Patent Publication Number: US-2021161427-A1

Title: Use of low-power rf energy for tissue diagnosis

Description:
STATEMENT OF RELATED APPLICATION 
     This application is a continuation of Ser. No. 15/454,203, filed Mar. 9, 2017, which claims the benefit of U.S. Provisional Application Ser. No. 62/306,441, filed Mar. 10, 2016 and entitled “USE OF LOW-POWER RF ENERGY FOR TISSUE DIAGNOSIS”, which is hereby incorporated by reference. 
    
    
     FIELD OF THE DISCLOSURE 
     Embodiments described herein relate to devices, systems and methods for in-vivo diagnosis of disease-state tissue within a body, for example, within a passageway within a body. In particular, embodiments of the present disclosure relate to devices, systems and methods for diagnosing tissue by delivering low power radiofrequency energy to tissue within a body and monitoring, for example, a reflected portion of the energy delivered to the tissue during the tissue diagnosis procedure. 
     BACKGROUND OF THE DISCLOSURE 
     There are currently many methods of detecting disease-state tissue in-vivo. Various methods rely on some sort of imaging principle to identify suspect areas for subsequent biopsy or treatment. Current methods have varying degrees of success rate and complexity. A compounding factor in disease state tissue detection, particularly in small passageways, is that the tissue is often difficult to visualize in high-definition because the imaging system is often too small to support high definition cameras. Furthermore, disease state tissue can lie below the surface (e.g., the submucosa) making direct visualization impossible. 
     SUMMARY 
     Embodiments of the present disclosure include those directed to devices, systems and methods for diagnosing disease-state tissue within a body, for example, within a passageway within a body. 
     In various aspects, the present disclosure pertains to a method for diagnosing tissue in a body, for example, within a passageway within a body. The method comprises: (a) positioning a medical device adjacent a diagnosis site adjacent the tissue, the medical device comprising (i) an elongate member having a proximal end and a distal end and (ii) an energy emitting portion comprising at least one electrode adjacent the distal end; (b) supplying an amount of low-power RF energy from an energy source to the energy emitting portion to diagnose tissue at the diagnosis site, a first portion of the amount of low-power RF energy being transmitted through the energy emitting portion to the tissue and a second portion of the amount of low-power RF energy being reflected back towards the proximal end of the elongate member (with the first portion and second portion each representing a percentage of the amount of low-power RF energy that is supplied); and (c) monitoring a signal corresponding to the second portion. 
     In certain embodiments, which can be used in conjunction with any of the above aspects, the power of the second portion, the voltage of the second portion, or both the power and voltage of the second portion may be measured. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the method further comprises monitoring a signal corresponding to the first portion. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the method further comprises expanding the energy emitting portion from a collapsed configuration to an expanded configuration such that the at least one electrode contacts tissue. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the method further comprises advancing the energy emitting portion along a passageway in the body. In such embodiments, the signal may be, for example, monitored continuously as the energy emitting portion is advanced along the passageway or monitored at a plurality of discrete positions along the passageway. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the signal may be monitored for each of a plurality of electrodes. In certain such embodiments, the monitored signal may be, for example, compared to a threshold value, compared to a signal monitored for another electrode, and/or compared to a baseline signal based on a collection of electrodes. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the low-power RF energy may have an energy level that is sufficiently high for diagnosis, while being sufficiently low to avoid tissue damage. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the low-power RF energy may have an energy level ranging from 0.1 dBm or less to 20 dBm or more, for example, ranging from 0.1 to 0.2 to 0.5 to 1 to 2 to 5 to 10 to 20 dBm (i.e., ranging between any two of the preceding values). 
     In various aspects, the present disclosure pertains to a system for diagnosing tissue within a body, for example, tissue of a passageway within a body. The system may comprise: (a) an energy source; (b) a medical device configured to deliver energy to a diagnosis site adjacent the tissue, the medical device comprising (i) an elongate member having a proximal end and a distal end and (ii) an energy emitting portion comprising at least one electrode adjacent the distal end of the elongate member, the medical device being configured to receive an amount of low-power RF energy from the energy source and to transmit a first portion of the amount of low-power RF energy through the energy emitting portion to adjacent tissue; (c) one or more components configured to detect at least a signal corresponding to a second portion of the amount of low-power RF energy that is reflected back towards the proximal end of the elongate member; and (d) a controller configured to analyze the signal to determine the state of diagnosis. 
