Improved heat transfer through ablation electrodes

Abstract

To provide a system for ablating tissue of a subject.SOLUTION: An apparatus includes a flexible, electrically insulating substrate 41 including an inner surface and an outer surface. The substrate is shaped to define multiple channels 46 passing between the inner surface and the outer surface, at least some of the channels being concave channels 49. The apparatus further includes an outer layer 50 of an electrically conducting metal covering at least part of the outer surface, an inner layer of the electrically conducting metal covering at least part of the inner surface, and respective columns 48 of the electrically conducting metal that fill the channels to connect the outer layer to the inner layer.SELECTED DRAWING: Figure 2A

Description

[Technical field]

[0001] The present invention relates to an intracellular probe and its use in an ablation procedure. [Background technology]

[0002] In some ablation procedures, an electrode disposed at the distal end of an intracellular probe is brought into contact with tissue and radio frequency (RF) energy is then passed from the electrode into the tissue.

[0003] U.S. Patent Application Publication No. 2018 / 0110562, the disclosure of which is incorporated herein by reference, describes a catheter including an insertion tube, a flexible substrate, and one or more electrical devices. The insertion tube is configured for insertion into a patient's body. The flexible substrate is configured to encase a distal end of the insertion tube and includes an electrical interconnect. The electrical device is coupled to the flexible substrate and connected to the electrical interconnect. Summary of the Invention [Means for solving the problem]

[0004] According to some embodiments of the present invention, there is provided an apparatus including a flexible, electrically insulating substrate, the substrate including an inner surface and an outer surface and shaped to define a plurality of channels passing between the inner and outer surfaces, at least some of the channels being concave channels, the apparatus further comprising an outer layer of conductive metal covering at least a portion of the outer surface, an inner layer of conductive metal covering at least a portion of the inner surface, and respective columns of conductive metal filling the channels to connect the outer layer to the inner layer.

[0005] In some embodiments, each of the recessed channels comprises: a circular central channel portion; one or more peripheral channel portions having an arcuate periphery and opening into the central channel portion.

[0006] In some embodiments, the peripheral channel portion consists of between 2 and 8 peripheral channel portions.

[0007] In some embodiments, the peripheral channel portion consists of six peripheral channel portions.

[0008] In some embodiments, some of the channels are circular channels, and the channels are arranged such that at least some of the circular channels are each surrounded by a corresponding three of the concave channels.

[0009] In some embodiments, each of the recessed channels comprises: a polygonal central channel portion; and one or more peripheral channel portions opening into the central channel portion.

[0010] In some embodiments, the central and peripheral channel portions are rectangular.

[0011] In some embodiments, each of the recessed channels has a star shape.

[0012] In some embodiments, the total area of ​​each outer opening of the channels is at least 30% of the area of ​​the exterior surface.

[0013] In some embodiments, the conductive metal comprises gold.

[0014] In some embodiments, the apparatus comprises: a probe configured to be inserted into a body of a subject; A support structure coupled to the inner layer and connected to the distal end of the probe.

[0015] In some embodiments, the support structure includes a plurality of ribs surrounding the lumen, with successive ones of the ribs being separated from one another by an opening that is wider than each of the ribs.

[0016] In some embodiments, the surface of the inner layer is shaped to define a plurality of recesses.

[0017] In some embodiments, the recesses are circular and arranged in a close-packed pattern.

[0018] In some embodiments, the average cross-sectional area of ​​each of the recessed channels is 345 μm 2 From 15,700 μm 2 It is between.

[0019] According to some embodiments of the invention, there is further provided a method of inserting a distal end of a probe including a substrate into a body of a subject, the substrate having an inner surface at least partially covered by an inner metal layer and an outer surface at least partially covered by an outer metal layer, the substrate being shaped to define a plurality of channels passing between the inner and outer surfaces and filled by metal columns, at least some of the channels being concave channels. The method further includes contacting tissue of the subject with the outer metal layer following the insertion of the distal end of the probe into the body of the subject. The method further includes passing an electric current through the tissue through the outer metal layer while in contact with the tissue to generate heat in the tissue and transfer it to the inner metal layer through the metal columns. The method further includes discharging heat from the inner metal layer into the blood of the subject by passing an irrigation fluid through the substrate.

[0020] In some embodiments, the tissue comprises cardiac tissue of the subject.

[0021] There is also provided, according to some embodiments of the present invention, a method of forming a plurality of channels, at least some of which are recessed channels, in a flexible, electrically insulating substrate, comprising: causing the channels to pass between an inner surface of the substrate and an outer surface of the substrate, the method further comprising at least partially coating the inner and outer surfaces with a conductive metal to fill the channels.

[0022] In some embodiments, forming the channel comprises: forming a close-packed pattern of circular channels; Following forming the close-packed pattern, forming recessed channels by expanding some of the circular channels such that each of the expanded circular channels opens onto six of the surrounding circular channels.

[0023] In some embodiments, the method further comprises: bonding a conductive metal coating on the inner surface to a support structure; and coupling a support structure to a distal end of a probe configured for insertion into a subject's body.

[0024] In some embodiments, the method further includes forming a plurality of recesses in a surface of the inner layer.

[0025] In some embodiments, forming the recesses includes forming circular recesses in a close-packed pattern.

[0026] The invention will be more fully understood from consideration of the following detailed description taken in conjunction with the drawings, in which: [Brief description of the drawings]

[0027] [Figure 1] FIG. 1 is a schematic diagram illustrating a system for ablating tissue of a subject, according to some embodiments of the present invention. [Figure 2A] 1 is a schematic diagram of an ablation electrode, according to some embodiments of the present invention. [Figure 2B] 2B illustrates a schematic diagram of a longitudinal cross section through the ablation electrode shown in FIG. 2A, according to some embodiments of the present invention. [Figure 3A] 2B is a schematic diagram of a cross section through the surface of the ablation electrode shown in FIG. 2A, according to some embodiments of the present invention. [Figure 3B]FIG. 2B is a schematic diagram of thermal vias through the surface of the ablation electrode shown in FIG. 2A, according to some embodiments of the present invention. [Figure 3C] 2B is a schematic diagram of irrigation holes through the surface of the ablation electrode shown in FIG. 2A, according to some embodiments of the present invention. [Figure 4-1] 1 is a flow chart of a method for manufacturing an ablation electrode, according to some embodiments of the present invention. [Figure 4-2] 1 is a flow chart of a method for manufacturing an ablation electrode, according to some embodiments of the present invention. [Diagram 5] 1A-1C are schematic diagrams of ablation electrodes before deformation, according to some embodiments of the present invention. [Figure 6A] 1A-1D are schematic diagrams of methods for forming recesses in a surface of a support structure according to some embodiments of the present invention. [Figure 6B] 1A-1C are schematic diagrams of methods for forming protrusions on a surface of a support structure according to some embodiments of the present invention. [Figure 7] 1A-1C are schematic diagrams illustrating the transfer of heat into an ablation electrode according to some embodiments of the present invention. [Figure 8] 1 is a schematic diagram of a support structure, according to some embodiments of the present invention. [Figure 9] 1A-1C are schematic diagrams illustrating various types of recessed channels, according to some embodiments of the present invention. [Figure 10] 1A-1C are schematic diagrams illustrating channel arrangements according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Glossary A concave perimeter protrudes inward such that any line joining two points in the perimeter on either side of the protrusion passes through the outside of the perimeter. In contrast, any line joining two points in a convex (or "non-concave") perimeter does not pass through the outside of the perimeter.

