WO2019094090A1

WO2019094090A1 - Operator preference storage system for intravascular catheter system

Info

Publication number: WO2019094090A1
Application number: PCT/US2018/048536
Authority: WO
Inventors: Chadi Harmouche
Original assignee: Cryterion Medical, Inc.
Priority date: 2017-11-13
Filing date: 2018-08-29
Publication date: 2019-05-16

Abstract

An operator preference storage system (26) for a medical device (10) that is usable by an operator (11) during an ablation procedure includes an interface (28) and a controller (29). The interface (28) is configured to receive input of ablation preferences of the operator (11). The controller (29) receives and stores the ablation preferences of the operator (11). Additionally, the controller (29) is configured to automatically and selectively recall and load the stored ablation preferences of the operator (11) when the operator (11) accesses the medical device (10). The ablation preferences of the operator (11) can be input into the operator preference storage system (26) via the interface (28) during creation of an operator profile for the operator (11). Additionally, the controller (29) can store the ablation preferences of the operator (11) when the operator (11) logs off the medical device (10) and/or following completion of the ablation procedure.

Description

OPERATOR PREFERENCE STORAGE SYSTEM FOR

INTRAVASCULAR CATHETER SYSTEM

RELATED APPLICATION

This application claims priority on U.S. Provisional Application Serial No. 62/585,443, filed on November 13, 2017, and entitled OPERATOR PREFERENCE STORAGE SYSTEM AND METHOD". As far as permitted, the contents of U.S. Provisional Application Serial No. 62/585,443 are incorporated in their entirety herein by reference.

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 and/or the use of medical devices, which can include implantable devices and/or catheter ablation of cardiac tissue, to name a few. In particular, 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's normal conduction pattern. The procedure is performed by positioning the tip 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 the most distal (i.e. farthest from the user or operator) portion of the catheter, and often at the tip of the catheter.

Various forms of energy can be used to ablate diseased heart tissue. These can include cryoablation procedures which use cryogenic fluid within cryoballoons (also sometimes referred to herein as "cryogenic balloons" or "balloon catheters"), radio frequency (RF), ultrasound and laser energy, to name a few. During a cryoablation procedure, with the aid of a guide wire, the distal tip of the catheter is positioned adjacent to targeted cardiac tissue, at which time energy is delivered to create tissue necrosis, rendering the ablated tissue incapable of conducting electrical signals. The dose of energy delivered is a critical factor in increasing the likelihood that the treated tissue is permanently incapable of conduction. At the same time, delicate collateral tissue, such as the esophagus, the bronchus, and the phrenic nerve surrounding the ablation zone can be damaged and can lead to undesired complications. Thus, the operator must finely balance delivering therapeutic levels of energy to achieve intended tissue necrosis while avoiding excessive energy leading to collateral tissue injury.

Atrial fibrillation (AF) is one of the most common arrhythmias treated using catheter ablation. AF is typically treated by pulmonary vein isolation, a procedure that removes unusual electrical conductivity in the pulmonary vein. In the earliest stages of the disease, paroxysmal AF, the treatment strategy involves isolating the pulmonary veins from the left atrial chamber. Cryoballoon ablation procedures to treat atrial fibrillation have increased in use in the last several years. In part, this stems from the ease of use, shorter procedure times and improved patient outcomes that are possible through the use of cryoballoon ablation procedures. Despite these advantages, there remains needed improvement to further improve patient outcomes and to better facilitate real-time physiological monitoring of tissue to optimally titrate energy to perform both reversible "ice mapping" and permanent tissue ablation.

The objective of any device for the treatment of AF is to achieve isolation in all, not just some, of the pulmonary veins. Also, it is understood that complete occlusion of each pulmonary vein with the cryogenic balloon is required for adequate antral ablation and electrical isolation. Without pulmonary vein occlusion, blood flow over the balloon during ablation decreases the likelihood of sufficient lesion formation.

An intravascular catheter system usable for performing ablation procedures is typically used by multiple operators and/or physicians. Each operator and/or physician generally has specific settings and/or preferences to use with the intravascular catheter system to perform the ablation procedure. This requires each operator and/or physician to change the settings and/or preferences for the intravascular catheter system each time an ablation procedure is to be performed by a different operator and/or physician. The need for changing of the settings and/or preferences when different operators use the intravascular catheter system to perform an ablation procedure results in an increased amount of time to begin the ablation procedure, and can lead to inconsistencies in settings from procedure to procedure.

SUMMARY

The present invention is directed toward an operator preference storage system for a medical device that is usable by an operator during an ablation procedure. In various embodiments, the operator preference storage system includes an interface and a controller. The interface is configured to receive input of ablation preferences of the operator. The controller receives and stores the ablation preferences of the operator. Additionally, the controller is configured to automatically and selectively recall and load the stored ablation preferences of the operator when the operator accesses the medical device.

In certain non-exclusive alternative embodiments, the ablation preferences include at least one of, at least two of, or each of an ablation timer, an alarm threshold, and a volume level.

Additionally, in some embodiments, the medical device includes a graphical display that is configured to display visual data to the operator during the ablation procedure. In such embodiments, the ablation preferences can include a configuration of the visual data on the graphical display.

Further, in certain embodiments, the medical device includes a catheter and a fluid source that contains a fluid that is selectively delivered to the catheter during the ablation procedure. In such embodiments, the ablation preferences includes a maximum time for fluid to be delivered from the fluid source to the catheter during the ablation procedure.

