ELECTRODE MARKERS AND METHODS OF USE

BACKGROUND OF THE INVENTION

[0001] Asthma is a disease in which bronchoconstriction, excessive mucus production, and inflammation and swelling of airways occur. This causes widespread variable airflow obstruction which makes it difficult for an asthma sufferer to breathe. Asthma is a chronic disorder, primarily characterized by persistent airway inflammation. Asthma is further characterized by acute episodes of additional airway narrowing via contraction of hyper- responsive airway smooth muscle. |0002] Asthma is traditionally managed pharmacologically by: ( 1 ) long term control through use of antiinflammatories and long-acting bronchodilators and (2) short term management of acute exacerbations through use of short-acting bronchodilators. Both of these approaches require repeated and regular use of prescribed drugs, which often present difficulties in patient compliance. High doses of corticosteroid anti-inflammatory drugs can have serious side effects that require careful management. In addition, some patients are resistant to steroid treatment. The difficulty of avoiding stimulus that triggers asthma is also a common barrier to successful asthma management. As such, current management techniques are neither completely successful nor free from side effects. 100031 Presently, a new treatment for asthma is showing promise. This treatment comprises the application of energy to the airway tissue. This treatment is described in more detail in commonly assigned U.S. Patent Nos. 6,41 1 ,852; 6,634,363; 7,027.869; 7,104,987 and U.S. Publication No. 2005/0010270, each of which is incorporated herein by reference. |0004] The application of energy to airway tissue, when performed via insertion of a treatment device into the bronchial passageways, requires navigation

through tortuous anatomy as well as the ability to treat a variety of sizes of bronchial passageways. As discussed in the above referenced patents and applications, use of a radio frequency (RF) energy delivery device provides one mechanism for treating tissue within the bronchial passageways. [0005] Fig. 1 illustrates a bronchial tree 90. As noted herein, devices treating areas of the lungs desirably have a construction that enables navigation through the tortuous passages. As shown, the various bronchioles 92 decrease in size and have many branching segments 96 as they extend into the right and left bronchi 94. Accordingly, an efficient treatment utilizes devices that are able to treat airways of varying sizes as well as function properly when repeatedly deployed after navigating through the tortuous anatomy.

100061 In addition to considerations of navigation and site access, there exists the matter of device orientation at the treatment site. The treatment devices generally make contact or are placed in close proximity to the target tissue. However, in utilizing the treatment devices in a patient, visibility of the energy delivery element, particularly depth perception, within the lung airways may be relatively limited as viewed from an imaging lens of an access device, such as a bronchoscope or endoscope. Limited visibility combined with a variety of other factors, including airway movement due to patient breathing, coughing, and/or wheezing (tidal motion) as well as movement of the access device, may make it difficult to ensure desired axial treatment of the lung airways with the energy delivery device. [0007] For example, in procedures where a relatively long region of tissue is to be treated (e.g., longer than a length of the energy delivery element), difficulty in ascertaining the amount of tissue being treated may result in over-treatment of the same region or non-treatment of the target region. In particular, as the energy

delivery element is translated from a first region to a second region and so on, portions of the target tissue may be over-treated or skipped entirely. Additionally, such conditions may result in slower procedures that increase total procedure time and patient discomfort. [0008] In view of the above, methods and devices are desired for treating tortuous anatomy such as the bronchial passages which enable a user to effectively and efficiently treat tissue and relocate an energy delivery device along one or more portions of the tissue.

SUMMARY OF THE INVENTION |0009] In treating tissue regions, such as within the lungs, a treatment device may utilize an elongate sheath or shaft having a plurality of markers, rings, bands, or other visual indicators along an outer surface thereof so as to facilitate guidance of the device to effectively and efficiently treat the tissue according to a predetermined axial treatment. The predetermined axial treatment may be contiguous (adjacent), overlapping, intermittently spaced apart (gapping), or a combination thereof as determined by the marker spacing, and as desired. The visual indicators may also serve as a mechanism for measuring a depth of the treatment device, the tissue length, and/or treatment length, as further described below. [00101 ^{m one} aspect of the present invention, an energy delivery device such as an RF electrode basket may be advanced within a working channel of an access device, such as a bronchoscope or endoscope, until a final proximal marker, e.g., a fourth mark, is extended outside the access device, such that the electrode basket, or at least a proximal insulation thereof, and the markers are visible via an imaging lens in the access device. The electrode basket may be deployed into contact against the tissue to be treated and then activated. The treatment device may then be pulled

