Patent Description:
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'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 (furthest from the operator) 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), cryogenics, ultrasound and laser energy, to name a few. The tip of the catheter is positioned adjacent to diseased tissue, at which time energy is delivered to create tissue necrosis, rendering the ablated tissue incapable of conducting electrical signals. The dose of the 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. In the earliest stages of the disease, paroxysmal AF, the treatment strategy involves isolating the pulmonary veins from the left atrial chamber. Recently, the use of techniques known as "balloon cryotherapy" catheter procedures to treat AF have increased. In part, this stems from the balloon cryotherapy's ease of use, shorter procedure times and improved patient outcomes. 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.

There remains an unmet need for an expansible tissue ablation device that is capable of providing effective therapeutic ablative energy and reliable physiological monitoring to improve delivery of ablative energy to achieve improved therapeutic outcomes. There is also a need to reduce excessive energy delivery that causes collateral tissue injury. The device should ideally control the amount of therapeutic energy based on real-time physiological monitoring to control the amount of ablative energy delivered to the tissue at a specified target location. This should include a manner of modulating ablative energy output based on real-time interrogation of tissue parameters such as temperature, device contact force, local blood pressure, etc..

Moreover, there is an unmet need for a device which can seamlessly integrate physiological monitoring sensors and ablative elements without compromising the function of the device in administering therapeutic energy or enabling device conversion between a collapsed state and an expanded state.

Further, there is a need for a cryoablation balloon catheter that treats atrial fibrillation and other arrhythmias, which can sense tissue parameters in real-time before, during and after ablation. Currently, the "mapping" function in cryoablation catheters is often handled by separate accessory devices. Adding conventional sensors to a balloon can add undesirable bulk to the balloon, which would necessitate a larger delivery sheath to introduce into and retract from the body of the patient.

There have been several attempts to attach sensors or mapping electrodes to balloons, all with limited success. Same disadvantages to earlier solutions include added bulk or balloon profile, a tendency for the electrodes to peel off a balloon during expansion and contraction, and difficulty routing wires to connect to the electrodes, to name a few.

<CIT> discusses an apparatus for medical diagnosis and/or treatment. The apparatus includes a flexible substrate forming an inflatable body and a plurality of force sensing elements disposed on the flexible substrate. The plurality of force sensing elements are disposed about the inflatable body such that the force sensing elements are disposed at areas of minimal curvature of the inflatable body in a deflated state.

<CIT> discusses an ablation catheter comprising: an expandable membrane and a plurality of ablation electrodes secured to the exterior of the expandable membrane; an imaging member disposed within the expandable membrane; a diffuse reflector secured to at least a proximal portion of the expandable membrane; and a light source disposed within the expandable member and positioned to direct light towards the diffuse reflector such that diffuse reflection of the light is directed towards a field of view of the imaging member.

<CIT> discusses an expandable structure and one or more sets of electrodes disposed on the surface of the expandable structure. Each one of the sets comprises an ablating electrode, and at least one sensing electrode that is electrically isolated from the ablating electrode. The sensing electrode is contained within the ablating electrode.

<CIT> discusses cardiac ablation which is carried out by introducing a catheter into the left atrium, extending a lasso guide through the lumen of the catheter to engage the wall of a pulmonary vein, and deploying a balloon over the lasso guide. The balloon has an electrode assembly disposed its exterior. The electrode assembly includes a plurality of ablation electrodes circumferentially arranged about the longitudinal axis of the catheter. The inflated balloon is positioned against the pulmonary vein ostium, so that the ablation electrodes are in galvanic contact with the pulmonary vein, and electrical energy is conducted through the ablation electrodes to produce a circumferential lesion that circumscribes the pulmonary vein.

The present disclosure is directed toward an intravascular catheter system for treating a condition in a body. In one example, the intravascular catheter system includes a catheter shaft, a first inflatable balloon and a plurality of electrodes. The catheter shaft has a shaft distal end that is selectively positioned within the body. The first inflatable balloon is positioned near the distal end of the catheter shaft. The first inflatable balloon is configured to move between an inflated state and a substantially deflated state. In the inflated state, the first inflatable balloon has a maximum circumference. The plurality of electrodes are attached to the first inflatable balloon. The plurality of electrodes can sense a physiological parameter within the body. Further, the plurality of electrodes can be positioned away from the maximum circumference of the first inflatable balloon so that none of the electrodes are positioned on the maximum circumference of the first inflatable balloon.

In certain examples, the first inflatable balloon has an inner surface and an opposed outer surface. In some such embodiments, the electrodes are positioned on the inner surface of the first inflatable balloon.

In another example, the first inflatable balloon has an inner surface and an opposed outer surface. In this embodiment, the electrodes are positioned on the outer surface of the first inflatable balloon.

In various examples, the intravascular catheter system can also include one or more flex circuits that are secured to the first inflatable balloon. In certain such examples, the electrodes are coupled to the first inflatable balloon via the one or more flex circuits. In various examples, the one or more flex circuits can be positioned away from the maximum circumference of the first inflatable balloon. In some examples, each of the flex circuits can be secured to the first inflatable balloon distal to the maximum circumference.