In some embodiments, the medical device includes a graphical display that is configured to display visual data to the operator during the ablation procedure, and the interface is accessible via the graphical display. Additionally, in certain such embodiments, the visual data includes the ablation preferences of the operator such that the ablation preferences of the operator are visible within the graphical display.

In certain embodiments, the ablation preferences of the operator are input into the operator preference storage system via the interface during creation of an operator profile for the operator.

Additionally, in some embodiments, the controller stores the ablation preferences of the operator when the operator logs off the medical device. Further, or in the alternative, the controller can store the ablation preferences of the operator following completion of the ablation procedure.

In certain applications, the present invention is further directed toward a method for using a medical device by an operator during an ablation procedure, the method including the steps of (i) inputting ablation preferences of the operator into the medical device via an interface; (ii) storing the ablation preferences of the operator within a controller; and (iii) automatically recalling and loading the stored ablation preferences of the operator with the controller when the operator accesses the medical device.

Additionally, in some applications, the present invention is directed toward an operator preference storage system for a medical device that is usable by a plurality of operators during ablation procedures, the operator preference storage system including (i) an interface that is configured to receive input of first ablation preferences of a first operator and second ablation preferences of a second operator; and (ii) a controller that receives and stores the first ablation preferences of the first operator and the second ablation preferences of the second operator, the controller being configured to automatically and selectively recall and load the stored first ablation preferences of the first operator when the first operator accesses the medical device, and the controller being configured to automatically and selectively recall and load the stored second ablation preferences of the second operator when the second operator accesses the medical device.

Further, in certain applications, the present invention is also directed toward a method for using a medical device by a plurality of operators during ablation procedures, the method including the steps of (i) inputting first ablation preferences of a first operator into the medical device via an interface; (ii) storing the first ablation preferences of the first operator within a controller; (iii) inputting second ablation preferences of a second operator into the medical device via the interface; (iv) storing the second ablation preferences of the second operator within the controller; (v) automatically recalling and loading the stored first ablation preferences of the first operator with the controller when the first operator accesses the medical device; and (vi) automatically recalling and loading the stored second ablation preferences of the second operator with the controller when the second operator accesses the medical device.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:

Figure 1 is a simplified schematic side view illustration of a patient, an operator and an embodiment of an intravascular catheter system having features of the present invention, the intravascular catheter system including an operator preference storage system;

Figure 2 is a simplified schematic side view illustration of a portion of the patient and a portion of an embodiment of the intravascular catheter system including the operator preference storage system; and

Figure 3 is a flowchart illustrating one representative embodiment of a method for utilizing the operator preference storage system.

DESCRIPTION

Embodiments of the present invention are described herein in the context of an operator preference storage system for use with an intravascular catheter system (also sometimes referred to simply as a "catheter system"). More particularly, as provided in detail herein, the operator preference storage system enables each operator that utilizes a given catheter system to input their individual preferred settings for performing ablation procedures. Such operator-specific settings can then be saved within the operator preference storage system and can be automatically recalled and reloaded each time that operator utilizes the catheter system. Thus, each operator can realize reduced time requirements in order to start an ablation procedure, and the operator preference storage system can also inhibit inconsistencies in settings from procedure to procedure for each individual operator.

Those of ordinary skill in the art will realize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention 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 invention 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'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 energy can be used to ablate diseased heart tissue. These can include radio frequency (RF), ultrasound and laser energy, as nonexclusive examples. The present invention is intended to be effective with any or all of these and other forms of energy.

Figure 1 is a simplified schematic side view illustration of an embodiment of a medical device 10 for use by an operator 1 1 with a patient 12, which can be a human being or an animal. Although the specific medical device 10 illustrated and described herein pertains to and refers to an intravascular catheter system 10 such as a cryogenic balloon catheter system, it is understood and appreciated that other types of medical devices 10 or systems can equally benefit by the teachings provided herein. For example, in certain non-exclusive alternative embodiments, the present invention can be equally applicable for use with any suitable types of ablation systems and/or any suitable types of catheter systems. As such, the medical device 10 may sometimes be referred to herein simply as a "catheter system". Thus, the specific reference herein to use as part of an intravascular catheter system is not intended to be limiting in any manner.

In the embodiment illustrated in Figure 1 , the operator 1 1 operates the intravascular catheter system 10 to perform ablation procedures on the patient 12. Additionally, it is understood that the operator 1 1 can be a healthcare professional such as a physician, a physician's assistant, or a nurse, and/or the operator 1 1 can be any other suitable person and/or individual. Further, while Figure 1 shows only one operator 1 1 , it is also understood that a plurality of different operators 1 1 can operate the catheter system 10 at different times to perform ablation procedures. In other words, the operator 1 1 illustrated in Figure 1 can represent any number of different operators 1 1 , i.e., a first operator, a second operator, a third operator, etc.

The design of the intravascular catheter system 10 can be varied. In certain embodiments, such as the embodiment illustrated in Figure 1 , the intravascular catheter system 10 can include one or more of a control system 14 (illustrated in phantom), a fluid source 16 (illustrated in phantom), a balloon catheter 18, a handle assembly 20, a control console 22, a graphical display 24, and an operator preference storage system 26.

