A balloon catheter having a coil for sensing tissue temperature and the position of the balloon

Abstract

To provide a catheter.SOLUTION: A catheter includes an inflatable balloon for insertion into an organ of a patient, one or more electrodes, and a coil. The one or more electrodes are disposed on a surface of the inflatable balloon and are configured to be placed in contact with tissue of the organ, and to perform at least one of the steps of (i) sensing one or more electrical signals from the tissue, and (ii) applying one or more ablation pulses to the tissue. The coil is disposed on the surface of the inflatable balloon, and is configured to output a signal indicative of at least one of (i) a temperature of the tissue, and (ii) a magnetic field indicative of a position of the catheter in the organ.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to techniques for incorporating position sensors and temperature sensors into balloon catheters having a diameter less than 10 mm and using them.

Background Art

[0002] Various types of diagnostic and therapeutic catheters, such as balloon catheters, can be used for mapping applications and / or therapeutic applications such as high-resolution cardiac ablation of the heart.

[0003] For example, U.S. Patent Application Publication No. 2019 / 0350489 describes a method in a processor that includes receiving position signals indicating the positions of (i) a plurality of electrodes disposed on an inflatable balloon attached at the distal end of a catheter, and (ii) first and second electrodes attached on the catheter shaft on both sides of the balloon. The positions of the plurality of electrodes disposed on the balloon are calculated based on the received position signals and based on a known distance between the first electrode and the second electrode.

[0004] U.S. Patent No. 7,001,383 describes a method for ablating tissue within a subject's heart during an ablation procedure. The method includes applying local treatment to the heart at a plurality of sites designated for ablation. At each respective site, a parameter serving as an indicator of the ablation level at that site is sensed. The method preferably includes displaying a map of the heart and, during the ablation procedure, designating an indicator of the ablation level at each site on the map in response to each sensed parameter.

Summary of the Invention

Means for Solving the Problems

[0005] Embodiments of the invention described herein provide a catheter that includes an inflatable balloon for insertion into a patient's organ, one or more electrodes, and a coil. The one or more electrodes are disposed on the surface of the inflatable balloon and are arranged to be in contact with the tissue of the organ and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue. The coil is disposed on the surface of the inflatable balloon and is configured to output a signal indicative of at least one of (i) the temperature of the tissue and (ii) a magnetic field indicative of the position of the catheter within the organ.

[0006] In some embodiments, the inflatable balloon has a diameter less than 10 mm in the inflated position. In other embodiments, the coil includes a magnetic sensor configured to sense a magnetic field to sense the position of the catheter within the organ. In still other embodiments, the coil comprises a resistance temperature detector (RTD) configured to output a signal indicative of the temperature of the tissue.

[0007] In one embodiment, it includes one or more thermocouples coupled to the surface of the inflatable balloon, and the thermocouples are configured to output an additional signal indicative of the temperature of the tissue. In another embodiment, the catheter includes a flexible printed circuit board (PCB) wrapped around the surface of the inflatable balloon. In yet another embodiment, the one or more electrodes and the coil are connected to electrical traces of the flexible PCB.

[0008] Furthermore, according to one embodiment of the present invention, there is provided a catheter including an inflatable balloon for insertion into a patient's organ, one or more electrodes, and one or more thermocouples. The one or more electrodes are disposed on the surface of the inflatable balloon and are configured to be in contact with the tissue of the organ and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue. The one or more thermocouples are coupled to the surface of the inflatable balloon for sensing the temperature of the tissue.

[0009] In some embodiments, the one or more electrodes and the one or more thermocouples are connected to electrical traces of a flexible PCB.

[0010] According to one embodiment of the present invention, there is further provided a method of manufacturing a catheter including receiving a flexible substrate including electrical interconnects formed on a first layer. A coil is formed on a second layer of the flexible substrate, and an end of the coil is connected to the electrical interconnects. One or more electrical devices are coupled to the flexible substrate, and the electrical devices are connected to the electrical interconnects. The flexible substrate is wrapped around the inflatable balloon, and the inflatable balloon is coupled to the distal end of the catheter shaft.

