System and method for improved delivery of expandable catheter assembly to body cavity

Abstract

To provide a lung treatment catheter and handle system that include a catheter assembly having an insertion tube coupled to a handle assembly.SOLUTION: A system can be detachably combined with a delivery device, such as a bronchoscope or endoscope which has a port for connecting the handle assembly thereto and a working channel that communicates with a port for delivering a catheter assembly into the body cavity through the delivery device. Optionally, the port channel of the port can be in line with the working channel of the delivery device. The catheter assembly, handle assembly, and delivery device cooperate to facilitate delivery and positioning of catheter electrodes at a treatment site, such as the airway, conduit, or blood vessel for tissue treatment while minimizing damage to the catheter assembly, delivery device, or both parts.SELECTED DRAWING: Figure 6

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is a continuation of U.S. Provisional Patent Application No. 62 / 347,980, filed June 9, 2016. No. 6,399,433, filed on Oct. 23, 2003, which is hereby incorporated by reference in its entirety.

[0002] The present invention relates generally to an expandable catheter assembly, and more particularly to an expandable catheter assembly for the delivery of a catheter to a body lumen for treatment. US20100233633A1 - Means for assisting delivery of an expandable catheter assembly via a delivery device into a patient - Google Patents do. [Background technology]

[0003] Lung diseases are some of the most common medical conditions, affecting tens of millions of people in the United States alone. Lung diseases are caused by problems in the respiratory system that prevent proper breathing. Many of these diseases are In order to restore adequate lung function and improve the patient's overall quality of life, medical considerations or Some of the more common lung diseases require intervention. This includes COPD. Lung diseases such as COPD and asthma have a wide variety of symptoms, but in most cases In some cases, symptoms include persistent coughing, shortness of breath, wheezing, chest tightness and shortness of breath. It gets worse when you do some strenuous activity, such as running, jogging, or brisk walking. However, these symptoms may become severe if the disease is allowed to progress unchecked. Over time, especially if medical attention is not sought, you may notice , a person's daily activities are significantly impaired and their overall quality of life is reduced.

[0004] Many lung diseases, whether acute or chronic, are often associated with airway inflammation. When such inflammation occurs in the airways, the infiltrating inflammatory cells form in the bronchi or This can damage lung tissue and ultimately lead to respiratory problems such as reduced respiratory flow or oxygen exchange. Over time, this inflammation leads to obstruction of the airway lumen, thickening of the airway walls, and Airway obstruction can lead to changes in the airway and structures in and around the airway walls. This can significantly reduce the amount of gas exchanged, resulting in shortness of breath. , which may be caused by excess intraluminal mucus, edema fluid, or both. Thickening of the airway wall is caused by excessive contraction of airway smooth muscle, hypertrophy of airway smooth muscle, hypertrophy of mucus glands, inflammation, edema, and This may be due to destruction of structures around the airways, such as the destruction of the lung tissue itself, or a combination of these. The change in structure leads to a loss of circumferential traction on the airway wall and subsequent narrowing of the airway. In general, pulmonary diseases such as COPD and asthma are characterized by local inflammatory cytokines. irritants (e.g., cold air, smoke, allergens, or other chemicals), systemic hormones, mons (e.g., cortisol and epinephrine), local nervous system inputs (i.e., airway wall Contained entirely within the nerves that can generate local reflex stimulation of smooth muscle cells and mucous glands cells), and central nervous system input (i.e., from the brain carried via the vagus nerve to smooth muscle cells The mechanism is the result of a complex interplay between the nervous system signals to the mucous glands and the vasculature.

[0005] Asthma is further characterized by acute attacks caused by hyperresponsive airway smooth muscle contraction that significantly increases airflow resistance. Symptoms of asthma may include recurrent episodes of shortness of breath, Symptoms include: shortness of breath or difficulty breathing, wheezing, chest tightness, and coughing. In addition, COPD, often called emphysema, is caused by inflammation surrounding or adjacent to the airways of the lungs. It is characterized by changes in lung tissue. Emphysema is caused by the addition of excess blood to the airway walls by surrounding lung tissue. Reduced gas exchange and reduced circumferential traction of lung tissue (e.g., alveolar sacs) The destruction of alveolar tissue can be accompanied by the influx of oxygen-rich air and the loss of healthy tissue. This can limit the proper functioning of the respiratory tract and result in significant shortness of breath. Exposure to tobacco smoke can significantly accelerate the rate of tissue damage or destruction. In addition, chronic bronchitis, another type of COPD, is characterized by constriction of airway smooth muscle, smooth muscle hypertrophy, and excess mucous membranes. It is characterized by fluid production, enlargement of mucus glands, and inflammation of the airway walls. As in asthma, these abnormalities , local inflammatory cytokines, inhaled irritants, systemic hormones, local nervous system and central nervous Asthma, where respiratory problems may be largely reversible, is the result of complex interactions of the immune system. Unlike chronic bronchitis, the airway obstruction in chronic bronchitis is primarily chronic and permanent.

[0006] Treatment of lung disease involves reducing exposure to harmful substances, administering medications (e.g., bronchodilators, steroids, etc.), and ides, phosphodiesterase inhibitors, theophylline, antibiotics, etc.), pulmonary therapies (e.g. Therapeutic interventions include oxygen therapy, pulmonary rehabilitation, and surgical interventions such as bronchial thermoplasty. Unfortunately, pharmacological treatment requires patient compliance and is often They cause harmful side effects and do not necessarily treat the underlying cause of the disease. Similarly, surgical interventions can help patients avoid inhaled irritants, systemic hormones, and local and central nervous system disorders. This leads to a disruption of smooth muscle tone and nerve function, such that the body is unable to respond favorably to both neuronal inputs. There is a possibility that.

[0007] Another method to treat lung disease is called targeted pulmonary denervation. This method targets the surface of the airway walls. target areas inside the airway wall (e.g., interstitial anatomical features) while protecting superficial tissues such as ) to selectively treat the tumor, such as by RF ablation via an ablation assembly. For example, mucus glands are used to treat mucus buildup that increases airflow resistance. While it may be damaged to reduce mucus production enough to prevent If necessary or desired, sufficient mucus to maintain effective mucociliary transport Nerve branches / fibers passing through the airway wall or other anatomy of the airway wall may maintain Biological characteristics may also be destroyed.