[0029] In the context of this application, including the claims, the "perimeter" of a channel generally refers to the perimeter of a cross-section of the channel or via. Similarly, unless otherwise indicated, the "shape" of a channel generally refers to the shape of the perimeter of the channel or via.

[0030] In the context of this application, including the claims, a concave channel or via is a channel or via that has a concave perimeter. Conversely, a convex channel or via is any channel or via that has a convex perimeter. (In general, a channel or via that is slightly concave due to imperfections in the manufacturing technique used to form the channel or via is considered to be convex rather than concave herein.)

[0031] Overview An embodiment of the invention includes an ablation electrode comprising at least one flexible printed circuit board (PCB) bonded to a support structure by an adhesive. The flexible PCB comprises a flexible, electrically insulating substrate having an outer surface coated with an outer layer of a conductive and biocompatible metal, such as, for example, gold, palladium, or platinum, and an inner surface coated with an inner layer of the same and / or another conductive metal. As described further below, the metal may be deposited on the substrate by placing the substrate in a plating bath for a period of time.

[0032] The inner surface may further support one or more electrical components, such as sensors (e.g., thermocouples) and traces, electrically insulated from the inner metal layer. After deposition of these electrical components and coating of the substrate, the PCB is bonded to a support structure. Subsequent to or simultaneously with bonding, the flexible PCB may be deformed into any suitable shape. For example, in some embodiments, the flexible PCB is deformed into a thimble-shaped electrode, hereinafter referred to as the "tip electrode." The electrode is then coupled to the distal end of an intracorporeal probe.

[0033] During the ablation procedure, the outer metal layer is brought into contact with the tissue to be ablated, and then an ablation current is passed through the outer metal layer into the tissue. While the ablation current is applied to the tissue, a sensor may obtain any relevant physiological indices from the tissue. Typically, plated vias through the electrode provide an electrical connection between the inner and outer metal layers, so that the ablation current can pass outward through the plated vias, and potential signals from the tissue can pass inward through the plated vias. Electrical connection may also be provided by blind vias, but each such via is formed by removing a portion of the substrate, so that the outer metal layer directly contacts the underlying traces.

[0034] The aforementioned plated vias also provide fluid communication between the inner and outer surfaces of the electrode such that irrigation fluid (e.g., saline) can pass through the plated vias and into the surrounding blood. The irrigation fluid draws heat away from the interior of the electrode into the blood and also dilutes the blood at the tissue-electrode interface reducing the likelihood of clot formation or charring. Due to the fact that the plated vias provide for the passage of irrigation fluid through their interior, the plated vias are also sometimes referred to as "irrigation channels" or "irrigation holes."

[0035] A problem with using electrodes of the above type is that the substrate may provide significant thermal resistance, limiting the amount of heat that can be transferred from the tissue-electrode interface to the interior of the electrode, which in turn limits the amount of heat that can be removed by the irrigation fluid.

[0036] U.S. Application Nos. 15 / 990,532 and 16 / 103,806, the disclosures of each of which are incorporated herein by reference, address this problem by providing closed vias, hereafter referred to as "thermal vias", that increase the thermal conductivity between the two surfaces of the electrode. Such thermal vias may, for example, include columns of gold that fill channels drilled through the substrate, thus connecting the outer metal layer to the inner metal layer. The thermal vias increase the amount of heat transferred to the interior of the electrode, thus facilitating its evacuation by the irrigation fluid.

[0037] In general, the thermal conductivity provided by a thermal via is a function of the total cross-sectional area of ​​the metal that fills the thermal via. However, as the inventors have discovered, it can be difficult to achieve a sufficient total cross-sectional area using thermal vias with a convex cross-sectional profile, such as a circular cross-sectional profile. In particular, if the cross-sectional area of ​​any one of the thermal vias is too large, it may take a relatively long time for the via to be filled during the plating process, which may result in too thick a layer of metal coating the surface of the substrate while the via is being filled. Although multiple smaller thermal vias may be provided, this may require the vias to be placed too close together, thus compromising the structural integrity of the substrate.

[0038] Thus, embodiments of the present invention provide concave thermal vias, where the periphery of the via protrudes into the via. The protrusions provide additional areas where metal may nucleate during the plating process and also reduce the distance from the periphery to the interior of the via, thus facilitating filling of the via. Thus, each concave thermal via may have a relatively large cross-sectional area without unduly lengthening the duration of the plating process. In some embodiments, the concave thermal vias are interspersed with smaller convex thermal vias.

[0039] Alternatively or additionally, various other techniques may be used to facilitate the transfer of heat to the irrigation fluid, as described in detail below. For example, the support structure may be shaped to define large openings that expose the inner metal layer to the irrigation fluid. In addition, the inner metal layer may be shaped to define a plurality of recesses that increase turbulence of the fluid flow over the inner metal layer.

[0040] System Description Reference is now made initially to FIG. 1, which is a schematic illustration of a system 20 for ablating tissue in a subject 26, according to some embodiments of the present invention.

[0041] FIG. 1 shows a physician 28 performing an ablation procedure on a subject 26 using an internal probe 22. In this procedure, the physician 28 first inserts an ablation electrode 40 disposed at the distal end of the probe 22 into the subject and then guides the electrode 40 to the tissue to be ablated. For example, the physician may advance the electrode through the subject's vasculature until it contacts cardiac tissue belonging to the subject's heart 24. Then, while the electrode 40 is in contact with the tissue, the physician passes a radio frequency (RF) current between the ablation electrode and another electrode, such that the current generates heat in the tissue. For example, in a unipolar ablation procedure, the current may pass between the ablation electrode and an indifferent electrode patch 30 that is connected external to the subject, for example, to the subject's back.

[0042] To facilitate guidance of the probe 22, the probe may include one or more electromagnetic position sensors that generate a signal that varies with the position of the sensor in the presence of an external magnetic field. Alternatively or additionally, any other suitable tracking system may be used, such as an impedance-based tracking system. For example, both electromagnetic tracking and impedance-based tracking may be used, as described, for example, in U.S. Pat. No. 8,456,182, the disclosure of which is incorporated herein by reference.

[0043] The probe 22 is connected proximally to a console 34, which includes, for example, a processor (PROC) 23, a pump 25, and a signal generator (GEN) 27. (The electrode patches 30 are also typically connected to the console 34 via a cable 42.) During an ablation procedure, the signal generator 27 generates the ablation currents described above. These currents are conveyed through the probe 22 to the electrodes 40 via one or more wires. In addition, the pump 25 supplies irrigation fluid, such as saline, to the distal end of the probe, as will be further described below with reference to Figures 2A and 2B, and 3C.

[0044] The console 34 further comprises a control knob 35 that may be used by the physician to control parameters of the ablation current. In particular, in response to manipulation of the control knob 35 by the physician 28, the processor 23 may adjust the parameters of the ablation current by outputting appropriate instructions to the signal generator 27 via any suitable wired or wireless communication interface. The processor 23 may likewise control the pump 25 via any suitable wired or wireless interface. In addition, the processor may receive and process any relevant signals from the distal end of the probe, such as signals received from any of the sensors described herein.

[0045] In some embodiments, the system 20 further comprises a display 38 that may display relevant output to the physician 28 during the procedure.