     In certain embodiments, the one or more components may comprise a bi-directional coupler that is configured to detect a signal corresponding to the first portion of the amount of low-power RF energy and the signal corresponding to the second portion of the amount of low-power RF energy. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the energy source may comprise a low-power RF generator. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the energy emitting portion may comprise a plurality of electrodes. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the energy emitting portion may comprise an expandable member upon which the electrodes are positioned. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the expandable member may comprises an expandable frame and/or an expandable balloon upon which the electrodes are positioned. The electrodes may be positioned, for example, around a circumference of the expandable member, for instance, equally spaced around a circumference of the expandable member. 
     In certain embodiments, which can be used in conjunction with any of the above aspects and embodiments, the electrodes may be elongated electrodes that extend lengthwise along the expandable member. For example the elongated electrodes may have a (length-to-width) aspect ratio ranging from 2:1 to 5:1 to 10:1 to 20:1 or more. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic illustration of a system for diagnosing tissue in a passageway within a body, the system including a low power radiofrequency energy delivery device having an energy emitting portion, according to an embodiment of the present disclosure. 
         FIG. 2  is a schematic side view of the energy emitting portion of  FIG. 1 , according to an embodiment of the present disclosure. 
         FIG. 3  is an exploded view of a portion of a leg of the energy emitting portion of  FIG. 2 , according to an embodiment of the present disclosure. 
         FIG. 4  is a schematic perspective view of an energy emitting portion, according to another embodiment of the present disclosure. 
         FIG. 5  is a schematic perspective view of an energy emitting portion, according to yet another embodiment of the present disclosure. 
         FIG. 6  is a schematic diagram of the system of  FIG. 1 , according to an embodiment of the disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Reference will now be made in detail to exemplary embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numbers will be used throughout the drawings to refer to same or like parts. 
     Generally described, the present disclosure relates to devices, systems and methods for diagnosing tissue by delivering low-power radiofrequency (RF) energy to tissue with a body, more typically, to tissue within the wall of a passageway in a patient&#39;s body and monitoring reflected power or voltage. “Passageway” as used herein refers to and includes any lumen, duct, cavity, space, or like within the body. Exemplary passageways include the esophagus, colon, common bile duct, pancreatic duct and blood vessels, among others. In this regard, the present disclosure is directed to the detection of disease-state tissue, for example, cancer tissue, through a low-power RF technique for in-vivo diagnosis in which changes in tissue impedance are detected by measuring changes in reflected power of a low-power RF signal during a scan. 
     In certain embodiments, the low-power RF energy may have a low-power energy level that is sufficiently high for diagnosis, while being sufficiently low to avoid tissue damage. 
     In certain embodiments, the low-power RF energy may have a low-power energy level ranging from 0.1 dBm or less to 20 dBm or more, for example, ranging from 0.1 to 0.2 to 0.5 to 1 to 2 to 5 to 10 to 20 dBm (i.e., ranging between any two of the preceding values). 
     In this regard, impedance refers to an opposition to the flow of electrical current through the tissue. Reflected power is a function of the impedance mismatch between an RF signal generator (e.g., a controller) and a load (e.g., tissue). 
     Radio frequency (RF) as defined herein is any of the electromagnetic wave frequencies that lie in the range of 3 kHz-300 GHz. RF energy delivered in accordance with the present disclosure may be selected from any portion of this range, for example, ranging from 3 kHz to 10 kHz to 30 kHz to 100 kHz to 300 kHz to 1 MHz to 3 MHz to 10 MHz to 30 MHz to 100 MHz to 300 MHz to 1 GHz to 3 GHz to 10 GHz to 30 GHz to 100 GHz to 300 GHz (i.e., ranging between any two of the preceding values). In certain embodiments, the range selected may optimized based on a tissue penetration depth of less than 1 cm. In certain embodiments, the frequency range of 1 MHz to 300 MHz may be less desirable due to potential ablation effects. 
     The power delivered to a load by an RF signal, P load , often expressed in units of dB (decibels) or dBm (decibel milliwatts), is defined as: 
     
