Devices and methods for targeted bronchial denervation by cryoablation

Abstract

Devices, systems and methods for treating pulmonary conditions such as COPD and asthma by denervating bronchial tissue using cryoablation. In one embodiment, a device for bronchial denervation includes: an elongated body having a distal portion and a proximal portion opposite the distal portion; a therapeutic element at the distal portion of the elongated body; and a first recording electrode and a second recording electrode, the first recording electrode being located distal to the therapeutic element and the second recording electrode being located proximal to the therapeutic element, the first recording electrode and the second recording electrode being configured to record an electromyogram. In one embodiment, the device includes a fluid delivery element within the therapeutic element and having a plurality of holes aligned with an equatorial portion of the therapeutic element.

Description

Technical Field

[0001] The present technology generally relates to devices, systems and methods for treating lung conditions, such as chronic obstructive pulmonary disease (COPD) and asthma, by denervating bronchial tissue using cryoablation. Background Art

[0002] Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes airflow obstruction in the lungs, and the term is also used to refer to a series of lung conditions, such as emphysema and chronic bronchitis. COPD ranks fourth in the leading causes of death, and about one-third of all health-related expenses are associated with the condition. Asthma is considered to be a risk factor for developing into COPD, and patients with COPD are more likely to develop into heart disease, lung cancer and other conditions. Studies have shown that COPD causes epithelial metaplasia, mucous metaplasia, fibrosis, smooth muscle mass increase, and other conditions that contribute to airway obstruction in addition to the contractile properties of bronchial smooth muscle. Additional, the bronchial smooth muscle of COPD patients is infiltrated by inflammatory cytokines, proteases and generative factors, which further aggravate airway obstruction.

[0003] Denervation or neuromodulation of the parasympathetic nervous system (PNPS) is a relatively new technique used to treat conditions such as hypertension and cardiovascular disease in a minimally invasive manner. However, there are few studies demonstrating the efficacy of denervation for other conditions, such as those affecting the lungs. Further, when performing denervation, care must be taken to avoid damage to non-target tissues. Summary of the invention

[0004] Some embodiments advantageously provide devices, systems, and methods for treating pulmonary conditions such as COPD by denervating bronchial tissue using cryoablation. In one embodiment, a device for bronchial denervation includes: an elongated body having a distal portion and a proximal portion opposite the distal portion; a healing element at the distal portion of the elongated body; and a first recording electrode and a second recording electrode, the first recording electrode being located distal to the healing element and the second recording electrode being located proximal to the healing element, the first recording electrode and the second recording electrode being configured to record electromyograms.

[0005] In one aspect of this embodiment, the healing element comprises at least one balloon. In one aspect of this embodiment, the healing element comprises an equatorial portion, the healing element further comprising a fluid delivery element within the at least one balloon, the fluid delivery element having a plurality of holes aligned with the equatorial portion of the healing element. In one aspect of this embodiment, the plurality of holes comprises at least twenty-four holes radially arranged around the fluid delivery element, each of the at least twenty-four holes having a diameter between about 0.0005 inches and about 0.0015 inches.

[0006] In one aspect of this embodiment, at least twenty-four apertures are radially arranged around the entire circumference of the fluid delivery element.

[0007] In one aspect of this embodiment, at least twenty-four apertures are radially arranged around a portion of the circumference of the fluid delivery element.

[0008] In one aspect of this embodiment, the at least twenty-four holes are arranged helically around the entire circumference of the fluid delivery element.

[0009] In one aspect of this embodiment, the healing element includes a balloon having a plurality of lobes and a plurality of splines extending parallel to a longitudinal axis of the elongated body, the plurality of splines alternating with the plurality of lobes.

[0010] In one embodiment, a system for bronchial denervation includes a cryoablation device including a therapeutic element and at least one recording electrode, an electromyography system in communication with the at least one recording electrode, and a control unit in fluid communication with the cryoablation device.

[0011] In one aspect of this embodiment, the cryoablation device further comprises a longitudinal axis, and the healing element comprises: a balloon having a plurality of lobes; and a plurality of splines extending parallel to the longitudinal axis of the cryoablation device and between the plurality of lobes.

[0012] In one aspect of this embodiment, the healing element includes a flexible portion transitionable between a first, at least substantially linear, configuration and an expanded, second configuration, the flexible portion having a helical configuration when in the expanded, second configuration.

[0013] In one aspect of this embodiment, the at least one recording electrode includes a first recording electrode located distally of the healing element, and a second recording electrode located proximally of the healing element.

[0014] In one aspect of this embodiment, the electromyography system includes a processing circuit system configured to: receive an electromyography signal from at least one recording electrode; calculate a difference between a first electromyography signal received from a first recording electrode and a second electromyography signal received from a second recording electrode to generate a recorded electromyogram; and compare the recorded electromyogram with a reference electromyogram.

[0015] In one aspect of this embodiment, the processing circuitry is further configured to determine whether denervation has occurred in the region of the target tissue proximate the treatment element based on a comparison between the recorded electromyogram and a reference electromyogram.

[0016] In one aspect of this embodiment, the processing circuitry is further configured to generate an alarm when the processing circuitry has determined that denervation has occurred in the region of the target tissue proximate the treatment element.

[0017] In one aspect of this embodiment, the control unit includes a coolant source in fluid communication with the healing element.

[0018] In one embodiment, a method for performing bronchial denervation includes: positioning a treatment element of a cryoablation device within a bronchus of a patient's lung; extending the treatment element so that at least a portion of the treatment element contacts at least a portion of at least one of bronchial tissue and nerves innervating the bronchial tissue; circulating a coolant within the treatment element to reduce the temperature of the treatment element to a temperature sufficient to cryoablate at least a portion of at least one of the bronchial tissue and nerves innervating the bronchial tissue; recording at least one electromyographic signal from at least a portion of at least one of the bronchial tissue and nerves innervating the bronchial tissue using each of a first recording electrode and a second recording electrode; and transmitting the recorded at least one electromyographic signal to an electromyographic system.