proximally until the next adjacent mark, e.g., a third mark, is reached. This process of activation and pulling proximally may be repeated until a last mark is reached providing for a contiguous and/or continuous axial treatment length of the tissue. (00111 In another aspect of the present invention, the treatment device which may be used in a body conduit, cavity, passageway, or lumen, such as a lung airway, may generally comprise an elongate body, an energy delivery element, and one or more visual indicators. The elongate body comprises a proximal portion with a proximal end and a distal portion with a distal end. The energy delivery element may be disposed at the distal end of the elongate body. The one or more visual indicators may be disposed on the distal portion of the elongate body. Significantly, the visual indicators are separated by a predetermined spacing distance so as to provide the desired predetermined axial treatment in the body conduit or cavity. [0012] In yet another aspect of the prevent invention, the treatment device may comprise a radio frequency energy delivery device for use in a lung airway so as to treat asthma. The device comprises an elongate body having a proximal portion with a proximal end and a distal portion with a distal end. A RF electrode is disposed at the distal end of the elongate body. A plurality of visual indicators are disposed on the distal portion of the elongate body, wherein the visual indicators are separated by a predetermined spacing distance so as to provide a predetermined axial treatment in a lung airway so as to treat asthma.

[0013] In a further aspect of the present invention, one method for using the treatment device to deliver energy may generally comprise positioning the access device having a visualization element within a lung airway so as to access airways that are typically 3 mm (or smaller) to 10 mm (or larger) in diameter, as can be properly viewed with direct real-time visualization. The access device may then be

stabilized or anchored. The energy delivery device is advanced within the access device so that at least one visual indicator disposed on a distal portion of the energy delivery device and proximal an energy element delivery element disposed on a distal end of the energy delivery device is positioned outside the access device as verified with the visualization element. The visual indicators in turn will provide the desired predetermined axial treatment in the lung airway with the energy delivery clement relative to the access device.

[0014] A further understanding of the nature and advantages of the present invention will become apparent by reference to the remaining portions of the specification and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

|0015] The following drawings should be read with reference to the detailed description. Like numbers in different drawings refer to like elements. The drawings. which are not necessarily to scale, illustratively depict embodiments of the present invention and are not intended to limit the scope of the invention.

[0016] Fig. 1 is an illustration of the airways within a human lung.

[0017J Fig. 2 illustrates a schematic view of a treatment system for delivering energy to tissue utilizing an expandable electrode basket.

[0018] Fig. 3A illustrates a side view of the treatment device of Fig. 2 extending distally from a bronchoscope, wherein the device has an active distal end for treating tissue using energy delivery.

[0019] Fig. 3B illustrates a variation of a treatment device comprising an expandable body, such as a balloon, having one or more electrodes disposed along its surface.

[0020] Fig. 4 illustrates an exemplary schematic view of an expandable electrode basket projecting distally from an elongate sheath having one or more markers delineated along its length and a representative image on a monitor corresponding to an image as viewed from the bronchoscope, wherein the spacing distance between each adjacent marker corresponds to a length of the electrodes located on the treatment device.