As an overview, in various embodiments, the intravascular catheter system 10 can be configured to allow the operator 1 1 to log on prior to performing an ablation procedure and/or log off after the ablation procedure. In some embodiments, the intravascular catheter system 10 can also be configured to allow the operator 1 1 to create an operator profile, i.e. via the operator preference storage system 26, which can include various settings, preferences, values and/or thresholds for use during an ablation procedure that are specific to the operator 1 1 . Further, in certain embodiments, the operator profile, i.e. including the various settings, preferences, values and/or thresholds, can be updated and/or changed at any time.

It is understood that although Figure 1 illustrates the structures of the intravascular 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 Figure 1 . It is also understood that the intravascular catheter system 10 can include fewer or additional components than those specifically illustrated and described herein.

In various embodiments, the control system 14 is configured to monitor and control various processes of the ablation procedure. More specifically, the control system 14 can monitor and control release and/or retrieval of a cooling fluid 27 (e.g., a cryogenic fluid) to and/or from the balloon catheter 18. The control system 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 27 that is released to the balloon catheter 18 during the cryoablation procedure. In such embodiments, the intravascular catheter system 10 delivers ablative energy in the form of 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. Further, or in the alternative, the control system 14 can receive data and/or other information (hereinafter sometimes referred to as "sensor output") from various structures within the intravascular catheter system 10.

In some embodiments, the control system 14 can receive, monitor, assimilate and/or integrate the sensor output and/or any other data or information received from any structure within the intravascular catheter system 10 in order to control the operation of the balloon catheter 18. As provided herein, in various embodiments, the control system 14 can initiate and/or terminate the flow of cryogenic fluid 27 to the balloon catheter 18 based on the sensor output. Still further, or in the alternative, the control system 14 can control positioning of portions of the balloon catheter 18 within the body of the patient 12, and/or can control any other suitable functions of the balloon catheter 18.

The fluid source 16 contains the cryogenic fluid 27, which is delivered to the balloon catheter 18 with or without input from the control system 14 during a cryoablation procedure. Once the ablation procedure has initiated, the cryogenic fluid 27 can be delivered to the balloon catheter 18 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. Additionally, the type of cryogenic fluid 27 that is used during the cryoablation procedure can vary. In one non-exclusive embodiment, the cryogenic fluid 27 can include liquid nitrous oxide. However, any other suitable cryogenic fluid 27 can be used. For example, in one non-exclusive alternative embodiment, the cryogenic fluid 27 can include liquid nitrogen.

The design of the balloon catheter 18 can be varied to suit the specific design requirements of the intravascular catheter system 10. As shown, the balloon catheter 18 is configured to be inserted into the body of the patient 12 during the cryoablation procedure, i.e. during use of the intravascular catheter system 10. 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 operator 1 1 . 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 by the control system 14. For example, in various embodiments, the sensor output is received by the control system 14, which can then provide the operator 1 1 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 operator 1 1 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 (not shown). 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 operator 1 1 to operate, position and control the balloon catheter 18. The design and specific features of the handle assembly 20 can vary to suit the design requirements of the intravascular catheter system 10. In the embodiment illustrated in Figure 1 , the handle assembly 20 is separate from, but in electrical and/or fluid communication with the control system 14, the fluid source 16 and/or the graphical display 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. It is understood that the handle assembly 20 can include fewer or additional components than those specifically illustrated and described herein.

In various embodiments, the handle assembly 20 can be used by the operator 1 1 to initiate and/or terminate the cryoablation process, e.g., to start the flow of the cryogenic fluid 27 to the balloon catheter 18 in order to ablate certain targeted heart tissue of the patient 12. In certain embodiments, the control system 14 can override use of the handle assembly 20 by the operator 1 1 . Stated in another manner, in some embodiments, based at least in part on the sensor output, the control system 14 can terminate the cryoablation process without the operator 1 1 using the handle assembly 20 to do so.

The control console 22 is coupled to the balloon catheter 18 and the handle assembly 20. Additionally, in the embodiment illustrated in Figure 1 , the control console 22 includes at least a portion of the control system 14, the fluid source 16, the graphical display 24, and the operator preference storage system 26. 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 Figure 1 . For example, in certain non-exclusive alternative embodiments, the control console 22 does not include the graphical display 24.

In various embodiments, the graphical display 24 is electrically connected to the control system 14 and the operator preference storage system 26. Additionally, the graphical display 24 provides the operator 1 1 of the intravascular catheter system 10 with information that can be used before, during and after the cryoablation procedure. For example, the graphical display 24 can provide the operator 1 1 with information based on the sensor output, and any other relevant information that can be used before, during and after the cryoablation procedure. The specifics of the graphical display 24 can vary depending upon the design requirements of the intravascular catheter system 10, or the specific needs, specifications and/or desires of the operator 1 1 .

In one embodiment, the graphical display 24 can provide static visual data and/or information to the operator 1 1. In addition, or in the alternative, the graphical display 24 can provide dynamic visual data and/or information to the operator 1 1 , such as video data or any other data that changes over time, e.g., during an ablation procedure. Further, in various embodiments, the graphical display 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator 1 1 . Additionally, or in the alternative, the graphical display 24 can provide audio data or information to the operator 1 1 .

As provided herein, the operator preference storage system 26 is configured to enable the operator 1 1 to input and selectively and automatically recall and reload one or more operator-dependent preferences to use during ablation procedures (sometimes also referred to herein as "ablation preferences"). As noted above, it is understood that a plurality of different operators 1 1 can operate the intravascular catheter system 10. Accordingly, corresponding ablation preferences for each of the plurality of operators 1 1 can be input into the intravascular catheter system 10, i.e. into the operator preference storage system 26. In other words, first ablation preferences of a first operator 1 1 , second ablation preferences of a second operator 1 1 , third ablation preferences of a third operator 1 1 , etc., can be input into the intravascular catheter system 10, i.e. into the operator preference storage system 26. Additionally, the ablation preferences of each individual operator 1 1 can be selectively and automatically recalled and reloaded when the operator 1 1 is utilizing the intravascular catheter system 10.

