Patent Publication Number: US-2019192207-A1

Title: Foot control assembly and method

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to U.S. Provisional Application Ser. No. 62/608,916 filed on Dec. 21, 2017 and entitled “FOOT CONTROL ASSEMBLY AND METHOD”. As far as permitted, the contents of U.S. Provisional Application Ser. No. 62/608,916 are incorporated in their entirety herein by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to medical devices and methods for treating cardiac arrhythmias. More specifically, the disclosure relates to devices and methods for cardiac cryoablation. 
     BACKGROUND 
     Cardiac arrhythmias involve an abnormality in the electrical conduction of the heart and are a leading cause of stroke, heart disease, and sudden cardiac death. Treatment options for patients with arrhythmias include medications, implantable devices, and catheter ablation of cardiac tissue. 
     Catheter ablation involves delivering ablative energy to tissue inside the heart to block aberrant electrical activity from depolarizing heart muscle cells out of synchrony with the heart&#39;s normal conduction pattern. The procedure is performed by positioning a portion of an energy delivery catheter adjacent to diseased or targeted tissue in the heart. The energy delivery component of the system is typically at or near a most distal (farthest from the user) portion of the catheter, and often at a tip of the device. Various forms of energy are used to ablate diseased heart tissue. These can include radio frequency (RF), ultrasound and laser energy, to name a few. One form of energy that is used to ablate diseased heart tissue includes cryogenics (also referred to herein as “cryoablation”). During an ablation procedure, with the aid of a guidewire, the distal tip of the catheter is positioned adjacent to diseased or targeted tissue, at which time the cryogenic energy can be delivered to create tissue necrosis, rendering the ablated tissue incapable of conducting electrical signals. 
     Atrial fibrillation is one of the most common arrhythmias treated using cryoablation. In the earliest stages of the disease, paroxysmal atrial fibrillation, the treatment strategy involves isolating the pulmonary veins from the left atrial chamber, a procedure that removes unusual electrical conductivity in the pulmonary vein. Recently, the use of techniques known as “balloon cryotherapy” catheter procedures to treat atrial fibrillation have increased. In part, this stems from ease of use, shorter procedure times and improved patient outcomes. During the balloon cryotherapy procedure, a refrigerant or cryogenic fluid (such as nitrous oxide, or any other suitable fluid) is delivered under pressure to an interior of one or more inflatable balloons which are positioned adjacent to or against the targeted cardiac tissue. Using this method, the extremely frigid cryogenic fluid causes necrosis of the targeted cardiac tissue, thereby rendering the ablated tissue incapable of conducting unwanted electrical signals. 
     Ablation procedures generally require the use of multiple hand-held and/or hand-controlled structures or devices. For example, a handle assembly may be handled or used by a user, an operator or another suitable health care physician or technician (hereinafter collectively referred to as “user”) to operate, position and/or control a catheter. Furthermore, a control console may often include various structures, components or devices, including a graphical display, which may require the user&#39;s manual control, guidance and/or input. There is thus a continuing need for improved cryoablation devices and systems. 
     SUMMARY 
     The present disclosure is directed towards a foot control assembly for an intravascular catheter system. The foot control assembly is for a user to control at least one stage of an ablation procedure. The foot control assembly can include a controller and a plurality of spaced apart foot members. The plurality of foot members are each configured to be manually actuated by the user. Each foot member can send at least one initiation signal to the controller to initiate at least one stage of the ablation procedure, and/or termination signal to the controller to terminate at least one stage of the ablation procedure. 
     In various embodiments, the plurality of foot members can include a first foot member and a second foot member. In one embodiment, the first foot member and the second foot member can both be configured to be manually actuated by the user to send at least one initiation signal to the controller to initiate at least one stage of the ablation procedure. In another embodiment, the first foot member and the second foot member can each be configured to be manually actuated by the user to send at least one termination signal to the controller to terminate at least one stage of the ablation procedure. In still another embodiment, the first foot member can be configured to be manually actuated by the user to send at least one initiation signal to the controller to initiate at least one stage of the ablation procedure and the second foot member can be configured to be manually actuated by the user to send at least one termination signal to the controller to terminate at least one stage of the ablation procedure. Alternatively, the first foot member can be configured to be manually actuated by the user to send at least one termination signal to the controller to terminate at least one stage of the ablation procedure and the second foot member can be configured to be manually actuated by the user to send at least one initiation signal to the controller to initiate at least one stage of the ablation procedure. 
     In certain embodiments, at least one of the plurality of foot members can include at least one of a foot pedal, a button or a switch. 
     In certain embodiments, the ablation procedure can include an inflation stage. In one embodiment, the initiation signal can initiate the inflation stage. In another embodiment, the termination signal can terminate the inflation stage. 
     In some embodiments, the ablation procedure can include an ablation stage. In one embodiment, the initiation signal can initiate the ablation stage. In another embodiment, the termination signal can terminate the ablation stage. 
     In other embodiments, the ablation procedure can include a time to isolation. In one embodiment, the initiation signal can initiate a calculation of the time to isolation. 
     In still other embodiments, the ablation procedure can include a thawing stage. In one embodiment, the termination signal can terminate the ablation stage and can substantially simultaneously initiate the thawing stage. Alternatively, the termination signal can terminate the thawing stage. 
     In some embodiments, at least one foot member can be configured to be manually actuated by the user to send a timer signal to the controller to initiate a timer. In alternative embodiments, at least one foot member can be configured to be manually actuated by the user to send at least one of a deactivation signal to deactivate the foot control assembly, and/or an activation signal to activate the foot control assembly. 
     In various embodiments, each foot member is configured to be positioned on a support surface. 
     The present disclosure is also directed toward a method for controlling at least one stage of an ablation procedure. The method can include the step of sending with each of a plurality of foot members at least one initiation signal to the controller to initiate at least one stage of the ablation procedure, and/or termination signal to the controller to terminate at least one stage of the ablation procedure. 
     In one embodiment, the step of sending can include sending the initiation signal to the controller to initiate an inflation stage. In another embodiment, the step of sending can include sending the initiation signal to the controller to initiate an ablation stage. In still another embodiment, the step of sending can include sending the initiation signal to the controller to initiate a calculation of a time to isolation. In yet another embodiment, the step of sending can include sending the termination signal to the controller to terminate the inflation stage. In even another embodiment, the step of sending can include sending the termination signal to the controller to terminate the ablation stage. Alternatively, the step of sending can include sending the termination signal to the controller to terminate the ablation stage and substantially simultaneously initiate a thawing stage. Still alternatively, the step of sending can include sending the termination signal to the controller to terminate the thawing stage. 