[0011] In some embodiments, receiving the flexible substrate includes receiving a printed circuit board (PCB), and the electrical interconnects include electrical traces of the PCB. In other embodiments, forming the coil includes printing a spiral-shaped trace or a serpentine-shaped trace. In still other embodiments, coupling the one or more electrical devices includes coupling at least one of (i) one or more electrodes and (ii) one or more thermocouples.

[0012] According to one embodiment of the present invention, there is further provided a catheter including an expandable balloon, one or more electrodes, and at least one coil. The expandable balloon defines a longitudinal axis extending through the balloon, and the balloon has a composite rotational surface centered on the longitudinal axis. The one or more electrodes are disposed on the composite surface of the expandable balloon and are arranged to contact the tissue of the organ, and are configured to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue. The at least one coil is at least one coil defining a coil axis extending at an angle with respect to the longitudinal axis of the balloon, and the at least one coil is disposed on the composite surface of the expandable balloon.

[0013] In some embodiments, the balloon comprises a distal toroidal surface portion approximating a circular torus and a proximal hemispherical surface portion approximating a truncated hemispherical surface, and the at least one coil is disposed on the composite surface of both the toroidal and hemispherical portions of the balloon. In other embodiments, the at least one coil is disposed on the composite surface of the balloon where no electrode is mounted. In one embodiment, the at least one coil is disposed between the electrode and the composite surface of the balloon. In another embodiment, the electrode includes a notch that allows the coil under the electrode to be exposed to the surrounding environment.

[0014] The present invention will be more fully understood by considering the following "Detailed Description of the Invention" in conjunction with the drawings.

Brief Description of the Drawings

[0015]

Figure 1

Figure 2A

Figure 2B

Figure 3

[0016] Overview Small-diameter balloon catheters, such as balloons having a diameter of about 9 mm, can be used for high-resolution mapping and ablation in (i) a patient's heart or (ii) other suitable organs of the patient when treating arrhythmias. In such procedures, it is important to receive high-resolution sensing in real time, particularly of (i) the position and orientation of the balloon catheter within the patient's heart and (ii) the temperature of the ablated tissue and / or the electrodes doing the ablation. Due to the small diameter of the balloon, it is very difficult to incorporate sensors configured to perform the above functions.

[0017] Embodiments of the present invention described herein provide a catheter comprising an inflatable balloon having a diameter of less than 10 mm for insertion into a patient's organ (e.g., the heart), one or more electrodes, and one or more coils.

[0018] In some embodiments, the electrodes are wound onto the inflatable balloon and coupled to a flexible printed circuit board (PCB) coupled to or formed within the surface thereof. The electrodes are configured to be placed in contact with tissue at a target location in the heart and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue.

[0019] In some embodiments, a system for ablating a patient's heart tissue comprises a magnetic position tracking system having a plurality (e.g., three) of magnetic field generators that are positioned at known locations external to the patient and configured to apply a magnetic field to a target region of the patient's heart.

[0020] In some embodiments, the catheter coil is patterned within or coupled to a flexible PCB of an inflatable balloon and is configured to output a signal indicative of at least the temperature of the tissue and / or a signal indicative of a magnetic field indicating the position of the catheter within the patient's heart. In a first embodiment, the coil comprises a resistive temperature detector (RTD).

[0021] In some embodiments, the system comprises a processor configured to receive signals from the electrodes and the coil, and the processor is configured to control an ablation procedure based on instructions from a physician performing the ablation and the received signals.

[0022] In other embodiments, instead of one or more coils, the balloon catheter may comprise one or more thermocouples coupled to the surface of the PCB and configured to output an additional signal indicative of the temperature of the tissue and / or the temperature of one or more electrodes proximate to the thermocouple.

[0023] In other embodiments, at least one of the coils is a planar coil.

[0024] The disclosed technology improves the quality of high-resolution sensing and ablation by enhancing the functionality of a small-diameter balloon catheter, e.g., temperature measurement and accurate position and orientation sensing.

[0025] Description of the System FIG. 1 is a schematic depiction of a catheter-based position tracking and radio frequency (RF) ablation system 20 according to an embodiment of the present invention.

[0026] Referring now to the inserted figure 25. In some embodiments, the system 20 includes a catheter tip 40 attached at the distal end 22a of the shaft 22 of the catheter 21.

