Patent Application
20160310210
The present invention relates generally to systems, apparatuses, and methods for treating tissue, and more particularly, the invention relates to a catheter and handle system including a catheter positioning handle assembly that facilitates both circumferential and axial positioning of a distal end of the catheter positioned in an airway, conduit, or vessel.
Pulmonary diseases are some of the most common medical conditions, affecting tens of millions of people in the U.S. alone. Pulmonary diseases result from problems in the respiratory tract that interfere with proper respiration. Many of these diseases require medical attention or intervention in order to restore proper lung function and improve a patient's overall quality of life. Some of the more common pulmonary diseases include asthma and chronic obstructive pulmonary disease or COPD. Symptoms of pulmonary disease like COPD and asthma vary but often include a persistent cough, shortness of breath, wheezing, chest tightness, and breathlessness. Generally, these symptoms are exacerbated when performing somewhat strenuous activities, such as running, jogging, brisk walking, etc. However, these symptoms may be noticed when performing non-strenuous activities, if the disease is allowed to progress unchecked. Over time, especially if medical attention is not sought, a person's daily activities will be significantly impaired, thus reducing overall quality of life.
Many pulmonary diseases, whether acute or chronic, often involve pathologic conditions associated with airway inflammation. When such inflammation has developed at the airway, infiltrated inflammatory cells cause damage to bronchial or lung tissue, which eventually results in the respiratory dysfunction characteristic of pulmonary diseases, such as reduction in respiratory flow rate or oxygen exchange capacity. Over time, this inflammation can lead to blockage of the airway lumen, thickening of the airway wall, and alteration of structures within or around the airway wall. Airway obstruction can significantly decrease the amount of gas exchanged in the lungs resulting in breathlessness. Blockage of an airway lumen can be caused by excessive intraluminal mucus, edema fluid, or both. Thickening of the airway wall may be attributable to excessive contraction of the airway smooth muscle, airway smooth muscle hypertrophy, mucous glands hypertrophy, inflammation, edema, or combinations of these. Alteration of structures around the airway, such as destruction of the lung tissue itself, can lead to a loss of circumferential traction on the airway wall and subsequent narrowing of the airway. Generally, pulmonary diseases like COPD and asthma are the result of a complex interplay of local inflammatory cytokines, inhaled irritants (e.g., cold air, smoke, allergens, or other chemicals), systemic hormones (e.g., cortisol and epinephrine), local nervous system input (i.e., nerve cells contained completely within the airway wall that can produce local reflex stimulation of smooth muscle cells and mucous glands), and the central nervous system input (i.e., nervous system signals from the brain to smooth muscle cells and mucous glands carried through the vagus nerve).
Asthma can further include acute episodes or attacks of additional airway narrowing via contraction of hyper-responsive airway smooth muscle that significantly increases airflow resistance. Asthma symptoms include recurrent episodes of breathlessness (e.g., shortness of breath or dyspnea), wheezing, chest tightness, and coughing. Additionally, COPD, often referred to as emphysema, is characterized by the alteration of lung tissue surrounding or adjacent to the airways in the lungs. Emphysema can involve destruction of lung tissue (e.g., alveolar sacs) that leads to reduced gas exchange and reduced circumferential traction applied to the airway wall by the surrounding lung tissue. The destruction of alveoli tissue restricts the in-flow of oxygen rich air and the proper function of healthier tissue, resulting in significant breathlessness. Exposure to chemicals or other substances (e.g., tobacco smoke) may significantly accelerate the rate of tissue damage or destruction. Additionally, chronic bronchitis, another type of COPD, is characterized by contraction of the airway smooth muscle, smooth muscle hypertrophy, excessive mucus production, mucous gland hypertrophy, and inflammation of airway walls. Like asthma, these abnormalities are the result of a complex interplay of local inflammatory cytokines, inhaled irritants, systemic hormones, local nervous system, and the central nervous system. Unlike asthma where respiratory obstruction may be largely reversible, the airway obstruction in chronic bronchitis is primarily chronic and permanent.
Treatment for pulmonary diseases includes reducing exposure to harmful agents, administering medications (e.g., bronchodilators, steroids, phosphodiesterase inhibitors, theophylline, antibiotics, etc.), administering lung therapy (e.g., oxygen therapy, pulmonary rehabilitation), and surgical intervention, such as bronchial thermoplasty. Unfortunately, pharmacological treatment requires patient compliance, often causes harmful side effects, and does not necessarily treat the underlying cause of the disease. Similarly, surgical intervention can result in the destruction of smooth muscle tone and nerve function, such that the patient is unable to respond favorably to inhaled irritants, systemic hormones, and both local and central nervous system input.
An alternative method for treating pulmonary disease is referred to as targeted lung denervation. This method utilizes ablation, such as RF ablation, via an ablation assembly to selectively treat target regions inside of the airway wall (e.g., anatomical features in the stromas) while protecting the superficial tissues, such as the surface of the airway wall. For example, the mucous glands can be damaged to reduce mucus production a sufficient amount to prevent the accumulation of mucus that causes increased air flow resistance while preserving enough mucus production to maintain effective mucociliary transport, if needed or desired. Nerve branches/fibers passing through the airway wall or other anatomical features in the airway wall can also be destroyed.