In certain examples, at least two electrodes are positioned on each of the one or more flex circuits. In some such examples, two of the electrodes on each flex circuit form a thermocouple.

In various examples, at least eight flex circuits are positioned on the first inflatable balloon. Alternatively, at least twelve flex circuits are positioned on the first inflatable balloon.

In some examples, the inflatable balloon includes a plurality of spines when the first inflatable balloon is in the substantially deflated state. In certain examples, two flex circuits are positioned between two adjacent spines. In some examples, two adjacent two flex circuits substantially face one another when the first inflatable balloon is in the substantially deflated state.

In another example, the intravascular catheter system can also include a second inflatable balloon that is positioned within the first inflatable balloon. In some such examples, the second inflatable balloon has an outer surface and an opposed inner surface, and the plurality of electrodes are positioned on the outer surface of the second inflatable balloon.

In various example, the intravascular catheter system also includes a guidewire lumen and a guidewire that is positioned at least partially within the guidewire lumen. The first inflatable balloon can be attached to the guidewire lumen. The intravascular catheter system can also include a controller and a plurality of conductors. In certain examples, each conductor carries an electrical signal between at least one of the electrodes and the controller. The electrical signal can be based on the physiological parameter.

In some examples, the guidewire lumen has a lumen distal end, and each conductor is routed from at least one of the electrodes to the controller via the lumen distal end of the guidewire lumen.

In certain examples, the intravascular catheter system can also include a pair of reference electrodes that are positioned away from the first inflatable balloon. In these examples, the pair of reference electrodes can form a thermocouple that senses a temperature of a portion of the body. The reference electrodes can generate a reference sensor output. In various examples, two of the plurality of electrodes generate a sensor output that is compared to the reference sensor output to determine a temperature of a portion of the body.

In another example, the intravascular catheter system can include a catheter shaft, a first inflatable balloon, a flex circuit and a pair of electrodes. The catheter shaft can have a shaft distal end that is selectively positioned within the body. The first inflatable balloon can be positioned near the distal end of the catheter shaft. The first inflatable balloon can be configured to move between an inflated state and a substantially deflated state. The flex circuit can be attached to the first inflatable balloon. The pair of electrodes can be secured to the flex circuit. The pair of electrodes can sense a physiological parameter within the body.

In a further example, the intravascular catheter system can include a catheter shaft, a first inflatable balloon and a plurality of electrodes. The catheter shaft can have a shaft distal end that is selectively positioned within the body. The first inflatable balloon can be positioned near the distal end of the catheter shaft. The first inflatable balloon can be configured to move between an inflated state and a substantially deflated state. The first inflatable balloon has an inner surface and an opposed outer surface. The plurality of electrodes each senses a physiological parameter within the body. In certain examples, the plurality of electrodes are attached to the inner surface of the first inflatable balloon.

In yet another example, the intravascular catheter system includes a catheter shaft, a first inflatable balloon, a plurality of electrodes and two flex circuits. The catheter shaft can have a shaft distal end that is selectively positioned within the body. The first inflatable balloon can be positioned near the distal end of the catheter shaft. The first inflatable balloon can be configured to move between an inflated state and a substantially deflated state. The plurality of electrodes sense one or more physiological parameters within the body. The two flex circuits couple the electrodes to the first inflatable balloon. In some examples, the two flex circuits can each be attached to the first inflatable balloon. In various examples, the two flex circuits substantially face one another when the first inflatable balloon is in the substantially deflated state.

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:.

Embodiments of the present invention are described herein in the context of a cryogenic balloon catheter system (also hereinafter sometimes referred to as an "intravascular catheter system"). 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 non-exclusive examples.

<FIG> is a schematic side view illustration of one embodiment of a medical device <NUM> for use with a patient <NUM>, which can be a human being or an animal. Although the specific medical device <NUM> shown and described herein pertains to and refers to a cryogenic balloon catheter system <NUM>, it is understood and appreciated that other types of medical devices <NUM> can equally benefit by the teachings provided herein. The design of the cryogenic balloon catheter system <NUM> can be varied. In certain embodiments such as the embodiment illustrated in <FIG>, the cryogenic balloon catheter system <NUM> can include one or more of a control system <NUM>, a fluid source <NUM>, a balloon catheter <NUM>, a handle assembly <NUM>, a control console <NUM> and a graphical display <NUM>. It is understood that although <FIG> illustrates the structures of the cryogenic balloon catheter system <NUM> 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>.

In various embodiments, the control system <NUM> can control release and/or retrieval of a cryogenic fluid <NUM> to and/or from the balloon catheter <NUM>. In various embodiments, the control system <NUM> can control activation and/or deactivation of one or more other processes of the balloon catheter <NUM>. Additionally, or in the alternative, the control system <NUM> can receive electrical signals, including data and/or other information (hereinafter sometimes referred to as "sensor output") from various structures within the cryogenic balloon catheter system <NUM>. In some embodiments, the control system <NUM> can assimilate and/or integrate the sensor output, and/or any other data or information received from any structure within the cryogenic balloon catheter system <NUM>. Additionally, or in the alternative, the control system <NUM> can control positioning of portions of the balloon catheter <NUM> within the body of the patient <NUM>, and/or can control any other suitable functions of the balloon catheter <NUM>.