The specifics of the ablation preferences can vary depending upon the design requirements of the intravascular catheter system 10, or the specific needs, specifications and/or desires of the operator(s) 1 1 . In particular, as noted above, the ablation preferences can include various settings, preferences, values and/or thresholds for the specific operator 1 1 that may be required during ablation procedures. For example, in certain non-exclusive embodiments, the ablation preferences can include ablation timers, alarm thresholds, volume level, positioning and/or configuration of visual data on the graphical display 24, positioning of the control console 22, and/or a maximum time allowance for flow of cryogenic fluid 27 to the balloon catheter 18, to name a few. Additionally, and or alternatively, the ablation preferences can include any other suitable operator-dependent settings, preferences, values and/or thresholds that may be used during ablation procedures.

As utilized herein, an ablation timer is a timer that can be used within the intravascular catheter system 10 during an ablation procedure to store and/or display actual timing and/or preferred timing of various stages of the ablation procedure. Additionally, as utilized herein, an alarm threshold is a stated and/or preferred threshold that must be met or exceeded prior to an alarm, e.g., a visual and/or audio alarm, going off.

The design of the operator preference storage system 26 can vary. In the embodiment illustrated in Figure 1 , the operator preference storage system 26 can include one or more of an interface 28 and a controller 29. However, it is understood that the operator preference storage system 26 can include fewer or additional components than those specifically illustrated and described herein.

In various embodiments, the interface 28 is configured to allow the operator 1 1 to interact with the operator preference storage system 26. More specifically, in such embodiments, the interface 28 is configured to allow each operator 1 1 to input their own personalized ablation preferences for use during ablation procedures. In such embodiments, the operator 1 1 and/or any other suitable person can input the ablation preferences into the intravascular catheter system 10, i.e. into the operator preference storage system 26, via the interface 28. In some embodiments, the ablation preferences can be input into the operator preference storage system 26 via the interface 28 when an operator profile is being created for the operator 1 1 . Additionally, or in the alternative, the ablation preferences can be input into the operator preference storage system 26 via the interface 28 at any time during use of the intravascular catheter system 10. Further, in various embodiments, the ablation preferences of each operator 1 1 can be updated and/or changed at any time through use of the interface 28.

The interface 28 can be positioned in any suitable position within the intravascular catheter system 10 for ease of access to the operator 1 1 . For example, in certain embodiments, the interface 28 can be integrated and/or included as part of the control console 22. Additionally, or in the alternative, as shown in Figure 1 , the interface 28 can be incorporated into the graphical display 24, such that the operator 1 1 can access the interface 28 through the graphical display 24. Still alternatively, the interface 28 can be included within a different structure of the intravascular catheter system 10, such as the handle assembly 20, as one non-limiting example. In various embodiments, the controller 29 is configured to receive and retain (i.e. store) the ablation preferences for each operator 1 1 that are input into the intravascular catheter system 10, i.e. into the operator preference storage system 26, via the interface 28. The design and/or configuration of the controller 29 can vary. For example, in certain embodiments, the controller 29 can include a processor 29A that is configured to receive and process data and other information pertaining to the ablation preferences of each operator 1 1 , and a memory system 29B that is configured to store the ablation preferences of each operator 1 1 . In the embodiment illustrated in Figure 1 , the controller 29 can be integrated and/or included as part of the control system 214. In other embodiments, the controller 232 can be separate and/or apart from the control system 214.

It is appreciated that the controller 29, i.e. the processor 29A, can receive the ablation preferences for each operator 1 1 via any suitable manner. For example, the controller 29 can be electrically connected to the interface 28 via a wired connection or via a wireless connection. Alternatively, the controller 29 can be coupled to the interface 28 in another suitable manner.

The processor 29A can be configured to perform any desired number and types of functions to enhance the overall operational capabilities of the operator preference storage system 26. Additionally, the processor 29A can be positioned within the intravascular catheter system 10 in any suitable manner. For example, as shown in Figure 1 , the processor 29A can be electrically coupled to and/or integrally formed within the control system 14. Alternatively, the processor 29A can be provided within a different structure of the intravascular catheter system 10, such as the handle assembly 20, as one non-limiting example.

After receiving the ablation preferences, the controller 29, i.e. the memory system 29B, can store and/or save the ablation preferences for each operator 1 1 to allow the operators 1 1 to use the ablation preferences at a later time and/or during later ablation procedures. In some embodiments, the controller 29 can automatically store and/or save the operator profile, including the ablation preferences for each operator 1 1 , within the memory system 29B. Additionally, or in the alternative, the controller 29 can automatically store and/or save the ablation preferences within the memory system 29B when the operator 1 1 logs off of the intravascular catheter system 10 and/or when the operator 1 1 completes an ablation procedure. Further, or in the alternative, the operator 1 1 can manually select to store and/or save the ablation preferences when logging off of the intravascular catheter system 10 and/or upon completion of an ablation procedure.

Additionally, the memory system 29B can be positioned within the intravascular catheter system 10 in any suitable manner. For example, as shown in Figure 1 , the memory system 29B can be electrically coupled to and/or integrally formed within the control system 14. Alternatively, the memory system 29B can be provided within a different structure of the intravascular catheter system 10, such as the handle assembly 20, as one non-limiting example.