Specially designed catheters allow for the introduction of an ablation assembly, generally comprising one or more collapsible electrodes or energy emitters, coupled to an expandable member, such as a balloon, into the airway of a patient via a delivery device. The delivery device can be a guide tube, a delivery sheath, a bronchoscope, or an endoscope and can include one or more viewing devices, such as optical viewing devices (e.g., cameras), optical trains (e.g., a set of lens), optical fibers, CCD chips, and the like. Once positioned in the desired region of the airway, such as the left and/or right main bronchi, the expandable member is expanded to position the one or more electrodes in contact with the airway wall.
Energy, such as RF energy, is supplied to the energy emitter to ablate the targeted tissue, causing a lesion to form, therefore temporarily or permanently damaging the targeted tissue, therefore affecting, e.g. attenuating nerve signals to or from, portions of the lungs associated with the targeted tissue. Simultaneously, a coolant is supplied through the catheter and is directed to the one or more electrodes and into the expandable member or balloon. This allows for cooling of the superficial tissue in contact with the electrode, as well as the adjacent tissues. The size, shape, and depth of the lesions are determined by the flow rate and temperature of the coolant, and the energy supplied to the energy emitter(s). Devices, systems, and methods of such procedures can be found, for example, in one or more of U.S. Pat. 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 entireties.
In order to ensure that most or all of the target nerves extending along the airway are treated, it is generally desirable to form a circumferential lesion around all or most of the circumference of the airway wall. Due to design constraints or preferences, the electrode or energy emitter may not extend around the entirety of the circumference of the airway wall. Therefore, a circumferential lesion may be formed by ablating tissue while slowly rotating the ablation assembly or by positioning the ablation assembly in a series of rotational positions at each of which energy is delivered for a desired time period. The adjacent lesions then become contiguous and form a circumferential band all the way around the airway wall. Additionally or alternatively, the catheter may be repositioned axially to treat other locations within the airway distally or proximally of the first treatment site.
Typically targeted lung denervation will be performed under bronchoscopic visualization. A bronchoscope may be introduced into the target airway and the treatment catheter then delivered either alongside the bronchoscope or, more preferably, through the working channel of the bronchoscope. However, placement through the working channel can create challenges in manipulating the catheter due to the small size of the working channel, friction between the catheter and the walls of the working channel, and, in the case of flexible bronchoscopes, the curvature or tortuosity of the working channel. Furthermore, it is easy to lose the relative position of the electrode from the camera if both can rotate independently because the camera will always project right side up in the airway, regardless of the position of the bronchoscope.
Disorientation of the electrode in the treatment site and/or unintended movement of the catheter relative to the bronchoscope during treatment may result in treatment inaccuracies, causing axial or circumferential misalignment of lesions, undesirable gaps between lesions, or excessive overlap between lesions.
To address these and other challenges, there remains a need for a system, device, or apparatus for precise positioning and manipulation of pulmonary treatment catheters, such as targeted lung denervation catheters, while easily maintaining electrode orientation when positioned in a pulmonary airway through a delivery device such as the working channel of bronchoscope.
Embodiments of the invention are directed to a pulmonary treatment catheter and handle system including a catheter assembly, a handle assembly, and a scope coupling assembly for coupling the handle assembly and catheter assembly to a delivery device, such as a bronchoscope. Embodiments are further directed to kit including the catheter assembly and handle assembly for coupling together and to a delivery device, such as a bronchoscope, via the scope coupling assembly, and instructions for methods of using such. The catheter assembly is further fluidly and electrically coupled to a system console, including a coolant supply and return reservoir, and an energy supply such as a RF generator, via the handle assembly.
The catheter assembly, handle assembly, and scope coupling assembly cooperate together to facilitate both circumferential and axial positioning of a catheter electrode in a treatment site, such as an airway, conduit, or vessel for treatment of the tissue, while maintaining known rotational and axial orientation of portions of the catheter assembly, such as an ablation assembly including an energy emitter or electrode, within the treatment site. The system can further facilitate optical coupling of the ablation assembly of the catheter assembly with a viewing device, such as a fiber optic camera at a working end of a bronchoscope, while maintaining independent movement of the viewing device with respect to the ablation assembly to achieve maximum viewing flexibility of the treatment site and ablation assembly. This allows for full viewing access of the electrode of the ablation assembly within the treatment site regardless of its or orientation or positioning within the treatment site.
In embodiments, the catheter assembly comprises a targeted lung denervation RF, microwave, or ultrasound catheter, and generally includes an elongate shaft, and an ablation assembly coupled to a distal portion of the shaft, the ablation assembly including an expandable member, such as a balloon or basket, and one or more electrodes or energy emitters coupled to the expandable member. The catheter assembly also includes a cooling circuit including a coolant inflow and outflow lumen within the elongate shaft, and a coolant inlet path and return path (e.g. cooling conduit(s)) to circulate coolant to the expandable member and to the energy emitter, one or more power wires for supplying power to the energy emitter, optional thermocouple(s) and associated wires for measuring and sensing temperature at locations proximal to the electrode, optional cooling circuit pressure sensors and associated wired for measuring and sensing pressure within the cooling circuit, and/or optional pressure relief valves.