[0008] A specially designed catheter is inserted into the patient's airway via a delivery device, and the catheter is then inflated with a balloon or other inflatable catheter. and one or more collapsible electrodes or energy emitters coupled to the movable member. The delivery device includes a guide tube, a delivery device, and an ablation assembly. The optical observation device (e.g., a camera) may be a catheter, a bronchoscope, or an endoscope. ), an optical system (e.g., a set of lenses), an optical fiber, a CCD chip, or The desired region of the airway, such as the left main bronchus and / or the right main bronchus, may be detected by a bronchoscope. Once positioned in the airway wall, the expandable member is expanded to place one or more electrodes in contact with the airway wall. Place it.

[0009] Energy, such as RF energy, is delivered to an energy emitter to ablate the target tissue. The effect is to induce the formation of lesions, thereby temporarily or permanently damaging the target tissue, and thus This has an effect such as attenuation of nerve signals to the part of the lung associated with the target tissue. A coolant is delivered through the catheter and the one or more electrodes and the expandable member or balloon are This allows for cooling of the surface tissue in contact with the electrode as well as adjacent tissue. The size, shape and depth of the lesion depend on the flow rate and temperature of the coolant, as well as the energy The energy delivered to the emitter is used to determine the amount of radiation emitted by the emitter. The method and system are described in, for example, "Systems, Assemblies, and Methods for Treating the Bronchial Tree." No. 8,088,127 entitled "Coolable Energy Emitting Assembly" and U.S. Pat. U.S. Patent Application Publication No. 2011 / 0152855, entitled "Delivery Device Having a Baffle" and one or more of the following documents, both of which are incorporated herein by reference in their entireties: INCORPORATED INTO THE SPECIFICATION.

[0010] 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 airway wall. Due to design constraints or preferences, the electrodes or energy emitters may be positioned circumferentially around the entire circumference of the airway wall. Therefore, the ablation assembly may not be rotated slowly. By ablating tissue while the energy is being applied for a desired period of time, By placing the ablation assembly in a series of rotational positions, each of which is delivered Circumferential lesions can form, and adjacent lesions can become contiguous and form part of the airway wall. Additionally or alternatively, the catheter may be The catheter may be repositioned axially to treat other locations within the airway distal or proximal to the catheter. Good too.

[0011] Typically, targeted pulmonary denervation is performed under bronchoscopic manipulation and visualization. A bronchoscope is introduced into the target airway, and then a therapeutic catheter is inserted next to or near the bronchoscope. Preferably, it is delivered through the working channel of the bronchoscope. Placement through the catheter is facilitated by the small size of the working channel, the contact between the catheter and the wall of the working channel, and the friction between the bronchoscope and, in the case of flexible bronchoscopes, curvature or tortuosity of the working channel. This can create difficulties in manipulating the catheter. For example, as shown in Figure 1 The working channel of a commonly available flexible endoscope or bronchoscope 10 is Access is via a side port 11 (or "Y" tube) located near the handle 12. , side port 11 and working channel of handle 12 and flexible shaft 1 of endoscope 10. 3. When inserting an instrument such as a needle probe, for example, the needle may be fully withdrawn. If not properly inserted, it may damage the working channel. A catheter including one or more retractable electrodes or energy emitters 15 coupled to a member 16. For instruments such as the stylus and handle assembly 14, the angle through which the instrument can be advanced and Forcing and / or retracting the force can increase the resistance or drag felt by the surgeon, which can In some cases, this can interfere with the surgeon's haptic feedback and, in certain scenarios, can cause the expandable member, energy This could cause damage to the laser, the emitter, or both.

[0012] To address these and other challenges, a delivery system for the working channel of a bronchoscope, etc. Minimize the occurrence of damage to the catheter when it is placed through the device into the lung airways for delivering and manipulating pulmonary therapeutic catheters, such as targeted pulmonary bronchiole catheters, while There remains a need for such a system, instrument, or device. Summary of the Invention

[0013] An embodiment of the present invention is a catheter having an insertion tube coupled to a handle assembly. The present invention relates to a catheter and handle system for treating lungs, the catheter and handle system including a catheter assembly. The system further includes a port for coupling the handle assembly to a delivery device and a catheter for delivery to a body cavity via the delivery device. and a working channel in communication with the port for delivering the catheter assembly to the It is removably connectable to a delivery device, such as a bronchoscope or endoscope. The catheter assembly, the handle assembly, and the delivery device are for the treatment of tissue while minimizing damage to the delivery device, or both. Delivery and positioning of catheter electrodes at treatment sites such as airways, ducts, or blood vessels Work together to facilitate

[0014] In certain embodiments, the catheter assembly is an RF, microwave, or ultrasound catheter. The device typically comprises a defibrillator having a proximal end and a distal end. The ablation assembly includes a long shaft and an ablation assembly coupled to a distal end of the shaft. The fusion assembly includes an expandable member, such as a balloon or basket, and an expandable member and one or more electrodes or energy emitters coupled to the catheter assembly. , and further comprising a coolant source and return reservoir and an RF generating and a system console including an energy supply such as a power supply. . In an embodiment, the handle assembly is coupled to a proximal end of the shaft of the catheter assembly. The handle assembly includes a housing fixedly coupled to the proximal end of the shaft and a spring. The pindle tube is rotatable and axially movable relative to the housing and catheter assembly. A spindle tube or a handle frame connected to the housing so as to be movable in the direction The present invention can include the above.

[0015] In an embodiment, the handle assembly and the catheter assembly are a single or unique The device can be attached to a delivery device such as a flexible bronchoscope in one orientation or multiple orientations as desired by the user. In some embodiments, the delivery device is a rigid body or a scope handle. and a working length flexible shaft terminating in a distal working end. At least a portion of the working shaft is disposed within the body cavity to be treated. The proximal end of the working channel extends through the bronchoscope and terminates in a port formed on the rigid body. The distal end of the work channel terminates in the working end of the flexible shaft. and the ablation assembly, via a port channel formed therethrough, and through a working channel for delivery into the lumen via the working end of the flexible shaft. and inserted into the port.

