Balloon catheter with coil for sensing tissue temperature and balloon position

Abstract

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 at least one of (i) sense one or more electrical signals from the tissue and (ii) apply 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.

Description

Technical Field

[0001] The present invention relates generally to medical devices, and more particularly to techniques for assembling and using position and temperature sensors in balloon catheters having a diameter of less than 10 mm. Background Technology

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

[0003] For example, U.S. Patent Application Publication 2019 / 0350489 describes a method comprising, in a processor, receiving position signals indicating the locations of: (i) a plurality of electrodes disposed on an inflatable balloon mounted at a distal end of a catheter, and (ii) a first electrode and a second electrode disposed on the axis of the catheter on either side 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 Application 7,001,383 describes a method for ablating tissue in the heart of a subject during an ablation procedure. The method includes applying local treatment to the heart at multiple sites designated for ablation. At each corresponding site, a parameter indicating the level of ablation at that site is sensed. The method preferably includes displaying a cardiac mapping in response to the corresponding sensed parameter, and indicating the level of ablation at the designated site on the mapping during the ablation procedure. Summary of the Invention

[0005] One embodiment of the invention described herein provides a catheter comprising 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 configured to be positioned in contact with tissue of the organ to perform at least one of the following operations: (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 configured to output a signal indicating at least one of: (i) the temperature of the tissue, and (ii) a magnetic field indicating the location of the catheter in the organ.

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

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

[0008] According to one embodiment of the invention, a catheter is also provided, comprising 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 configured to be positioned in contact with tissue of the organ, and to perform at least one of the following operations: (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 implementations, one or more electrodes and one or more thermocouples are connected to electrical traces on a flexible PCB.

[0010] According to one embodiment of the invention, a method for manufacturing a catheter is also provided, the method comprising 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 connected to the electrical interconnects. The flexible substrate is wound around an inflatable balloon, and the inflatable balloon is coupled to a distal end of the catheter's axis.

[0011] In some embodiments, receiving the flexible substrate includes receiving a printed circuit board (PCB), and the electrical interconnects include electrical traces on the PCB. In other embodiments, forming the coil includes printing helical or spiral traces. In still other embodiments, coupling 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 invention, a catheter is also provided, comprising one or more inflatable balloons, one or more electrodes, and at least one coil. The inflatable balloon defines a longitudinal axis extending through it, and the balloon has a compound rotational bending surface about the longitudinal axis. The one or more electrodes are disposed on the compound bending surface of the inflatable balloon and configured to be placed in contact with tissue of the organ and to perform at least one of the following operations: (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 defines a coil axis extending at an angle to the longitudinal axis of the balloon, and the at least one coil is disposed on the compound bending surface of the inflatable balloon.

[0013] In some embodiments, the balloon includes a distal annular surface portion that is approximately annular and a proximal hemispherical surface portion that is approximately truncated hemispherical, with at least one coil disposed on the composite curved surface of both the annular and hemispherical portions of the balloon. In other embodiments, at least one coil is disposed on the composite curved surface of the balloon, which does not have electrodes mounted thereon. In one embodiment, at least one coil is disposed between the electrodes of the balloon and the composite curved surface. In another embodiment, the electrodes include cutouts to allow the coil beneath the electrodes to be exposed to the surrounding environment.

[0014] The invention will be more fully understood from the following detailed description of embodiments thereof, taken in conjunction with the accompanying drawings, wherein: Attached Figure Description

[0015] Figure 1 A schematic diagram of a catheter-based localization-tracking and radiofrequency (RF) ablation system according to one embodiment of the present invention;

[0016] Figure 2A A schematic diagram of a balloon coupled to the distal end of a catheter according to one embodiment of the present invention;

[0017] Figure 2B This is a schematic diagram of a balloon coupled to the distal end of a catheter according to another embodiment of the present invention; and

[0018] Figure 3 A flowchart illustrating a method for manufacturing a catheter tip comprising a balloon according to one embodiment of the present invention is provided. Detailed Implementation

[0019] Overview

[0020] When treating (i) arrhythmias in a patient's heart or (ii) arrhythmias in other suitable organs of the patient, small-diameter balloon catheters (such as balloons with a diameter of approximately 9 mm) can be used for high-resolution mapping and ablation. 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 in the patient's heart, and (ii) the temperature of the ablated tissue and / or the ablation electrode. Due to the small diameter of the balloon, it is difficult to assemble sensors configured to achieve the above-mentioned functions.

[0021] One embodiment of the invention described herein provides 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.