[0019] In one aspect of this embodiment, the method further includes: calculating the difference between at least one electromyographic signal received from the first recording electrode and at least one electromyographic signal received from the second recording electrode to generate a recorded electromyogram; comparing the recorded electromyogram with a reference electromyogram; determining whether denervation has occurred in at least a portion of at least one of the bronchial tissue and the nerves innervating the bronchial tissue based on the comparison; and when it is determined that denervation has occurred in at least a portion of at least one of the bronchial tissue and the nerves innervating the bronchial tissue, terminating the circulation of the coolant within the treatment element.

[0020] In one aspect of this embodiment, the method further includes generating an alarm upon determining that denervation has occurred in at least a portion of at least one of the bronchial tissue and the nerves innervating the bronchial tissue.

[0021] In one aspect of this embodiment, the healing element includes at least one balloon and expanding the healing element includes inflating the balloon.

[0022] In one aspect of this embodiment, at least one balloon includes: a balloon having a plurality of lobes; and a plurality of splines extending between the plurality of lobes.

[0023] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] A more complete understanding of the present invention, together with attendant advantages and features thereof, will be more readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which:

[0025] Figure 1 An exemplary system for bronchial denervation is shown; the system includes a cryoablation device;

[0026] Figure 2 shows a partial cross-sectional view of an exemplary cryoablation device according to the present disclosure;

[0027] Figure 3 An exemplary cryoablation device having an exemplary embodiment of a fluid delivery element according to the present disclosure is shown;

[0028] Figure 4 An exemplary cryoablation device having another exemplary embodiment of a fluid delivery element according to the present disclosure is shown;

[0029] Figure 5A shows a side view of an exemplary embodiment of a fluid delivery element according to the present disclosure;

[0030] Figure 5B It shows that according to the present disclosure Figure 5A a cross-sectional view of a fluid delivery element;

[0031] Fig. 6A shows a side view of another exemplary embodiment of a fluid delivery element according to the present disclosure;

[0032] Figure 6B It shows that according to the present disclosure Fig. 6A a cross-sectional view of a fluid delivery element;

[0033] Fig. 7A shows a side view of another exemplary embodiment of a fluid delivery element according to the present disclosure;

[0034] Figure 7B It shows that according to the present disclosure Fig. 7A a cross-sectional view of a fluid delivery element;

[0035] Figure 8 shows a side view of another exemplary cryoablation device according to the present disclosure;

[0036] Fig. 9 It shows that according to the present disclosure Figure 8 A front view of an exemplary embodiment of a cryoablation device;

[0037] Fig.10 shows a side view of another exemplary embodiment of a cryoablation device according to the present disclosure;

[0038] Fig.11 shows a side view of another exemplary embodiment of a cryoablation device in a delivery configuration according to the present disclosure;

[0039] Fig.12 shows an expanded configuration according to the present disclosure Fig.11 A side view of an exemplary embodiment of a cryoablation device;

[0040] Fig.13 shows a cryoablation device positioned at an exemplary treatment site within a bronchus in accordance with the present disclosure;

[0041] Fig.14 shows an exemplary lesion pattern created within a bronchus by a cryoablation device according to the present disclosure;

[0042] Fig.15 Another exemplary lesion pattern created within a bronchus by a cryoablation device according to the present disclosure is shown;

[0043] Fig.16 Another exemplary lesion pattern created within a bronchus by a cryoablation device according to the present disclosure is shown;

[0044] Fig.17 Another exemplary lesion pattern created within a bronchus by a cryoablation device according to the present disclosure is shown;

[0045] Fig.18 An exemplary electromyogram before bronchial denervation is shown;

[0046] Fig.19 shows another exemplary electromyogram after bronchial denervation according to the present disclosure; and

[0047] Fig. 20 An exemplary method of performing bronchial denervation using a cryoablation device according to the present disclosure is shown. DETAILED DESCRIPTION

[0048] Before describing the exemplary embodiments in detail, it should be noted that the embodiments reside primarily in combinations of device components and processing steps related to performing a denervation procedure. Therefore, the components of the systems and methods have been represented in appropriate locations by conventional reference numerals in the drawings, so that only those specific details relevant to understanding the embodiments of the present disclosure are shown so as not to obscure the disclosure with details that are obvious to those skilled in the art having the benefit of the description herein. In addition, although specific embodiments or figures described herein may show features that are not expressly indicated in other figures or embodiments, it is understood that the features and components of the systems and devices disclosed herein are not necessarily mutually exclusive of each other and may be included in various different combinations or configurations without departing from the scope and spirit of the invention.

[0049] As used herein, relational terms such as "first" and "second", "top" and "bottom", etc., may be used solely to distinguish one entity or element from another entity or element, without necessarily requiring or implying any physical or logical relationship or order between such entities or elements. The terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the concepts described herein. The singular forms "a", "an", and "the" used herein are also intended to include the plural forms, unless the context clearly indicates otherwise. It will be further understood that when used herein, the terms "comprises", "comprising", "includes", and / or "including" specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0050] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by ordinary technicians in the field to which the present disclosure belongs. It will be further understood that the terms used herein should be interpreted as having the meaning consistent with their meaning in the context of this specification and the relevant technology, and unless explicitly stated herein, will not be interpreted as idealized or overly formal meanings.

[0051] In the embodiments described herein, "in communication with" and other connection terms may be used to indicate electrical or data communication, which may be accomplished by, for example, physical contact, induction, electromagnetic radiation, radio signaling, infrared signaling, or optical signaling. Those skilled in the art will appreciate that the various components may interoperate, and modifications and variations may be possible to achieve electrical and data communication.

[0052] The parasympathetic nervous system (PNPS) is a branch of the autonomic nervous system that involves parasympathetic control of the lungs. The activation of PNPS causes postganglionic parasympathetic nerve fibers to release acetylcholine, which causes contraction of the smooth muscles around the bronchus, thereby reducing airflow. Using cryoablation to denervate the bronchial tubes in the lungs may be a safe and effective way to treat COPD and asthma. Many other larger nerves (e.g., between 100 and 250 μm) are located within 5 mm of the inner surface of the bronchus. As discussed herein, cryoablation of target nerve tissue in or along the bronchial wall radially outward from the tissue position can reduce airway resistance through the bronchus. Using cryoablation can minimize structural tissue damage in the bronchial wall of the airway, while denervating (multiple) parasympathetic nerves around the bronchus and reducing the activity (and contraction) of smooth muscle.