[0046] It should be noted that although a particular type of procedure is illustrated in FIG. 1 , the embodiments described herein may be applied to any other suitable type of ablation procedure, such as an ENT or neurological ablation procedure, or any other procedure that requires the transfer of heat through a flexible PCB (such as draining heat from a circuit board to a surrounding fluid).

[0047] Ablation Electrodes Reference is now made to Figure 2A, which is a schematic illustration of an ablation electrode 40, according to some embodiments of the present invention, and further reference is now made to Figure 2B, which is a schematic illustration of a longitudinal cross section through electrode 40, according to some embodiments of the present invention.

[0048] As described above with reference to FIG. 1, the probe 22 includes at least one ablation electrode 40, such as the tip electrode shown in FIGS. 2A and 2B. The electrode 40 includes a plated flexible, electrically insulating substrate 41 that is bonded to a support structure 36 at the distal end of the probe 22 by an adhesive. The substrate 41 may be made of any suitable flexible, electrically insulating material, such as a flexible polymer (e.g., polyimide) or liquid crystal polymer (LCP). The support structure 36 may be made of any suitable strong material, such as cobalt chrome, stainless steel, magnesium, or a polymer. For example, the support structure may include an alloy of cobalt chrome, such as L-605 cobalt-chromium-tungsten-nickel alloy, or a polyetheretherketone (PEEK), such as glass-filled PEEK.

[0049] In general, the electrode 40 may have any suitable shape. In some embodiments, as shown in Figures 2A and 2B, the electrode 40 is thimble-shaped including a cylindrical portion 40b capped by a dome-shaped portion 40a. Typically, a tab 47 at the proximal end of the electrode provides a soldering pad to which a wire that runs the length of the probe may be soldered, such as to establish an electrical connection between the electrode and the proximal end of the probe. These soldering pads are described in more detail below with reference to Figures 4 and 5.

[0050] Reference is now also made to Figure 3A, which is a schematic diagram of a cross section through a surface of an electrode 40, according to some embodiments of the present invention. Figure 3A corresponds to the "AA" cross section shown in Figure 2A.

[0051] The substrate 41 has an inner surface 76 facing the support structure 36 and an outer surface 45 facing away from the support structure 36. Typically, the thickness T0 of the substrate (i.e. the distance between the inner and outer surfaces of the substrate) is between 5 and 75 (e.g., between 12 and 50) micrometers. At least a portion of the inner surface is coated with an inner layer 70 of a conductive metal, such as gold. Typically, the inner layer 70 has a thickness T1 between 10 and 50 micrometers. Similarly, at least a portion of the outer surface 45 is coated with an outer layer 50 of a metal. Typically, the outer layer 50 has a thickness T2 between 1 and 50 micrometers, e.g., between 5 and 35 micrometers.

[0052] Typically, the outer layer 50 is discontinuous in that it includes a main portion 54 and one or more insulating portions that are electrically insulated from the main portion 54 by exposed portions of the substrate. These insulating portions may include one or more "islands" that function as sensing microelectrodes 56. For example, the outer layer 50 may include between three and seven microelectrodes 56 distributed around the circumference of the electrode. Alternatively or additionally, the insulating portions may include a sensing ring electrode 43, which may be disposed, for example, near the proximal end of the electrode 40.

[0053] Disposed beneath each of the sensing electrodes is a respective conductive trace 78, electrically insulated from the inner layer 70 by an exposed portion of the inner surface 76. Prior to the sensing electrodes being formed, holes, referred to herein as blind vias 80, are formed (e.g., drilled) in the substrate above the traces 78, as will be further described below with reference to FIG. 4. When the sensing electrodes are subsequently deposited on the outer surface of the substrate, the sensing electrodes at least partially fill the blind vias 80, thereby contacting the traces. Thus, during treatment, electrical potential signals from the subject's cardiac tissue sensed by the sensing electrodes may be conveyed via the traces 78 to wires extending through the probe 22 to the proximal end of the probe. In this manner, the signals may be delivered to the processor 23 (FIG. 1) for analysis.

[0054] Reference is now additionally made to Figure 3B, which is a schematic diagram of thermal vias passing through the surface of electrode 40, according to some embodiments of the present invention. Figure 3B corresponds to the "BB" cross section shown in Figure 2A.

[0055] The substrate 41 is shaped to define a plurality of channels 46 passing between the substrate's inner surface 76 and outer surface 45. Typically, each channel 46 is tapered along its length in that the cross-sectional area of ​​the channel at the substrate's inner surface is slightly larger than its cross-sectional area at the outer surface.

[0056] As can be seen in Figure 2A, at least some of the channels 46 are concave channels 49, which are described in more detail below with reference to Figures 9 and 10. Optionally, the channels may further include one or more convex channels 51. In some embodiments, each convex channel 51 is circular and has a diameter d0 between 5 and 50 micrometers (e.g., between 5 and 30 micrometers).

[0057] Due to the recessed nature of the channels 49 as discussed above in the overall diagram, the cross-sectional area A0 of each channel 49 may be relatively large. For example, the average cross-sectional area of ​​each of the recessed channels may be 345 μm 2 ~15,700μm 2 Alternatively or additionally, the total area of ​​the outer openings of each of the channels 46, including the concave channels and any convex channels, may be at least 30% of the area of ​​the outer surface.

[0058] The channels 46 are filled with respective columns 48 of conductive metal that connect the outer layer 50 to the inner layer 70. The columns 48 may have any suitable three-dimensional shape, which will depend on the three-dimensional shape of the channels 46. Due to the heat conducted by the columns 48, the filled channels 46 are referred to herein as thermal vias 74. (For simplicity, the thermal vias are not shown in FIG. 3A above.)

[0059] Reference is now additionally made to Figure 3C, which is a schematic illustration of irrigation holes 72 through the surface of electrode 40, according to some embodiments of the present invention. Figure 3C corresponds to the "CC" cross section shown in Figure 2A.

[0060] Typically, the substrate 41 is further shaped to define a plurality of wide channels 44, each of which is plated with a plating layer 52 of conductive metal connecting the outer layer 50 to the inner layer 70. Typically, each of the wide channels 44 is circular and has a diameter d1 between 50 and 300 micrometers. The channels 44 are referred to herein as "wide" channels due to the fact that the cross-sectional area of ​​each channel 44 is greater than the cross-sectional area of ​​each channel 46. For the same reason, the channels 46 are referred to hereinafter as "narrow channels."

[0061] Typically, the electrode includes 30-100 wide channels. The plated wide channels provide electrical and thermal conductivity between the outer and inner layers of metal. Additionally, the plated wide channels provide a fluid passage between the interior and exterior of the electrode so that irrigation fluid 39 supplied by pump 25 (see FIG. 1) can flow therethrough. The plated wide channels are therefore referred to herein as "irrigation holes" 72. (The diameter of each irrigation hole is smaller than diameter d1 by an amount corresponding to approximately twice the length of the thickness of plated layer 52.)

[0062] 2B, the support structure 36 is shaped to define openings 62 that are aligned with the irrigation holes 72 so that the support structure does not obstruct the irrigation holes. In some embodiments, as further described below with reference to FIG. 8, the openings 62 also expose a relatively large area of ​​the inner layer 70, thus increasing the transfer of heat to the irrigation fluid by exposing the inner layer to the fluid.

