Patent Publication Number: US-2016228175-A1

Title: Ablation system with blood leakage minimization and tissue protective capabilities

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 12/648,797, filed 29 Dec. 2009 (the &#39;797 application), which claims the benefit of U.S. provisional application No. 61/141,379 filed Dec. 30, 2008 (the &#39;379 application). The &#39;797 application and the &#39;379 application are both hereby incorporated by reference as though fully set forth herein. 
    
    
     BACKGROUND OF THE INVENTION 
     a. Field of the Invention 
     The present invention relates generally to medical systems for performing therapeutic functions, such as, for example, ablation procedures. More particularly, the present invention relates to an ablation system that includes blood leakage minimization and/or tissue protective capabilities. 
     b. Background Art 
     It is known to use minimally invasive surgical devices or ablating tools to perform ablation procedures in, for example, the heart. For instance, in treating a condition known as atrial fibrillation, it is known to advance an ablating tool through the vasculature of a patient to a desired location, and to then thermally ablate tissue within, for example, an ostium (OS) connecting a pulmonary vein to the heart, or to ablate the tissue within the heart surrounding the OS. 
     One example of a type of tool known in the art to perform such procedures is a catheter-based ablating device such as that or those described in U.S. Pat. No. 6,635,054 entitled “Thermal Treatment Methods and Apparatus with Focused Energy Application,” U.S. Patent Publication No. 2004/0176757 entitled “Cardiac Ablation Devices,” and International Publication No. WO 2005/102199 entitled “Ablation Devices with Sensor Structures.” These known devices generally include, among other components, an elongate shaft having a proximal end, a distal end, and a longitudinal axis extending therebetween. The devices further include an ablation element mounted at or near the distal end of the elongate shaft. In at least one such device, the ablation element comprises a pair of inflatable balloons that share a common wall therebetween, with one of the balloons being disposed proximally of the other balloon. The balloons are configured to have a collapsed condition and an expanded condition, and are configured such that one is liquid or fluid inflated and one is gas inflated. The ablation element further includes an ultrasound transducer mounted or otherwise disposed within the distally disposed balloon that is configured to emit high intensity ultrasonic waves radially outwardly into the liquid or fluid within the balloon with respect to the longitudinal axis of the elongate shaft. The ultrasonic waves have the strength and intensity to burn or ablate tissue after they are reflectively focused forward (more distally onto the OS interior) by the reflectively curved fluid/gas interface defined, in part, by the common wall shared by the two overlying balloons. 
     In operation, once such an ablating device is positioned in a desired location within the patient&#39;s anatomy (e.g., in a pulmonary vein OS), the balloons are respectively inflated with saline (inner balloon) and carbon dioxide gas (outer balloon). The ultrasound transducer is then selectively activated to emit ablating energy (e.g., intense ultrasonic waves). When the ultrasound transducer, which is typically cylindrical, emits the ultrasonic waves in radial directions into the fluid-filled balloon, the waves are reflected and redirected (focused) forward by the common reflective interface wall between the two balloons, and re-directed forward of the balloons and focused to define, for example, a focused ring-like ablation region in the circumferential interior OS annular wall. Such radial or circumferential ablating devices provide an efficient and effective means by which to simultaneously circumferentially ablate myocardial tissue around the OS of the pulmonary vein. Typically, multiple pulmonary ostia are ablated separately and sequentially with the same device as it is moved and placed in each OS needing ablation. 
     However, these known devices are not without their drawbacks. For instance, one function of the balloons of the ablating device, when the ablation element is inserted within an orifice or OS and inflated, is to serve as a blood flow barrier to seal the interface between the balloons and the inner annular wall of the orifice or OS, thereby temporarily preventing blood flow past the balloons through the OS. If the blood flow is not stopped substantially completely around all 360 degrees, then the residual blood flow may prevent thermal lesioning due to unwanted cooling of target tissues. However, when the balloons are manufactured and then inflated, they are manufactured and inflated to be rotationally symmetric (bodies of revolution) because it is the most manufacturable approach and does not require any rotational device alignment to target tissues. Conversely, the orifices or ostia within which the device, and the ablation element thereof, in particular, is to be inserted are not typically rotationally symmetric, but rather oftentimes are irregular and have a more oval or oblong shape with, for example, as much as a 3:1 aspect ratio. As such, when the balloons are inflated in an oval-shaped or irregular orifice, a sealed (to blood flow) interface between the balloon(s) and OS cannot be created, and as a result, cooling blood may leak past the balloons across the interface where ablative heating is to take place. When the blood leaks past the balloon(s), it undesirably serves to cool the surface of the tissue over which it flows, and does so in a non-uniform manner that cannot be easily corrected or compensated for. This is undesirable as these unintended cooled areas of tissue cannot be sufficiently continuously ablated or burned because they are being cooled by the blood, therefore, surface lesions cannot be controllably formed. Accordingly, the quality and adequacy of the ablation procedure may be substantially reduced, or require additional ablating procedures to be performed in order to complete the desired continuous ablation lesion of the targeted tissue. 
     Another drawback in known endocardial catheter pulmonary vein ostia ablation systems relates to the monitoring, maintenance, and/or control of the temperature in non-targeted tissue proximate the targeted ablation site during the ablation procedure. Such non-targeted tissue must not be damaged during the ablation procedure. More particularly, when certain heart tissue is being ablated, the energy emitted from the ablating device may be strong enough or generate a high enough temperature to cause tissue necrosis in non-targeted tissue. For example, portions of the esophagus are located proximate the heart and if an endocardial ablation site is near the esophagus the ablation energy itself, or heat generated by it and conducted away from the target, can potentially cause the nearby esophageal tissue to experience cell death. 
     Conventional suggested methods of addressing this concern include the use of one or more thermocouples or thermistor-based sensors that are passed either blindly or with the assistance of imaging or visualization systems (e.g., fluoroscopic, impedance-based, MRI, etc.) down the throat on an expandable member configured to monitor the temperature of the esophageal tissue and detect undesirable energy transfer to the esophagus. Such a technique may require the use of a dense macroscopic thermistor array, which may result in a disposable temperature monitoring device being cost-prohibitive or large. Additionally, such a technique may cause challenges with respect to the accuracy of the placement of the sensor(s), and it may be difficult to detect loss-of-contact between the sensor and the non-targeted tissue to be protected, or to sense the actual positioning of the sensor relative to the non-targeted tissue. Further, without using one or more imaging means, it is exceedingly difficult to locate a single protective thermocouple directly opposite or in the field of energy delivery of the ablating device. If such difficulty is compensated for by providing a thermocouple or thermistor array of larger area, another issue is presented, that being obtaining good thermal contact to the esophageal interior. Finally, apparent proper placement of the monitoring thermocouple using fluoroscopy still cannot guarantee proper thermal contact to the esophagus, or thermal wetted contact to the esophagus (i.e., a wet contact which stays wet and thermally sinking during an ablation procedure so as prevent the corresponding tissue from drying out and overheating). 
     Accordingly, there is a need for an ablation tool or system that will minimize and/or eliminate one or more of the above-identified deficiencies. 
     BRIEF SUMMARY OF THE INVENTION 
     The present disclosure is directed to an ablation system and its constituent components that include blood leakage minimization and tissue protective capabilities during an ablation procedure. The system according to the present teachings includes an ablating device configured to be inserted into the anatomy of a patient and to deliver ablating energy to a target-tissue ablation site. The system further includes a protective probe. The protective probe is configured for insertion into the anatomy of a patient and to be positioned in close proximity to a region of non-targeted tissue proximate the ablation site such as on the opposite side of the region of non-targeted tissue from the ablating device or collateral to the targeted ablation site. 
     In one exemplary embodiment, the ablating device comprises an elongate shaft having a proximal end and a distal end. The ablating device further includes a handle mounted to the elongate shaft at the proximal end thereof. The ablating device still further includes an ablation element mounted to the elongate shaft at the distal end. The ablation element includes an ultrasound transducer and at least one inflatable balloon surrounding the ultrasound transducer. The balloon includes an inner surface and an outer surface, and has a layer of shape-conforming gel disposed on at least a portion of the outer surface. 
     In one exemplary embodiment, the probe includes an elongate shaft having proximal and distal ends, and a longitudinal axis extending from the proximal end to the distal end of the shaft. The probe further includes a handle disposed at the proximal end of the shaft, and a tissue protecting apparatus disposed at the distal end of the shaft. The tissue protecting apparatus extends from a point on the shaft at or near the distal end thereof a predetermined distance along the longitudinal axis of the shaft toward the proximal end of the shaft. The tissue protecting apparatus is configured to protect non-targeted tissue in the region of non-targeted tissue from receiving unintended ablation energy intentionally targeted at nearby opposed, collateral, or upbeam targeted tissue, such as, for example, ablation energy delivered to tissue opposite the region of non-targeted tissue from the tissue protecting apparatus. 
     In accordance with another aspect of the present disclosure, an apparatus for use in monitoring temperature in a region of non-targeted tissue during an ablation procedure performed on targeted tissue proximate the region of non-targeted tissue is provided. The apparatus includes a probe configured to be inserted into the anatomy of a patient, and includes a proximal end and distal end. The apparatus further comprises a temperature monitoring apparatus associated with the probe, at least a portion of which is disposed at or near the distal end thereof. The temperature monitoring apparatus has a field of view and is configured to generate an image of the tissue disposed within the field of view, and to detect temperatures in the imaged tissue. 
     In accordance with yet another aspect of the present disclosure, a method of monitoring temperature in a region of non-targeted tissue during an ablation procedure performed on targeted tissue proximate the region of non-targeted tissue is provided. The method comprises a first step of providing a protective probe including a temperature monitoring apparatus having a field of view, wherein the probe and at least a portion of the temperature monitoring apparatus is configured to be inserted into the anatomy of a patient. The method includes a second step of thermally or thermographically imaging tissue within the field of view of the temperature monitoring apparatus and disposed within the non-targeted region of tissue. The method includes a third step of detecting at least one temperature of the imaged tissue, which, in an exemplary embodiment, is the maximum temperature in the imaged tissue. 
     The foregoing and other aspects, features, details, utilities, and advantages of the present teachings will be apparent from reading the following description and claims, and from reviewing the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  illustrates a diagrammatic view of an exemplary embodiment of a system for performing an ablation procedure, and for monitoring and/or managing the temperature generated proximate an ablation site during the ablation procedure, in accordance with the present teachings. 
         FIG. 2  is a partial cross-section view of an exemplary embodiment of an ablation element of an ablating device of the system illustrated in  FIG. 1 , wherein balloons of the ablating device are inflated. 