[0027] In some embodiments, the catheter tip 40 includes an inflatable balloon 66 having a plurality of electrodes, such as, but not limited to, a plurality of sensing electrodes and / or RF ablation electrodes 77 and one or more spiral electrodes 50. The balloon 66 and the electrodes 50 and 77 are described in detail in FIG. 2 below.

[0028] In some embodiments, at least one spiral electrode 50 is configured to function as a magnetic sensor and / or a temperature sensor. In the embodiments described herein, at least one spiral electrode 50 is used to sense the temperature of the tissue at the opening 51 of the pulmonary vein (PV) within the heart 26. In one embodiment, one or more of the spiral electrodes 50 can take the form of a circular spiral and / or a rectangular spiral, as shown and described in detail in FIG. 2B below.

[0029] In some embodiments, the proximal end of the catheter 21 is connected to a control console 24 that includes an RF generator 45. An ablation protocol that includes ablation parameters is stored in the memory 48 of the console 24.

[0030] Referring now to the overall view of FIG. 1. In some embodiments, a physician 30 inserts the distal end 22a of the shaft 22 through the sheath 23 into the heart 26 of a patient 28 lying on a table 29. The physician 30 advances the distal end of the shaft 22 to a target position within the heart 26 by operating the shaft 22 using a manipulator 32 near the proximal end of the catheter 21. While inserting the distal end portion 22a, the catheter tip 40 is maintained within the sheath 23 to minimize vascular trauma along the path to the target position.

[0031] In one embodiment, physician 30 navigates the distal end of shaft 22 to a target position by tracking the direction of catheter tip 40. While navigating distal end 22a in heart 26, console 24 receives a signal from helical electrode 50 at catheter tip 40 that operates as a magnetic sensor in response to a magnetic field from external magnetic field generator 36. Magnetic field generator 36 is disposed at a known location external to patient 28, such as under table 29, for example. Console 24 also includes driver circuit 34 configured to drive magnetic field generator 36.

[0032] In some embodiments, processor 41 of system 20 is configured to estimate the position and orientation of catheter tip 40 within a patient's heart 26 based on signals received from helical electrode 50. Processor 41 is further configured to display, for example, on display 27 of console 24, at least markers indicative of the position and orientation of catheter tip 40. In one embodiment, the position and orientation of the markers may be displayed relative to the orientation of the approximate axis of symmetry of aperture 51. In one embodiment, display 27 is configured to display the tracked position of catheter tip 40 superimposed on an anatomical image or anatomical model of heart 26.

[0033] This position tracking method using an external magnetic field is implemented in various medical applications, for example, in the CARTO (trademark) system manufactured by Biosense Webster Inc. (Irvine, California), and is described in detail in U.S. Patent Nos. 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612, and 6,332,089, International Publication No. 96 / 05768, and U.S. Patent Application Publication Nos. 2002 / 0065455(A1), 2003 / 0120150(A1), and 2004 / 0068178(A1), the disclosures of which are hereby incorporated by reference in their entirety as if fully set forth herein. In one embodiment, the signal from helical electrode 50 is further used for position sensing using the CARTO (trademark) system described above.

[0034] In some embodiments, when the distal end 22a of the shaft 22 reaches the heart 26, the physician 30 withdraws the sheath 23 and further manipulates the shaft 22 to navigate the catheter tip 40 to the opening 51 of the pulmonary vein or any other desired location in the heart 26.

[0035] In some embodiments, while the catheter tip 40 is disposed in contact with tissue, the physician 30 can control the RF generator 45 to apply a pulse of RF current between the electrodes 77 of the catheter tip 40 and an indifferent (i.e., neutral) electrode patch typically attached to the skin of the patient 28 and connected externally to the skin. The patch may comprise a single electrode or multiple electrodes, referred to herein as electrode 38, shown connected by wires routed within the cable 37. The processor 41 is configured to adjust the parameters of the ablation current by outputting appropriate instructions to the RF generator 45 that generates the current.

[0036] In other embodiments, the processor 41 is configured to control the RF generator 45 to apply bipolar RF ablation pulses to one or more of the electrodes 77 of the catheter tip 40.

[0037] In some embodiments, the processor 41 includes a temperature sensing module 47 configured to receive an electrical signal conducted by a wire routed from the spiral electrode 50 through the shaft 22 to the processor 41.

