed operation of the catheter assembly and bronchoscope when rotated and / or axially translated for coarse adjustments, and enable independent rotation and axial fine adjustment of the ablation assembly relative to the bronchoscope.

[0025] The above summary of several exemplary embodiments of the present invention is not intended to describe every illustrated embodiment or every instance of the invention. Rather, these embodiments were chosen and described so that those skilled in the art can appreciate and understand the principles and practices of the invention. These embodiments are illustrated in more detail by the accompanying drawings, which are described in detail below. Attached Figure Description

[0026] The invention can be more fully understood by considering the following detailed description of various embodiments of the invention in conjunction with the accompanying drawings.

[0027] Figure 1 This is an illustration of a lung treatment catheter and handle system including a catheter assembly according to an embodiment, the catheter assembly having an elongated shaft and an ablation assembly connected to one end of the shaft and a handle assembly connected to the other end of the shaft.

[0028] Figure 2 This is a top view of a lung treatment catheter and handle system including a catheter assembly according to an embodiment, the catheter assembly having an elongated shaft and an ablation assembly connected to one end of the shaft and a handle assembly connected to the other end of the shaft.

[0029] Figure 3 This is an illustration of an ablation assembly connected to the distal portion of the elongated shaft of a catheter, according to an embodiment.

[0030] Figure 4 It is a diagram showing the direction of fluid flow in the cooling circuit according to an embodiment.

[0031] Figures 5A-5C This is a diagram showing three locations of the conduit and handle assembly connected to the delivery device according to an embodiment.

[0032] Figure 6 This is an exploded view of the handle assembly and the connecting assembly according to the embodiment.

[0033] Figure 7 yes Figure 4 The handle assembly is in a partial cross-sectional view in a collapsed or closed configuration.

[0034] Figure 8 This is a cross-sectional view of the elongated axis of the conduit according to the embodiment.

[0035] Figure 9 This is a cross-sectional side view of the manifold connecting the catheter shaft, catheter tube, and umbilical cable according to an embodiment.

[0036] Figure 10 This is a partially exploded perspective view of the manifold and conduit shaft according to an embodiment of the present invention.

[0037] Figure 11 This is a cross-sectional side view of a manifold connected to the conduit shaft and umbilical cable according to an embodiment.

[0038] Figure 12 This is a perspective view of the manifold according to the implementation method.

[0039] Figure 13 This is a cross-sectional front view of a conduit and handle system with pressure monitoring components according to an embodiment.

[0040] Figure 14 This is a cross-sectional front view of a catheter and handle system with a pressure monitoring component according to an alternative embodiment.

[0041] Figure 15 This is a cross-sectional front view of a conduit and handle system having a pressure monitoring component according to another alternative embodiment.

[0042] Figure 16 This is an end view of the working end of a bronchoscope according to an embodiment, wherein the catheter extends through the working channel.

[0043] Figures 17A to 17C These are the front view, sectional view, and exploded view of the distal end of the elongated axis of the catheter assembly with an orientation indicator.

[0044] Figure 18 This is an illustration of the axial and circumferential controls of the handle assembly according to an alternative embodiment.

[0045] Figure 19 This is an illustration of a handle assembly according to an alternative embodiment, wherein the axial and circumferential controls are separate.

[0046] Figure 20A This is a perspective view of a mirror adapter assembly according to an embodiment, the mirror adapter assembly including a cover and a connector.

[0047] Figure 20B yes Figure 20A The exploded view of the adapter component.

[0048] Figure 20C It is installed on the delivery device Figure 20A A cross-sectional view of the adapter component.

[0049] Figure 20D This is a perspective view of an alternative connector according to another embodiment.

[0050] Figure 20EThis is a perspective view of the adapter assembly and delivery device in a first position according to an embodiment.

[0051] Figure 20F It is attached to the delivery device Figure 20E A 3D view of the adapter component.

[0052] Figure 21 This is a schematic diagram of a set of equipment according to one embodiment. Detailed Implementation

[0053] like Figure 1 and 2 As shown, a catheter and handle system 100 according to an embodiment of the present invention may include an ablation catheter assembly 101 having an elongated shaft 102 and an ablation component 106 coupled to a first end or distal end of the shaft 102; a positioning handle assembly 104 coupled to a second end or proximal end of the shaft 102; and an endoscope coupling assembly 103 for coupling the catheter assembly 101 and the handle assembly 104 to the working channel of a delivery device (e.g., a bronchoscope). The catheter assembly 101 is also fluidly and electrically coupled to a system console (not shown) via the handle assembly 104, the system console including a coolant supply and a return reservoir and an energy supply (e.g., an RF generator). The handle assembly 104 is configured to manipulate the distal portion or end of the shaft 102 during treatment to manipulate the ablation component 106 axially and circumferentially.

[0054] like Figure 3 As shown, in a non-limiting embodiment of the invention, the ablation assembly 106 may include one or more energy emitters 510 (e.g., electrodes) and expandable members 520 (e.g., balloons or cages). In some embodiments, the ablation assembly 106 may include a coolant fluid path or cooling circuit 600 for cooling the electrode 510 and a surface of the expandable member 520 for protecting surface tissues in contact with and adjacent to the electrode 510. Figure 4As shown, the cooling circuit 600 includes coolant supplied from a reservoir 601 of the system console. The coolant passes through an optional heat exchanger 603 of the system console, through a handle 104, through an inflow chamber in shaft 102, through a conduit 540 connecting to the electrode 510, through an expandable member 520, through an outflow chamber in shaft 102, through the handle 104, and back to the system console. Non-limiting examples of system consoles can be found in U.S. Patent Application Publication No. 2013 / 0289556 entitled "Delivery Devices with Coolable Energy Emitting Assemblies" and U.S. Patent No. 8,489,192 entitled "System and Method for Bronchial Dilation," the contents of which are incorporated herein by reference in their entirety. Fluid circulation is accomplished, for example, by a peristaltic pump 605. In an alternative embodiment, the flow is reversed such that the coolant flows past the expandable member before the electrode.

[0055] Refer to Figure 3 The ablation assembly 106 may optionally include a throttle valve 530 for regulating flow between the conduit 540 and the expandable member 520. The ablation assembly 106 may also optionally include a support wire 1214, such as a Nitonol wire, extending along at least a length of the conduit shaft 102 and between the proximal end 520a and the distal end 520b of the expandable member 520, thereby providing additional axial, torsional, and buckling support for the expandable member 520 and the conduit shaft 102. More specifically, a first portion or end 1214a of the support wire 1214 is coupled to the distal end 102a of the conduit shaft 102, while a second end 1214b is coupled to the distal end 520b of the expandable member 520 at the junction between the throttle valve 530 and the expandable member 520.

[0056] Further details of the ablation components are described in U.S. Patent No. 8,088,127 entitled “Systems, Assemblies, and Methods for Treating a Bronchial Tree” and U.S. Patent Application No. 2011 / 0152855 entitled “Delivery Devices with Coolable Energy Emitting Assemblies”, both of which are incorporated herein by reference in their entirety.

[0057] In some implementation methods, refer to Figure 1and 2 The handle assembly 104 may include an umbilical cable 120 connected to an end of the handle assembly 104 via a strain relief element 121. This umbilical cable 120 is used to fluidly and / or electrically connect the conduit assembly 101 to auxiliary devices or accessories, such as a power source, energy source, fluid or coolant supplier, heat exchanger, and controller, preferably integrated within a system console. The umbilical cable 120 may include, for example, connections for input and return fluid conduits or cavities 105 for fluidly connecting the shaft 102 to a fluid or coolant supplier from the console, which optionally includes a heat exchanger for cooling and / or heating the input fluid and one or more cables / connectors 107 for electrically connecting the shaft and / or ablation assembly to a power source, to a thermocouple for temperature monitoring, and / or a pressure sensor for coolant loop pressure. In other embodiments, the handle assembly 104 may include an internal power source for operating the handle assembly 104 and any auxiliary devices or accessories.