         FIG. 3  is a partial cross-section diagrammatic view of an exemplary embodiment of a protective probe of a temperature monitoring and/or management subsystem of the system illustrated in  FIG. 1 , wherein the probe is disposed within the esophagus of a patient and includes a tissue protecting apparatus disposed at or near the distal end thereof 
         FIG. 4  is a schematic view of an exemplary embodiment of the tissue protecting apparatus illustrated in  FIG. 3 . 
         FIG. 5  is a cross-section view of an exemplary embodiment of the tissue protecting apparatus of  FIG. 3  including fluid delivery lumens and corresponding outlets disposed therein. 
         FIG. 6  is partial cross-section diagrammatic view of another exemplary embodiment of the probe of the temperature monitoring and/or management subsystem of the system illustrated in  FIG. 1 , wherein the probe is disposed within the esophagus of a patient, and further wherein the ablating device of the ablation system includes an acoustic transducer mounted thereon. 
         FIG. 7  is partial cross-section diagrammatic view of yet another exemplary embodiment of the probe of the temperature monitoring and/or management subsystem of the system illustrated in  FIG. 1 , wherein the probe is disposed within the esophagus of a patient, and further wherein an acoustic transducer is mounted at the distal end of the probe. 
         FIG. 8  is partial cross-section diagrammatic view of yet still another exemplary embodiment of the probe of the temperature monitoring and/or management subsystem of the system illustrated in  FIG. 1 , wherein the probe is disposed within the esophagus of a patient, and further wherein a thermal imaging chip is mounted at the distal end of the probe; 
         FIG. 9  is a graphical representation of a thermographic map generated by the thermal imaging chip illustrated in  FIG. 8 ; and 
         FIG. 10  is a flow diagram of an exemplary method of monitoring the temperature in a region of non-targeted tissue during an ablation procedure being performed on targeted tissue disposed proximate the desired region of non-targeted tissue. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings wherein like reference numerals are used to identify identical components in the various views,  FIG. 1  illustrates an exemplary embodiment of a system  10  for performing ablation procedures and for monitoring, managing, and/or controlling the temperature in non-targeted tissue proximate an ablation site during the ablation procedure, in accordance with the present disclosure. The system  10  includes an ablation subsystem  12 , a temperature monitoring and management subsystem  14 , and, in an exemplary embodiment, a system controller  16  connected to each of the ablation subsystem  12  and the temperature monitoring and management subsystem  14 . As is generally known in the art, (see, for example, U.S. Pat. No. 6,635,054 entitled “Thermal Treatment Methods and Apparatus with Focused Energy Application,” U.S. Patent Publication No. 2004/0176757 entitled “Cardiac Ablation Devices,” and International Publication No. WO 2005/102199 entitled “Ablation Devices with Sensor Structures”, the disclosures of which are hereby incorporated by reference in their entireties), in an exemplary embodiment, the ablation subsystem  12  includes an ablating device  18 , comprised, in part, of at least one ablation element  30  coupled to an elongate and typically flexible shaft  20  having a proximal end  22 , a distal end  24 , and a longitudinal axis  26  extending from the proximal end  22  through the distal end  24 . As will be described in greater detail below, the ablating device  18  further includes a handle  28  coupled to the elongate shaft  20  at the proximal end  22  thereof, and the at least one ablation element  30  is mounted to the elongate shaft  20  at or near the distal end  24  thereof. While it should be understood that the ablating device  18  may include one or more ablation elements  30 , and that ablating devices  18  having more than one ablation elements  30  are within the spirit and scope of the present disclosure, for ease of description purposes only the description below will be limited to an embodiment wherein the ablating device  18  includes a single ablation element  30 . 
     The flexible elongate shaft  20  may be formed of any number of materials, such as, for example and without limitation, PEBAX®, Nylon, and polyurethane. In another exemplary embodiment, the elongate shaft  20  is constructed of, or incorporates, a metal wire braid, as is known in the art. The elongate shaft  20  further includes at least one, and typically multiple, inner passageways or lumens  32  disposed therein (shown in  FIG. 2 ). The lumens  32  extend longitudinally along an axial portion of the shaft  20  from the proximal end  22  to the distal end  24 , and are configured to have one or more components of the ablating device  18  disposed therein, such as, for example and without limitation, pull wires, planarity wires, fluid irrigation or drainage lumens, lead wires for the ablation element  30 , a rotation wire, or, as will be described in greater detail below, components required for inflating and deflating balloons with, for example, fluid, gas, and/or extruding gels, associated with the ablating device  18 , and the ablation element  30 , in particular. 
     As briefly described above, the handle  28  of the ablating device  18  is disposed at the proximal end  22  of the elongate shaft  20 . The handle  28  is operative to, among other things, effect movement of the shaft  20  (i.e., steer the ablating device  18 ), and/or selectively manipulate the distal end  24  of the elongate shaft  20  to position the distal end  24 , and therefore, the at least one ablation element  30 , in a desired location when the ablating device  18  is disposed within a patient. More particularly, in one embodiment provided for exemplary purposes only, one or more pull wire(s) (not shown) are coupled to and between both the distal end  24  of the elongate shaft  20  and an actuator(s)  34  located on the handle  28 . As the actuator  34  is manipulated, the corresponding pull wire(s) is caused to be pushed and pulled, for example, to effect movement, such as bending deflection, of the distal end  24  of the elongate shaft  20 . It should be noted, however, that while only this particular method or technique of steering or effecting movement of the elongate shaft  20 , and/or the distal end  24  thereof, is described in detail herein, the present invention is not meant to be so limited. Rather, those of ordinary skill in the art will appreciate that other methodologies or techniques of steering and/or manipulating ablating devices exist that remain within the spirit and scope of the present invention. In addition to actuator  34 , other components may also be disposed within the handle  28 . For example, electrical matching circuits to electrically impedance-match the components of the ablation element  30  to an ablation energy generator or power source, or other components of the ablation subsystem  12 , for example, may be disposed within the handle  28 . The ablation element  30  and the energy generator can be configured to deliver one or more types of ablation energy (e.g., high intensity focused ultrasound, or HIFU, radiofrequency, laser, microwave and the like). 
     With reference to  FIG. 2 , the ablation element  30  of the ablating device  18  will now be described. In an exemplary embodiment wherein the ablation element  30  is configured to deliver ultrasound energy to target tissue, the ablation element  30  includes a pair of inflatable balloons  36 , 38 , and an ultrasound transducer or emitter  40  (hereinafter “ultrasound transducer  40 ” or “transducer  40 ”) mounted within one of the balloons (i.e., the distally disposed fluid-filled balloon  38 , for example). In an exemplary embodiment, the transducer  40  may take the form of tubular or cylindrically-shaped ultrasound transducer formed of a piezoelectric material (e.g., piezoceramic, for example) which radiates ultrasound in radial directions around all 360 degrees. If, as will be described below, the transducer  40  is rotatable about the axis  26  during ablation, it may comprise a full cylinder or an angular sector of a cylinder. When the balloons  36 , 38  are deflated or in a collapsed condition, they form a small and compact unit that is substantially flush with the outer surface of the elongate shaft  20 , or at least forming a low profile therewith, so as to allow the ablating device  18  to be easily inserted into and removed from a patient&#39;s body. Alternatively, the ablating device  18  may be inserted into and removed from a patient&#39;s body via a sheath or introducer (not shown). 
     As illustrated in  FIG. 2 , when in an inflated state, the balloon  38  is positioned distally or forward relative to the balloon  36 . The two balloons  36 , 38  share an acoustically reflective common wall or balloon-wall interface  42  that, in the inflated state, essentially forms a parabolic surface with, as will be described below, fluid on one side and gas on the other side. In an exemplary embodiment, the common wall  42  comprises a single layer of material such that the wall is integral with each balloon  36 , 38  and therefore is truly shared by the balloons  36 , 38 . In another exemplary embodiment, such as that illustrated in  FIG. 2 , the wall  42  comprises two layers of material that are fused or otherwise joined together to form a single wall (i.e., each balloon  36 , 38  has a wall, and the walls are fused or joined together to form a single wall). In yet still another embodiment, the common wall  42  is formed by the respective walls of the balloons  36 , 38  abutting each other to form a single wall. 
     As will be described in greater detail below, in an exemplary embodiment, the balloon  38  is inflated with an acoustically-transmissive fluid or flowable material, such as, for example, liquid saline or gel, while the balloon  36  is inflated with a gas, such as, for example, biocompatible carbon dioxide (CO 2 ). Accordingly, when the balloons are in an inflated state, the common wall  42  has saline on one side (i.e., inside balloon  38 ) and gas on the other side (i.e., inside balloon  36 ). As such, the fluid/gas interface acts as an acoustic mirror, and so by shaping the common wall  42  as, for example, a parabola, the ultrasound waves emitted from the transducer  40  are reflected and focused (reflectively focused) into an annular lesion target region in the wall of the OS (the target tissue), as is illustrated in  FIG. 2 . 
     Accordingly, in operation, a practitioner inserts the distal portion  24  of the elongate shaft  20 , and therefore, the ablation element  30  with its balloons deflated or in a collapsed condition, into an incision in a patient&#39;s body, for example. The practitioner may then advance the device through the patient&#39;s vasculature until it reaches a desired location (e.g., an ablation site within the heart, such as, for example, an orifice or OS connecting a pulmonary vein with the left atrial chamber of the heart). The desired location may be within the OS, or, alternatively, may be a location external to the OS. Once the desired location is reached, the balloons are inflated, as will be described in greater detail below, and the ablation procedure can be carried out. In the instance where the desired location is external to the OS, the balloons  36 , 38  may be inflated and then advanced into the OS, rather than being inflated within the OS. 
     In an exemplary embodiment, the gas-filled balloon  36  is coupled with, and configured to be inflated by, a gas source  44  (shown in  FIG. 1 ). More particularly, one of the lumens  32  disposed within the elongate shaft  20  is configured to be an inflation lumen (hereinafter “lumen  32   1 ”) and is further configured to couple the balloon  36  to the gas source  44  that supplies gas, such as, for example, carbon dioxide, under pressure to the balloon  36 . Accordingly, when the gas source  44  is activated, the balloon  36  inflates. Typically, a controlled gas pressure will be maintained in the balloon  36  to maintain a controlled balloon firmness. 
     Conversely, in an exemplary embodiment, the fluid-filled balloon  38  is coupled with, and configured to be inflated by, a fluid or liquid source  46  (shown in  FIG. 1 ). More particularly, one of the lumens  32  disposed within the elongate shaft  20  other than the inflation lumen  32   1  associated with the balloon  36  is configured to be an inflation lumen (hereinafter “lumen  32   2 ”) and is further configured to couple the balloon  38  to the fluid source  46  that supplies fluid, such as, for example, isotonic saline solution, to the balloon  38 . Accordingly, when the liquid source  46  is activated, the balloon  38  inflates. As with the gas in the balloon  36 , the fluid in the balloon  38  will typically be pressurized to a desired level to maintain a controlled balloon firmness. The gas and fluid pressurization levels, although not necessarily equal in magnitude, are chosen to assure full distended inflation of the balloons  36 , 38  yet be below the burst pressures of the respective balloons. 