[0021] Fig. 5 illustrates the energy delivery device of Fig. 4 advanced into a bronchial airway and positioned for treatment upon the tissue. [0022] Figs. 6A and 6B illustrates the treatment device advanced distally within an airway lumen for treating the tissue and the corresponding image from a bronchoscope on a monitor showing the markers along the sheath. [0023] Figs. 7 A and 7B illustrate the treatment device pulled proximally along the tissue by a length corresponding to a length between markers along the sheath such that the treatment device is aligned to an adjacent region of tissue to be treated. [0024] Figs. 8A and 8B illustrate the treatment device pulled further proximally along the tissue by a length corresponding to a length between markers along the sheath such that the treatment device is aligned to another adjacent region of tissue to be treated. 100251 Fig. 9A illustrates a variation of the sheath utilizing dashed markers. [0026] Fig. 9B illustrates another variation of the sheath utilizing non-uniform markers.

|0027| Fig. 9C illustrates another variation of the sheath utilizing markers which have a length between adjacent markers which is less than a length of the electrodes on the treatment device such that overlapping regions of tissue may be treated.

[0028] Fig. 9D illustrates yet another variation of the sheath utilizing markers having graduated measurements therealong to provide a visual indication of tissue or treatment length and/or electrode basket depth.

[0029] Fig. 9E illustrates yet another variation of the sheath utilizing markers having alternative colors, such as a green marker to indicate treatment device deployment or a red marker to indicate a maximum length of sheath extension. [0030] Fig. 9F illustrates still another variation of the sheath utilizing markers which have a length between adjacent markers which is greater than a length of the electrodes on the treatment device such that intermittent regions of tissue may be treated.

DETAILED DESCRIPTION OF THE INVENTION

[0031] It will be appreciated that the examples below discuss uses in the airways of the lungs. However, unless specifically noted, the devices and methods described herein are not limited to use in the bronchial passageways. Instead, such devices and methods may have applicability in various parts of the body, such as the upper respiratory tract, trachea, esophagus, urethra, ureter, digestive tract, cardiovascular system, circulatory system, arthroscopic, brain, liver, etc. Moreover, the present invention may be used in various procedures where the benefits of the device are desired. [0032] Generally, in treating tissue regions within the lungs, the treatment device may utilize an elongate body, such as tubular sheath, shaft, or catheter, having a plurality of markers, rings, bands, or other visual indicators (e.g., circular or otherwise) along an outer surface thereof. The plurality of visual indicators facilitate guidance of the device to effectively and efficiently treat the tissue according to a predetermined axial treatment. The predetermined axial treatment may be contiguous,

overlapping, or intermittently spaced apart treatment of the lung airway walls with the energy delivery element(s). The plurality of visual indicators may also serve as a mechanism to measure a depth of the device, tissue length, airway segment length, and/or treatment length. [0033] In one example of operation, the treatment device, such as an RF electrode basket assembly, may be advanced within a working channel of an access device, such as a bronchoscope, until a final proximal marker is extended distal Iy from the access device while under direct real-time visualization. With the treatment device and the markers visible through the access device, the electrode basket assembly may be deployed against the tissue to be treated and activated. The treatment device may then be pulled proximally relative to the access device until the next adjacent marker is reached. The treatment device may then be activated to treat the portion of tissue adjacent to the previously treated portion without overlap (i.e., over-treatment of the same region) or separation (i.e., non-treatment of target tissue) between the adjacent portions of treated tissue. This process of activation and pulling proximally may be repeated until the last mark is reached providing for a continuous axial treatment where the target tissue regions are neither over-treated nor skipped. [0034] Referring now to Fig. 2, a schematic diagram of one example of a treatment system 10 for delivering therapeutic energy to tissue of a patient is illustrated. The system 10 comprises a power supply having an energy generator 12, a controller 14 coupled to the energy generator 12, and a user interface surface 16 in communication with the controller 14. The system 10 further includes an energy delivery device 20, a return electrode 40 (if the system 10 employs a mono-polar RF configuration), and foot actuation pedal(s) 42. It will be appreciated that the above depictions are for illustrative purposes only and do not necessarily reflect the actual

shape, size, or dimensions of the system 10 or device 20. This applies to all depictions hereinafter.