[0058] Reference Figures 5A-5C The catheter assembly 101 and handle assembly 104 can be coupled to the delivery device 200, such as a guide tube, delivery sheath, bronchoscope, or endoscope. The delivery device 200 may include one or more observation devices, such as optical observation devices (e.g., a camera), optical systems (e.g., a set of lenses), etc. In one embodiment, the delivery device 200 includes a flexible bronchoscope. An ablation assembly (not shown) and an elongated shaft 102 are inserted into the working channel port 202 of the device 200. The handle assembly 104 is then secured to the device 200 via the endoscope coupling assembly 103. The endoscope coupling assembly 103 may be integral with or coupled to the handle assembly 104, or it may be a separate adapter for both the handle assembly 104 and the port 202. The endoscope coupling assembly 103 is securely fitted to the port 202, for example, by friction or mating engagement, locking lever, threaded engagement of corresponding threads, bayonet or snap-fit ​​engagement, spring-loaded engagement, or any of a variety of mechanisms known to those skilled in the art. The mirror coupling assembly 103 may also include a locking mechanism 208 (e.g., a lever or slide lock) to prevent the handle assembly 104 from accidentally disengaging from the port 202. Once secured, the mirror coupling assembly 103 is axially and rotatably fixed relative to the device 200. If not previously assembled, the handle assembly 104 is secured to the mirror coupling assembly 103, as will be described in more detail below.

[0059] In a specific embodiment of the handle assembly 104, and referring to Figure 6 and 7The handle assembly 104 generally includes a handle housing or cover 1002 and a handle frame such as a spindle tube 1024, wherein the handle housing or cover 1002 defines an internal space of the handle assembly 104 having a longitudinal axis A. In one embodiment, the housing 1002 includes a first handle housing 1002a and a second handle housing 1002b connected to the first handle housing 1002a by one or more mortises and tenons, the mortises and tenons corresponding to male / female interlocking components, screws, adhesives, welds, or any of a variety of mechanisms for engaging the housings. In other embodiments not shown, the housing is integral or optionally formed of more than two parts.

[0060] A portion of the elongated shaft 102 of the catheter assembly 101 extends along the longitudinal axis A within the handle housing 1002. The catheter tube portion 1004 houses the shaft 102 within the housing 1002 and protects the shaft 102 within the housing 1002. In this embodiment, refer to... Figure 8 The catheter shaft 102 includes a central coolant inlet chamber 102a for supplying fresh or recirculated coolant from a coolant supply unit on the system console to an ablation assembly coupled to the distal end of the catheter 102 (e.g., Figure 6 (As shown). The coolant return chamber 102b surrounds the coolant inlet chamber 102a, such that the coolant return chamber 102b and the coolant inlet chamber 102a are coaxial. However, other non-coaxial arrangements (e.g., side by side) are also conceivable.

[0061] Reference Figure 6 The umbilical cable assembly 1006 at the proximal end of the handle assembly 104 connects the coolant inlet chamber 102a and the coolant return chamber 102b of the shaft 102 to the coolant supply source and the return reservoir. (Refer to previous...) Figure 1 and 2 Explained, the umbilical cable assembly 1006 can connect any variety of fittings and / or wires or cables to the catheter section 1004 and / or handle assembly 104 for fluid and / or electrical connection of the catheter shaft 102 and ultimately the ablation assembly 106 to accompanying devices or accessories, such as power sources, energy sources, fluid or coolant suppliers, heat exchangers, and controllers, preferably integrated in a system control console. Preferably, the umbilical cable assembly 1006 includes a flexible umbilical cable 120 terminated with a rubber strain relief member 121.

[0062] Reference Figures 9 to 12 The proximal ends of the conduit tube 1004 and shaft 102 are operatively connected to the umbilical cable assembly 1006 via manifold 1008. Manifold 1008 distributes or redirects inflow, outflow, and / or current between shaft 102 and a system control panel (not shown).

[0063] In the implementation method, refer to Figure 11 and Figure 12Manifold 1008 includes a first input port 1008a and a second input port 1008b. The first input port 1008a and the second input port 1008b are in fluid communication with each other via conduits 1009a and 1009b and a gate 1111. The proximal end of the coolant supply conduit 1006a of the umbilical cable assembly 1006 extends within the inner surface of the first portion 1008a of the manifold 1008 and is engaged with the inner surface of the first portion 1008a of the manifold 1008 by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms. The distal end (not shown) of the coolant supply conduit 1006a is coupled to a coolant supply unit, optional heat exchanger, and pump at a system control console.

[0064] The input cavity 102a and output cavity 102b of shaft 102 extend in the second port 1008b of manifold 1008, and the output cavity 102b is joined to the inner surface of port 1008b by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms. The input cavity 102a extends beyond the output cavity 102b of shaft 102 through conduits 1009a and 1009b and enters the coolant supply conduit 1006a. Optionally, the diameter of conduit 1009b is similar to the diameter of input cavity 102a, such that input cavity 102a is joined to the inner surface of conduit 1009b by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms.

[0065] Manifold 1008 also includes a third port 1008c. The proximal end of the coolant return pipe 1006b of the umbilical cable assembly 1006 extends into port 1008c and is bonded to the inner surface of the third portion 1008c by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms. The third port 1008c is in fluid communication with the second port 1008b, to which the output chamber 102b is secured via pipes 1009c and 1009a separated by gate 1111. The distal end (not shown) of the coolant return pipe 1006b is coupled to a reservoir on the system control panel for coolant recirculation and / or treatment.

[0066] In use, coolant is supplied from the coolant supply unit on the system console via the coolant supply line 1006a of the umbilical cable assembly 1006. The coolant then flows from the coolant supply line 1006a into the inlet chamber 102a of the conduit shaft 102. As described below, the coolant flows along the length of the shaft 102 into the ablation assembly 106. The coolant circulates through the ablation assembly and enters the outlet chamber 102b, then flows along the length of the shaft 102 into manifold ducts 1009a, reservoirs, 1111, and duct 1009c. The coolant exits the manifold 1008 via the coolant return line 1006b and returns to the system console for recirculation and / or processing.

[0067] Refer to Figure 9 and 10 The conduit portion 1004 is attached to the outer surface of the second port 1008a of the manifold 1008, thereby covering the second port 1008a and the portion of the shaft 102 extending along the handle assembly 100 within the handle assembly 100. The conduit portion 1004 is secured to the manifold 1008 by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms.

[0068] Reference Figure 9 , Figure 11 and Figure 12 The manifold 1008 may also include a recess 1113 formed in its surface and one or more liquid pressure sensors and meters, flow sensors and meters, and / or thermocouples, wherein the recess 1113 is used to receive and secure one or more printed circuit boards, for example by direct soldering or adding printing thereon, and the one or more liquid pressure sensors and meters, flow sensors and meters, and / or thermocouples are used to detect and optionally display pressure, coolant inlet and outlet flow rates, and / or temperature at multiple locations in the conduit assembly 101 and / or ablation assembly 106. Leads from the pressure sensors, flow sensors, and / or thermocouples then pass through holes 1115 formed in the seat 1113 of the manifold 1008, the holes 1115 fluidly connecting the seat 1113 and the gate 1111. The leads extend through shaft 102 to ultimately reach the ablation assembly 106. In an embodiment, refer again to Figure 8 The first lead 1010a and the second lead 1010b pass through the output cavity 102b of the shaft 102 and are supplied to the ablation assembly 106.

