Patent Publication Number: US-2020281639-A1

Title: Resistive heat ablation for treatment of the anatomy

Description:
FIELD 
     These teachings relate to a medical device for treating the anatomy and a method thereof 
     BACKGROUND 
     Menorrhagia is a medical condition that includes abnormally heavy and prolonged menstrual bleeding and pain. For decades, hormone pills and/or hysterectomy were used to treat menorrhagia. 
     Recently, medical devices have been introduced to treat menorrhagia by way of endometrium ablation, where the endometrium is exposed to various treatment modalities such as RF energy, cryogenics, thermal energy, microwave energy, and/or steam. 
     While often effective, some medical devices include some shortcomings. 
     For example, some medical devices require a user to wiggle or manipulate the medical device inside the body cavity to spread the ablation; however, such wiggling or manipulation may result in tissue perforation, user discomfort, may prolong a medical procedure, and/or may cause fatigue to the user. 
     For example, some medical devices include an electrode array; however, inserting an electrode array into a body cavity risks tissue perforation. 
     For example, some medical devices utilize a fluid that is circulated inside of single-walled balloon. However, circulating a fluid inside of a single-walled balloon risks fluid entering the body cavity if the balloon breaks or leaks. 
     Some examples of medical devices are disclosed in U.S. Pat. No. 7,211,079, US 20130172877, and US 20080243103, the disclosures of which are hereby incorporated by reference herein for all purposes. 
     It may be desirable to have a medical device that is able to overcome at least one of the aforementioned difficulties. 
     SUMMARY 
     A medical device is disclosed. The medical device according to these teachings overcomes as least some of shortcomings discussed in the background section of this application. 
     A medical device is disclosed that includes an expandable member, a fluid cavity, and a heating element. The expandable member has an inner expandable member and an outer expandable member. The fluid cavity is defined between the inner expandable member and the outer expandable member. One or more heating elements are located inside of the fluid cavity. 
     A medical device is disclosed that includes an introducer, expandable member, and a heating element. The expandable member is connected to the introducer, the expandable member comprises an outer surface. The heating element is disposed on the outer surface of the expandable member. The introducer is configured to be at least partially inserted into a body cavity. 
     A medical device is disclosed that includes expandable member; a fluid cavity, and a heating element. The fluid cavity is located inside of the expandable member. The fluid cavity is configured to connect to a fluid source to supply a fluid into the fluid cavity. The heating element is configured to connect to a power source to supply power to the heating element to generate heat. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side view of a medical device. 
         FIG. 2  is a cross-sectional view of a distal end of the medical device of  FIG. 1   
         FIG. 3  is a side view of a medical device. 
         FIG. 4  is a cross-sectional view of a distal end of the medical device of  FIG. 3 . 
     
    
    
     DETAILED DESCRIPTION 
     These teachings relate to a medical device. The medical device may be used to treat or effect an anatomical feature. The medical device may be configured to treat an anatomical feature by way of ablation. The medical device may be configured to effect or destroy an anatomical feature, such as the endometrium with heat. The anatomical feature may be any anatomical feature, such as a body cavity or a body lumen. The body cavity may be a uterus. The medical device may be configured to treat menorrhagia. 
     While the medical device disclosed herein may be used to treat menorrhagia, it is understood that the medical device can be used in other applications as well. For example, the device and system can be used to treat tissue in the bladder, vagina, esophagus, trachea, urethra, ureter, prostate gland, kidney, intestinal growths or abnormal tissues of the intestine, cancerous tissue, etc. 
     The medical device comprises a hand piece. The hand piece may function to be held by a user or robot and/or support or contain one or more components of the medical device. For example, the hand piece may support or contain one or more elements or devices for treating the anatomy and/or for operating the medical device. For example, the hand piece may house or contain the fluid source, the power source, the second fluid source, or a combination thereof. Stated another way, the fluid source and/or the second fluid source may be a container or receptacle located within the hand piece or introducer. In other configurations, the hand piece or the introducer may comprise the fluid connector, the power connector, and/or the second fluid connector for connecting the medical device to one or more wires or tubes for connecting with the fluid source, the power source, and/or the second fluid source, respectively. The fluid connector, the power connector, the second fluid connector, or a combination thereof may be a plug, port, socket, tube, opening, orifice, or other passageway configured to diver fluid and power from the corresponding source to the medical device. 