[0053] Reference now Figure 1 , an exemplary medical system 10 for bronchial denervation is shown. New research indicates that denervation in the lungs using cryoablation is a safe and effective way to treat conditions such as COPD and asthma, and can therefore be used to potentially reduce the risk of developing other conditions such as heart disease and lung cancer. In one embodiment, the medical system 10 generally includes a medical device (such as a cryoablation device 12) having one or more treatment elements 14 and a control unit 16 that communicates with the cryoablation device 12. In one embodiment, the medical system 10 also includes an electromyography system 10 that communicates with the cryoablation device 12 and the control unit 16. Although the cryoablation device 12 is described herein as operating to reduce the temperature of the target tissue in order to ablate the nerves in the lungs, it will be understood that the cryoablation device 12 can also be used with one or more additional modalities, such as radiofrequency (RF) ablation, pulsed field ablation, ultrasound ablation, microwave ablation, etc. In addition, the cryoablation device 12 can be used for treatment, denervation, or neuromodulation of other locations in the patient's body (such as the heart).

[0054] The one or more treatment elements 14 are configured to deliver cryotherapy, and may be further configured to deliver radiofrequency energy, pulsed field ablation energy, etc., for energy transfer to a region of target tissue (such as lung tissue). In particular, the treatment element(s) 14 are configured to reduce the temperature of adjacent tissue to facilitate cryotherapy and / or cryoablation, and thereby perform denervation. For example, the treatment element(s) 14 may include one or more balloons 20 (such as Figure 1), a coolant may be circulated within the one or more balloons 20 to reduce the temperature of the balloons 20. Additionally, the treatment element(s) 14 may include other thermally and / or electrically conductive components, such as one or more electrodes (not shown) that communicate with the control unit 16.

[0055] exist Figure 1 and Figure 2 In the embodiment shown in , the cryoablation device 12 includes a handle 22 and an elongated body 24 coupled to the handle 22. The elongated body 24 is sized and configured to be passable through a patient's vasculature and / or positionable near a tissue region for diagnosis or treatment, such as a catheter, sheath, or intravascular introducer. The elongated body 24 defines a longitudinal axis 26, a proximal portion 28, and a distal portion 30, and may further include one or more lumens disposed within the elongated body 24 that provide mechanical, electrical, and / or fluid communication between the proximal portion 28 of the elongated body 24 and the distal portion 30 of the elongated body 24. Further, the treatment element(s) 14 (such as Figure 1 and Figure 2 ) is coupled to the elongated body distal portion 30. In one embodiment, the cryoablation device 12 further includes a shaft 32 that is longitudinally movable within the lumen of the elongated body 24 such that the shaft 32 can be advanced or retracted within the elongated body 24, and such movement of the shaft 32 can affect the shape and configuration of the healing element(s) 14. For example, the cryoablation device 12 can include one healing element 14, and the shaft 32 can be fully advanced when the healing element 14 is deflated and in a delivery (or first) configuration in which the healing element 14 has a minimum diameter suitable, for example, for retracting the cryoablation device 12 into a sheath for delivery to and removal from a target tissue site. Conversely, when the healing element 14 is inflated or expanded and in a healing (or second) configuration, the shaft 32 can be advanced or retracted a distance that affects the size and configuration of the inflated or expanded healing element 14. Further, the shaft 32 may include a guidewire lumen through which a sensing device, mapping device, guidewire 34, or other system component may be positioned and extend from the distal end of the cryoablation device 12 (e.g., from the distal portion 36 of the shaft 32). When expanded, the (multiple) treatment element 14 is sized and configured to fit within the target bronchus. For example, the expanded (multiple) treatment element 14 may have a maximum outer diameter of about 5 mm to about 40 mm (± 2 mm).

[0056] In one embodiment, the healing element 14 includes two balloons: an inner (or first) balloon 20A and an outer (or second) balloon 20B. However, it will be appreciated that the healing element 14 may include any number of balloons. Figure 2, the proximal portion of the healing element 14 is coupled to the distal portion 30 of the elongated body 24, and the distal portion of the healing element 14 is coupled to the proximal portion 36 of the shaft 32. The cryoablation device 12 also includes one or more nozzles, holes, or other fluid delivery elements 38 for delivering a fluid (e.g., a coolant) to the inner chamber 40 of the healing element 14. For example, the fluid may be delivered to the inner chamber 40 of the inner balloon 20A and / or the inner chamber of the outer balloon 20B (i.e., to the interstitial space 42 between the inner balloon 20A and the outer balloon 20B). For simplicity, the coolant is referred to herein as being delivered to the inner chamber 40 of the healing element 14. During operation, coolant may flow from the coolant supply reservoir 44 through coolant delivery tubing within the elongated body 24 of the cryoablation device 12 to the distal portion 30, where the coolant may then enter the inner chamber 40 of the healing element 14, such as through one or more fluid delivery elements 38, where the coolant may expand to cool the balloon(s) 20. The expanded coolant may then enter the coolant recovery reservoir 46 and / or collection system from the inner chamber 40 of the healing element 14 through coolant recovery tubing.