[0035] The system 10 depicted in Fig. 2 shows the user interface portion 16 having one or more connections 36, 44, 46 for the device 20, the return electrode 40 (optional), and the actuation pedal(s) 42 (optional) respectively. The user interface 16 may also include visual prompts 48, 50, 52, 54 for user feedback regarding setup or operation of the system 10. The user interface 16 may also employ graphical representations of components of the system 10, audio tone generators, as well as other features to assist the user with system operation. [0036] The controller 14 may be configured to deliver RF energy in either a mono-polar or bi-polar configuration. In many variations of the system 10, the controller 14 may include a processor 38 that is generally configured to accept information from the system and system components, and process the information according to various algorithms to produce control signals for controlling the energy generator 12. The processor 38 may also accept information from the system 10 and system components, process the information according to various algorithms and produce information signals that may be directed to the visual indicators, digital display or audio tone generator of the user interface in order to inform the user of the system status, component status, procedure status or any other useful information that is being monitored by the system. The processor 38 of the controller 14 may be a digital IC processor, analog processor, or any other suitable logic or control system that carries out the control algorithms.

[0037] Detailed descriptions on the processor 38, user interface 16, and safety algorithms that are useful for the treatment of asthma as discussed above may be found in commonly assigned U.S. Patent Application No. 1 1/408,688, filed April 21.

2006. entitled CONTROL METHODS AND DEVICES FOR ENERGY DELIVERY, which is incorporated herein by reference.

|0038| It is understood that the device 20 of the present invention may be used with a variety of systems 10, having the same or different components as described in Fig. 2. For example, although the device 20 is described with reference to RF energy delivery systems 10, variations of the device and system may include light energy sources, laser systems, resistive heating systems, infrared heating elements, microwave energy systems, focused ultrasound, cryo-ablation, radiation, electrical stimulation, or any other energy delivery system or configuration. [00391 The energy delivery device 20 may include a flexible tubular sheath

22. an elongate shaft 24 (in this example, the shaft 24 extends out from the distal end of the sheath 22), and a handle or other optional operator interface 26 secured to a proximal end of the sheath 22. The distal portion of the device 20 includes an energy transfer element 28 for applying energy to the tissue of interest. The energy transfer element 28. such as an expandable electrode basket, may be advanced into and through the patient body in an atraumatic low profile configuration. Upon reaching the designed tissue region to be treated, the energy transfer element 28 may be expanded or reconfigured into a treatment configuration which facilitates contact of the element 28 against the tissue to be treated. In one example, the energy transfer element 28 may be reconfigured via a pull wire 21 routed proximally through elongate shaft 24 and/or flexible sheath 22 and affixed to a handle 26 and actuated with a slide mechanism 34.

[0040] Additionally, the device 20 may includes a connector 30 common to such energy delivery devices. The connector 30 may be integral to the end of a cable 32 coupled to the handle 26 or the connector 30 may be fitted to receive a separate

cable 32. In any case, the device 20 is configured for attachment to the power supply via some type of connector or adaptor plug 30. The elongate shaft 24 and/or flexible sheath 22 may also be configured and sized to permit passage through a working channel of a commercially available bronchoscope or endoscope. However, the device 20 may also be advanced into a body conduit or cavity with or without a steerable catheter, in a minimally invasive procedure, in an open surgical procedure, or with or without the guidance of various vision or imaging systems. |0041 J The devices 20 of the present invention will have a sufficient length and/or diameter and/or flexibility to access the tissue targeted for treatment. For example, treating airways as small as 3 mm in diameter may utilize the flexible sheath 22 and/or elongate shaft 24 which is sufficiently long and sized in diameter to reach deep into the lungs to treat the airways. Generally the device shaft 24 and/or sheath 22 will have a length in range from about 0.5 feet to about 8.0 feet and an expanded basket diameter 28 in a range from about 1 mm to about 25 mm, more preferably from about 3 mm to about 10 mm. However, it is noted that this example is merely illustrative and is not limiting in dimension or flexibility.

10042] Referring now to Fig. 3 A, an example of an energy transfer device 28 is illustrated as an expandable electrode basket. The device 28 has one or more legs 60 configured in the form of a basket 62 converging to an atraumatic common distal tip 68. The basket 62 may reconfigure from an atraumatic low profile shape to an expanded or deployed configuration to facilitate contact against the tissue walls of a body conduit, cavity, passageway, or lumen, such as a lung airway wall. Examples of such devices are described in greater detail in commonly assigned U.S. Publication No. 2003/0233099, which is incorporated herein by reference.

