Ablation electrodes made from electrical traces of flexible printed circuit boards

Abstract

To provide a catheter.SOLUTION: The catheter includes a shaft for insertion into an organ of a patient, an expandable distal-end assembly, and at least an electrical interconnection. The expandable distal-end assembly is coupled to the shaft and includes multiple splines, at least one of the splines includes a flexible substrate, which is configured to conform to tissue of the organ. The electrical interconnection has: (i) a first section, which is formed within the flexible substrate and is configured to conduct ablation signals, and (ii) a second section thicker than the first section, which is formed over an outer surface of the flexible substrate and is configured to apply the ablation signals to the tissue.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention generally relates to medical devices, and more particularly to an expandable catheter having a manufacturing method and ablation electrodes made from electrical traces.

Background Art

[0002] Various techniques for manufacturing expandable catheters having electrodes have been disclosed.

[0003] For example, U.S. Patent Application Publication No. 2009 / 0131930 describes a device that can be disposed within a cavity of a body organ (e.g., the heart) that can distinguish between a fluid (e.g., blood) and a non-fluid tissue (e.g., the heart wall) and provide information or mapping indicators of the position and / or orientation of the device within the cavity. The distinction may be based on flow or some other property, such as dielectric constant or force. The device can selectively ablate portions of the non-fluid tissue based on the information or mapping. The device can detect a property (e.g., potential) indicating whether the ablation was successful. The device may include a plurality of transducers that are guided in a non-deployed form within a blood vessel and disposed in a deployed form proximate to the non-fluid tissue. The deployment mechanism may include a helical member or an expandable member.

[0004] U.S. Patent Application Publication No. 2020 / 0061340 describes an intravascular catheter comprising a handle assembly having first and second handle actuators, the actuators being adapted to separately control the shafts of the inner and outer catheters in at least one of axial displacement, deflection, or rotation. These catheters may also include a medical instrument fixed to the outer shaft.

Summary of the Invention

Means for Solving the Problems

[0005] One embodiment of the present invention provides a catheter comprising a shaft for insertion into a patient's organ, an expandable distal end assembly, and at least one electrical interconnect. The expandable distal end assembly is coupled to the shaft and includes a plurality of splines, at least one of which includes a flexible substrate configured to conform to the tissue of the organ. The electrical interconnect has (i) a first section formed within the flexible substrate and configured to conduct ablation signals, and (ii) a second section thicker than the first section formed on the outer surface of the flexible substrate and configured to apply ablation signals to the tissue.

[0006] In some embodiments, the second section has a thickness greater than 0.1 mm. In other embodiments, the flexible substrate includes a flexible printed circuit board (FPCB), and the electrical interconnects include electrical traces made of gold.

[0007] In one embodiment, the FPCB includes at least one electrically insulating layer formed on the first section and configured to electrically insulate the first section from the tissue. In another embodiment, the second section is not covered by an electrically insulating layer and has at least one surface configured to apply an ablation signal to the tissue.

[0008] According to one embodiment of the present invention, a method for manufacturing a catheter is further provided, the method comprising generating one or more electrical interconnects in a flexible substrate, at least one of the electrical interconnects being made of a conductive layer comprising (i) a first section formed within the flexible substrate and (ii) a second section formed on the outer surface of the flexible substrate and thicker than the first section. One or more stripes of the flexible substrate are cut to generate one or more splines of a catheter, and the one or more splines are assembled into a distal end assembly of the catheter.

[0009] In some embodiments, assembling one or more splines involves (i) coupling the proximal end of a spline to a proximal element of a distal end assembly, and (ii) coupling the distal end of a spline to a distal element of a distal end assembly, wherein the proximal and distal elements are movable relative to each other to expand and fold the distal end assembly. In other embodiments, generating an electrical interconnect involves generating an electrical trace made from a biocompatible layer. In yet another embodiment, the biocompatible layer comprises gold.

[0010] In one embodiment, the conductive layer includes a first sublayer and a second sublayer, and the formation of the conductive layer includes (i) forming the first sublayer in the first section and the second section, and (ii) forming the second sublayer on top of the first sublayer in the second section. In another embodiment, the first and second sublayers are made of gold, and the first and second sublayers have a total thickness greater than 0.1 mm. In yet another embodiment, the formation of the conductive layer includes (i) forming the conductive layer in the first section and the second section, and (ii) thinning the conductive layer in the first section.