       
         
           
             
               
                 P 
                 
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               = 
               
                 [ 
                 
                   
                     
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                         V 
                         f 
                       
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                         | 
                         2 
                       
                     
                     
                       Z 
                       0 
                     
                   
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                         V 
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                       Z 
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             , 
           
         
       
     
     where V f  is forward voltage, V r  is the reflected voltage, and Z 0  is the transmission line impedance. In general, power with respect to voltage is defined as: 
     
       
         
           
             P 
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                   | 
                   V 
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                     2 
                   
                 
                 
                   Z 
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     Therefore, the power delivered to a load is a function of both forward and reflected power. As reflected power increases, the power delivered to load decreases. Reflected voltage (and reflected power) increase due to impedance mismatches between the RF signal generator and load as defined by: 
     
       
         
           
             
               
                 V 
                 r 
               
               = 
               
                 
                   V 
                   - 
                   
                     ( 
                     
                       
                         Z 
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                       I 
                     
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             , 
           
         
       
     
     where V is source voltage and I is source current. For V=Z 0 I, V r =P r =0 and therefore the power delivered to the load will be equal to P f , where P f  is forward power. 
     Biological tissue possesses a characteristic impedance depending upon its molecular composition. For instance, it is understood that cancerous tissue generally possesses a lower characteristic impedance compared to that of healthy tissue of the same type. Other disease states are also expected to have impedance differences compared to healthy tissue. 
     Consequently, a controller may be tuned such that the transmission line impedance is similar to that of healthy tissue associated with the diagnosis site, resulting in small amounts of reflected power. In this regard, the impedance of the transmission line, which includes the signal path from generator to the probe, should be well understood and in some embodiments, may be tuned to the match the load anticipated for healthy tissue. A transmission line tuned to have impedance equal to the tissue load will result in minimal (theoretically zero) reflected power. During diagnosis, tissue impedance changes will result in differences in reflected power, increasing impedance mismatch resulting in an increase in reflected power. A reflected power threshold may be identified to indicate a disease state. Methods based on is principle may allow for detection below the visible surface, and for mucosa-lined passageways, may improve detection within the submucosa. 
     In the present disclosure an RF probe including one or more electrodes and an RF controller including an RF generator, may be used as a diagnostic system. The RF probe may be re-usable or disposable. In certain embodiments, the system may further include a catheter (i.e., a tube, including vascular catheters, endoscopes, etc.), which may be re-usable or disposable, and which may be provided in various sizes depending on the anatomy intended to be analyzed. The catheter may be provided with visualization to guide the physician and may be provided with a working channel through which the RF probe may be passed. 
     In this regard, the RF probe may be passed through the catheter to the distal tip. A health care professional can then pass the probe over the anatomy. For improved accuracy, the probe preferably stays in contact with tissue while at the same time being atraumatic. The RF controller may be configured to deliver low-power RF energy, typically an energy level that is sufficiently high for diagnosis, while being sufficiently low to avoid tissue damage (e.g., maintaining cells of tissue being diagnosed to 40° C. or less), to the probe. The RF controller may also be configured to control the electrode state, delivering RF energy to the active electrode(s) at the tissue interface and measuring reflected power from the tissue. Algorithms may be used to control the electrode state with respect to time. 
     Turning now to the drawings,  FIG. 1  illustrates an exemplary system  10 . System  10  includes an energy generator  12 , a controller  14 , a user interface  16 , and a probe  18 . Energy generator  12  may be any suitable device configured to produce low-power RF energy for diagnosing tissue as described herein. The RF energy generator may be configured to emit energy at specific frequencies and for specific amounts of time. 
     More particularly, energy generator  12  may be configured to generate energy with a wattage output sufficient to diagnose tissue without harming (ablating) the tissue. 
     An energy controlling mechanism  22  may be associated with energy generator  12 . Energy controlling mechanism  22  may be any suitable automatic and/or user operated device in operative communication with energy generator  12  via a wired or wireless connection, such that energy controlling mechanism  22  may be configured to enable activation of energy generator  12 . Energy controlling mechanism  22  may therefore include a switch, a push-button, or a computer, among other possibilities. In the exemplary embodiment of  FIG. 1 , energy controlling mechanism  22  is a footswitch. A conductive cable  24  may extend from energy controlling mechanism  22  to user interface  16 , and may include a coupler  24   a  configured to be electrically coupled to an interface coupler  26  disposed on user interface surface  16 . 