[0043| The one or more legs 60 may be configured into the basket shape 62 such that the legs 60 may expand radially during operation to a working diameter as described above that will achieve contact between the legs 60 having active electrode regions 64 and the airway walls. The legs 60 may also include temperature sensors for tissue temperature feedback to the controller 14. In this configuration, four legs 60 are shown, however any number of legs 60 may be utilized to form the basket 62 (e.g.. 2. 3. 4. 5. 6, 7, 8. 9. 10. etc.).

[0044| As illustrated in Fig. 3A, a pull wire 66 may extend through a lumen of the elongate shaft body 24, to which the basket 62 may be directly mounted. Pull wire 66 may be utilized to deliver energy to the active electrodes 64 and/or assist basket 62 in expanding into its deployed treatment configuration. The treatment device 62 may optionally be delivered to a treatment site directly through the elongate delivery sheath or sleeve body 22. In still other embodiments, pull wire 66 may be omitted entirely in which case basket 62 may be expanded or deployed by utilizing one or more legs 60 which arc fabricated as elastic, super-elastic, or shape memory alloys (e.g., nickel-titanium alloys) which may self-expand from a compressed configuration when removed from the elongate sheath 22. In summary, basket 62 may expand upon activation by the user or it may automatically expand when advanced out of a restraining sheath 22 or when the sheath 22 is withdrawn proximally from the basket 62.

|0045| The energy transfer device 28 is shown in association with a bronchoscope access device 70. The elongate shaft 24 and flexible sheath 22 are received within a working channel 72 of the bronchoscope 70. Accordingly, the energy transfer device 28 may be utilized along with an imaging lumen 76 and/or light optical fibers 74 of the bronchoscope 70. The imaging lumen 76 may utilize

visualization elements, such as CCD imaging or a camera lens. The bronchoscope 70 may additionally comprise an aspiration lumen (not shown). [0046] Referring now to Fig. 3B. an alternative configuration of the energy transfer device 80 is illustrated. The active member 80 is configured as a body 82 having a set diameter and length. One or more electrodes 84 are shown secured to the body 82 through holes 86 or adhesives or other attachment mechanisms. The electrodes 84 may be oriented axially relative to the body 82 to optimize contact along the tissue walls during treatment. The diameter of active member 80 is set to correspond to that desired for treating a given body lumen or passageway, such as lung airway. Accordingly, body 82 may be configured as an inflatable balloon member, an expandable scaffold member, and the like, where the electrodes 84 will move outward upon body 82 expansion.

[0047| Energy delivery devices 28, 80 of wire frames and/or basket configurations will generally have its members (e.g., electrodes) symmetrically deployed. This shape may be round, rounded, or polygonal in cross section. These and other configurations, including asymmetrical active member configurations, are described in detail in U.S. Patent Application Nos. 1 1/255,796, filed October 21 , 2005. entitled IMPROVED ENERGY DELIVERY DEVICES AND METHODS and 1 1/420,438, filed May 25, 2006, entitled MEDICAL DEVICE WITH PROCEDURE IMPROVEMENT FEATURES, each of which is incorporated herein by reference. |0048| Referring now to Fig. 4, one variation of an exemplary treatment device is shown which facilitates guidance of the expandable electrode basket 62 so as to effectively and efficiently treat tissue as desired, particularly relatively long portions of tissue (e.g.. regions of tissue longer than a length of the electrode 64). In this embodiment, the basket 62 is disposed at the distal end of the elongate sheath 22

which in turn is shown projecting distally outward from the bronchoscope 70. One or more visual indicators 100 are disposed along a length of the elongate sheath 22 (or shaft 24). preferably on a distal portion of the sheath 22 and proximal to the basket 62. Visual indicators 100 may generally comprise one or more markers, rings, bands, and the like. For example, a first marker 102 may be positioned proximally of basket 62. a second marker 104 may be positioned proximally of first marker 102, a third marker 106 may be positioned proximally of second marker 104. and a fourth marker 108 may be positioned proximally of third marker 106. In another variation, at least two circular bands or rings may be utilized and in other variations, four circular bands or rings may be utilized. It will be appreciated that any number, type, and/or combination of markers, rings or bands may be utilized in the present invention (e.g., 2. 3. 4. 5. 6. 7. 8. 9. 10. etc.).