In certain embodiments, the controller 29 can automatically recall and load the stored ablation preferences of a particular operator 1 1 when the intravascular catheter system 10 is accessed and/or operated by that particular operator 1 1 . As one nonexclusive example, the controller 29 can automatically recall and load the stored ablation preferences from the memory system 29B when the operator 1 1 turns on and/or logs on to the intravascular catheter system 10. In alternative embodiments, the controller 232 can automatically recall and load the stored ablation preferences from the memory system 29B via any other suitable manner.

In various embodiments, the interface 28 can provide the stored ablation preferences from the controller 29 to the operator 1 1 to allow the operator 1 1 to view, update and/or change the stored ablation preferences, as desired. The stored ablation preferences can be viewed, updated and/or changed via any suitable manner.

Figure 2 is a simplified schematic side view illustration of a portion of one embodiment of the intravascular catheter system 210 and a portion of a patient 212. In the embodiment illustrated in Figure 2, the intravascular catheter system 210 includes one or more of a control system 214 (illustrated in phantom), a fluid source 216 (illustrated in phantom), a balloon catheter 218, a handle assembly 220, a control console 222, a graphical display 224, and an operator preference storage system 226. More particularly, Figure 2 illustrates various aspects of the balloon catheter 218 in greater detail.

As above, the control system 214 is configured to control various functions of the intravascular catheter system 210. As shown in Figure 2, in certain embodiments, the control system 214 can be positioned substantially within the control console 222. Alternatively, at least a portion of the control system 214 can be positioned in one or more other locations within the intravascular catheter system 210, e.g., within the handle assembly 220. In various embodiments, the control system 214 can receive the sensor output or other output from other components of the intravascular catheter system 210, and can send the sensor output and any other output to the graphical display 224. Further, the control system 214 can control various functions of the remainder of the intravascular catheter system 210 based at least in part on the sensor output and/or any other output received by the control system 214.

The design of the balloon catheter 218 can be varied to suit the design requirements of the intravascular catheter system 210. In this embodiment, the balloon catheter 218 includes one or more of a guidewire 230, a guidewire lumen 232, a catheter shaft 234, and a balloon assembly 235 including an inner inflatable balloon 236 (sometimes referred to herein as a "first inflatable balloon", an "inner balloon" or a "first balloon") and an outer inflatable balloon 238 (sometimes referred to herein as a "second inflatable balloon", an "outer balloon" or a "second balloon"). As used herein, it is recognized that either balloon 236, 238 can be described as the first balloon or the second balloon. Alternatively, the balloon catheter 218 can be configured to include only a single balloon. It is also understood that the balloon catheter 218 can include other structures as well. However, for the sake of clarity, these other structures have been omitted from the Figures.

As shown in the embodiment illustrated in Figure 2, the balloon catheter 218 is configured to be positioned, e.g., by the operator 1 1 (illustrated in Figure 1 ), within the circulatory system 240 of the patient 212. The guidewire 230 and guidewire lumen 232 are inserted into a pulmonary vein 242 of the patient 212, and the catheter shaft 234 and the balloons 236, 238 are moved along the guidewire 230 and/or the guidewire lumen 232 to near an ostium 244 of the pulmonary vein 242. In general, it is the object of the balloon catheter 218 to seal the pulmonary vein 242 so that blood flow is occluded. Only when occlusion is achieved does the cryothermic energy, e.g., of the cryogenic fluid 27 (illustrated in Figure 1 ), cause tissue necrosis which, in turn, provides for electrically blocking aberrant electrical signals that could otherwise trigger atrial fibrillation. Additionally, as shown, the guidewire lumen 232 encircles at least a portion of the guidewire 230. During use, the guidewire 230 is inserted into the guidewire lumen 232 and can course through the guidewire lumen 232 and extend out of a distal end 232A of the guidewire lumen 232. In various embodiments, the guidewire 230 can also include a mapping catheter (not shown) that maps electrocardiograms in the heart, and/or can provide information needed to position at least portions of the balloon catheter 218 within the patient 212.

As illustrated in this embodiment, the inner balloon 236 is positioned substantially, if not completely, within the outer balloon 238. With such design, the outer balloon 238 can protect against the cryogenic fluid 27 leaking out of the balloon assembly 235 should the inner balloon 236 rupture or develop a leak during a cryoablation procedure.

Additionally, in some embodiments, one end of the inner balloon 236 is bonded to a distal end 234A of the catheter shaft 234, and the other end of the inner balloon 236 is bonded near the distal end 232A of the guidewire lumen 232. Further, one end of the outer balloon 238 may be bonded to a neck of the inner balloon 236 or to the distal end 234A of the catheter shaft 234, and the other end of the outer balloon 238 may be bonded to the other end of the inner balloon 236 or to the guidewire lumen 232. Alternatively, the balloons 236, 238 can be secured to other suitable structures. It is appreciated that a variety of bonding techniques can be used and include heat- bonding and adhesive-bonding.

During use, the inner balloon 236 can be partially or fully inflated so that at least a portion of the inner balloon 236 expands toward and/or against at least a portion of the outer balloon 238. Stated in another manner, during use of the balloon catheter 218, at least a portion of an outer surface 236A of the inner balloon 236 expands and can be positioned substantially directly against a portion of an inner surface 238A of the outer balloon 238. As such, when the inner balloon 236 has been fully inflated, the inner balloon 236 and the outer balloon 238 have a somewhat similar physical footprint.