[0011] In some embodiments, the conductive layer contains gold and has a thickness greater than 0.1 mm. In other embodiments, the conductive layer contains gold and, after thinning, the first section has a thickness of less than 0.1 mm. In yet another embodiment, the method includes coupling the distal end assembly to the shaft of the catheter.

[0012] This invention will be more fully understood by considering the following "Modes for Carrying Out the Invention" in conjunction with the drawings. [Brief explanation of the drawing]

[0013] [Figure 1] This is a schematic diagram of a catheter-based position tracking system and ablation system according to one embodiment of the present invention. [Figure 2] This is a schematic diagram of the distal end assembly of a catheter in an expanded position according to an embodiment of the present invention. [Figure 2A] This is a cross-sectional view along section line AA in Figure 2, showing the first cross-section and the thicker second cross-section. [Figure 2B] These are alternating cross-sectional views of conductor 77 and electrode 88'. [Figure 3] This flowchart schematically illustrates a method for manufacturing a basket catheter having an ablation electrode made from an electrical trace, according to an embodiment of the present invention. [Modes for carrying out the invention]

[0014] Overview Embodiments of the present invention described below provide an improved technique for manufacturing expandable catheters, such as basket catheters having ablation electrodes formed on splines made from a flexible substrate.

[0015] In some embodiments, the ablation catheter includes a shaft for insertion into the patient's heart and an expandable distal end, a basket-shaped distal end assembly, also referred to herein as the basket in this example. The basket is coupled to the shaft and is configured to be in a folded position when entering and exiting the heart through the vascular structure and to expand to one or more expanded positions, for example, to ablate cardiac tissue.

[0016] The basket comprises several arms, also referred to herein as splines. In some embodiments, at least one (and typically all) of the splines includes a flexible substrate configured to conform to cardiac tissue when positioned in contact with the tissue, so as to apply a radio frequency (RF) ablation signal (e.g., pulses) to the tissue via the aforementioned ablation electrodes.

[0017] In some embodiments, each spline of the basket includes one or more electrical interconnects, typically made of gold or any other suitable type of conductive biocompatible material.

[0018] In some embodiments, each electrical interconnect includes first and second sections. The first section is formed within a flexible substrate and configured to conduct ablation signals but is not exposed to cardiac tissue.

[0019] In some embodiments, a second section of the electrical interconnect is thicker than the first section, for example, about 0.5 mm thick or any other suitable thickness, and functions as an ablation electrode. The second section has an outer surface that is exposed to cardiac tissue and configured to apply an ablation signal to the cardiac tissue. In principle, it is possible to couple the ablation electrode to the electrical interconnect, but having a thick trace on the second section simplifies the basket manufacturing process and reduces costs.

[0020] In some embodiments, the flexible substrate includes a multilayer flexible printed circuit board (FPCB) having an outer layer configured to conform to cardiac tissue. The FPCB may include multiple polymer layers. The outer layer is configured to electrically insulate the first section from the tissue.

[0021] In some embodiments, the electrical interconnects are formed during the fabrication of the FPCB by patterning gold traces. Each gold trace has a first section patterned on one side of the polymer layer of the FPCB substrate, while at least the surface of a second section patterned on the opposite side of the polymer layer of the FPCB substrate is exposed to and faces the tissue to function as an electrode. By using a common electrical trace for both conduction (by the first section) and application of ablation signals (by the second section), the flow of ablation signals from the RF generator of the ablation system to cardiac tissue can be improved.

[0022] The disclosed technology improves the product quality and reduces manufacturing costs of expandable catheters, particularly those with multiple electrodes, such as basket catheters with a large number of electrodes (e.g., tens, hundreds, or thousands).

[0023] Description of the System FIG. 1 is a schematic depiction of a catheter-based position tracking and ablation system 20 according to an embodiment of the present invention. In some embodiments, system 20 includes a catheter 22, which is an expandable heart catheter having a basket shape in this example, and a control console 24. In the embodiments described herein, catheter 22 can be used for any suitable therapeutic and / or diagnostic purpose, such as ablation of tissue of heart 26, but is not limited thereto.