     Further, the method can also include the step of sending with at least one foot member a timer signal to the controller to initiate a timer. Alternatively, the method can include the step of sending with at least one foot member a deactivation signal to the controller to deactivate the foot control assembly, and/or an activation signal to the controller to activate the foot control assembly. 
     Additionally, the present disclosure is also directed toward a foot control assembly for a user to control at least one stage of an ablation procedure. The foot control assembly can include a controller and a first foot member that is configured to be manually actuated by the user following a first foot member sequence. The first foot member sends at least a plurality of initiation signals to the controller to initiate at least one stage of the ablation procedure, and/or a plurality of termination signals to the controller to terminate at least one stage of the ablation procedure. 
     In one embodiment, the first foot member sequence can be predetermined by the user. In another embodiment, the first foot member sequence can be preprogrammed. 
     The ablation procedure includes an inflation stage, an ablation stage, a time to isolation and a thawing stage, as non-exclusive examples. In certain embodiments, the first foot member can be manually actuated a first time by the user to send a first initiation signal to the controller to initiate the inflation stage. In various embodiments, the first foot member can be manually actuated a plurality of times to send a second initiation signal to the controller to initiate the ablation stage. In some embodiments, the first foot member can be manually actuated the plurality of times to send a third initiation signal to the controller to initiate a calculation of the time to isolation. In other embodiments, the first foot member can be manually actuated the plurality of times to send a first termination signal to the controller to terminate the inflation stage. In still other embodiments, the first foot member can be manually actuated the plurality of times to send a second termination signal to the controller to terminate the ablation stage. In yet other embodiments, the first foot member can be manually actuated the plurality of times to send a third termination signal to the controller to terminate the thawing stage. Additionally, the first foot member can be manually actuated the plurality of times to send a timer signal to the controller to initiate a timer. 
     In some embodiments, the foot control assembly can include a second foot member that is configured to be manually actuated by the user following a second foot member sequence to send the timer signal to the controller to initiate the timer. 
     In other embodiments, the foot control assembly can include the second foot member that is configured to be manually actuated by the user following the second foot member sequence to send a deactivation signal to the controller to deactivate the foot control assembly, and/or an activation signal to the controller to activate the foot control assembly. For example, the second foot member can be actuated a first time to send the deactivation signal to the controller to deactivate the foot control assembly. Further, the second foot member can be actuated a plurality of times to send the activation signal to the controller to activate the foot control assembly. 
     In various embodiments, the foot control assembly can include the second foot member that is configured to be manually actuated by the user following the second foot member sequence to send the plurality of initiation signals to the controller to initiate at least one stage of the ablation procedure, and/or the plurality termination signals to the controller to terminate at least one stage of the ablation procedure. In one embodiment, the second foot member can be actuated a first time during the inflation stage to send the first termination signal to the controller to terminate the inflation stage. In another embodiment, the second foot member can be actuated a first time during the ablation stage to send the second termination signal to the controller to terminate the ablation stage. Alternatively, the second foot member can be actuated a first time during the ablation stage to send the second termination signal to the controller to terminate the ablation stage and substantially simultaneously initiate the thawing stage. In yet another embodiment, the second foot member can be actuated a first time during the thawing stage to send the third termination signal to the controller to terminate the thawing stage. 
     In certain embodiments, the first foot member is configured to be positioned on a support surface. 
     The present disclosure is further directed toward a method for controlling at least one stage of an ablation procedure. The method can include the step of manually actuating a first foot member following a first foot member sequence to send at least one of a plurality of initiation signals to the controller to initiate at least one stage of the ablation procedure, and/or a plurality of termination signals to the controller to terminate at least one stage of the ablation procedure. 
     In various embodiments, the step of manually actuating can include actuating the first foot member a first time to send a first initiation signal to the controller to initiate an inflation stage. In some embodiments, the step of manually actuating can include actuating the first foot member a plurality of times to send a second initiation signal to the controller to initiate an ablation stage. In other embodiments, the step of manual actuating can include actuating the first foot member the plurality of times to send a third initiation signal to the controller to calculate a time to isolation. In still other embodiments, the step of manual actuating can include actuating the first foot member the plurality of times to send a first termination signal to the controller to terminate the inflation stage. In yet other embodiments, the step of manual actuating can include actuating the first foot member the plurality of times to send a second termination signal to the controller to terminate the ablation stage. In even other embodiments, the step of manual actuating can include actuating the first foot member the plurality of times to send a third termination signal to the controller to terminate a thawing stage. 
     In some embodiments, the method can also include the step of manually actuating a second foot member following a second foot member sequence to send a timer signal to the controller to initiate a timer. 
     In other embodiments, the method can further include the step of manually actuating the second foot member following the second foot member sequence to send a deactivation signal to the controller to deactivate the foot control assembly, and/or an activation signal to the controller to activate the foot control assembly. In one embodiment, the step of manually actuating can include actuating the second foot member a first time to send the deactivation signal to the controller to deactivate the foot control assembly. In another embodiment, the step of manually actuating can include actuating the second foot member a plurality of times to send the activation signal to the controller to activate the foot control assembly. 
     In certain embodiments, the method can further include the step of manually actuating the second foot member following the second foot member sequence to send the plurality of initiation signals to the controller to initiate at least one stage of the ablation procedure, and/or the plurality of termination signals to the controller to terminate at least one stage of the ablation procedure. In one embodiment, the step of manually actuating can include actuating the second foot member a first time during the inflation stage to send the first termination signal to the controller to terminate the inflation stage. In another embodiment, the step of manually actuating can include actuating the second foot member a first time during the ablation stage to send the second termination signal to the controller to terminate the ablation stage. Alternatively, the step of manually actuating can include actuating the second foot member a first time during the ablation stage to send the second termination signal to the controller to terminate the ablation stage and substantially simultaneously initiate the thawing stage. In still another embodiment, the step of manually actuating can include actuating the second foot member a first time during the thawing stage to send the third termination signal to the controller to terminate the thawing stage. 
     Additionally, the method can also include the step of manually actuating a third foot member following a third foot member sequence to send the timer signal to the controller to initiate the timer. 
     Further, in some applications, the present disclosure is directed toward a foot control assembly for a user to control a flow rate of a cryogenic fluid to a balloon catheter. The foot control assembly can include a controller and a first foot member that is configured to be manually actuated by the user. The first foot member sends a first depression signal to the controller to control the flow rate of the cryogenic fluid to the balloon catheter when the first foot member is depressed and held down. The first foot member sends a first release signal to the controller to maintain the flow rate of the cryogenic fluid to the balloon catheter when the first foot member is released. 