[0069] The manifold 1008 is fixedly connected to the interior of the first handle cover 1002a and / or the second handle cover 1002b, such that the manifold 1008 and thus the conduit portion 104 are axially and rotatably fixed to the cover 1002. For example, as Figure 12 As seen, the manifold 1008 can be secured to the handle cover 1002a and / or 1002b by inserting a wedge formed inside the housing 1002a or 1002b into a corresponding sleeve 1117 formed on the manifold 1008. However, any of a variety of attachment mechanisms is conceivable.

[0070] Thermocouples can be placed anywhere in the conduit assembly 101, including the energy emitter or electrode portion of the ablation assembly 106, to measure the temperature of the coolant in the cooling component of the ablation assembly, and / or to measure the temperature of the inflow and / or outflow of coolant in the inflow and / or outflow chambers 102a and 102b in the elongated shaft 102. The coolant temperature and / or coolant flow are then manually or automatically adjusted at the system control panel to ensure that the ablation site is sufficiently heated to cause permanent damage to the target tissue, while ensuring that the surface tissue is in contact with the electrode, and that the cooling component is sufficiently cooled to suppress or prevent permanent damage to the surface tissue.

[0071] Pressure and / or flow rate can be measured in the inflow and / or outflow chambers and / or in the cooling component and / or ablation assembly to measure the theoretical and / or direct pressure of the ablation assembly. Due to a throttling valve located in the ablation assembly, the pressure in the inflow chamber can be higher than the pressure in the outflow chamber. In a specific embodiment, the pressure of the expandable component (e.g., a balloon) of the ablation assembly is maintained below a predetermined pressure to prevent the balloon from over-expanding or becoming too large in the airway, which could cause undesirable damage to the airway. In the event of blockage in the inflow chamber, throttling valve, or outflow chamber, a pressure sensor, such as a pressure sensor located on the handle, will detect the pressure increase in the corresponding line and will automatically trigger to shut down the coolant pump to prevent the expandable cooling component from rupturing or the balloon from over-expanding, and / or automatically trigger to shut down the power supply to the electrodes to prevent overheating of the treatment site. In an alternative embodiment, a pressure relief valve may be incorporated into the system to alleviate pressure increases at predetermined or user-controlled pressure limits. Specific pressure measurement components are described in more detail below.

[0072] In one implementation, and referring to Figure 13 The pressure sensor 1200 is positioned on or near the handle assembly 1202 and configured to measure the pressure in the output chamber 1204 of the catheter shaft 1203. This embodiment is based on a pressure measurement downstream of the ablation assembly 1206 (i.e., the output chamber 1204), thus requiring a theoretical pressure bias to estimate the pressure in the expandable member 1208 of the ablation assembly 1206. In this embodiment, the estimated pressure in the expandable member 1208 is greater than the pressure at the meter 1200 due to the resistance of the flow in the catheter shaft 1203 relative to the expandable member 1208.

[0073] In another embodiment of the invention, it is desirable to directly measure the pressure in the balloon or ablation assembly 1206 to eliminate or reduce undetected blockages or occlusions between the pressure sensor 1200 and the expandable member 1208, which could cause possible over-inflation or rupture of the expandable member 1208. (Refer to...) Figure 14A pressure sensor 1200 is disposed on or near the handle assembly 1202. A polymer tube and / or metal tube 1210 is disposed along the output cavity 1204 of the conduit shaft 1203. A first end 1210a of the tube 1210 is operatively coupled to the pressure sensor 1200, while a second end 1210b terminates within the ablation assembly 1206. The tube 1210 serves as a static column to directly measure the pressure in the ablation assembly 1206; that is, the pressure through the conduit shaft 1203 in the tube 1210 is constant, such that the pressure measured at the pressure sensor 1200 is equal to the pressure in the ablation assembly 1206.

[0074] In this embodiment, the tube 1210 can be flexible or rigid. As shown, a support line 1214, such as a Nitinol line, extends between the proximal and distal ends of the expandable member 1208 to provide additional axial, torsional, and buckling support to the expandable member 1208. More specifically, a first end 1214a of the support line 1214 is coupled to the distal end 1203a of the conduit shaft 1203, while a second end 1214b is coupled to the distal end of the expandable member 1208 at the junction between the throttle valve 1209 and the expandable member 1208. In this embodiment, the tube 1210 may supplement the support line 1214.

[0075] In another embodiment, and referring to Figure 15 In this embodiment, the pressure tube 1220 replaces the support line of the aforementioned embodiment. At its first end 1220a, the tube 1220 is coupled to a pressure sensor 1200 disposed on or near the handle assembly 1202. The distal portion 1222 of the tube 1220 extends between the proximal and distal ends of the expandable member 1208. More specifically, the proximal end 1222a of the distal portion 1222 is coupled to the distal end 1203a of the guide shaft 1203, while the distal end 1222b of the distal portion 1222 is coupled to the distal end of the expandable member 1208 at the junction between the throttle valve 1209 and the expandable member 1208. The distal portion 1222 of the tube 1220 includes one or more holes 1224 positioned perpendicular to the longitudinal axis of the tube 1220. Similar to the aforementioned embodiments, tube 1210 serves as a static column to directly measure the pressure in ablation assembly 1206; that is, the pressure through the catheter shaft 1203 in tube 1210 is constant, such that the pressure measured at pressure sensor 1200 is equal to the pressure in ablation assembly 1206. Furthermore, tube 1220 provides axial, torsional, and buckling support for the length of catheter shaft 1203 and expandable member 1208, allowing for thinner and more flexible fluid-containing tubes (e.g., inlet and outlet cavities).

[0076] A process control loop, which is connected to a system that responds to automatic shutdown and includes real-time measurements of pressure, flow, and / or temperature within the system, provides a safety mechanism to prevent unintended tissue or airway damage.

[0077] Refer to Figure 6 and Figure 7 The handle assembly 104 is releasably but securely coupled to the working channel of the bronchoscope via the bronchoscope positioning assembly 1012. In one embodiment, the positioning assembly 1012 includes a shaped endoscope connector 1014, which can be mounted to the working channel in only a single rotational orientation. The endoscope connector 1014 is coupled to the bronchoscope (or the bronchoscope adapter assembly described below) via a spring-loaded claw lever 1016, a claw return spring (compression spring) 1018, a sliding claw 1020, a fixed claw 1022, and a silicone seal 1023, the silicone seal 1023 optionally coupled to the fixed claw 1022 or the connector 1014. A force applied to the lever 1016 causes the spring 1018 to extend, thereby disengaging the sliding claw 1020 and the claw 1022 from their locking engagement with a recess in the working channel to release the endoscope connector 1014 therefrom.

[0078] The spindle tube 1024 is fixedly connected to the mirror connector 1014 in both the rotational and axial directions at its first end 1024a. More specifically, the flange or skirt 1026 of the spindle tube 1024 abuts the plane 1028 of the mirror connector 1014. The protrusion 1030 of the mirror connector 1014 extends into the opening 1032 of the spindle tube 1024 in a mortise and tenon manner. A retaining ring 1034 engages with a portion of the protrusion 1030 to lock the mirror connector 1014 to the spindle tube 1024. The spindle cover 1036 is connected to the handle cover 1002, allowing the spindle tube 1024 to slide axially along its length through the spindle cover 1036.