[0016] In an embodiment, the port is configured such that the port channel is the same as the working channel of the scope handle. The ports are formed in a rigid position on a straight line. The direction of the ports on this straight line is The catheter assembly can be angled as in the side port of the row technique without the need to use a scope handpiece. This allows the catheter assembly to be loaded directly through the catheter Reduces resistance or drag on the assembly, minimizing damage to the catheter assembly In yet another embodiment, the port channel is a working channel of the scope handle. and a first insertion position in line with the catheter assembly through the working channel. Once inserted and the handle assembly is mated to the port, the port channel will be displaced off-axis. and a second operating position in which the port is moved or tilted or angled relative to the first operating position. The port is rotatable relative to the scope handle so that the scope can be moved. This allows the handle assembly to be positioned relative to the scope body in multiple positions. to.

[0017] In an embodiment, the catheter assembly includes an insertion tube movably coupled to a shaft. In these embodiments, the insertion tube is longitudinal and optionally rotatable. The insertion tube is rotatably coupled to the outer surface of the shaft of the catheter assembly. When the cooling assembly is in a deflated configuration, e.g., when the expandable balloon is deflated, The expandable ablation assembly located at the tip of the shaft is inserted into the port channel of the delivery device. The ablation assembly is sized to guide the insertion tube through the nozzle. The catheter assembly provides a rigid support structure for introducing the catheter assembly into the port channel. Once the catheter is inserted through the working channel of the delivery device, the insertion tube is inserted into the catheter adapter. along the shaft of the ablation assembly from the ablation assembly towards the handle assembly. The insertion tube also translates or slides through the port of the delivery device. When coupled to the handle assembly, the handle assembly is sized to nest within the handle assembly.

[0018] The system and device according to the embodiment are more flexible than conventional systems. The ablation assembly has an expandable configuration into and through a delivery device such as a scope. The improved system can facilitate insertion of the catheter assembly into the catheter. Reduces the resistance or drag felt by the surgeon during ablation, helping to prevent damage to the ablation assembly Reduce.

[0019] The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter of this specification. The figures and detailed description which follow more particularly exemplify various embodiments. [Brief description of the drawings]

[0020] The subject matter herein may be best understood in light of the following detailed description of various embodiments taken in conjunction with the accompanying drawings, in which: can be more fully understood. [Figure 1] FIG. 1 is a perspective view of a catheter and handle system coupled to the angled side port of a conventional bronchoscope. [Diagram 2] FIG. 2 is a side view of a catheter and handle system according to an embodiment of the present invention (insertion tube not shown). [Diagram 3] FIG. 3 is a side view of an ablation assembly of a catheter assembly according to an embodiment of the present invention. [Figure 4] FIG. 4 is a side view of the catheter and handle system of FIG. [Diagram 5] FIG. 5 is a flow diagram of a catheter handle system in accordance with an embodiment of the present invention. [Figure 6] FIG. 6 is a perspective view of a catheter and handle assembly having an insertion tube according to an embodiment of the present invention. [Figure 7A] 7A is a side view of the insertion tube of FIG. [Figure 7B] FIG. 7B is a cross-sectional view of the insertion tube of FIG. 7A. [Figure 8A] FIG. 8A is a perspective view of a catheter and handle assembly with an insertion tube in a first insertion position. [Figure 8B] FIG. 8B is a perspective view of the catheter and handle assembly with the insertion tube in a second, nested position. [Figure 9A] FIG. 9A is a side cross-sectional view of an insertion tube and delivery device according to an embodiment of the present invention. [Figure 9B] FIG. 9B is a side cross-sectional view of an insertion tube and delivery device according to another embodiment of the invention. [Figure 9C] FIG. 9C is a side cross-sectional view of an insertion tube and delivery device in accordance with yet another embodiment of the present invention. [Figure 10A] FIG. 10A is a side view of an insertion tube funnel according to an embodiment of the present invention. [Figure 10B] FIG. 10B is a cross-sectional view of the insertion tube funnel of FIG. 10A. [Figure 11A] FIG. 11A is a side view of the insertion tube funnel of FIG. 10A mated with the insertion tube of FIG. 7A, according to an embodiment of the present invention. [Figure 11B] FIG. 11B is a cross-sectional view of the insertion tube and insertion tube funnel assembly of FIG. 11A. [Figure 12] FIG. 12 is a side view of a catheter and insertion tube assembly having an insertion tube funnel fitted thereto. [Figure 13] 13 is a side view of the catheter and insertion tube assembly of FIG. 12 with the insertion tube funnel removed. [Figure 14] FIG. 14 is a side view of a delivery device having collinear ports and working channels according to an embodiment of the present invention. [Figure 15]15 is a side view of a delivery device having a pivot port according to an embodiment of the present invention. Various embodiments are susceptible to various modifications and alternative forms, details of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that it is not intended to limit the claimed invention to the particular embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter defined by the claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] According to some embodiments, a catheter and handle system, as shown in FIG. 100 includes an elongated shaft 102 and an ablation coupled to a first or distal end of the shaft 102. A positioning assembly 106 is coupled to the second or proximal end of the shaft 102. a handle assembly 104, an ablation assembly 106 and a handle assembly An insertion tube 107 is movably connected to the shaft 102 between the catheter 104 and the catheter The lens assembly 101 and the handle assembly 104 are attached to a flexible endoscope or a bronchoscope. and a scope coupling assembly 103 for coupling to a working channel of a delivery device. The catheter assembly 101 may include an insertion tube 107. The ablation assembly 106 is inserted into an insertion tube 107 at the tip of the shaft 102. In a first position, the catheter is retracted and compressed into a working channel of a delivery device (not shown). The insertion tube 107 is inserted into the handle assembly 104 when coupled to the port of the From the second position where it is tilted, it translates along the shaft 102 .