The fluid source <NUM> contains the cryogenic fluid <NUM>, which is delivered to the balloon catheter <NUM> with or without input from the control system <NUM> during a cryoablation procedure. The type of cryogenic fluid <NUM> that is used during the cryoablation procedure can vary. In one non-exclusive embodiment, the cryogenic fluid <NUM> can include liquid nitrous oxide. However, any other suitable cryogenic fluid <NUM> can be used.

The balloon catheter <NUM> is inserted into the body of the patient <NUM>. In one embodiment, the balloon catheter <NUM> can be positioned within the body of the patient <NUM> using the control system <NUM>. Alternatively, the balloon catheter <NUM> can be manually positioned within the body of the patient <NUM> by a health care professional (also sometimes referred to herein as an "operator"). In certain embodiments, the balloon catheter <NUM> is positioned within the body of the patient <NUM> utilizing the sensor output from the balloon catheter <NUM>. In various embodiments, the sensor output is received by the control system <NUM>, which then can provide the operator with information regarding the positioning of the balloon catheter <NUM>. Based at least partially on the sensor output feedback received by the control system <NUM>, the operator can adjust the positioning of the balloon catheter <NUM> within the body of the patient <NUM>. While specific reference is made herein to the balloon catheter <NUM>, it is understood that any suitable type of medical device and/or catheter may be used.

The handle assembly <NUM> is handled and used by the operator to operate, position and control the balloon catheter <NUM>. The design and specific features of the handle assembly <NUM> can vary to suit the design requirements of the cryogenic balloon catheter system <NUM>. In the embodiment illustrated in <FIG>, the handle assembly <NUM> is separate from, but in electrical and/or fluid communication with the control system <NUM>, the fluid source <NUM> and/or the graphical display <NUM>. In some embodiments, the handle assembly <NUM> can integrate and/or include at least a portion of the control system <NUM> within an interior of the handle assembly <NUM>. It is understood that the handle assembly <NUM> can include fewer or additional components than those specifically illustrated and described herein.

In the embodiment illustrated in <FIG>, the control console <NUM> includes the control system <NUM>, the fluid source <NUM> and the graphical display <NUM>. However, in alternative embodiments, the control console <NUM> can contain additional structures not shown or described herein. Still alternatively, the control console <NUM> may not include various structures that are illustrated within the control console <NUM> in <FIG>. For example, in one embodiment, the control console <NUM> does not include the graphical display <NUM>.

The graphical display <NUM> provides the operator of the cryogenic balloon catheter system <NUM> with information that can be used before, during and after the cryoablation procedure. The specifics of the graphical display <NUM> can vary depending upon the design requirements of the cryogenic balloon catheter system <NUM>, or the specific needs, specifications and/or desires of the operator.

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

<FIG> is a simplified side view of a portion of a patient <NUM> and a portion of one embodiment of the cryogenic balloon catheter system 210A. In this embodiment, the cryogenic balloon catheter system 210A includes a balloon catheter 218A. In the embodiment illustrated in <FIG>, the balloon catheter 218A includes a guidewire 226A, a guidewire lumen 227A, a catheter shaft 228A, an inner inflatable balloon 230A (sometimes referred to herein as a "first inflatable balloon" or "first balloon"), an outer inflatable balloon 232A (sometimes referred to herein as a "second inflatable balloon" or "second balloon") and a sensor assembly 234A. As used herein, it is recognized that either balloon 230A, 232A can be described as the first balloon or the second balloon. It is also understood that in some embodiments, the balloon catheters described herein may have only one inflatable balloon. In the embodiment illustrated in <FIG>, the portion of the cryogenic balloon catheter system 210A is positioned within the circulatory system 235A (also sometimes referred to herein as the "body") of the patient <NUM>. The guidewire 226A and guidewire lumen 227A are inserted into a pulmonary vein 236A of the patient, and the catheter shaft 228A and the balloons 230A, 232A are moved along the guidewire 226A and/or guidewire lumen 227A to near an ostium 238A of the pulmonary vein 236A.

In one embodiment, the inner inflatable balloon 230A can be made from a relatively non-compliant or semi-compliant material. Some representative materials suitable for this application include PET (polyethylene terephthalate), nylon, polyurethane, and co-polymers of these materials such as polyether block amide (PEBA), known under its trade name as PEBAX® (supplier Arkema), 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 inflatable balloon 230A. The inner inflatable balloon 230A can be relatively inelastic in comparison to the outer inflatable balloon 232A.