[0024] In some embodiments, console 24 includes a processor 42, which is typically a general-purpose computer having a front-end circuit and an interface circuit. The front-end circuit and the interface circuit are suitable for receiving signals from catheter 22 and controlling other components of system 20 described herein. Processor 42 may be programmed with software to perform the functions used by the system, and processor 42 is configured to store data for the software in memory 50. This software may be downloaded to console 24 in electronic form via a network, for example, or may be provided on a non-transitory tangible medium such as an optical storage medium, a magnetic storage medium, or an electronic storage medium. Alternatively, some or all of the functions of processor 42 may be performed using an application-specific integrated circuit (ASIC) or any suitable type of programmable digital hardware component.

[0025] Refer to inset 25 here. In some embodiments, the catheter 22 comprises a distal end assembly 40 having multiple splines (shown in detail in Figure 2 below) and a shaft 23 for inserting the distal end assembly 40 into a target position to perform tissue ablation within the heart 26. During the ablation procedure, the physician 30 inserts the catheter 22 through the vascular system of the patient 28 lying on a table 29. The physician 30 uses a manipulator 32 near the proximal end of the catheter 22, which is connected to an interface circuit of the processor 42, to move the distal end assembly 40 into a target position within the heart 26.

[0026] In some embodiments, the catheter 22 includes a position sensor 39 of a position tracking system, which is connected to the distal end of the catheter 22 in close proximity to the distal end assembly 40, for example. In this example, the position sensor 39 includes a magnetic position sensor, but in other embodiments, any other suitable type of position sensor (e.g., one other than a magnetic base) may be used.

[0027] Refer again to the schematic diagram in Figure 1. In some embodiments, during induction of the distal end assembly 40 within the heart 26, the processor 42 receives a signal from a magnetic position sensor 39 in response to a magnetic field from an external magnetic field generator 36 to measure, for example, the position of the distal end assembly 40 within the heart 26. In some embodiments, the console 24 includes a drive circuit 34 configured to drive the magnetic field generator 36. The magnetic field generator 36 is located at a known location outside the patient 28, for example, under a table 29.

[0028] In some embodiments, the processor 42 is configured to display, for example, the tracked position of the distal end assembly 40 superimposed on an image 44 of the heart 26 on the display 46 of the console 24.

[0029] This position sensing method, which uses an external magnetic field, is implemented in various medical applications, for example, in the CARTO® system manufactured by Biosense Webster Inc. (Irvine, Calif.), and is 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, International Publication 96 / 05768, and U.S. Patent Application Publications 2002 / 0065455(A1), 2003 / 0120150(A1), and 2004 / 0068178(A1), all of which are incorporated herein by reference.

[0030] Distal end assembly with ablation electrodes made from electrical traces Figure 2 is a schematic diagram of the distal end assembly 40 of the catheter 22 in the expanded position according to an embodiment of the present invention.

[0031] In some embodiments, the distal end assembly 40 includes an expandable basket catheter coupled between the shaft 23 and the apex 89 of the distal end assembly 40. Note that the apex 89 is typically (but not necessarily) the most distal portion of the catheter 22 perpendicular to the axis 71 of the shaft 23.

[0032] In this example, the distal end assembly 40 comprises a plurality of splines 55. Each spline 55 is made from a flexible substrate such as a multilayer flexible printed circuit board (FPCB) 66, or from any other suitable alloy or multilayer substrate. It should be noted that the FPCB 66 is selected for the splines 55 so that (i) it is conductive as described below, and (ii) it is sufficiently flexible to conform to the tissue of the heart 26 that is intended to be ablated. In such embodiments, any other material selected for the splines 55 must be sufficiently flexible to conform to the aforementioned tissue when placed in contact with it.

[0033] In some embodiments, at least each spline 55 of a given spline 55, typically of the distal end assembly 40, has one or more electrical interconnects configured to conduct electrical signals and / or pulses. At least one of the electrical interconnects, typically each electrical interconnect, has (i) a first section referred to herein as a conductor 77 and a second section referred to herein as an electrode 88.

[0034] In some embodiments, each conductor 77 is formed within the FPCB 66, for example, between the polymer layers of the FPCB 66, and is therefore indicated by a dashed line. In this embodiment, the conductor 77 is configured to conduct an ablation signal from the console 24 to the electrode 88.

[0035] In some embodiments, the electrode 88 is formed on the outer surface of the FPCB 66 facing the tissue of the heart 26. When positioned in contact with the tissue, the electrode 88 is configured to apply an ablation signal to the tissue (from the console 24 via the conductor 77). The electrode 88 can have any suitable shape, such as circular, rectangular, or square, but is not limited to these.