[0049] Each marker 102, 104, 106, 108 may be uniformly spaced apart from one another with each spacing matching the length of the active electrodes 64 of basket 62. Thus, each spacing between markers 102, 104, 106, 108 may be set to correspond to a length of a active electrode 64 located centrally between proximal and distal insulation regions 61, 63 of the basket leg 60. For instance, active electrodes 64 having a length of 5 mm along basket 62 may provide for a length of 5 mm between markers 102, 104, 106, 108. It will be appreciated that the active electrode length 64 and corresponding marker spacing of 5 mm is illustrative and other lengths fewer than 5 mm or greater than 5 mm may also be utilized as desired. For example, the predetermined spacing distance may range anywhere from about 3 mm to about 30 mm. more preferably in a range from about 5 mm to about 15 mm, depending on the active electrode length, basket leg length, electrode array length parallel to a

longitudinal axis of the airway lumen, treatment temperature, time, power, current, voltage, and/or energy settings, and/or polarity configuration. 10050 j λs mentioned above, in one variation the spacing between these markers 102, 104, 106, 108 may each correspond to a length LE of the active electrodes 64 on basket 62. For instance, a first marker distance LSI between first marker 102 and second marker 104, a second marker distance LS2 between second marker 104 and third marker 106, and a third marker distance LS3 between third marker 106 and fourth marker 108 may each correspond in length to the length LE of active electrodes 64 on basket 62. Moreover, although four markers are illustrated in this example, fewer than four or more than four markers, as desired, may be utilized along the length of elongate sheath 22 in alternative variations. |0051 ] Bronchoscope 70 may be electrically coupled 110 to a monitor 112 and/or processor configured to display images 114 received from imaging lumen 76. As represented on monitor 112, the displayed image corresponds to an image as viewed from the perspective of lumen 76 showing basket 62 projected from the elongate sheath 22. Also illustrated are the visual markings 100 positioned along the sheath 22.

|0052| Advantageously, the embodiment of Fig. 4 allows for the amount of tissue being treated by the basket 62 to be easily ascertained with reference to the visual markers 100. In particular, markers 100 improve visibility and/or navigation of locating and placing the treatment electrodes 64 so as to reliably and uniformly apply predetermined axial treatments (e.g., continuous activation treatments). This in turn may reduce physician effort or fatigue (e.g., less surgical technique sensitive), total treatment procedure time, and/or patient discomfort and improve procedure efficacy.

[0053] Referring now to Figs. 5 through 8B, the basket 62 and elongate sheath

22 may be deployed from bronchoscope 70 and positioned distally of bronchoscope 70 along the tissue wall of a bifurcated airway 96. In one example of use, basket 62 may be deployed from bronchoscope 70 and advanced distally relative to bronchoscope working channel 72, as shown in Fig. 6A, while visualizing the passage of markers 102, 104, 106. 108 in monitor 112 directly in real-time, as illustrated in Fig. 613. With basket 62 positioned, it may be expanded into contact against the surrounding tissue wall 96 and the active electrodes 64 may be activated to heat the airway tissue 120 along a treatment length LE3. The treated tissue length LE3. extending between tissue borders 122, 124, may correspond in length to third marker spacing distance LS3 on elongate sheath 22.