[0079] The main shaft tube 1024 extends axially into and out of the handle housing 1002 via the handle housing 1002 and thus via the manifold 1008 and the catheter shaft 102, relative to the main shaft tube 1024, through axial translation along the longitudinal axis A, for axial fine-tuning. More specifically, the inner diameter of the main shaft tube 1024 is larger than the outer diameter of the catheter section 1004 and therefore larger than the outer diameter of the shaft 102, allowing the catheter section 1004 and the shaft 102 to axially retract into and out of the main shaft tube 1024 to achieve axial adjustment of the ablation assembly 106. The stroke length of the shaft 102 relative to the main shaft tube 1024 is selected based on the desired stroke length of the ablation assembly 106 relative to the working or distal end of the bronchoscope. In one embodiment, because the handle housing 1002 extends axially away from the endoscope connector 1014, the manifold 1008 fixed to the housing 1002 pulls the shaft 102 along with it to extend away from the endoscope connector 1014, thereby causing the ablation assembly 106 connected to the distal portion of the shaft 102 to retract toward the bronchoscope and optionally enter the bronchoscope wholly or partially, or vice versa, in the case of axial translation toward the endoscope connector 1014.

[0080] The handle housing 1002 and the guide tube portion 1004, and thus the shaft 102, are prevented from being completely pulled out of the spindle tube 1024. More specifically, the second end 1024b of the spindle tube 1024 is axially held in the housing 1002 by a spindle retaining assembly 1040. The spindle retaining assembly 1040 includes a spindle end cap 1042 attached to one end of the spindle tube 1024 and a handle stop 1044 connected to the spindle end cap 1042 by a U-pin. Since the handle housing 1002 extends axially from the mirror connector 1014, when fully extended, the radial protrusion of the handle stop 1044 abuts against a radially extending feature protruding from the inner surface of the handle housing 1002, thereby inhibiting further axial extension. Similarly, a feature on the inner surface of the handle housing 1002 along the longitudinal length of the handle housing 1002 abuts a radially extending protrusion on the outer surface of the handle stop 1044 to inhibit the rotation of the handle stop 1044 within the housing 1002, while the spindle end cap 1042 rotates together with the spindle tube 1024.

[0081] The handle stop 1044 also includes a notch for releasably engaging the manifold 1008 when the handle stop 1044 and the manifold 1008 are adjacent to each other in a fully retracted or closed configuration to lock the spindle tube 1024 in axial translation relative to the manifold 1008 and the housing 1002.

[0082] The desired axial travel length of the ablation component 106 relative to the working or distal end of the bronchoscope is configured or determined by the total length of the shaft 102 of the catheter assembly 101 and the relationship between the catheter tube portion 1004 and the main shaft tube 1024 of the handle assembly 104. In one embodiment, the desired travel length of the ablation component 106 relative to the working or distal end of the bronchoscope is equal to or greater than the longitudinal length of the ablation component 106. In embodiments, such as Figure 7 As seen, the longitudinal length of the ablation assembly 106 includes the length of the expandable component (e.g., a balloon) in addition to the conduit / electrode; in an alternative embodiment, the longitudinal length of the ablation assembly 106 includes only the length of the expandable component. For simplicity, the longitudinal length of the ablation assembly 106 generally refers to and may refer to either length.

[0083] To confirm this relationship, in a non-limiting embodiment, the distance from the proximal opening of the working channel (to which the handle assembly can be coupled) to the distal working end or distal end (see...) Figure 16 The working length of commercially available bronchoscopes is approximately 40 cm to 80 cm, more specifically from approximately 50 cm to 65 cm, and more specifically from approximately 55 cm to 60 cm. The length of the portion of shaft 102 extending within the housing 1002 of the handle assembly 101 can be approximately 15 cm to 20 cm. The total length of shaft 102 of the catheter assembly 101, including the portion within the housing 1002 and the length extending through the bronchoscope (excluding the length of ablation assembly 106), is approximately 55 cm to 100 cm, more specifically from approximately 65 cm to 85 cm, and more specifically from approximately 70 cm to 80 cm. This ensures that shaft 102 can extend through and out of the handle housing 1002, and also through and out of the bronchoscope when the handle assembly 104 is coupled to the bronchoscope. In a specific embodiment, shaft 102 includes an additional length such that the distal portion of shaft 102 connected to ablation assembly 106 can extend beyond the working or distal end of the bronchoscope, such that shaft 102 is exposed to the distal end of the bronchoscope by about 0.1 cm to about 4 cm.

[0084] Furthermore, in this embodiment, the ablation assembly 106 includes a balloon or basket-like portion with a longitudinal length of approximately 1 cm to approximately 8 cm, more specifically approximately 3 cm to approximately 5 cm, and more specifically approximately 4 cm. With the main shaft tube 1024 fixed to the endoscope connector 1014, the handle housing 1002 can travel axially a selected distance to allow the catheter tube portion 1004, and thus a portion of the shaft 102, to extend or retract within the main shaft tube 1024 of the handle assembly 104, or to translate axially relative to the main shaft tube 1024 of the handle assembly 104 by a length equal to or greater than the longitudinal length of the ablation assembly 106. This allows the ablation assembly 106 to shift between being fully extended out of the working end or distal end of the bronchoscope (with or without clearance outside the working end, depending on the total length of the shaft 102) and being fully retracted within the working end of the bronchoscope (with or without clearance within the working end, depending on the total length of the shaft 102).

[0085] For example, the total length of shaft 102 can be selected such that when the handle assembly 104 is attached to the bronchoscope and fully closed or collapsed (e.g., the tube portion 1004 is at its maximum nesting position within the main shaft 1024, referred to herein as the "fully closed handle configuration"), the proximal shoulder of the balloon of the ablation assembly 106 extends beyond the working end of the bronchoscope by approximately 0.1 to approximately 4.0 cm, and more specifically, approximately 2 cm. When the handle assembly 104 is in the "fully extended handle configuration," in which the shell 1002 is at its maximum axial distance from the endoscope attachment assembly 103, the ablation assembly 106 is fully retracted within the working end to allow unobstructed visualization of the airway. In this embodiment, the travel length is greater than the length of the balloon, for example, from approximately 1 cm + 0.1 - 4.0 cm to approximately 8.0 cm + 0.1 - 4.0 cm. The optical connection between the bronchoscope's observation device and the balloon occurs at a partial axial extension of the handle assembly 106 (i.e., "partially extended handle configuration"), where the proximal shoulder of the balloon abuts the working end of the bronchoscope.

[0086] In an alternative embodiment, when the handle assembly 104 is in a fully closed handle configuration, the proximal shoulder of the balloon of the ablation assembly 106 abuts the working end of the bronchoscope and is optically coupled to an observation device positioned on the working end of the bronchoscope. The catheter tube portion 1004, and therefore the shaft 102, is axially translated relative to the main shaft tube 1024 by a distance at least equal to the length of the balloon, so that when the handle assembly 104 is fully axially extended to the fully extended handle configuration, the entire balloon retracts into the working end of the bronchoscope.

[0087] In another alternative embodiment, when the handle assembly 104 is in the fully extended handle configuration, the proximal shoulder of the balloon of the ablation assembly 106 abuts against the working end of the bronchoscope and is optically coupled to an observation device positioned on the working end of the bronchoscope. In this embodiment, the ablation assembly 106 is non-retractable within the bronchoscope.

[0088] Specifically, the stroke length of the handle housing 1002 and therefore the ablation component 106 is about 1% to about 20% of the total length of the shaft 102, and more specifically about 1% to about 10% of the total length of the shaft 102. In a preferred embodiment, the stroke length of the handle housing 1002 relative to the spindle tube 1024 and therefore relative to the ablation component 106 is at least the length of the ablation component 106, preferably at least about 105% of the length of the ablation component 106, and more preferably at least about 110% of the length of the ablation component 106.