In embodiments, the handle assembly is coupled to a proximal portion of the shaft. The handle assembly can include a housing fixedly coupled to the proximal end of the shaft, and a spindle tube or handle frame coupled to the housing such that the spindle tube is rotatably and axially shiftable with respect to the housing and the catheter assembly. The handle assembly can further include an umbilical cable with strain relief for coupling the handle assembly, and ultimately the catheter assembly, to a system console including a heat exchanger, coolant pump, energy generator (such as an RF, microwave, or ultrasound generator), and a system controller. The umbilical cable can aid in coupling, for example, inlet and return fluid tubes (coolant) from the system console for fluidly coupling the catheter assembly to the heat exchanger and pump of the console, an electrical cable/connector to electrically connect the electrode of the catheter assembly to an energy source, thermocouple wires to monitor temperature of the surface tissue of the treatment site, the electrode, or both, and/or pressure sensors to monitor the high pressure coolant inlet flow and the low pressure return flow.
In embodiments, the scope coupling assembly removably couples the handle assembly and catheter assembly to a working channel of a delivery device, such as a bronchoscope, in a unique or single orientation, such that the initial rotational and axial orientation of the catheter assembly with respect to the working end or tip of the bronchoscope is known. The coupling assembly is fixedly coupled to the spindle tube, such that the handle housing and catheter assembly are rotatably and axially shiftable with respect to the working channel.
In some embodiments, the handle assembly is configured to maneuver the distal portion of the catheter shaft having the ablation assembly thereon with respect to the delivery device and airway wall, in axial and circumferential directions during or in preparation for the administration of treatment for a pulmonary disease. In some aspects, the delivery device is a bronchoscope that comprises a working channel or port through which the elongate shaft and ablation assembly of the catheter can be inserted, and the handle assembly can be secured to the bronchoscope in a manner that functionally engages the handle assembly movements with the bronchoscope and the ablation assembly of the catheter assembly. For example, the handle assembly can be fixed to the bronchoscope such that the shaft of the catheter assembly, and therefore the ablation assembly, rotates and axially translates with corresponding rotational and axial translation of the bronchoscope for coarse adjustment of the ablation assembly within the airway. The handle assembly may also include one or more steering or manipulation mechanisms that are functionally coupled with the shaft and/or ablation assembly to translate the shaft and/or ablation assembly rotationally and/or axially with respect to the scope for either coarse or fine circumferential and/or axial adjustment while other portions of the handle assembly remain engaged with and stationary relative to the bronchoscope.
In a particular embodiment, a length of the elongate shaft of the catheter assembly and the manipulation mechanism of the handle assembly are configured to allow for a travel length of the ablation assembly to be equal to or greater than a longitudinal length of the ablation assembly such that an axial stroke of the handle assembly (fully retracted to fully extended) allows the ablation assembly to shift between being fully extended out of the working end or tip (with or without a gap outside of the working end) of the bronchoscope to fully retracted within the working end of the bronchoscope (with or without a gap inside of the working end).
In some embodiments, once engaged with the bronchoscope, a user can maneuver the bronchoscope, and the elongate shaft and ablation assembly thereon, into a position advantageous for conducting treatment for a pulmonary disease (e.g., a targeted lung denervation procedure). In some embodiments, the handle assembly can comprise controls for independently adjusting the distal portion of the elongate shaft of the catheter and/or the ablation assembly from the bronchoscope. In yet another embodiment, the handle assembly can comprise independent control mechanisms for axial translation of the catheter assembly and rotational movement of the catheter assembly with respect to the working channel of the bronchoscope.
In use, the handle is permanently or temporarily coupled to the catheter assembly, and the distal portion of the catheter shaft and ablation assembly are inserted into the working channel or port of a delivery device, such as a bronchoscope. The handle assembly is then coupled to the bronchoscope via the coupling assembly in a unique orientation. In some embodiments, the distal portion of the delivery device can comprise a visualization device, a camera, and/or an aspiration lumen or vacuum. In some embodiments, the distal end of the catheter shaft and ablation assembly can be positioned using the axial and circumferential controls of the handle assembly, such that a specific portion of airway tissue can be targeted for treatment (e.g., radio frequency energy emission from an electrode). In embodiments, the working end of bronchoscope can be maneuvered independently of the catheter shaft and ablation assembly. For example, the handle assembly can be used to more accurately position an electrode of the ablation assembly based on visual cues from the camera of the delivery device, without moving the delivery device and camera.
In embodiments, the distal end of the catheter assembly includes a longitudinal indicator band or stripe. When the catheter assembly and handle assembly are coupled to the working channel of the bronchoscope, the indicator band aligns with the center point of the camera of the bronchoscope. This band provides a visual confirmation of the ablation assembly orientation within the treatment site, and regardless of the rotational orientation of the bronchoscope within the treatment site, the location of the ablation assembly with respect to the working end of the bronchoscope is known. Furthermore, the band provides a visual confirmation of the axial location of the ablation assembly with respect to the working end of the bronchoscope to provide optimal optical coupling of the bronchoscope camera and the ablation assembly.
The system according to embodiments allows for one-handed operation of both the catheter assembly and the bronchoscope when rotated and/or translated axially together for coarse adjustment, as well as for the independent rotationally and axial fine adjustment of the ablation assembly with respect to the bronchoscope.
The above summary of the various representative embodiments of the invention is not intended to describe each illustrated embodiment or every implementation of the invention. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices of the invention. The figures in the detailed description that follow more particularly exemplify these embodiments.
The invention can be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
As illustrated in
As shown in
Referring back to
Further details of the ablation assembly are described in U.S. Pat. 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 were incorporated by reference in their entireties above.