In certain embodiments, the outer inflatable balloon 232A can be made from a relatively compliant material. Such materials are well known in the art. One non-exclusive example is aliphatic polyether polyurethanes in which carbon atoms are linked in open chains, including paraffins, olefins, and acetylenes. Another available example goes by the trade name Tecoflex® (Lubrizol). Other available polymers from the polyurethane class of thermoplastic polymers with exceptional elongation characteristics are also suitable for use as the outer inflatable balloon 232A. In one embodiment, either of the balloons 230A, 232A, may be rendered electrically conductive by doping the material from which it is made with a conductive metal or other conductive substance. These electrically conductive balloons are particularly suitable for the outer inflatable balloon 232A described herein.

During use, the inner inflatable balloon 230A can be partially or fully inflated so that at least a portion of the outer surface 240A of the inner inflatable balloon 230A expands against an inner surface 242A of the outer inflatable balloon 232A (although a space is shown between the inner inflatable balloon 230A and the outer inflatable balloon 232A in <FIG> for clarity and ease in understanding). Further, at certain locations between the inner inflatable balloon 230A and the outer inflatable balloon 232A, there can exist a balloon gap 244A, e.g. an open space between the balloons 230A, 232A, after the inner inflatable balloon 230A is inflated. As provided herein, once the inner inflatable balloon 230A is sufficiently inflated, an outer surface 245A of the outer inflatable balloon 232A can then be positioned within the circulatory system 235A of the patient <NUM> to abut and/or substantially form a seal with the ostium 238A of the pulmonary vein 236A to be treated.

In the embodiment illustrated in <FIG>, the sensor assembly 234A is positioned and/or embedded within the guidewire lumen 227A at or near a lumen distal end 246A of the guidewire lumen 227A. As used herein, the lumen distal end 246A is the portion of the guidewire lumen 227A that is first inserted into the circulatory system 235A of the patient <NUM>. In the embodiment illustrated in <FIG>, the sensor assembly 234A is positioned along the guidewire lumen 227A between a lumen distal end 246A and the outer inflatable balloon 232A. With this design, once the outer inflatable balloon 232A abuts and/or forms a seal with the ostium 238A of the pulmonary vein 236A to be treated, the sensor assembly 234A is positioned within the pulmonary vein 236A to be treated. As such, the sensor assembly 234A can sense various physiological parameters within the pulmonary vein 236A with greater accuracy due to the more stable and/or controlled environment within the sealed-off pulmonary vein 236A.

The sensor assembly 234A is configured to sense one or more physiological parameters within the pulmonary vein 236A. Further, the sensor assembly 234A can provide sensor output regarding the physiological parameters to the control system <NUM> (illustrated in <FIG>) for storage and/or processing. In one non-exclusive embodiment, the sensor assembly 234A can include a plurality of different sensors, including a first sensor 252AF, a second sensor 252AS, and a third sensor 252AT. However, it is understood that any suitable number of sensors, greater or fewer than three, can alternatively be included in the sensor assembly 234A. Further, in one embodiment, the sensors 252AF, 252AS, 252AT, can include one or more thermocouples.

In one embodiment, the first sensor 252AF, the second sensor 252AS and the third sensor 252AT can include, in no particular order, a pressure sensor, a temperature sensor and an electrode, or any combination thereof. Alternatively, the first sensor 252AF, the second sensor 252AS and the third sensor 252AT can include a plurality of the same type of sensor, and can exclude one or more types of sensors. In one embodiment, the pressure sensor, e.g. a microelectromechanical systems or "MEMS" sensor, can sense the pressure within the blood of the pulmonary vein 236A. The temperature sensor can sense the temperature of the blood within the pulmonary vein 236A. The electrode can sense electrical potentials within the blood of the pulmonary vein 236A. The uses and benefits of these types of sensors during cryogenic ablation procedures are well known and understood.

Additionally, or in the alternative, one of the sensors 252AF, 252AS, 252AT (or an additional sensor within the sensor assembly 234A), can include an ultrasound device/sensor which can assist in determining a location of the guidewire 226A, the guidewire lumen 227A and/or the sensor assembly 234A within the circulatory system of the patient <NUM>. More specifically, the ultrasound device/sensor can provide a sensor output that accurately shows a user of the cryogenic balloon catheter system 210A the location of the sensor assembly 234A within the pulmonary vein 236A while the cryogenic balloon catheter system 210A is in use.

In certain embodiments, the control system <NUM> (illustrated in <FIG>) is configured to process and integrate the sensor output to determine proper functioning of the cryogenic balloon catheter system 210A. Based on the sensor output, the control system <NUM> can determine that certain modifications to the functioning of the cryogenic balloon catheter system 210A are required.

The control system <NUM> can abort the delivery of cryogenic fluid <NUM> (illustrated in <FIG>), can increase the fluid flow rate to get more cooling, reduce the fluid flow rate, and/or can have an initial flowrate to reduce temperature to a set point then change the flow rate to maintain a set temperature. In certain embodiments, the control system <NUM> can also change the cycle time and/or amount of fluid delivery.