     In various embodiments, the first depression signal can be sent to the controller each time the first foot member is depressed and held down. Further, the first release signal can be sent to the controller each time the first foot member is released. 
     In some embodiments, the foot control assembly can further include a second foot member that is configured to be manually actuated by the user. The second foot member sends a second depression signal to the controller to control the flow rate of the cryogenic fluid to the balloon catheter when the second foot member is depressed and held down. The second foot member sends a second release signal to the controller to maintain the flow rate of the cryogenic fluid to the balloon catheter when the second foot member is released. 
     In certain embodiments, the first foot member and the second foot member are configured to be positioned on a support surface. 
     The present disclosure is also directed toward a method for controlling a flow rate of a cryogenic fluid to a balloon catheter. The method can include the step of manually actuating a first foot member to send at least one first depression signal to the controller to control the flow rate of the cryogenic fluid to the balloon catheter, and/or first release signal to the controller to maintain the flow rate of the cryogenic fluid to the balloon catheter. 
     In certain embodiments, the step of manually actuating can include depressing and holding down the first foot member and/or releasing the first foot member. 
     In some embodiments, the method can also include the step of manually actuating a second foot member to send at least one second depression signal to the controller to control the flow rate of the cryogenic fluid to the balloon catheter, and/or second release signal to the controller to maintain the flow rate of the cryogenic fluid to the balloon catheter. 
     While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic side view of a patient, a user and an embodiment of an intravascular catheter system having features of the present disclosure, including one embodiment of a foot control assembly; 
         FIG. 2  is a schematic side view of the patient, the user and another embodiment of the intravascular catheter system, including another embodiment of the foot control assembly; and 
         FIG. 3  is a flowchart illustrating one embodiment of a method for operating the foot control assembly. 
     
    
    
     While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims. 
     DETAILED DESCRIPTION 
     Embodiments of the present disclosure are described herein in the context of a foot control assembly for an intravascular catheter system. Those of ordinary skill in the art will realize that the following detailed description of the present disclosure is illustrative only and is not intended to be in any way limiting. Other embodiments of the present disclosure will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations of the present disclosure as illustrated in the accompanying drawings. 
     In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer&#39;s specific goals, such as compliance with application-related and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure. 
     Although the disclosure provided herein focuses mainly on cryogenics, it is understood that various other forms of ablative energy can be used to ablate diseased heart tissue. These can include radio frequency (RF), ultrasound, pulsed DC electric fields and laser energy, as non-exclusive examples. The present disclosure is intended to be effective with any or all of these and other forms of energy. 
       FIG. 1  is a side view illustration of one embodiment of an intravascular catheter system  10  (also sometimes referred to herein as a “catheter system”) for use by a user  11 , such as a health care professional, with a patient  12 , which can be a human being or an animal. In this embodiment, the user  11  operates and/or controls the catheter system  10  to perform the ablation procedure on the patient  12 . While  FIG. 1  shows only one user  11 , it is understood that a plurality of different users  11  can operate or assist in the operation of the catheter system  10  at the same or at different times throughout the ablation procedure. In other words, the user  11  illustrated in  FIG. 1  can represent any number of different users  11 , i.e., a first user, a second user, etc. Further, it is understood that while specific reference is made to the user  11  as a healthcare professional, healthcare professional can include an operator, a physician, a physician&#39;s assistant, nurse and/or any other suitable person and/or individual. 
     In the embodiment illustrated in  FIG. 1 , the patient  12  is positioned on a gurney  13 . However, it is understood that the patient  12  can be positioned on any suitable surface, such as a table or a bed, as non-exclusive examples. 
     Although the catheter system  10  is specifically described herein with respect to the intravascular catheter system, it is understood and appreciated that other types of catheter systems and/or ablation systems can equally benefit by the teachings provided herein. For example, in certain non-exclusive alternative embodiments, the present disclosure can be equally applicable for use with any suitable types of ablation systems and/or any suitable types of catheter systems. Thus, the specific reference herein to use as part of the intravascular catheter system is not intended to be limiting in any manner. 
     The design of the catheter system  10  can be varied. In certain embodiments, such as the embodiment illustrated in  FIG. 1 , the catheter system  10  can include one or more of a control system  14 , a fluid source  16  (e.g., one or more fluid containers), a balloon catheter  18 , a handle assembly  20 , a control console  22 , a graphical display  24  (also sometimes referred to as a graphical user interface or “GUI”) and a foot control assembly  26 . It is understood that although  FIG. 1  illustrates the structures of the catheter system  10  in a particular position, sequence and/or order, these structures can be located in any suitably different position, sequence and/or order than that illustrated in  FIG. 1 . It is also understood that the catheter system  10  can include fewer or additional structures than those specifically illustrated and described herein. 
     In various embodiments, the control system  14  is configured to monitor and control the various processes of an ablation procedure. More specifically, the control system  14  can monitor and control release and/or retrieval of a cryogenic fluid  27  to and/or from the balloon catheter  18 . The control system  14  can also control various structures that are responsible for maintaining or adjusting a flow rate and/or a pressure of the cryogenic fluid  27  that is released to the balloon catheter  18  during the ablation procedure. In various embodiments, the catheter system  10  delivers ablative energy in the form of the cryogenic fluid  27  to cardiac tissue of the patient  12  to create tissue necrosis, rendering the ablated tissue incapable of conducting electrical signals. Additionally, in various embodiments, the control system  14  can control activation and/or deactivation of one or more other processes of the balloon catheter  18 . Additionally, or in the alternative, the control system  14  can receive electronic signals, data and/or other information (also sometimes referred to as “sensor output”) from various structures within the catheter system  10 . In certain embodiments, the control system  14  and/or the GUI  24  can be electrically connected and/or coupled. In some embodiments, the control system  14  can receive, monitor, assimilate and/or integrate any sensor output and/or any other data or information received from any structure within the catheter system  10  in order to control the operation of the balloon catheter  18 . Still further, or in the alternative, the control system  14  can control positioning of portions of the balloon catheter  18  within a circulatory system (also sometimes referred to herein as the “body”) of the patient  12 , and/or can control any other suitable functions of the balloon catheter  18 . 