     Additionally, when the balloons  36 , 38  each transition from an inflated to a deflated states, the gas and fluid in the respective balloons  36 , 38  must be drained or otherwise removed or expelled from the balloons  36 , 38 . In an exemplary embodiment, the lumens  32  through which the gas and fluid were delivered to the balloons  36 , 38  also serve the purpose of providing a path through which the gas and the fluid in the balloons  36 , 38  is returned to the respective gas/fluid sources  44 , 46 , or otherwise drained or expelled. In such an instance, the respective lumens  32  may be selectively coupled with a suction source, vent, or drain to cause or allow the gas/fluid in the balloons  36 , 38  to exit the balloons  36 , 38 . Alternatively, separate drainage lumens (not shown) may be provided within the elongate shaft  20  to carry out the above described functionality. 
     As can be seen in  FIG. 2 , and as was described above, the gas-filled balloon  36  and the fluid-filled balloon  38  share the common wall  42 . As was also briefly described above, when the balloons  36 , 38  are inflated, the common wall  42  acts as an acoustic reflecting and focusing mirror capable of reflecting ultrasonic waves emitted by the transducer  40 . It is primarily the fluid/gas acoustic impedance discontinuity that provides this efficient acoustic reflection capability and the thin balloon wall  42  physically maintains the fluid/gas interface. However, while the fluid/gas interface substantially provides the acoustically reflective capability, it should be understood that both the material of the balloon and its thickness do have a small, but nonzero, effect on reflectivity, particularly when it is thin as inflated. 
     With continued reference to  FIG. 2 , in an exemplary embodiment, the ultrasound transducer  40  is mounted to the distal portion of the elongate shaft  20  at or near distal end  24  thereof, for example, and within the balloon  38 . It should be noted, however that in other exemplary embodiments that remain within the spirit and scope of the present invention, the transducer  40  may be mounted to structure within the balloon  38  other than the elongate shaft  20 . Additionally, the transducer  40  may be positioned within the balloon  38  at a number of locations, including, for example, at the back (proximal region) of the balloon  38  close to or abutting the common wall  42 . 
     In an exemplary embodiment wherein the ultrasound transducer  40  comprises a tubular cylindrical emitter and the balloons  36 , 38  are in an inflated state, the ultrasound transducer  40  uniformly emits acoustical energy from its cylindrical outer surfaces around the 360 degrees of that outer surface directed toward the shaped mirror fluid/gas interface (i.e., common wall  42 ). It will be appreciated by those having ordinary skill in the art that the transducer  40  may be driven in a lower frequency “breathing” mode, or in a higher frequency “wall thickness” mode, and/or in harmonics of these. The transducer  40  may further include overlying matching layers (not shown) or interior back materials (not shown). The transducer  40  may further be “pinged” such that, using the pulse-echo approach, the lesion and/or thickness or depths thereof may be assessed. 
     As illustrated in  FIG. 1 , the transducer  40  is electrically connected to an energy or ablation power source  48  by electrical leads or wires (not shown) that are disposed within one or more of the lumens  32  in the elongate shaft  20 , and that extend through to the proximal end  22  thereof. When the ablation power source  48  is activated, the transducer  40  emits ultrasonic waves  50  along various paths in radial direction relative to the longitudinal axis  26  (i.e., toward the common wall  42  between and defined by the balloons  36 , 38 ). As shown in  FIG. 2 , and as briefly described above, as the acoustic waves  50  impinge upon the reflective fluid/gas interface (i.e., the common wall  42 ), they are reflected as illustrated in  FIG. 2  and simultaneously focused into a ring-like ablation region. The focused ablation region permits the efficient and effective ablation of targeted myocardial tissue, for example. It should be noted that, as is generally known in the art, the transducer  40  may be omnidirectional and/or rotatable relative to the balloons  36 , 38  about the axis  26 . Rotation allows for circumferentially uniform energy exposure (lesioning extent) despite having some circumferential non-uniformity of the circumferential output of the transducer  40 . Accordingly, by rotating the transducer  40 , any angular non-uniformity of acoustic output will be rotated such that all tissue target points on the OS receive the integrated same time-power treatment. Therefore, rotating the transducer  40  allows use of a less-uniform transducer. Alternatively, using rotation, other transducers, such as, for example, a directional transducer (emitting less than 360 degrees at a given moment), whether cylindrical or not, may be used. In an embodiment wherein the transducer  40  is rotated, a rotation wire (not shown) coupled with the transducer  40  and manually driven from a control on the handle  28 , or driven by a motor, may be employed to cause the transducer to rotate. 
     In addition to serving to cooperatively form the reflectively focusing surface for the ultrasonic waves emitted by the transducer  40 , one or both of the balloons  36 , 38  are configured and operative to serve other purposes. More particularly, when inserted into an orifice or OS between a vein and the heart, for example, and inflated (or inserted already inflated), the balloons  36 , 38  are intended to serve as a barrier to blood flow through the orifice or OS, and/or to generally center the transducer  40  in the OS. However, one disadvantage with known ablating devices is that when inflated, the balloons of the device are rotationally symmetric. However, most orifices or ostia into which the device is inserted are not rotationally symmetric, but rather are irregular and/or have an oval or other similar non-round shape. Accordingly, when the device is inserted into the oval-shaped orifice and the rotationally symmetric balloons are inflated, a sealed blood flow between the balloons and the adjacent surface of the orifice or OS cannot be achieved, or at least cannot be achieved without potentially damaging force being applied to the OS. Because the interface is not sufficiently sealed, blood may be permitted to leak through any balloon-OS gaps, which may act to cool the local surface of the orifice or OS that is being ablated. When the tissue is cooled by the blood flow, it counteracts the ablation procedure, thereby preventing surface and/or somewhat deeper lesioning. Therefore, one aspect of the present invention is directed to the elimination, or at least the substantial reduction, of blood leakage cooling experienced in these ablating devices. 
     Accordingly, with reference to  FIG. 2 , one exemplary embodiment of the ablating device  18  with blood leakage minimization capability operative to eliminate, or at least substantially prohibit, blood flow leakage past the balloon(s)  36 , 38  in the balloon/OS interface is illustrated. In this exemplary embodiment, at least a portion of the outer surface of one or both of the balloons  36 , 38  is coated with a gel  52 , such as, for example, a low-flow or pressure formable gel, which acts as a conformable or deformable gasket material to stop blood flow in non-round ostia. The gel  52  may comprise one of many different known types of biocompatible implantable gels. One gel, provided for exemplary purposes only, is that available from MacroMed, Inc. under the trademark ReGel®. Another exemplary gel that may be used is that available from Mebiol, Inc. under the name “Mebiol Gel.” The latter exemplary gel hardens upon exposure to a sufficient amount of heat, and softens upon subsequent cooling. The gel can be fabricated of a biocompatible and bio-absorbable material as well. It will be appreciated by those of ordinary skill in the art that any number of gels could be used, and thus, the invention is not limited to those specifically identified above. In an exemplary embodiment, the gel is acoustically transparent and so it will not block or substantially impede ablative energy emitted by the ablating device, such as, for example, high-intensity focused ultrasound (HIFU) ablating devices. Additionally, in an exemplary embodiment, the gel is of a type such that it will not boil or bubble below about 100° C. Those having ordinary skill in the art will appreciate that while gels are typically network polymers which are water or solvent based, the term “gel” as used in accordance with the present disclosure is intended to include any material whose flow resistance can prevent it from being displaced or washed way by blood pressure and blood flow. Therefore, the gel may be prepositioned on the outer surface of one or both of the balloons  36 , 38 , or might be extruded from the balloon, but in any event, will have a viscosity high enough that it resists the blood flow forces while allowing for physical conformance to non-round OS geometries. 
     As illustrated in  FIG. 2 , in one exemplary embodiment, it is the outer surface of the balloon  36  that has the gel  52  disposed thereon. In other exemplary embodiments, however, in addition to or instead of the gel  52  being disposed on the outer surface of the balloon  36 , the gel  52  is disposed on the outer surface of the balloon  38 , or at the interface between the two balloons  36 , 38 . The gel  52  is configured to act as a blood flow-seal between the balloon(s)  36 , 38  and the interior surface of an orifice or OS into which the ablating device  18  is inserted. In other words, the gel  52  fills gaps between the outer surfaces of the balloons  36 , 38  and the interior and/or face surfaces of the orifice or OS to inhibit blood flow therebetween. Once the gaps are filled, the gel  52  may or may not further stiffen (i.e., upon exposure to heat or cooling), however, in an exemplary embodiment, the gel has a fixed viscosity sufficient to conform yet still block blood flow. 
     In an exemplary embodiment, at least a portion of the outer surface of one or both of the balloons  36 , 38  is coated with a layer of the gel  52  prior to the ablating device  18 , and the distal portion of the elongate shaft  20 , in particular, being inserted into a patient&#39;s body. In such an embodiment, when the balloons  36 , 38  are inflated, the gel  52  is already disposed on either the entire outer surface of the balloon(s)  36 , 38 , or a portion(s) thereof. In an alternative embodiment, rather than pre-coating the surface of the balloon(s)  36 , 38  with the gel  52 , the ostia or OS are pre-coated with the gel. In such an embodiment, a separate gel application tool (possibly including a gel extruding permeable balloon) may be used to coat the OS. In another exemplary embodiment, the ablating device  18  itself may have the capability to apply the gel to the surface of the OS as by pressurized extrusion out of one or more orifices. 
     In another exemplary embodiment wherein the balloon(s)  36 , 38  are coated with the gel  52 , the ablating device  18  is configured such that the gel  52  is distributed onto at least a portion of the outer surface of the balloon(s)  36 , 38  after the balloon(s) are inflated rather than prior to insertion into the patient&#39;s body. In an exemplary embodiment, rather than the balloon  38  being inflated with a liquid such as saline, the balloon  38  may be inflated with a gel. In such an embodiment, the balloon  38  is configured and constructed of a gel-permeable material to ooze or leak the gel therefrom and into the balloon/OS interface gaps. Alternatively, the balloon may include one or more perforations or outlets (not shown) therein to allow gel in the balloon to flow out of the balloon when a modest amount of pressure is applied to the gel (when the pressure is removed, the gel stops flowing). Such gel gasket extrusion may take place as part of the balloon inflation process. Accordingly, in this embodiment the gel would serve not only the blood leakage minimization function, but to also act with the gas used to inflate the balloon  36  as the fluid/gas mirror. One exemplary type of gel that is suitable to serve this dual function is a sufficiently acoustically transparent water-based gel. In another exemplary embodiment wherein the common wall  42  comprises the walls of each of the balloons  36 , 38  abutting each other to form a single wall (as opposed to a single layer or two fused layers), a dedicated gel distribution lumen (not shown) may deliver gel to the interstitial space between the two balloons  36 , 38  through a port (not shown) within the shaft  20 . As a result of capillary action, the gel will be pushed out to the periphery, and therefore, onto the surface(s) of the balloon(s)  36 , 38 . 