[0063] Typically, the probe 22 includes a fluid supply tube (not shown) that extends through the entire length of the tubular body 22m of the probe 22. The fluid supply tube is distally coupled to a flow diverter 60 shaped to define one or more fluid flow openings 64. The flow diverter 60 redirects fluid 39 received from the proximal end of the probe through the fluid flow openings 64. In such an embodiment, the electrode 40 may be coupled to a base 58 of the flow diverter 60 such that the flow diverter is disposed inside the inner lumen of the electrode. For example, the support structure 36 may be coupled to the base 58. Alternatively or additionally, the base 58 may be shaped to define a plurality of protrusions, and the support structure 36 may be shaped to define a plurality of complementary holes such that the protrusions snap into the holes.

[0064] As described above with reference to FIG. 1, during an ablation procedure, the physician 28 contacts the electrode 40, and in particular the outer layer 50, with tissue of the subject 26. While contacting the tissue with the outer layer 50, the physician passes an electric current through the outer layer and into the tissue. The electric current generates heat in the tissue such that lesions are formed therein. This heat is transferred through the thermal vias 74 (i.e., through the columns 48) to the inner layer 70. At the same time, the pump 25 (FIG. 1) pumps irrigation fluid 39 through the fluid supply tube, forcing the fluid into the interior of the electrode through the fluid flow openings 64 of the flow diverter 60. The fluid then flows out of the electrode through the openings 62 and the irrigation holes 72, thereby discharging heat from the inner layer 70 into the subject's blood.

[0065] It should be noted that the outer layer 50, inner layer 70, plating layer 52, and columns 48 may collectively be described as a unitary body of metal coating the substrate. It should be further noted that in some embodiments, the narrow channels 46 are not filled, but rather are simply plated, similar to the wide channels 44. However, even in such embodiments, a large amount of heat may be transferred to the interior of the electrode.

[0066] Fabrication of ablation electrodes Reference is now made to Figure 4, which is a flow chart of a method 82 of manufacturing an electrode 40, according to some embodiments of the present invention. Reference is now also made to Figure 5, which is a schematic diagram of an electrode 40 prior to deformation, according to some embodiments of the present invention. (Figure 5 shows various elements coupled to the interior of the electrode 40, i.e., the inner surface of the substrate 41.)

[0067] 4 assumes that at least the inner surface of the substrate is first coated with a layer of copper. Thus, method 82 begins with an etching step 84 in which all copper is etched away from the inner surface except for copper traces 114 that connect to the outer sensing electrodes of the electrodes. (Copper on the outer surface is also etched away.) This etching may be performed, for example, by placing a mask over the portions of copper designated for traces 114 and then chemically removing the exposed copper. Alternatively, if the inner surface of the substrate is initially exposed, copper traces 114 may be deposited on the inner surface.

[0068] Subsequently, in a trace deposition step 86, a constantan trace 118 used for the thermocouple is deposited on the interior surface of the substrate. The trace deposition step 86 may be performed by physical vapor deposition (PVD), such as, for example, sputtering deposition. For example, a mask may be placed over the entire interior surface except for the portion of the interior surface designated for the constantan trace 118. Subsequently, a seed layer of a base metal, such as titanium tungsten, may be sputtered onto the substrate. Finally, constantan may be sputtered onto the base metal.

[0069] Typically, to minimize the wiring required, the constantan traces terminate at a common constantan trace solder pad 120. In some embodiments, holes (or "pile vias") are drilled into the substrate at the locations of the solder pads 120 prior to deposition of the constantan. The holes are then filled with the deposited constantan, and the solder pads 120 are then formed over the holes. Alternatively, instead of drilling holes completely through the substrate, depressions can be drilled into the substrate and filled with the deposited constantan. In either case, the solder pads 120 are "pile" to the substrate by the constantan beneath the solder pads. (A draft angle may be used to taper the holes or depressions to facilitate filling of the holes or depressions, as described immediately below for narrow and wide channels.)

[0070] Next, in a drilling step 88, narrow and wide channels are drilled into the substrate, typically using laser drilling techniques. (The narrow channels are visible in FIG. 5, but the narrow channels are not.) Typically, the channels are drilled from the substrate's inner surface using a draft angle so that the channels narrow as they approach the outer surface. This facilitates metal collection on the walls of the channels during the subsequent sputtering process. In addition, blind vias 80 may be drilled (e.g., laser drilled) through the substrate from the substrate's outer surface at the portions of the outer surface designated for the sensing electrodes, using the copper traces 114 as the defining portions. (In other words, portions of the substrate disposed over the copper traces may be removed to expose the copper traces.) Typically, a draft angle is used for the blind vias so that the blind vias narrow as they approach the substrate's inner surface. This facilitates metal collection on the walls of the blind vias.

[0071] (Typically, following drilling step 88, the substrate is treated with a plasma to remove any thermally damaged portions of the substrate. Typically, as a result of this treatment process, the channels are widened and therefore the size of each drilled channel may be narrower than the desired final size of the channel.)

[0072] Next, in a first masking step 90, the copper and constantan traces are masked, along with exclusion zones 91 (i.e., exposed portions of the substrate's inner surface) designated for insulating these traces. (However, portions of the constantan trace designated for thermocouple junctions are not masked.) Additional exclusion zones designated for insulating gold traces that cross the constantan traces (thus forming constantan-gold thermocouples) are also masked. In addition, exclusion zones on the outer surface designated for insulating the sensing electrodes are masked.

[0073] Thereafter, in a deposition step 92, a thin layer of gold is deposited on the interior and exterior surfaces of the substrate and also within the channels. Deposition step 92 may be performed, for example, by physical vapor deposition (PVD), such as sputter deposition. (Typically, a seed layer of a base metal, such as titanium-tungsten, is sputtered onto the substrate prior to sputtering the gold.) Thanks to the mask, the gold is not deposited on the traces or on the exclusion zones.

[0074] The deposited gold includes the inner layer 70, the outer layer 50, the plating layer 52, and the initialization layer for the columns 48. The deposited gold further includes gold traces 122 that cover the constantan traces at the thermocouple junctions 124. Each gold trace 122 terminates in a respective gold trace soldering pad 126. The deposited gold further includes a respective copper trace soldering pad 116 for each of the copper traces. In some embodiments, the copper trace soldering pad 116 and / or the gold trace soldering pad 126 are staked to the substrate as previously described with respect to the constantan trace soldering pads. The deposited gold further includes at least one gold soldering pad 128 connected to the inner layer 70. The gold soldering pad 128 may also be staked to the substrate.

[0075] After deposition, the mask (along with any gold deposited on it) is removed in a mask removal step 93. Then, in a second masking step 94, the traces, the interior surface exclusion zones surrounding the traces, and the entire exterior surface of the substrate are masked.

[0076] Following the second masking step 94, the substrate is plated in a gold plating bath for a first time interval in a first plating step 98, with the traces and exterior surface remaining masked. Plating the substrate fills any voids in the gold, further increasing the thickness of the gold, such that, for example, the inner layer 70 reaches a thickness of 5-40 micrometers, while the diameter of the wide channels decreases to 30-200 micrometers. Narrow channels may also be completely filled.

[0077] Typically, plating of the substrate is electrochemical, whereby the gold already coating the substrate is attracted to gold ions in a plating bath by the flow of electric current through the gold. The amplitude and duration of the electric current may be controlled so that the gold reaches a desired thickness.