[0036] In some embodiments, one spline 55 may include two or more electrical interconnections. In this embodiment, a first conductor 77 is configured to conduct the ablation signal to a rectangular electrode 88, and a second long conductor 77 is configured to conduct the ablation signal to a circular electrode 88, the circular electrode being positioned near the vertex 89 of the rectangular electrode 88. In other embodiments, all electrodes 88 of the distal end assembly 40 have the same shape. Furthermore, each spline 55 can have any suitable number of electrodes 88 (e.g., 1 to 50) formed along the spline. In the example of Figure 2, each ablation signal is sent to a separate electrode 88 using a separate conductor 77. In such embodiments, the physician 30 controls both the location and type of signal applied to the tissue.

[0037] In other embodiments, one conductor 77 may be connected to two or more electrodes 88 to conduct the same ablation signal to multiple electrodes 88. In such embodiments, the physician 30 controls the type of ablation signal applied to the tissue, but the same signal is applied to multiple locations in the tissue simultaneously.

[0038] In some embodiments, each spline 55 may have one or more electrodes positioned at the same distance from the vertex 89. In this embodiment, the circular electrodes 88 of each spline are positioned at the same first distance from the vertex 89. In such embodiments, the physician 30 may apply a first set of ablation pulses to tissue with pores (not shown) having a given diameter. Similarly, all rectangular electrodes 88 are positioned at the same second (larger) distance from the vertex 89. In such embodiments, the physician 30 may apply a second set of ablation pulses to tissue with different pores (not shown) having a diameter smaller than the given diameter. The first set and / or the second set may be applied to the electrodes 88 simultaneously or at different times.

[0039] Here, we refer to inset 60, which shows cross-sectional view AA in Figure 2A of one cross-section of spline 55 marked with the arrow "A" in the overall view of Figure 2.

[0040] In some embodiments, the FPCB 66 includes an outer layer 70 having an outer surface 72 configured to conform to the tissue to be ablated. In this embodiment, the conductor 77 is made of gold or any other suitable biocompatible conductive layer and has a thickness 74 of, for example, about 1 μm to about 50 μm, or any other suitable thickness.

[0041] In the context of this disclosure and the claims, any numerical term “about” or “approximately” relating to a number or range of numbers indicates a suitable dimensional tolerance that enables a part or set of components to function in accordance with its intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values ​​within ±20% of the listed values, for example, “about 90%” may refer to a range of values ​​between 71% and 99%.

[0042] In some embodiments, the electrode 88 is made from the same material as the conductor 77 and typically has a thickness 76 greater than the thickness 74, for example, about 100 μm to about 1 mm, or any other suitable thickness. To understand the concept, it should be noted that the cross-section of the electrode 88 can be any cross-sectional configuration, such as elongated or curved, as shown in Figure 2A, although the cross-section of the electrode 88 is shown as linear, the cross-section of the electrode 88 can be an oval or truncated elliptical electrode 88' as shown in Figure 2B. If the cross-section of the electrode is not constant, the thickness is measured at the maximum thickness of the cross-section of the electrode. Compared with a linear (Figure 2A) or square cross-section, a curved or oval cross-section (electrode 88' in Figure 2B) can be used to reduce stress concentration on the electrode 88' during spine expansion or folding. With these cross-sections in mind, it should be noted that the ratio of the thickness 76 of the electrode 88 or 88' to the thickness 74 of the conductive trace 77 can be selected from about 100:1 to about 20:1. That is, the thickness of the second section (designated as 88) is approximately 20 to 100 times thicker than the thickness of the first section (designated as conductor 77). Similarly, in the cross section of the second section (i.e., electrodes 88 or 88' are collectively shown as 88) designed as a curved cross section, the relevant thickness 76 to satisfy the ratio of the thickness of the second section to the thickness of the first section (i.e., conductive trace thickness 74) is measured at the maximum thickness of the second section (or electrode 88).

[0043] In some embodiments, both the conductor 77 and the electrode 88 are made from gold and from a common (i.e., the same) trace having different thicknesses in each section. As shown in inset 60, the conductor 77 is embedded within the FPCB 66, and the electrode 88 has two or more layers, layers 80 and 82 in this example. Layer 82 is an extension of the conductor 77, and layer 80 (located on top of layer 82) has a surface 84 that is exposed to the tissue intended to be ablated in order to receive ablation pulses from the conductor 77 and apply the ablation signal to the aforementioned tissue. It should be noted that layer 70 is physically and electrically insulated from the conductor 77 and the tissue, and as a result, the ablation pulses are applied to the tissue via the surface 84.