In some embodiments, and referring back to
Referring to
In a particular embodiment of handle assembly 104 and referring to
A portion of elongate shaft 102 of the catheter assembly 101, extends along longitudinal axis A within handle housing 1002. A catheter tube 1004 sheaths and protects shaft 102 within housing 1002. In an embodiment, and referring to
Referring to
Referring to
In an embodiment, and referring to
Inlet lumen 102a and outlet lumen 102b of shaft 102 extends within second port 1008b of manifold 1008, and outlet lumen 102b is bonded to an interior surface of port 1008b by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms. Inlet lumen 102a extends beyond outlet lumen 102b of shaft 102 through conduits 1009a and 1009b, and into coolant supply tube 1006a. Optionally, a diameter of conduit 1009b is similar to a diameter of inlet lumen 102a, such that inlet lumen 102a can be bonded to an interior surface of conduit 1009b by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms.
Manifold 1008 further comprises a third port 1008c. A proximal end of coolant return tube 1006b of umbilical cable assembly 1006 extends within port 1008c and is bonded to an interior surface of third port 1008c by adhesive bonding, heat sealing, ultrasonic welding, or any of a variety of attachment mechanisms. Third port 1008c is in fluid communication with second port 1008b, and therefore outlet lumen 102b secured thereto, via conduits 1009c and 1009a, separated by gate 1111. A distal end (not shown) of coolant return tube 1006b is coupled to a reservoir of the system console for recycle and/or disposal of coolant.
In use, coolant is supplied from the coolant supply of the system counsel through coolant supply tube 1006a of umbilical cable assembly 1006. Coolant then flows from coolant supply tube 1006a into inflow lumen 102a of catheter shaft 102. Coolant flows along the length of shaft 102 into ablation assembly 106, as described below. The coolant circulates through ablation assembly 106 and into outlet lumen 102b, along the length of shaft 102 into manifold conduit 1009a, reservoir, 1111, and conduit 1009c. Coolant flows out of manifold 1008 via coolant return tube 1006b and back to the system console for recycle and/or disposal.
Referring back to
Referring to
Manifold 1008 is fixedly coupled to an interior of first and/or second handle cover 1002a,b such that manifold 1008 and therefore catheter tube 1004 are fixed axially and rotationally to covering 1002. Manifold 1008 can be fixed to handle cover 1002a and/or 1002b by insertion of a peg formed on the interior of housing 1002a or b into a corresponding sleeve 1117 formed on manifold 1008 as seen in
Thermocouples can be placed anywhere within the catheter assembly 101 including at the energy emitter or electrode site of the ablation assembly 106, within the cooling member of the ablation assembly to measure the temperature of the coolant in the cooling member, and/or within the inflow and/or outflow lumens 102a, 102b in the elongate shaft 102 to measure the temperatures of the inflow and/or outflow coolant flows. Coolant temperature and/or coolant flow are then either manually or automatically regulated at the system console to ensure that the ablation site is sufficiently heated to cause permanent damage to target tissue, while ensuring that surface tissue in contact with the electrode and cooling member is sufficiently cooled to inhibit or prevent permanent damage to the surface tissue.
Pressure and/or flow rate can be measured within the inflow and/or outflow lumens, and/or within the cooling member and/or ablation assembly to measure theoretical and/or direct pressure of the ablation assembly. Pressure within the inflow lumen can be high compared to pressure within the outflow lumen due to a throttle positioned within the ablation assembly. In a particular embodiment, a pressure of the expandable member, e.g. balloon, of the ablation assembly is held at a pressure less than a predetermined pressure to guard against over-dilating or over-sizing the balloon within the airway, which can cause unwanted damage to the airway. In the event that the inflow lumen, throttle, or outlet lumen gets clogged, a pressure sensor, such as one positioned on the handle, will detect the buildup of pressure in the corresponding line and will automatically trigger the coolant pump to shut off so as not to rupture the expandable cooling member or over-dilate the balloon, and/or the energy source for the electrode to shut off so that the treatment site does not overheat. In an alternative embodiment, pressure relief valves may be incorporated within the system to alleviate a buildup of pressure at a predetermined or user-controlled pressure limit. Specific pressure measurement assemblies are described in more detail below.
In one embodiment, and referring to
In yet another embodiment of the invention, a direct measurement of the pressure in the balloon or ablation assembly 1206 is desired so as to eliminate or reduce undetected obstructions or occlusions between pressure sensor 1200 and the expandable member 1208, which can cause possible over-inflation or rupturing of the expandable member 1208. Referring to
In this embodiment, tube 1210 can be flexible or rigid. As seen in the figure, a support wire 1214, such as a Nitinol wire, extends between an interior of a proximal and distal end of expandable member 1208 to provide added axial, torsional, and buckling support for expandable member 1208. More particularly, a first end 1214a of support wire 1214 is coupled to the distal end 1203a of catheter shaft 1203, while a second end 1214b is coupled to the distal end of expandable member 1208 at a junction between throttle valve 1209 and expandable member 1208. In this embodiment, tube 1210 can supplement support wire 1214.
In yet another embodiment, and referring to
Process control loops including the real-time measurements of pressure, flow, and/or temperature within the system coupled with system response to automatically shut off provides a safety mechanism to guard against undesired tissue or airway injury.