<FIG> is a cross-sectional view of the balloon catheter 218A taken on line 2B-2B in <FIG>. In this embodiment, the balloon catheter 218A includes the guidewire 226A, the guidewire lumen 227A, and the sensor assembly 234A. In this embodiment, the guidewire lumen 227A has a lumen interior 248A and an outer perimeter 250A. The guidewire 226A is positioned within the lumen interior 248A of the guidewire lumen 227A. In this embodiment, the sensor assembly 234A is positioned between the lumen interior 248A and the outer perimeter 250A of the guidewire lumen 227A.

As shown in <FIG>, the sensor assembly 234A includes the first sensor 252AF. Sensors 252AS, 252AT, are not shown in <FIG>. However, the sensor assembly 234A includes sensor conductors 254AS, 254AT, which transmit the sensor output for sensors 252AS, 252AT (illustrated in <FIG>) to the control system <NUM> (illustrated in <FIG>). The sensor assembly 234A also includes a sensor conductor (not shown) for the first sensor 252AF in order to transmit sensor output for sensor 252AF to the control system <NUM>. Alternatively, the sensors 252AF, 252AS, 252AT, can communicate wirelessly with the control system <NUM>.

In one embodiment, the sensor assembly 234A can be at least partially, if not fully, covered by a sensor outer cover 255A. The sensor outer cover 255A can include an elastomeric material that isolates one or more of the sensors 252AF, 252AS, 252AT, from the blood in the circulatory system of the patient <NUM>, and can inhibit damage to one or more of the sensors 252AF, 252AS, 252AT, during insertion and removal from the patient <NUM>. In one embodiment, the sensor outer cover 255A can be part of the guidewire lumen 227A. The sensor assembly 234A can also be housed within a sensor housing 256A that can form part of the guidewire lumen 227A.

<FIG> is a simplified side view of a portion of a patient <NUM> and a portion of another embodiment of the cryogenic balloon catheter system 210C. In this embodiment, the cryogenic balloon catheter system 210C includes a balloon catheter 218C. In the embodiment illustrated in <FIG>, the balloon catheter 218C includes a guidewire 226C, a guidewire lumen 227C, a catheter shaft 228C, an inner inflatable balloon 230C, an outer inflatable balloon 232C and a sensor assembly 234C. In this embodiment, the portion of the cryogenic balloon catheter system 210C illustrated in <FIG> is positioned within the circulatory system of the patient <NUM>. The guidewire 226C and guidewire lumen 227C are inserted into a pulmonary vein 236C of the patient <NUM>, and the catheter shaft 228C and the balloons 230C, 232C are moved along the guidewire 226C and/or the guidewire lumen 227C to near an ostium 238C of the pulmonary vein 236C.

The inner inflatable balloon 230C and the outer inflatable balloon 232C can be constructed from materials in a somewhat similar manner as those previously described herein. Further, the inner inflatable balloon 230C and the outer inflatable balloon 232C can operate in a somewhat similar manner as previously described herein. However, in the embodiment illustrated in <FIG>, the sensor assembly 234C is positioned between the inner inflatable balloon 230C and the outer inflatable balloon 232C. In one embodiment, the sensor assembly 234C can be adhered or otherwise secured to an outer surface 240C of the inner inflatable balloon 230C. In certain embodiments, the sensor assembly 234C can be adhered or otherwise secured to the inner inflatable balloon 230C in the balloon gap 244C.

Alternatively, the sensor assembly 234C can be positioned in another location between the inner inflatable balloon 230C and the outer inflatable balloon 232C. As such, the sensor assembly 234C can sense various physiological parameters that are occurring at or near the ostium 238C of the pulmonary vein 236C. One advantage to placing the sensor assembly 234C between the two balloons 230C, 232C, includes providing a robust bond to an outer surface 240C of the inner inflatable balloon 230C, which is relatively non-compliant, thereby providing a better surface for bonding structures such as the sensor assembly 234C described herein. In contrast, bonding structures to a more compliant outer inflatable balloon 232C can cause wires and/or sensors to become loose, which can cause entangling with delicate cardiac structures such as valves, etc. By bonding to the outer surface 240C of the inner inflatable balloon 230C, a safety benefit is thereby achieved.

In this embodiment, the sensor assembly 234C is configured to sense one or more physiological parameters near or within the pulmonary vein 236C. Further, the sensor assembly 234C can provide sensor output to the control system <NUM> (illustrated in <FIG>) for storage and/or processing regarding the physiological parameters. In one non-exclusive embodiment, the sensor assembly 234C can include a plurality of different sensors, including a first sensor 252CF, a second sensor 252CS, and a third sensor 252CT. However, it is understood that any suitable number of sensors can be included in the sensor assembly 234C, which may be fewer or greater than three sensors. In one embodiment, the sensor assembly 234C can include a flex circuit that can be bonded to the outer surface 240C of the inner inflatable balloon 230C. Alternatively, the sensor assembly 234C can include any other suitable type of electrical communication device or wiring between the sensors 252CF, 252CS, 252CT, and the control system <NUM>. Still alternatively, the sensors 252CF, 252CS, 252CT, can communicate wirelessly with the control system <NUM>.