[0022] In some embodiments, electrodes are coupled to or formed in a flexible printed circuit board (PCB) that is wound around and coupled to the surface of an inflatable balloon. The electrodes are configured to be placed in contact with tissue at a target location on the heart and to perform at least one of the following operations: (i) sensing one or more electrical signals from the tissue, and (ii) applying one or more ablation pulses to the tissue.

[0023] In some implementations, the system for ablating tissue of a patient's heart includes a magnetic position tracking system having multiple (e.g., three) field generators placed at a known location outside the patient and configured to apply a magnetic field to a region of interest in the patient's heart.

[0024] In some embodiments, the catheter's coil is patterned in or coupled to the flexible PCB of the inflatable balloon and configured to output a signal indicating at least the temperature of the tissue and / or a magnetic field indicating the catheter's position in the patient's heart. In a first embodiment, the coil includes a resistance temperature detector (RTD).

[0025] In some implementations, the system includes a processor configured to receive signals from the electrodes and coils, and the processor is configured to control the ablation procedure based on instructions from the physician performing the ablation and the received signals.

[0026] In other embodiments, instead of one or more coils in the coil, the balloon catheter may include one or more thermocouples coupled to the surface of the PCB and configured to output an additional signal indicating the temperature of the tissue and / or the temperature of one or more electrodes near the thermocouple.

[0027] In one embodiment, at least one of the coils comprises a planar coil.

[0028] The technology disclosed in this invention improves the quality of high-resolution sensing and ablation by enhancing the functionality of small-diameter balloon catheters (e.g., temperature measurement and accurate position and orientation sensing).

[0029] System Description

[0030] Figure 1 This is a schematic diagram of a catheter-based positioning-tracking and radiofrequency (RF) ablation system 20 according to one embodiment of the present invention.

[0031] Referring now to illustration 25. In some embodiments, system 20 includes a catheter tip 40 fitted at the distal end 22a of the shaft 22 of catheter 21.

[0032] In some embodiments, the catheter tip 40 includes an inflatable balloon 66 having multiple electrodes, such as, but not limited to, multiple sensing and / or RF ablation electrodes 77 and one or more helical electrodes 50. The balloon 66 and the electrodes 50 and 77 are described in detail in Figure 2 below.

[0033] In some embodiments, at least one helical electrode 50 is configured to function as a magnetic sensor and / or a temperature sensor. In one embodiment described herein, at least one helical electrode 50 is used to sense the temperature of tissue at the orifice 51 of the pulmonary vein (PV) in the heart 26. In one embodiment, one or more helical electrodes of the helical electrode 50 may take the form of a circular helix and / or a rectangular helix, as follows: Figure 2B It is shown and described in detail in the text.

[0034] In some embodiments, the proximal end of catheter 21 is connected to console 24, which includes RF generator 45. An ablation protocol, including ablation parameters, is stored in memory 48 of console 24.

[0035] See now Figure 1 A full view. In some embodiments, the physician 30 inserts the distal end 22a of shaft 22 through sheath 23 into the heart 26 of a patient 28 lying on a workbench 29. The physician 30 advances the distal end of shaft 22 to the target location in the heart 26 by manipulating shaft 22 using a manipulator 32 located near the proximal end of catheter 21. During insertion of the distal end 22a, the catheter tip 40 is held inside sheath 23 to minimize vascular trauma along the path to the target location.

[0036] In one embodiment, physician 30 navigates the distal end of axis 22 to a target location by tracking the orientation of catheter tip 40. During navigation of the distal end 22a within heart 26, console 24 receives a signal at catheter tip 40 from helical electrode 50, which acts as a magnetic sensor in response to a magnetic field from external field generator 36. The magnetic field generator 36 is placed at a known location outside patient 28, for example, below workbench 29. Console 24 also includes drive circuitry 34 configured to drive the magnetic field generator 36.

[0037] In some embodiments, based on signals received from the helical electrode 50, the processor 41 of the system 20 is configured to estimate the position and orientation of the catheter tip 40 within the patient's heart 26. The processor 41 is also configured (e.g., on the display 27 of the console 24) to display at least one marker indicating the position and orientation of the catheter tip 40. In one embodiment, the position and orientation of the marker may be displayed relative to an approximate axis of symmetry of the orifice 51. In one embodiment, the display 27 is configured to display the tracked position of the catheter tip 40 overlaid on an anatomical image or model of the heart 26.