[0089] In specific terms, other components of the spindle tube 1026, the catheter section 1004, or the handle assembly 104 may include indicator notches or raised markings, sensors, luminous indicators, or other suitable devices located at predetermined positions to provide visual and / or tactile responses indicating the optical connection between the observation device and the ablation assembly when the ablation assembly is fully retracted into the bronchoscope and / or at any of a plurality of other desired positions, and when the balloon of the ablation assembly 106 is physically adjacent to the working end of the bronchoscope.

[0090] The handle housing 1002, and therefore the manifold 1008, catheter section 1004, and catheter shaft 102, can also be rotated relative to the spindle tube 1024 by rotating the handle housing 1002 relative to the bronchoscope and endoscope connector 1014 to allow for circumferential fine-tuning of the ablation assembly within the treatment area. One or more bearings 1038a, 1038b are frictionally attached to the inner surface of the handle housing 1004 to facilitate smooth rotation of the handle housing 1002 about the spindle tube 1024. Optionally, because the handle stop 1044 rotates together with the housing 1002 about the spindle tube 1024 and the spindle end cap 1042, the handle stop 1044 and / or the spindle tube 1024 may include indentations providing a tactile indication or "engagement" corresponding to a certain amount of rotation. For example, engagement may correspond to 1 degree or more of rotation from the neutral position.

[0091] As described in the background section, the fiber optic camera portion of the bronchoscope is fixed relative to the bronchoscope, such that as the bronchoscope and tubing assembly rotate, the captured image remains face up. This can cause misalignment regarding the actual orientation of the ablation assembly within the treatment location (e.g., the airway). See now... Figure 16 and Figure 17A- Figure C, in an embodiment, the distal end 2000 of shaft 102 may include one or more markings 2002 for indicating the orientation of the ablation assembly 106 within the treatment position. In an embodiment, the markings 2002 include longitudinal strips or bands (e.g., black pad printed bands) extending along at least a portion of the exterior of the distal end 2000. When the endoscope coupling assembly 103 and the handle assembly 104 are coupled to the bronchoscope, the elongated shaft 102 of the catheter assembly 101 is fed through the working channel 201 and the endoscope 200, and the working channel 201 extends out at the working end 200a of the endoscope 200, as shown in Figure C. Figure 16 As shown. Because the handle assembly can only be coupled to the working channel 201 in one unique orientation, the elongated shaft 102 extends through and out of the working channel 201 with a known or initial orientation. In this embodiment, the elongated shaft 102 is coupled to the handle assembly such that the marker 2002 extends through the bronchoscope to align it with the center of the camera 2004.

[0092] Alternatively, radiopaque markings (not shown) may be printed or otherwise deposited on the ablation assembly (e.g., near or on the electrode) to allow the orientation of the ablation assembly to be observed by radiography, fluorescence microscopy, ultrasound or other rapid confirmatory scans.

[0093] The band 2002 also assists in the axial orientation of the ablation assembly relative to the working end of the bronchoscope. For example, once the ablation assembly expands in the airway, it can be retracted closer to the bronchoscope until the band is no longer visible to the camera. This indicates the optimal distance between the balloon or expandable component and the camera, enabling optical connection of the ablation assembly. This allows observation of the electrodes of the ablation assembly from the working end of the bronchoscope. The camera can then move independently of the ablation assembly.

[0094] The braided section 2006 may be incorporated along at least a portion of the distal end 2000 of the shaft 102. The braided section 2006 provides torsional stability to the distal end 2000, allowing the housing 1002 of the handle assembly 104 and the manifold 1008 to translate along the entire length of the shaft 102, thereby enabling the ablation assembly 106 to rotate and translate axially directly in response to movement of the handle and / or bronchoscope. The braided section 2006 also prevents or inhibits kinking of the shaft 102. A small gap may be included on the end of the distal end 2000 of the unbraided section 2008 to avoid interfering with the optical connection, as described above.

[0095] Return to reference Figures 5A-5COnce engaged with device 200, the user can manipulate catheter assembly 101 and ablation assembly 106 within the cavity or conduit where the treatment takes place (e.g., airway). Coarse adjustment of ablation assembly 106 is achieved by axial and rotational movement of device 200, causing handle assembly 104 and thus manifold 1008 and catheter portion 1006 to move together with endoscope coupling assembly 103 and device 200, resulting in axial translation and / or rotation of ablation assembly 106.

[0096] like Figures 5A-5C As shown, the ablation assembly 106 is fine-tuned by the axial and rotational movements (220 and 230) of the handle housing 1002 relative to the device 200 and the mirror coupling assembly 103. For example, the housing 1002 is moved relative to the delivery device 200 to a retracted axial position ( Figure 5B This allows the catheter portion 1004 to be nested within the spindle tube 1024, providing maximum extension relative to the distal end of the device 200, which is divided into the spindle 102 and the distal end with the ablation assembly 106, into which treatment takes place. For example, this allows the user to target a larger area of ​​tissue for treatment. Handle housing 1002 ( Figure 5A The extension of the spindle tube 1024 (the conduit tube 1004 retracts from the spindle tube 1024 in the handle housing 1002) causes the distal end of the spindle 102 and thus causes the ablation assembly 106 to retract toward the distal portion of the device 200, and in some cases retract within the working end of the device 200.

[0097] In some implementations, and referring to Figure 5C The handle housing 1002 acts as a control or steering mechanism to adjust the circumferential or rotational position of the shaft 102 and / or the ablation assembly 106. For example, the handle housing 1002, and therefore the manifold 1008 and the catheter portion 1006, can be configured to rotate or rotate continuously relative to the mirror connector 1014 and the device 200 in predetermined degree increments. Any of a variety of rotational scales can be visually and / or strategically (e.g., engaging) incorporated into the handle 104 (e.g., increments of 1, 5, 10, 20, 30, 45, 90, 120, or 180 degrees).

[0098] exist Figure 18In the alternative embodiment shown, the handle assembly 304 includes a control mechanism for circumferential / rotational operability, the control mechanism including a body portion 310 configured to rotate about the spindle tube 305 fixed to the endoscope connector 303, such that when the body portion 310 rotates circumferentially in one direction, the catheter shaft and ablation assembly rotate circumferentially in the same direction, while the device 200, the working channel port 202, and the endoscope connector 303 are fixed. In other embodiments, the body portion 310 is also configured to move axially relative to the spindle tube 305 and the endoscope connector 303, such that when the body portion 310 moves axially in one direction, the catheter shaft and ablation assembly move axially relative to the device 200 and the endoscope connector 303 in the same direction.

[0099] In alternative implementations, such as Figure 19 As shown, the handle assembly 402 includes a first body portion 404 for axial maneuverability and a second body portion 406 for rotational maneuverability. The handle assembly 402 is coupled to the working channel port 202 of the endoscope 200 via an endoscope adapter 403. The adapter 403 is fixed both axially and rotatably relative to the port 202. The spindle tube 405 is axially fixed to the adapter 403. The handle assembly 402 may include a first body portion 404 configured to translate axially along the spindle tube for axial maneuverability of an ablation assembly fixed to the distal end of the catheter shaft. The second body portion 406, the spindle tube 405, and the first body portion 404 are configured to rotate about the endoscope adapter 403, which is displaced for rotational maneuverability of the ablation assembly.

[0100] In other embodiments (not shown), controls for axial and circumferential maneuverability may include one or more motors, hydraulic cylinders, pneumatic cylinders, or other power actuators with associated buttons, switches, sensors, etc., configured to manipulate the distal portion of the endoscope without manual operation of mechanisms on the handle. In yet another embodiment (not shown), controls for axial and / or rotational fine-tuning or micro-adjustment are automated, for example, via servo motors.