[0057] Reference now Figure 3 and Figure 4 , shows an exemplary embodiment of a cryoablation device 12 having at least one fluid delivery element 38. In one embodiment, Figure 1 and Figure 2 The medical device 12 is generally shown and described in FIG. 1 , and each fluid delivery element 38 includes a fluid delivery conduit that surrounds or wraps around the shaft 32 at least one turn. In one non-limiting example, as Figure 3As shown in , the cryoablation device 12 includes a fluid delivery element 38 that includes a plurality of holes 39 radially arranged around the fluid delivery element 38 in a winding portion (and in some embodiments, radially arranged around the axis 32). In one non-limiting example, the fluid delivery element 38 includes twenty-four or more holes 39, each hole 39 having a diameter between about 0.0005 inches and about 0.0015 inches, and the fluid delivery conduit has a diameter between about 0.005 inches and about 0.025 inches. Further, when the healing element 14 is expanded, the holes 39 are positioned within a central swath or equatorial portion 41 of the healing element 14. In one embodiment, the equatorial portion 41 corresponds to the portion of the balloon(s) 20 at which the balloon(s) 20 has a maximum outer diameter when the balloon(s) 20 is inflated (such as when the balloon(s) 20 is fully inflated). In one way of stating it, the equatorial portion 41 extends around the balloon(s) 20 of the treatment element 14, and the fluid delivery element(s) 38 are positioned within the treatment element 14 at a location aligned with the equatorial portion 41. In other words, the equatorial portion 41 is located in a cross-sectional plane of the treatment element 14 that includes a portion of the treatment element 14 having a largest outer diameter, and the fluid delivery element(s) 38 are positioned within the equatorial portion 41. Further, if the device includes two balloons 20, then in one embodiment, the equatorial portion 41 of the first balloon 20A and the equatorial portion 41 of the second balloon 20B are in an overlapping position, such that the treatment element 14 as a whole defines the equatorial portion 41. In another non-limiting example, as Figure 4 As shown in , the cryoablation device 12 includes a first fluid delivery element 38A and a second fluid delivery element 38B, wherein each of the first fluid delivery elements includes a plurality of holes 39 radially arranged around the fluid delivery element (and in some embodiments, around the axis 32) in a winding portion. In one non-limiting example, each of the fluid delivery elements 38A, 38B includes twenty-four or more holes 39, each hole 39 having a diameter between about 0.0005 inches and about 0.0015 inches, and the fluid delivery conduit has a diameter between about 0.005 inches and about 0.025 inches. Figure 2-Figure 4 The embodiment shown in contrast to currently known devices, such as those used in atrial fibrillation treatment procedures, which typically include a fluid delivery element having eight holes, each of which has a diameter of 0.0025 inches. It will be appreciated that more than twenty-four holes 39 may be used. Thus, in some embodiments, the device of the present disclosure includes at least one fluid delivery element 38 having more holes 39 than currently known devices, and wherein each hole 39 has a smaller diameter than currently known devices.

[0058] Continue to refer Figure 3 and Figure 4 When the treatment element 14 is expanded, the apertures 39 of both fluid delivery elements 38A, 38B are positioned within the central swath or equatorial portion 41 of the treatment element 14, as described above with respect to Figure 3 In other words, the aperture 39 is coaxially aligned or longitudinally aligned with the equatorial portion 41. In one embodiment, the equatorial portion 41 includes a portion of the balloon(s) 20 having the largest outer diameter. Thus, during use, coolant may be delivered to a portion of the balloon(s) 20 that is in contact with or most likely to be in contact with the target tissue (and in some embodiments, coolant is delivered only to that portion of the balloon(s) 20). Figure 2-Figure 4 The configuration shown in FIG. 4 allows coolant to be directed to the region (i.e., the equatorial portion 41) of the balloon (s) 20 that is most likely to create circumferential lesions in the bronchial tissue to achieve bronchial denervation. Further, because each hole 39 has a relatively small diameter, the increased number of holes 39 and the placement of the holes 39 in the equatorial portion 41 preserve the effective cooling of the coolant flow and the total amount of coolant flow.

[0059] Reference now Figures 5A-7B , a further exemplary embodiment of a fluid delivery element is shown. Figures 5A-7B In the embodiment shown in FIG. 1 , the fluid delivery element 38 is a plurality of holes 39 in the shaft 32 (i.e., extending from the outer surface through the wall of the shaft 32 to a cavity in the shaft 32), rather than including a fluid delivery conduit around the shaft, such as Figure 3 and Figure 4 However, it will be understood that Figure 2-Figure 4 The hole 39 of the fluid delivery conduit 38 shown in FIG. Figures 5A-7B For example, in one embodiment, the holes 39 are arranged radially around the entire circumference of the fluid delivery element 38 (such as, Figure 5A and Figure 5B In the configuration shown in FIG); in one embodiment, the holes 39 are radially arranged around a portion of the circumference of the fluid delivery element 38 (such as, Fig. 6A and Figure 6B and in one embodiment, the holes 39 are arranged helically around at least a portion of the circumference of the fluid delivery element 38 (such as, for example, in Fig. 7A and Figure 7B Similarly, Figures 5A-7B The fluid delivery conduit 38 shown in FIG. 3 may include the fluid delivery conduit 38 described above with respect to Figure 2-Figure 4 The number of holes 39 discussed and / or placement within the equatorial portion 41 of the balloon(s) 20.

[0060] exist Figure 5A and Figure 5B In the embodiment shown in FIG. 1 , the fluid delivery element 38 is a plurality of holes 39 within the shaft 32, and the plurality of holes 39 are arranged so that the holes 39 circumscribe the shaft 32 at at least one location. In one embodiment, the plurality of holes 39 are positioned within a distal portion of the shaft 32 within the balloon 20 at least partially. This configuration creates a circular fluid delivery pattern on the inner surface of the balloon 20 (in one embodiment, on the inner surface of the inner balloon 20A) to create circular lesions in the bronchial tissue, such as Fig.14 As shown in Fig. 6A and Figure 6B In the embodiment shown in FIG. 1 , the fluid delivery element 38 is a plurality of holes 39 in the shaft 32, and the plurality of holes 39 are arranged so that the holes 39 partially encircle the shaft 32 at at least one location. In one embodiment, the holes 39 extend around approximately half of the circumference of the shaft 32 and produce a hemispherical fluid delivery pattern on the inner surface of the balloon 20 (in some embodiments, on the inner surface of the inner balloon 20A) to create a semicircular lesion in the bronchial tissue, such as Fig.15 As shown in Fig. 7A and Figure 7B In the embodiment shown in FIG. 1 , the fluid delivery element 38 is a plurality of holes 39 in the shaft 32, and the plurality of holes 39 are arranged such that the holes 39 extend at least one turn around the shaft 32 in a spiral arrangement at at least one location on the shaft 32. This configuration produces a spiral fluid delivery pattern on the inner surface of the balloon 20 (in one embodiment, on the inner surface of the inner balloon 20A) to create spiral lesions in the bronchial tissue, such as Fig.17 Although Figures 5A-7B The embodiments of the present invention each include a plurality of holes 39 in the shaft 32 (i.e., extending through the shaft wall), but it will be understood that the fluid delivery element 38 may have other shapes or configurations, such as separate fluid delivery elements 38 wrapped around the shaft 32, such as Figure 1 as shown in , to produce the same fluid delivery mode discussed herein.