Referring back to
Spindle tube 1024 is fixedly coupled in both rotational and axial directions to scope coupler 1014 at a first end 1024a. More particularly, a flange or skirt 1026 of spindle tube 1024 abuts a flat surface 1028 of scope coupler 1014. A protrusion 1030 of scope coupler 1014 extends into an opening 1032 of spindle tube 1024, in a mortise and tenon fashion. A tab 1034 clicks into a portion of protrusion 1030 to lock scope coupler 1014 to spindle tube 1024. A spindle cover 1036 is coupled to handle cover 1002, such that spindle tube 1024 is axially slidable along its length through spindle cover 1036.
Spindle tube 1024 is axially extendable into and out of handle housing 1002 for fine axial adjustment via axial translation of handle housing 1002, and therefore manifold 1008 and catheter shaft 102, along longitudinal axis A with respect to spindle tube 1024. More particularly, spindle tube 1024 has an inner diameter larger than an outer diameter of catheter tube 1004 and therefore shaft 102, such that catheter tube 1004 and shaft 102 telescope axially within and out of spindle tube 1024 to achieve axial adjustment of ablation assembly 106. A length of travel of shaft 102 with respect to spindle tube 1024 is chosen based on a desired length of travel of ablation assembly 106 with respect to the working end or tip of the bronchoscope. In an embodiment, as handle housing 1002 extends axially away from scope coupler 1014, manifold 1008, being fixed to housing 1002, also extends away, pulling shaft 102 with it, thereby retracting the ablation assembly 106 coupled to a distal portion of the shaft 102 toward and optionally entirely or partly into the bronchoscope, and vice versa upon axial translation toward scope coupler 1014.
Handle housing 1002 and catheter tube 1004, and therefore shaft 102, are prevented from being completely pulled away from spindle tube 1024. More particularly, a second end 1024b of spindle tube 1024 is axially retained within housing 1002 via a spindle retainer assembly 1040. Spindle retainer assembly 1040 includes a spindle end cap 1042 affixed to an end of spindle tube 1024, and a handle stop 1044 coupled to spindle end cap 1042 via a U-shaped pin. As handle housing 1002 is axially extended from scope coupler 1014, in its full extension, radial protrusions of handle stop 1044 abut radially extending features protruding from an interior surface of handle housing 1002, thereby prohibiting further axial extension. Similarly, features on an interior surface of handle housing 1002 along the longitudinal length of housing 1002 about radially extending protrusions on an exterior surface of handle stop 1044 to inhibit handle stop 1044 from rotating within housing 1002, while spindle end cap 1042 rotates with spindle tube 1024.
Handle stop 1044 further includes a notch for releasably engaging manifold 1008 when adjacent to each other in a fully retracted or closed configuration to lock spindle tube 1024 in axial translation with respect to manifold 1008 and housing 1002 if desired.
A desired length of axial travel of ablation assembly 106 with respect to the working end or tip of the bronchoscope is configured or determined by a total length of shaft 102 of catheter assembly 101, and the relationship of catheter tube 1004 with respect to spindle tube 1024 of the handle assembly 104. In one embodiment, the desired length of travel of ablation assembly 106 with respect to the working end or tip of the bronchoscope is equal to or greater than a longitudinal length of ablation assembly 106. In an embodiment, a longitudinal length of ablation assembly 106 includes a length of an expandable member (e.g. balloon) in addition to the conduit/electrode as seen in
To demonstrate the relationship, in a non-limiting embodiment, a working length of a commercially available bronchoscope, measured from the proximal opening of the working channel (to which the handle assembly is couplable) to the distal working end or tip (see
Further, in this embodiment, an ablation assembly 106 comprises a balloon or basket having a longitudinal length from about 1 to about 8 cm, more particularly from about 3 to about 5 cm, and more particularly from about 4 cm. With spindle tube 1024 fixed to scope coupler 1014, handle housing 1002 can travel axially a distance selected so that catheter tube 1004, and therefore a portion of shaft 102, telescopes within or axially translates with respect to spindle tube 1024 of the handle assembly 104 a length of equal to or greater than a longitudinal length of ablation assembly 106. This allows ablation assembly 106 to shift between being fully extended out of the working end or tip (with or without a gap outside of the working end depending on the total length of shaft 102) of the bronchoscope to fully retracted within the working end of the bronchoscope (with or without a gap inside of the working end depending on the total length of shaft 102).
For example, a total length of shaft 102 may be selected such that, when handle assembly 104 is coupled to the bronchoscope and is fully closed or collapsed (e.g. catheter tube 1004 is at maximum nesting position within spindle 1024, herein referred to as “fully closed handle configuration”), a proximal shoulder of the balloon of ablation assembly 106 extends from about 0.1 to about 4.0 cm, and more particularly about 2 cm, beyond the working end of the bronchoscope. When handle assembly 104 is in a “fully extended handle configuration” in which housing 1002 is at a maximum axial distance from scope coupling assembly 103, ablation assembly 106 entirely retracts within the working end to allow for unobstructed visualization of the airway. In this embodiment, the length of travel is greater than the length of the balloon, such as, for example, the length of travel is from about 1 cm+0.1-4.0 cm to about 8.0 cm+0.1-4.0 cm. Optical coupling between the viewing device of the bronchoscope and the balloon occurs at a partial axial extension of handle assembly 106 (i.e. “partially extended handle configuration”) in which the proximal shoulder of the balloon abuts the working end of the bronchoscope.