     The fluid source  16  (also sometimes referred to as “fluid container  16 ”) can include one or more fluid container(s)  16 . It is understood that while one fluid container  16  is illustrated in  FIG. 1 , any suitable number of fluid containers  16  may be used. The fluid container(s)  16  can be of any suitable size, shape and/or design. The fluid container(s)  16  contains the cryogenic fluid  27 , which is delivered to an ablation element (e.g., a balloon) on the balloon catheter  18  with or without input from the control system  14  during the ablation procedure. Once the ablation procedure has initiated, the cryogenic fluid  27  can be injected or delivered and the resulting gas, after a phase change, can be retrieved from the balloon catheter  18 , and can either be vented or otherwise discarded as exhaust. More specifically, the cryogenic fluid  27  delivered to and/or removed from the balloon catheter  18  can include a flow rate that varies. Additionally, the type of cryogenic fluid  27  that is used during the ablation procedure can vary. In one non-exclusive embodiment, the cryogenic fluid  27  can include liquid nitrous oxide. In another non-exclusive embodiment, the cryogenic fluid  27  can include liquid nitrogen. However, any other suitable cryogenic fluid  27  can be used. 
     The design of the balloon catheter  18  can be varied to suit the design requirements of the catheter system  10 . As shown, the balloon catheter  18  is inserted into the body of the patient  12  during the ablation procedure. In one embodiment, the balloon catheter  18  can be positioned within the body of the patient  12  using the control system  14 . Stated in another manner, the control system  14  can control positioning of the balloon catheter  18  within the body of the patient  12 . Alternatively, the balloon catheter  18  can be manually positioned within the body of the patient  12  by the user  11 . In certain embodiments, the balloon catheter  18  is positioned within the body of the patient  12  utilizing at least a portion of the sensor output that is received from the balloon catheter  18 . For example, in various embodiments, the sensor output is received by the control system  14 , which can then provide the user  11  with information regarding the positioning of the balloon catheter  18 . Based at least partially on the sensor output feedback received by the control system  14 , the user  11  can adjust the positioning of the balloon catheter  18  within the body of the patient  12  to ensure that the balloon catheter  18  is properly positioned relative to targeted cardiac tissue. While specific reference is made herein to the balloon catheter  18 , as noted above, it is understood that any suitable type of medical device and/or catheter may be used. 
     The handle assembly  20  is handled and used by the user  11  to operate, position and/or control the balloon catheter  18 . The design and specific features of the handle assembly  20  can vary to suit the design requirements of the catheter system  10 . In the embodiment illustrated in  FIG. 1 , the handle assembly  20  is separate from, but in electrical and/or fluid communication with the control system  14 , the fluid container  16  and the GUI  24 . In some embodiments, the handle assembly  20  can integrate and/or include at least a portion of the control system  14  within an interior of the handle assembly  20 . In one embodiment, the user  11  can steer and/or navigate the balloon catheter  18  by utilizing the handle assembly  20 . It is understood that the handle assembly  20  can include fewer or additional components than those specifically illustrated and described herein. 
     In the embodiment illustrated in  FIG. 1 , the control console  22  includes at least a portion of the control system  14 , the fluid container  16  and/or the GUI  24 . However, in alternative embodiments, the control console  22  can contain additional structures not shown or described herein. Still alternatively, the control console  22  may not include various structures that are illustrated within the control console  22  in  FIG. 1 . For example, in certain non-exclusive alternative embodiments, the control console  22  does not include the GUI  24 . 
     In various embodiments, the GUI  24  is electrically connected to the control system  14 . Additionally, the GUI  24  provides the user  11  of the catheter system  10  with information that can be used before, during and/or after the ablation procedure. For example, the GUI  24  can provide the user  11  with information based on the sensor output, and any other relevant information that can be used before, during and/or after the ablation procedure. The specifics of the GUI  24  can vary depending upon the design requirements of the catheter system  10 , or the specific needs, specifications and/or desires of the user  11 . 
     In one embodiment, the GUI  24  can provide static visual data and/or information to the user  11 . In addition, or in the alternative, the GUI  24  can provide dynamic visual data and/or information to the user  11 , such as video data or any other data that changes over time, e.g., during the ablation procedure. Further, in various embodiments, the GUI  24  can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the user  11 . Additionally, or in the alternative, the GUI  24  can provide audio data or information to the user  11 . 
     As an overview, and as provided in greater detail herein, the foot control assembly  26  allows the user  11  to manually operate and/or control certain stages of the ablation procedure. As used herein, the term “manually” can include the user  11  using his or her foot or feet, in contrast to his or her hand(s), to operate and/or control at least a portion and/or a stage of the ablation procedure. As used herein, foot or feet can include any portion of the leg or lower extremities of the user  11 , including any attachment thereto, such as a shoe, for example. Furthermore, as described in greater detail, each ablation procedure can include one or more stages, such as: (i) an inflation stage, (ii) an ablation stage, (iii) a time to isolation, and/or (iv) a thawing stage, as non-exclusive examples. Alternatively, the ablation procedure may also include other stages not specifically mentioned herein. 
     As utilized herein, the “inflation stage” refers generally to the portion of the ablation procedure, wherein the cryogenic fluid  27  is being delivered from the fluid source  16  to the balloon catheter  18  at a flow rate that does not cause tissue necrosis. More specifically, the cryogenic fluid  27  is being delivered to the inflatable balloon of the balloon catheter  18 . During the inflation stage, the user  11  may adjust and/or position the balloon catheter  18  within the body of the patient  12  to achieve positioning of the inflatable balloon adjacent to a targeted tissue of the patient  12 . The targeted tissue can include at least a portion of heart tissue of the patient  12  that is to be treated by the catheter system  10 , such as an ostium of a pulmonary vein, for example. Once positioned adjacent to the targeted tissue and the pulmonary vein is occluded, ablation of the targeted tissue may be initiated. 
     The “ablation stage” refers generally to the cryogenic fluid  27  being delivered from the fluid source  16  to the inflatable balloon of the balloon catheter  18  at a flow rate to create tissue necrosis. Tissue necrosis has the effect of rendering targeted tissue incapable of conducting cardiac electrical signals. During ablation of the targeted tissue, the inflatable balloon of the balloon catheter  18  is positioned adjacent to targeted tissue, with the pulmonary vein being occluded. 
     The “time to isolation” or “time to effect” refers to the moment when cardiac electrical signals during the ablation procedure are lost or “isolated” due to tissue ablation. It is appreciated that the time to isolation is a variable that is determined only through the process of the ablation procedure, and potentially may not actually be achieved in any given ablation procedure. As such, although the ablation procedure can be said to include a time to isolation, it is understood that the specific time to isolation for any given ablation procedure is actually unknown and only a potentiality until it happens (if it does at all) during the ablation procedure. One representative example of time to isolation would be when signals from a left atrium no longer appear in the pulmonary vein due to a circumferential lesion. 