     The medical device and/or the hand piece may comprise one or more user controls. Movement or manipulation of the one or more user controls may function to move or actuate the introducer; expand or contract one or more expandable members; supply, cease, increase, or decrease a supply or flow of one or more fluids to the expandable member(s); supply, cease, increase, or decrease a supply of power to the one or more heating elements; or a combination thereof. 
     The one or more user controls may be one or more switches, levers, buttons, triggers, knobs, rotation wheels, or a combination thereof. The one or more user controls may also be a foot pedal in communication with the medical device. 
     The medical device comprises one or more introducers. The introducer may function to permit a portion of the medical device to be inserted into a patient or the anatomy, while a portion of the device remains outside of the patient or anatomy. 
     The introducer may be a tubular member. The introducer may be a braided or coiled tube. The introducer may be a tube that is generally smooth on the inside and outside surfaces. The introducer may be an elongated member that extends along a longitudinal axis. The proximal end of the introducer may be connected to the hand piece. The introducer may have a relatively small diameter, on the order of about 10 mm or less, 9 mm or less, 8 mm or less, 7 mm or less, or even 6 mm or less. The diameter of the introducer may be less than 6 mm. Such relatively small sized introducer may be advantageous in minimizing patient trauma during insertion and/or removal of the introducer into and from a body lumen and/or body cavity. 
     The introducer may be substantially straight and/or may include sections that are substantially straight; may include one or more angles, bends or arcs and/or may include sections that have one or more angles, bends or arcs; or a combination thereof. The introducer may be substantially rigid, substantially flexible, substantially resilient, substantially kink-resistant, or a combination thereof. The introducer may be configured in such a way to allow angular movements and/or can be advanced along a tortuous path within a body lumen and/or body cavity. 
     The introducer may comprise one or more internal channels or lumen. The channel or lumen may be configured to direct, deliver, and/or withdrawal one or more fluids to and/or from the one or more expandable members or fluid lumen. One or more electrical wires may extend inside or outside of the introducer when extending between the one or more heating elements and the power source. 
     The medical device may be configured to connect to or with one or more fluid sources. The one or more fluid sources may be referred to herein as a fluid source and/or a second fluid source. The one or more fluid sources may function to contain or store fluid for supply to the medical device. The fluid source may be a container, bag, cartridge, squeeze bottle, or other suitable receptacle. The fluid source may be a pump or a source of pressurized fluid and a control valve. The fluid may be supplied or provided from the fluid source to the medical device (i.e., to the cavity of the expandable member and/or to the fluid cavity) by way of gravity (i.e., an elevated fluid container relative to the medical device), a pump, a hand pump, by squeezing a squeeze bottle or depressing a plunger of a syringe, or a combination thereof. One or more of the fluid sources may be connected to the medical device by way of a connector or port, or may be directly contained within the hand piece or introducer. The fluid may be withdrawn from the medical device (i.e., to the cavity of the expandable member and/or to the fluid cavity) by way of withdrawing a plunger of a syringe, a pump, or a vacuum. 
     The fluid sources may be referred to herein as a first fluid source and a second fluid source. The first and second fluid sources may be configured to supply the same fluid to the medical device. The first and second fluid sources may be configured to supply different fluid to the medical device. 
     The fluids may be referred to herein as a first fluid and a second fluid. The first and second fluids may be the same fluids. The first and second fluids may be different fluids. 
     The first and/or the second fluid may be a gas that is configured to inflate the medical instrument. For example, the first and/or the second fluid may be air, carbon dioxide, nitrogen. 
     The first and/or the second fluid may be a liquid that is configured to be heated. For example, the first and/or the second fluid may be a sterile liquid, saline, dextrose and/or water solution. 
     The fluid may be supplied to the medical device to expand or inflate the expandable member, the inner expandable member, the outer expandable member, the fluid cavity, or a combination thereof. The fluid may be configured to absorb heat from the one or more heating elements. The fluid may function to transfer heat from the one or more heating elements to the expandable member for thermal transfer to tissue or anatomy in contact with the outer surface of the expandable member or the outer surface of the outer expandable member. 
     The medical device may be in electrical communication with one or more power sources. The one or more power sources may function to contain and supply power to the medical device, the one or more heating elements, the one or more fluid supplies, or a combination thereof. 