     The gel  52  may be held in or on the balloon(s)/OS interface in a number of ways. In an exemplary embodiment, the gel  52  is configured to solidify or stiffen when sufficiently heated. The gel  52  may be heated in any number of ways, such as, for example and without limitation, by the heat generated by the ablation procedure being performed proximate to the location of the gel  52 , by the gel  52  being exposed to body temperature of the patient, or by separate and distinct heat source. For example, and without limitation, heated saline maybe delivered to or circulated within the balloon  38 , a resistive wire may be disposed within the balloon  38 , a heated gas may be delivered to or circulated within the balloon  36 , and the like. It will be appreciated that the particular temperature required to stiffen the gel will be dependent upon the gel used, however, an exemplary temperature may be, for example and without limitation, 39° C., which is slightly higher than body temperature. For illustrative, not limiting, purposes, in an embodiment wherein a gel such as ReGel® described above is used, the relative amounts of the two constituent type A and B block copolymers may set such that the gel stiffens at a particular desired temperature. 
     In another exemplary embodiment, rather than solidifying or stiffening when exposed to heat, the gel  52  solidifies or stiffens when sufficiently cooled. In such an embodiment, any means by which the gel may be cooled may be used, such as, for example and without limitation, an artificial cooling means. In such embodiment, the ablation element  18  may include a cooling or heat-extracting device (not shown) configured to sufficiently cool the gel  52  to cause it to solidify or stiffen. For example, and without limitation, cooled saline or some other cryogenic or cold fluid may be delivered to or circulated within the balloon  38 , a cooled gas may be delivered to or circulated within the balloon  36 , and the like. 
     Notwithstanding the description above, it will be appreciated by those having ordinary skill in the art that any number of biocompatible gels which will not substantially flow during an ablation procedure under modest blood flow pressure (i.e., the gel is thick and viscous or thixotropic enough to physically maintain its position and form during the ablation procedure) may be used for the purposes described above. In any instance, depending on the particular gel used, the gel may be left in the patient&#39;s body for immediate or gradual dissolution or biodegradation after the ablation procedure is completed. One way to leave the gel within the body is to leave it on the OS interior in “molded” form for gradual surface-wise dissolution. Alternatively, using temperature manipulation (by removing heat, and/or otherwise heating or cooling the gel), the gel may be reflowed or re-liquefied after the completion of the ablation procedure to ensure that no solid or semi-solid lumps of gel are left in the circulatory system for any period of time. 
     In addition to, and independent of, the blood leakage concerns described above, another drawback to known ablating devices is that it oftentimes proves difficult to reliably monitor temperature and/or sufficiently cool non-targeted regions of tissue proximate an ablation site during the performance of an ablation procedure. One such non-targeted region of tissue, which is provided for exemplary and illustrative purposes only, is esophageal tissue disposed close to the heart. More particularly, as ablating energy is directed to a region of the heart by an ablating device, such as, for example and without limitation, any endocardially-delivered ablating device including radio frequency (RF), microwave, cryogenic, and ultrasound-based devices, the ablating energy may have sufficient strength and intensity to pass through and outward of the heart and be applied to non-targeted tissue in the esophagus that is located on the other side of the ablated tissue from the ablating device. Likewise, even if the ablating energy itself does not directly penetrate that far, if a large hotspot is developed at the target site, then the non-targeted tissue may be overheated simply due to proximity. In either instance, this may cause the temperature in the esophageal tissue to rise, thereby forming “hotspots” that may potentially cause cell death within or on the esophagus. The burning of this tissue may cause severe damage to the esophagus. Therefore, another aspect of the present invention is directed to the improved monitoring, management, and/or control of temperature rise or energy delivery in non-targeted tissue regions proximate an ablation site. 
     Accordingly, with reference to  FIGS. 1 and 3-10 , the temperature monitoring and management subsystem  14  of system  10  will now be described. In an exemplary embodiment, the temperature monitoring and management subsystem  14  includes a protective probe  100 , a fluid source  102 , and an actuator  104 . 
     With continued reference to  FIGS. 1 and 3-10 , the probe  100  includes an elongate shaft  106 , a handle  108 , and a tissue protecting apparatus  110 . As with the shaft  20  described above, the elongate shaft  106  has a proximal end  112 , a distal end  114 , and a longitudinal axis  116  extending from the proximal end  112  through the distal end  114 . The handle  108  is disposed at the proximal end  112  and, as described above with respect to the handle  28 , may be configured, among other things, to steer or manipulate portions of the probe  100  as it is inserted into the anatomy of a patient, such as, for example, the esophagus. In an exemplary embodiment, the probe  100  is directly inserted into the esophagus such as through the mouth or sinus. However, in another exemplary embodiment, the probe  100  is introduced into the esophagus through an introducer-lumen already in place. The tissue protecting apparatus  110  of the probe  100  is disposed at or near the distal end  114  of the elongate shaft  106 . 
     In an exemplary embodiment, the tissue protecting apparatus  110  comprises a wetted heat sink (hereinafter “heat sink  110 ”). It should be noted that the term “heat sink” as used herein is intended to mean an element or structure having the capability of (i) carrying away heat deposited in the esophagus wall tissue by an OS ablator element(s) being used inside the heart of the patient, and/or (ii) cooling or pre-cooling the esophageal tissue that is to be protected. In either instance, this may be accomplished by either contacting the tissue or causing cooling fluid to be dispensed onto the tissue. The heat sink  110  is disposed at the distal end  114  of the elongate shaft  106  and extends therefrom a predetermined distance along the longitudinal axis  116  toward the proximal end  112  of the elongate shaft  106 . 
     In one exemplary embodiment, the heat sink  110  comprises an inflatable balloon, membrane, or bladder  118  (collectively “bladder  118 ”). The bladder  118  has a collapsed or deflated condition, and an expanded or inflated condition. In the collapsed condition, the bladder  118  provides a low profile distal portion to probe  100 , which is easily passed down the throat. In an exemplary embodiment, the bladder  118  is formed of an elastomeric material to assure that no folds occur upon inflation of the bladder  118 . In another exemplary embodiment, the bladder may be pleated or folded upon itself when in the deflated condition, but configured to be inflated to a point ridding it of the folds or pleats at a diameter less than that of the esophagus such that when seated upon the esophagus during further inflation, not pleats or folds exist. 
     In an exemplary embodiment, the bladder  118  is configured to be inflated with a biocompatible fluid. However, in other exemplary embodiments the bladder  118  may be inflated with gas, air, gel, liquid or other suitable medium, including nutritious and/or therapeutic constituent elements or components. In the exemplary embodiment described hereinafter, the bladder  118  is inflated with liquid saline, but the present invention is not meant to be limited to saline. In addition to inflating the bladder  118 , the fluid also serves as the coolant or heat transfer medium for either drawing heat away from, or for cooling or pre-cooling esophageal tissue. More particularly, and as will be described in greater detail below, the fluid (e.g., saline or another type of thermally conductive fluid, for example) may be kept inside and/or circulated within the bladder  118  such that heat in the tissue that the bladder  118  contacts (when, for example, the bladder  118  is inflated against esophageal tissue) is transferred to the fluid via thermal conducting through the thin bladder wall. 
     In addition, or alternatively, the bladder  118  may have perforations, microscopic holes, pores, outlets, permeation paths, and the like therein configured to allow the fluid in the bladder  118  to be leaked, weeped, sprayed, or otherwise dispensed therefrom upon the tissue to be protected in order to cool or pre-cool the tissue. In an exemplary embodiment, the fluid may be pre-cooled below body temperature such that esophageal tissue is actually sub-cooled below natural body temperatures. 
     Accordingly, in such an embodiment, the bladder  118  is connected to, or otherwise coupled with, an inflation or filling lumen  119  disposed within the elongate shaft  106  (shown in  FIG. 3 , for example). The inflation lumen  119  is disposed between, and coupled to, each of the bladder  118  and the fluid source  102  of the subsystem  14  to allow the bladder  118  to be inflated. In an exemplary embodiment, the fluid source  102  is configured to supply fluid, such as, for example, various saline solutions, distilled water, deionized water, or other forms of biocompatible water to the bladder  118 . If water is to be ingested down the esophagus, a water composition similar to drinking water may be used (e.g., frozen, partially frozen, and/or at a reduced temperature) and may include flavorants or, as mentioned above, nutritious and/or therapeutic constituent elements or components that are delivered or circulated therethrough. Accordingly, as illustrated in  FIGS. 3 and 6-8 , the shaft  106  of the probe  100  includes one or more openings or ports  120  therein to allow fluid in the lumen  119  to flow into the bladder  118 . In one exemplary embodiment, the distal end of the shaft  106  is open, thereby defining opening  120 . In addition, or in the alternative, the shaft  106  may have one or more lateral openings or ports  120  in the wall thereof to allow fluid to flow into the bladder  118 . 
     As briefly described above, in an exemplary embodiment, the subsystem  14  further includes the actuator  104 , such as, for example and without limitation, a flow-volume controller, a pressure controller, or both. The actuator  104  is disposed between the inflation lumen  119  and the fluid source  102 , and is configured to control the supply of fluid to the bladder  118 , and therefore, the inflation of the bladder  118 . In an exemplary embodiment, the actuator  104  is further configured to control the amount of fluid distributed from the bladder  118 . The actuator  104  may be mounted on or otherwise associated with the handle  108  of the probe  100 , or may be separate and distinct from the probe  100 . 
     In an exemplary embodiment, the cooling fluid supplied to the bladder  118  by the fluid source  102  is circulated between the bladder  118  and the fluid source  102 . More particularly, in an exemplary embodiment illustrated, for example, in  FIG. 3 , the probe  100  may further include a return or drainage lumen  121  (referred to hereinafter as “return lumen  121 ” and which may comprise lumen  119  or a separate and distinct lumen) disposed within the elongate shaft  106  to allow fluid to flow from the bladder  118  back to the fluid source  102  or to some other drain external to the patient. This allows, for example, fluid to be circulated through the system to facilitate the replacement of warmer fluid with cooler (i.e., pre-cooled) fluid, for example. In addition, it allows for much higher convective heat transfer from potential undesired esophageal-tissue hotspots. 