[0022] Referring now to FIG. 3, the ablation assembly 106 includes an electrode or transducer. One or more energy emitters 510, such as a balloon or basket, and The one or more energy emitters may include, for example, a stretchable member 520. The device is configured to deliver energy in the form of microwaves, microwaves, or ultrasound. In the embodiment, one or more energy emitters may be configured to use a coolant to cool the energy emitter 510. The conduit 540 is connected to a conduit 540 configured to carry the coolant. For this purpose, the expandable member 520 is in fluid communication with the shaft 102. Referring to FIG. , the ablation assembly 106 includes an energy emitter 510 and an expandable member 52 0 is cooled to contact the energy emitter 510 and Coolant flow paths to achieve deep tissue ablation while sparing adjacent superficial tissue or A cooling circuit 600 may be provided.

[0023] Returning to FIG. 3, the ablation assembly 106 may optionally include a conduit 540 and an expansion A throttle valve 530 may be provided to regulate flow to and from the movable member 520 . The ablation assembly 106 also includes an expansion member 520 and a catheter, as needed. To provide additional axial, torsional, and buckling support to the shaft 102, Along at least a portion of the length of the catheter shaft 102 and at the base of the expandable member 520 A support wire, such as a Nitinol wire, extending between end 520a and the interior of tip 520b. 1214. Further details of the ablation assembly 106 can be found in U.S. Patent No. 8, entitled "Systems, Assemblies, and Methods for Treating the Bronchial Tree" ,088,127 and "Delivery Device Having a Coolable Energy Emitting Assembly" " and is described in U.S. Patent Application Publication No. 2011 / 0152855, both of which are incorporated herein by reference in their entireties.

[0024] In some embodiments, with reference to FIGS. 2 and 4, the handle assembly 104 includes , which is coupled to the proximal end of the shaft 102 of the catheter assembly 101. The reel 104 includes a housing 1001 fixedly connected to the base end of the shaft 102 and a spindle. The needle tube is rotatable within the housing 1001 and the catheter assembly 101. A spindle tube is coupled within the housing 1001 so as to be movable axially. The actuator may include a handle or a handle frame (not shown).

[0025] The umbilical cable 120 may be used to connect a power source, an energy source (e.g., an RF generator), a fluid or a coolant The catheter assembly is connected to ancillary devices or accessories such as a source, a heat exchanger, and a controller. A strain relief 121 is provided to fluidly and / or electrically couple the bridge 101. 10 is coupled to an end of the handle assembly 104 via a The umbilical cable 120 may, for example, be used to cool and / or heat the input fluid. A console, optionally including a heat exchanger for cooling the fluid or coolant supply, is provided. inlet and return fluid tubes or lumens 105a for fluidly coupling the suction cap 102; 105a', the shaft and / or ablation assembly, temperature Electrically connect the thermocouple for monitoring and / or pressure sensor for coolant circuit pressure to a power source. and one or more electrical cables / connectors 105b for connecting the power supply to the power source. In this embodiment, the handle assembly 104 and any accessories may be Alternatively, an internal battery source may be provided for operating the accessories. The assembly is disclosed in US Pat. No. 6,399,343 entitled "Catheter and Handle Assemblies, Systems and Methods." No. 6,399,623, filed on Oct. 20, 2015, and incorporated herein by reference. The entirety of which is incorporated herein.

[0026] The catheter assembly 101 further includes a handle assembly 104 for receiving a coolant A cooling circuit (600 shown in FIG. 5) including a supply and return reservoir and an energy source such as an RF generator. The system is fluidly and electrically coupled to a system console (not shown) which includes a power supply and an energy source. The handle assembly 104 supports the system during administration of therapy, such as targeted pulmonary defibrillation (TLD) therapy. The tip or end of the shaft 102, and thus the ablation assembly 106, is rotated axially. and configured for circumferential operation, details of which are described in U.S. Pat. No. 8,088,127. No. 2011 / 0152855 and U.S. Patent Application Publication No. , both of which are incorporated herein by reference in their entireties.

[0027] As shown in FIG. 5, the cooling circuit 600 includes an optional heat exchanger 603 in the system console. Electrode 510 is connected to the handle 104 via an inflow lumen in the shaft 102. Outflow within the shaft 102 through the expandable member 520 via the associated conduit 540 via the lumen, through the handle 104, and back to the system console. Contains coolant supplied from reservoir 601 in the system console. A non-limiting example of the present invention is entitled "Delivery Device Having a Coolable Energy Emitting Assembly." US Patent Application Publication No. 2013 / 0289556 and "System for Bronchiectasis" No. 8,489,192, entitled "System and Method for Producing a High-Performance, ... and High-Performance, Combination of the Presence and Ability of a Microcomputer," The circulation of the fluid may be achieved, for example, by a peristaltic pump. In another embodiment, the coolant is passed through the expandable member before the electrodes. The flow is reversed, as if to say,

[0028] The catheter assembly 101 and the handle assembly 104 are connected to an insertion port (e.g., 1 and 113 in FIG. 9 ), for example, through a guide tube, The device is configured to be removably coupled to a delivery device, such as a sheath, a bronchoscope, or an endoscope. The delivery device may include an optical observation device (e.g., a camera), an optical system (e.g., a lens set), In one particular embodiment, the delivery device may include one or more observation devices, such as a viewing device. The device includes a flexible bronchoscope, an ablation assembly (not shown) and an elongated shaft. The handle assembly 102 is inserted into the working channel port of the instrument. 104 is fixed to the instrument via the scope coupling assembly 103. The assembly 103 may be integral with or coupled to a handle assembly 104. or a unique stand-alone device coupled to both the handle assembly 104 and the port. The scope coupling assembly 103 may be a friction or abutment fit, Locking lever, threaded engagement with corresponding screw, bayonet or snap fit, spring loaded fit The connector may be secured to the port by any of a variety of mechanisms known to those skilled in the art. When secured, the scope coupling assembly 103 is axially aligned with the delivery device. Further details regarding the coupling assembly 103 are also available from International Publication WO 2005 / 023363. No. 2015 / 089377, which is incorporated herein by reference. The entirety of the above is incorporated first.

[0029] 6-8B, the insertion tube 107 may be configured to extend longitudinally or between the ablation assembly 106 and the handle assembly 104. 7A and 7B, the shaft 102 is movably and coaxially coupled to the shaft 102. Tube 107 has a first or distal end 107a and a second or proximal end 107b. The elongated portion 109 has a constant inner diameter 109a and an outer diameter 109b along the elongated portion 109 extending between In an alternative embodiment, the elongated portion 109 has a diameter that varies along its length. For example, the elongated portion 109 has a diameter that is greatest at the center of the elongated portion 109 and at each end. Alternatively, the elongated portion 109 may be elliptical in shape such that it tapers toward the It reduces or tapers inwardly from the ends toward the center so that the smaller diameter is at the center.