     The power source may be an AC power source. The power source may be a standard 120- or 220-volt wall outlet. The power source may be a DC power source. The power source may be located inside of the medical device, like in the hand piece or introducer for example. 
     The power source may be in electrical communication with the one or more heating elements via one or more wires. By manipulating one or more of the user controls, power may be supplied from the power supply to the one or more heating elements so that the one or more heating elements generate heat. An amount of power supplied to the one or more heating elements may be controlled via the one or more user controls to increase or decrease a heat output from the one or more heating elements and therefore increase or decrease a temperature of the expandable member, the fluid, or both. 
     The power source may be in electrical communication with the one or more fluid sources. By manipulating one or more of the user controls, power may be supplied from the power supply to the one or fluid sources so that the one or more fluid sources (e.g., a pump) supply fluid to the expandable member, the cavity, the fluid cavity, or a combination thereof. 
     The medical device comprises one or more expandable members. An expandable member may expand and conform to a body cavity or body cavity. The expandable member may be inflated via one or more fluids from the one or more fluid sources. The expandable member may be a balloon or other ductile, flexible, and/or fluid impermeable member. 
     An outer surface of the expandable member may be configured to directly contact tissue or the anatomy. The outer surface of the expandable member may include one or more heating elements. The one or more heating elements may be configured to directly contact tissue of the anatomy. The expandable member may be expanded until the one or more heating elements are in contact with the walls of the body cavity so that heat from the heating elements can be transferred to the walls or tissue of the body cavity to effect or ablate the tissue. The one or more heating elements may be resistive heaters that are electrically connected to the power source. The one or more heating elements may be painted, dipped, or applied onto the outer surface of the expandable members. The one or more heating elements may be impregnated into an outer surface of the expandable member. 
     The expandable member may be inflated or expanded by manipulating one or more of the user controls so that fluid from the one or more fluid source flows into the cavity and expands the expandable member. The expandable member may be deflated or contracted by manipulating one or more of the user controls so that fluid from the one or more fluid source is withdrawn or evacuated from within cavity, which causes the cavity to contract. 
     The expandable member may be made of a suitable medical grade material, such as a polyurethane, silicone, natural rubber, synthetic rubber, or latex. 
     In some configurations, the expandable member may comprise an inner expandable member (also referred to herein as an inner member) and an outer expandable member (also referred to herein as an outer member). The inner member may be located within the outer member. Fluid may be contained between the inner and outer member, which may function to protect or reduce chances of the fluid leaking or spilling into the anatomy. 
     The inner and/or outer member may be made of a suitable medical grade material, such as a polyurethane, silicone, natural rubber, synthetic rubber, or latex. One or both of the inner and outer members may be made of a non-stick material to restrict or prevent the facing surfaces of each of the members from sticking to allow the fluid cavity to be inflated. 
     The inner and outer members may have a similar shape. The inner and outer members may have a similar size. The outer member may have a size that is slightly larger than the inner member so that when the inner member is inflated inside of the inflated outer member a space, or channel, or passageway, or fluid cavity is defined between the outer surface of the inner member and the inner surface of the outer member. 
     Between the inner and outer members, the medical device or expandable member may comprise one or more fluid cavities. The fluid cavity may be a path or passageway that is configured to contain fluid. The fluid cavity may be an inner portion of a tubular structure that is defined by the outer surface of the inner member and the inner surface of the outer member. The fluid cavity may include its own walls that are located between the outer surface of the inner member and the inner surface of the outer member. Preferably, the fluid cavity is fluid impermeable so that fluid is contained in the fluid cavity does not leak from inside the fluid cavity into the anatomy or other portions of the expandable member. 
     The fluid cavity may have a substantially uniform size or uniform cross section or uniform clearance between the surfaces of the inner and outer members defining the fluid cavity. 
     The fluid cavity may be in fluid communication with one or more of the fluid sources. The fluid cavity may function to receive, store, and/or pass fluid from the one or more fluid sources. The fluid lumen is fluidly isolated from the cavity defined inside of the inner expandable member. This means that fluid inside of the fluid cavity does not and is restricted or prevented from exchanging or mixing with the fluid inside of the cavity, and vice versa. 
     Fluid may be supplied to the fluid cavity and circulated therein, or may be supplied to the fluid cavity and not circulated therein. The fluid may be supplied to the fluid cavity via a pump, squeeze bottle, or compressing a plunger of a syringe. A pump may not be required to communicate the fluid into the fluid cavity. Fluid may be withdrawn from the fluid cavity via a vacuum or withdrawing a plunger of a syringe. 