[0038] Position tracking methods using external magnetic fields have been implemented in various medical applications, such as in CARTO, manufactured by Biosense Webster Inc. (Irvine, California). TM The system is implemented and described in detail in U.S. Patents 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612, and 6,332,089, PCT Patent Publication WO 96 / 05768, and U.S. Patent Application Publications 2002 / 0065455 A1, 2003 / 0120150 A1, and 2004 / 0068178 A1, the disclosures of which are incorporated herein by reference in their entirety as if fully listed. In one embodiment, the signal from the spiral electrode 50 is also used to utilize the aforementioned CARTO TM The system performs position sensing.

[0039] In some implementations, once the distal end 22a of the shaft 22 has reached the heart 26, the physician 30 retracts the sheath 23 and further manipulates the shaft 22 to navigate the catheter tip 40 to the orifice 51 of the pulmonary vein or any other target location of the heart 26.

[0040] In some embodiments, when the catheter tip 40 is positioned in contact with tissue, the physician 30 controls the RF generator 45 to apply pulses of RF current that are transmitted between the electrode 77 of the catheter tip 40 and an externally coupled (typically attached to the skin of the patient 28) unrelated (i.e., neutral) electrode patch. The patch may include a single electrode or multiple electrodes (referred to herein as electrode 38) connected by wires extending in cable 37. The processor 41 is configured to adjust parameters of the ablation current by outputting appropriate instructions to the RF generator 45 that generates the current.

[0041] In other embodiments, the processor 41 is configured to control the RF generator 45 to apply bipolar RF ablation pulses to one or more pairs of electrodes 77 at the catheter tip 40.

[0042] In some embodiments, the processor 41 includes a temperature sensing module 47 configured to receive electrical signals from the helical electrode 50 conducted by wires extending through the shaft 22 to the processor 41.

[0043] Processor 41 is typically a general-purpose computer with a suitable front end and (a) ECG interface circuitry 44 for receiving ECG signals from electrode 38, and (b) electrical interface circuitry 55 for receiving signals from catheter 21, for applying RF energy therapy via catheter 21 to the left atrium of heart 26, and for controlling other components of system 20. Processor 41 typically includes software in memory 48 of system 20 programmed to perform the functions described herein. This software can be downloaded electronically to a computer via a network, or alternatively or additionally set and / or stored on a non-transitory tangible medium such as magnetic storage, optical storage, or electronic storage.

[0044] This particular configuration of system 20 is illustrated by way of example to demonstrate certain problems addressed by embodiments of the invention and to show the application of these embodiments in enhancing the performance of such ablation systems. However, embodiments of the invention are by no means limited to this particular category of exemplary systems, and the principles described herein can be similarly applied to other categories of ablation systems.

[0045] An ablation balloon catheter with a diameter of less than 10 mm, which assembles a temperature sensor and a magnetic position sensor.

[0046] Figure 2A A schematic diagram of a balloon 66 of a catheter tip 40 coupled to the distal end 22a of a catheter 21 according to an embodiment of the present invention.

[0047] In some implementations, when the physician 30 moves the catheter tip 40 to the target location, the balloon 66 is typically in a collapsed position and is configured to inflate at the target location.

[0048] In this example, at the inflated position, balloon 66 has a diameter of approximately 9 mm and includes electrodes 77 disposed on the surface of balloon 66. In some embodiments, when positioned to contact the tissue of heart 26, the electrodes 77 are configured to sense intracardiac electrical signals from the tissue. In the example of Figure 2, balloon 66 has multiple electrodes 77 to obtain high-resolution mapping of electrical signals in the tissue. In other embodiments, balloon 66 may have any other suitable diameter, typically but not necessarily less than 10 mm.

[0049] In the context of this disclosure and claims, the terms “about” or “approximately” for any numerical value or range indicate a suitable dimensional tolerance that allows a portion or assembly of parts to function for the intended purpose described herein. More specifically, “about” or “approximately” may refer to a range of ±20% of the enumerated values, for example, “about 90%” may refer to a range of values ​​from 71% to 99%.

[0050] In some embodiments, electrode 77 is further configured to apply one or more RF ablation pulses to tissue, the one or more RF ablation pulses being received from RF generator 45 and controlled by processor 41 and / or physician 30, as described above. Figure 1 As described above. In some embodiments, a plurality of electrodes 77 disposed on the surface of the balloon 66 provide physician 30 with several ablation configurations. For example, by applying RF pulses using all electrodes 77 in simultaneous contact with tissue, physician 30 can form a spatially wide ablation foci. Alternatively, by using one or more electrodes 77 in contact with tissue, physician 30 can achieve high-resolution ablation (e.g., forming narrow ablation foci) at one or more desired locations of the ablated tissue.