[0054| Once the treatment is completed along tissue length LE3, basket 62 may be retracted and withdrawn proximally relative to bronchoscope 70 while visualizing on monitor 112 by one marker length until the fourth marker 108 is no longer visible and third marker 106 is verified as visible in the monitor 112, as shown in Fig. 7B. Moving elongate sheath 22 by such a distance also translates basket 62 proximally by one marker length LS3 and correspondingly translates the active electrodes 64 to an adjacent tissue region proximal to the previously treated tissue length LE3. Once desirably positioned, basket 62 may then again be actuated so as to deploy against the airway wall 96 and activated to heat the airway tissue 121 along a treatment length LE2 which borders treated tissue length LE3 contiguously without overlapping or leaving any gap between the two treated tissue lengths, as shown in Fig. 7λ. |0055| Once the tissue along tissue length LE2 has been treated, basket 62 may once again be retracted and withdrawn proximally relative to bronchoscope 70

by another marker length such that third marker 106 is no longer visible and second marker 104 is verified as visible on the monitor 1 12, as shown in Fig. 8B. Accordingly, basket 62 is translated proximally by a corresponding distance along the tissue such that the active electrodes 64 are aligned between tissue borders 126 and 128. The basket 62 may then be activated to treat the tissue region 123 along tissue length LEl which borders treated tissue length LE2, as illustrated in Fig. 8A. This process of deploying, activating, retracting, and pulling proximally may be repeated, as desired, until first marker 102 is reached or by pulling the bronchoscope 70 proximally with respect to the sheath markers 100 and following the above steps relative to the stationary bronchoscope 70. Thus, longer portions of the tissue may be treated as desired.

|0056| The resulting treated tissue may be thus formed into a contiguous length of treated tissue (e.g., LEl, LE2, LE3) which avoids over-treating the tissue by avoiding overlapping regions and avoids the formation of gaps between adjacent tissue lengths. Once the treatment is completed, the basket 62 may be withdrawn proximally into the bronchoscope working channel 72 for withdrawal from the patient or advancement into another region of tissue to be treated. Thus, if the length of the active electrode 64 is 5 mm and the corresponding marker lengths LSI. LS2. LS3 are each 5 mm in length, the tissue may be treated in increments of 5, 10. 15, 20 mm or more in a contiguous manner depending upon the desired length of tissue to be treated. The predetermined axial treatment (e.g.. LEl. LE2, LE3) may comprise treatment of the lung airways for a length of at least 10 mm, preferably in a range from about 10 mm to about 75 mm, more preferably in a range from about 20 mm to about 30 mm.

[0057J It will be appreciated that there are several ways to use the device of the present invention, and as such is not limited by the above example. In an alternative method of use, elongate sheath 22 may be translated distally relative to bronchoscope 70 such that the initial treatment is initiated when first marker 102 is visualized. Accordingly, subsequent portions of tissue may be treated by advancing the basket 62 distally relative to bronchoscope 70 while viewing advancement of the markers on monitor 112. In yet another variation, the elongate sheath 22 and basket 62 may be initially advanced distally until the first marker 102. second marker 104. or third marker 106 is exposed rather than being fully advanced until the fourth marker 108 is exposed. Thus, shorter portions of the tissue may be treated as desired.

10058] Referring now to Figs. 9A through 9F, although markers 100 may be identical, it will be appreciated that they may also be varied in any number of configurations. For example. Fig. 9A illustrates one variation where the markers 130. 132. 134, 136 may be dashed rather than solid. Another variation is shown in Fig. 9B where the markers may be non-uniform in width, or alternating in width. For instance, markers 140. 144 may have a first width while alternating markers 142. 146 may have a second width larger than the first width.

|0059] In yet another variation, the markers 150, 152, 154, 156 may be aligned to correspond to the active electrode length, as described above. Additional half markers 158. 160, 162 may be marked at, e.g.. intermediate positions between markers 150. 152, 154, 156, to denote positions where portions of tissue may be treated by overlapping the treatment regions, as shown in Fig. 9C. |0060] Another variation is illustrated in Fig. 9D where markers 170. 172.