     Supplying fluid to the fluid cavity may assist in expanding or inflating the fluid cavity, the inner member, the outer member, or both. The fluid in the fluid cavity may function to absorb heat from the one or more heating elements and then transfer the heat to the outer surface of the outer member. The heat transferred to the outer surface of the outer member may then be transferred to the anatomy or tissue in contact with the outer surface of the outer member or expandable member. 
     The medical device may include one or more heating elements. The one or more heating elements may function to generate heat. The one or more heating elements may be painted, sprayed, dipped, pumped, brushed, wiped, deposited, or otherwise applied onto an outer surface of the expandable member, on the outer surface of the inner member, on the inner surface of the outer member, inside the fluid cavity, or a combination thereof. The one or more heating elements may be at least partially impregnated into the outer surface of the expandable member, into the outer surface of the inner member, into the inner surface of the outer member, inside the walls defining fluid cavity, or a combination thereof. The one or more heating elements may be resistive heaters. Use of a resistive heater may be advantageous because it does not require high voltages associated with electrosurgical systems. Moreover, use of a resistive heater does not require a return electrode that need to be positioned somewhere on the body. 
     The heating elements may function to generate and transfer heat to the tissue or anatomy in contact with or surrounding the outer member, the expandable member, or both. The heating elements may generate and transfer heat to the fluid inside of the fluid cavity, which may then transfer the heat to the outer member and tissue adjacent to the outer surface of the outer member. The heating elements may generate and transfer heat to the fluid inside of the cavity or fluid cavity, which may then transfer the heat to the fluid inside of the fluid cavity, the outer member, and tissue adjacent to the outer surface of the outer member by bringing the expandable member into contact with the tissue or by bringing the expandable member near the tissue. 
       FIG. 1  illustrates a medical device  10 . The medical device  10  comprises a hand piece  12  and an introducer  14 . The hand piece  12  is configured to be gripped or held by a user. The hand piece  12  comprises one or more user controls  16  for operating, manipulating, and/or using the medical device  10 . The introducer  14  has a proximal end  20  connected to the hand piece  12 . The introducer  14  comprises a distal end  22 . 
     The medical device  10  comprises a fluid connector  24 . The fluid connector  24  is configured to fluidly connect the medical device  10  to a fluid source  26  via one or more fluid lines  28 . In some configurations, the fluid source  26  may be contained in the hand piece  12  and in other configurations, the fluid source  26  may be located a distance away from the hand piece  12 . 
     The medical device  10  comprises a power connector  30 . The power connector  30  is configured to electrically connect the medical device  10  to a power source  32  via one or more power wires  34 . In some configurations, the power source  32  may be contained in the hand piece  12  and in other configurations, the power source  32  may be located a distance away from the hand piece  12 . 
     The medical device  10  comprises an expandable member  36 . In  FIG. 1 , the expandable member  36  is in a collapsed position, and located at least partially inside of the introducer  14 . 
       FIG. 2  illustrates the expandable member  36  in the expanded position, where the expandable member  36  is at least partially extended from the distal end  22  of the introducer  14 . 
     The expandable member  36  comprises a balloon that is configured to conform to an inside of a body cavity or body lumen. The body cavity can be any body cavity. The body cavity may be a uterus. 
     The expandable member  36  comprises an outer surface  38 . One or more heating elements  40  may be disposed on the outer surface  38  of expandable member  36  and/or may be impregnated into the outer surface  38  of the expandable member  36 . In some configurations, the one or more heating elements  40  may be disposed on an inside surface of the expandable member  36  (i.e., inside of the cavity  42 ). The one or more heating elements  40  are electrically connected to the one or more power wires  34  that are electrically connected to the power source  32  ( FIG. 1 ). 
     The expandable member  36  comprises an inner portion or cavity  42 . The cavity  42  is in fluid communication with the fluid connector  24 , which is fluidly connected to the one or more fluid lines  28 , which are fluidly connected to the fluid source  26  ( FIG. 1 ). 
     Referring to  FIGS. 1 and 2 , during a medical procedure, the introducer  14  can be configured for insertion or placement into a body cavity or body lumen while the expandable member  36  is in the collapsed position and located at least partially inside of the introducer  14  ( FIG. 1 ). 