     In addition to aiding in the circulation (flow) of the fluid into the bladder  118 , the return lumen  121  may also provide a means by which the bladder  118  may be emptied or deflated once the ablation procedure is concluded or the heat sink  110 /bladder  118  is no longer needed (i.e., the actuator  104  may shut off the flow through the inflation lumen  119  and/or apply suction to the return lumen  121 , thereby causing the fluid to be drained from the bladder  118  through the return lumen  121 ). Such a return lumen  121  could also be used in the same manner in an embodiment that does not include circulation of the fluid during use of the probe  100 , but rather simply allows for the deflation of the bladder  118 . In any event, the shaft  106  of the probe  100  includes one or more openings or ports  122  therein to allow fluid in the bladder  118  to flow into the lumen  121 . In one exemplary embodiment, the distal end of the shaft  106  is open, thereby defining opening  122 . In addition, or in the alternative, the shaft  106  may have one or more lateral openings or ports  122  in the wall thereof to allow fluid to flow into the lumen  121 . 
     Accordingly, in operation, and in accordance with one exemplary embodiment, once the probe  100 , and the distal portion thereof, in particular, is inserted and appropriately positioned within the patient&#39;s body (e.g., opposite the ablation element  30 ), the bladder  118  is inflated or filled so as to contact the inner surfaces of the passageway within which the probe  100  is inserted (e.g., the inner wall of the esophagus). The bladder  118  and the fluid therein is configured to spread and transfer the heat from the tissue to and through the surface of the bladder  118  and into the fluid in the bladder  118  to quell any hotspots (see reference numeral  123  in  FIG. 3 , for example) in the region of non-targeted tissue in contact with the probe  100 . 
     In order to better distribute the heat from the non-targeted tissue about the surface of the bladder  118 , and thus, better transfer the heat away from the tissue, in an exemplary embodiment the outer surface of the bladder  118  is coated with a thermally conductive material, such as, for example, a metallic thin-film material and/or a hydrophilic hydrogel. 
     In another exemplary embodiment, the bladder  118  comprises a thin-walled unmetallized (bare) balloon with internally circulating (or at least convecting locally) fluid. In such an embodiment, the wall of the bladder  118  is so thin (on the order of 15-40 microns, for example) that only a very small thermal gradient of a couple of degrees Celsius can be maintained across it. For example, in an exemplary embodiment provided for illustrative purposes only, the tissue cannot get any hotter than 2° C. above the bladder circulating fluid despite unintended ablation heating (presuming intimate wetted contact between the bladder  118  and the tissue). As has been or will be described elsewhere herein, in an exemplary embodiment, the exterior surface of the bladder  118  is hydrophilic or wettable such that the bladder/tissue interface is well-coupled thermally. A number of techniques may be used to ensure that the outer surface of the bladder  118  stays wetted. For example, and as will be described in greater detail below, the wall of the bladder  118  may include fluid-weeping or spray perforations or holes therein, or be fluid permeable, to assure its outer surface and surrounding tissue stay wetted. In addition, or alternatively, the outer surface of the bladder  118  may be gel coated to assure wetted contact between the tissue and bladder  118 , and therefore, the heat sink  110 . In an exemplary embodiment, the bladder  118  is configured to weep fluid therefrom in order to maintain saturation of the gel coating the surface of the bladder  118 . 
     In an exemplary embodiment, the protective probe  100 , and the heat sink  110  thereof, in particular, may be further configured to force-cool the tissue by flushing the tissue with fluid from the bladder  118  and/or from the fluid source  102 . This force-cooling may be done prior to the commencement of an ablation procedure (i.e., pre-cooling the tissue), during the procedure, or a combination of the two. This may be accomplished in a number of ways. In one exemplary embodiment illustrated, for example, in  FIG. 4 , a plurality of perforations or holes  124  are formed in the wall of the bladder  118 . The holes  124  permit the fluid within the bladder  118  to flow therefrom and onto the outer surface of the bladder  118  and/or the tissue proximate thereto. Obviously, the larger the holes, the more fluid will be dispensed from the bladder  118 . 
     In another exemplary embodiment, the bladder  118  is configured to allow fluid to be sprayed therefrom and onto the surrounding tissue in an aerosol or steam-spray fashion. In this embodiment, the bladder  118  need not be designed to fit snugly against the esophageal wall and, in an exemplary embodiment, may be left hanging loosely in the esophagus. One means by which this may be done is to force air or gas into the bladder  118  causing the fluid in the bladder  118  to be dispensed or “sprayed” therefrom. Accordingly, an air-delivery lumen may be provided that extends from an air or gas source to the bladder  118 . In an exemplary embodiment, the air-delivery lumen may be the fluid delivery lumen  119  or, alternatively, may comprise a separate and distinct lumen. When activated, the air source sends a stream of air to the bladder  118  with enough force to cause the fluid therein to spray out of, for example, the holes  124 . In another exemplary embodiment, illustrated, for example, in  FIG. 5 , the bladder  118  includes one or more outlets  126  therein that are coupled to a fluid source, such as, for example, fluid source  102 , through one or more fluid delivery lumens, such as, for example, lumen  119 . In such an embodiment, when the fluid source  102  is activated, fluid is delivered directly to the outlet(s)  126  by the corresponding lumen(s) and is dispensed from the outlet to surrounding tissue. It will be appreciated that this particular embodiment may find application in embodiments of the probe  100  wherein the bladder  118  is inflated with gas or fluid. 
     In yet another exemplary embodiment, the bladder  118  is constructed of a fluid-permeable polymer that is configured to weep a film of fluid onto the outer surface of the bladder  118  when the bladder  118  is filled with fluid. In an exemplary embodiment, the polymer material may comprise, for example and without limitation, a porous urethane or a porous PEBAX®. It will be understood that the term “porous” as used herein is intended to mean permeable to fluid due to the presence of one or more apertures or holes, regardless of how or when the holes we formed in the bladder  118  (e.g., during manufacture of the bladder, or post manufacture by laser drilling or punching operations). 
     In any of the embodiments described above in which the bladder is configured to contact the wall of the esophagus and to expel or distribute fluid or gel onto the outer surface of the bladder  118  and/or surrounding esophageal tissue (or in an embodiment wherein the bladder  118  is pre-coated with a gel, for example), it may be desirable to maintain wetted contact between the bladder  118  and the tissue. Wetted contact assures low-resistance heat transfer across the bladder/tissue interface, and therefore, provides good heat-sinking capabilities. By distributing fluid and/or gel onto the outer surface of the bladder  118  and/or the surrounding tissue (or pre-coating the bladder  118  with gel), drying out of the interface as a result of the heat produced during the ablation procedure is substantially prevented. Additionally, in certain instances the bladder  118  may have folds, pleats, or creases as inflated against the wall of the esophagus. By distributing fluid or gel from the bladder  118 , or by pre-coating the bladder with a gel, gaps between the bladder and the tissue caused by the folds, pleats, or creases can be filled to preserve thermal conductivity. 
     In each of these embodiments, because cooling fluid is dispensed from the bladder  118  onto the surrounding tissue, it may be that a certain margin of tolerance is permitted with respect to the positioning of the heat sink  110  directly opposite the ablating device  18 , and the ablation element  30  thereof, in particular. It will be understood and appreciated that in some or all of these embodiments, the fluid dispensed from the bladder  118  will flow down the walls of the esophagus (presuming vertical orientation) protecting regions of non-targeted tissue even below the heat sink  110 , and the bladder  118  thereof, in particular. The patient may also be oriented with gravity in a manner to assure that it is the heart-facing portion of the esophagus that is wetted by the fluid. Additionally, in an exemplary embodiment, the bladder  118  is configured to be many times larger in area than the size of the potential thermal esophageal fistula, and therefore, only crude accuracy in placement is required. However, in order to aid accuracy of placement of the bladder  118  (and/or the balloons  36 , 38  discussed above) one or more tracking or visualization elements can be coupled thereto or therein. For example, one or more magnets, coils or electrodes can be utilized that are MRI-, radio- or fluoro-opaque, or responsive or capable of being visualized with an impedance-based system such as the EnSite NavX™ system commercially available from St. Jude Medical, Inc. Additionally, a fluoroscopic contrast-bearing fluid may be distributed within or onto the outer surface of the bladder  118  to allow for fluoroscopic imaging of the bladder  118  to assist in bladder  118  placement. 
     As briefly described above, each of the above-described embodiments may be used to cool the tissue during the performance of an ablation procedure, or to pre-cool the non-targeted tissue in the region proximate to or wherein an ablation procedure is to be performed. In the latter instance, the bladder  118  may be used to cool the tissue with the fluid from the bladder  118  a certain amount, such as, for example, 5-20° C. below natural body (esophagus) temperature. This provides even more temperature safety margin before a thermal fistula can be formed. 
     Accordingly, in view of the above, it will be understood and appreciated that the esophagus, or at least portions thereof, may be thermally protected by abutting the bladder  118  against the esophagus wall, and/or by spraying, leaking, weeping or otherwise dispensing fluid from the bladder  118  and onto the surrounding tissue from a distance of zero to several millimeters between the bladder and the tissue. Therefore, it will be further understood and appreciated that the bladder may or may not physically touch the tissue in order to protect the tissue. 
     Turning now to  FIGS. 6-8 , in an exemplary embodiment, a means for ensuring the probe  100 , and the tissue protecting apparatus  110  thereof, in particular, is positioned in close proximity to the ablation site, and therefore, the ablation element  30  of the ablating device  18 , is provided. In an exemplary embodiment wherein the tissue protecting apparatus  110  does perform a heat sinking function, the degree of wetted or acoustic contact between the heat sink  110  and the tissue may also be determined. This locating and/or degree of contact functionality ensures that the tissue protecting apparatus  110  is positioned in an area in which hotspots are most likely to be generated, and it may be carried out in a number of ways. 
     In an exemplary embodiment, known imaging systems or modalities that allow the user of the system  10  to visually determine where the probe  100  is positioned, and to then confirm whether it is in an acceptable location, may be employed. One such imaging modality, which is provided for exemplary purposes only and not meant to be limiting in nature, is fluoroscopy. Fluoroscopy provides a real-time image of a region of interest of a patient&#39;s anatomy and medical devices disposed therein, and therefore, is a good imaging system for real-time probe location detection/confirmation. In an embodiment of the system  10  employing fluoroscopy, markers, such as radio opaque markers or other markers well known in the art, may be placed in or on the probe  100  and the tissue protecting apparatus  110 , in particular, to allow for them to be visualized or imaged by the fluoroscopic imaging system. Alternatively, in an embodiment wherein the tissue protecting apparatus includes a fluid-inflatable bladder, the fluid within the bladder  118  may contain a fluoroscopic contrast agent or other imaging-modality contrast agent to allow the bladder  118  to be visualized using fluoroscopy or another imaging modality. Additionally, or alternatively, the material of the bladder  118  may itself be fluoroscopically visible. In any instance, this allows for the verification of bladder placement and inflation. 