     Additionally, the “thawing stage” refers generally to the stage of the ablation procedure, wherein targeted tissue of the patient  12  that has been ablated is allowed to thaw to a certain temperature and/or for a certain period of time. The thawing stage can be temperature based, time based, or both. Temperature based means that the ablated heart tissue is allowed to thaw to a certain temperature. Time based means the ablated heart tissue is allowed to thaw for a certain period of time. The temperature and period of time can vary depending on the patient  12  and/or any other cryoablation parameters. During the thawing stage of the targeted tissue of the patient  12 , the cryogenic fluid  27  may be delivered from the fluid source  16  to the inflatable balloon of the balloon catheter  18  and/or retrieved from the inflatable balloon of the balloon catheter  18 , but at a flow rate sufficient to maintain the inflatable balloon at least partially or substantially inflated to prevent the balloon catheter  18  from falling out of position and/or to reduce the likelihood of tissue damage to the patient  12 . 
     In certain embodiments, the foot control assembly  26  can be used to initiate and/or terminate any stage of the ablation procedure. As non-exclusive examples, the foot control assembly  26  can be used to initiate and/or terminate the inflation stage, the ablation stage and/or the thawing stage. In other embodiments, the foot control assembly  26  can allow the user  11  to time, measure and/or calculate different events and/or stages of the ablation procedure, such as time to isolation. In yet other embodiments, the foot control assembly  26  can initiate and/or terminate timers and/or other predetermined events. Additionally, and/or alternatively, the foot control assembly  26  can perform any other suitable function of the catheter system  10  that may be manually controlled by the user  11 . 
     The design and specific features of the foot control assembly  26  can vary to suit the design requirements of the catheter system  10 . In the embodiment illustrated in  FIG. 1 , the foot control assembly  26  can include one or more of a controller  28  and a plurality of foot members, i.e., a first foot member  32 , a second foot member  34 , a third foot member (not shown), etc. The plurality of foot members can be spaced apart from one another. It is recognized that the terms “first foot member  32 ,” “second foot member  34 ,” “third foot member,” etc. can be used interchangeably. In this embodiment, while specific reference is made herein to the first foot member  32  and the second foot member  34 , it is further recognized that the foot control assembly  26  can include any number of foot members, which may allow the user  11  to manually control any suitable function of the catheter system  10 . Further, it is understood that the foot control assembly  26  can include fewer or additional components than those specifically illustrated and described herein. 
     In the embodiment illustrated in  FIG. 1 , the foot control assembly  26  is designed as a single structure that is coupled and/or connected to the control system  14 . The foot control assembly  26  can be electrically and/or mechanically coupled and/or connected to the control system  14  via any suitable manner. Alternatively, the foot control assembly  26  can be coupled and/or connected to other structures of the catheter system  10 . Additionally, and/or in the alternative, the foot control assembly  26 , can be designed to include various structures. 
     Additionally, as illustrated in  FIG. 1 , the foot control assembly  26  can be positioned or otherwise situated on or near a support surface  36 , such as a floor, for example. In the embodiment illustrated in  FIG. 1 , the user  11 , the gurney  13  and the control console  22  can also be positioned or otherwise situated on or near the support surface  36 . The foot control assembly  26  can be positioned on or near the support surface via any suitable manner. In one embodiment, the foot control assembly  26  can include wheels. Alternatively, the foot control assembly  26  can rest directly on the support surface  36 , or the foot control assembly  26  can be positioned on top of a non-skid pad or some other dampening material, for example. 
     In various embodiments, the controller  28  is configured to receive and/or process electronic or other signals. In certain embodiments, the controller  28  can receive and/or process signals to initiate and/or terminate varying stages of the ablation procedure. More specifically, the controller  28  can receive and/or process signals to initiate and/or terminate the inflation stage, the ablation stage and/or the thawing stage, as non-exclusive examples. In alternative embodiments, the controller  28  can receive and/or process signals to time, measure and/or calculate different stages of the ablation procedure. For example, the controller  28  can calculate and/or measure the time to isolation. Additionally, the controller  28  can receive and/or process other signals to perform any other suitable function. 
     In the embodiment illustrated in  FIG. 1 , the controller  28  can be integrated and/or included as part of the foot control assembly  26 . In other embodiments, the controller  28  can be positioned remotely from the foot control assembly  26 . For example, the controller  28  can be integrated and/or included as part of the control system  14  and/or control console  22 . 
     In various embodiments, the controller  28  can include at least one processor (e.g., microprocessor) that executes software and/or firmware stored in memory of the controller  28 . The software/firmware code contains instructions that, when executed by the processor, cause the controller  28  to perform the functions of the control algorithm described herein. The controller  28  may alternatively include one or more application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), digital signal processors (DSPs), hardwired logic, or combinations thereof. The controller  28  may receive information from a plurality of system  10  components and feed the information (e.g., sensor data, signals from the foot control assembly  26 , and user inputs from the GUI  24 ) into a control algorithm which determines at least one control parameter which may in part govern operation of the catheter system  10 . 
     In certain embodiments, the first foot member  32  can be selectively and/or manually actuated by the user  11  to send a plurality of initiation signals to initiate one or more stages of the ablation procedure. As one non-exclusive example, the first foot member  32  can be selectively and/or manually actuated by the user  11  to send a first initiation signal to the controller  28 . In this embodiment, while specific reference is made herein to sending the first initiation signal, it is recognized that the first foot member  32  can send one or more initiation signals, i.e., the first initiation signal, a second initiation signal, a third initiation signal, etc. to initiate certain stages of the ablation procedure, which can be collectively referred to herein as an “initiation signal.” It is understood that first initiation signal, the second initiation signal, the third initiation signal, etc. can be used interchangeably. In various embodiments, the controller  28  can process the first initiation signal and can initiate one or more stages of the ablation procedure. Furthermore, the first foot member  32  can have any suitable design that can enable the user  11  to selectively and/or manually actuate the first foot member  32 . 
     In various embodiments, the first foot member  32  can send one or more initiation signals to the controller  28  to initiate certain stages of the ablation procedure depending on how the user  11  actuates the first foot member  32 . More specifically, the function or operation of the first foot member  32  can depend on how the user  11  actuates the first foot member  32 . In other words, the function or operation of the first foot member  32  can depend on a first foot member sequence. As referred to herein, the term “first foot member sequence” can include the method or manner in which the first foot member  32  is actuated, i.e., a number of times, an order, an arrangement, a series, a length of time, etc. and/or any combination thereof. In this embodiment, while specific reference is made to the first foot member sequence, it is recognized that the foot control assembly  26  can include any number of foot member sequences, i.e., the first foot member sequence, a second foot member sequence, a third foot member sequence, etc. It is further understood that the first foot member sequence, the second foot member sequence, the third foot member sequence, etc., can be used interchangeably. 
