Abstract:
A device and method for treating intraluminal tissue employ an inflatable member having a plurality of heating zones adapted for selective activation, whereby one or more of the heating zones can be activated, by one or more energy sources, to deliver heat to selected intraluminal tissue. The inflatable member can be a balloon that is attached to a catheter having a plurality of passageways for delivering fluids (i.e., liquid or air) to internal chambers of the balloon, thereby inflating the balloon. Each energy source is positioned within a corresponding chamber and may be any one of various types, including a piezoelectric cylinder, a microwave antenna, a cylindrical RF (radio-frequency) source, or a resistive heating coil.

Description:
FIELD OF THE INVENTION 
   The present invention relates to a device and a method for selectively treating intraluminal tissue, especially intraluminal tissue that is diseased. 
   BACKGROUND OF THE INVENTION 
   There are a number of surgical procedures that relate to the treatment of intraluminal tissue, i.e., tissue located within a luminal structure such as the esophagus, colon, fallopian tube or urethra. Some of these procedures involve treating intraluminal tissue that is otherwise healthy, while others involve the treatment of diseased intraluminal tissue. For example, during a tubal sterilization procedure on a female patient, the intraluminal mucosal tissue of the fallopian tubes is defunctionalized by heating the tissue, thereby destroying it. In addition, one type of surgical treatment for stress incontinence involves heating the intraluminal tissue of the urethra, thereby shrinking or partially occluding the inner passage of the urethra so as to impede the passage of urine to a small, but necessary, degree. These are only a couple examples of the medical conditions and reasons that involve the controlled treatment of selected intraluminal tissue. 
   With reference to the treatment of diseased intraluminal tissue, there are various intraluminal disorders that occur in the tissues of luminal structures, including, but not limited to, the esophagus, jejunum, small intestine, fallopian tubes, colon and rectum. Left untreated, such diseases may progress into more serious, and potentially life-threatening, diseases. For example, in Barretts&#39; esophagus the intraluminal mucosal lining has hyperplastic cells that, if left untreated, are at a very high risk over time of developing into malignant tissue, i.e., cancer. 
   Successful treatment of many such intraluminal disorders can be achieved by the application of heat to the diseased intraluminal tissue from within the luminal structure. However, application of heat radially to the entire circumference of the lumen may result in the unnecessary heating of healthy tissue and, in some cases, also causes stenosis of the luminal structure. Thus, it is preferable for the heat treatment to be applied selectively to the diseased intraluminal tissue or to treat the diseased intraluminal tissue in specified zones spaced over time. 
   Various methods of treating intraluminal disorders, achieving varying degrees of success, have been developed. For example, coagulation of the mucosal layer of Barretts&#39; esophagus has been attempted using argon beam coagulation. This method of treatment has been less than optimal for the following reasons. First, the argon beam is difficult to initiate when the device is parallel to the esophagus wall. Second, the argon beam requires the surgeon to be relatively close to the esophagus wall. Lastly, the beam quickly quenches and thus leaves a small area of mucosal tissue treated, with untreated zones around it, which results in very spotty, discontiguous treatment of the diseased mucosal tissue. 
   In addition to the foregoing treatment method, other methods have used surgical ablation tools that require pressure against the mucosa and movement around the target region. Mucousectomy is another treatment method, which involves the surgical removal of the thin mucosal layer of the esophagus. A mucousectomy is difficult to perform because the instrumentation currently available in the GI endoscopy suite does not provide good access to the intraluminal area to be treated. 
   The device and method of the present invention address the shortcomings of the foregoing treatments for intraluminal tissues by providing for the selective heat treatment of a selected contiguous area of intraluminal tissue. 
   SUMMARY OF THE INVENTION 
   The present invention relates to a device for treating intraluminal tissue and includes an inflatable member having a plurality of heating zones and activating means for selectively activating the heating zones, whereby one or more of the heating zones can be activated to deliver heat to selected intraluminal tissue. In one embodiment, the inflatable member is a balloon that is attached to a catheter. The catheter has a plurality of passageways for delivering fluids (i.e., liquid or air) to internal chambers of the balloon, each chamber defining a corresponding heating zone. The activating means includes at least one energy source, each energy source being positioned within a corresponding chamber of the balloon. The energy source may be any one of various types, including a piezoelectric cylinder, a microwave antenna, a cylindrical RF (radio-frequency) source, or a resistive heating coil. The type of fluids that are selected to fill the chambers, and thereby inflate the balloon, depend upon the type of energy source that is used. 