[0061] In another embodiment, if Figure 8 and Fig. 9As shown in , the healing element 14 includes a plurality of splines 48 and a single balloon 20, the plurality of splines 48 being arranged about the elongated body longitudinal axis 26, and the single balloon 20 having a plurality of lobes 50 radially arranged about the elongated body longitudinal axis 26 between the splines 48. The splines 48 may be constructed of a material having a lower thermal conductivity than the balloon 20. In one embodiment, the lobes 50 are elongated and extend parallel to the elongated body longitudinal axis 26. Alternatively, the healing element 14 may include a plurality of individual balloons 20 radially arranged about the elongated body longitudinal axis 26 and between the splines 48, each of the plurality of balloons 20 forming a lobe 50. Alternatively, the healing element 14 may include a single balloon 20 that is not manufactured or configured with lobes, but that extends from the elongated body 24 in the region between the splines 48 when the single balloon 20 is inflated to create a plurality of lobe regions 50 of the healing element 14. In one embodiment, the lobes 50 and splines 48 extend parallel to the elongated body longitudinal axis 26. Figure 2 The balloons shown in Figure 8 and Fig. 9 Both the distal portion(s) and the proximal portion(s) of the balloon(s) 20 (and splines 48) of the embodiment of are coupled to the distal portion 30 of the elongated body 24 and are not coupled to the shaft 32. However, it will be understood that Figure 8 and Fig. 9 The cryoballoon device 12 shown in FIG. 4 may include a shaft 32, at least a portion of which is coupled to the balloon(s) 20 and / or the splines 48. During use, a coolant circulates within the balloon(s) 20 to cool the balloon(s) to a temperature sufficient to cryoablate and thereby denervate adjacent target tissue.

[0062] In another embodiment, if Figure 10-12 As shown in FIG. 1 , the treatment element 14 includes a flexible segment 52 that is convertible between the following configurations: a delivery (or first) configuration in which the flexible segment 52 is in a linear or at least substantially linear configuration; and an expanded (or second) configuration in which the flexible segment 52 is in a spiral (e.g., as shown in FIG. 1 ). Fig.10 ), curves or other configurations. The flexible segment 52 is constructed of a thermally conductive material and includes one or more lumens or expansion chambers (referred to as inner chambers 40) therein, thereby allowing a coolant to circulate within the flexible segment 52 to cool the flexible segment 52 to a temperature sufficient to cryoablate and thereby denervate adjacent target tissue. Fig.10 In the embodiment shown in the figure, the flexible segment 52 is formed of a shape memory material or a material that is biased toward an expanded structure (or includes a forming element therein, the shape of which controls the shape of the flexible segment 52), thereby allowing the flexible segment 52 to transform from a delivery structure to an expanded structure when extending out of the slender body 24 and / or the delivery sheath.

[0063] Fig.11 and Fig.12 The cryoablation device 12 shown in FIG. 1 includes a shaft 53 slidably disposed within the elongated body 24, or a shaft 53 coupled to the outside of the elongated body 24 and slidably movable relative to the elongated body 24 (e.g., Fig.11 and Fig.12 ). In one embodiment, the shaft 53 is movably coupled to the elongated body 24 using one or more coupling elements 54 (such as, a ring, annular guide, etc.). Further, the flexible segment 52 includes a distal portion 55 fixedly coupled to both the shaft 53 and the elongated body distal portion 30. Retraction of the shaft 53 within or relative to the elongated body 24 allows the flexible segment 52 to transition between the delivery configuration and the expanded configuration.

[0064] exist Fig.10 or Fig.11 and Fig.12 In any of the embodiments of the present invention, the flexible segment 52 has the size and shape of the bronchus to be treated. Further, the flexible segment 52 can have a helical shape with any number of windings when in the expanded configuration. In one embodiment, the flexible segment 52 includes one winding. In another embodiment, the flexible segment 52 includes multiple windings. However, it will be understood that the cryoablation device 12 may include a treatment element 14 having any suitable size, number, shape, or configuration for ablating tissue from within a bronchus of a lung.

[0065] In any embodiment, the cryoablation device 12 may optionally include at least two recording electrodes 56 capable of stimulating tissue, sensing and / or recording action potential signals from within the smooth muscle tissue of the bronchus. The recording electrode(s) 56 communicate with and transmit signals to the electromyography system 18, which interprets those signals and transmits them to the user, as will be discussed in greater detail below. In one embodiment, the cryoablation device 12 includes a first recording electrode 56A positioned distal to the treatment element 14, and a second recording electrode 56B positioned proximal to the treatment element 14 (e.g., Figure 2 , Figure 8 , Figure 10-12 Each recording electrode 56 records a smooth muscle action potential, and the combined electromyographic signal represents the potential (voltage) difference between the action potentials recorded by the electrodes. In one embodiment, a first recording electrode 56A is coupled to the distal portion 55 of the flexible segment 52, and a second recording electrode 56B is coupled to the distal portion 30 of the elongated body (e.g., as shown in FIG. Fig.10 In another embodiment, the first recording electrode 56A is coupled to the distal portion of the shaft 53, and the second recording electrode 56B is coupled to the shaft 53 at a location proximal to the first recording electrode 56A (e.g., as shown in Fig.11 and Fig.12 However, it will be appreciated that recording electrode 56 may be at any suitable location on cryoablation device 12.

[0066] Reference again Figure 1 , the electromyography system 18 includes one or more controllers, processors and / or software modules that contain instructions or algorithms to provide automatic operation and execution of the features, sequences or procedures described herein. For example, in one embodiment, the electromyography system 18 includes a processing circuit system 57 having a memory and a processor. The memory is in electrical communication with the processor and includes instructions that, when executed by the processor, configure the processor to receive, process or otherwise use signals from the cryoablation device 12 and / or other system components. Further, the electromyography system 18 may include one or more user input devices, controllers, speakers and / or displays 58 for collecting information from a user and transmitting information to a user. Additionally or alternatively, the electromyography system 18 may communicate with the control unit 16, thereby allowing information to be received and / or communicated from the electromyography system 18 and reach the user through the control unit 16.