[0078] Following the first plating step 98, the inner and outer surfaces of the substrate are unmasked in a mask removal step 100, except for the aforementioned exclusion zones designated to insulate the sensing electrodes. Next, at least one coverlay 130 is applied over the traces and over the inner surface exclusion zones in a coverlay application step 101. (In some embodiments, the coverlay 130 is transparent or nearly transparent, as illustrated in the inset of FIG. 5.)

[0079] Typically, the proximal portion of the coverlay 130 covering the tabs 47 is shaped to define a window 132 exposing the solder pads, thereby allowing the solder pads to be thickened during a subsequent plating process. (An additional cover 142 having a window aligned with the window 132 may cover the proximal portion of the coverlay.) Typically, the solder pads are not completely exposed, but rather are maintained in a "captured" state by the coverlay 130, in that one or more edges of each solder pad are covered by the rim of the window 132. Thus, the coverlay 130 helps hold the solder pads down to the substrate 41 during the subsequent soldering process.

[0080] Subsequently, in a second plating step 102, the substrate is plated in the plating bath for a second time interval to fill any gaps in the outer layer 50 and thicken the inner layer, the outer layer, and the plating layer. For example, the second plating can reduce the diameter of the wide channels to 15-150 micrometers while increasing the thickness of the inner layer to 10-50 micrometers. Typically, the final thickness of the inner layer is the same as the thickness of the coverlay to obtain a smooth inner surface. (To avoid any confusion, the term "inner surface" is used herein to refer to the surface formed by the coverlay and the inner gold layer, while the term "inner surface" is used to refer to the underlying surface of the substrate.) In addition, if the narrow channels were not completely filled during the first plating step 98, these channels are completely filled during the second plating step 102. As with the first plating step 98, the amplitude and duration of the current in the plating bath can be controlled to obtain the desired thickness.

[0081] (In some embodiments, the exterior surface is masked prior to deposition step 92 so that gold is not deposited on the exterior surface during deposition step 92. In such embodiments, a thin layer of gold is deposited on the exterior surface after mask removal step 100 and prior to the second plating step 102.)

[0082] In some embodiments, as envisioned in Figures 4 and 5, the support structure 36 comprises a support sheet that is deformed into a suitable three-dimensional shape following bonding of a PCB (i.e., a substrate with various elements disposed thereon) to the support sheet. In such embodiments, following the second plating step 102, openings 62 may be drilled through the support sheet in an opening drilling step 104. (Instead of drilling, any other suitable technique may be used to form the openings, such as chemical etching.) Recesses and / or protrusions may then be formed in the surface of the sheet. The recesses and protrusions, along with the steps in which they may be formed (including a third masking step 105, a chemical etching step 107, and a sheet removal step 109), are described below with reference to Figures 6A and 6B.

[0083] Following the second plating step 102, optionally followed by drilling of openings and / or formation of recesses and / or protrusions in the support sheet, a bonding step 106 is performed. In the bonding step 106, an adhesive is applied between the outer surface of the support structure and the inner surface of the PCB formed by the coverlay 130 and the inner layer 70, such that the adhesive bonds these two surfaces together. Typically, the support structure is bonded to the inner surface such that the openings 62 are aligned with the irrigation holes 72. Typically, the area of ​​the openings is larger than the area of ​​the irrigation holes, such that any small misalignment is compensated for during bonding. In some embodiments, the openings are much larger than the irrigation holes, as described below with reference to FIG. 8, so that a larger portion of the inner surface is still exposed to the irrigation fluid.

[0084] Following or simultaneously with bonding, in a deformation step 108, the electrode 40 is deformed into the desired shape. For example, assuming the support structure initially comprises a flat support sheet as shown in FIG. 5, the electrode may be inserted into a forming jig, following bonding step 106, which forms the electrode around a suitable mandrel. After the electrode is inserted into the jig, the jig is placed into an oven. The oven then heats the electrode to a suitable temperature while pressure is applied to the electrode. The combination of heat and pressure causes the electrode to bond to itself in the desired shape.

[0085] In general, the substrate and support sheet may be deformed into any desired shape. Typically, however, during the deformation step 108, the substrate and support sheet are shaped to define an interior lumen that is at least partially surrounded by the inner surface of the sheet. For example, as described above with reference to Figures 2A and 2B, the substrate and support sheet may be shaped to define a thimble.

[0086] In some embodiments, to facilitate the manufacture of thimble-shaped electrodes, the substrate 41 comprises two continuous portions, a distal circular portion 41a and a proximal rectangular portion 41b. Similarly, the support sheet may comprise two continuous portions, a distal support portion 36a including a plurality of spokes 134 radiating from a central hub 136, and a proximal support portion 36b. During the bonding step 106, the distal support portion 36a is bonded to the inner surface of the circular portion 41a, and adhesive is applied to the outer surface of the distal support portion 36a, e.g., the outer surface of each spoke 134. Additionally, the proximal support portion 36b is bonded to the inner surface of the rectangular portion 41b, leaving a distal portion of the inner surface exposed. Adhesive is applied to the outer surface of an overhanging tab 138 of the proximal support portion 36b, which overhangs the side of the rectangular portion 41b. (Proximal support portion 36b may also overhang the proximal end of rectangular portion 41b.)

[0087] Then, during the deformation step 108, the distal support portion 36a and the circular portion 41a are folded over the top of the core rod, while the proximal support portion 36b and the rectangular portion 41b are wrapped around the core rod. To maintain this configuration, the outer surface of the distal support portion 36a (e.g., the outer surface of each spoke 134) is bonded to an exposed distal portion of the inner surface of the rectangular portion 41b, and the outer surface of the tab 138 is bonded to the opposite end of the proximal support portion 36b. (Also, the inner surface of at least one of the spokes may be bonded to the tab 138.) Thus, the distal support portion 36a and the circular portion 41a are formed into a dome-shaped portion 40a (see FIG. 2A), while the proximal support portion 36b and the rectangular portion 41b are formed into a cylindrical portion 40b.

[0088] Thereafter, wires are soldered onto the soldering pads in a soldering step 110. Specifically, wires that deliver RF current from the generator 27 (see FIG. 1) are soldered onto gold soldering pads 128, while other wires that deliver signals to the processor 23 are soldered to other soldering pads.

[0089] Finally, in a coupling step 112, the electrodes are coupled to the probe. For example, the proximal support part 36b may be bonded to the base 58 of the flow diverter (see FIG. 2B). Alternatively or additionally, protrusions belonging to the base 58 may snap into complementary holes 140 in the proximal support part 36b, as already described with reference to FIG. 2B. The flow diverter may then be coupled to a fluid supply tube belonging to the probe. (Alternatively, the flow diverter may be coupled to the fluid supply tube before the electrodes are coupled to the flow diverter.)

[0090] Instead of, or in addition to, the traces described above, any other suitable electrical or electronic components may be deposited on the inner surface of the substrate. Such components may include a thermistor for measuring tissue temperature, a pressure sensor for measuring the pressure applied to the distal end of the probe, and / or an electromagnetic sensor for guiding the catheter. These components (along with suitable surrounding exclusion zones) may be masked or covered whenever masking or covering is necessary, as already described for the traces.