   In use, the inflatable member is inserted into the luminal structure of a patient. After the inflatable member is inflated in situ, its heating zones are selectively activated, thereby delivering heat to selected intraluminal tissue. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     For a better understanding of the present invention, reference is made to the following detailed description of various exemplary embodiments considered in conjunction with the accompanying drawings, in which: 
       FIG. 1  is a schematic front elevational view of the device of the present invention, having an inflatable balloon that is connected to a catheter, the balloon being shown in its deflated condition; 
       FIG. 1A  is a cross-sectional view of the catheter of the device of  FIG. 1 , taken along section line A—A and looking in the direction of the arrows, showing the longitudinal passageways therethrough; 
       FIG. 2  is a schematic front elevational view of the device shown in  FIG. 1 , with the balloon in its inflated condition; 
       FIG. 3  is a schematic perspective cross-sectional view of a first exemplary embodiment of the balloon shown in  FIG. 2 , taken along section line B—B and looking in the direction of the arrows, showing the inner chambers of the balloon and an energy source inserted into an activated chamber; 
       FIG. 4  is a schematic top view of the balloon shown in  FIG. 3 ; 
       FIG. 5  is a schematic top view of the balloon shown in  FIG. 3 , wherein the energy source is an active RF source electrode and the activated chamber has a return electrode therein; 
       FIG. 6  is a schematic view of an alternative type of RF source having alternating active and return electrodes; 
       FIG. 7  is a schematic perspective cross-sectional view, similar to  FIG. 3 , of a second exemplary embodiment of the balloon of the present invention, showing the inner chambers of the balloon and a central axial lumen with an energy source inserted therethrough; 
       FIG. 8  is a schematic top view of the second embodiment of the balloon shown in  FIG. 7 ; 
       FIG. 9  is a schematic top view of the balloon shown in  FIG. 7 , wherein the energy source is an active RF source electrode and the activated chamber has a return electrode therein; 
       FIG. 10A  is a schematic perspective view of a channeled piezoelectric cylinder to be used in connection with the embodiment of  FIGS. 7 and 8 ; and 
       FIG. 10B  is a schematic top plan view of the channeled piezoelectric cylinder of FIG.  10 A. 
   

   DETAILED DESCRIPTION OF THE INVENTION 
   With reference to  FIGS. 1 ,  1 A and  2 , the device of the present invention includes an inflatable member, or balloon  10 , which is connected proximately to the end of a flexible or semi-rigid tube-like structure, such as a catheter  12 . The catheter  12  is a conventional type of medical catheter, well known in the art. As will be described in further detail hereinafter, the catheter  12  is used to deliver fluid to the inflatable balloon  10  and has a plurality of passageways  13 ,  14 ,  15 ,  16 ,  17  for this purpose. More particularly, as can be seen most clearly in  FIG. 1A , the catheter has a central longitudinal passageway  13  and plurality of intramural longitudinal passageways,  14 ,  15 ,  16 ,  17 . The dimensions of the catheter  12  depend upon the luminal structure that the catheter will be used to treat and are determined in accordance with the typical dimensions for medical catheters. 
   Referring still to  FIGS. 1 and 2 , the balloon  10  is made of a relatively flexible biocompatible material such as latex, polyurethane, or silicone. The balloon  10  is approximately 5 centimeters to 10 centimeters in length, depending upon the longitudinal extent of the intraluminal tissue to be treated within the luminal structure. As shown in  FIG. 1 , prior to insertion into the luminal structure (not shown), the balloon  10  is in its deflated condition and has a diameter that is substantially the same as the catheter  12 . 
   As shown  FIG. 2 , after insertion into the luminal structure (not shown), the balloon  10  inflates to a cylindrical shape having a diameter of between approximately 2 millimeters and 20 millimeters, depending upon the inner diameter of the luminal structure into which the balloon will be inserted. More particularly, the diameter of the balloon  10  in its inflated condition should be large enough to cause slight dilation of the luminal structure. This ensures firm and continuous contact between the outer wall of the inflated balloon  10  and the selected intraluminal tissue of the inner wall of the luminal structure that is to be treated with heat from the balloon  10 , as discussed hereinafter. 