     In another exemplary embodiment illustrated in  FIG. 6 , an acoustic transducer  128  electrically connected to circuitry associated with the system  10 , such as, for example the ablating subsystem  12 , the temperature monitoring and management subsystem  14 , or the system controller  16 , is mounted or otherwise disposed on the ablating device  18  in close proximity to the ablation element  30 . In an exemplary embodiment, a processor  130  is also provided, which may be part of either the ablation subsystem  12 , the temperature monitoring and management subsystem  14 , or, as illustrated in  FIG. 1 , the system controller  16 , and is electrically connected to the transducer  128 . 
     The acoustic transducer  128  is configured to emit acoustic waves directed toward the ablation site, and therefore, in the direction of where the distal portion of the probe  100  should be located, to ping the probe  100 , and preferably, the tissue protecting apparatus  110  thereof, in particular. The acoustic transducer  128  is further configured to receive a pulse-echo reflection of the signal and to communicate that signal to the processor  130 . From the sent and received signals, the processor  130  can determine whether the probe  100  is properly positioned and/or whether there is a high degree of wetted or acoustic contact between the probe  100  and the tissue using methods well known in the art (e.g., a large reflection is indicative of an air-filled esophagus without the probe  100  (e.g., the bladder  118 ), and a much smaller reflection is indicative of the wet-coupled presence of the probe  100  (e.g., the bladder  118 ). Additionally, or alternatively, in an embodiment including the inflatable bladder  118 , a microbubble contrast agent, such as, for example, a liposome-based material, may be put in the inflating fluid such that it can be acoustically recognized as a large reflector). This indication can then be provided to the practitioner performing the ablation procedure either audibly or visually, such as, for example, on a display monitor or through an audio indicator. 
     Additionally, or alternatively, in an exemplary embodiment wherein one or more focused ultrasonic ablators (e.g., HIFU ablator) is employed by the ablating subsystem  12 , the ablator may be configured to acoustically detect, in a pinging mode similar to that described above, the acoustical/thermal contact of the opposed tissue protecting apparatus  110  and the tissue. 
     In still another exemplary embodiment illustrated, for example, in  FIG. 7 , the subsystem  14  includes an acoustic transducer  132  coupled with or mounted to the probe  100 , preferably at the distal end  114  thereof (as opposed to the transducer being mounted to the ablating device). In an exemplary embodiment, a processor  134  is further provided and electrically connected to the transducer  132 . The processor  134  may be part of the subsystem  14 , or in other exemplary embodiments, part of the ablation subsystem  12  or the system controller  16  (as is illustrated in  FIG. 1 ). The acoustic transducer  132  is configured to emit acoustic waves in the perceived direction of the ablation site, and therefore, in the direction of where the ablating device  18 , and the ablation element  30  thereof, in particular, should be located, to ping or bounce low power energy off of the ablating device  18 . The acoustic transducer  132  is further configured to receive a pulse-echo reflection of the signal and to communicate that signal to the processor  134 . From the sent and received signals, the processor  134  can determine whether the probe  100  is properly positioned relative to the ablating device  18  using methods well known in the art (e.g., a weak return signal indicative of the ablating device  18  not being present, while a strong return signal indicative of proper, or at least close, placement of the probe  100  relative to the ablating device  18 ). This indication can then be provided to the practitioner performing the ablation procedure audibly and/or visually, for example. This particular embodiment provides the advantage that the “coupling” (e.g., thermal coupling) between the ablating device  18  and the probe  100  can be monitored throughout the performance of an ablation procedure without disrupting the operation of the ablating device  18 . 
     In yet still another exemplary embodiment illustrated in  FIG. 8 , the subsystem  14  further includes a temperature monitoring apparatus at least a portion of which is coupled, mounted, otherwise disposed within or on the probe  100  at or near the distal end thereof. In an exemplary embodiment, the temperature monitoring apparatus includes a thermal imaging chip  136  that is mounted to the probe  100  proximate the distal end thereof. In another exemplary embodiment described below, the temperature monitoring apparatus comprises the thermal imaging chip  136  as well as an imaging fiber bundle electrically connected to said thermal imaging chip  136 . In such an embodiment, a portion of the imaging fiber bundle is disposed proximate the distal end of the probe  100 . In either embodiment, the temperature monitoring apparatus (e.g., the thermal imaging chip  136 , for example) has a field of view  138  and is configured to generate an image or images of the tissue, such as, for example, esophageal tissue, disposed within the field of view  138 . In an exemplary embodiment, the thermal imaging chip  136  is an infrared imaging chip, such as, for example, a mid-IR or long-IR wavelength infrared imaging chip, and is further configured to visually detect temperatures of the imaged tissue. In the illustrated embodiment, the tissue protecting apparatus  110  (i.e., the inflatable bladder and components thereof), is configured to act as a clamp of sorts to stabilize the position of the probe  100  to provide a desired line-of-sight for the thermal imaging chip  136 . 
     In one exemplary embodiment, the tissue protecting apparatus  110  does not dispense fluid as described above, and, if the tissue protecting apparatus  110  includes an inflatable component, it may or may not be inflated with fluid. In another exemplary embodiment, however, wherein the tissue protecting apparatus  110  includes an inflatable bladder, such as, for example, bladder  118 , in addition to stabilizing the position of the probe  100 , the bladder  118  may be inflated with, and/or configured to dispense, fluid therefrom as described above. It will be understood by those having ordinary skill in the art that when using infrared thermography, such as, for example, those techniques identified above, it is the nearest surface of the tissue or surface of the fluid-covering the tissue that is being visualized or imaged. The surface temperature is thus being measured and not the potentially much hotter interstitial tissue of the targeted tissue, or for that matter, the non-targeted tissue. Additionally, in certain embodiments, the temperature monitoring apparatus, or at least a portion thereof, may be disposed within the fluid in the bladder  118 . Accordingly, in such an embodiment, the fluid used to inflate and/or cool the tissue must be an infrared transparent (as opposed to opaque) fluid such that thermography works even through the fluid, and the temperature monitoring apparatus can look through or from within the fluid. 
     Additionally, in an exemplary embodiment, the thermal imaging chip  136  may have a lens or window  140 , and the lens  140  may be warmed in order to prevent it from fogging so as to maximize the resolution and contrast of the images. Further, the thermal imaging chip  136  may include a protective covering (not shown) in case the thermal imaging chip  136  comes into contact with tissue. 
     In one exemplary embodiment, using known techniques, the temperature monitoring apparatus is configured to determine the highest temperature in the imaged tissue, and to communicate the same to a processor  142  (shown in  FIG. 1 ) or other circuitry associated with subsystem  14  (or the ablation subsystem  12  or the system controller  16 ). The processor  142  is configured, at least in part, to compare the determined highest temperature or a too-rapid time rate of change measured surface temperature with a predetermined threshold temperature or rate of change, and to provide the practitioner performing the ablation procedure an audible and or visual warning if the measured highest temperature approaches or reaches the predetermined threshold (e.g., a temperature at or near the highest temperature at which burning or damage to the esophageal tissue is not expected to occur, or a predetermined rate of change threshold). For example, the subsystem  14  may further include an alarm system controllable by, for example, the processor  142 , to provide an audible and/or haptic warning that the threshold has been met or is being approached, and/or a display monitor  144  (best shown in  FIG. 1 ) controllable by, for example, the processor  142 , to display the imaged tissue, as well as a visual warning that the threshold has been met or is being approached. This information may be further communicated to the system controller  16 , for example, or to ablation subsystem  12 , which may then cause the ablating device  18  to be turned “off” or turned “down” in order to prevent or mitigate burning in the esophageal tissue, for example, or to take other corrective or mitigating actions. The detected thermal hotspot may also be used to predict the temperature trajectory and have the system undertake preventative or warning actions, and/or to control the ablative energy level. In an exemplary embodiment, low energy may be delivered by the ablating device  18  for purposes of estimating how hot the esophageal tissue will get at higher ablation energy. 
     In an exemplary embodiment, the predetermined temperature/rate of change threshold may be adjustable so as to allow for the adjustment of the sensitivity of the system. In such an embodiment, the subsystem  14  may include a conventional user input device electrically coupled to, and configured for communication with, the processor  142  to allow for the adjustment of the threshold. Accordingly, in such an embodiment, the processor  142  may be preprogrammed with an initial threshold, and then reprogrammed to adjust the threshold, or may be programmable. Alternatively, the predetermined threshold may be a preprogrammed and fixed value that may not be adjusted. 
     In another exemplary embodiment, the thermal imaging chip  136 , and/or other circuitry of the temperature monitoring apparatus or subsystem  14 , such as, for example and without limitation, the processor  142 , may be configured to generate a thermographic map  146  of the imaged tissue (best shown in  FIG. 9 ). The thermographic map  146  depicts the temperature of various areas of the imaged tissue. In such an embodiment, the display monitor  144  may be configured to display and/or store a temporal representation of the generated thermographic map  146 . The thermographic map may be color coded by temperature, or may provide other indicators of the respective detected and depicted temperatures. 
     As briefly described above, in addition to the thermal imaging chip  136 , in an exemplary embodiment the temperature monitoring apparatus may also include an imaging fiber bundle that is electrically connected to the thermal imaging chip  136 . In such an embodiment, rather than or in addition to the imaging chip  136  being inserted into the patient&#39;s anatomy, the imaging fiber bundle is inserted into the patient&#39;s body. Because the imaging fiber bundle is electrically connected to the thermal imaging chip  136 , the thermal imaging chip  136  is optically coupled to the interior anatomical site with the image fiber bundle. In this embodiment, the imaging chip  136  may be disposed, for example, within the probe  100 , in the handle  108  thereof, or elsewhere within the temperature management and monitoring subsystem  14 . 
     In another exemplary embodiment, rather than incorporating both the tissue protecting apparatus  110  and the temperature monitoring apparatus, the probe  100  may only include the temperature monitoring apparatus disposed at the distal end  114  thereof. In such an embodiment, the description set forth above relating to the temperature monitoring apparatus and its functionality applies here with equal force, and therefore, will not be repeated. Additionally, it will be appreciated that while in one exemplary embodiment, the probe  100  may be passed down the throat of the patient by itself, in another exemplary embodiment the probe  100  may be used in conjunction with a sheath. 
     Advantages offered by the use of the thermal imaging chip  136  include the ability to display the entire temperature map of the imaged tissue without having to perform any interpolation, which is required in physical thermistor arrays. Additionally, there are generally no loss-of-contact issues as the chip provides a visual image as opposed to taking measurements of the surface of the tissue itself. Finally, a wide view of a passageway, such as, for example, the esophagus can be achieved without having to move the probe once it is properly positioned. 