[0101] The catheter positioning handle assembly and system allow for fine-tuning and maneuverability of the catheter shaft and ablation assembly independent of the bronchoscope or other delivery device and accessories attached to the delivery device (e.g., camera and / or light source). For example, the handle can be used to more precisely position the ablation assembly under visualization using a camera or other optics associated with the bronchoscope (through which the catheter is positioned). Preferably, the handle facilitates catheter manipulation so that the ablation assembly is visible using optics during treatment. In a preferred embodiment, the handle facilitates optical coupling of the catheter assembly's expandable components to the bronchoscope's optics, and a second source of visual cues for positioning may be in the form of a radiopaque mark or radiopaque indicator on the ablation assembly to indicate the position of the catheter in the energy emitter relative to the bronchoscope, maintaining such optical coupling during treatment.

[0102] According to a non-limiting embodiment, during use, in the treatment of lung diseases (e.g., targeted lung denervation procedures), the bronchoscope can be positioned in the airway according to a typical bronchoscopic procedure. The user can select the right or left main bronchus. A catheter assembly including a balloon (with one or more electrodes coupled to it) can be folded, compressed, or wrapped around the distal end of the catheter shaft. The shaft and ablation assembly are inserted into the working channel of the bronchoscope, and the handle assembly and endoscope adapter are connected so that the handle assembly is secured to the bronchoscope. The catheter shaft is then aligned with a strap on the distal end of the catheter shaft, allowing the user to understand the position and orientation of the electrodes relative to the airway through this initial positioning. In some embodiments, markings on the shaft can be visualized through the bronchoscope, which can assist the user during electrode positioning. Optionally, radiopaque markings may be incorporated for additional confirmation of position.

[0103] The user can position the catheter shaft and ablation assembly within the airway (e.g., the right or left bronchus). Coarse adjustments are made via the axial and rotational displacement of the bronchoscope itself, as the handle moves with the endoscope. Fine adjustments are made within the airway for the treatment (e.g., lung denervation using radiofrequency ablation) using the axial and circumferential controls of the handle, which adjusts the shaft and ablation assembly relative to the endoscope (i.e., without moving the endoscope) to position the electrodes in a favorable location for the treatment. Once positioned (e.g., between the cartilaginous rings of the airway), the user can inflate the balloon, thereby bringing the electrodes into contact with the airway wall.

[0104] A camera (e.g., a lens with fiber optics and / or a charge-coupled device (CCD) chip) coupled to a bronchoscope can be used to indicate the positioning of the electrodes and balloons in the airway. The camera provides visual cues related to the position of the electrodes and balloons relative to the anatomical location of the airway and other devices. Visualization of the electrodes and balloons can be performed by moving the camera independently of the electrodes and balloons. For example, the user can keep the handle of the catheter assembly fixed and then move the camera axially toward the electrodes and balloons without disturbing their position. With the handle held in a fixed position, the electrodes and balloons of the catheter assembly remain in a fixed position in the airway, thus allowing the user to move the camera freely axially and circumferentially for various visual observations. Once the desired position is reached, the user can perform treatment by powering one or more electrodes while circulating coolant through a cooling circuit, as described above.

[0105] In some embodiments, the procedure is repeated when a circumferential lesion is desired and the electrode size is smaller than the circumference of the airway. For example, after the initial application of energy, the user at least partially or completely depresses the balloon, for example by stopping or slowing the coolant flow to depressurize the balloon with the electrode and, optionally, the tubing. The user can then reposition the electrode to a different quadrant that is rotatably and / or axially displaced from the first quadrant of the tissue by rotating and / or moving the bronchoscope (coarse adjustment), and then rotating and / or moving the control mechanism on the handle (fine adjustment) to move the electrode. In some embodiments, the electrode can be further fine-tuned in one or both of the axial and circumferential directions using the handle before ablation without moving the position of the bronchoscope.

[0106] In one specific embodiment, the electrode is one-quarter the circumference of the main bronchus, and its initial position upon insertion of the bronchoscope is in the abdomen. When positioned in the left main bronchus, for example, the handle assembly and bronchoscope are then rotated 90 degrees counterclockwise so that the electrode is now positioned in the left quadrant. Axial and / or rotational fine adjustments to the electrode may be made, if necessary and as described above. The camera is used to confirm that the black band remains centered on the camera, and other optional confirmations are performed. The ablation assembly is pressurized as described above, and energy is supplied to the electrode to ablate the target tissue. After the procedure is complete, the balloon is at least partially depressurized, and the bronchoscope and handle assembly are rotated together 90 degrees clockwise so that the electrode is now positioned in the abdominal quadrant. The procedure is repeated as described. The bronchoscope and handle assembly are then rotated 90 degrees clockwise to the right side, and the procedure is repeated. Finally, the bronchoscope and handle assembly are rotated 90 degrees clockwise to the back quadrant, and the procedure is repeated. The catheter assembly can then be retracted into the bronchoscope, and the bronchoscope can be positioned within the right main bronchus, and the treatment can be repeated if necessary. This clockwise rotation of the procedure allows the practitioner to easily rotate the bronchoscope and ablation assembly with one hand around the airway.

[0107] In some implementations, the processing conditions may require vacuum operation of the bronchoscope to clean a specific area or the end of the bronchoscope. In this implementation, the bronchoscope can be brought to its fully extended position by pulling the handle (see, for example, [link to relevant documentation]). Figure 5A This allows the entire distal portion of the catheter shaft and the ablation assembly to be withdrawn into the working channel of the bronchoscope. Then, the vacuum device or aspiration chamber can be extended through the working channel of the bronchoscope into the vacuum fragment location without compromising the position of the bronchoscope.

[0108] After processing is complete, the user can pull the handle 100 to its fully extended position (see, for example, see...). Figure 5A This allows the entire shaft of the catheter and ablation assembly to be withdrawn into the working channel of the bronchoscope without disengaging the handle from the bronchoscope. This allows the catheter to remain out of the bronchoscope's field of view, which can help, for example, assess the effectiveness of the treatment. The user can then orient the bronchoscope to other bronchi for treatment, and the catheter shaft and ablation assembly can be advanced from the working channel of the bronchoscope into other bronchi.

[0109] Now refer to Figures 20A-20F An embodiment of a bronchoscope adapter assembly is illustrated. The adapter assembly 1700 is configured to facilitate coupling of a handle assembly of a catheter assembly, as previously described, to a working channel port 202 of the device 200, the working channel being different in size or smaller than the port for receiving a coupling assembly 103. The adapter assembly 1700 typically includes a cover 1702 and a coupling 1720. The cover (or housing) 1702 includes a housing portion 1704, a through-hole 1706, and an optional alignment protrusion 1708. The coupling 1720 includes a flange 1722, a neck 1724, a collar portion 1726, a through-hole 1727, an alignment groove 1728, one or more optional partial release grooves 1729, and a lug 1730 located on the inner surface of the coupling 1720. Figure 20A-20F As shown, flange 1722 may include a tapered surface to allow handle 104 to be more easily connected to adapter assembly 1700.

[0110] like Figure 20D As shown, flange 1722 has an inner diameter D1 and an outer diameter D2. (As...) Figure 20C As shown, the inner diameter D3 of the neck 1724 is larger than the inner diameter D1 of the flange 1722, such that an abutment lug 1723 is formed at the junction between the neck 1724 and the flange 1722. The abutment lug 1723 can cooperate with the retaining flange F1 in an abutment relationship at the end of the port 202.

[0111] The variable inner diameter D4 of the collar portion 1726 is larger than the inner diameter D3, resulting in an adjacent lug 1730 forming at the joint between the neck 1724 and the collar portion 1726. For example... Figure 20CAs shown, the adjacent lug 1730 can cooperate with the retaining flange F2 in an adjacent relationship at the end of the port 202.