   Referring now to  FIGS. 3 and 4 , a first exemplary embodiment of the balloon  10  of the present invention is shown in its inflated condition and without the catheter  12 . As seen in  FIGS. 3 and 4 , the balloon  10  includes an inner cavity  18  having four baffles  20 ,  22 ,  24 ,  26 , which divide the inner cavity  18  into four axial chambers  28 ,  30 ,  32 ,  34 . As also can be seen in  FIGS. 3 and 4 , at the bottom of the balloon  10 , proximate to the catheter  12 , there is a plurality of die cut holes  36 ,  38 ,  40 ,  42 ,  44 , which provide openings into the chambers  28 ,  30 ,  32 ,  34 , for a purpose to be described hereinafter. More particularly, two of the holes  36 ,  38  open into the chamber  28 , and each of the remaining holes  40 ,  42 ,  44  open into a corresponding one of the remaining chambers  30 ,  32 ,  34 , respectively. 
   The balloon  10  is connected to the catheter  12 , in a known manner, such that the longitudinal passageways  13 ,  14 ,  15 ,  16 ,  17  of the catheter  12  communicate, through the holes  36 ,  38 ,  40 ,  42 ,  44 , with the chambers  28 ,  30 ,  32 ,  34  of the balloon  10 . More particularly, the central longitudinal passageway  13  of the catheter  12  aligns with the hole  36  such that the central longitudinal passageway  13  communicates with one of the chambers  28  of the balloon  10 , for a purpose that will be clarified hereinafter. One or more of the intramural longitudinal passageways  14 ,  15 ,  16 ,  17  of the catheter  12  align with corresponding holes  38 ,  40 ,  42 ,  44  such that one, or more, of the intramural longitudinal passageways  14 ,  15 ,  16 ,  17  communicates with a corresponding one, or more, of the chambers  28 ,  30 ,  32 ,  34  of the balloon, for a purpose that will be clarified hereinafter. 
   The balloon  10  further includes an energy source  46  that is inserted into the chamber  28 , which is referred to hereinafter as the activated chamber. More particularly, the energy source  46  is inserted into the central longitudinal passageway  13  of the catheter  12 , through the hole  36  of the balloon, and into the activated chamber  28 . The energy source  46  may be any one of various types, including a piezoelectric cylinder (ultrasound source), a microwave antenna, an RF (radio-frequency) source, or a resistive heating coil. It is noted that, while it is possible to use other types of energy sources, the following discussion of the first exemplary embodiment of the present invention will discuss, in particular, the use of the four types of energy sources listed above. 
   In general, the balloon  10  of the present invention achieves the object of applying heat to selected intraluminal tissue by controlling the directionality of the heat transfer through the chambers  28 ,  30 ,  32 ,  34  of the balloon  10 . More particularly, by filling the activated chamber  28  with an appropriate fluid and filling the remaining chambers  30 ,  32 , 34  with a different fluid (i.e., liquid or air), the vast majority of the heat created by the energy source  46  passes through the activated chamber  28  of the balloon  10  to the targeted intraluminal tissue, while the remaining chambers  30 ,  32 ,  34  transmit significantly less heat, or no heat at all, to the remaining intraluminal tissue. It is noted that the chambers are filled with the aforesaid fluids, by known conventional methods, through one or more of the intramural longitudinal passageways  14 ,  15 ,  16 ,  17  of the catheter  12  and through the holes  38 ,  40 ,  42 ,  44  aligned therewith, which, as stated previously above, communicate with one, or more, of the chambers  28 ,  30 ,  32 ,  34  of the balloon  10 . In addition, where desired, the aforesaid fluids can be circulated into and out of the chambers  28 ,  30 ,  32 ,  34  through the intramural longitudinal passageways  14 ,  15 ,  16 ,  17  of the catheter  12 , by known and conventional methods. The fluids that are used to fill or circulate through the chambers  28 ,  30 ,  32 ,  34  depend upon the type of energy source  46  that is used, as follows. 