[0051] In some implementations, the physician 30 can determine the depth of the ablation foci by controlling the energy and duration of the RF ablation pulse applied to the tissue, particularly at the target location.

[0052] In some embodiments, balloon 66 may include a flexible substrate with printed electrical interconnects, such as, but not limited to, a flexible printed circuit board (PCB). In this example, the electrical interconnects include 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 balloon 66 such that electrical traces 76 and 78 are configured to conduct electrical signals and / or RF ablation pulses between electrodes 77 and 50 and console 24.

[0053] In other embodiments, in addition to or in place of the traces 76 and 78, the balloon 66 may include traces having any suitable orientation other than an orientation or parallel to the axis 74.

[0054] Referring now to illustration 60, which shows a spiral electrode (SE) 50. In some embodiments, the SE 50 may include a coil 75 disposed on the surface of the balloon 66 and configured to output a signal indicating the temperature of tissue at the location of the SE 50. Alternatively, in response to a magnetic field generated by a magnetic field generator 36, the coil 75 of the SE 50 is configured to output a signal indicating the magnetic field, wherein the output signal indicates the position of the balloon 66 within the heart 26.

[0055] In principle, balloon catheters with a diameter of less than 10 mm (such as balloon 66) may include impedance-based position sensors, such as those found in active current position (ACL) position stent systems. In ACLs, the tracking catheter is typically based on measuring the catheter (e.g., catheter tip 40) against external body electrodes (such as those described above). Figure 1 The impedance between electrodes 38 (described in the diagram) is then used to determine the position of the catheter within the body. Each measurement is then converted into the corresponding position of the catheter. This conversion is typically based on a pre-built, suitable mapping, and the impedance measured using the electrodes is translated into the corresponding position of the catheter. Such impedance-based position sensors can include any type of coil and are therefore easily implemented in small-diameter balloons. However, the position sensing accuracy of this impedance-based position sensor is generally less accurate than that of the aforementioned magnetic-based position sensors. Furthermore, the ACL may not provide the orientation of the catheter tip 40, which is particularly important in high-resolution mapping and ablation procedures.

[0056] In some embodiments, the coil 75 of the SE 50 has a first end 70 connected to an electrical trace 76 and a second end 80 connected to an electrical trace 78. The electrical traces 76 and 78 are connected to wires extending through the shaft 22 to the processor 41. It should be noted that the coil 75 may be formed on a layer different from the layer of at least one of the electrical traces 76 and 78, and may be connected to predetermined sections of the traces 76 and 78 via electrical connectors referred to herein as through-holes. In the example shown in Illustration 60, the trace 76 and the coil 75 are formed in different layers, and are therefore electrically connected at the first end 70 of the coil 75. If the electrical trace 76 and the coil 75 are formed in the same layer, each winding of the SE 50 is shorted to the electrical trace 76, and therefore the SE 50 will not be able to perform the aforementioned magnetic position sensing and / or temperature sensing functions.

[0057] In this example, the coil 75 of the SE 50 has a circular geometry, but in other embodiments, the coil 75 may have any other suitable geometry, such as, but not limited to, a square geometry.

[0058] In some embodiments, the signal received from SE 50 may be processed by temperature sensing module 47 to determine the temperature of the tissue. In some embodiments, SE 50 may include a resistance temperature detector (RTD) typically made of pure materials such as platinum, nickel, or copper. The material of coil 75 has an accurate relationship between resistance and temperature. In such embodiments, processor 41 is configured to maintain data indicating the resistance-temperature relationship and to provide an indication of the temperature of the ablated tissue based on that relationship. Note that SE 50 is also configured to measure the temperature of the electrodes or any other component of balloon 66.

[0059] In an alternative embodiment, in addition to or in place of one or more SECs 50, balloon 66 may include one or more thermocouples coupled to the surface of balloon 66 and configured to output an additional signal indicating the temperature of the ablated tissue of heart 26.

[0060] In other embodiments, the signals received from the SE 50 may 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 in any other suitable coordinate system of the RF ablation system 20.

[0061] The configuration of the spiral electrode 50 is provided by way of example, and the invention is not limited to this particular configuration. For example, instead of coil 75, SE 50 may have a three-dimensional (3D) structure attached to or formed in a PCB. Furthermore, SE 50 may be made of one or more coils, or coils having any other suitable shape, size, and spacing.