[0044] In some embodiments, the conductor 77 and layer 82 are formed in one common process step, and layer 80 is formed on top of layer 82 using a different process step. In other embodiments, both the conductor 77 and electrode 88 are fabricated simultaneously by forming an electrical trace having a thickness of 76, then thinning the conductor 77 to a thickness of 74, and generating layer 70 on top of the conductor 77. In both embodiments, the conductor 77 and electrode 88 are made from the same electrical trace but have different thicknesses 74 and 76, respectively. The manufacturing process for the distal end assembly 40, in particular the spline 55, is described in detail in Figure 3 below.

[0045] Refer again to the schematic diagram in Figure 2. In some embodiments, when the physician 30 moves the distal end assembly 40 of the catheter 22 to the target position in the heart 26, the distal end assembly 40 is in the folded position and all splines 55 are straight. Once the distal end assembly 40 is positioned at the target position in the heart 26, the physician 30 reduces the distance between the ring 54 and the apex 89 (for example, by pulling the apex 89 toward the ring 54, or by pushing the ring 54 and / or shaft 23 toward the apex 89, or by using any other technique) so that the distal end assembly 40 is positioned in the extended position where the splines 55 are bent, typically as shown in Figure 2.

[0046] In some embodiments, the distal end assembly 40 includes a bump stop 91 connected to the apex 89 and configured to control the minimum distance between the shaft 23 and the apex 89. In the expanded position shown in the example of Figure 2, the distal end assembly 40 may have a gap distance 92 between the shaft 23 and the bump stop 91. In such embodiments, as the physician 30 further reduces the distance between the ring 54 and the apex 89, the bump stop 91 limits the expansion of the distal end assembly 40. In other words, the bump stop 91 acts as a hard stop and is configured to prevent the basket shape of the distal end assembly 40 from becoming completely flat.

[0047] In some embodiments, the physician 30 may use a manipulator 32 (shown in Figure 1 above) to control the distance between the vertex 89 and the ring 54, and thus the amount of expansion of the distal end assembly 40.

[0048] Manufacturing of catheters with ablation electrodes made from electrical traces Figure 3 is a schematic flowchart illustrating a method for manufacturing a basket catheter in the distal end assembly 40 of this example, which has an ablation electrode 88 made from an electrical trace, according to an embodiment of the present invention.

[0049] The method begins with an electrical trace generation step 100, which generates one or more electrical traces within an FPCB 66, at least one of which has first and second sections. The first section includes a conductor 77 formed within the FPCB 66 and covered by a layer 70. The second section, which functions as an electrode 88, is typically thicker than the conductor 77 and has at least a surface 84, which is exposed by being formed on the outer surface 72 of the layer 70 of the FPCB 66, as shown and described in detail in Figure 2 above.

[0050] In some embodiments, the first section is made from a gold layer such as the conductor 77 shown in Figure 2 above, and the second section is made from two or more gold layers such as layers 82 and 84 shown in inset 60 of Figure 2 above.

[0051] In such embodiments, the conductor layer 77 (of the first section) and the layer 82 (of the second section) are patterned using the same process sequence, except that the layer 80 (and optionally any additional layers of the second section) are formed on top of the layer 82.

[0052] In an alternative embodiment, both the conductor 77 and the electrode 88 are fabricated simultaneously by forming an electrical trace (shown in Figure 2 above) having a thickness of 76, and then thinning the conductor 77 to a thickness of 74 (e.g., by etching). The process then includes fabricating a layer 70 on top of the conductor 77 to provide different and electrically insulating insulation between the conductor 77 and the tissue of the heart 26, as shown in Figure 2 above.

[0053] It should be noted that in both embodiments, the conductor 77 and the electrode 88 are made from the same electrical trace (made from gold or any other suitable biocompatible conductive material), but have different thicknesses 74 and 76, respectively.

[0054] In spline generation step 102, splines 55 are generated by cutting multiple stripes of the FPCB 66 from the flexible printed circuit board. Note that each stripe includes at least one conductor 77 and at least one electrode 88, as shown and described in detail in Figure 2 above.