   Where the energy source  46  is a piezoelectric cylinder, which emits acoustic ultrasound energy, the activated chamber  28  is filled with water, saline solution or gel, which will transmit the acoustic energy. The remaining three chambers  30 ,  32 ,  34  are filled with air, which will not absorb or transmit the acoustic energy emitted by the piezoelectric cylinder. Thus, in the foregoing configuration, the ultrasound energy transmitted by the piezoelectric cylinder energy source  46  would be transmitted through only the activated chamber  28  to the selected intraluminal tissue adjacent to the activated chamber  28 . The air in the remaining three chambers  30 ,  32 ,  34  would insulate the remaining intraluminal tissue adjacent to these chambers  30 ,  32 ,  34  from the acoustic energy. 
   Alternatively, where the energy source  46  is a microwave antenna, which emits microwave energy, the activated chamber  28  is filled with deionized water or air, which is ideal for transmitting microwave energy to the selected intraluminal tissue adjacent thereto. Saline solution, which absorbs the electromagnetic field created by the emitted microwave energy, is circulated into and out of the remaining three chambers  30 ,  32 ,  34  of the balloon  10  to remove the heat therefrom, thereby cooling the remaining intraluminal tissue adjacent thereto. Alternatively, all four chambers  28 ,  30 ,  32 ,  34  can be filled with saline solution, but the saline solution circulated through only the remaining three chambers  30 ,  32 ,  34 . By not circulating the saline solution through the activated chamber  28 , the saline solution will absorb and be heated by the microwave energy and then transmit the heat energy to the adjacent intraluminal tissue selected for treatment. 
   Where a resistive heating coil is used as the energy source  46 , the activated chamber  28  of the balloon  10  is filled with non-circulating water, which is heated by the resistive heating coil and, in turn, transmits heat to the selected intraluminal tissue that is adjacent to the activated chamber  28 . The water could be circulated to eliminate thermal gradients but kept inside the activated chambers  28 . The remaining three chambers  30 ,  32 ,  34  are filled with circulating water, which may absorb some of the heat from the adjacent heated active chamber  28  but, since it is being circulated, will transport the absorbed heat out of the balloon  10 , thereby keeping the three remaining chambers  30 ,  32 ,  34  and the adjacent intraluminal tissue cool. Alternatively, the three remaining chambers  30 ,  32 ,  34  may be filled with air, either circulating or not, to provide insulation from the heat generated by the resistive heating coil energy source  46  in the activated chamber  28 . 
   With reference to  FIG. 5 , where the energy source  46  is an RF (radio frequency) source, it includes an active RF source electrode  48 . A return electrode  50  is provided by coating the interior wall of the active chamber with a conductive metal or polymer. It is noted that the frequency emitted by the active RF electrode is preferably in the range of approximately 200-700 kHz. 
   In addition, when an RF source is used as the energy source  46 , the activated chamber  28  is filled with saline solution. In the configuration described above, i.e., having an active RF source electrode  48  and a return electrode  50 , the saline solution absorbs the RF energy and is heated and then, in turn, heats the selected intraluminal tissue. To optimize the homogeneous distribution of heat in the saline solution, the saline solution can be circulated in the activated chamber  28 , thereby increasing the convective transfer of heat within the active chamber  28 . The remaining three chambers  30 ,  32 ,  34  are filled with air, which will not absorb or transmit the RF energy, thereby insulating the remaining intraluminal tissue that is adjacent to the remaining three chambers  30 ,  32 ,  34 . 
   It is noted that alternative configurations are possible using an RF source as the energy source  46 . As shown in  FIG. 6 , for example, an RF source  46 ′ that includes two or more alternating active and return electrodes  52 ,  54  (designated by a “+” sign and a “−” sign, respectively) could be used, thereby eliminating the necessity of having a return electrode  50  coated onto the inner wall of the active chamber  28 . The alternating active and return electrodes  52 ,  54  can be either adjacent (as shown in  FIG. 6 ) or spaced from one another. It is, again, recommended that the saline solution can be circulated in the activated chamber  28  to optimize the homogeneous distribution of heat throughout the saline solution in the activated chamber  28 . Furthermore, if the frequency of the active RF source electrode  48  of the former configuration is increased to approximately 2-12 MHz, and a return electrode is placed somewhere on the patient. The RF source will capacitatively couple to the patient through the saline solution-filled activated chamber  28 . An alternate device would permanently affix an energy source in every chamber so that no insertion or removal would be required. In this alternate device, the energy sources are part of the assembly and would be disposed of after treatment use. 