     Controller  14  may be coupled to energy generator  12 . Controller  14  may include a processor  20  configured to produce signals for controlling the energy generator  12 , receive information feedback signals (e.g., reflected signals), process the information feedback signals according to various algorithms, and produce signals directed to visual and/or audio indicators. For example, processor  20  may include one or more integrated circuits, microchips, microcontrollers, and/or microprocessors, which may be all or part of a central processing unit (CPU), a digital signal processor (DSP), an analog processor, a field programmable gate array (FPGA), or any other circuit known to those skilled in the art that may be suitable for executing instructions or performing logic operations. That is, processor  20  may include any electric circuit that may be configured to perform a logic operation on at least one input variable. In some embodiments, processor  20  may be configured to use a control algorithm to analyze a reflected portion and/or a forward portion of the energy delivered to targeted tissue and generate control signals for energy generator  12 . 
     Controller  14  may additionally be coupled to and in communication with user interface  16 . In the exemplary embodiment illustrated in  FIG. 1 , controller  14  may be electrically coupled to user interface  16  via a wire connection. In alternative embodiments, controller  14  may be in wireless communication with user interface  16 . User interface  16  may be any suitable device capable of providing information to an operator of the energy delivery system  10 . Accordingly, user interface  16  may be configured to be operatively coupled to each of the components of energy delivery system  10 , receive information signals from the components, and output at least one visual or audio signal to a device operator in response to the information received. In the exemplary embodiment, the surface of user interface  16  includes at least one switch  36  and a display  38 . It is contemplated that user interface  16  may additionally include one or more audio tone indicators and/or graphical representations of components of system  10 . 
     Probe  18  may be coupled to user interface  16 . For example, a cable  40  may extend from probe  18  to user interface  16 , and include a coupler  40   a  configured to be electrically coupled to an interface coupler  42  associated with user interface  16 . 
     Probe  18  may include a handle portion  44 , an elongate member  46 , and an energy emitting portion  48 . In certain embodiments, one or more of the user interface  16 , controller  14  and energy generator  12  may be integrated into the handle portion  44 . Elongate member  46  has a proximal end  46   a  and a distal end  46   b . As used herein, “proximal” refers to the end closer to the device operator during use, and “distal” refers to the end further from the device operator during use. Thus, handle portion  44  may be disposed at proximal end  46   a  of elongate member  46  and energy emitting portion  48  may be disposed at distal end  46   b . Handle portion  44  may be any suitable handle and may have one or more actuators, switches, or the like to control movement of elongate member  46  and/or manipulate energy emitting portion  48 . 
     Elongate member  46  extends distally from handle portion  44 . Elongate member  46  may be a flexible tube, made from any suitable biocompatible material having sufficient flexibility to traverse non-linear anatomy. Such materials may include, but are not limited to, rubber, silicon, other polymers, metal-polymer composites, metals including metal alloys of one or more of nickel, titanium, copper cobalt, vanadium, chromium or iron (e.g., stainless steel), superelastic material such as nitinol, which is a nickel-titanium alloy. 
     Elongate member  46  and energy emitting portion  48  may be provided with a coating. The coating may be any coating known to those skilled in the art enabling ease of movement of probe  18  through an access device such as a catheter and/or a passageway within a patient&#39;s body. The coating may include a lubricious coating and/or an anesthetic. 
     As indicated above, in some embodiments, system may further include a catheter  80  (represented by dashed lines) that includes an elongate member with one or more lumens or channels formed therein for the passage of a variety of surgical equipment, including, but not limited to, probe  18 , imaging devices and tools for irrigation, insufflation, vacuum suctioning, biopsies, and drug delivery. The catheter may include an imaging device mounted at the distal end of the catheter. The catheter may include an atraumatic exterior surface having a rounded shape and/or a coating like that described above. 
     Energy emitting portion  48  may be attached to and extend from distal end  46   b  of elongate member  46 . Energy emitting portion  48  may be formed from the same piece of material as elongate member  46 . Alternatively, energy emitting portion  48  may be fabricated independently of elongate member  46  by any known means and may be made permanently or removably attached to distal end  46   b  of elongate member  46 . For example, energy emitting portion  48  may be permanently or removably attached to distal end  46   b  of elongate member  46  via a flexible junction enabling movement of energy emitting portion  48  relative to distal end  46   b  of elongate member  46 . 
     Referring to  FIG. 2 , energy emitting portion  48  may be any size, shape and/or configuration having dimensions that can be inserted into a passageway within a body and advanced to a diagnosis site  60 . In the embodiment shown, energy emitting portion  48  may comprise an expandable frame that is configured to be advanced to the diagnosis site in a first, collapsed configuration (not shown) whereupon it takes on a second, expanded configuration as shown once positioned at a diagnosis site  60  in a passageway. For example, the expandable frame may be advanced to the diagnosis site  60  within a catheter at which point the expandable frame is advanced relative to the catheter and/or the catheter is retracted relative to the expandable frame, such that the expandable frame extends beyond a distal end of the catheter. In some embodiments, the frame has a shape memory and is maintained in a first, collapsed position by walls of the catheter and subsequently expands to a second, expanded