     Before, during, or after insertion or placement of the introducer  14  into the body cavity, one or more of the user controls  16  can be manipulated so that fluid F from the fluid source  26  is supplied to the cavity  42  of the expandable member  36  via the one or more fluid lines  28 . Supplying the fluid F from the fluid source  26  into the cavity  42  functions to inflate the expandable member  36  into an inflated position illustrated in  FIG. 2 . 
     The one or more fluid lines  28  may be one or more single or individual lines or passageways configured to inflate the expandable member  36 . This means that the fluid is not circulated inside the expandable member  36  or provided into and then withdrawn out of the expandable member  36  while the expandable member  36  remains inflated. Instead, the one or more fluid lines  28  may be configured to deliver the fluid to the expandable member  36  to inflate the expandable member. After use, the one or more fluid lines  28  may then be configured to withdrawal the fluid from inside the expandable member  36  to deflate the expandable member. In some configurations, however, the one or more fluid lines  28  may be configured to circulate the fluid inside of the expandable member  36  while the expandable member  36  remains inflated. This means that the fluid moves inside of the expandable member  36  while the expandable member  36  remains inflated and/or there is an exchange of the fluid supplied to and from the expandable member  36  while the expandable member  36  remains inflated. 
     It is understood that because the expandable member  36  is configured to conform to a body cavity during or after inflation, and because the body cavity can be virtually any size and shape, the inflated expandable member  36  can have virtually any shape. In the example of  FIG. 2 , the expandable member  36  is shown conforming to a shape of an inside of a uterus. The expandable member  36  can be inflated until at least a portion, but preferably most or all of the outer surface  38  of the expandable member  36  is in contact with, or at least in close contact with, the walls or anatomy defining the body cavity. 
     Before, during, or after the expandable member  36  is in an expanded configuration, one or more user controls  16  can be manipulated so that power from the power source  32  is communicated to the one or more heating elements  40  via the one or more power wires  34 . This causes the one or more heating elements  40  to generate heat. The heat generated by the heating elements  40  may cause the outer surface  38  of the expandable member  36  to heat up. The heat generated by the heating elements  40  may cause the fluid F inside of cavity  42  to heat up. The heat generated by the heating elements  40  may cause the inner surface of the expandable member  36  to heat up. The one or more heating elements  40  may be resistive heaters. During use, the heat generated by the one or more heating elements  40  and/or from the heated outer surface  38  of the expandable member  36  is then transferred to the walls or anatomy defining the body cavity by bringing the outer surface  38  of the expandable member  36  near the walls or anatomy defining the body cavity and/or by bringing the outer surface  38  of the expandable member  36  into actual contact with the walls or anatomy defining the body cavity to treat or ablate the walls or structure thereof. 
     During or after completion of the medical procedure, one or more of the user controls  16  can be manipulated to cease providing the power to the one or more heating elements  40  so that the heat elements  40  cease generating heat. During or after completion of the medical procedure, one or more of the user controls  16  can be manipulated to release or draw or evacuate the fluid F from inside of the cavity  42  so that the expandable member  36  at least partially collapses. During or after completion of the medical procedure, one or more of the user controls  16  can be manipulated so that the expandable member  36  is at least partially drawn back into a distal end  22  of the introducer  14 . During or after completion of the medical procedure, the medical device  10  or introducer  14  can be removed or withdrawn from the body cavity. 
       FIG. 3  illustrates a medical device  10 . The medical device  10  comprises a hand piece  12  and an introducer  14 . The hand piece  12  is configured to be gripped or held by a user. The hand piece  12  comprises one or more user controls  16  for operating, manipulating, and/or using the medical device  10 . The introducer  14  has a proximal end  20  connected to the hand piece  12 . The introducer  14  comprises a distal end  22 . 
     The medical device  10  comprises a fluid connector  24 . The fluid connector  24  may also be referred to herein as a first fluid connector. The fluid connector  24  is configured to fluidly connect the medical device  10  to a fluid source  26  via one or more fluid lines  28 . The fluid source  26  may be referred to herein as a first fluid source  26 . In some configurations, the fluid source  26  may be contained in the hand piece  12 . In other configurations, the fluid source  26  may be located a distance away from the hand piece  12 . The fluid source  26  contains fluid F, which may also be referred to herein as a first fluid F. 