[0062] Figure 2B This is a schematic illustration of a balloon 67 according to another embodiment of the invention. The balloon 67 may be replaced with, for example... Figure 1 and Figure 2A The balloon 66.

[0063] In some implementations, coil 75 may have any suitable shape other than a helix. For example... Figure 2B As shown in the example, balloon 67 may include a coil 52 having a circular shape and / or a coil 50' having a rectangular helical shape. Furthermore, instead of coil 52 or in addition to it, balloon 67 may include one or more electrodes having a helical trace or any other suitable shape, provided that such shape allows it to serve its intended purpose as a magnetic position sensor and / or thermocouple.

[0064] It should be noted that, although coils 50' and 52 are in Figure 2AThe coil can be schematically shown as being disposed on a flat surface, but in actual use, the coil is disposed on a composite surface defined by the surface of the balloon membrane, such as... Figure 2B As shown. In Figure 2B In this design, the membrane surface of the balloon 67 can be considered to have two parts: a distal membrane portion 100A and a proximal membrane portion 100B. The distal membrane 100A can be considered an annular membrane because the distal portion 100A approximates a circular surface. On the other hand, the proximal portion 100B can be considered a hemispherical surface membrane because the distal portion approximates a truncated hemispherical surface. This approximation means that the annular or hemispherical surface of rotation can cover the surface of the actual balloon membrane, such that the annular or hemispherical surface of rotation will overlap with the surface of rotation of the actual balloon membrane.

[0065] exist Figure 2B In the illustrated configuration, coil 50' may be positioned above electrode 77, which is disposed on the composite surface of the membrane of balloon 67. Alternatively, coil 52 may be positioned below electrode 77, for example, between electrode 77 and the composite surface of balloon 67. In the latter configuration, electrode 77 may be configured with cutouts to allow coil 52 to be exposed to the surrounding environment for temperature sensing or to avoid electrical interference from electrode 77. Another available coil location is a location on the balloon membrane not occupied by electrodes. Coil 50' may be placed on the membrane surface between any two electrodes 77. In one example, coil 50' may be placed in an empty surface 80 between two electrodes 77. In another example, the circular helical coil of coil 52 is located on the balloon membrane such that coil 52 overlaps with both annular portion 100A and hemispherical portion 100B, while being positioned in an area of ​​balloon not occupied by electrodes. Again, within the scope of the invention, coil 52 may be placed on either annular portion 100A or hemispherical portion 100B.

[0066] exist Figure 2B In the balloon, coil 52 has an axis A that extends at an angle to the longitudinal axis 74 of the balloon. Axis A may intersect axis 74, but is not required to do so. Coil 50' has an axis B that may be orthogonal to the longitudinal axis 74, but does not need to intersect axis 74.

[0067] Figure 3 A flowchart illustrating a method for manufacturing a conduit tip 40 is provided to schematically illustrate an embodiment of the invention. The method begins with a substrate receiving step 100, in which a flexible PCB substrate having electrical interconnects, such as, but not limited to, electrical traces 76 and 78 formed on a given layer, also referred to herein as the first layer of the PCB, is received. In one embodiment, at least one of the electrical traces 76 and 78 may be formed on another layer to create a multi-level interconnect in the flexible PCB.

[0068] At coil formation step 102, a coil 75 of SE 50 with a helical shape is formed on a layer other than the first layer of the flexible PCB (also referred to herein as the second layer) to allow ends 70 and 80 to be electrically interconnected with traces 76 and 78, respectively. In other embodiments, coil 75 may be formed by printing helical traces (to create helical electrode 50) or any other suitable shape of trace (such as a spiral trace) to form another electrode configured to perform the magnetic position sensing and / or temperature sensing functions described in Figure 2 above.

[0069] At the electrical device coupling step 104, one or more electrical devices, such as, but not limited to, electrode 77, and optionally one or more thermocouples (instead of one or more SE 50 or other than the one or more SEs), are coupled to the flexible PCB and connected to electrical interconnects, such as one or more of electrical traces 76 and 78.

[0070] At the catheter tip assembly step 106, which concludes the method, a flexible PCB is wrapped around and coupled to the balloon 66 (e.g., using adhesive or welding), and the balloon 66 is coupled to the distal end 22a of the shaft 22 to complete the formation of the catheter tip 40.

[0071] For clarity of concept, the construction of the catheter tip 40 and its manufacturing method are simplified and described to illustrate the key features disclosed in this invention.