[0112] like Figure 20B As shown, collar 1726 may include one or more through slots and / or partial release slots (1728, 1729) to facilitate expansion and / or contraction that may occur during engagement and / or disengagement of adapter assembly 1700 with port 202.

[0113] like Figure 20C and 20F As shown, the connector 1720 is mounted around the outer perimeter or outer diameter of the port 202, thereby effectively creating a larger interface for the connecting assembly 103 of the handle 104. The slot 1728 of the connector 1720 is configured to communicate with the protrusion 1708 of the cover 1720. To mount the adapter assembly 1700 onto the port 202 of the device 200, the cover 1702 is first positioned such that the hole 1706 is arranged closest to the neck portion 1724 of the connector 1720, and the collar portion 1726 is unconstrained, for example, D4 ​​is at rest diameter, as... Figure 20E As shown. The adapter assembly 1700 can then be advanced onto port 202, where the collar portion 1726 expands freely (and therefore D4 expands freely) to allow the lug 1730 to pass over the first retaining flange F1 on port 202 and abut against the second retaining flange F2. The cover 1702 can then be moved to a locked position, in which the hole 1706 of the cover 1702 is aligned with the collar portion 1726 of the coupling 1720 (as shown). Figure 20F (As shown), thereby squeezing the collar portion 1726 to minimize D4, so that it fits securely around the port 202. Then, the adapter assembly 1700 is engaged with the port 202, and the handle assembly 104 of the conduit assembly 101 can be connected to the flange 1722 of the coupling 1720 via the adapter assembly 103.

[0114] Optionally, the slot 1728 may include a tapered feature, which is wider toward the collar portion 1726 and narrower toward the flange portion 1722. This tapered arrangement of the slot 1728 facilitates easier engagement and / or disengagement of the adapter assembly 1700 from the port 202, because as the cover 1702 advances from the collar portion 1726 toward the flange 1722 of the connector 1720 to disengage the adapter assembly 1700 from the port 202, the protrusion 1708 of the cover 1702 advances in the narrowing slot 1728, causing the collar portion 1726 to extend, allowing the ridge 1730 to clear the retaining flange on the port 202, thereby allowing the adapter assembly 1700 to be removed from the port 202.

[0115] The size of the adapter assembly 1700 can be selected to connect with a variety of delivery devices 200, depending on the desired configuration.

[0116] In an alternative embodiment, the cover does not include an alignment protrusion (not shown), thereby allowing Figure 20D The alternative connector 1800 shown is configured to have multiple partial release slots 1802 instead of a through slot, which facilitate expansion and / or contraction that may occur during engagement and / or disengagement of the adapter assembly 1700 with the port 202.

[0117] In an embodiment, the kit 150 may include the catheter assembly 101 and handle assembly 104 as described above, as well as a set of instructions 152 for using the contents of 150, for example... Figure 21 As shown. The kit 150 may also include a coupling assembly 103 and / or an adapter assembly 1700, or the adapter assembly 103 and / or the adapter assembly 1700 may be provided independently of the kit 150. The kit 150 may include one or more airtight and sterile packages. The contents of the kit 150 may be provided pre-assembled as needed, or the contents may be provided separately, and the specification 152 includes steps for connecting the contents together as described herein. The kit 150 and / or the individual contents of the kit 150 may be provided by manufacturing the kit and / or the contents and making these kits and / or the contents available to the user.

[0118] The instruction manual 152 may be any of a variety of tangible or intangible media, including but not limited to written manuals, CDs or CD-ROMs, CDs, CD-ROMs, DVDs, Blu-rays, media that can be digitally downloaded to or viewed on a personal device (e.g., a computer, tablet, smart device), and / or oral instructions from the provider of the kit 150. In another embodiment, the instruction manual 152 for using the components according to the various embodiments described herein may be provided separately from the component manufacturer or supplier, for example, through information available via the Internet or through seminars, lectures, training sessions, etc.

[0119] Therefore, embodiments of the present invention allow users to manipulate the catheter shaft and ablation assembly independently of the bronchoscope, and easily and conveniently access positions conducive to efficient and effective treatment, ultimately improving patient outcomes and shortening recovery time. Furthermore, the handle assembly connected to the bronchoscope functions as a pointer or indicator of the ablation assembly within the treatment site, supplementing the visual cues provided by the bronchoscope observation device or camera. Finally, the handle assembly connected to the bronchoscope allows for simple and efficient visual or optical connection of the bronchoscope observation device to the ablation assembly.

[0120] The handle and catheter system according to embodiments can be used to manipulate ablation components as described above, which may include expandable members and one or more energy emitters or electrodes, and / or can be designed or configured to manipulate any of a variety of treatment components axially, rotationally, and / or otherwise, including needle-based and / or needle-free injection or drug delivery systems, such as those for injecting or delivering neurotoxins, sclerosing agents, or any of a variety of agents for treating lung diseases. For example, the handle and catheter system can be configured to manipulate one or more needles or ports axially (forward and constriction) and / or rotationally within and around the airway. Various non-limiting examples of components are described in one or more of the following patents and applications, all of which are incorporated herein by reference in their entirety or above:

[0121] U.S. Patent No. 8,088,127, entitled “Systems, Assemblies, and Method for Treating a Bronchial Tree”;

[0122] U.S. Patent Application No. 2011 / 0152955, entitled “Delivery Devices with Coolable Energy Emitting Assemblies”, has been published.

[0123] U.S. Patent Application No. 2012 / 0310233, entitled “Systems, Apparatus, and Methods for Treating Tissue and Controlling Stenosis”, has been published.

[0124] U.S. Patent Application No. 2011 / 0118725, entitled “Non-invasive and Minimally Invasive Denervation Methods and Systems for Performing the Same”, has been published.

[0125] U.S. Patent Application No. 2012 / 0302909, entitled “Methods and Systems for Screening Subjects”, has been published.

[0126] U.S. Patent Application No. 2011 / 0301587, entitled "System and Method for Pulmonary Treatment," has been published.

[0127] U.S. Patent No. 8,172,827, entitled “Apparatus for Treating Asthma Using a Neurotoxin”;

[0128] U.S. Patent Application No. 1, entitled “Method and Apparatus for Controlling Narrowing of at Least One Airway”, has been published.

[0129] U.S. Patent No. 8,483,831, entitled "System and Method for Bronchial Dilation";

[0130] U.S. Patent No. 8,483,831, entitled “Apparatuses and Methods for Injuring Nerve Tissue”;

[0131] PCT application No. WO 2013 / 052501 entitled “Apparatuses and Methods for Injuring Nerve Tissue”;

[0132] U.S. Patent Application No. 2013 / 0310822, entitled “Compact Delivery Pulmonary Treatment System and Method for Improving Pulmonary Function”, has been published.

[0133] U.S. Provisional Patent Application No. 61 / 746,460, entitled “Methods for Improving Drug Efficacy”;

[0134] U.S. Provisional Patent Application No. 61 / 779,371, entitled “Fluid Delivery System and Method for Treatment”;

[0135] U.S. Provisional Patent Application No. 61 / 876,925, entitled “Systems, Devices, and Methods for Treating a Pulmonary Disease with Ultrasound Energy”;

[0136] U.S. Provisional Patent Application No. 61 / 847,477, entitled “Methods for Protecting the Esophagus During Pulmonary Treatment Procedures”, and U.S. Provisional Patent Applications Nos. 61 / 799,742 and 61 / 870,373, entitled “Systems, Devices, and Methods for Treating a Pulmonary Disorder with an Agent”;

[0137] It should also be understood that the one or more exemplary embodiments are merely examples and are not intended to limit the scope, applicability, or configuration of the subject matter of this application in any way. Rather, the foregoing detailed description will provide those skilled in the art with achievable disclosures to implement the one or more exemplary embodiments. It should be understood that various changes can be made to the function and arrangement of the elements without departing from the scope of the subject matter set forth as stated in the appended claims and their legal equivalents.