[0091] It should be noted that the scope of the present disclosure includes any suitable modifications made to method 82 with respect to the order of steps performed and / or with respect to the various materials used, as would be apparent to one of ordinary skill in the art. For example, any suitable conductive metal could be used in place of copper, gold, or constantan.

[0092] Heat Transfer To facilitate the transfer of heat to the irrigation fluid as the fluid flows through the electrodes, various techniques may be used to increase the surface area of ​​the inner surface of the support structure, increase the turbulence of the fluid flow, increase the transfer of heat from the PCB to the support structure, increase the area over which the fluid may directly contact the inner surface of the PCB, and / or increase the cross-sectional area of ​​the thermal vias.

[0093] In this regard, reference is first made to Figure 6A, which is a schematic illustration of a method for forming recesses in a surface of support structure 36, according to some embodiments of the present invention, and now also to Figure 6B, which is a schematic illustration of a method for forming protrusions in another surface of support structure 36, according to some embodiments of the present invention.

[0094] In some embodiments, as shown in Figures 6A and 6B, a plurality of recesses 144 are formed in an outer surface 146 of the support structure 36 (i.e., the surface of the structure designated for bonding to a PCB) and / or a plurality of protrusions 148 are formed in an inner surface 150 of the structure. Typically, the formation of the recesses 144 and / or protrusions 148 is performed on embodiments in which the support structure is initially a flat sheet, as shown in Figure 5. Thus, the description of Figures 6A and 6B generally uses the term "sheet" when referring to the support structure.

[0095] In some embodiments, to form recesses 144, an outer mask 152, which is shaped to define a plurality of mask openings 154, is coupled to outer surface 146. The sheet is then placed in a chemical etching bath and left in the bath for a predetermined period of time, such that the portions of outer surface 146 exposed by mask openings 154 are etched away. Similarly, to form protrusions 148, a plurality of inner masks 156 are coupled to inner surface 150, and the sheet is then placed in a chemical etching bath and left in the bath for a predetermined period of time, such that the portions of the inner surface disposed between masks 156 are etched away.

[0096] Typically, both the recesses 144 and the protrusions 148 are formed. In some embodiments, the recesses and the protrusions are formed simultaneously. (In such embodiments, the height of the protrusions is approximately equal to the depth of the recesses.) For example, returning to FIG. 4, in a third masking step 105, an outer mask 152 may be coupled to an outer surface of the sheet, and an inner mask 156 may be coupled to an inner surface of the sheet. The sheet may then be placed in a bath in a chemical etching step 107, resulting in the formation of both the recesses and the protrusions. Following the formation of the recesses and the protrusions, the sheet is removed from the bath in a sheet removal step 109.

[0097] In other embodiments, the recesses and protrusions are formed at separate times. For example, the outer surface of the sheet may be masked by an outer mask 152 during a first chemical etching step, while the inner surface of the sheet is completely masked, resulting in the formation of recesses but not protrusions. The inner surface of the sheet may then be masked by an inner mask during a second chemical etching step, while the outer surface of the sheet is completely masked, resulting in the formation of protrusions. Advantageously, this technique facilitates the formation of protrusion heights that differ from recess depths, since the respective durations of the two chemical etching steps can be made to differ from one another.

[0098] In some embodiments, each mask opening 154 is circular, such that each recess 144 has a circular perimeter. In such embodiments, the diameter L2 of each mask opening may be between 0.01 mm and 0.2 mm. Alternatively, some or all of the mask openings may have any other suitable shape.

[0099] The mask openings 154 (and thus the recesses 144) may be arranged in a grid pattern, or any other suitable arrangement. For example, as shown in Figure 6A, a plurality of circular mask openings may be arranged in a close-packed pattern with a distance L3 between the centers of adjacent mask openings of 0.05 mm to 0.5 mm. In some embodiments, L3 is about twice L2.

[0100] In some embodiments, each inner mask 156 is rectangular, such that (the inner surface of) each protrusion 148 has a rectangular perimeter. For example, each inner mask may be square with a length L0 of 0.01 mm to 0.2 mm. Alternatively, some or all of the inner masks may have any other suitable shape. For example, each inner mask may be star-shaped, such that (the inner surface of) each of the protrusions has a star-shaped perimeter. An example of such a shape that provides a relatively large surface area for contacting the irrigation fluid and a large number of edges for generating turbulence includes a star shape with N vertices, where N is 3 or more.

[0101] The inner mask 156 (and thus the protrusions 148) may be arranged in any suitable arrangement, such as a grid pattern. For example, a plurality of square inner masks may be arranged in a grid, with adjacent squares separated by a distance L1 of 0.05 mm to 0.5 mm. In some embodiments, the distance between adjacent squares is approximately equal to the length of each square, i.e., L1 is approximately equal to L0.

[0102] Typically, the area of ​​each opening 154 is smaller than the area of ​​each inner mask 156, and the inner masks are aligned with the outer masks such that the entire perimeter of each opening is the inverse of its respective inner mask (this reduces the risk of accidentally forming through-holes during the chemical etching process). As a result of this sizing and alignment, each of the recesses is the exact inverse of the protrusions (as shown in FIG. 7, described below).

[0103] Alternatively, instead of chemical etching, other techniques such as laser etching may be used to form the protrusions 148 and / or recesses 144.

[0104] In some embodiments, the substrate and support sheet are shaped to define a ring or an arc. In some such embodiments, a plurality of such ring-shaped and / or arc-shaped electrodes are coupled together at the distal end of the probe to define a ball. Spaces between the rings and / or arcs allow blood to flow through the ball during an ablation procedure. Thus, heat generated from ablation can be transferred directly from the protrusions 148 to the subject's blood.

[0105] In general, any suitable masking technique may be used in each of the steps where a mask is required. Examples of suitable masks include liquid and film photoresists.

[0106] Reference is now additionally made to FIG. 7, which illustrates a schematic of heat transfer into the interior of electrode 40, according to some embodiments of the present invention.

[0107] 4, adhesive 158 bonds support structure 36 to the inner surface of the PCB. Advantageously, in some embodiments, adhesive 158 fills recesses 144, thus improving adhesion of the support structure to the PCB, while reducing the amount of adhesive between the non-pressed portion of outer surface 146 and the PCB. In other words, adhesive collection in the recesses may cause outer surface 146 to contact, or nearly contact, the inner surface of the PCB. As a result, more heat may be transferred to the support structure.

[0108] As explained further above, during and / or after application of the ablation current, irrigation fluid 39 is caused to flow through the electrodes, such that in some embodiments, the irrigation fluid flows over the surfaces of the protrusions 148. Due to the large surface area provided by the protrusions and / or the turbulence caused by the protrusions, a large amount of heat is transferred from the protrusions to the fluid 39. (As discussed above with reference to FIGS. 6A and 6B, in some embodiments, the subject's blood, rather than fluid 39, flows over the surfaces of the protrusions, such that heat is transferred directly from the protrusions to the blood.)

[0109] In some embodiments, the height H1 of each protrusion and / or the depth H2 of each recess is between 5% and 60% of the thickness H0 of the support structure. The depth of the recesses can be made different from the height of the protrusions by forming the recesses and protrusions in two separate chemical etching steps (as described above with reference to Figures 6A and 6B). For example, if H0 is between 0.025 mm and 0.2 mm, then each of H1 and H2 can be between 0.00125 mm and 0.12 mm.