     In certain embodiments, the first foot member  32  can initiate varying stages of the ablation procedure depending on the first foot member sequence the user  11  selects and/or follows to actuate the first foot member  32 . In other words, the first foot member  32  can initiate varying stages of the ablation procedure depending on the first foot member sequence selected by the user  11 . In some embodiments, the first foot member sequence and the resulting initiation signal may be predetermined by the user  11  and may depend on certain preferences of user  11  and/or any other ablation parameters. As used herein, “predetermined” can include the user  11  selecting and programming the foot control assembly  26 . In other embodiments, the first foot member sequence and the resulting initiation signal may be preprogrammed. As used herein, “preprogrammed” can mean preset and/or programmed as part of the foot member assembly  26 . 
     In certain embodiments, the first foot member sequence the user  11  selects and/or follows to actuate the first foot member  32  can determine which stage of the ablation procedure will be initiated. As one non-exclusive example, when the first foot member  32  has been actuated a first time, the first foot member  32  can send the first initiation signal to the controller  28  to initiate the inflation stage. In the event the first foot member  32  has been actuated a plurality of times, i.e., a second time, the first foot member  32  can send the second initiation signal to the controller  28  to initiate the ablation stage. Further, in the event the first foot member  32  is actuated a plurality of times, i.e., a third time, the first foot member  32  can send the third initiation signal to the controller  28  to initiate the calculation and/or measurement of the time to isolation. 
     In another non-exclusive example, the length of time the user  11  depresses and holds down the first foot member  32  can determine which stage of the ablation procedure will be initiated. For example, if the user  11  depresses and holds down the first foot member  32  for half a second and releases, the inflation stage can be initiated. If the user  11  depresses and holds down the first foot member  32  for two seconds, the ablation stage can be initiated. 
     The method and/or manner in which the user  11  actuates the first foot member  32  can vary. In one embodiment, the first foot member  32  can include a foot pedal wherein certain stages of the ablation procedure can be initiated by the controller  28  depending on the first foot member sequence the user  11  selects and/or follows to depress the foot pedal. In another embodiment, the first foot member  32  can include a single button wherein stages of the ablation procedure can be initiated by the controller  28  depending on the first foot member sequence the user  11  selects and/or follows to depress the button. In yet another embodiment, the first foot member  32  can include a plurality of buttons, with each button corresponding to one of the stages of the ablation procedure, such that alternatingly depressing each of the buttons selectively causes the controller  28  to initiate one of the stages of the ablation procedure. In still another embodiment, the first foot member  32  can include a switch that can be selectively and/or manually moved or slid to enable the user  11  to cause the controller  28  to initiate one of the stages of the ablation procedure. Alternatively, the first foot member  32  can have any other suitable design that enables the user  11  to selectively and/or manually actuate the first foot member  32  to cause the controller  28  to initiate varying stages of the ablation procedure. 
     In various embodiments, the second foot member  34  can also be selectively and/or manually actuated by the user  11  to send a plurality of termination signals to terminate one or more stages of the ablation procedure. As one non-exclusive example, the second foot member  34  can be selectively and/or manually actuated by the user  11  to send a first termination signal to the controller  28 . In this embodiment, while specific reference is made herein to sending the first termination signal, it is recognized that the second foot member  34  can send one or more termination signals, i.e., the first termination signal, a second termination signal, a third termination signal, etc. to terminate certain stages of the ablation procedure, which can be collectively referred to herein as a “termination signal.” It is further understood, that the first termination signal, the second termination signal, the third termination signal, etc. can be used interchangeably. Once actuated, the second foot member  34  can send the first termination signal to the controller  28 . In various embodiments, the controller  28  can then process the first termination signal to terminate certain stages of the ablation procedure. Additionally, the second foot member  34  can have any suitable design so as to enable the user  11  to selectively and/or manually actuate the second foot member  34 . 
     In certain embodiments, the second foot member  34  can terminate certain stages of the ablation procedure depending on the second foot member sequence the user  11  selects and/or follows to actuate the second foot member  34 . More specifically, the function or operation of the second foot member  34  can depend on how the user  11  actuates the second foot member  34 . In other words, the second foot member  34  can terminate certain stages of the ablation procedure depending on the second foot member sequence selected by the user  11  and/or preprogrammed as part of the foot member assembly  26 . As referred to herein, the term “second foot member sequence” can include the method or manner in which the second foot member  34  is actuated, i.e., a number of times, an order, an arrangement, a series, a length of time, etc. and/or any combination thereof. 
     More specifically, in one non-exclusive example, in the event the second foot member  34  has been actuated a first time during the inflation stage, the second foot member  34  can send the first termination signal to the controller  28  to terminate the inflation stage. Alternatively, when the second foot member  34  has been actuated a first time during the ablation stage, the second foot member  34  can send the second termination signal to the controller  28  to terminate and/or stop the ablation stage. In some embodiments, when the second foot member  34  has been actuated a first time during the ablation stage, the thawing stage may also be initiated. The thawing stage can be initiated at any time at or after the ablation stage has been terminated or stopped, i.e., substantially simultaneously with the termination of the ablation stage, for example. In the event the second foot member  34  is actuated a plurality of times, i.e., a second time after the ablation stage has initiated and/or a first time during the thawing stage, the second foot member  34  can send a third termination signal to the controller  28  to terminate the ablation stage and/or the thawing stage. In various embodiments, should the inflation stage, the ablation stage and/or the thawing stage be terminated or stopped, the catheter system  10  may return to an idle position, at which time the controller  28  can reset the foot control assembly  26 . In other words, the first foot member sequence of the first foot member  32  and/or the second foot member sequence of the second foot member  34  selected and/or followed by the user  11  is reset or recalibrated. 
     The method and/or manner in which the user  11  actuates the second foot member  34  can vary. In certain embodiments, the second foot member  34  can include a foot pedal, wherein certain stages of the ablation procedure can be terminated by the controller  28  depending on the second foot member sequence selected and/or followed by the user  11  to depress the foot pedal. In other embodiments, the second foot member  34  can include a single button wherein certain stages of the ablation procedure can be terminated by the controller  28  depending on the second foot member sequence selected and/or followed by the user  11  to depress the button. In yet other embodiments, the second foot member  34  can include a plurality of buttons, with each button corresponding to one of the stages of the ablation procedure, such that alternatingly depressing each of the buttons selectively causes the controller  28  to terminate one of the stages of the ablation procedure. In still other embodiments, the second foot member  34  can include a switch that can be selectively and/or manually moved or slid to enable the user  11  to cause the controller  28  to terminate one of the stages of the ablation procedure. Alternatively, the second foot member  34  can have any other suitable design that enables the user  11  to selectively and/or manually actuate the second foot member  34  to cause the controller  28  to terminate certain stages of the ablation procedure. 