At certain times during usage of the intravascular catheter system 210, the inner balloon 236 and the outer balloon 238 define an inter-balloon space 246, or gap, between the balloons 236, 238. The inter-balloon space 246 is illustrated between the inner balloon 236 and the outer balloon 238 in Figure 2 for clarity, although it is understood that at certain times during usage of the intravascular catheter system 210, the inter-balloon space 246 has very little or no volume. As provided herein, once the inner balloon 236 is sufficiently inflated, an outer surface 238B of the outer balloon 238 can then be positioned within the circulatory system 240 of the patient 212 to abut and/or substantially form a seal with the ostium 244 of the pulmonary vein 242 to be treated. In particular, during use, it is generally desired that an outer diameter of the balloon assembly 235 be slightly larger than a diameter of the pulmonary vein 242 being treated to best enable occlusion of the pulmonary vein 242. Having a balloon assembly 235 with an outer diameter that is either too small or too large can create problems that inhibit the ability to achieve the desired occlusion of the pulmonary vein 242.

The specific design of and materials used for each of the inner balloon 236 and the outer balloon 238 can be varied. For example, in various embodiments, specialty polymers with engineered properties can be used for forming the inner balloon 236. In such embodiments, two specific families of materials can be especially suitable for use in the inner balloon 236. In particular, some representative materials suitable for the inner balloon 236 include various grades of polyether block amides (PEBA) such as the commercially available PEBAX^® (marketed by Arkema, Colombes, France), or a polyurethane such as Pellathane™ (marketed by Lubrizol). Additionally, or in the alternative, the materials can include PET (polyethylene terephthalate), nylon, polyurethane, and other co-polymers of these materials, as non-exclusive examples. In another embodiment, a polyester block copolymer known in the trade as Hytrel^® (DuPont™) is also a suitable material for the inner balloon 236. Further, the materials may be mixed in varying amounts to fine tune properties of the inner balloon 236.

Additionally, in certain embodiments, the outer balloon 238 can be formed from similar materials and can be formed in a similar manner as the inner balloon 236. For example, some representative materials suitable for the outer balloon 238 include various grades of polyether block amides (PEBA) such as the commercially available PEBAX^®, or a polyurethane such as Pellathane™. Additionally, or in the alternative, the materials can include aliphatic polyether polyurethanes in which carbon atoms are linked in open chains, including paraffins, olefins, and acetylenes. Another suitable material goes by the trade name Tecoflex^® (marketed by Lubrizol). Other available polymers from the polyurethane class of thermoplastic polymers with exceptional elongation characteristics are also suitable for use as the outer balloon 238. Further, the materials may be mixed in varying amounts to fine tune properties of the outer balloon 238.

As with the previous embodiment, the operator preference storage system 226 provides the operator 1 1 with a mechanism by which the operator 1 1 can input, store and utilize their own specific ablation preferences to more easily and precisely control the various stages of the ablation procedure and the various components of the intravascular catheter system 210. As above, in certain embodiments, the operator preference storage system 226, i.e. the interface 228 and the controller 229, can be electrically connected to the control system 214 and the graphical display 224. Alternatively, the operator preference storage system 226 can be provided in another suitable manner.

Figure 3 is a flowchart illustrating one representative embodiment of a method for utilizing the operator preference storage system, e.g., the operator preference storage system 26 illustrated in Figure 1 and/or the operator preference storage system 226 illustrated in Figure 2. It is appreciated that the order of the steps illustrated and described in Figure 3 is not necessarily indicative of how the operator preference storage system 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 operator preference storage system and method.

At step 301 , first ablation preferences of a first operator are input into the intravascular catheter system, i.e. into the operator preference storage system. For example, in various embodiments, the first ablation preferences of the first operator can be input into the operator preference storage system via access to the interface of the operator preference storage system. In certain embodiments, the first ablation preferences can be input into the intravascular catheter system by the first operator or any other suitable person. Additionally, in some embodiments, the first ablation preferences of the first operator can be input when an operator profile is created for the first operator. In alternative embodiments, the first ablation preferences can be input at any time during use of the intravascular catheter system. Further, in certain embodiments, the first ablation preferences of the first operator can be updated and/or changed at any time via access to the interface of the operator preference storage system.

At step 303, the controller, e.g., the memory system of the controller, stores and/or saves the first ablation preferences of the first operator. In certain embodiments, the controller receives the first ablation preferences that are input via the interface. In such embodiments, the controller can receive the first ablation preferences via any suitable manner. Additionally, in some embodiments, the controller can be configured to automatically store and/or save the operator profile of the first operator, including the first ablation preferences. For example, the controller can automatically store and/or save the first ablation preferences when the first operator logs off of the intravascular catheter system and/or when the first operator completes an ablation procedure. Additionally, or in the alternative, the first operator can manually select to store and/or save the first ablation preferences when logging off and/or upon completion of the ablation procedure. Further, and/or alternatively, the first ablation preferences can be stored and/or saved via any other suitable manner.

At step 305, second ablation preferences of a second operator are input into the intravascular catheter system, i.e. into the operator preference storage system. For example, in various embodiments, the second ablation preferences of the second operator can be input into the operator preference storage system via access to the interface of the operator preference storage system. In certain embodiments, the second ablation preferences can be input into the intravascular catheter system by the second operator or any other suitable person. Additionally, in some embodiments, the second ablation preferences of the second operator can be input when an operator profile is created for the second operator. In alternative embodiments, the second ablation preferences can be input at any time during use of the intravascular catheter system. Further, in certain embodiments, the second ablation preferences of the second operator can be updated and/or changed at any time via access to the interface of the operator preference storage system.