configuration at the diagnosis site  60  when freed from the catheter as a result of the shape memory. In other embodiments, one or more actuators, which may be operated from the handle portion  48 , may be used to lengthen the frame during advancement in a first, collapsed configuration, after which the frame may subsequently be expanded into a second, expanded configuration at the diagnosis site  60 , for example, by providing the frame with a shape memory effect that causes the frame to radially expand or by using the actuator to shorten length of the frame, thereby causing the frame to radially expand. In still other embodiments, the energy emitting portion  48  may comprise an expandable balloon is configured to be advanced to the diagnosis site  60  in a first, collapsed state and take on a second, expanded configuration by inflating the balloon once positioned at a diagnosis site  60  in a passageway. Once in a second, expanded configuration, a contact region  50  of energy emitting portion  48  may be configured to contact tissue at diagnosis site  60 . 
     Energy emitting portion  48  may have any shape, size, and/or configuration in the second, expanded configuration. In the exemplary embodiment shown in  FIG. 2 , energy emitting portion  48  comprises a having a plurality of curved legs  52  that converge at a distal tip  53 . Also shown is an actuation rod  57  for lengthening and shortening the frame. Legs  52  may be configured so that the legs  52  correspond to lines drawn along a surface of an imaginary prolate spheroid (represented by shaded area) in the second, expanded configuration. In this embodiment, region  50  may be the portion of frame that is the greatest distance from the longitudinal axis of energy emitting portion  48  when energy emitting portion  48  is in the second, expanded configuration. It is contemplated that legs  52  may form any other shape and/or configuration that facilitates contact between contact region  50  and tissue of diagnosis site  60  in the second, expanded configuration. 
     Legs  52  may be constructed from a material such as, for example, a shape memory metal or metal alloy or a polymeric material so that legs  52  may collapse to have a smaller cross-section in the first, collapsed configuration (not shown). Although  FIG. 2 , shows that that energy emitting portion  48  comprises four legs  52 , energy emitting portion  48  may include any number of legs  52  (e.g., 2, 3, 5, 6, 7, 8, etc. legs) having any desired pattern and/or configuration. For example, legs  52  may correspond to a surface of an imaginary cylinder or any other suitable shape. In addition, legs  52  may have any cross-sectional shape including, but not limited to, circular, square, or ovular. 
     Energy emitting portion  48  may further include at least one electrode  56 . The at least one electrode  56  may be located along the length of at least one of the plurality of legs  52  and may include at least a portion of the contact region  50  of energy emitting portion  48 . In the exemplary embodiment illustrated in  FIG. 3 , the at least one leg  52  of the energy emitting portion  48  comprises a single, elongate conducting element, portions of which may be covered by an insulating material  54 , such as, for example, a non-conducting polymeric sheath that is heat shrunk onto each leg  52 . In addition, another portion of the elongate conducting element disposed between the insulated portions  54  is exposed, forming an electrode  56  for delivering energy to tissue at diagnosis site  60 . The electrode  56  may be, for example, any suitable electrode known to those skilled in the art configured to emit RF energy. In the embodiment of  FIG. 2 , four electrodes  56   a ,  56   b ,  56   c ,  56   d  are shown. The electrodes  56   a ,  56   b ,  56   c ,  56   d  may be operated in monopolar mode or bipolar mode. 
     In embodiments where energy emitting portion  48  includes monopolar electrodes  56   a ,  56   b ,  56   c ,  56   d , system  10  further includes a return electrode component configured to complete an electrical energy emission or patient circuit between energy generator  12  and a patient (not shown). Referring to  FIG. 1 , the return electrode component may include a conductive pad  28  for this purpose. Conductive pad  28  may include a conductive adhesive surface configured to removably adhere to a patient&#39;s skin. In addition, conductive pad  28  may include a surface area having a sufficient size in order to alleviate burning or other injury to the patient&#39;s skin that may occur in the vicinity of the conductive pad  28  during energy emission. A cable  30  may extend from conductive pad  28  and may include a coupler  30   a . Coupler  30   a  may be configured to be coupled to an interface coupler  32  on a surface of user interface  16  to electrically couple conductive pad  28  to the user interface  16 . 
     In other embodiments, electrodes  56   a ,  56   b ,  56   c ,  56   d  may be operated in bipolar mode, in which case a separate return electrode component (e.g., conductive pad) is not required, but which may nonetheless be provided in the event that it is also desired to operate the electrodes  56   a ,  56   b ,  56   c ,  56   d  in monopolar mode. With regard to bipolar mode, for example, electrode  56   a  may be operated as an active electrode while electrode  56   b  is simultaneously operated as a return electrode, after which electrode  56   a  may be operated as a return electrode while electrode  56   b  is simultaneously operated as an active electrode. Similarly, electrode  56   c  may be operated as an active electrode while electrode  56   d  is simultaneously operated as a return electrode, after which electrode  56   c  may be operated as a return electrode while electrode  56   d  is simultaneously operated as an active electrode. In other words, electrodes  56   a ,  56   b  are operated as a first bipolar pair and electrodes  56   c ,  56   d  are subsequently operated as a second bipolar pair. 
     As another example, electrodes  56   a  and  56   c  may be operated as active electrodes while electrodes  56   b  and  56   d , respectively, are simultaneously operated as return electrodes for electrodes  56   a  and  56   c , respectively, after which electrodes  56   a  and  56   c  may be operated as return electrodes while electrodes  56   b  and  56   d , respectively, are simultaneously operated as active electrodes. In other words, electrodes  56   a ,  56   b  and electrodes  56   c ,  56   d  are simultaneously operated as first and second bipolar pairs. 