     In one non-exclusive embodiment, the foot control assembly  26  may include only the first foot member  32 . In this embodiment, the first foot member  32  can initiate and terminate certain stages of the ablation procedure depending on the first foot member sequence the user  11  selects and/or follows to actuate the first foot member  32 . In other words, the first foot member  32  can initiate and terminate certain stages of the ablation procedure depending on the first foot member sequence selected by the user  11  and/or preprogrammed as part of the foot member assembly  26 . For instance, when the first foot member  32  has been actuated a first time, the first foot member  32  can send the first initiation signal to the controller  28  to initiate the inflation stage. In the event the first foot member  32  has been actuated a plurality of times, the first foot member  32  can send either the second initiation signal to the controller  28  to initiate the ablation stage and/or the third initiation signal to the controller  28  to initiate the calculation and/or measurement of the time to isolation. Additionally, in the event the first foot member  32  has been actuated a plurality of times, the first foot member can send either the first termination signal to the controller  28  to terminate the inflation stage, the second termination signal to the controller  28  to terminate the ablation stage and/or the third termination signal to the controller  28  to terminate the thawing stage. 
     In another non-exclusive embodiment, the first foot member  32  and/or the second foot member  34  can allow the user  11  to control a flow rate of the cryogenic fluid  27  to and/or from the balloon catheter  18 . In other words, the first foot member  32  and/or the second foot member  34  can control the cryogenic fluid  27  that is released to the balloon catheter  18  during the ablation procedure, which may adjust (i.e., increase or decrease) and/or maintain an inflatable balloon size, a temperature and/or a pressure within the inflatable balloon of the balloon catheter  18 . As used herein, the term “control” can include to initiate, increase or decrease. More specifically, the user  11  can depress and hold down the first foot member  32  and/or second foot member  34  in order to achieve or reach, a desired flow rate, temperature and/or pressure. Further, the user  11  can depress and hold down the first foot member  32  and/or second foot member  34  in order to achieve or reach the desired inflatable balloon size. While in this embodiment, the method of depressing is described, it is understood that the first foot member  32  and/or second foot member  34  may be moved, slid, etc. and held. Once the desired flow rate, inflatable balloon size, temperature and/or pressure is achieved, the user  11  can release the first foot member  32  and/or the second foot member  34 . As the first foot member  32  and/or the second foot member  34  is released, the desired flow rate, inflatable balloon size, temperature and/or pressure may be maintained. As used herein, the term “maintain” means to keep, sustain, preserve, etc. substantially the same flow rate, inflatable balloon size, temperature and/or pressure as at the time the first foot member  32  and/or the second foot member  34  was released. 
     In one embodiment, the first foot member  32  can be depressed and held down a first time to send a first depression signal to the controller  28  to control, i.e., initiate and/or increase, the flow of cryogenic fluid  27  until the desired flow rate, inflatable balloon size, temperature and/or pressure for the initiation stage is achieved or reached. Once the desired flow rate, inflatable balloon size, temperature and/or pressure for the initiation stage is achieved, the user  11  can release the first foot member  32 . As the first foot member  32  is released, the first foot member  32  can send a first release signal to the controller  28  to maintain the desired flow rate, inflatable balloon size, temperature and/or pressure for the inflation stage. Further, the first foot member  32  can be depressed and held down a second time to send the first depression signal to the controller  28  to control, i.e., increase, the flow rate of the cryogenic fluid  27  until the desired flow rate, inflatable balloon size, temperature and/or pressure for the ablation stage is achieved. Once the desired flow rate, inflatable balloon size, temperature and/or pressure for the ablation stage is achieved, the user  11  can release the first foot member  32 . As the first foot member  32  is released, the first foot member  32  can send the first release signal to the controller  28  to maintain the desired flow rate, inflatable balloon size, temperature and/or pressure for the ablation stage. Still further, the second foot member  34  can be depressed and held down at any point during the ablation procedure to send a second depression signal to the controller  28  to control, i.e., decrease, the flow rate of the cryogenic fluid  27 . For example, the second foot member  34  can be depressed and held down by the user  11  until the desired flow rate, inflatable balloon size, temperature and/or pressure for thawing stage has been achieved. Once the desired flow rate, inflatable balloon size, temperature and/or pressure for the thawing stage is achieved, the user  11  can release the second foot member  34  to send a second release signal to the controller  28  to maintain the desired flow rate, inflatable balloon size, temperature and/or pressure for the thawing stage. 
       FIG. 2  is a schematic side view of the user  211 , the patient  212  and another embodiment of the catheter system  210 . In the embodiment illustrated in  FIG. 2 , the catheter system  210  includes the control system  214 , the fluid source  216 , the balloon catheter  218 , the handle assembly  220 , the control console  222 , the GUI  224  and the foot control assembly  226 . However, in the embodiment illustrated in  FIG. 2 , the foot control assembly  226  includes the controller  228  and the plurality of foot members, i.e., the first foot member  232 , the second foot member  234  and a third foot member  242 . 
     In this embodiment, the foot control assembly  226  includes several structures which are coupled and/or connected to each other and the controller  228 . Alternatively, the first foot member  232 , the second foot member  234  and the third foot member  242  can be separately coupled and/or connected to the controller  228 . The controller  228 , the first foot member  232 , the second foot member  234  and the third foot member  242  can be coupled and/or connected via any suitable manner. 
     In the embodiment illustrated in  FIG. 2 , the controller  228  can be integrated and/or included as part of the control system  214 . In other embodiments, the controller  228  can be separate and/or apart from the control system  214 , and integrated and/or included as part of the control console  222 , for example. Additionally, and/or alternatively, the controller  228  can be integrated and/or included as part of any other suitable structure in the catheter system  210 . 
     Additionally, in  FIG. 2 , the user  211 , the gurney  213 , the control console  222  and the foot control assembly  226  are positioned, situated and/or placed on or near the support surface  236 . 
     In certain embodiments, the third foot member  242  can be selectively and/or manually actuated by the user  211  to send a timer signal or a plurality of timer signals. As one non-exclusive example, the third foot member  242  can be selectively and/or manually actuated by the user  211  to send a first timer signal to the controller  228 . In this embodiment, while specific reference is made herein to sending the first timer signal, it is recognized that the third foot member  242  can send one or more timer signals, i.e., the first timer signal, a second timer signal, etc. to initiate and/or terminate timers, which can be collectively referred to herein as a “timer signal.” It is further understood that the first timer signal, the second timer signal, etc., can be used interchangeably. 