[0038] Processor 41 is typically a general-purpose computer with a suitable front end and (a) an ECG interface circuit 44 for receiving an ECG signal from electrode 38 and (b) an electrical interface circuit 55 for receiving signals from catheter 21, applying RF energy treatment via catheter 21 within the left atrium of heart 26, and controlling other components of system 20. Processor 41 typically includes software within memory 48 of system 20 programmed to perform the functions described herein. The software can be downloaded in electronic form to a computer, for example, over a network, or alternatively or additionally, provided and / or stored on a non-transitory tangible medium such as magnetic memory, optical memory, or electronic memory.

[0039] This particular configuration of system 20 is shown by way of example to illustrate the particular problems addressed in embodiments of the present invention and to demonstrate the application of these embodiments in improving the performance of such ablation systems. However, embodiments of the present invention are not limited to this particular type of exemplary system, and the principles described herein can be similarly applied to other types of ablation systems.

[0040] An ablation balloon catheter having a diameter less than 10MM and incorporating a temperature sensor and a magnetic position sensor FIG. 2A is a schematic depiction of balloon 66 coupled to catheter tip 40 at the distal end 22a of catheter 21, according to one embodiment of the present invention.

[0041] In some embodiments, balloon 66 is typically in a collapsed position when physician 30 moves catheter tip 40 to the target position and is configured to be inflated at the target position.

[0042] In this embodiment, at the inflation position, the balloon 66 has a diameter of about 9 mm and includes electrodes 77 disposed on the surface of the balloon 66. In some embodiments, when disposed in contact with the tissue of the heart 26, the electrodes 77 are configured to sense intracardiac electrical signals from the tissue. In the example of FIG. 2, the balloon 66 has a plurality of electrodes 77 to obtain a high-resolution mapping of the electrical signals within the tissue. In other embodiments, the balloon 66 may have any other suitable diameter less than 10 mm, which is typical but not essential.

[0043] In the context of the present disclosure and in the claims, the term "about" or "approximately" as used with any numerical value or range of numerical values indicates an appropriate dimensional tolerance that allows a component or a set of components to function in accordance with its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values within ± 20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 99%.

[0044] In some embodiments, the electrodes 77 are further configured to apply one or more RF ablation pulses received from the RF generator 45 and controlled by the processor 41 and / or the physician 30 to the tissue, as described in FIG. 1 above. In some embodiments, the multiple electrodes 77 disposed on the surface of the balloon 66 provide the physician 30 with several ablation configurations. For example, by applying RF pulses using all of the electrodes 77 that are simultaneously in contact with the tissue, the physician 30 can form a spatially extensive lesion. Alternatively, by using one or more of the electrodes 77 that are in contact with the tissue, the physician 30 can obtain high-resolution ablation at one or more desired locations of the ablated tissue (e.g., form a narrow lesion).

[0045] In some embodiments, the physician 30 can determine the depth of the lesion, inter alia, by controlling the energy and duration of the RF ablation pulses applied to the tissue at the target location.

[0046] In some embodiments, balloon 66 may comprise a flexible substrate such as, but not limited to, a flexible printed circuit board (PCB) having printed electrical interconnections. In this example, the electrical interconnection portion comprises an electrical trace 76 parallel to the axis 74 of the catheter tip 40 and an electrical trace 78 orthogonal to the axis 74. The flexible PCB is wound around the surface of the balloon 66 such that the electrical traces 76 and 78 are configured to conduct electrical signals and / or RF ablation pulses between the electrodes 77 and 50 and the console 24.

[0047] In other embodiments, balloon 66 may comprise electrical traces having any suitable orientation that is not orthogonal or parallel to the axis 74, in addition to or instead of electrical traces 76 and 78.

[0048] Referring now to the inset view 60 showing the spiral electrode (SE) 50. In some embodiments, SE50 may be disposed on the surface of balloon 66 and may comprise a coil 75 configured to output a signal indicative of the temperature of the tissue at the location of SE50. Additionally or alternatively, the coil 75 of SE50 is configured to output a signal indicative of a magnetic field in response to a magnetic field generated by the magnetic field generator 36, and the output signal indicates the position of the balloon 66 within the heart 26.