     The medical device  10  comprises a power connector  30 . The power connector  30  is configured to electrically connect the medical device  10  to a power source  32  via one or more power wires  34 . In some configurations, the power source  32  may be contained in the hand piece  12 . In other configurations, the power source  32  may be located a distance away from the hand piece  12 . 
     The medical device  10  comprises a second fluid connector  44 . The second fluid connector  44  is configured to fluidly connect the medical device  10  to a second fluid source  46  via one or more second fluid lines  48 . In some configurations, the second fluid source  46  may be contained in the hand piece  12 . In other configurations, the second fluid source  46  may be located a distance away from the hand piece  12 . The second fluid source  46  contains second fluid  2 F. 
     The medical device  10  comprises an expandable member  36 . In  FIG. 3 , the expandable member  36  is in a collapsed position, and is located at least partially inside of the distal end  22  of the introducer  14 . 
       FIG. 4  illustrates the expandable member  36  in the expanded position and at least partially extending from the distal end  22  of the introducer  14 . 
     The expandable member  36  comprises a balloon that is configured to conform to an inside of a body cavity. For example, the body cavity may be a uterus. 
     The expandable member  36  comprises an inner expandable member  50  located inside of an outer expandable member  52 . The inner expandable member  50  comprises an inner surface  54  defining a cavity  56  inside the inner expandable member  50 . The inner expandable member  50  comprises an outer surface  58 . 
     The cavity  56  is in fluid communication with the fluid connector  24 , which is fluidly connected to the one or more fluid lines  28 , which are fluidly connected to the fluid source  26  ( FIG. 3 ) containing the first fluid F. 
     The outer expandable member  52  comprises an inner surface  60  located adjacent to the outer surface  58  of the inner expandable member  50 . The outer expandable member  52  comprises an outer surface  62 . 
     The expandable member  36  comprises a fluid cavity  64  defined between the inner expandable member  50  and the outer expandable member  52 . The fluid cavity  64  is defined by or between the outer surface  58  of the inner expandable member  50  and the inner surface  60  of the outer expandable member  52 . The fluid cavity  64  is in fluid communication with the second fluid source  46  that contains the second fluid  2 F via the one or more second fluid lines  48 . 
     The fluid cavity  64  comprises a first fluid opening  68  and a second fluid opening  70 . The first fluid opening  68  may be a supply or delivery opening or line where fluid is supplied or delivered into the fluid cavity  64 , and the second fluid opening  70  may be an output or withdrawal opening or line where the fluid is removed or withdrawn from the fluid cavity  64 , or vice versa. The fluid openings  68 ,  70  are in fluid communication with the one or more second fluid lines  48 . The second fluid  2 F can be supplied into the fluid cavity  64  through one of the fluid openings  68 ,  70  and then withdrawn from the fluid cavity  65  via the other of the fluid openings  68 ,  70 . The second fluid  2 F may be circulated inside of the fluid cavity  64  by suppling the second fluid  2 F into the fluid cavity  64  and then withdrawing the second fluid  2 F via the fluid openings  68 ,  70 . In other configurations, the second fluid  2 F can be supplied into the fluid cavity  64  through one of the fluid openings  68 ,  70  and then withdrawn from the fluid cavity  65  via the same fluid opening  68 ,  70 . 
     The fluid cavity  64  is fluidly isolated from the cavity  56 . This means that fluids contained or provided in each of the cavity  64  and cavity  56  are restricted or prevented from mixing inside of the medical device  10 . Preferably the fluids are restricted or prevented from mixing because the fluids are different. For example, the first fluid F supplied into the cavity  56  may be carbon dioxide, nitrogen, air, (or other such gases) and the second fluid  2 F supplied into the fluid cavity  64  may be saline. 
     The medical device  10  comprises one or more heating elements  66 . The one or more heating elements  66  are located inside of the expandable member  36 . The one or more heating elements  66  may be located inside of the fluid cavity  64 . The one or more heating elements  66  may be disposed on the outer surface  58  of the inner expandable member  50 , disposed on the inner surface  60  of the outer expandable member  52 , impregnated on one or both of the surfaces  58 ,  60 , or a combination thereof. The one or more heating elements  66  are in electrical communication with the power source  32  via the one or more power wires  34 . The one or more heating elements  66  may be resistive heaters. The one or more heating elements  66  may be configured to generate heat. The heat generated by the heating elements  66  may be configured to heat up or increase a temperature of the second fluid  2 F that is located inside of the fluid cavity  64  and/or circulated inside of the fluid cavity  64 . 