The sensors 252CF, 252CS, 252CT, can operate in a somewhat similar manner as those previously described herein. In certain embodiments, the control system <NUM> is configured to process and integrate the sensor output to determine proper functioning of the cryogenic balloon catheter system 210C. Based on the sensor output, the control system <NUM> can determine that certain modifications to the functioning of the cryogenic balloon catheter system 210C are required.

Although the foregoing embodiments show and describe various sensors being positioned either (<NUM>) between the lumen distal end 246A and the outer inflatable balloon 232A, or (<NUM>) between the inner inflatable balloon 230C and the outer inflatable balloon 232C, it is recognized that an alternative embodiment can include one or more sensors being positioned between the lumen distal end 246A and the outer inflatable balloon 232A, and one or more sensors being positioned between the inner inflatable balloon 230C and the outer inflatable balloon 232C. In other words, sensors can be positioned in both locations in this alternative embodiment without deviating from the spirit of the cryogenic balloon catheter system <NUM> described herein. Additionally, one or more of the sensors can be positioned on the guidewire 226A. All of the data collected from the sensors, regardless of the position of the sensors, can be sent to the control system <NUM> for use by a user (health care physician or other user) or by the control system <NUM> itself.

<FIG> is a cross-sectional view of one embodiment of a portion of the cryogenic balloon catheter system 310A. In this embodiment, the cryogenic balloon catheter system 310A includes a guidewire lumen 327A, a catheter shaft 328A, an inner inflatable balloon 330A, an outer inflatable balloon 332A, a sensor assembly 334A and a fluid injection line 358A. In the embodiment illustrated in <FIG>, the sensor assembly 334A is positioned and/or embedded outside of the outer inflatable balloon 332A within the catheter shaft 328A at or near a shaft distal end 346A of the catheter shaft 328A, as described previously herein. Further, in this embodiment, the fluid injection line 358A extends through the outer inflatable balloon 332A and the inner inflatable balloon 330A, and into an inner inflatable balloon interior 362A. The fluid injection line 358A can be configured and/or positioned in any suitable manner. Although the fluid injection line 358A is illustrated in <FIG> as a straight tube, the fluid injection line 358A can be coiled, or can have any other suitable geometry or configuration. The control system <NUM> (illustrated in <FIG>) can direct dispensing of the cryogenic fluid <NUM> into the inner inflatable balloon interior 362A to appropriately fill the inner inflatable balloon 330A during an ablation procedure.

<FIG> is a cross-sectional view of another embodiment of a portion of the cryogenic balloon catheter system 310B. In this embodiment, the cryogenic balloon catheter system 310B includes a guidewire lumen 327B, a catheter shaft 328B, an inner inflatable balloon 330B, an outer inflatable balloon 332B, a sensor assembly 334B and a fluid injection line 358B. In the embodiment illustrated in <FIG>, the sensor assembly 334B is positioned between the inner inflatable balloon 330B and the outer inflatable balloon 332B, as described previously herein. Further, in this embodiment, the fluid injection line 358B extends through the outer inflatable balloon 332B and the inner inflatable balloon 330B, and into an inner inflatable balloon interior 362B. The fluid injection line 358B can be configured and/or positioned in any suitable manner. Although the fluid injection line 358B is illustrated in <FIG> as a straight tube, the fluid injection line 358B can be coiled, or can have any other suitable geometry or configuration. The control system <NUM> (illustrated in <FIG>) can direct dispensing of the cryogenic fluid <NUM> into the inner inflatable balloon interior 362B to appropriately fill the inner inflatable balloon 330B during an ablation procedure.

<FIG> is a cross-sectional view of a portion of the cryogenic balloon catheter system 310A including the balloon catheter 318A taken on line <NUM>-<NUM> in <FIG>. In the embodiment illustrated in <FIG>, the catheter shaft 328A encircles the guidewire lumen 327A and the fluid injection line 358A. Additionally, within the guidewire lumen 327A are the sensor conductors 354AF, 354AS, 354AT, the lumen interior 348A, the guidewire 326A and a catheter housing 364A. The catheter housing 364A houses the various structures within the catheter shaft 328A.

An alternative embodiment includes placing a pressure sensor into an assembly comprised of three conductors, a sensor housing, and a sealed tube enclosing the wiring. In this embodiment, the assembly is routed internally through the catheter, from the shaft distal end of the catheter shaft to the handle assembly and/or the control system.

<FIG> is a perspective view of a portion of another embodiment of the cryogenic balloon catheter system <NUM>. In this embodiment, the cryogenic balloon catheter system <NUM> includes a catheter shaft <NUM>, an inflatable balloon <NUM> and a portion of a sensor assembly <NUM>. In the embodiment illustrated in <FIG>, the inflatable balloon <NUM> is shown in an inflated state. Further, in <FIG>, the guidewire 226A, 226C (illustrated in <FIG> and <FIG>, respectively), has been omitted for clarity.