[0138] The above embodiments are intended to be illustrative and not restrictive. Additional embodiments are within the scope of the claims. Although the subject matter of this application has been described with reference to specific embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of its subject matter.

[0139] Upon reading this disclosure, various modifications to its subject matter will become apparent to those skilled in the art. For example, those of ordinary skill in the art will recognize that, within the spirit of the subject matter, various features described for different embodiments of the subject matter can be suitably combined, not combined, and recombinated with other features, either alone or in different combinations. Similarly, the foregoing features should be considered as exemplary embodiments and not as limitations on the scope or spirit of the subject matter. Therefore, it is not intended that the foregoing content restricts the scope of the subject matter of this invention.

[0140] For the purpose of interpreting the claims of this application, unless the specific terms “component for…” or “step for…” are recited in the claims, it is expressly intended that the provisions of paragraph 6 of Chapter 112 of 35 U.S.SC not be invoked.

Claims

1. A catheter and handle assembly for coupling to a delivery device having a proximal working port, a distal working tip, and a working channel extending between the working port and the working tip, the working channel defining a working length, the catheter and handle assembly comprising: a catheter assembly, the catheter assembly comprising: an elongate shaft, and an ablation assembly coupled to a first end of the elongate shaft, the ablation assembly having an energy emitter thereon; a handle assembly coupled to a second end of the elongate shaft, the handle assembly comprising: a handle frame rotatably and slidably connected to a control via a bearing, the bearing being slidable along the handle frame and axially fixed to the control, the control being movable relative to the handle frame, and a manifold disposed within the control, the manifold fixedly connecting the control to the elongate shaft such that moving the control moves the ablation assembly relative to the handle frame in at least one of an axial direction and a circumferential direction; and a coupling assembly configured to couple to the handle assembly and the working port of the delivery device, the coupling assembly configured to remain fixed relative to the delivery device and the handle frame while transmitting axial and rotational motion of the control to the ablation assembly via the manifold, wherein, when the handle assembly is operably coupled to the delivery device via the coupling assembly, a first portion of the elongate shaft extends within the working channel of the delivery device and extends through the working channel of the delivery device.

2. The catheter and handle assembly of claim 1, wherein, moving the control moves both the elongate shaft and the ablation assembly relative to the delivery device.

3. The catheter and handle assembly of any of the preceding claims, wherein, the coupling assembly includes a coupling and a locking mechanism for securing the handle assembly to the working port of the delivery device.

4. The catheter and handle assembly of claim 1, wherein, the control is configured for axial and circumferential manipulation of the ablation assembly relative to the delivery device.

5. The catheter and handle assembly of any of the preceding claims, wherein, the control includes a body configured to rotate circumferentially about a longitudinal axis of the handle frame to rotate the ablation assembly circumferentially.

6. The catheter and handle assembly of claim 5, wherein, when the body is rotated circumferentially in one direction, the ablation assembly is rotated circumferentially in the same direction.

7. The catheter and handle assembly of claim 5, wherein, the body includes a handle housing rotatably coupled to the handle frame.

8. The catheter and handle assembly of any of the preceding claims, wherein, the manifold is configured to move axially along a longitudinal axis of the handle for axial manipulability.

9. The catheter and handle assembly of claim 8, wherein, the manifold is configured to move axially along a longitudinal axis of the handle such that when the manifold is moved axially in one direction, the elongate shaft and the ablation assembly are moved axially in the same direction.

10. The catheter and handle assembly of any of the preceding claims, wherein, the control is transitionable relative to the handle frame between a closed or retracted state and an expanded state, the control being coupled to the elongate shaft such that transitioning the control moves the ablation assembly in an axial direction relative to the handle frame, and wherein, when the control is in one of the retracted state and the expanded state, a nominal catheter length of the elongate shaft of the catheter assembly is equal to or greater than the working length of the delivery device.

11. The catheter and handle assembly of claim 10, wherein, The nominal catheter length enables the ablation assembly to be optically coupled with a viewing device coupled to or integral with the working end of the delivery device.

12. The catheter and handle assembly of claim 10, wherein, The control is transitionable to an at least partially extended state to cause at least a portion of the ablation assembly to retract within the working channel.

13. The catheter and handle assembly of claim 12, wherein, When the control is in the extended state, the ablation assembly is fully retracted within the working channel.

14. The catheter and handle assembly of claim 10, wherein, When the control is in the retracted state, the ablation assembly extends a distance of about 0.1 cm to about 4.0 cm from the working end of the delivery device.

15. The catheter and handle assembly of claim 10, wherein, When the control is transitioned between the retracted state and the extended state, the total travel length of the ablation assembly is equal to or greater than the longitudinal length of the ablation assembly.

16. The catheter and handle assembly of claim 15, wherein, The total travel length of the ablation assembly is about 1% to about 20% of the nominal catheter length.

17. The catheter and handle assembly of claim 16, wherein, The total travel length of the ablation assembly is about 1% to about 10% of the nominal catheter length.

18. The catheter and handle assembly of any of the preceding claims, wherein, The handle further includes a connector for connecting to a power cord.

19. The catheter and handle assembly of any of the preceding claims, wherein, The handle further includes an internal battery as a power source.

20. The catheter and handle assembly of any of the preceding claims, wherein, The manifold is configured to be connected to a fluid source.

21. The catheter and handle assembly of any of the preceding claims, wherein, The first end of the elongated shaft includes a fluoroscopically visible indicator device, wherein the indicator device indicates an alignment of the ablation assembly relative to the delivery device.

22. The catheter and handle assembly of claim 21, wherein, The indicator device includes an elongated strip along an outer surface of the first end of the elongated shaft, the elongated strip being generally parallel to the elongated shaft.

23. The catheter and handle assembly of any of the preceding claims, wherein, The ablation assembly includes a radiopaque marker for indicating a position of the ablation assembly relative to the delivery device under fluoroscopic visualization.

24. The catheter and handle assembly of any of the preceding claims for coupling to a delivery device, wherein, The delivery device includes a bronchoscope.

25. The catheter and handle assembly of any of the preceding claims, wherein, The ablation assembly further includes an expandable member movable between a first retracted state and a second expanded state, the energy emitter being positioned on or in a portion of the expandable member.

26. The catheter and handle assembly of claim 25, wherein, The ablation assembly includes a coolant fluid path for circulating a coolant through the coolant fluid path to cool a surface of the energy emitter and / or the expandable member.

27. The catheter and handle assembly of claim 26, the catheter assembly comprising a pressure tube extending along the elongate shaft from the second end of the catheter into the expandable member of the ablation assembly, wherein, The first end of the pressure tube is operably coupled to a pressure sensor positioned on or proximate to the handle assembly, and the second end of the pressure tube is positioned in the expandable member and includes at least one aperture such that the pressure sensor senses a pressure in the expandable member.

28. The catheter and handle assembly of claim 27, wherein, The pressure tube is formed of Nitinol.

29. The catheter and handle assembly of claim 1, further comprising a set of instructions for using the catheter and handle assembly, the instructions comprising: positioning the ablation assembly in an airway through a channel of a delivery device; securing the coupling assembly to the delivery device; and moving the control while the coupling assembly remains secured to the delivery device so as to move the ablation assembly axially and circumferentially to a position in the airway to perform a lung treatment on a patient.

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