174, 176 may be graduated with length measurements, e.g., 5 mm, 10 mm, 15 mm, 20 mm. etc., much like an endoscope to facilitate measurement of basket 62 insertion

depth or to facilitate measurement of the tissue region (e.g., length of the lung airway). In this manner, a portion of tissue or the depth in which the treatment device is advanced may be ascertained by directly visualizing the elongate sheath 22 extending from the stationary bronchoscope 70. Although the measurement values are illustrated in 5 mm increments corresponding to the length of the active electrode 64 on the electrode basket 62, any number of incremental values may be marked and delineated either in a corresponding or even non-corresponding manner with respect to the active electrodes, if so desired. |0061 ] Referring now to Fig. 9E, an elongate sheath 22 having markers which are in various colors to denote particular features associated with that particular marking is illustrated. Although the markers may be colored in the same color (e.g.. black), various colors may be utilized, particularly to indicate predetermined device states. For example, marker 180 may comprise a first color (e.g.. green) to indicate that once marker 180 is visible, electrode basket 62 is sufficiently advanced relative to the bronchoscope 70 for expansion and/or activation. Additional markers 182. 184 may also comprise various colors as well while the proximal marker 186 may also be colored in yet another color (e.g., red) as a visual indication that the elongate sheath 22 should not be advanced any further distal into the airway lung. [0062] In yet another variation, markers 171, 173, 175 (with graduations 7 mm. 14 mm. 21 mm) may have a length between adjacent markers which is greater than a length of the active electrodes 64 of the treatment device so that intermittent regions of tissue may be treated, as shown in Fig. 9F. Still further, the sheath may have a second set of markers 177, 179, 181, 183 that have a different spacing distance, e.g., set to the active electrode 64 length, so that a user may utilize a particular marker set based on a particular anatomy section to be treated.

[0063] In these and other variations described herein, each of the markers may be marked on the elongate sheath 22 in various increments and are not limited to just the length of the active electrodes 64, as described above in detail. Moreover, additional markers may be utilized or as few as a single marker may be utilized depending upon the desired visual indications.

[0064] The markers may also serve as a safety feature to discourage the premature deployment of the electrode basket 62 within the bronchoscope 70. For example, the first proximal marker may serve this purpose so as to prevent against any electrical discharge from flowing proximally along the sheath 22, shaft 24 and/or bronchoscope 70, which could potentially result in injury or harm to the patient or user. Additionally, the final proximal marker, which may be positioned along sheath 22 up to 75 mm or more, more preferably up to 50 mm or 30 mm, from the electrode basket 62, may also serve as a visual safety feature to ensure against advancing the electrode basket 62 too deep into the patient body (i.e., beyond bronchoscopic vision), which in turn prevents against any patient harm, such as puncturing of the airway wall into the parenchyma, pneumothorax, pneumomediastinum, etc. |0065| In yet another alternative, at least one of the markers may also be aligned with an anatomical landmark within the lung airway to provide not only for alignment of the device but also to facilitate measurement of the lung airway, if so desired. For example, a marker may be aligned with a particular airway bifurcation, colored tissue, cartilage ring, tissue nodule, and the like, so as to ensure against user disorientation due to tidal motion or movement of the access device. 100661 Referring back to Fig. 8 B, it will be further appreciated that the markers 102 further allow for user differentiation of the sheath 22 from the insulated electrodes 61, 63, particularly the proximal insulation regions of the basket legs 60.

This visualization is important to ensure proper deployment of the basket electrode 62.

|0067] Although certain exemplary embodiments and methods have been described in some detail, for clarity of understanding and by way of example, it will be apparent from the foregoing disclosure to those skilled in the art that variations, modifications, changes, and adaptations of such embodiments and methods may be made without departing from the true spirit and scope of the invention. For example, the plurality of visual indicators may be located on the device shaft, the energy delivery device may comprise a non-RF source, and/or the expandable energy device may comprise an inflatable balloon member. Still further, the markers of the present invention may be positioned alternatively or additionally on a proximal portion of the sheath or shaft that extends at least partially outside the access device and patient. Proximal makers may also facilitate quicker and more confident introduction of the shaft into the access device by indicating a measurement of the shaft within the access device. Reference to a singular element, includes the possibility that there are plural of the same elements present. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless the context clearly dictates otherwise. Therefore, the above description should not be taken as limiting the scope of the invention which is defined by the appended claims.