     With reference to  FIG. 10 , an exemplary method of monitoring temperature in a region of non-targeted tissue during an ablation procedure performed on targeted tissue proximate the non-targeted region of tissue will be described. In a first step  148 , a probe including a temperature monitoring apparatus with a field of view  138  is provided. In a second step  150 , tissue within the field of view  138  and also disposed within the desired region of tissue is imaged by the temperature monitoring apparatus (e.g., the imaging chip  136 ). In a third step  152 , at least one temperature within the imaged tissue is determined. In an exemplary embodiment, step  152  comprises detecting the highest temperature in the imaged tissue, and fourth step  154  comprises initiating a warning if the detected highest temperature exceeds a predetermined threshold. Alternatively, a warning may be provided if the temperature is approaching the threshold temperature or if it is anticipated that the temperature threshold will be exceeded. In another exemplary embodiment, step  152  comprises determining a rate of change of the temperature in the tissue, and fourth step  154  comprises initiating a warning if the determined rate of change exceeds a predetermined threshold. Alternatively, a warning may be provided if the rate of change is approaching the threshold or if it is anticipated that the threshold will be exceeded. Still further, other actions in addition to, or instead of, providing a warning may be carried out. For example, a step  155  includes throttling or gating the ablation energy being applied by the ablating device to reduce or stop the application of ablation energy. 
     In another exemplary embodiment, step  152  comprises detecting a plurality of temperatures in the imaged tissue, and a subsequent step  156  includes generating a thermographic map corresponding to the detected plurality of temperatures. In a still further subsequent step  158 , the generated thermographic map is displayed on a display monitor and/or stored in a storage medium. 
     The following examples of various embodiments of the invention, and/or further and other aspects of the invention, are provided for illustrative purposes and are not meant to be limiting in nature. 
     Example (1) 
     A system for performing an ablation procedure, comprising: an ablation subsystem including a thermal ablation device configured to be inserted into the anatomy of a patient and to deliver thermally heating ablating energy to a target ablation site; and a temperature monitoring and management subsystem including a protective probe configured to be inserted into the anatomy of said patient and positioned in close proximity to a region of non-targeted tissue proximate said targeted ablation site at a second site to be protected from said nearby ablation, said probe including a heat sink comprising a balloon, membrane or bladder (collectively referred to as “bladder”) disposed at a distal portion of said probe and configured to be inflated or flushed with a cooling or heat-extracting fluid; and a fluid source configured to be coupled to said bladder and to supply fluid to said bladder; said heat sink of said temperature monitoring and management subsystem configured to transfer or remove heat generated or deposited in tissue in said region of non-targeted tissue by said ablating device such that it is not ablated. The bladder may also be coated with a hydrophilic gel or coating. 
     Example (2) 
     The system of example (1) wherein tissue in said region of non-targeted tissue is also pre-cooled below its natural body temperature by said bladder or heat sink thereby providing additional protection from unintended ablation. 
     Example (3) 
     The system of example (1) wherein said ablating device is configured to be inserted into the heart of a patient and said probe is configured to be inserted into the esophagus of said patient, and wherein the target ablation site is an endocardial tissue in a heart wall, and said second site is a nearby esophageal portion. 
     Example (4) 
     The system of example (3) wherein the ablating device is meant to ablate at least a portion of a pulmonary artery or ostium thereof. 
     Example (5) 
     The system of example (1) wherein the ablating device utilizes any one or more of radio frequency (RF), microwave, laser, or ultrasound ablation energy. 
     Example (6) 
     The system of example (1), further comprising a system controller electrically connected to said ablation subsystem and said temperature monitoring and management subsystem. 
     Example (7) 
     The system of example (1) further comprising a temperature monitor or temperature controller which is capable of at-least detecting a temperature of a tissue, a heat sink or a heat sinking fluid. 
     Example (8) 
     The system of example (1) wherein said bladder has an outer surface and said outer surface is lined with a thin film metallic material and/or a hydophilic coating. 
     Example (9) 
     The system of example (1) wherein said bladder includes a plurality of microscopic holes or permeable paths therein to allow fluid in said bladder to flow or permeate out of said bladder to the outer surface of the bladder. 
     Example (10) 
     The system of example (1) wherein said bladder is constructed of a water permeable polymer configured to weep a film of fluid onto the outer surface of said bladder when said bladder is filled with fluid. 
     Example (11) 
     The system of example (1) wherein said bladder is designed to be hydrophilic or water-wettable regardless of whether fluid is delivered to the bladder surface from the bladder interior. 
     Example (12) 
     The apparatus of example (1) wherein said bladder includes at least one outlet therein configured to allow fluid to be sprayed, sheeted or dripped therefrom upon or across a protectable tissue surface. 
     Example (13) 
     The system of example (1) wherein said ablating device includes an acoustic transducer mounted thereon, said acoustic transducer electrically connected to a processor, and further wherein said acoustic transducer and said processor are configured to determine a location and/or a degree-of-contact of said probe relative to esophageal tissue. 
     Example (14) 
     The system of example (13) wherein said acoustic transducer is configured to transmit an acoustic signal and to receive a reflected acoustic signal corresponding to said transmitted acoustic signal reflected by said probe, said processor configured to process said transmitted and received acoustic signals and to determine said relative location of said probe or how well said probe is acoustically and therefore thermally coupled to the esophagus. A low acoustic reflection is indicative of a good thermally conducting wetted interface between the bladder and the tissue. 
     Example (15) 
     The system of example (1) wherein said probe further includes an acoustic transducer mounted thereon, said acoustic transducer electrically connected to a processor, and further wherein said acoustic transducer and said processor are configured to determine a location of said probe relative to said region of non-targeted tissue. 
     Example (16) 
     The system of example (15) wherein said acoustic transducer is configured to transmit an acoustic signal toward said region of non-targeted tissue and to receive a reflected acoustic signal corresponding to said transmitted acoustic signal reflected by tissue in said region of non-targeted tissue, said processor configured to process said transmitted and received acoustic signals to determine said relative location of said probe. 
     Example (17) 
     The system of example (1) wherein said probe further includes an thermal imaging chip mounted thereon, said thermal imaging chip having a field of view and configured to generate a thermal image of tissue in said region of non-targeted tissue that is disposed within said field of view, said imaging chip further configured to detect temperatures of said imaged tissue. 
     Example (18) 
     The system of example (17) wherein said thermal imaging chip is configured to generate a thermographic map corresponding said imaged tissue. 
     Example (19) 
     The system of example (18), further comprising a display monitor electrically connected to said imaging chip and configured to display said thermographic map. 
     Example (20) 
     The system of example (17) wherein said thermal imaging chip is configured to detect the highest temperature in said imaged tissue or in a fluid film on said tissue. 
     Example (21) 
     The system of example (17) wherein said bladder is operative to act as a clamp to stabilize a position of said imaging chip to provide a desired line-of-sight for said imaging chip. 
     Example (22) 
     A system for monitoring temperature in a region of non-targeted tissue not to be ablated during an ablation procedure performed on tissue proximate said region of non-targeted tissue, comprising a probe including an elongate shaft having a proximal end, a distal end, and an inflation or filling lumen disposed therein, said elongate shaft defining a longitudinal axis extending from said proximal end through said distal end; a handle disposed at said distal end; and a heat sink, wherein said heat sink comprises a bladder disposed at said distal end of said elongate shaft and extending therefrom a predetermined distance along said longitudinal axis of said elongate shaft toward said proximal end of said elongate shaft, wherein said bladder is configured to be filled with a fluid; a fluid source, wherein said inflation or filling lumen of said elongate shaft is coupled between and to each of said fluid source and said bladder, and said fluid source is configured to supply fluid to said bladder through said inflation or filling lumen; and an actuator configured to cause said balloon to be filled, emptied, flushed with fresh replacement fluid through its interior, or to emit fluid from at least one orifice or pore in its surface. 
     Example (23) 
     The system of example (22) wherein said actuator is mounted on or in said handle of said probe. 
     Example (24) 
     The system of example (22) wherein said actuator is associated with said fluid source. 
     Example (25) 
     The system of example (22) wherein said bladder has an outer surface and said outer surface is lined with a thin film metallic material and/or has a hydrophilic coating thereon. 
     Example (26) 
     The system of example (22) wherein said bladder includes a plurality of microscopic holes, pores, or permeable paths therein to allow fluid in said bladder to flow out of said bladder. 
     Example (27) 
     The system of example (22) wherein said bladder is constructed of a water permeable polymer configured to weep a film of fluid on the outer surface of said bladder when said bladder is filled with fluid. 
     Example (28) 
     The apparatus of example (22) wherein said bladder includes at least one outlet therein configured to allow fluid to be sprayed, sheeted or dripped therefrom across the surface of a protectable tissue. 
     Example (29) 
     The system of example (22) wherein said heat sink further includes a return lumen disposed between, and in fluid communication with, said bladder and said fluid source, said return lumen configured to return fluid from said bladder to said fluid source or to a patient-external drain. 
     Example (30) 
     The system of example (22), further comprising an acoustic transducer mounted on an ablating device performing said ablation procedure, said acoustic transducer electrically connected to a processor, and said acoustic transducer and said processor configured to determine a location of said probe relative to said ablating device or to determine a degree of wetted or acoustic coupling between said probe and said tissue. The ablation device in this example may be a HIFU ablation device wherein the HIFU ablation and pinging are both done by the same transducer. 
     Example (31) 
     The system of example (30) wherein said acoustic transducer is configured to transmit an acoustic signal and to receive a reflected acoustic signal corresponding to said transmitted acoustic signal reflected by said probe, said processor configured to process said transmitted and received acoustic signals and to determine said relative location of said probe or to determine a degree of wetted or acoustic coupling between said probe and said tissue. 
     Example (32) 
     The system of example (22), further comprising an acoustic transducer mounted to said elongate shaft of said probe proximate said distal end thereof and electrically connected to a processor, said ultrasound transducer and said processor configured to determine a location of said probe relative to said region of non-targeted tissue or to determine a degree of wetted or acoustic coupling between said probe and said tissue. 
     Example (33) 
     The system of example (22) wherein said acoustic transducer is configured to transmit an acoustic signal toward said region of non-targeted tissue and to receive a reflected acoustic signal corresponding to said transmitted acoustic signal reflected by tissue in said region of non-targeted tissue, said processor configured to process said transmitted and received acoustic signals to determine said relative location of said probe or to determine a degree of coupling between said probe and said tissue. 
     Example (34) 
     The system of example (22), further comprising an thermal imaging chip mounted to said elongate shaft of said probe proximate said distal end thereof, said thermal imaging chip having a field of view and configured to generate an image of tissue in said region of non-targeted tissue disposed within said field of view, said imaging chip further configured to detect temperatures of said imaged tissue. 
     Example (35) 
     The system of example (34) wherein said imaging chip is configured to generate a thermographic map corresponding said imaged tissue. 
     Example (36) 
     The system of example (35), further comprising a display monitor connected to said thermal imaging chip and configured to display said thermographic map. 