   A second preferred embodiment, shown in  FIGS. 7 and 8 , will now be described in detail. It is noted that, elements illustrated in  FIGS. 7 and 8 , which correspond to the elements described above with respect to  FIGS. 3 and 4 , have been designated by corresponding reference numerals increased by one hundred. The second embodiment of  FIGS. 7 and 8 , as well as the various elements thereof, are constructed and designated for use in the same manner as the embodiment of  FIGS. 3 and 4  and the elements thereof, unless otherwise stated. 
   With reference now to  FIGS. 7 and 8 , a second exemplary embodiment of the balloon  110  of the present invention is shown, in its inflated condition and without the catheter  112  (see FIGS.  1  and  2 ). As seen in  FIGS. 7 and 8 , the balloon  110  includes an inner cavity  118  having a central axial lumen  136  and four baffles  120 ,  122 ,  124 ,  126  therein. As in the first exemplary embodiment, the baffles  120 ,  122 ,  124 ,  126  divide the inner cavity  118  into four axial chambers  128 ,  130 ,  132 ,  134 . The chambers  128 ,  130 ,  132 ,  134  are positioned circumferentially about the axial lumen  136 . Furthermore, the balloon  110  is provided with a plurality of holes  138 ,  140 ,  142 , and  144 , that are proximate to the catheter  112  and communicate with chambers  128 ,  130 ,  132 , and  134 . 
   With reference still to  FIGS. 7 and 8 , it is noted that, like the embodiment described above in connection with  FIGS. 3 and 4 , the balloon  110  and the catheter  112  are connected in a conventional and known manner. In the second exemplary embodiment, however, the central longitudinal passageway  113  of the catheter  112  communicates with the central axial lumen  156  of the balloon  110  via the hole  136  of the balloon  110 . One or more of the intramural longitudinal passageways  114 ,  115 ,  116 ,  117  of the catheter  112  align with corresponding holes  138 ,  140 ,  142 ,  144  such that one, or more, of the intramural longitudinal passageways  114 ,  115 ,  116 ,  117  communicates with a corresponding one, or more, of the chambers  128 ,  130 ,  132 ,  134  of the balloon  110 . 
   The balloon  110  of the second exemplary embodiment further includes an energy source  146  that is inserted through the central longitudinal passageway  113  of the catheter  112  and into the axial lumen  156  of the balloon  110 . The energy source  146  may be any one of various types, including a piezoelectric cylinder, a microwave antenna, a cylindrical RF (radio-frequency) source, or a resistive heating coil. It is noted that, while it is possible to use other types of energy sources, the following will discuss, in particular, the use of the four types of energy sources listed above. Moreover, in the second exemplary embodiment, the energy source  146  is preferably a piezoelectric cylinder or a microwave antenna. 
   In the second exemplary embodiment of the present invention, the chambers  128 ,  130 ,  132 ,  134  of the balloon  110  are filled with different types of fluids which are selected, depending upon the type of energy source  146  that is inserted into the axial lumen  156 , in the same manner as discussed above in connection with the first exemplary embodiment. It is further noted that the activated chamber of the second embodiment is the chamber  128 , which transmits the energy emitted by the energy source  146  by virtue of the fluid with which it is filled. For example, where the energy source  146  is a piezoelectric cylinder, the activated chamber  128  is filled with water, saline solution or gel, which will transmit the acoustic energy, while the remaining three chambers  130 , 132 ,  134  are filled with air, which will not absorb or transmit the acoustic energy emitted by the piezoelectric cylinder. Thus, in the foregoing configuration, the activated chamber  128  transmits the ultrasound energy to the selected intraluminal tissue adjacent thereto. The energy source as depicted in  FIG. 10A , could also be rotated to affect the tissue in contact with the chamber made active by the rotation. 
   It should be noted that where the energy source  146  is an RF source, the axial lumen  156  must have a plurality of holes (not shown) that communicate only with the activated chamber  128  so as to allow the fluid in the activated chamber  128  to physically contact the energy source  146 . This is because the energy transmitted by an RF source must be in direct contact with the medium (i.e., fluid), which is to absorb the emitted energy and transmit it as heat. Additionally, there must be a return electrode  150  provided in the activated chamber  128 , for example, as shown in  FIG. 5 , a coating of conductive metal or polymer material on the inside wall of the activated chamber  128 . Alternatively, the RF source  46 ′ described above and shown in  FIG. 6 , which has alternating active and return electrodes  52 ,  54 , could be inserted into the axial lumen  156  of the second exemplary embodiment, thereby eliminating the necessity of having a separate return electrode  150  within the activated chamber  128 . 