[0055] In the distal end assembly manufacturing step 104, the splines 55 are assembled together to manufacture the distal end assembly 40. In some embodiments, the proximal end of each spline 55 is connected to a movable ring 54, and the distal end of each spline 55 is connected to a vertex 89.

[0056] In the shaft coupling step 106, which completes the method, the distal end assembly 40 is coupled to the shaft 23 to manufacture the catheter 22. In some embodiments, the physician 30 may use the shaft 23 to expand and fold the distal end assembly 40 by moving the ring 54 along the axis 71 relative to the apex 89, as described in detail in Figure 2 above.

[0057] The embodiments described herein primarily address basket catheters or other types of expandable catheters used in cardiac ablation. The methods and systems described herein may also be used in other applications such as denervation of the neurological, otolaryngological, and renal regions.

[0058] Accordingly, it will be understood that the embodiments described above are cited as examples and that the present invention is not limited to those specifically shown and described above. Rather, the scope of the present invention includes both combinations and partial combinations of the various features described in the above specification, as well as variations and modifications thereof not disclosed in the prior art, which would be conceivable to those skilled in the art by reading the foregoing description. Documents incorporated into this patent application by reference shall be considered integral parts of this application, except that, in such incorporated documents, only the definitions herein shall be considered to the extent that any term is defined in a manner that contradicts the definitions expressed or implied herein.

[0059] [Implementation Method] (1) A catheter, A shaft for insertion into the patient's organs, An expandable distal end assembly coupled to the shaft and comprising a plurality of splines, wherein at least one of the splines includes a flexible base material configured to conform to the tissue of the organ, (i) a first section formed within the flexible substrate and configured to conduct an ablation signal, and (ii) a second section formed on the outer surface of the flexible substrate and configured to apply the ablation signal to the tissue, having at least one electrical interconnect, A catheter equipped with [a specific feature / equipment]. (2) The catheter according to Embodiment 1, wherein the second section has a thickness greater than 0.1 mm. (3) The catheter according to Embodiment 1, wherein the flexible substrate includes a flexible printed circuit board (FPCB) and the electrical interconnect includes an electrical trace made of gold. (4) The catheter according to Embodiment 3, wherein the FPCB includes at least one electrically insulating layer formed on the first section and configured to electrically insulate the first section from the tissue. (5) The catheter according to Embodiment 4, wherein the second section is not covered by the electrical insulating layer and has at least one surface configured to apply the ablation signal to the tissue.

[0060] (6) The catheter according to Embodiment 1, wherein the second section is about 100 times thicker than the first section. (7) The catheter according to Embodiment 1, wherein the second section is about 20 times thicker than the first section. (8) A method for manufacturing a catheter, The present invention relates to generating one or more electrical interconnections in a flexible substrate, wherein at least one of the electrical interconnections is made of a conductive layer comprising (i) a first section formed within the flexible substrate and (ii) a second section formed on the outer surface of the flexible substrate and thicker than the first section. To generate one or more splines of the catheter, one or more stripes of the flexible substrate are cut, Assembling one or more of the splines onto the distal end assembly of the catheter, A method that includes [a certain feature]. (9) The method according to Embodiment 8, wherein assembling the one or more splines includes (i) coupling the proximal end of the spline to the proximal element of the distal end assembly, and (ii) coupling the distal end of the spline to the distal element of the distal end assembly, wherein the proximal element and the distal element are movable relative to each other to expand and fold the distal end assembly. (10) The method of Embodiment 8, wherein generating the one or more electrical interconnects comprises generating the second section having a thickness greater than 0.1 mm.

[0061] (11) The method according to Embodiment 8, wherein generating the electrical interconnection includes generating an electrical trace made from a biocompatible layer. (12) The method according to embodiment 11, wherein the biocompatible layer contains gold. (13) The method according to Embodiment 8, wherein the conductive layer comprises a first sublayer and a second sublayer, and generating the conductive layer comprises (i) forming the first sublayer in the first section and the second section, and (ii) forming the second sublayer on top of the first sublayer in the second section. (14) The method according to Embodiment 13, wherein the first sublayer and the second sublayer are made of gold, and the first sublayer and the second sublayer have a total thickness greater than 0.1 mm. (15) The method according to Embodiment 8, wherein generating the conductive layer comprises (i) forming the conductive layer in the first section and the second section, and (ii) thinning the conductive layer in the first section.