In an alternative embodiment, when handle assembly 104 is in the fully closed handle configuration, a proximal shoulder of the balloon of ablation assembly 106 abuts the working end of the bronchoscope, and is optically coupled to a viewing device positioned on the working end of the bronchoscope. Catheter tube 1004, and therefore a shaft 102, axially translates with respect to spindle tube 1024 at least a distance equal to length of the balloon such that upon full axial extension of handle assembly 104 to the fully extended handle configuration, the entire balloon is retracted into the working end of the bronchoscope.
In another alternative embodiment, when handle assembly 104 is in the fully extended handle configuration, the proximal shoulder of the balloon of ablation assembly 106 abuts the working end of the bronchoscope, and is optically coupled to a viewing device positioned on the working end of the bronchoscope. In this embodiment, ablation assembly 106 is not retractable within the bronchoscope.
In a particularly aspect, the length of travel of handle housing 1002, and hence ablation assembly 106, is from about 1 to about 20% of the total length of shaft 102, and more particularly from about 1 to about 10% of total length of shaft 102. In preferred embodiments, the length of travel of handle housing 1002 relative to spindle tube 1024, and hence ablation assembly 106, is at least the length of ablation assembly 106, preferably being at least about 105% of the length of ablation assembly 106, and more preferably at least about 110% of the length of ablation assembly 106.
In a particularly aspect, spindle tube 1026, catheter tube 1004, or other components of handle assembly 104 can comprise indicator notches or tabs markings, sensors, lighted indicators, or other suitable devices at predetermined position(s) to provide a visual and/or tactile response when the balloon of ablation assembly 106 is physically abutting the working end of the bronchoscope to indicate optical coupling of the viewing device and the ablation assembly, when the ablation assembly has been fully retracted into the bronchoscope, and/or at any of a variety of other desired locations.
Handle housing 1002, and therefore manifold 1008, catheter tube 1004, and catheter shaft 102, are also rotatable with respect to spindle tube 1024 by rotation of handle housing 1002 with respect to the bronchoscope and scope coupler 1014 for fine circumferential adjustment of the ablation assembly within a treatment area. One or more bearings 1038a, b are frictionally affixed to an interior surface of handle housing 1004 to aid smooth rotation of handle housing 1002 about spindle tube 1024. Optionally, because handle stop 1044 rotates with housing 1002 about spindle tube 1024 and spindle end cap 1042, handle stop 1044 and/or spindle tube 1024 can include indentations that provide a tactile indication or “clicks” corresponding to an amount of rotation. For example, a click can correspond to 1 or more degrees of rotation from a neutral position.
As described in the Background section, a fiber optic camera portion of the bronchoscope is fixed in relation to the bronchoscope, such that as the bronchoscope and catheter assembly rotates, the image portrayed remains right side up. This can cause disorientation as to the actual orientation of the ablation assembly within a treatment site, such as an airway. Referring now to
Optionally, radioopaque markers (not shown) can be printed or otherwise deposited on the ablation assembly, such as near or on an electrode, such that the orientation of the ablation assembly can be viewed by radiography, fluoroscopy, ultrasound, or other quick confirmation scan.
Band 2002 can also aid in the axial orientation of the ablation assembly with respect to the working end of the bronchoscope. For example, once the ablation assembly is expanded in the airway, it can be retracted closer to the bronchoscope until the band is no longer visible by the camera. This indicates an optimal distance between the balloon or expandable member and the camera such that optical coupling of the ablation assembly is accomplished. This allows the electrode of the ablation assembly to be viewed from the working end of the bronchoscope. The camera can then be moved independently of the ablation assembly.
Braiding 2006 can be incorporated along at least a portion of distal end 2000 of shaft 102. Braiding 2006 gives torsional stability to distal end 2000 so that steering of housing 1002 and manifold 1008 of handle assembly 104 is translated the entire length of shaft 102 so that ablation assembly 106 rotates and axially translates directly in response to handle and/or bronchoscope movements. Braiding 2006 also prevents or inhibits kinking of shaft 102. A small gap of unbraided section 2008 can be included on the end of distal end 2000 so as not to interfere with optical coupling, as described above.
Referring back to
Fine adjustment of ablation assembly 106 is accomplished via axial and rotational movement (220 and 230) of handle housing 1002 with respect to device 200 and scope coupling assembly 103 as depicted in
In some embodiments, and referring to
In an alternative embodiment, depicted in
In alternative embodiments, as depicted in
In still other embodiments (not shown), the controls for axial and circumferential maneuverability can comprise one or more motors, hydraulic or pneumatic cylinders, or other powered manipulators with associated buttons, switches, sensors, etc. configured to maneuver the distal portion of the endoscopic device without the need to manually manipulate a mechanism on the handle. In still other embodiments (not shown), the control mechanisms for precise or fine axial and/or rotational adjustment are automated, such as by servomotors.
Catheter positioning handle assemblies and systems allow for fine adjustment and maneuverability of the catheter shaft and ablation assembly independent of the bronchoscope or other delivery device and accessories coupled to the delivery device, such as cameras and/or lighting sources. For example, the handle can be used to more accurately position the ablation assembly under visualization with a camera or other optical element associated with the bronchoscope through which the catheter is positioned. Preferably the handle will facilitate maneuvering the catheter such that the ablation assembly is visible with the optical element during treatment. In preferred embodiments, the handle will facilitate optically coupling of an expandable member of the catheter assembly with an optical element of the bronchoscope, and a secondary source for visual cues for positioning can be in the form of radiopaque marks or radiopaque indicators on the ablation assembly to indicate fixing the catheter in position of the energy emitter relative to the bronchoscope to maintain such optical coupling during treatment.