[0072] While the embodiments described herein primarily relate to the use of balloon catheters with a diameter of less than 10 mm for sensing and ablation of cardiac tissue, the methods and systems described herein can also be modified as necessary for use in other applications, such as using balloon catheters with any suitable diameter for sensing and ablation of cardiac tissue.

[0073] Therefore, it should be understood that the embodiments described above are cited by way of example, and the invention is not limited to what is specifically shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art. Documents incorporated herein by reference are considered an integral part of this application, except that if any terminology defined in such incorporated documents conflicts with the definitions expressly or implicitly given in this specification, only the definitions in this specification shall be considered.

Claims

1. A catheter, comprising: An inflatable balloon for insertion into a patient's organs; A flexible substrate, comprising a first layer and a second layer, and 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 configured to be placed in contact with the tissue of the organ, and performing at least one of the following operations: (i) sensing one or more electrical signals from the tissue, and (ii) applying one or more ablation pulses to the tissue; as well as A spiral coil extending radially outward from a first end to a second end, the spiral coil being disposed on the second layer, the first end and the second end being respectively connected to a first electrical trace and a second electrical trace that are orthogonal to each other in the electrical interconnect, and being configured to output a signal indicating (i) the temperature of the tissue, and (ii) a magnetic field indicating the position of the catheter in the organ.

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

3. The catheter according to claim 1, wherein, The spiral coil includes a magnetic sensor configured to sense the magnetic field to sense the location of the catheter in the organ.

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

5. The catheter of claim 1 further comprises one or more thermocouples coupled to the surface of the inflatable balloon and configured to output an additional signal indicating the temperature of the tissue.

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

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

8. A method for manufacturing a catheter, the method comprising: A flexible substrate is received, the flexible substrate including electrical interconnects formed on a first layer of the flexible substrate; A spiral coil is formed on the second layer of the flexible substrate, extending radially outward from a first end to a second end, and the first end and the second end of the spiral coil are respectively connected to a first electrical trace and a second electrical trace that are orthogonal to each other in the electrical interconnect, wherein the spiral coil is configured to output a signal indicating the following: (i) the temperature of the tissue of the organ, and (ii) a magnetic field indicating the position of the catheter in the organ; Couple one or more electrical devices to the flexible substrate and connect the electrical devices to the electrical interconnects; and The flexible substrate is wound around the inflatable balloon, and the inflatable balloon is coupled to the distal end of the axis of the catheter.

9. The method according to claim 8, wherein, Receiving the flexible substrate includes receiving a printed circuit board (PCB), and wherein the electrical interconnects include electrical traces of the PCB.

10. The method according to claim 8, wherein, Forming the spiral coil includes printing spiral traces or spiral traces.

11. The method according to claim 8, wherein, Coupling the one or more electrical devices includes coupling at least one of the following: (i) one or more electrodes, and (ii) one or more thermocouples.

12. A catheter, comprising: An inflatable balloon, the inflatable balloon defining a longitudinal axis extending through the balloon, the balloon having a composite curved surface that rotates about the longitudinal axis; A flexible substrate, comprising a first layer and a second layer, and wound around the inflatable balloon; Electrical interconnects formed on the first layer; One or more electrodes, disposed on the composite curved surface of the inflatable balloon and configured to be placed in contact with the tissue of an organ, and performing at least one of the following operations: (i) sensing one or more electrical signals from the tissue, and (ii) applying one or more ablation pulses to the tissue; as well as A helical coil extends radially outward from a first end to a second end and defines a coil axis extending at an angle to the longitudinal axis of the balloon, the helical coil being disposed on the second layer, the first end and the second end being respectively connected to a first electrical trace and a second electrical trace orthogonal to each other in the electrical interconnect, wherein the helical coil is configured to output a signal indicating: (i) the temperature of the tissue, and (ii) a magnetic field indicating the position of the catheter in the organ.

13. The catheter according to claim 12, wherein, The balloon includes a distal annular surface portion that is approximately circular and a proximal hemispherical surface portion that is approximately truncated, with a helical coil disposed on the composite curved surface of both the annular and hemispherical surface portions of the balloon.

14. The catheter according to claim 12, wherein, The spiral coil is disposed on the composite curved surface of the balloon on which no electrode is mounted.

15. The catheter according to claim 12, wherein, The spiral coil is disposed between the composite curved surface of the balloon and the one or more electrodes.

16. The catheter according to claim 15, wherein, The one or more electrodes include cutouts to allow the helical coil beneath the one or more electrodes to be exposed to the surrounding environment.

Images