     More broadly, the electrodes may be operated as the following bipolar pairs: electrodes  56   a ,  56   b , electrodes  56   a ,  56   c , electrodes  56   a ,  56   d , electrodes  56   b ,  56   c , electrodes  56   b ,  56   d , and electrodes  56   c ,  56   d.    
     In  FIG. 2 , the electrodes are placed on an expandable frame that comprises a plurality of legs  12  as structural support members for the electrodes. In another embodiment shown in  FIG. 4 , an energy emitting portion  48  is shown in which the expandable electrodes placed on a surface of an expandable balloon  55 . In the example shown, three electrodes,  56   a ,  56   b ,  56   c  (out of six total electrodes) are shown, which extend longitudinally along a length of the balloon, although energy emitting portion  48  may include any number of electrodes (e.g., 2, 3, 4, 5, 7, 8, etc.) having any desired pattern disposed on the balloon. As in  FIG. 2 , the electrodes may be operated in monopolar mode or bipolar mode. For example, a balloon formed from a material such as polyimide or polyethylene terephthalate may be patterned with gold electrodes, for example, using processes like those described in U.S. Patent Pub. No. 2014/0128859. Because the electrodes are disposed around the balloon, a scan may be made around a circumference of the energy emitting portion  48 , and the balloon need not be rotated inside the lumen. 
     While the energy emitting portion  48  of  FIG. 2  includes one electrode  56  per leg. In other embodiments, a plurality of electrodes is provided along a length of each leg. With reference now to  FIG. 5 , an energy emitting portion  48  is shown in which three electrodes are located along the length of at least one of the plurality of legs  52  (an analogous distribution of electrodes could be created on a balloon surface). Due to the fact that the outermost radial portions of the legs  12  linear, the contact region  50  of the energy emitting portion  48  is significantly longer than that of  FIG. 2 . Twelve electrodes  56   a ,  56   b ,  56   c ,  56   d ,  56   e ,  56   f ,  56   g ,  56   h ,  56   i ,  56   j ,  56   k ,  56   l  are shown. As in  FIG. 2 , the electrodes  56   a ,  56   b ,  56   c ,  56   d ,  56   e ,  56   f ,  56   g ,  56   h ,  56   i ,  56   j ,  56   k ,  56   l  may be operated in monopolar mode or bipolar mode. 
     In one specific example, among other possibilities, the following electrodes may be operated as bipolar pairs at a given longitudinal position on the energy emitting portion  48 : (a) adjacent electrodes  56   a ,  56   b , electrodes  56   b ,  56   c , electrodes  56   c ,  56   d  and electrodes  56   d ,  56   a , as well as non-adjacent electrodes  56   a ,  56   c  and electrodes  56   b ,  56   d , (b) adjacent electrodes  56   e ,  56   f , electrodes  56   f ,  56   g , electrodes  56   g ,  56   h  and electrodes  56   h ,  56   e , as well as non-adjacent electrodes  56   e ,  56   g  and electrodes  56   f ,  56   h , (c) adjacent electrodes  56   i ,  56   j , electrodes  56   j ,  56   k , electrodes  56   k ,  56   l  and electrodes  56   l ,  56   i , as well as non-adjacent electrodes  56   i ,  56   k  and electrodes  56   j ,  56   l . In this way, a scan may be made around a circumference of the energy emitting portion  48  at three different longitudinal positions along the energy emitting portion  48  without moving the energy emitting portion  48 . 
     In another specific example, among other possibilities, the following electrodes may be operated as bipolar pairs at a given angular position on the energy emitting portion  48  (i.e., a given angle of rotation around the longitudinal axis of the on the energy emitting portion  48 ): (a) electrodes  56   i ,  56   e , electrodes  56   e ,  56   a , electrodes  56   i ,  56   a , (b) electrodes  56   j ,  56   f , electrodes  56   f ,  56   b , electrodes  56   j ,  56   b , (c) electrodes  56   k ,  56   g , electrodes  56   g ,  56   c , electrodes  56   k ,  56   c , (d) electrodes  56   l ,  56   h , electrodes  56   h ,  56   d , electrodes  56   l ,  56   d . In this way, a length of tissue along the diagnosis site can be scanned without moving the energy emitting portion  48 . In this way, a scan may be made along the length of the energy emitting portion  48  at four different angles of rotation around the axis of the energy emitting portion  48  without moving the energy emitting portion  48 . 
       FIG. 6  is a simplified representation of system  10 . As will be described below, components of system  10  may be configured to deliver energy to tissue at diagnosis site  60  and to monitor a reflected portion of that energy. 
     With reference to  FIG. 6 , energy generator  12  of system  10  may be controlled by controller  14 , and may be configured to generate a forward signal for delivering energy to tissue at diagnosis site  60 . As discussed above, energy generator  12  may be an RF generator configured to generate a forward RF signal. The forward RF signal may be carried to the at least one electrode  56  in contact with tissue at diagnosis site  60  via transmission line  58 . Transmission line  58  broadly refers to any structure or structures designed to carry alternating current of, for example, radio frequency. In the exemplary embodiment, transmission line  58  may include energy generator  12 , the at least one electrode  56 , and conducting elements therebetween including, but not limited to, cable  40 , and conductors within the elongate member  46  and energy emitting portion  48 . 
     The forward RF signal carried via transmission line  58  may be supplied to the at least one electrode  56 . The at least one electrode  56  may then deliver energy to tissue at diagnosis site  60 . In particular, low-power RF energy may be delivered through the electrode  56  in contact with tissue at diagnosis site  60  in order to analyze tissue at the diagnosis site. 
     As will be described in more detail below, system  10  may be configured to analyze tissue at the diagnosis site  60  using a reflected portion of the energy delivered to the at least one electrode  56 . The reflection of energy may be a function of the impedance of tissue at diagnosis site  60 . 