[0110] In some embodiments, alternatively or additionally, recesses are formed in the inner layer 70 to form recesses in the support structure. Each recess (or "dimple") may be formed, for example, by using a laser to melt a small portion of the metal and moving the molten metal radially outward. Upon solidification, the molten metal forms a rim that surrounds the recess.

[0111] Typically, the recesses are circular and arranged in a close-packed pattern, as shown in Figure 6A for recess 144. The recesses on the opposite side of the support structure can facilitate bonding of the PCB to the support structure (as described above with respect to recess 144), while those recesses exposed to the irrigation fluid can facilitate greater heat transfer to the irrigation fluid by increasing flow turbulence.

[0112] Reference is now made to FIG. 8, which is a schematic illustration of a support structure 36, according to some embodiments of the present invention.

[0113] In some embodiments, the support structure 36 includes a plurality of ribs 166 surrounding an internal lumen 168 through which irrigation fluid flows, as described above with reference to FIG. 2B. In such embodiments, the openings 62, each separating a pair of consecutive ribs 166, are typically relatively wide. For example, the width w0 of each of the openings may be 50%-300%, such as 80%-150%, wider than the width w1 of each of the ribs. In addition to exposing the irrigation holes in the PCB, the openings expose a relatively large portion of the interior surface of the PCB. Thus, heat may be transferred directly from the PCB to the irrigation fluid. As described above with reference to FIG. 7, the transfer of heat may be further increased by providing recesses on the interior surface of the PCB.

[0114] (Another advantage of such an embodiment is that the ribs can increase the structural integrity of the support structure compared to embodiments in which the support structure is made from a flat sheet of metal.)

[0115] Typically, the ribs 166 are circumferentially oriented, with the ends of each rib joined to or continuing into a support column 170 that extends along the length of the structure. Typically, the ribs are arranged in multiple columns. For example, as shown in FIG. 8, a support structure may include three columns of ribs, with a first column disposed between a first support column 170a and a second support column 170b, a second column between the second support column 170b and a third support column 170c, and a third column between the third support column 170c and the first support column.

[0116] In some embodiments, the support structure 36 comprises a molded polymer such as PEEK, e.g., glass-filled PEEK. In such embodiments, the exterior surface 146 is typically rough as a result of the molding process. Alternatively or additionally, the exterior surface may be roughened after the molding process, e.g., the exterior surface may be plasma etched to expose a portion of the glass that fills the PEEK. The roughness of the exterior surface may promote bonding and heat transfer, as discussed above with respect to the recesses 144 (FIG. 6A).

[0117] In other embodiments, the support structure comprises a machined metal.

[0118] The bonding step 106 and the deformation step 108 (FIG. 4) may be performed simultaneously to shape the electrode. In other words, following application of adhesive to the support structure, the PCB may be wrapped around the support structure. Heat and / or pressure may be applied to the electrode during and / or after wrapping of the PCB to facilitate bonding.

[0119] Reference is now made to FIG. 9, which is a schematic diagram of various types of recessed channels 49, according to some embodiments of the present invention.

[0120] As discussed above with reference to Figures 2A and 3B, substrate 41 is shaped to define a plurality of recessed channels 49 filled with columns of metal. In general, the scope of the invention includes any suitable recessed shape for channels 49 (and thus for the columns of metal filling the channels). As an example, Figure 9 shows a recessed channel 49a having a first shape, another recessed channel 49b having a second shape, and yet another recessed channel 49c having a third shape.

[0121] The recessed channel 49a includes a circular central channel portion 160a and one or more (e.g., 2-8) peripheral channel portions 162a that open into the central channel portion 160a. The peripheral channel portions 162a have an arcuate perimeter such that the peripheral channel portions are shaped as partial circles.

[0122] Recessed channel 49b and recessed channel 49c each include a polygonal central channel portion and one or more peripheral channel portions that open into the central channel portion. In recessed channel 49b, central channel portion 160b and peripheral channel portion 162b are rectangular. For example, central channel portion 160b and / or peripheral channel portion 162b may be square. Recessed channel 49c has a star shape in that the channel includes a central channel portion 160c shaped as an N-sided polygon, where N is 3 or more, and includes N triangular peripheral channel portions 162c, each of which opens into central channel portion 160c at a different corresponding edge of the polygon.

[0123] Advantageously, as explained in the summary above, the recessed channels provide a relatively long perimeter around which metal may nucleate during the plating process, and also reduce the distance from the perimeter to the interior of the channel, so that the channels may provide a large cross-sectional area, yet still be able to fill relatively quickly during the plating process.

[0124] As an example, to demonstrate this advantage, in channel 49b, each peripheral channel portion is assumed to be a square having a length of one arbitrary unit (AU), and the central channel portion is assumed to be a square having a length of 3 AU. Assuming these dimensions, the cross-sectional area of ​​the channel is 13 AU. 2 and the circumference of the channel is 20 AU. In contrast,

[0125]

number

[0126]

number

[0127] Reference is now also made to FIG. 10, which is a schematic diagram of an arrangement of channels 46, according to some embodiments of the present invention.

[0128] Typically, the concave channel 49a includes exactly six peripheral channel portions that open into a central channel portion. In such an embodiment, to form the concave channel 49a, the drilling step 88 (FIG. 4) may be performed in two stages. Specifically, during a first pass of drilling, a close-packed pattern of circular channels 46 may be drilled through the substrate, as shown in FIG. 10. (In this close-packed pattern, the distance between the centers of each of the adjacent channels may be, for example, 20-60 μm.) Then, during a second pass of drilling, some of the circular channels may be expanded such that each of the expanded circular channels opens into the surrounding six channels, thus forming the concave channel 49a. The advantage of forming the channels in this manner is that only a circular cut is required.

[0129] For example, every third channel may be expanded in both the vertical and horizontal directions, as indicated by dashed expansion indicator 164 in Figure 10. Following expansion of every third channel, channels 46 are positioned such that at least a portion of each of the convex channels 51 is surrounded by three of each of the concave channels.

[0130] Alternatively, the channel configuration illustrated in FIG. 10 can be obtained during a single pass of the drilling process by tracing the perimeter of each of both the circular and concave channels.

[0131] In some embodiments, at least one of the convex thermal vias has a length at least twice its width. (Such vias may be shaped as an oval or rectangle, for example.) Advantageously, such vias can provide a relatively large perimeter while also providing a relatively small distance from the perimeter to the interior of the via.

[0132] In general, the embodiments described herein can be combined with any of the embodiments described in U.S. Patent Application Publication No. 2018 / 0110562 or U.S. Patent Application Publication No. 2019 / 0117296, the disclosures of each of which are incorporated herein by reference.

[0133] It will be understood by those skilled in the art that the present invention is not limited to what has been specifically shown and described herein. Rather, the scope of the embodiments of the present invention includes both combinations and subcombinations of the various features described herein, as well as variations and modifications of features not present in the prior art that would occur to one skilled in the art upon reading the above description. Documents incorporated by reference into this patent application shall be considered as part of this application, except that if any term is defined in these incorporated documents in a manner that is inconsistent with the definition expressly or impliedly made herein, then only the definition in this specification shall be considered.