[0030] In an embodiment, the first end 107a is flared, i.e., has an inner diameter 111a and an outer diameter The diameter 111b is the inner diameter 111a of the insertion tube 107 and the ablation assembly. The inner and outer diameters 109a, 109b are tapered to form a taper for guiding the rib 106. In an embodiment, the insertion tube at the flared end 107a is angled radially outward. The outer diameter 111b of 107 is the insertion port of a delivery device (not shown in FIGS. 7A and 7B). 113. The working channel of the port 113 is adapted to fit within, i.e., form a friction fit. It is made to size.

[0031] Inner diameter 109a is formed when ablation assembly 106 is folded within tube 107. The ablation assembly 106 is sized so that it can be compressed and attached to a delivery device. This allows the catheter to be safely and easily delivered into the working channel of the device.

[0032] The second end 107b of the insertion tube 107 has a tapered outer diameter 109b that is smaller than the outer diameter 109b. 15. This taper occurs when the insertion tube 107 tapers toward the housing of the handle assembly 104. The insertion tube 107 is inserted into the handle 106 so that it is fully or substantially nested within the handle 106. The assembly 104 is guided into an internal recess or pocket 117 (shown at 117 in FIG. 6). This enables

[0033] The insertion tube 107 may be made of any suitable material, including but not limited to polyethylene, polypropylene, of various suitable rigid or semi-rigid materials, such as PTFE polymers, or mixtures thereof. In one particular embodiment, the insertion tube 107 is , allowing the tube 107 to slide easily along the shaft 102 and The tube 107 has a low coefficient of friction that allows the assembly 106 to slide within the tube 107. The material is made from a polymeric material such as PTFE.

[0034] 8A-B, in use, the insertion tube 107 is inserted into the shaft 102. The ablation assembly 106 is retracted within the insertion tube 107 at the distal end of the ablation assembly 106. In the first position (FIG. 8A), the insertion tube 107 is compressed by the insertion tube 107 and inserted into the port 11 of the delivery device. 3, the second position (FIG. 8) is nested within the handle assembly 104. B) and then translated along the shaft 102. More specifically, as shown in FIG. The tube 107 is then compressed or contracted into an ablation assembly. on the ablation assembly 106 so as to completely or substantially cover the ablation assembly 106. The tube 107 is then slid into an insertion port formed on a delivery device (not shown). It is inserted into slot 113.

[0035] The catheter assembly 101 is configured to extend the handle assembly 104 toward the port 113. 113a of a delivery device (not shown) by moving the As shown in FIG. 8B, when the handle assembly 104 is moved toward the port 113, Tube 107 remains fixed in port 113 and shaft 102 is The handle assembly 104 slides over the tube 107 until it contacts the port 113. 107 to allow the ablation assembly 106 to be deployed. The tube 107 is connected to the handle assembly 104 as described in more detail below. fully within the handle assembly 104 so that it can be secured to the port 113. Or substantially nested.

[0036] 9A-9C, the insertion tube 107 is partially inserted into the delivery device 130. As shown in FIG. 9A, the insertion tube 107 can be inserted either partially or substantially. , is placed into the insertion port 113 without substantially entering the working channel 113a. In this embodiment, the flared first end 107a extends beyond the insertion tube 107 by a certain length. The insertion tube 107 is secured to the port 113 so as not to extend into the working channel 113a. Prevent extension beyond 113.

[0037] In an alternative configuration shown in FIG. 9B, the insertion tube 107 is inserted into the working chamber of the delivery device 130. In this embodiment, the straight portion 114 of the groove 113a is inserted into the straight portion 114 of the groove 113a. The first end 107a is where the insertion tube 107 connects to the port 113 and the working channel 1. 13a. The first end 107a is not wide enough to pass through the second end 107b. Similarly, it can be the same diameter as the insertion tube 107 or can be tapered. good.

[0038] As mentioned above, the insertion tube 107 may be constructed from a material with a low coefficient of friction. 107, allowing the ablation assembly 106 to slide easily within the tube 107. However, the various delivery devices 130 do not necessarily have smooth, low-friction working channels. 9B may not include working channel 113a of delivery device 130. a to reduce the distance traveled by the ablation assembly 106 through the ablation This reduces the potential for damage to the assembly 106. In this embodiment, the tube 107 A portion of the tube 107 remains outside the working channel 113a and the port 113. 104 is connected to the port 113 so as to be nested within the handle 104. In this embodiment, the straight portion 114 of the working channel 113a has a length longer than that of the straight portion 114 of the working channel 113a. , the insertion tube 107 may interfere with the port 113 to prevent the tube 107 from working. The mounting member may include a flange 107c configured to limit insertion into the mounting channel 113a. The flange 107c is substantially the same length as the straight portion 114 of the working channel 113a. A similar length may be formed on the tube 107. The bracing assembly 106 is directly connected to the working channel 113a in the insertion tube 107. Tube 10 moves along linear portion 114 and into non-linear portion 116 of working channel 113a. 7 and enters flexible section 118 of working channel 113a.

[0039] In yet another alternative configuration shown in FIG. 9C, the insertion tube 107 is inserted into the working channel 113. a substantially interposes with at least a portion of the straight portion 114 of the delivery device 130 and the non-straight portion 116 of the delivery device 130. In this embodiment, the first end 107a is configured to be inserted into the insertion tube 1 07 does not extend through port 113 and working channel 113a. The first end 107a accommodates a tapered junction between the non-linear portion 116 and the flexible portion 118. For this purpose, the insertion tube 107 may be of the same diameter or the second end 107b and It may be tapered as well.

[0040] As mentioned above, the insertion tube 107 may be constructed from a material with a low coefficient of friction. 107, allowing the ablation assembly 106 to slide easily within the tube 107. The material must be sufficiently rigid to allow the ablation assembly 106 to pass through. However, the insertion tube 107 is flexible so as to bend and guide the curve of the non-linear portion 116. The configuration of FIG. 9C allows the ablation assembly 106 to be attached to the working surface of the delivery device 130. By reducing the distance traveled directly through channel 113a and around the curve of non-linear portion 116 Reduces the possibility of damage to the ablation assembly 106, such as by interlocking To make.