[0049] As a general rule, balloon catheters having a diameter smaller than 10 mm, such as balloon 66, may be provided with an impedance-based position sensor, such as an active current location (ACL) location lacking system. In the ACL, catheter tracking is typically based on the measurement of impedance between the catheter, e.g., catheter tip 40, and an external body electrode such as electrode 38 described in FIG. 1 above. Each measurement is then converted to the respective position of the catheter within the body. The conversion is typically based on a suitable mapping that pre-builds and converts the electrical impedance measured using the electrodes to the respective position of the catheter. Such an impedance-based position sensor may comprise any kind of coil and, thus, is easy to implement within a small-diameter balloon. However, the accuracy of position sensing is typically not as accurate as compared to the aforementioned magnetic-based position sensor. Further, the ACL may not provide the orientation of catheter tip 40 which is particularly important in high-resolution mapping and ablation procedures.

[0050] In some embodiments, coil 75 of SE50 has a first end 70 connected to electrical trace 76 and a second end 80 connected to electrical trace 78. Electrical traces 76 and 78 are connected to wires routed through shaft 22 to processor 41. Coil 75 may be formed on a layer different from at least one of electrical traces 76 and 78 and may be connected to a predetermined area of traces 76 and 78 by an electrical plug, referred to herein as a via. In the example shown in inset 60, trace 76 and coil 75 are formed on different layers and are thus electrically connected at the first end 70 of coil 75. If electrical trace 76 and coil 75 were formed on the same layer, each winding of SE50 would short circuit to electrical trace 76 and, thus, SE50 would not be able to perform the magnetic position sensing function and / or temperature sensing function described above.

[0051] In this embodiment, the coil 75 of the SE50 has a circular geometry, but in other embodiments, the coil 75 may have any other suitable shape, such as, but not limited to, a square shape.

[0052] In some embodiments, the signal received from the SE50 can be processed by the temperature sensing module 47 to determine the temperature of the tissue. In some embodiments, the SE50 may typically include a resistance temperature detector (RTD) made of a pure substance such as platinum, nickel, or copper. The material of the coil 75 has an accurate relationship between electrical resistance and temperature. In such embodiments, the processor 41 is configured to hold data indicating the relationship between resistance and temperature and provide an indication of the temperature of the ablated tissue based on this relationship. Note that the SE50 is further configured to measure the temperature of the electrodes or any other component of the balloon 66.

[0053] In an alternative embodiment, in addition to or instead of one or more SE50s, the balloon 66 may include one or more thermocouples coupled to the surface of the balloon 66, and the thermocouples are configured to output an additional signal indicative of the temperature of the ablated tissue of the heart 26.

[0054] In other embodiments, the signal received from the SE50 can be processed by the processor 41 to determine the position of the balloon 66 in the coordinate system of the magnetic position tracking system or the position of the balloon 66 in any other suitable coordinate system of the RF ablation system 20.

[0055] The configuration of the spiral electrode 50 is provided by way of example, and the present invention is not limited to this particular configuration. For example, instead of the coil 75, the SE50 may have a three-dimensional (3D) structure attached to or formed within a printed circuit board (PCB). Further, the SE50 may be made of one or more coils or may be made of coils having any other suitable shape, size, and pitch.

[0056] Figure 2B is a schematic drawing of balloon 67 according to another embodiment of the present invention. Balloon 67 can replace, for example, balloon 66 of FIGS. 1 and 2A above.

[0057] In some embodiments, coil 75 may have any suitable shape other than a spiral. As shown in the example of FIG. 2B, balloon 67 may include a coil 52 having a circular shape and / or a coil 50' having a rectangular spiral shape. Further, instead of or in addition to coil 52, balloon 67 may include one or more electrodes having a serpentine trace or any other suitable shape as long as the serpentine trace or any other suitable shape enables the intended purpose as a magnetic position sensor and / or a thermocouple.