   In a third exemplary embodiment, which is constructed similarly to the second embodiment of  FIGS. 7 and 8 , the energy source  146  may be a channeled piezoelectric cylinder  158  having channels  162  therein, which are shown schematically in  FIGS. 10A and 10B . The channels  162  are cut axially on the outside surface  164  of the piezoelectric cylinder  158 . The activated section  160  of the channeled piezoelectric cylinder  158  transmits the acoustic ultrasound energy in only a limited pre-selected radial direction, shown by the arrows in  FIGS. 10A and 10B , which is defined by the location of the channels  162 . Such a channeled piezoelectric cylinder  158  can be inserted into the axial lumen  156  of the balloon  110  shown in  FIGS. 7 and 8  such that the ultrasound energy is transmitted in the direction of the activated chamber  128 . Alternatively, the axial lumen  156  could be entirely replaced by the channeled piezoelectric cylinder  158 . 
   With reference to each of the exemplary embodiments discussed above, it is contemplated that more than one of the chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134  of the balloon  10 ,  110  could be made into activated chambers by filling them with, or circulating therethrough, the appropriate fluid, as specified above. In this way, the heat treatment could be applied to a wider radial area, in the event that the area of the selected intraluminal tissue required a wider zone of treatment. In addition, it is noted that the balloon  10 ,  110  may have more or less than four chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134 , as is described above in connection with the exemplary embodiments. For example, the balloon  10 ,  110  could be provided with only two or three chambers, or up to eight chambers. Furthermore, the balloon  10 ,  100  could have an additional set of chambers positioned adjacent to the first set of chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134 , i.e., longitudinally on either side of the first set of chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134 . 
   With reference now to the method of the present invention, the balloon  10 ,  110  and the catheter  12 ,  112  of the present invention are inserted, with the balloon  10 ,  110  in its deflated condition as shown in  FIG. 1 , into a luminal structure having intraluminal tissue to be treated. More particularly, the balloon  10 ,  110  is inserted into the luminal structure such that the activated chamber  28 ,  128  is proximate and adjacent to the selected intraluminal tissue to be treated. The balloon  10 ,  110  is then inflated by filling the chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134  with the appropriate fluids, depending upon the type of energy source  46 ,  146  being used, as discussed above, and circulating the fluids in and out of the chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134 , as necessary. The aforesaid inflation of the balloon  10 ,  110  will slightly dilate the luminal structure, thereby ensuring that good, continuous contact is achieved between the balloon  10 ,  110  and the intraluminal tissues. The energy source  46 ,  146  is then activated to emit its corresponding type of energy. The energy source  46 ,  146  is activated for the period of time that is required to achieve penetration of the heat into the selected intraluminal tissue to a depth of approximately 2 millimeters to 3 millimeters, or as deep as otherwise required. It is noted that a resistive heating coil or an RF source will require more time to achieve the same depth of tissue penetration as a piezoelectric cylinder or a microwave antenna. It is contemplated that the patient will undergo up to three additional such treatments, spaced over time. 
   It will be understood that the embodiments described herein are merely exemplary and that a person skilled in the art may make many variations and modifications without departing from the spirit and scope of the present invention. For instance, one or more temperature probes can be provided within the activated chamber  28 ,  128  to monitor the temperature achieved. In addition, one or more temperature probes can be provided on the exterior of the balloon  10 ,  110 , proximate to the activated chamber  28 ,  128 , to monitor the temperature of the treatment that is actually delivered to the selected intraluminal tissue. Furthermore, the operation of the balloon  10 ,  110  can be automated, in a known and conventional manner, by using a computer system and appropriate software, to assist in the placement of the balloon  10 ,  110  within the luminal structure or to monitor and control the temperature of the chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134  and the circulation rates of the fluids in the chambers  28 ,  30 ,  32 ,  34 ,  128 ,  130 ,  132 ,  134 . All such variations and modifications are intended to be included within the scope of the invention as defined in the appended claims.