     Once actuated, the third foot member  242  can send one or more timer signals to the controller  228 . In various embodiments, the controller  228  can then process each timer signal to initiate and/or terminate certain timers. As used herein, “timers” can include the monitoring and/or recording of time for any suitable function of the catheter system  210 . In one embodiment, the timer can be configured to monitor elapsed time during the ablation procedure until the time to isolation is achieved. In another embodiment, the timer can be configured to monitor elapsed time from the beginning of the ablation procedure to when targeted tissue is effectively isolated and non-conducting, i.e., at the time to isolation. In various embodiments, the third foot member  242  can be substantially similar in design and/or configuration to the first foot member  232  and the second foot member  234 . Alternatively, the third foot member  242  can have any other suitable design so as to enable the user  211  to selectively and/or manually actuate the third foot member  242 . 
     In some non-exclusive embodiments, the third foot member  242  can be configured to specifically provide the user  211  with the means to selectively and/or manually actuate the third foot member  242  to cause the controller  228  to initiate and/or terminate timers during varying stages of the ablation procedure. In certain embodiments, the third foot member  242  can initiate and/or terminate timers during varying stages of the ablation procedure depending on the third foot member sequence the user  211  selects and/or follows to actuate the third foot member  242 . In other words, the third foot member  242  can initiate and/or terminate timers during varying stages of the ablation procedure depending on the third foot member sequence selected by the user  211 . For example, in certain embodiments, the third foot member  242  can initiate or terminate certain timers depending on the number of times the user  211  actuates, i.e., depresses, moves, slides, etc., the third foot member  242 . Alternatively, the third foot member  242  can initiate or terminate timers depending on the length of time the user  211  holds down the third foot member  242 . 
     The method and/or manner in which the user  211  actuates the third foot member  242  can vary. In certain embodiments, the third foot member  242  can include a foot pedal wherein timers during varying stages of the ablation procedure can be initiated and/or terminated by the controller  228  depending on the third foot member sequence selected and/or followed by the user  211  to depress the foot pedal. More specifically, in one non-exclusive embodiment, when the third foot member  242  has been actuated and/or depressed a first time, the third foot member  242  can send the first timer signal to the controller  228  to initiate the timer. In the event the third foot member  242  has been actuated and/or depressed a plurality of times, i.e., a second time, the third foot member  242  can send the second timer signal to the controller  228  to terminate the timer. Additionally, and/or alternatively, the third foot member  242  can have any other suitable design that effectively enables the user  211  to selectively and/or manually actuate the third foot member  242  to cause the controller  228  to initiate and/or terminate timers. 
     In one non-exclusive embodiment, the third foot member  242  can function to activate and/or deactivate the foot control assembly  226 . More specifically, in certain embodiments, while the foot control assembly  226  is in the idle position the user  211  can actuate the third foot member  242  to send a deactivation signal to the controller  228  to deactivate the foot control assembly  226 . Additionally, the user  211  can actuate the third foot member  242  to send an activation signal to the controller  228  to activate or reactivate the foot control assembly  226 . For example, the user  211  can depress the third foot member  242  a first time for a certain period of time or number of times, i.e., x amount of seconds or times, to send the deactivation signal to the controller  228  to deactivate the foot control assembly  226 . This may have the effect of relatively minimizing any accidental initiation of the inflation stage and/or ablation stage by the user  211 . The user  211  can also depress the third foot member  242  the plurality of times, i.e., second time, to send the activation signal to the controller  228  to activate or reactivate the foot control assembly  226 . 
       FIG. 3  is a flowchart illustrating one embodiment of a method for operating the foot control assembly  326 . It is appreciated that the order of the steps illustrated and described in  FIG. 3  is not necessarily indicative of how the foot control assembly  326  operates chronologically, as one or more of the steps can be combined, reordered, repeated and/or performed simultaneously without deviating from the intended breadth and scope of the foot control assembly  326  and method. It further is recognized that the flowchart shown in  FIG. 3  is merely one representative example of how the foot control assembly  326  can be utilized within the catheter system  310  and is not intended to be limiting in any manner. 
     At step  344 , a determination is made whether the first foot member is actuated. The first foot member is actuated when the first foot member is depressed, moved, slid, etc. by the user. 
     At step  346 , in the event the first foot member has been actuated the first time, the first foot member sends the first initiation signal to the controller to initiate the inflation stage, i.e., to “Start Inflation”. 
     At step  348 , a determination is made whether the second foot member is actuated. The second foot member is actuated when the second foot member is depressed, moved, slid, etc. by the user during the inflation stage or the first time. 
     At step  350 , in the event the second foot member is actuated during the inflation stage or the first time, the second foot member sends the first termination signal to the controller to terminate or stop the inflation stage, i.e., to “Stop Inflation”. 
     At step  352 , in the event the inflation stage is terminated or stopped, the catheter system may return to the idle position, i.e., “Idle”, at which time the controller can reset or recalibrate the foot control assembly. 
     At step  354 , a determination is made whether the first foot member has been actuated during the inflation stage or the second time. 
     At step  356 , in the event the first foot member is actuated during the inflation stage or the second time, the first foot member sends the second initiation signal to the controller to initiate the ablation stage, i.e., to “Start Ablation”. 
     At step  358 , a determination is made whether the second foot member has been actuated during the ablation stage or the first time after the ablation stage has been initiated. 
     At step  360 , in the event the second foot member is actuated during the ablation stage or the first time after the ablation stage has initiated, the second foot member sends the second termination signal to the controller to terminate the ablation stage. In some embodiments, the second termination signal may also initiate the thawing stage. The second termination signal can initiate the thawing stage substantially at or after the time the ablation stage has been terminated or stopped. 
     At step  362 , a determination is made whether the second foot member has been actuated the first time during the thawing stage or the second time after the ablation stage has initiated. 
     At step  364 , in the event the second foot member is actuated the first time during the thawing stage and/or the second time after the ablation stage has initiated, the second foot member sends the third termination signal to the controller to terminate or stop the ablation stage and/or the thawing stage, i.e., to “Stop Ablation”. 
     At step  366 , in the event the ablation stage and/or the thawing stage are terminated or stopped, the catheter system may return to the idle position, i.e., “Idle”, at which time the controller can reset or recalibrate the foot control assembly. 
     At step  368 , a determination is made whether the first foot member has been actuated during the ablation stage or the third time. 
     At step  370 , in event the first foot member is actuated during the ablation stage or the third time, the first foot member sends the third initiation signal to the controller to initiate the calculation and/or measurement of the time to isolation or time to effect. 
     It is understood that although a number of different embodiments of the catheter system and/or the foot control assembly have been illustrated and described herein, one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments, provided that such combination satisfies the intent of the present disclosure. 
     Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present disclosure is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.