[0041] In this embodiment, the tube 107 is disposed such that a portion of the tube 107 is external to the delivery device 130. and nests within the handle 104 when the handle 104 is mated with the port 113. As shown, the entire length of the straight portion 114 and the non-straight portion 116 of the working channel 113a is In this embodiment, the insertion tube 107 may be inserted into the port 106 as needed. 113 to limit the insertion of tube 107 into working channel 113a. Such a flange may include a flange (not shown) formed on the work channel. The length of the straight portion 114 and the length of the non-straight portion 116 of the panel 113a are substantially equal to at least a part of the length of the straight portion 114 and the length of the non-straight portion 116 of the panel 113a. In this embodiment, the tubing 107 may be formed along a similar length. The ablation assembly 106 is inserted into the insertion tube 107 through a working channel 113a. 114 and at least a portion of the non-linear portion 116 of the working channel 110. Non-linear portion 116 of working channel 113a aligned with flexible portion 118 of 113a The tube 107 exits at the end of the tube 107 .

[0042] In some embodiments, referring now to FIGS. 10A-13, insertion tube leakage The ablation assembly 106 is folded and slidably supported within the insertion tube 107 by the ablation guide 150. To aid in this, the insertion tube 107 may be used as a tube and funnel assembly 151. The end 107a (e.g., the flared end 107a) of the funnel 15 can be fitted to the end 107a of the funnel 15. 0, the 90 degree elbow of the conduit 540 while helping to collapse the conduit 540 within the funnel 150. 3, placing less stress on the components of the ablation assembly 106, such as the ablation The contact point of the bration assembly 106 is configured to move away from the axis.

[0043] 10A and 10B, the insertion tube funnel 150 has a first end 152a and a second end 152b, extending along the length of the funnel 150 to a minor inner diameter 156. The first end 152a has a truncated cone portion 153 having a long inner diameter 154 at the first end 152a. The elongated stem portion 158 extends from the short inner diameter 156 of the truncated cone portion 153 to the funnel 154. In an embodiment, the diameter of the stem portion 158 is The minor diameter 156 is constant along the length of the stem portion 15. 0 has a diameter that varies along its length.

[0044] 11A and 11B, the second end 152b of the funnel 150 is configured to have a friction fit. , threaded connection, snap fit, or any other connection mechanism. Preferably, the minor inner diameter 156 is sized to fit the The funnel 150 is sized to fit inside diameter 111a of end 107a, and an insertion tube is inserted through the funnel 150. It forms a smooth lead in the transition to the tip 107.

[0045] In use, referring to FIG. 12, the funnel 150 is configured such that the catheter shaft 102 is inserted into the funnel 150 . and extends through the insertion tube 107, thereby providing the ablation assembly 10 The funnel 150 is fitted to the insertion tube 107 so as to axially align the funnel 16 with the funnel 150. The insertion tube 107 with the 50 attached thereto is slid along the shaft 102 and abraded. When pulled onto the ablation assembly 106, the major diameter 154 of the funnel 150 The assembly 106 is captured and compressed and folded to form the ablation assembly 106. The profile of assembly 106 is reduced so that it fits completely within insertion tube 107, as shown in FIG. The ablation assembly 106 is mounted within an insertion tube 107. Once loaded, the funnel 150 is no longer needed and is removed from the insertion tube 107. As mentioned above, this allows the insertion tube to mate with a port on the delivery device.

[0046] In some embodiments, the funnel 150 is disposable and configured for single use. and may include, for example, a polymeric material having a low coefficient of friction, such as polyethylene. In other embodiments, the funnel 150 may be made of any suitable material, such as polyethylene, polypropylene, or polyethylene. (PTFE), or any of a variety of other materials with low coefficients of friction. Coated or uncoated paper, foil, rubber materials, plastics In an alternative embodiment, the funnel 150 is reusable and can include an autoclave. The catheter is formed from a material that is durable enough to be sterilized between uses, such as a catheter.

[0047] In some embodiments, referring to FIG. 14, a catheter and a catheter are inserted into the lumen to be treated. The delivery device 200 for improved delivery of the scope and handle system includes a rigid scope body 20. 2 and a rigid elongated portion 203, a first tip of the elongated portion 203 202a, a flexible shaft 204 having a working channel 202 defined therethrough. 08, a linear or collinear port 206 formed in the second proximal end 202b of the body 202; The delivery device 200 may include, for example, a system connection 205 (e.g., air, optical cable or optical fiber), deflection lever 207, optical fiber, suction part, etc. These various components may include any of a variety of components such as port 20. 6 and can be positioned to the side of the working channel 208. In one particular example, A CCD chip is integrated into the working end of the shaft 204, which allows the working channel This eliminates the need for optical fibers running parallel to or along the cable 208.

[0048] In an embodiment, the working channel 208 is connected to the port channel 206 at the proximal end 202b. a, extends through the body 202 and along the shaft 204, The catheter assembly (not shown) is connected to the working end 204a of the catheter 204 and terminates at 208b. ) indicates the lumen to be treated through the ablation assembly via working channel end 208b. The catheter is introduced into the port 206 through the channel 208 until it is delivered to the patient. aligning the working channel 208 with the port channel 206a so that The side port of the prior art does not require angling the catheter assembly, allowing for easy access to the scope. Allows direct loading of the catheter assembly through the body, thus Reduces resistance or drag at the bridge to minimize damage to the catheter assembly can.