[0058] Coils 50' and 52 can be schematically shown as coils disposed on the flat surface of FIG. 2A, but it should be noted that in actual use, the coils are disposed on a composite surface defined by the balloon membrane surface shown in FIG. 2B here. In FIG. 2B, the membrane surface of balloon 67 can be seen as having two parts, a distal membrane part 100A and a proximal membrane part 100B. The distal membrane 100A can be regarded as a toroidal membrane in that the distal part 100A approximates the surface of a circular torus. On the other hand, the proximal part 100B can be regarded as a hemispherical surface membrane in that it approximates a frustoconical surface. Here, "approximates" means that the rotational surface of the torus or hemisphere can be superimposed on the surface of the actual balloon membrane such that the rotational surface of the torus or hemisphere overlaps the surface of the actual balloon membrane.

[0059] In the configuration shown in FIG. 2B, the coil 50' can be disposed above the electrode 77 disposed on the composite surface of the balloon 67 membrane. Alternatively, the coil 52 can be disposed below the electrode 77, for example, between the electrode 77 and the composite surface of the balloon. In the latter configuration, the electrode 77 can be configured to have a notch to expose the coil 52 to the ambient environment for the purpose of sensing temperature or avoiding electrical interference by the electrode 77. Another possible coil position is the position of the balloon membrane not occupied by the electrode. The coil 50' can be disposed on the membrane surface between any two electrodes 77. In one example, the coil 50' can be disposed on the blank surface 80 between two electrodes 77. In another example, the circular spiral coil of the coil 52 is located on the balloon membrane, whereby the coil 52 overlaps both the toroidal portion 100A and the hemispherical portion 100B while being disposed within the region on the balloon not occupied by the electrode. Similarly, it is within the scope of the present invention that the coil 52 can be exclusively disposed in either the toroidal portion 100A or the hemispherical portion 100B.

[0060] In FIG. 2B, the coil 52 has an axis A that can extend at an angle with respect to the longitudinal axis 74 of the balloon. The axis A can intersect the axis 74, but this is not essential. The coil 50' has an axis B that can be orthogonal to the longitudinal axis 74 or may not intersect the axis 74.

[0061] FIG. 3 is a flowchart schematically showing a method of manufacturing the catheter tip 40 according to an embodiment of the present invention. The method starts by receiving, in a substrate receiving step 100, a flexible PCB substrate having electrical interconnects such as electrical traces 76 and 78 (although not limited to) formed on a given layer, also referred to herein as the first layer of the PCB. In one embodiment, at least one of the electrical traces 76 and 78 can be formed on another layer to create multi-level interconnects within the flexible PCB.

[0062] In the coil forming step 102, a coil 75 of SE50 having a spiral shape is formed on another layer, which is also referred to herein as the second layer and is different from the first layer of the flexible PCB, such that the ends 70 and 80 are electrically interconnected to the electrical traces 76 and 78, respectively. In other embodiments, the coil 75 may be formed by printing a spiral trace (so as to generate the spiral electrode 50) or an electrical trace of any other suitable shape, such as a meandering trace, to form another electrode configured to perform the magnetic position sensing function and / or the temperature sensing function described in FIG. 2 above.

[0063] In the electrical device connection step 104, one or more electrical devices, such as, but not limited to, the electrode 77, and optionally one or more thermocouples (instead of or in addition to one or more SE50s) are connected to the flexible PCB and connected to an electrical interconnection, such as one or more of the electrical traces 76 and 78.

[0064] In the catheter tip assembly step 106 that completes the method, the flexible PCB is wrapped around the balloon 66 and connected to the balloon 66 (e.g., using bonding or soldering), and the balloon 66 is connected to the distal end 22a of the shaft 22 so as to complete the formation of the catheter tip 40.

[0065] The configuration of the catheter tip 40 and the method of manufacturing the same are simplified and described for the sake of conceptual clarity to show the main features of the disclosed invention.

[0066] The embodiments described herein are mainly directed to sensing and ablating heart tissue using a balloon catheter having a diameter of less than 10 mm, and the methods and systems described herein can also be used in other applications, such as sensing and ablating other hearts of tissue, using a balloon catheter of any suitable diameter with the necessary modifications.

[0067] Accordingly, it should be understood that the above-described embodiments are cited as examples, and the present invention is not limited to what is specifically shown and described in the above specification. Rather, the scope of the present invention includes both various combinations and sub-combinations of the features described in the above specification, as well as those variations and modifications that would be apparent to those skilled in the art upon reading the foregoing description and are not disclosed in the prior art. Documents incorporated by reference into this patent application are considered an essential part of this application, except that if any term is defined in these incorporated documents in a manner inconsistent with the definition explicitly or implicitly made in this specification, only the definition in this specification shall be considered.