     As indicated above, when the impedance of transmission line  58  is tuned to match the impedance of the load (in this case comprising the impedance of the tissue at diagnosis site  60 ), a substantial portion of the energy delivered via transmission line  58  may be transmitted through the at least one electrode  56  to tissue at diagnosis site  60 . When the impedance of the transmission line  58  and the impedance of the tissue at diagnosis site  60  are not matched, a portion of energy supplied to electrode  56  may be reflected back along transmission line  58  to energy generator  12  via secondary signals. The secondary signals may have reflected power. As indicated above, having the ability to measure reflected power provides the possibility to monitor tissue impedance. 
     The magnitude of the reflected power may be proportional to the mismatch between the impedance of transmission line  58  and the impedance of tissue at diagnosis site  60 . That is, the magnitude of the reflected power may increase as the impedance of tissue at diagnosis site  60  decreases from a matched impedance value during diagnosis. In addition, the net forward power, which is approximately equal to the difference between the forward power (associated with the forward signal) and the reflected power (associated with the secondary signal), may decrease. 
     The system  10  may be provided with ability to measure both forward and reflected power, with suitable methods and devices for doing so determined by one of ordinary skill in the art. As illustrated in  FIG. 6 , system  10  may include a bi-directional coupler  62  for detecting the reflected power and the forward power of the primary RF signal carried via transmission line  58 . Bi-directional coupler  62  may be positioned between energy generator  12  and the at least one electrode  56 , and in communication with energy generator  12  and the at least one electrode  56 . In some embodiments, bi-directional coupler  62  may be integrally provided with energy generator  12 . In other embodiments, bi-directional coupler  62  may be a separate component placed between energy generator  12  and the at least one electrode  56 . As shown in  FIG. 6 , the primary RF signal may be inputted to bi-directional coupler  62 . The primary RF signal may pass therethrough unaffected and may be outputted from bi-directional coupler  62  to be transmitted to the at least one electrode  56 . 
     Bi-directional coupler  62  may be any known coupler configured to provide one or more signal sample outputs for measurement. In the exemplary embodiment, bi-directional coupler  62  may be configured to sample the forward and reflected RF signal passing therethrough and detect the forward power and the reflected power. Bi-directional coupler  62  may output a first signal  64  indicative of the forward power and a second signal  66  indicative of the reflected power to first monitoring device  68  and second monitoring device  70 , respectively. 
     First monitoring device  68  and second monitoring device  70  may be any known electrical component configured to measure a power signal. In some embodiments, one or both of first monitoring device  68  and second monitoring device  70  may be a power meter. First monitoring device  68  and second monitoring device  70  may be in communication with processor  20  either wirelessly or via a wired connection to transmit information relating to the forward power and the reflected power. In this manner, the forward and reflected powers may be measured in real time, and changes in the net power level may be detected. Alternative known means for detecting and measuring the forward power and the reflective power are also contemplated. 
     Prior to initiating the diagnosis procedure, controller  14  may be configured to tune transmission line  58  to have an impedance that is based on that of healthy tissue at diagnosis site  60 . For example, the transmission line  58  may be tuned to have an impedance that is substantially equal to the impedance of the healthy tissue at diagnosis site  60 , which will result in a negligible amount of reflected power. The impedance of the healthy tissue may be well-known or may be calculated by any known means such as empirical data and/or clinical measurements. 
     As diagnosis is initiated, probe  18  may be inserted into and advanced through a passageway within a patient&#39;s body to diagnosis site  60 . After energy emitting portion  48  has been positioned at diagnosis site  60 , energy emitting portion  48  may be expanded from a first, collapsed configuration to a second, expanded configuration so that contact region  50  is placed in contact with tissue at diagnosis site  60 . 
     Energy generator  12  may be continuously activated, or an operator may engage energy controlling mechanism  22  to activate energy generator  12 . Activation of energy generator  12  may generate a forward signal, for example, a forward RF signal, for delivery through the least one electrode  56  of energy emitting portion  48  to tissue at diagnosis site. In particular, energy generator  12  may generate a forward signal that may be supplied to the at least one electrode  56  via transmission line  58 . The low-power RF energy supplied to the at least one electrode  56  may be delivered to tissue at diagnosis site  60 . Accordingly, a portion of the energy supplied to electrode  56  may be reflected back along transmission line  58  to energy generator  12  via secondary signals. The secondary signals have reflected power. 
     In various embodiments, the energy emitting portion  48  may then be moved longitudinally within the passageway and the reflected power measured continuously during movement or at a plurality of discrete positions along the passageway. As movement progresses, the magnitude of the reflected power may change (i.e., increase or decrease), indicating a change in tissue impedance and thus a change in tissue state. Where the transmission line impedance is matched to that of healthy tissue, an increase in reflected power may indicated the presence of diseased (e.g., cancerous) tissue. 
     Over the course of the diagnosis, bi-directional coupler  62  may be configured to sample the signal passing therethrough and output a first signal  64  indicative of forward power and a second signal  66  indicative of reflective power to first monitoring device  68  and second monitoring device  70 , respectively. In some cases, first signal  64  and second signal  66  may be proportional to the forward power and the reflected power of the forward signal, respectively. 
     In the exemplary embodiment, second monitoring device  70  may continuously monitor the second signal  66  corresponding to the reflected power. In particular, second monitoring device  70  may monitor second signal  66  to measure the magnitude of the reflective power. Second monitoring device  70  may then transmit the measured value to processor  20 . 