[0067] In one non-limiting example, the processing circuit system 57 of the electromyograph system 18 is configured to receive data (e.g., action potential signals) from the recording electrode 56 of the cryoablation device 12 and convert the data into information that can be communicated to the user, such as a visual display, an audio signal, etc. Further, the processing circuit system 57 of the electromyograph system 18 can be configured to compare the data received from the recording electrode 56 with one or more reference values ​​or ranges and generate an alarm based on the comparison. For example, the processing circuit system of the electromyograph system 18 can compare the electrogram signal voltage and / or the amplitude of the electromyogram signal over time (AOT) received from the recording electrode with a threshold or reference electrogram signal voltage and / or electromyogram signal AOT indicating that denervation has occurred. If the received electromyogram signal voltage and / or AOT is within the threshold range of the reference electromyogram signal voltage and / or AOT, the processing circuit system can then generate an alarm (such as a visual display or an audio tone) indicating that denervation has occurred and send the alarm to the user, and the user can stop the cryoablation procedure. Additionally, the processing circuit system 57 of the EMG system 18 can be configured to calculate the time for denervation based on the difference between the received EMG signal voltage and / or AOT and the reference EMG signal voltage and / or AOT, so that the user can understand how long the cryoablation procedure should continue.

[0068] As used herein, the term "control unit" may include, for simplicity, any system component that is not part of the cryoablation device 12 itself, other than a component of the electromyography system 18, whether or not the component is physically located within or external to the control unit 16. Further, the electromyography system 18 may be a separate system that communicates with the control unit 16 or may be included within or integrated with the control unit 16, although the electromyography system 18 may be a separate system that communicates with the control unit 16. Figure 1 12 is shown as being physically separated from the control unit 16. In one embodiment, the control unit 16 includes a coolant supply reservoir 44, a coolant recovery reservoir 46, or a discharge or collection system for recovering or discharging the expanded fluid for reuse or disposal, and various control mechanisms. In addition to providing a discharge function for the coolant supply, the control unit 16 may also include pumps, valves, controllers, etc. for recovering and / or recirculating fluid delivered to the elongated body 24 and / or the fluid pathways of the system. Further, the control unit 16 may include a vacuum pump 60 for creating a low pressure environment in one or more conduits within the cryoablation device 12, thereby causing the coolant to be drawn into the (multiple) conduits / (multiple) cavities of the elongated body 24, away from the distal portion 30 of the elongated body 24 and toward the proximal portion 28 of the elongated body 24.

[0069] In one embodiment, the control unit 16 includes one or more controllers, processors and / or software modules that contain instructions or algorithms to provide automatic operation and execution of the features, sequences or programs described herein. In one embodiment, for example, the control unit 16 includes a processing circuit system 62 that is programmed or programmable to perform automatic or semi-automatic operation and execution of the features, sequences, calculations or programs described herein. For example, in one embodiment, the control unit 16 includes a processing circuit system 62 having a memory and a processor. The memory is in electrical communication with the processor and includes instructions that, when executed by the processor, configure the processor to receive, process or otherwise use signals from the cryoablation device 12 and / or other system components. Further, the control unit 16 may include one or more user input devices, controllers, speakers and / or displays 64 for collecting information from a user and transmitting information to a user.

[0070] Although not shown, the medical system 10 may include one or more sensors for monitoring operating parameters such as pressure, temperature, coolant flow rate, etc. through the medical system 10. The sensor(s) may communicate with the control unit 16 for initiating or triggering one or more alarms or coolant delivery modifications during operation of the cryoablation device 12.

[0071] Reference now Fig. 20 , and refer to Figure 13-Figure 19, an exemplary method of performing bronchial denervation using a cryoablation device 12 is shown. In a first step 101, a treatment element 14 of the cryoablation device 12 is positioned within a bronchus 66 of a patient's lung at a location near a target area of ​​tissue (e.g., such as Fig.13 In a second step 102, the healing element 14 of the cryoablation device 12 is inflated, expanded, or otherwise manipulated so that at least a portion of the healing element 14 is in contact with at least a portion of the target area of ​​tissue.

[0072] In the third step 103, the recording electrodes 56 are positioned so that they are in contact with the target area of ​​tissue and are used to record electromyographic signals (smooth muscle action potential signals) from the target area of ​​tissue. Further, the electromyographic signals may be recorded by the recording electrodes before, during, and / or after the cryoablation procedure. Thus, the third step 103 may occur at any time during the method.

[0073] In a fourth step 104, coolant is delivered from the coolant supply reservoir 44 to the healing element 14 and circulated within the healing element 14 to reduce the temperature of the healing element 14 to a temperature sufficient to cryoablate tissue in contact with the healing element 14. As mentioned above, the recording electrodes 56 may continue to record electromyographic signals from the bronchial tissue over time while the coolant is circulating within the healing element 14 (i.e., during the cryoablation procedure). Fig. 20 However, it will be understood that the third step 103 may be performed at the same time, before and / or after the fourth step 104 is performed. Figure 14-17 A non-limiting example of an ablation pattern created by the treatment element 14 within the bronchial tissue is shown in FIG. For example, in one embodiment, a device such as Figure 1 and Figure 2 In one embodiment, the embodiment shown and described in FIG. 1 has a fluid delivery element 38 (eg, Figure 5A and Figure 5B A healing element 14 such as the one shown in FIG. 1 (i.e., at least one balloon 20 without a lobe) can create a circumferential lesion 68A in bronchial tissue 66, the stylized representation of which is shown in FIG. Fig.14 As shown in; using such as Figure 1 and Figure 2 In one embodiment, the fluid delivery element 39 (eg, Fig. 6A and Figure 6B The healing element 14, such as the healing element shown in FIG. 1 , can create a partially circumferential or semicircular lesion 68B (e.g., a semicircular lesion) in the bronchial tissue 66, the stylized representation of which is shown in FIG. Fig.15As shown in; using such as Figure 8 and Fig. 9 A healing element 14 such as the one shown and described in FIG. 1 (i.e., a balloon having lobes 50 or a plurality of balloons forming lobed regions 50) can create a series of lesions 68C in bronchial tissue 66 (a stylized representation of the series of lesions 68C is shown in FIG. 1 ). Fig.16 ), or create interrupts such as Fig.14 circumferential damage such as that shown in ; and using Fig.10 A healing element 14 such as the one shown and described in Figure 1 and Figure 2 In one embodiment, the fluid delivery element 38 (eg, Fig. 7A and Figure 7B A healing element 14, such as a healing element 14 shown in FIG. 1 , can create a spiral lesion 68D in bronchial tissue 66, a stylized representation of which is shown in FIG. Fig.17 Shown in.