[0068] 〔Embodiment〕 (1) A catheter, comprising: an inflatable balloon for insertion into an organ of a patient; one or more electrodes disposed on the surface of the inflatable balloon and configured to be in contact with the tissue of the organ and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue; a coil disposed on the surface of the inflatable balloon and configured to output a signal indicating at least one of (i) the temperature of the tissue and (ii) a magnetic field indicating the position of the catheter within the organ; and the catheter comprising the above. (2) The catheter according to Embodiment 1, wherein the inflatable balloon has a diameter smaller than 10 mm in the inflated position. (3) The catheter according to Embodiment 1, wherein the coil comprises a magnetic sensor configured to sense the magnetic field to sense the position of the catheter within the organ. (4) The catheter according to Embodiment 1, wherein the coil includes a resistance temperature detector (RTD) configured to output the signal indicating the temperature of the tissue. (5) The catheter according to Embodiment 1, comprising one or more thermocouples connected to the surface of the inflatable balloon, the thermocouple being configured to output an additional signal indicating the temperature of the tissue.

[0069] (6) The catheter according to Embodiment 1, comprising a flexible printed circuit board (PCB) wound around the surface of the inflatable balloon. (7) The catheter according to Embodiment 6, wherein the one or more electrodes and the coil are connected to electrical traces of the flexible PCB. (8) A catheter, an inflatable balloon for insertion into a patient's organ, one or more electrodes disposed on the surface of the inflatable balloon and configured to be in contact with the tissue of the organ and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue, one or more thermocouples connected to the surface of the inflatable balloon for sensing the temperature of the tissue, comprising a catheter. (9) The catheter according to Embodiment 8, wherein the inflatable balloon has a diameter smaller than 10 mm in the inflated position. (10) The catheter according to Embodiment 8, comprising a flexible printed circuit board (PCB) wound around the surface of the inflatable balloon.

[0070] (11) The catheter according to Embodiment 10, wherein the one or more electrodes and the one or more thermocouples are connected to electrical traces of the flexible PCB. (12) A method for manufacturing a catheter, comprising: receiving a flexible substrate having electrical interconnects formed on a first layer; forming a coil on a second layer of the flexible substrate and connecting an end of the coil to the electrical interconnects; coupling one or more electrical devices to the flexible substrate and connecting the electrical devices to the electrical interconnects; wrapping the flexible substrate around an inflatable balloon and connecting the inflatable balloon to a distal end of a shaft of the catheter; A method comprising the above steps. (13) The method according to embodiment 12, wherein receiving the flexible substrate includes receiving a printed circuit board (PCB), and the electrical interconnects comprise electrical traces of the PCB. (14) The method according to embodiment 12, wherein forming the coil includes printing a spiral-shaped trace or a meandering-shaped trace. (15) The method according to embodiment 12, wherein coupling the one or more electrical devices includes coupling at least one of (i) one or more electrodes and (ii) one or more thermocouples.

[0071] (16) A catheter, comprising: an inflatable balloon defining a longitudinal axis extending therethrough, the balloon having a composite rotational surface centered about the longitudinal axis; one or more electrodes disposed on the composite surface of the inflatable balloon and configured to contact tissue of an organ and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue; At least one coil defining a coil axis extending at an angle to the longitudinal axis of the balloon, the at least one coil being disposed on the composite surface of the expandable balloon, at least one coil; A catheter comprising. (17) The balloon comprises a distal toroidal surface portion approximating a circular torus and a proximal hemispherical surface portion approximating a frustum of a hemisphere, and the at least one coil is disposed on the composite surfaces of both the toroidal portion and the hemispherical portion of the balloon. The catheter according to embodiment 16. (18) The at least one coil is disposed on the composite surface of the balloon having no attached electrodes. The catheter according to embodiment 16. (19) The at least one coil is disposed between the electrode and the composite surface of the balloon. The catheter according to embodiment 16. (20) The electrode includes a notch that allows the coil under the electrode to be exposed to the surrounding environment. The catheter according to embodiment 19.