     The volume of the second fluid  2 F that is heated inside of the fluid cavity  64  is less than the volume of the fluid located inside of the cavity  42  of the expandable member  36  in  FIG. 2 . Advantageously, this means that the time required to heat the second fluid  2 F is less than the time required to heat the fluid located inside of the cavity  42  of the expandable member  36  in  FIG. 2 . Moreover, the time required to fill and withdrawal the second fluid  2 F from the fluid cavity  64  is less than the time required to fill and withdrawal the fluid located inside of the cavity  42  of the expandable member  36  in  FIG. 2 . 
     Referring to  FIGS. 3 and 4 , during a medical procedure, the introducer  14  can be configured for insertion or placement into a body cavity while the expandable member  36  is in the collapsed position at least partially inside of the introducer  14  ( FIG. 3 ). 
     Before, during, or after insertion or placement into the body cavity, one or more of the user controls  16  can be manipulated so that fluid F from the fluid source  26  is supplied to the cavity  56  of the expandable member  36  via the one or more fluid lines  28 . Supplying the first fluid F from the fluid source  26  into the cavity  56  functions to inflate the inner expandable member  50 , which causes the outer expandable member  52  to also expand, even though the first fluid F is contained only within the cavity  56  of the inner expandable member  50 . 
     The one or more fluid lines  28  may be one or more single or individual lines or passageways configured for inflating the expandable member  36 . This means that the first fluid F is not circulated inside the expandable member  36  or provided into and then withdrawn out of the expandable member  36  while the expandable member  36  remains inflated. Instead, the one or more fluid lines  28  may be configured to deliver the first fluid F to the expandable member  36  to inflate the expandable member. The one or more fluid lines  28  may then be configured to withdrawal the first fluid F from inside the expandable member  36  to deflate the expandable member. In some configurations, however, the one or more fluid lines  28  may be configured to circulate the first fluid F inside of the expandable member  36  while the expandable member  36  remains inflated. This means that the first fluid F moves inside of the expandable member  36  while inflated and/or there is an exchange of the first fluid F supplied to and from the expandable member  36  while the expandable member  36  remains inflated. 
     The expandable member  36  can be expanded into the exemplary position illustrated in  FIG. 4 . It is understood that because the expandable member  36  is configured to conform to a body cavity and because the body cavity can be virtually any size and shape, the inflated expandable member  36  can have virtually any shape. In the example of  FIG. 4 , the expandable member  36  confirms to a uterus. The expandable member  36  can be inflated until at least a portion, but preferably most or all of the outer surface  62  of the outer expandable member  52  is in contact with the walls or anatomy defining the body cavity. 
     Before, during, or after the expandable member  36  is in an expanded configuration and generally or mostly in contact with the wall or anatomy defining the body cavity, one or more user controls  16  can be manipulated so that fluid  2 F from the second fluid source  46  is communicated into the fluid cavity  64  via the one or more second fluid lines  48 . Because the expandable members are  50 ,  52  are fluid impermeable, the fluid  2 F is contained within the fluid cavity  64  and therefore fluidly isolated from the fluid in the cavity  56 . A sufficient amount of the fluid  2 F can be communicated into the fluid cavity  64  to fill, or at least partially fill, the fluid cavity  64 . 
     Because the fluid cavity  64  and the cavity  56  are separate and fluidly isolated from one another (i.e., the first fluid F and the second fluid  2 F do not mix), the second fluid  2 F can be flushed or withdrawn from the fluid cavity  64  while the first fluid F remains inside of the cavity  56  so that the general shape of the expandable member  36  is maintained. The second fluid  2 F can also be circulated inside of the fluid cavity  64  by supplying and withdrawing the second fluid  2 F via one or both of the fluid openings  68 ,  70 , while the first fluid F remains inside of the cavity  56  so that the general shape of the expandable member  36  is maintained. 