At step 307, the controller, e.g., the memory system of the controller, stores and/or saves the second ablation preferences of the second operator. In certain embodiments, the controller receives the second ablation preferences that are input via the interface. In such embodiments, the controller can receive the second ablation preferences via any suitable manner. Additionally, in some embodiments, the controller can be configured to automatically store and/or save the operator profile of the second operator, including the second ablation preferences. For example, the controller can automatically store and/or save the second ablation preferences when the second operator logs off of the intravascular catheter system and/or when the second operator completes an ablation procedure. Additionally, or in the alternative, the second operator can manually select to store and/or save the second ablation preferences when logging off and/or upon completion of the ablation procedure. Further, and/or alternatively, the second ablation preferences can be stored and/or saved via any other suitable manner.

At step 309, the controller automatically recalls and loads the first ablation preferences anytime the intravascular catheter system is accessed and/or operated by the first operator. In certain embodiments, the first operator can log on to the intravascular catheter system to perform an ablation procedure on the patient. After the first operator logs on to the intravascular catheter system, the controller can automatically recall and load the first ablation preferences that have been stored in the memory system of the controller. It is appreciated that the controller can automatically recall and load the stored first ablation preferences via any suitable manner. In various embodiments, as provided herein, the stored first ablation preferences can be updated and/or changed at any time, as desired. In certain embodiments, upon completion of the ablation procedure, the first operator can log off the intravascular catheter system, at which time the first ablation preferences can again be manually or automatically saved within the memory system.

At step 31 1 , the controller automatically recalls and loads the second ablation preferences anytime the intravascular catheter system is accessed and/or operated by the second operator. In certain embodiments, the second operator can log on to the intravascular catheter system to perform an ablation procedure on the patient. After the second operator logs on to the intravascular catheter system, the controller can automatically recall and load the second ablation preferences that have been stored in the memory system of the controller. It is appreciated that the controller can automatically recall and load the stored second ablation preferences via any suitable manner. In various embodiments, as provided herein, the stored second ablation preferences can be updated and/or changed at any time, as desired. In certain embodiments, upon completion of the ablation procedure, the second operator can log off the intravascular catheter system, at which time the second ablation preferences can again be manually or automatically saved within the memory system.

As provided herein, any number of different operators may store their respective ablation preferences in the operator preference storage system for the intravascular catheter system.

It is understood that although a number of different embodiments of the operator preference storage system 26, 226 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 invention.

While a number of exemplary aspects and embodiments of the operator preference storage system 26, 226 have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

Claims

What is claimed is:

1 . An operator preference storage system for a medical device that is usable by an operator during an ablation procedure, the operator preference storage system comprising:

an interface that is configured to receive input of ablation preferences of the operator; and

a controller that receives and stores the ablation preferences of the operator, the controller being configured to automatically and selectively recall and reload the stored ablation preferences of the operator when the operator accesses the medical device.

2. The operator preference storage system of claim 1 wherein the ablation preferences include at least one of an ablation timer, an alarm threshold, and a volume level.

3. The operator preference storage system of claim 2 wherein the ablation preferences include at least two of the ablation timer, the alarm threshold, and the volume level.

4. The operator preference storage system of claim 3 wherein the ablation preferences include each of the ablation timer, the alarm threshold, and the volume level.

5. The operator preference storage system of claim 1 wherein the medical device includes a graphical display that is configured to display visual data to the operator during the ablation procedure; and wherein the ablation preferences include a configuration of the visual data on the graphical display.

6. The operator preference storage system of claim 1 wherein the medical device includes a catheter and a fluid source that contains a fluid that is selectively delivered to the catheter during the ablation procedure; and wherein the ablation preferences includes a maximum time for fluid to be delivered from the fluid source to the catheter during the ablation procedure.

7. The operator preference storage system of claim 1 wherein the medical device includes a graphical display that is configured to display visual data to the operator during the ablation procedure; and wherein the interface is accessible via the graphical display.

8. The operator preference storage system of claim 1 wherein the medical device includes a graphical display that is configured to display visual data to the operator during the ablation procedure; and wherein the visual data includes the ablation preferences of the operator such that the ablation preferences of the operator are visible within the graphical display.

9. The operator preference storage system of claim 1 wherein the ablation preferences of the operator are input into the operator preference storage system via the interface during creation of an operator profile for the operator.

10. The operator preference storage system of claim 1 wherein the controller stores the ablation preferences of the operator when the operator logs off the medical device.

1 1 . The operator preference storage system of claim 1 wherein the controller stores the ablation preferences of the operator following completion of the ablation procedure.

12. The operator preference storage system of claim 1 wherein the medical device is a catheter system.

13. A method for using a medical device by an operator during an ablation procedure, the method comprising the steps of:

inputting ablation preferences of the operator into the medical device via an interface;

storing the ablation preferences of the operator within a controller; and automatically recalling and loading the stored ablation preferences of the operator with the controller when the operator accesses the medical device.

14. The method of claim 13 wherein the step of inputting includes the ablation preferences including at least one of an ablation timer, an alarm threshold, and a volume level.