According to a non-limiting embodiment, in use, during treatment for a pulmonary disease (e.g., a targeted lung denervation procedure) a bronchoscope can be positioned in the airway according to a typical bronchoscopic procedure. The user can chose the right or left main bronchi. A catheter assembly including a balloon with one or more electrodes coupled thereto can be folded, deflated, or wrapped on the distal end of the shaft of the catheter. The shaft and ablation assembly are inserted into a working channel of the bronchoscope and the handle assembly and scope adapter are connected such that the handle assembly is secured to the bronchoscope. The catheter shaft will then be aligned via the band on the distal end of the catheter shaft such that the user will have knowledge of electrode positioning and orientation relative to the airway by this initial positioning. In some embodiments, markings on shaft can be visible from the bronchoscope, which can aid the user during positioning of electrode. Optionally, radiopaque markers can be incorporated for additional confirmation of position.
The user can position the catheter shaft and ablation assembly within the airway (e.g., right or left bronchi). Coarse adjustments are made by axial and rotational translation of the bronchoscope itself, as the handle moves with the scope. Fine adjustments are made in the airway for treatment (e.g., lung denervating using radiofrequency therapy) using the axial and circumferential controls of the handle that adjust the shaft and ablation assembly relative to the scope (i.e. without moving the scope) to position electrode in a position advantageous for treatment. Once positioned, such as between cartilaginous rings of the airway, the user can inflate the balloon, which in turn causes the electrode(s) to contact the airway wall.
The positioning of the electrode and the balloon in the airway can be informed using a camera coupled to the bronchoscope, such as a lens with fiber optics and/or charge-coupled device (CCD) chip, which provides visual cues as to the position of electrode and balloon, relative to the anatomy of the airway and the other devices. Visualization of the electrode and balloon can be performed by moving the camera independently of the electrode and balloon. For example, the user can hold the handle of catheter assembly fixed, and then axially move the camera towards the electrode and the balloon without disturbing their position. With the ability to hold the handle in a stationary position, the electrode and balloon of the catheter assembly maintain a fixed position in the airway, thus allowing a user to freely move the camera axially and circumferentially for various visual views. Once the desired position is achieved, the user can perform treatment by powering the one or more electrodes, while simultaneously cycling coolant through the cooling circuit, as described above.
In some embodiments, such that when a circumferential lesion is desired, and the electrode size is less than the circumference of the airway, the treatment is repeated. For example, after the initial application of energy, the user deflates the balloon at least partially or fully, such as by stopping or slowing the coolant flow to depressurize balloon and the optional conduit having the electrode thereon. The user can then reposition electrode to a different quadrant rotationally and/or axially displaced from the first quadrant of the tissue by rotating and/or moving the bronchoscope (coarse adjustment) and then the control mechanism on the handle (fine adjustment), which in turn moves the electrode. In some embodiments, the electrode can be adjusted more finely in one or both axial and circumferential directions before ablation using the handle without moving the position of the bronchoscope.
In one particular embodiment, in which the electrode is a quarter of the circumference of the main bronchus, the initial position of the electrode when inserted through the bronchoscope is ventral. 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 lateral quadrant. Fine axial and/or rotational adjustments can be made to the electrode as necessary, and as described above. Confirmation from the camera that the black band is still centered with the camera is made, as well as other optional confirmations. The ablation assembly is pressurized as described above, and energy is supplied to the electrode to ablate the target tissue. Upon completion of treatment, the balloon is at least partly depressurized, and the bronchoscope and handle assembly are together rotated 90 degrees clockwise such that the electrode is now positioned in the ventral quadrant. The treatment is repeated as described. The bronchoscope and handle assembly are then rotated 90 degrees clockwise to the right lateral, and treatment is repeated. Finally, the bronchoscope and handle assembly are rotated 90 degrees clockwise to the dorsal quadrant and treatment 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 therapy repeated, as needed. This clockwise rotation of treatment allows a practitioner to easily, and single handedly rotate the bronchoscope and ablation assembly about the circumference of the airway.
In some embodiments, treatment conditions can require the use of vacuum operation of the bronchoscope, such as to clean an area or the bronchoscope tip. In such embodiments, the entire distal portion of the catheter shaft and ablation assembly can be withdrawn into the working channel of the bronchoscope by pulling the handle so that it is in its fully extended position (See, e.g.,
Upon completion of treatment, the user can withdraw the entire shaft and ablation assembly of the catheter into the working channel of the bronchoscope by pulling handle 100 to its fully extended position (See, e.g.,
Referring now to
As shown in
Collar portion 1726 has a variable inner diameter D4 larger than inner diameter D3 of such that at the junction between neck portion 1724 and collar portion 1726, an abutment ledge 1730 is formed. Abutment ledge 1730 can cooperate with a retaining flange F2 in abutting relationship on an end of port 202, as shown in
As shown in
As depicted in
Optionally, slot 1728 may comprise a tapered profile, being wider toward collar portion 1726 and narrower toward flange portion 1722. Such a tapered arrangement of slot 1728 facilitates easier engagement and/or disengagement of adapter assembly 1700 with port 202, in that as shroud 1702 is advanced from collar portion 1726 toward flange 1722 of coupler 1720 to disengage adapter assembly 1700 from port 202, tab 1708 of shroud 1702 advances in the narrowing slot 1728 causing the collar portion 1726 to spread open such that ridge 1730 clears the retaining flange on port 202, allowing adapter assembly 1700 to be removed from port 202.