     The fluid  2 F is configured to be heated by the one or more heating elements  66 . It may be preferred that the fluid  2 F is not circulated inside the cavity  64  during a medical procedure. This means that the one or more fluid lines  48  may be one or more single or individual lines or passageways configured for supplying the fluid  2 F into the fluid cavity  64 . This means that the fluid is not circulated inside the fluid cavity  64  or provided into and then withdrawn out of the fluid cavity  64  while the fluid cavity  64  remains inflated. Instead, the one or more fluid lines  48  may be configured to deliver the fluid  2 F to the fluid cavity  64  to inflate the fluid cavity  64 . The one or more fluid lines  48  may then be configured to withdrawal the fluid  2 F from inside the fluid cavity  64  to deflate the fluid cavity  64 . In some configurations, however, the one or more fluid lines  48  may be configured to circulate the fluid  2 F inside of the fluid cavity  64  while the fluid cavity  64  remains inflated. This means that the fluid  2 F moves inside of the fluid cavity  64  while inflated and/or there is an exchange of the fluid  2 F supplied to and from the fluid cavity  64  while the fluid cavity  64  remains inflated. 
     Before, during, or after the expandable member  36  is in an expanded configuration and/or before, during, or after the fluid  2 F is supplied into the fluid cavity  64 , one or more user controls  16  can be manipulated so that power from the power source  32  is communicated to the one or more heating elements  40  via the one or more power wires  34 . This causes the one or more heating elements  66  to generate heat. The heat from the heating elements  66  is transferred to the fluid  2 F located in the fluid cavity  64  so that a temperature of the fluid  2 F increases. The heat from the fluid  2 F is then transferred to the outer expandable member  52  or the outer surface  60  of the outer expandable member  52 . The heat at the outer expandable member  52  is then transferred to the walls or anatomy defining the body cavity treat or ablate the walls or anatomy by way of contact between the warm or heated outer expandable member  52  and the walls or anatomy. 
     After completion of the medical procedure, one or more of the user controls  16  can be manipulated to at least partially withdrawal the fluid from inside of the cavity  42  and/or from inside of the fluid cavity  64  so that the expandable member  36  at least partially collapses. The medical device  10  or introducer  14  can then be removed or withdrawn from the body cavity. One or more of the user controls  16  can be manipulated to cease providing power to the one or more heating elements  40  before, during, or after the expandable member  36  is collapsed and/or before during or after the medical device  10  or introducer  14  is withdrawn from the body cavity. 
     LISTING OF REFERENCE NUMERALS 
     
         
         
           
               10  medical device 
               12  hand piece 
               14  introducer 
               16  user controls 
               18  longitudinal axis 
               20  proximal end 
               22  distal end 
               24  fluid connector 
               26  fluid source 
               28  fluid line 
               30  power connector 
               32  power source 
               34  power wire 
               36  expandable member 
               38  outer surface of expandable member  36   
               40  heating element 
               42  cavity of expandable member  36   
               44  second fluid connector 
               46  second fluid source 
               48  fluid line 
               50  inner expandable member 
               52  outer expandable member 
               54  inner surface of inner expandable member  50   
               56  cavity of inner expandable member  50   
               58  outer surface of inner expandable member  50   
               60  inner surface of the outer expandable member  52   
               62  outer surface of the outer expandable member  52   
               64  fluid cavity 
               66  heating element 
               68  fluid line 
               70  fluid line 
           
         
       
    
     The explanations and illustrations presented herein are intended to acquaint others skilled in the art with the invention, its principles, and its practical application. The above description is intended to be illustrative and not restrictive. Those skilled in the art may adapt and apply the invention in its numerous forms, as may be best suited to the requirements of a particular use. 
     Accordingly, the specific embodiments of the present invention as set forth are not intended as being exhaustive or limiting of the teachings. The scope of the teachings should, therefore, be determined not with reference to this description, but should instead be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. The omission in the following claims of any aspect of subject matter that is disclosed herein is not a disclaimer of such subject matter, nor should it be regarded that the inventors did not consider such subject matter to be part of the disclosed inventive subject matter. 
     Plural elements or steps can be provided by a single integrated element or step. Alternatively, a single element or step might be divided into separate plural elements or steps. 
     The disclosure of “a” or “one” to describe an element or step is not intended to foreclose additional elements or steps. 
     While the terms first, second, third, etc., may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings. 
     Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. 
     The disclosures of all articles and references, including patent applications and publications, are incorporated by reference for all purposes. Other combinations are also possible as will be gleaned from the following claims, which are also hereby incorporated by reference into this written description.