[0049] In another embodiment, referring to FIG. 15, the port 206 of the device 200′ may be a first position in which the panel 206a is aligned with the working channel 208 of the body 202; and the port channel 206a' is tilted off-axis relative to the working channel 208. or from a second angled position (shown in dashed lines) into port 206 The body 202 is pivotally attached to the body 202 via a pivot pin 201 so that the In use, for example, the catheter assembly may include an ablation assembly and a working channel. in the port 206 when in the first position to facilitate loading into the nozzle 208. The catheter assembly can be inserted through the working channel and When the handle assembly is coupled to the port 206, the port 206 is in a first colinear position. This allows the catheter and handle assembly to be rotated from its original position as desired by the surgeon. It allows the port to be positioned relative to the scope body in multiple positions. 06 is a catheter assembly for removing or repositioning the catheter assembly, etc., in a desired first position. can be returned to

[0050] The delivery device 200 delivers the ablation assembly through a working channel into the body cavity to be treated. To improve delivery of the assembly, an insertion channel 107 and a catheter and handle system are provided. The present invention may be used in combination with or in place of the system 100. The system and device according to the embodiment are more flexible than conventional systems in terms of the ability to measure the volume of a flexible endoscope or bronchoscope. Having an ablation assembly that is expandable into and through a delivery device such as a mirror The improved system allows for easy insertion of the catheter assembly during use. Reduces the resistance or drag felt by the user and reduces the ablation This operates to reduce the occurrence of damage to the assembly.

[0051] Various embodiments of the systems, devices, and methods are described herein. The embodiments are given by way of example only and are not intended to limit the scope of the invention as defined by the claims. Moreover, it is not intended that various features of the described embodiments be implemented in various ways. It should be understood that the above and other elements may be combined to produce numerous additional embodiments. Various materials, sizes, shapes, configurations, and locations may be used with the disclosed embodiments. However, the disclosure is not intended to be limiting without going beyond the scope of the invention described in the claims. Others than those shown may be utilized.

[0052] Those of ordinary skill in the art will appreciate that the subject matter herein may be practiced in a variety of forms, including but not limited to those exemplified in the individual embodiments above. It will be appreciated that the embodiments described herein may include features not shown. It is not intended to be an exhaustive listing of the ways in which various features of the subject matter of this specification can be combined. Thus, the embodiments are not mutually exclusive combinations of features. Rather, Various embodiments may be selected from different individual embodiments, as will be appreciated by those skilled in the art. Moreover, the present invention may include combinations of different individual features described in relation to one embodiment. Elements illustrated may be included in any embodiment even if they are not described therein unless otherwise stated. may also be implemented in other embodiments.

[0053] A dependent claim defines a specific combination with one or more other claims in the scope of the claim. However, other embodiments may be implemented by combining the subject matter of the dependent claims with the subject matter of each of the other dependent claims. or a combination of one or more features with other dependent or independent claims. Unless it is stated that a particular combination is not intended, Such combinations are proposed herein.