In the embodiment illustrated in <FIG>, the catheter shaft <NUM> can include one or more reference electrodes <NUM> (two reference electrodes <NUM> forming a thermocouple are illustrated in <FIG>). The reference electrodes <NUM> can be used to provide a reference sensor output to provide the operator with a known temperature at or near their location. As provided in greater detail herein, the reference sensor output of the reference electrodes <NUM> can be compared to sensor output of other portions of the sensor assembly <NUM> to aid in determining positioning (mapping) of the inflatable balloon <NUM>, temperature, pressure, etc., or for any suitable purpose during an ablation procedure.

In this embodiment, the inflatable balloon <NUM> can represent either the inner inflatable balloon 230A (illustrated in <FIG>) or the outer inflatable balloon 232A (illustrated in <FIG>). Alternatively, the inflatable balloon <NUM> can be a single inflatable balloon with no balloon positioned within its interior space.

The sensor assembly <NUM> can include a plurality of electrodes <NUM> that are secured to the inflatable balloon <NUM> on an outer surface 240A (illustrated in <FIG>) of the inner inflatable balloon 230A (illustrated in <FIG>), on an inner surface 242A (illustrated in <FIG>) of the outer inflatable balloon 232A (illustrated in <FIG>), and/or on an outer surface 245A (illustrated in <FIG>) of the outer inflatable balloon 232A. In one embodiment, the electrodes <NUM> can be adhered to the inflatable balloon <NUM> with a flexible adhesive. Alternatively, the electrodes <NUM> can be secured to the inflatable balloon <NUM> by any other suitable manner. Any suitable number of electrodes <NUM> can be used.

In the embodiment illustrated in <FIG>, the electrodes <NUM> can be in electrode pairs <NUM> (one pair of electrodes <NUM> that form a thermocouple are identified in <FIG>), with each electrode pair <NUM> positioned on and/or embedded within a flex circuit <NUM>. In this embodiment, each electrode pair <NUM> can provide sensor output that is compared to the sensor output of the reference electrodes <NUM>, or any other electrode pair(s), in order to determine the temperature at or near any particular electrode pair <NUM>. In the embodiment illustrated in <FIG>, a plurality of flex circuits <NUM> are positioned on and/or secured to the inflatable balloon <NUM>.

<FIG> is an end view of a portion of the cryogenic balloon catheter system <NUM> illustrated in <FIG>, shown in the inflated state. In <FIG>, the guidewire 226A, 226C (illustrated in <FIG> and <FIG>, respectively), has been omitted for clarity. In this embodiment, the flex circuits <NUM> and/or the electrodes <NUM> can be positioned in a somewhat radial or spoke-like pattern on a surface of the inflatable balloon <NUM>. For example, in one embodiment, the flex circuits <NUM> and/or the electrodes <NUM> can extend in a substantially evenly spaced, radial pattern on the inflatable balloon <NUM>. Alternatively, the flex circuits <NUM> and/or the electrodes <NUM> can have any other suitable configuration on the inflatable balloon <NUM>. In certain embodiments, in the radial configuration (as well as other configurations), the electrodes <NUM> can provide mapping information to the operator so that the operator can determine the positioning of the inflatable balloon <NUM> within the body of the patient <NUM> (illustrated in <FIG>, for example).

In the embodiment illustrated in <FIG>, there are twelve flex circuits <NUM> positioned on the inflatable balloon <NUM>, each with two electrodes <NUM>. It is recognized, however, that any suitable number (greater or fewer than twelve) or combination of flex circuits <NUM> and/or electrodes <NUM> can be used. In the embodiment illustrated in <FIG>, the electrodes <NUM> and/or the flex circuits <NUM> are positioned distal to a maximum circumference <NUM> of the inflatable balloon <NUM>, and are not positioned along or about the maximum circumference <NUM> of the inflatable balloon <NUM>. As used herein, the "maximum circumference" is the largest circumference of the inflatable balloon <NUM> while the inflatable balloon <NUM> is in the inflated state. When in the deflated state, the inflatable balloon <NUM> is less cumbersome and more easily positioned and/or withdrawn into a sheath (not shown) that surrounds the inflatable balloon <NUM> during insertion and/or removal of the balloon catheter <NUM> (illustrated in <FIG>) into or from the patient <NUM>. In an alternative embodiment, the electrodes <NUM> and/or the flex circuits <NUM> are positioned proximal to the maximum circumference <NUM> of the inflatable balloon <NUM>, and are not positioned along or about the maximum circumference <NUM> of the inflatable balloon <NUM>.

In one embodiment, the flex circuits <NUM> are in electrical communication with the control system <NUM> (illustrated in <FIG>) via sensor conductors 254AS, 254AT, 354AF, 354AS, 354AT (illustrated in <FIG> and/or <NUM>), which can be substantially similar and somewhat similarly positioned as those previously described herein. Alternatively, the sensor conductors can be positioned in another suitable manner. For example, in one embodiment, one or more of the sensor conductors can extend along a portion of the inflatable balloon <NUM>, and can enter or extend along the guidewire lumen 227A (illustrated in <FIG>), 227C (illustrated in <FIG>), at the shaft distal end 346A (illustrated in <FIG>, for example).