[0062] (16) The method according to embodiment 15, wherein the conductive layer contains gold and has a thickness greater than 0.1 mm. (17) The method according to Embodiment 15, wherein the conductive layer contains gold, and after thinning, the first section has a thickness of less than 0.1 mm. (18) The method according to embodiment 8, comprising coupling the distal end assembly to the shaft of the catheter. (19) The method according to Embodiment 8, wherein the second section is about 100 times thicker than the first section. (20) The method according to Embodiment 8, wherein the second section is about 20 times thicker than the first section.

Claims

1. It is a catheter, A shaft for insertion into the patient's organs, An expandable distal end assembly coupled to the shaft and comprising a plurality of splines, wherein at least one of the splines includes a flexible base material configured to conform to the tissue of the organ, (i) a first section formed within the flexible substrate and configured to conduct an ablation signal, and (ii) a second section thicker than the first section that protrudes from the outer surface of the flexible substrate and is configured to contact the tissue and apply the ablation signal to the tissue, Equipped with, A catheter in which the first section and the second section are formed from the same material.

2. The catheter according to claim 1, wherein the second section has a thickness greater than 0.1 mm.

3. The catheter according to claim 1, wherein the flexible substrate includes a flexible printed circuit board (FPCB), and the electrical interconnect includes an electrical trace made of gold.

4. The catheter according to claim 3, wherein the FPCB includes at least one electrically insulating layer formed on the first section and configured to electrically insulate the first section from the tissue.

5. The catheter according to claim 4, wherein the second section is not covered by the electrical insulating layer and has at least one surface configured to apply the ablation signal to the tissue.

6. The catheter according to claim 1, wherein the second section is 100 times thicker than the first section.

7. The catheter according to claim 1, wherein the second section is 20 times thicker than the first section.

8. The catheter according to claim 1, wherein the second section has a curved or oval shape in a cross-section extending in the thickness direction.

9. A method for manufacturing a catheter, The present invention relates to generating one or more electrical interconnects in a flexible substrate, wherein at least one of the electrical interconnects is made of a conductive layer comprising (i) a first section formed within the flexible substrate, and (ii) a second section protruding from the outer surface of the flexible substrate and configured to contact the tissue, and being thicker than the first section. Cutting the flexible substrate to generate one or more splines of the catheter, Assembling one or more of the splines onto the distal end assembly of the catheter, Equipped with, A method wherein the first section and the second section are formed from the same material.

10. The method according to claim 9, wherein assembling the one or more splines includes (i) coupling the proximal end of the spline to the proximal element of the distal end assembly, and (ii) coupling the distal end of the spline to the distal element of the distal end assembly, wherein the proximal element and the distal element are movable relative to each other to expand and fold the distal end assembly.

11. The method according to claim 9, wherein generating the electrical interconnection portion comprises generating the second section having a thickness greater than 0.1 mm.

12. The method according to claim 9, wherein generating the electrical interconnection portion includes generating an electrical trace made from a biocompatible layer.

13. The method according to claim 12, wherein the biocompatible layer contains gold.

14. The method according to claim 9, wherein the conductive layer comprises a first sublayer and a second sublayer, and the production of the conductive layer comprises (i) forming the first sublayer in the first section and the second section, and (ii) forming the second sublayer on top of the first sublayer in the second section.

15. The method according to claim 14, wherein the first sublayer and the second sublayer are made of gold, and the first sublayer and the second sublayer have a total thickness greater than 0.1 mm.

16. The method according to claim 9, wherein generating the conductive layer includes (i) forming conductive portions having the same thickness in locations corresponding to the first section and the second section, and (ii) making the conductive portion in the location corresponding to the second section the second section of the conductive layer without thinning it, and making the conductive portion in the location corresponding to the first section the first section of the conductive layer by thinning it.

17. The method according to claim 16, wherein the conductive layer comprises gold, and the second section of the conductive layer has a thickness greater than 0.1 mm.

18. The method according to claim 16, wherein the conductive layer contains gold, and the first section of the conductive layer has a thickness of less than 0.1 mm.

19. The method according to claim 9, comprising coupling the distal end assembly to the shaft of the catheter.

20. The method according to claim 9, wherein the second section is 100 times thicker than the first section.

21. The method according to claim 9, wherein the second section is 20 times thicker than the first section.

22. The method according to claim 9, wherein the second section has a curved or oval shape in a cross-section extending in the thickness direction.

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