[0054] Any incorporation by reference of the above documents is not intended to be construed as contravening the express disclosure herein. The subject matter is limited to not being incorporated. Any undertaking by reference to the above documents is hereby expressly excluded. and further disclaims any claims contained therein which are hereby incorporated by reference. Any incorporation by reference of any of the above documents is expressly hereby expressly incorporated herein by reference. Unless otherwise stated, the definitions provided in that document are not incorporated herein by reference. The above is further limited as follows. For purposes of claim interpretation, the specific terms "means for" or "step for" may be used interchangeably. " is not invoked unless the following is stated in the claims: 35 U.S.C. 112(f) It is expressly intended that. The present application provides the following aspects of the invention. (Aspect 1) 1. A system for ablating targeted tissue in an airway of a patient, comprising: 1. A catheter assembly comprising: an elongate shaft having a proximal end and a distal end; a distal end of the elongated shaft coupled to the distal end of the elongated shaft for delivering energy to a target tissue within the airway; 1. An ablation assembly configured to be disposed on a an expandable member movable between a contracted configuration and an expanded configuration; an energy emitter coupled to the expandable member, the expandable member being in an expanded position; an energy emitter configured to be positioned adjacent to the target tissue when the an ablation assembly including: an insertion tube slidably disposed on the elongate shaft, in the retracted configuration; a first position in which the ablation assembly is compressed within the insertion tube; a first position at the distal end of the ablation assembly, the second position being movable between the ablation tube and the distal end of the ablation assembly; and an insertion tube configured and sized as follows: A controller configured to deliver energy from an energy source to the energy emitter. A system comprising: (Aspect 2) The insertion tube is an elongated portion having a constant inner diameter and an outer diameter; A first angled surface having said inner and outer diameters angled outwardly from said constant inner and outer diameters. a flared end of the ablation assembly for inserting the deflated ablation assembly into the insertion tube. and a first enlarged end sized to bias the Tem. (Aspect 3) 3. The system of embodiment 2, wherein the flared end terminates in a flange. (Aspect 4) The insertion tube further comprises: a second tapered end opposite the first widened end, 3. The method of claim 2, wherein the outer diameter is smaller than the constant outer diameter, thereby forming a chamfer. system. (Aspect 5) The catheter assembly further comprises a removably attached to the first end of the insertion tube. a funnel connectable to the insertion tube, the funnel being adapted to connect the expandable member to the insertion tube; and folding the ablation assembly into a compressed configuration while in the contracted configuration to The system of embodiment 1, configured as follows: (Aspect 6) moreover, A handle secured to the proximal end of the elongate shaft and connectable to a port of a delivery device. a handle assembly, the handle assembly including a housing defining an internal recess; The insertion tube is inserted into the housing when the insertion tube is in the second position. Any one of the preceding paragraphs, which is partially or completely nested in The system described in (Aspect 7) The system includes a delivery device for delivering the ablation assembly into an airway. can be coupled to a port, The insertion tube is coupled to the port when the insertion tube is in the first position. The device is configured to be integrated with the When the handle assembly moves toward and contacts the port, The insertion tube is moved to the second position to insert the ablation assembly into the delivery device. and moving at least a portion of the insertion tube through a working channel of the device into the airway. is configured to be nested within the handle assembly. system. (Aspect 8) The system includes a delivery device for delivering the ablation assembly into the airway. and further comprising: The insertion tube is inserted through the port into the working channel of the delivery device. 13. The system of claim 12, further configured for partial insertion of the . (Aspect 9) The working channel of the delivery device includes a straight portion and a non-straight portion, one end of the straight section is coupled to the port and a second end of the straight section is coupled to the non-straight section; moreover, The insertion tube extends through and along the straight portion of the working channel. The system of embodiment 8, wherein the system is partially extended. (Aspect 10) Further, the insertion tube is at least partially connected to the non-linear portion through the linear portion. 10. The system of claim 9, wherein the distal end of the first end of the first cavity extends along the distal end of the first cavity. (Aspect 11) The insertion tube has a distal end that restricts the distance the insertion tube is inserted into the working channel. 9. The system of embodiment 8, comprising a flange configured to limit (Aspect 12) 1. A method for delivering an ablation assembly into an airway of a patient, comprising: A catheter assembly is provided, the catheter assembly comprising: an elongate shaft having a proximal end and a distal end; a distal end of the elongated shaft coupled to the distal end of the elongated shaft for delivering energy to a target tissue within the airway; 1. An ablation assembly configured to be disposed on a an expandable member movable between a contracted configuration and an expanded configuration; an energy emitter coupled to the expandable member, the expandable member being in an expanded position; an energy emitter configured to be positioned adjacent to the target tissue when the an ablation assembly including: a proximal end and a distal end slidably disposed on the elongated shaft and movable between the proximal end and the distal end; an insertion tube; When the expandable member is in the contracted configuration, the ablation assembly Sliding the insertion tube; The insertion channel is inserted into the insertion port of a delivery device by the ablation assembly therein. Coupling the tubes; A working channel of the delivery device with the insertion tube secured to the insertion port. moving the ablation assembly and the elongate shaft through a How to prepare. (Aspect 13) moreover, A handle assembly coupled to the proximal end of the elongate shaft, the handle assembly comprising: A handle assembly including a housing sized to nest the tube therein. providing A working channel of the delivery device with the insertion tube secured to the insertion port. Moving the ablation assembly and the elongate shaft through a The insertion tube is adapted to be partially or completely nested within the housing. moving the handle assembly toward and into contact with the insertion port. 13. The method of embodiment 12, (Aspect 14) moreover, 14. The method of claim 13, further comprising fixedly coupling the handle assembly to the port. Method of posting. (Aspect 15) Additionally, prior to sliding the insertion tube over the ablation assembly, A funnel is coupled to a first end of the insertion tube proximate the ablation assembly. and wherein the funnel is adapted to insert into the insertion tube. Any of aspects 12-14, wherein the assembly is configured to fold into a compressed configuration. 2. The method according to claim 1. (Aspect 16) The insertion channel is inserted into the insertion port of a delivery device by the ablation assembly therein. Joining the tubes The insertion port is inserted at least partially into the working channel of the delivery device through the port. 16. The method of any one of aspects 12-15, comprising inserting an infusion tube. (Aspect 17) The insertion channel is inserted into the insertion port of a delivery device by the ablation assembly therein. a working channel of the delivery device having straight and non-straight sections; a line portion, a first end of the line portion being coupled to the port, and a second end of the line portion being coupled to the port; is coupled to the non-linear portion, The insertion tube is inserted at least partially into the non-linear portion through the entire linear portion. 17. The method of embodiment 16, comprising: (Aspect 18) 1. A delivery device for delivering an ablation assembly into an airway of a patient, comprising: A rigid body; a flexible working shaft coupled to the body at a first shaft end, the shaft is configured to be partially or completely disposed within the airway; a shaft, the second end of the shaft comprising a working end; an insertion port formed on the rigid body, the insertion port including structure defining a port channel; Ports and defining a working channel extending through said rigid body and said flexible working shaft; and a structure for A first end of the working channel is coupled to the port channel, and the working channel a second end of the flexible shaft coupled to a working end of the flexible shaft; The insertion port is pivotally coupled to the rigid body, and the insertion port is a first insertion position where the first end of the channel is collinear with the port channel; The first end of the working channel is in a second position that is not collinear with the port channel. The delivery device is rotatable between the delivery position and the (Aspect 19) 20. The delivery device of embodiment 18, wherein the delivery device comprises a flexible bronchoscope or a flexible endoscope. (Aspect 20) The insertion port is configured to be coupled to a catheter assembly, The catheter assembly is an elongate shaft having a proximal end and a distal end; a distal end of the elongate shaft coupled to the actuator for delivering energy to a target tissue; an ablation assembly configured to be placed in an airway via an industrial channel, There was, an expandable member movable between a contracted configuration and an expanded configuration; an energy emitter coupled to the expandable member, the expandable member being in an expanded position; an energy emitter configured to be positioned adjacent to the target tissue when the 20. The delivery device of embodiment 18 or 19, comprising an ablation assembly including:

Claims

1. 1. A medical device for treating an airway of a patient, the medical device comprising: A handle assembly; a shaft engaging the handle assembly; an ablation assembly connected to an end of the shaft; an insertion tube slidably coupled to the shaft, the shaft is disposed within the insertion tube; and the insertion tube having a coupling feature at one or more of a first end and a second end.

2. The medical device of claim 1 , wherein the insertion tube is configured to be introduced into an opening in a scope via the first end.

3. The medical device of claim 2 , wherein the interlocking feature facilitates introduction of the insertion tube into the scope.

4. The medical device of claim 1 , wherein the interlocking feature is an external taper.

5. The medical device of claim 1 , wherein the insertion tube is telescoped within the handle assembly.

6. The medical device of claim 1 , wherein the interlocking feature facilitates connection of the insertion tube to the handle assembly.

7. The medical device of claim 1 , wherein the connecting feature is a splay.

8. The medical device of claim 7 , wherein the expansion creates a friction fit with an inner diameter of the scope.

9. The medical device of claim 7 , wherein the expansion is inwardly tapered.

10. the expansion is configured to receive a funnel; and The medical device of claim 7 , wherein the funnel facilitates compression and insertion of the ablation assembly into the insertion tube.

11. The medical device of claim 1 , wherein the insertion tube is relatively rigid.

12. The medical device of claim 1 , wherein the insertion tube is at least partially flexible.

13. The medical device of claim 12 , wherein the insertion tube is configured for flexibly insertion into a non-linear portion of a scope.

14. The medical device of claim 1 , wherein in a contracted configuration, the insertion tube covers and compresses an expandable member of the ablation assembly.

15. The medical device of claim 1 , wherein the insertion tube is formed from a polymer that has a low coefficient of friction with the ablation assembly.

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