[0074] Here, the third step 103 may be performed again. The electromyographic signals are transmitted from the recording electrodes 56 to the electromyographic system 18. Additionally, these signals may be continuously recorded and transmitted before, during, and after the cryoablation procedure. The processing circuit system 57 of the electromyographic system 18 then uses the received electromyographic signals to make one or more comparisons and determinations (thus, the received electromyographic signals may be referred to as raw electromyographic signals). For example, in the fifth step 105, the processing circuit system 57 of the electromyographic system 18 calculates the difference between at least one electromyographic signal received from the first recording electrode 56A and at least one electromyographic signal received from the second recording electrode 56B. In one non-limiting example, the processing circuit system 57 of the electromyographic system 18 calculates the voltage difference between the received or raw electrogram signals transmitted from the recording electrodes during the cryoablation procedure and generates a recorded electromyogram 70. Thus, the recorded electromyogram 70 includes (multiple) voltage differences over time. For example, Fig.18 An electromyogram 70A recorded before denervation occurs (i.e., recorded before a cryoablation procedure and / or during a cryoablation procedure and before denervation occurs) is shown. As mentioned above, the recording electrodes 56 may record electrogram signals during and / or after the cryoablation procedure, and the processing circuit system 57 of the electromyography system 18 may continue to generate the recorded electromyogram 70.

[0075] Further, in one embodiment, the processing circuit system 57 of the electromyography system 18 is further configured to compare the recorded electromyogram 70 generated based on the electromyography signals received before the cryoablation procedure with the recorded electromyogram 70 generated based on the electromyography signals received during and / or after the cryoablation procedure, and use the comparison to determine whether denervation of the bronchial tissue 66 has occurred (such as in the sixth step 106). In a non-limiting example, if the difference (such as the voltage difference) of the recorded electromyograms exceeds a threshold difference, the processing circuit system 57 of the electromyography system 18 may determine that denervation has occurred (such as in the seventh step 107). Additionally or alternatively, the processing circuit system 57 of the electromyography system 18 is configured to compare the recorded electromyogram 70 generated based on the electromyography signals received during and / or after the cryoablation procedure with a reference electromyogram indicating that denervation has occurred. If the recorded EMG 70 is the same as the reference EMG or is within a threshold range or difference from the reference EMG, the processing circuitry 57 of the EMG system 18 may determine that denervation has occurred (such as in a seventh step 107). Fig.19 An electromyogram 70B is shown recorded after denervation has occurred, showing a decaying electromyogram voltage.

[0076] In an eighth step 108, the processing circuit system 57 of the electromyography system 18 generates an alarm when it determines that denervation has occurred. In one non-limiting example, the electromyography system 18 generates an audible and / or visual alarm that is sent to the user that denervation has occurred, and gives the user an opportunity to terminate the cryoablation procedure (e.g., terminate or reduce the circulation of the coolant within the treatment element 14). Additionally or alternatively, the electromyography system 18 generates the alarm in the form of alarm data and transmits the data to the control unit 16. The control unit 16 may then send the alarm (e.g., audible and / or visual alarm) to the user to remind the user to manually terminate the cryoablation procedure, and / or the control unit 16 may automatically terminate or reduce the circulation of the coolant within the treatment element 14 to end the cryoablation procedure.

[0077] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, according to examples, certain actions or events of any of the processes or methods described herein may be performed in different orders, and certain actions or events of any of the processes or methods described herein may be added, merged, or omitted altogether (e.g., not all described actions or events are necessary for performing the technology). In addition, although certain aspects of the present disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the technology of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0078] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a non-transient computer-readable storage medium, which corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and can be accessed by a computer).

[0079] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Accordingly, the term "processor" as used herein may refer to any of the above structures or any other physical structure suitable for implementing the described techniques. In addition, these techniques may be fully implemented in one or more circuits or logic elements.

[0080] Certain embodiments of the invention include:

[0081] Embodiment 1: A device for bronchial denervation, comprising:

[0082] an elongated body having a distal portion and a proximal portion opposite the distal portion;

[0083] a healing element located at the distal portion of the elongated body; and

[0084] A first recording electrode and a second recording electrode, the first recording electrode is located distally of the treatment element, the second recording electrode is located proximal to the treatment element, the first recording electrode and the second recording electrode are configured to record electromyogram.

[0085] Embodiment 2: The device according to embodiment 1, wherein the healing element comprises at least one balloon.

[0086] Embodiment 3: The device according to embodiment 1, wherein the healing element comprises:

[0087] a first balloon coupled to the distal portion of the elongated body;

[0088] a second balloon coupled to the distal portion of the elongated body, the first balloon being positioned within the second balloon; and

[0089] A fluid delivery element is within the first balloon.

[0090] Embodiment 4: The device according to embodiment 1, wherein the healing element comprises:

[0091] a balloon having a plurality of lobes; and

[0092] A plurality of splines extend parallel to the longitudinal axis of the elongated body, the plurality of splines alternating with the plurality of lobes.

[0093] Embodiment 5: A system for bronchial denervation, the system comprising:

[0094] a cryoablation device comprising a therapeutic element and at least one recording electrode;

[0095] an electromyography system in communication with the at least one recording electrode; and

[0096] A control unit is in fluid communication with the cryoablation device.

[0097] Embodiment 6: A system according to embodiment 5, wherein the healing element comprises at least one balloon.

[0098] Embodiment 7: The system of embodiment 5, wherein the cryoablation device further comprises a longitudinal axis, and the treatment element comprises:

[0099] a balloon having a plurality of lobes; and

[0100] A plurality of splines extend parallel to a longitudinal axis of the cryoablation device and between the plurality of leaves.

[0101] Embodiment 8: The system of Embodiment 5, wherein the healing element comprises a flexible portion transitionable between a first at least substantially linear configuration and a second expanded configuration.