     Example (37) 
     The system of example (34) wherein said thermal imaging chip or supportive software analyzing the image is configured to detect the highest temperature in said imaged tissue. 
     Example (38) 
     The system of example (34) wherein said bladder is operative to act as a clamp to stabilize a position of said thermal imaging chip to provide a desired line-of-sight for said imaging chip. 
     Example (39) 
     An apparatus for use in monitoring and/or managing temperature in a region of non-targeted tissue during an ablation procedure performed proximate said region of non-targeted tissue, comprising an elongate shaft having a proximal end, a distal end, and an inflation lumen disposed therein, said elongate shaft defining a longitudinal axis extending from said proximal end through said distal end; a handle disposed at said proximal end; a heat sink, wherein said heat sink assembly comprises a bladder disposed at said distal end of said elongate shaft and extending therefrom a predetermined distance along said longitudinal axis of said elongate shaft toward said proximal end of said elongate shaft, said bladder coupled with said inflating lumen and configured to be filled with a heat-transfer or cooling fluid supplied by a fluid source to which said bladder is coupled; and an actuator or valve configured to cause said bladder to be at least partially filled or emptied of fluid and preferably to also weep or spray fluid from its surface upon or across tissue. 
     Example (40) 
     The apparatus of example (39) wherein said bladder has an outer surface and said outer surface is lined with a thin film metallic material and/or a hydrophilic coating. 
     Example (41) 
     The apparatus of example (39) wherein said bladder includes a plurality of microscopic holes, pores, or permeable paths therein to allow fluid in said bladder to flow out of said bladder at least to the outer surface of the bladder. 
     Example (42) 
     The apparatus of example (39) wherein said bladder is constructed of a water permeable polymer configured to weep or permeate a film of fluid on or onto the outer surface of said bladder when said bladder is filled with fluid. 
     Example (43) 
     The apparatus of example (39) wherein said bladder includes at least one outlet or orifice therein configured to allow fluid to be sprayed, sheeted or dripped therefrom. 
     Example (44) 
     The apparatus of example (39) wherein said heat sink further includes a return lumen disposed between, and in fluid communication with, said bladder and said fluid source, said return lumen configured to return fluid from said bladder to said fluid source or to a patient-external drain. 
     Example (45) 
     The apparatus of example (39), further comprising an acoustic transducer mounted to said elongate shaft proximate said distal end thereof and electrically connected to a processor, said ultrasound transducer and said processor configured to determine a location of said apparatus relative to said region of non-targeted tissue or to determine a degree of wetted or acoustic coupling between said probe and said tissue. 
     Example (46) 
     The apparatus of example (45) wherein said acoustic transducer is configured to transmit an acoustic signal toward said region of non-targeted tissue and to receive a reflected acoustic signal corresponding to said transmitted acoustic signal, and said processor is configured to process said transmitted and received acoustic signals to determine said relative location of said apparatus or to determine a degree of wetted or acoustic coupling between said probe and said tissue. 
     Example (47) 
     The apparatus of example (39), further comprising a thermal imaging chip mounted to said elongate shaft proximate said distal end thereof, said thermal imaging chip having a field of view and configured to generate an image of tissue in said region of non-targeted tissue disposed within said field of view, said imaging chip further configured to detect temperatures of said imaged tissue. 
     Example (48) 
     The apparatus of example (47) wherein said thermal imaging chip is configured to generate a thermographic map corresponding said imaged tissue. 
     Example (49) 
     The apparatus of example (47) wherein said thermal imaging chip or supportive software is configured to detect the highest temperature in said imaged tissue. 
     Example (50) 
     The apparatus of example (47) wherein said bladder is operative to act as a clamp to stabilize a position of said imaging chip to provide a desired line-of-sight for said imaging chip. 
     Example (51) 
     An apparatus for use in monitoring temperature in a region of non-targeted tissue during an ablation procedure performed on targeted tissue proximate said region of non-targeted tissue, comprising: a probe having a proximal end and a distal end; and an infrared thermal imaging chip mounted to said probe proximate said distal end thereof; wherein said thermal imaging chip has a field of view and is configured to generate an image of tissue in said region of non-targeted tissue disposed within said field of view, and further wherein said imaging chip, or supportive software working with the image, is configured to detect temperatures of said imaged tissue. 
     Example (52) 
     The apparatus of example (51) wherein at least a portion of said probe containing said thermal imaging chip is configured to be disposed within the body of a patient. 
     Example (53) 
     The apparatus of example (51) wherein at least a portion of said probe containing said thermal imaging chip is configured to be disposed outside of the body of a patient. 
     Example (54) 
     The apparatus of example (51) wherein said thermal imaging chip is configured to generate a thermographic map corresponding said imaged tissue. 
     Example (55) 
     The apparatus of example (54), further comprising a display monitor connected to said thermal imaging chip and configured to display said thermographic map. 
     Example (56) 
     The apparatus of example (51) wherein said thermal imaging chip or software used to analyze the image is configured to detect the highest temperature in said imaged tissue. 
     Example (57) 
     The apparatus of example (51), wherein said probe further comprises an inflatable clamp mounted thereon to stabilize a position of said thermal imaging chip when inflated to provide a desired line-of-sight for said imaging chip. 
     Example (58) 
     The apparatus of example (51) wherein said imaging chip is a CCD chip which may optionally also have visible-wavelength imaging capabilities. 
     Example (59) 
     The apparatus of example (51) wherein said imaging chip is a CMOS chip which may optionally also have visible-wavelength imaging capabilities. 
     Example (60) 
     A method of monitoring temperature in a region of non-targeted tissue during an ablation procedure performed on targeted tissue proximate said region of non-targeted tissue, said method comprising: providing a probe including an infrared thermal imaging chip having a field of view; imaging tissue within said field of view of said thermal imaging chip and disposed within said region of non-targeted tissue; and detecting at least one temperature of said imaged tissue. 
     Example (61) 
     The method of example (60) wherein said detecting step comprises detecting the highest temperature in said imaged tissue. 
     Example (62) 
     The method of example (61), further comprising the step of initiating a warning or throttling/gating ablation power if said detected highest temperature exceeds or is anticipated to exceed a predetermined threshold. 
     Example (63) 
     The method of example (60) wherein said detecting step comprises detecting a plurality of temperatures in said imaged tissue. 
     Example (64) 
     The method of example (63), further comprising the step of generating a thermographic map corresponding to said detected plurality of temperatures. 
     Example (65) 
     The method of example (64), further comprising the step of displaying said thermographic map on a display monitor. 
     Example (66) 
     An ablating device, comprising an elongate shaft having a proximal end and a distal end; a handle mounted to said elongate shaft at said proximal end thereof; and an ablation element mounted to said elongate shaft at said distal end, said ablation element including an ultrasound transducer and at least one inflatable balloon surrounding said ultrasound transducer, and wherein said balloon having an inner surface and an outer surface, and said balloon further having a layer of semisolid gel or hydrophilic coating disposed on at least a portion of said outer surface at-least during ablative operation. The gel or hydrophilic coating allowing for an external balloon surface to provide a reliable flow-seal against blood flow during an ablation procedure. 
     Example (67) 
     The ablation device of example (66) wherein said gel or coating is configured to become more solid or less flowable when heated or while warmed. 
     Example (68) 
     The ablation device of example (67) wherein said gel or coating is configured to become more flowable or more liquid-like when cooled from at least one higher temperature to at least one lower temperature. 
     Example (69) 
     The ablation device of example (67), further comprising a heating or cooling device configured to apply or remove heat to/from said gel or coating in order to change its degree of solidity or flowability. 
     Example (70) 
     The ablation device of example (66) wherein the gel or coating is introduced into the device as a flowable liquid, is thermally rendered semisolid or poorly flowable during ablation, and is thereupon thermally rendered again flowable after ablation. 
     Example (71) 
     The ablation device of example (66) wherein said at least a portion of said outer surface of said balloon is coated with said gel or hydrophilic coating material prior to said elongate shaft being inserted into a patient, and/or by passage of gel or coating material from inside the balloon through the balloon wall to the outer balloon surface. 
     Example (72) 
     The ablation device of example (71) wherein said gel or coating material is distributed onto said at least a portion of said outer surface of said balloon after said balloon is inflated. 
     Example (73) 
     The ablation device of example (72) wherein said balloon further includes at least one port disposed therein configured to distribute said gel or coating material onto said at least a portion of said outer surface of said balloon. 
     Example (74) 
     The ablation device of example (73), further comprising a gel or coating distribution lumen disposed in said elongate shaft and extending from said proximal end to said distal end, said lumen being coupled to said port and configured to communicate said liquefying gel or coating material from a source to said port. 
     Example (75) 
     A method of ablating pulmonary vein ostia or any portion of a myocardium while thermally protecting a nearby esophagus from ablation comprising: a thermal ablation device operable from within the heart to ablate one or more ostia, myocardial tissues, or portions thereof; a heat sinking protective probe insertable down an esophagus to thermally couple to esophageal tissues to be protected from ablation taking place nearby in the heart; wherein at least one of (a) the heat sinking probe pre-cools the protectable esophageal tissues thereby providing increased thermal margin for ablation protection of those protected tissues; and (b) the heat sinking probe acts to sink away heat for potential undesirable hotspots developed in the esophagus by the nearby thermal ablator. 
     Example (76) 
     The method of example (75) wherein any one or more of: (a) the heat sinking probe utilizes a thermally conductive fluid or utilizes a circulated fluid; (b) the heat sinking probe utilizes a fluid inflatable balloon, membrane or bladder; (c) the heat sinking probe is inflated at least partially against interior esophageal tissues; (d) the heat sinking probe is rendered hydrophilic or water wettable on its external surface during manufacturing or during use; (e) the thermal ablator is any one of an RF, microwave, laser, cryogenic or ultrasonic ablator; and (f) the heat sinking probe sprays, weeps, sheets, or drips fluid across or upon an esophageal tissue to be protected. 
     Example (77) 
     In any of the above examples, the transducer of the ablation element may be rotated during an ablation procedure to counteract an angular non-uniformity of the transducer output via rotational averaging. This is particularly applicable to a non-uniform 360 degree piezotube which benefits from rotation or to a sector transducer of less than 360 degrees which must be rotated. 
     Although only certain embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the scope of this invention. For example, various types of gel and many different gel dispensing techniques may be used to prevent blood leakage during an ablation procedure, and the gel may be distributed onto the outer surface of one or more of the balloon(s) in a number of ways. Further, the heat sink of the temperature monitoring and management subsystem may be inflated, and also cool proximate tissue, in any number of ways. Still further, the determination of the location of the probe of the temperature monitoring subsystem may be accomplished using various other methodologies or techniques. Additionally, any and all directional references (e.g., up, down, left, right) are only used for identification purposes to aid the reader&#39;s understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, mounted and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected/coupled and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the invention as defined in the appended claims.