Claims

1. A catheter, comprising: an inflatable balloon for insertion into a patient's organ; a flexible substrate having a first layer and a second layer, the flexible substrate being wound around the inflatable balloon; electrical interconnects formed on the first layer; one or more electrodes disposed on the surface of the inflatable balloon and arranged to contact the tissue of the organ, and configured to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue; a spiral-shaped coil disposed on the second layer and spirally wound radially outwardly from a first end to a second end, at least one of the first end or the second end being connected to at least one of the electrical interconnects, the spiral-shaped coil being configured to output a signal indicative of at least one of (i) the temperature of the tissue and (ii) a magnetic field indicative of the position of the catheter within the organ; A catheter comprising the above.

2. The catheter according to claim 1, wherein the inflatable balloon has a diameter of less than 10 mm in the inflated position.

3. The catheter according to claim 1, wherein the spiral-shaped coil comprises a magnetic sensor configured to sense the magnetic field to sense the position of the catheter within the organ.

4. The catheter according to claim 1, wherein the spiral-shaped coil comprises a resistance temperature detector (RTD) configured to output the signal indicative of the temperature of the tissue.

5. The catheter according to claim 1, comprising one or more thermocouples connected to the surface of the inflatable balloon, the thermocouples being configured to output an additional signal indicative of the temperature of the tissue.

6. The catheter according to claim 1, wherein the flexible substrate is a flexible printed circuit board.

7. The catheter according to claim 6, wherein the one or more electrodes and the spiral-shaped coil are connected to electrical traces of the flexible printed circuit board.

8. A method for manufacturing a catheter, comprising: Receiving the flexible substrate comprising electrical interconnects formed on a first layer of the flexible substrate; Forming a spiral-shaped coil wound radially outwardly in a spiral from a first end to a second end on a second layer of the flexible substrate, and connecting the first end and the second end of the spiral-shaped coil to the electrical interconnects; Coupling one or more electrical devices to the flexible substrate and connecting the one or more electrical devices to the electrical interconnects; Wrapping the flexible substrate around an inflatable balloon and connecting the inflatable balloon to a distal end of the catheter shaft; A method comprising. **Claim 9** The method of claim 8, wherein receiving the flexible substrate comprises receiving a printed circuit board, and the electrical interconnects comprise electrical traces of the printed circuit board. **Claim 10** The method of claim 8, wherein forming the spiral-shaped coil comprises printing a spiral-shaped trace or a meandering trace. **Claim 11** The method of claim 8, wherein coupling the one or more electrical devices comprises coupling at least one of (i) one or more electrodes and (ii) one or more thermocouples. **Claim 12** A catheter comprising: An inflatable balloon defining a longitudinal axis extending therethrough, the inflatable balloon having a composite surface of revolution about the longitudinal axis; A flexible substrate having a first layer and a second layer and wrapped around the inflatable balloon; Electrical interconnects formed on the first layer; One or more electrodes disposed on the composite surface of the inflatable balloon and configured to be in contact with tissue of an organ and to perform at least one of (i) sensing one or more electrical signals from the tissue and (ii) applying one or more ablation pulses to the tissue. At least one helical coil that is spirally wound radially outward from a first end to a second end and extends at an angle with respect to the longitudinal axis of the expandable balloon, wherein the at least one helical coil is disposed on the second layer, and at least one of the first end or the second end is connected to at least one of the electrical interconnects, the at least one helical coil A catheter comprising. **Claim 13** The balloon comprises a distal toroidal surface portion approximating a circular torus and a proximal hemispherical surface portion approximating a truncated hemispherical surface, and the at least one helical coil is disposed on the composite surface of both the toroidal surface portion and the hemispherical surface portion of the balloon. The catheter according to claim 12. **Claim 14** The at least one helical coil is disposed on the composite surface of the expandable balloon having no attached electrodes. The catheter according to claim 12. **Claim 15** The at least one helical coil is disposed between the one or more electrodes and the composite surface of the expandable balloon. The catheter according to claim 12. **Claim 16** The one or more electrodes include notches that allow the at least one helical coil under the one or more electrodes to be exposed to the surrounding environment. The catheter according to claim 15.

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