The dimensions of adapter assembly 1700 may be selected as desired in order to couple with a variety of delivery devices 200.
In an alternative embodiment, the shroud does not include an alignment tab (not shown), allowing an alternative coupler 1800, depicted in
In embodiments, a kit 150 can include a catheter assembly 101 and handle assembly 104 as described above, and a set of instructions 152 for using the contents of 150, such as depicted in
Instructions 152 can be any of a variety of tangible or intangible media including, but not limited to a written manual, a CD or CD-ROM, CD, CD-ROM, DVD, BluRay, digitally downloadable or viewable on onto a personal device, such as a computer, tablet, smart device, and/or via verbal instruction by a provider of the kit 150. In another embodiment, instructions 152 for using the assemblies in accordance with the various embodiments described herein are provided, for example, by a manufacturer or supplier of the assemblies, separately from providing the assemblies, such as by way of information that is accessible using the Internet or by way of seminars, lectures, training sessions or the like.
Embodiments of the present invention thus allow a user to maneuver the catheter shaft and ablation assembly independently from the bronchoscope, and easily and conveniently into a position that facilitates efficient and effective treatment, ultimately improving patient outcomes and decreasing recovery times. Further, the handle assembly coupled to the bronchoscope becomes a pointer or indicator of the ablation assembly within the treatment site to supplement visual cues provided by the bronchoscope viewing device or camera. Finally, the handle assembly coupled to the bronchoscope allows for easy and efficient visual or optical coupling of the bronchoscope viewing device to the ablation assembly.
The handle and catheter systems according to embodiments can be used to maneuver ablation assemblies comprising expandable members and one or more energy emitters or electrodes as described above, and/or can be designed or configured for axially, rotational, and/or other manipulation of any of a variety of treatment assemblies including needle and/or needleless injection or drug delivery systems such as, for example, for the injection or delivery of neurotoxins, sclerosing agents, any of a variety of agents for the treatment of pulmonary disorders. For example, the handle and catheter system can be configured to axially (advancing and retracting) and/or rotationally manipulate one or more needles or ports within and around the airway. Various non-limiting examples of assemblies are described in one or more of the patents and applications listed below, all of which are incorporated by reference in their entireties either herein or above:
U.S. Pat. No. 8,088,127 entitled “Systems, Assemblies, and Method for Treating a Bronchial Tree;”
U.S. Patent Application Publication No. 2011/0152955 entitled “Delivery Devices with Coolable Energy Emitting Assemblies;”
U.S. Patent Application Publication No. 2012/0310233 entitled “Systems, Apparatus, and Methods for Treating Tissue and Controlling Stenosis;”
U.S. Patent Application Publication No. 2011/0118725 entitled Non-invasive and Minimally Invasive Denervation Methods and Systems for Performing the Same;”
U.S. Patent Application Publication No. 2012/0302909 entitled “Methods and Systems for Screening Subjects;”
U.S. Patent Application Publication No. 2011/0301587 entitled “System and Method for Pulmonary Treatment;”
U.S. Pat. No. 8,172,827 entitled “Apparatus for Treating Asthma Using a Neurotoxin;”
U.S. Patent Application Publication No. entitled “Method and Apparatus for Controlling Narrowing of at Least One Airway;”
U.S. Pat. No. 8,483,831 entitled “System and Method for Bronchial Dilation;”
PCT Application Publication No. WO 2013/052501 entitled “Apparatuses and Methods for Injuring Nerve Tissue;”
U.S. Patent Application Publication No. 2013/0310822 entitled “Compact Delivery Pulmonary Treatment System and Method for Improving Pulmonary Function;”
U.S. Provisional Patent Application No. 61/746,460 entitled “Methods for Improving Drug Efficacy;”
U.S. Provisional Patent Application No. 61/779,371 entitled “Fluid Delivery System and Method for Treatment;”
U.S. Provisional Patent Application No. 61/876,925 entitled “Systems, Devices, and Methods for Treating a Pulmonary Disease with Ultrasound Energy;”
U.S. Provisional Patent Application No. 61/847,477 entitled “Methods for Protecting the Esophagus During Pulmonary Treatment Procedures;” and
U.S. Provisional Patent Application Nos. 61/799,742 and 61/870,373, both entitled “Systems, Devices, and Methods for Treating a Pulmonary Disorder with an Agent.”
It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the subject matter hereof in any way. Rather, the foregoing detailed description will provide those skilled in the art with an enabling disclosure for implementing the exemplary embodiment or exemplary embodiments. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of the subject matter hereof as set forth in the appended claims and the legal equivalents thereof.
The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. Although the present subject matter has been described with reference to particular embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the subject matter hereof.
Various modifications to the subject matter hereof may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant art will recognize that the various features described for the different embodiments of the subject matter can be suitably combined, un-combined, and re-combined with other features, alone, or in different combinations, within the spirit of the subject matter hereof. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the subject matter hereof. Therefore, the above is not contemplated to limit the scope of the present subject matter hereof.
For purposes of interpreting the claims for the present subject matter, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.
The present application claims the benefit of U.S. Provisional Application No. 61/915,282 filed Dec. 12, 2013, which is incorporated herein in its entirety by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US14/69971 | 12/12/2014 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 61915282 | Dec 2013 | US |