<FIG> is a perspective view of a portion of the cryogenic balloon catheter system <NUM> illustrated in <FIG>, with the inflatable balloon <NUM> shown in a substantially deflated state. In this embodiment, the inflatable balloon <NUM> can be either the inner inflatable balloon or the outer inflatable balloon. Alternatively, the inflatable balloon <NUM> can be a single balloon rather than one of two balloons as previously described herein.

In the deflated state, the inflatable balloon <NUM> becomes somewhat pleated to permit spines <NUM> between one or more of the flex circuits <NUM>, which each contains at least one electrode pair <NUM> of electrodes <NUM>. With this design, the flex circuits <NUM> themselves are not folded when the inflatable balloon <NUM> is in the deflated state. However, spines <NUM> between the flex circuits <NUM> inhibit unwanted peeling off of the flex circuits <NUM> from the inflatable balloon <NUM> during deflation and while in the deflated state. Further, in the deflated state, the inflatable balloon <NUM> is pleated which facilitates a smaller, more organized profile of the inflatable balloon <NUM> for removal from the body of the patient <NUM> (illustrated in <FIG>).

In one embodiment, in the deflated state, two flex circuits <NUM> are positioned between two adjacent spines <NUM>. In one embodiment, the two flex circuits <NUM> that are positioned between two adjacent spines <NUM> are adjacent to one another. Alternatively, the two flex circuits <NUM> that are positioned between two adjacent spines <NUM> need not be adjacent to one another. With this design, two such adjacent flex circuits <NUM> and/or two adjacent electrode pairs <NUM> will substantially face one another upon deflation of the inflatable balloon <NUM>. Stated another way, in one embodiment, the inflatable balloon <NUM> will include a pleat or crease between two such adjacent flex circuits <NUM> and/or the two such adjacent electrode pairs <NUM>, such that each two such adjacent flex circuits <NUM> will substantially face one another when the inflatable balloon <NUM> is substantially and/or completely deflated.

In this embodiment, the flex circuits <NUM> will alternate substantially facing an adjacent flex circuit <NUM> on one side, and facing substantially away from the other adjacent flex circuit <NUM> on an opposite side of the spine <NUM> when the inflatable balloon <NUM> is substantially completely deflated. In such embodiment, two flex circuits <NUM> are positioned between two adjacent spines <NUM> of the inflatable balloon <NUM>. In other words, as the spines <NUM> are moved closer toward one another when the inflatable balloon <NUM> is in the deflated state, the two flex circuits <NUM> that are positioned between two adjacent spines <NUM> can rotate toward one another so that the flex circuits <NUM> substantially face one another. Further, with this design, folding or creasing of the flex circuits <NUM> is inhibited.

It is understood that although a number of different embodiments of the cryogenic balloon catheter system <NUM> 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.

Claim 1:
An intravascular catheter system (<NUM>; <NUM>) for use in a cryoablation procedure for treating a condition in a body, the intravascular catheter system comprising:
a catheter shaft (228A; <NUM>) having a shaft distal end that is configured to be selectively positioned within the body;
a first inflatable balloon (230A; 232A; <NUM>) positioned near the distal end of the catheter shaft (228A; <NUM>), the first inflatable balloon (230A; 232A; <NUM>) being configured to move between an inflated state and a substantially deflated state, the first inflatable balloon (230A; 232A; <NUM>) having a maximum circumference in the inflated state;
a plurality of electrodes (<NUM>) that are attached to the first inflatable balloon (230A; 232A; <NUM>), the plurality of electrodes (<NUM>) configured to sense a physiological parameter within the body, the plurality of electrodes (<NUM>) being positioned away from the maximum circumference of the first inflatable balloon (230A; 232A; <NUM>) so that none of the electrodes (<NUM>) are positioned on the maximum circumference of the first inflatable balloon (230A; 232A; <NUM>); and
a plurality of flex circuits (<NUM>) secured to the first inflatable balloon (230A; 232A; <NUM>), wherein the electrodes (<NUM>) are coupled to the first inflatable balloon (230A; 232A; <NUM>) via the plurality of flex circuits (<NUM>), and wherein at least two electrodes are positioned on each of the flex circuits (<NUM>) , and wherein each of the flex circuits (<NUM>) is positioned distal to the maximum circumference the first inflatable balloon (230A; 232A; <NUM>);
a controller and a plurality of conductors, each conductor carrying an electrical signal between at least one of the electrodes and the controller, the electrical signal being based on the physiological parameter; and
a guidewire lumen (227A) and a guidewire (226A) that is positioned at least partially within the guidewire lumen (227A), wherein the first inflatable balloon (230A; 232A; <NUM>) is attached to the guidewire lumen (227A), wherein the guidewire lumen (227A) has a lumen distal end (246A), and wherein each conductor is routed from at least one of the electrodes to the controller via the lumen distal end (246A) of the guidewire lumen (227A).