     Where the energy emitting portion  48  contains a plurality of electrodes, each electrode at a different angle of rotation around a longitudinal axis of the energy emitting portion  48  (see, e.g.,  FIGS. 2 and 4 ), the reflected power may be analyzed from each electrode, either through operation in unipolar mode or bipolar mode, as each electrode is advanced through the body passageway. 
     Processor  20  may analyze the magnitude of the reflected power or voltage from each electrode for changes in reflected power or voltage, which would indicate changes in tissue state as the energy emitting portion  48  is moved along the passageway. For example, as previously noted it is understood that cancerous tissue possesses a lower characteristic impedance compared to that of healthy tissue of the same type. Thus, where the transmission line  58  is tuned to have an impedance matching that of healthy tissue at diagnosis site  60 , movement of an electrode  56  from healthy tissue to cancerous tissue can cause an increase in the reflected power or voltage. In other embodiments, the transition from healthy tissue to diseased tissue may be reflected by a change in impedance. 
     In various embodiments, processor  20  may be configured to monitor the magnitude of the reflected power or voltage signal as the energy emitting portion  48  is moved along the passageway. Any method of signal processing, including measuring the derivative of the reflected power signal as a function of longitudinal movement (or time, assuming constant longitudinal movement) can be used to detect a change in slope which reflects a tissue change. 
     In some embodiments, the magnitude of the reflected power and/or voltage signal can be displayed to the operator, for example, via a screen. 
     In some embodiments, processor  20  may be configured to compare the magnitude of the reflected power or voltage signal to a pre-set threshold to determine if the magnitude of the reflected power signal reaches or passes the pre-set threshold value. In those embodiments, operator may be notified when the magnitude of the reflected power or voltage exceeds the threshold, which may indicate the presence of diseased tissue such as cancerous tissue. 
     In some embodiments, processor  20  may be configured to compare changes in the magnitude of the reflected power or voltage signal (e.g., a percent change) to a pre-set threshold value. In those embodiments, operator may be notified when the change in magnitude of the reflected power or voltage exceeds the threshold, which may indicate a change in tissue state, for example, a change from healthy tissue to diseased tissue such as cancerous tissue. 
     In some embodiments, the energy emitting portion  48  comprises a number of electrodes  56  and remains stationary within the passageway as the reflected power associated with the individual electrodes  56  is measured, whereby allowing the passageway to be mapped without moving the energy emitting portion  48 . Analogous to the embodiments above, the magnitude of the reflected power may change (i.e., increase or decrease) change from one electrode  56  to another, indicating a change in tissue impedance and thus a change in tissue state. 
     As in the embodiments above, bi-directional coupler  62  may be configured to sample the signal passing therethrough and output a first signal  64  indicative of forward power and a second signal  66  indicative of reflective power to first monitoring device  68  and second monitoring device  70 , respectively. For example, second monitoring device  70  may monitor the second signal  66  corresponding to the reflected power at each electrode position. In particular, second monitoring device  70  may monitor second signal  66  to measure the magnitude of the reflected power or voltage. Second monitoring device  70  may then transmit the measured value to processor  20 . 
     Processor  20  may analyze the magnitude of the reflected power or voltage from each electrode for changes in reflected power or voltage between electrodes, which could indicate changes in the state of the tissue adjacent to the electrodes. For example, as noted above, it is understood that diseased tissue such as cancerous tissue generally possesses a lower characteristic impedance compared to that of healthy tissue of the same type. Thus, where the transmission line  58  is tuned to have an impedance similar to the healthy tissue at diagnosis site  60 , the presence of cancerous tissue would be detected by an increased value for the reflected power or voltage. 
     In some embodiments, the magnitude of the reflected power or voltage signal can be conveyed to the operator, for example, via a screen. 
     In some embodiments, processor  20  may be configured to compare the magnitude of the reflected power or voltage signal from each electrode to a preset threshold to determine of the magnitude of the reflected power signal is greater than or equal to the pre-set threshold value, which may indicate the presence of diseased tissue such as cancerous tissue in some cases. In those embodiments, the electrodes for which the magnitude of the reflected power signal is greater than or equal to the pre-set threshold value may be displayed to the operator, for example, via a screen. 
     In some embodiments, processor  20  may be configured to compare the magnitude of the reflected power or voltage signal to some baseline value for the reflected power or voltage signal (e.g., the average reflected power and/or average reflected voltage). In those embodiments, each electrode for which the magnitude of the reflected power or voltage signal is greater than baseline value by a pre-determined amount (e.g., by a predetermined percentage) may be displayed to the operator, for example, via a screen. 
     In certain embodiments, reflected low-power RF energy may be analyzed to determine if the at least one electrode  56  is in contact with the tissue at diagnosis site  60 , as described in detail in U.S. Patent Pub. No. 2013/0324995. 
     In certain embodiments, high-power RF energy may also be delivered through the at least one electrode  56  in contact with tissue at diagnosis site  60  in order to raise a temperature of the tissue to a threshold temperature that ablates or otherwise alters the target tissue. Such power may be applied based on the results of the tissue analysis at low-power RF energy.