15. The method of claim 14 wherein the step of inputting includes the ablation preferences including at least two of the ablation timer, the alarm threshold, and the volume level.

16. The method of claim 15 wherein the step of inputting includes the ablation preferences including each of the ablation timer, the alarm threshold, and the volume level.

17. The method of claim 13 further comprising displaying visual data to the operator during the ablation procedure on a graphical display; and wherein the step of inputting includes the ablation preferences including a configuration of the visual data on the graphical display.

18. The method of claim 13 further comprising selectively delivering a fluid from a fluid source to a catheter of the medical device during the ablation procedure; and wherein the step of inputting includes the ablation preferences including a maximum time for fluid to be delivered from the fluid source to the catheter during the ablation procedure.

19. The method of claim 13 further comprising displaying visual data to the operator during the ablation procedure on a graphical display; and wherein the step of inputting includes the interface being accessible via the graphical display.

20. The method of claim 13 further comprising displaying visual data to the operator during the ablation procedure on a graphical display; and wherein the visual data includes the ablation preferences of the operator such that the ablation preferences of the operator are visible within the graphical display.

21 . The method of claim 13 wherein the step of inputting includes inputting the ablation preferences of the operator into the medical device via the interface during creation of an operator profile for the operator.

22. The method of claim 13 wherein the step of storing includes storing the ablation preferences of the operator within the controller when the operator logs off the medical device.

23. The method of claim 13 wherein the step of storing includes storing the ablation preferences of the operator within the controller following completion of the ablation procedure.

24. An operator preference storage system for a medical device that is usable by a plurality of operators during ablation procedures, the operator preference storage system comprising:

an interface that is configured to receive input of first ablation preferences of a first operator and second ablation preferences of a second operator; and a controller that receives and stores the first ablation preferences of the first operator and the second ablation preferences of the second operator, the controller being configured to automatically and selectively recall and load the stored first ablation preferences of the first operator when the first operator accesses the medical device, and the controller being configured to automatically and selectively recall and load the stored second ablation preferences of the second operator when the second operator accesses the medical device.

25. The operator preference storage system of claim 24 wherein the medical device includes a graphical display that is configured to display visual data to the plurality of operators during the ablation procedures; and wherein the interface is accessible via the graphical display.

26. The operator preference storage system of claim 24 wherein the medical device includes a graphical display that is configured to display visual data to the plurality of operators during the ablation procedures; and wherein the visual data alternatively includes (i) the first ablation preferences of the first operator such that the first ablation preferences of the first operator are visible within the graphical display, and (ii) the second ablation preferences of the second operator such that the second ablation preferences of the second operator are visible within the graphical display.

27. The operator preference storage system of claim 24 wherein the first ablation preferences of the first operator are input into the operator preference storage system via the interface during creation of a first operator profile for the first operator.

28. The operator preference storage system of claim 27 wherein the second ablation preferences of the second operator are input into the operator preference storage system via the interface during creation of a second operator profile for the second operator.

29. The operator preference storage system of claim 24 wherein the controller stores the first ablation preferences of the first operator when the first operator logs off the medical device; and wherein the controller stores the second ablation preferences of the second operator when the second operator logs off the medical device.

30. The operator preference storage system of claim 24 wherein the controller stores the first ablation preferences of the first operator following completion of a first ablation procedure by the first operator; and wherein the controller stores the second ablation preferences of the second operator following completion of a second ablation procedure by the second operator.

31 . The operator preference storage system of claim 24 wherein the medical device is a catheter system.

32. A method for using a medical device by a plurality of operators during ablation procedures, the method comprising the steps of:

inputting first ablation preferences of a first operator into the medical device via an interface;

storing the first ablation preferences of the first operator within a controller;

inputting second ablation preferences of a second operator into the medical device via the interface;

storing the second ablation preferences of the second operator within the controller;

automatically recalling and loading the stored first ablation preferences of the first operator with the controller when the first operator accesses the medical device; and

automatically recalling and loading the stored second ablation preferences of the second operator with the controller when the second operator accesses the medical device.

33. The method of claim 32 further comprising displaying visual data to the plurality of operators during the ablation procedures on a graphical display; and wherein the step of inputting the first ablation preferences includes the interface being accessible via the graphical display.

34. The method of claim 32 further comprising displaying visual data to the plurality of operators during the ablation procedures on a graphical display; and wherein the visual data alternatively includes (i) the first ablation preferences of the first operator such that the first ablation preferences of the first operator are visible within the graphical display, and (ii) the second ablation preferences of the second operator such that the second ablation preferences of the second operator are visible within the graphical display.

35. The method of claim 32 wherein the step of inputting the first ablation preferences includes inputting the first ablation preferences of the first operator into the medical device via the interface during creation of a first operator profile for the first operator.

36. The method of claim 35 wherein the step of inputting the second ablation preferences includes inputting the second ablation preferences of the second operator into the medical device via the interface during creation of a second operator profile for the second operator.

37. The method of claim 32 wherein the step of storing the first ablation preferences includes storing the first ablation preferences of the first operator within the controller when the first operator logs off the medical device; and wherein the step of storing the second ablation preferences includes storing the second ablation preferences of the second operator within the controller when the second operator logs off the medical device.

38. The method of claim 32 wherein the step of storing the first ablation preferences includes storing the first ablation preferences of the first operator within the controller following completion of a first ablation procedure by the first operator; and wherein the step of storing the second ablation preferences includes storing the second ablation preferences of the second operator within the controller following completion of a second ablation procedure by the first operator.