[0102] Embodiment 9: The system of embodiment 8, wherein the flexible segment has a helical configuration when in the expanded second configuration.

[0103] Embodiment 10: The system of Embodiment 5, wherein the at least one recording electrode comprises a first recording electrode located distally of the healing element, and a second recording electrode located proximally of the healing element.

[0104] Embodiment 11: The system of embodiment 10, wherein the electromyography system comprises a processing circuit system configured to:

[0105] receiving an electromyographic signal from at least one recording electrode;

[0106] calculating a difference between a first electromyogram signal received from the first recording electrode and a second electromyogram signal received from the second recording electrode for use in generating a recorded electromyogram; and

[0107] The recorded EMG was compared with the reference EMG.

[0108] Embodiment 12: The system of Embodiment 11, wherein the processing circuit system is further configured to determine whether denervation has occurred in the area of ​​the target tissue near the treatment element based on a comparison between the recorded electromyogram and a reference electromyogram.

[0109] Embodiment 13: The system of Embodiment 12, wherein the processing circuitry is further configured to generate an alarm when the processing circuitry has determined that denervation has occurred in the region of the target tissue proximate the treatment element.

[0110] Embodiment 14: The system of Embodiment 5, wherein the control unit comprises a coolant source in fluid communication with the healing element.

[0111] Embodiment 15: A method for performing bronchial denervation, the method comprising:

[0112] positioning a therapeutic element of a cryoablation device within a bronchus of a patient's lung;

[0113] expanding the healing element so that at least a portion of the healing element contacts at least a portion of the bronchial tissue;

[0114] circulating a coolant within the treatment element to reduce the temperature of the treatment element to a temperature sufficient to cryoablate at least a portion of the bronchial tissue;

[0115] recording at least one electromyographic signal from at least a portion of bronchial tissue using each of the first recording electrode and the second recording electrode; and

[0116] The at least one recorded electromyographic signal is transmitted to an electromyographic system.

[0117] Embodiment 16: The method according to embodiment 15 further comprises:

[0118] calculating a difference between at least one electromyographic signal received from the first recording electrode and at least one electromyographic signal received from the second recording electrode for use in generating a recorded electromyogram;

[0119] comparing the recorded EMG to a reference EMG; and

[0120] Based on the comparison, it is determined whether denervation has occurred in at least a portion of the bronchial tissue.

[0121] Embodiment 17: The method according to embodiment 16 further comprises:

[0122] An alarm is generated when it is determined that denervation has occurred in at least a portion of the bronchial tissue.

[0123] Embodiment 18: The method according to embodiment 16 further comprises:

[0124] Circulation of the coolant within the treatment element is terminated when denervation is determined to have occurred in at least a portion of the bronchial tissue.

[0125] Embodiment 19: The method of Embodiment 15, wherein the healing element comprises at least one balloon, and expanding the healing element comprises inflating the balloon.

[0126] Embodiment 20: The method of embodiment 19, wherein at least one balloon comprises:

[0127] a balloon having a plurality of lobes; and

[0128] A plurality of splines extends between the plurality of leaves.

[0129] It will be appreciated by those skilled in the art that the present invention is not limited to the contents specifically shown and described herein above. In addition, unless otherwise mentioned above, it should be noted that all drawings are not to scale. Various modifications and variations are possible under the inspiration of the above teachings without departing from the scope and spirit of the present invention, which is limited only by the appended claims.

Claims

1. A system for bronchial denervation, the system include: Medical equipment, the medical equipment comprising: an elongated body having a distal portion, a proximal portion opposite the distal portion, and a longitudinal axis; a healing element located at the distal portion of the elongated body; and a first recording electrode and a second recording electrode, wherein the first recording electrode is located distally of the healing element and the second recording electrode is located proximal to the healing element, the first recording electrode and the second recording electrode being configured to record an electromyogram; an electromyography system in communication with the first recording electrode and the second recording electrode and comprising processing circuitry configured to: calculating a difference between a first electromyogram signal received from the first recording electrode and a second electromyogram signal received from the second recording electrode for use in generating a recorded electromyogram; and comparing the recorded electromyogram to a reference electromyogram; and A control unit is in communication with the medical device.

2. The system according to claim 1, It is characterized in that The healing element comprises at least one balloon, the healing element further comprising an equatorial portion, the healing element further comprising a fluid delivery element within the at least one balloon, the fluid delivery element having a plurality of apertures aligned with the equatorial portion of the healing element.

3. The system according to claim 2, It is characterized in that The at least one balloon includes a first balloon, and the medical device further includes a shaft having a distal portion at least partially located within the first balloon, the fluid delivery element including a plurality of holes in the distal portion of the shaft, each of the plurality of holes having a diameter between 0.0005 inches and 0.0015 inches.

4. The system according to claim 3, It is characterized in that The plurality of holes are radially arranged around the axis and are configured to direct fluid flow toward an inner surface of the first balloon.

5. The system according to claim 3, It is characterized in that The plurality of holes at least partially encloses the shaft.

6. The system according to claim 3, It is characterized in that The plurality of holes extend at least one turn around the shaft in a spiral arrangement at least at one location on the shaft.

7. The system according to any one of claims 1 to 6, It is characterized in that The medical element comprises: a balloon having a plurality of lobes; and A plurality of splines extend parallel to the longitudinal axis of the elongated body, the plurality of splines alternating with the plurality of lobes.

8. The system according to any one of claims 1 to 6, It is characterized in that The healing element includes a flexible portion transitionable between a first, at least substantially linear, configuration and a second, expanded configuration.

9. The system according to claim 8, It is characterized in that The flexible portion has a helical configuration when in the expanded second configuration.

10. The system according to claim 1, It is characterized in that The processing circuitry is further configured to determine whether denervation has occurred in a region of target tissue proximate the healing element based on a comparison between the recorded electromyogram and the reference electromyogram.

11. The system according to claim 10, It is characterized in that The processing circuitry is further configured to generate an alarm when the processing circuitry has determined that denervation has occurred in the region of target tissue proximate the healing element.

12. The system according to claim 10, It is characterized in that The region of target tissue is bronchial tissue.

13. The system according to any one of claims 1 to 6, It is characterized in that The control unit includes a coolant source in fluid communication with the healing element.

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