[0134] [Embodiment] (1) An apparatus comprising: a flexible, electrically insulating substrate including an inner surface and an outer surface and shaped to define a plurality of channels passing between the inner surface and the outer surface, at least some of the channels being recessed channels; an outer layer of a conductive metal covering at least a portion of said outer surface; an inner layer of the conductive metal covering at least a portion of the inner surface; and respective columns of the conductive metal filling the channels so as to connect the outer layer to the inner layer. (2) each of said recessed channels: a circular central channel portion; 2. The device of embodiment 1, comprising one or more peripheral channel portions having an arcuate periphery and opening into the central channel portion. (3) The device described in embodiment 2, wherein the peripheral channel portion consists of two to eight peripheral channel portions. (4) The device described in embodiment 3, wherein the peripheral channel portion consists of six peripheral channel portions. (5) The device of embodiment 4, wherein some of the channels are circular channels, and the channels are arranged such that at least some of the circular channels are each surrounded by a corresponding three of the concave channels.

[0135] (6) each of said recessed channels: a polygonal central channel portion; and one or more peripheral channel portions opening into the central channel portion. (7) The device described in embodiment 6, wherein the central channel portion and the peripheral channel portion are rectangular. (8) The device of embodiment 6, wherein each of the concave channels has a star shape. (9) The device of embodiment 1, wherein the total area of ​​the outer openings of each of the channels is at least 30% of the area of ​​the outer surface. (10) The device of embodiment 1, wherein the conductive metal comprises gold.

[0136] (11) A probe configured to be inserted into a body of a subject; 2. The device of claim 1, further comprising a support structure bonded to the inner layer and connected to a distal end of the probe. (12) The device of embodiment 11, wherein the support structure includes a plurality of ribs surrounding the lumen, successive ones of the ribs being separated from one another by openings wider than each of the ribs. (13) The device of embodiment 1, wherein the surface of the inner layer is shaped to define a plurality of recesses. (14) The device of embodiment 13, wherein the recesses are circular and arranged in a close-packed pattern. (15) The average cross-sectional area of ​​each of the recessed channels is 345 μm 2 From 15,700 μm 2 2. The device of embodiment 1, wherein

[0137] (16) A method comprising the steps of: inserting into a body of a subject a distal end of a probe including a substrate having an inner surface at least partially coated by an inner metal layer and an outer surface at least partially coated by an outer metal layer, the substrate being shaped to define a plurality of channels passing between the inner and outer surfaces and filled by metal columns, at least some of the channels being concave channels; contacting tissue of the subject with the outer metallic layer following insertion of the distal end of the probe into the body of the subject; passing an electric current through the tissue through the outer metallic layer while in contact with the tissue, so as to generate heat within the tissue and transfer it through the metallic column to the inner metallic layer; and dissipating the heat from the inner metallic layer into the subject's blood by passing an irrigation fluid through the substrate. (17) The method of embodiment 16, wherein the tissue comprises cardiac tissue of the subject. (18) A method comprising the steps of: forming a plurality of channels, at least some of which are recessed channels, in a flexible, electrically insulating substrate, said channels passing between an inner surface of said substrate and an outer surface of said substrate; and at least partially coating said interior and exterior surfaces and filling said channels with a conductive metal. (19) Each of the recessed channels comprises: a circular central channel portion; 19. The method of claim 18, further comprising: one or more peripheral channel portions having an arcuate periphery and opening into the central channel portion. (20) The forming of the channel forming a close-packed pattern of circular channels; 20. The method of claim 19, further comprising forming the concave channels by expanding some of the circular channels following the formation of the close-packed pattern, such that each of the expanded circular channels opens to six of the circular channels around.

[0138] (21) bonding the conductive metal coating on the inner surface to a support structure; 20. The method of embodiment 18, further comprising coupling the support structure to a distal end of a probe configured for insertion into a body of a subject. 22. The method of claim 21, wherein the support structure includes a plurality of ribs surrounding a lumen, consecutive ones of the ribs being separated from one another by openings wider than each of the ribs. 23. The method of claim 18, further comprising forming a plurality of recesses in a surface of the inner layer. 24. The method of claim 23, wherein forming the recesses comprises forming circular recesses in a close-packed pattern.

Claims

1. An ablation probe having an ablation electrode located at a distal end of the ablation probe, The ablation electrode comprises: a flexible, electrically insulating substrate including an inner surface and an outer surface and shaped to define a plurality of channels passing between the inner surface and the outer surface, at least some of the channels being recessed channels; an outer layer of a conductive metal covering at least a portion of said outer surface; an inner layer of the conductive metal covering at least a portion of the inner surface; and respective columns of the conductive metal filling the channels to connect the outer layer to the inner layer.

2. Each of the recessed channels comprises: a circular central channel portion; 10. The ablation probe of claim 1, further comprising: one or more peripheral channel portions having an arcuate periphery and opening into the circular central channel portion.

3. The ablation probe of claim 2 , wherein the one or more peripheral channel portions consist of between two and eight peripheral channel portions.

4. The ablation probe of claim 3 , wherein the one or more peripheral channel portions consist of six peripheral channel portions.

5. 5. The ablation probe of claim 4, wherein some of the channels are circular channels, and the channels are arranged such that at least some of the circular channels are each surrounded by a corresponding three of the concave channels.

6. Each of the recessed channels comprises: a polygonal central channel portion; and one or more peripheral channel portions opening into the polygonal central channel portion.

7. The ablation probe of claim 6 , wherein the polygonal central channel portion and the peripheral channel portion are rectangular.

8. The ablation probe of claim 6 , wherein each of the recessed channels has a star shape.

9. The ablation probe of claim 1 , wherein a total area of ​​the outer openings of each of the channels is at least 30% of an area of ​​the outer surface.

10. The ablation probe of claim 1 , wherein the conductive metal comprises gold.

11. The ablation probe of claim 1, further comprising a support structure bonded to the inner layer and connected to the distal end of the ablation probe.

12. The ablation probe of claim 11 , wherein the support structure includes a plurality of ribs surrounding a lumen.

13. The ablation probe of claim 1 , wherein a surface of the inner layer is shaped to define a plurality of recesses.

14. The ablation probe of claim 13 , wherein the recess is circular.

15. The average cross-sectional area of ​​each of said recessed channels is 345 μm ２ From 15,700 μm ２ The ablation probe of claim 1 , wherein the ablation probe is between 16. A method of manufacturing an ablation probe having an ablation electrode located at a distal end of the ablation probe, comprising: forming a plurality of channels, at least some of which are concave channels, in a flexible electrically insulating substrate of the ablation electrode such that the channels pass between an inner surface of the flexible electrically insulating substrate and an outer surface of the flexible electrically insulating substrate; and at least partially coating said interior and exterior surfaces and filling said channel with a conductive metal.

17. Each of the recessed channels comprises: a circular central channel portion; and one or more peripheral channel portions having an arcuate perimeter and opening into the circular central channel portion.

18. forming each of the plurality of channels 20. The method of claim 17, wherein forming the concave channel includes opening the circular central channel portion into six peripheral channel portions around the circular central channel portion to form the concave channel.

19. bonding the conductive metal coating on the inner surface to a support structure; The method of claim 16 , further comprising coupling the support structure to the distal end of the ablation probe.

20. The method of claim 19 , wherein the support structure includes a plurality of ribs surrounding a lumen.

21. A method for manufacturing an ablation probe as described in claim 16, further comprising forming a plurality of recesses in a surface of the conductive metal that is coated on at least a portion of the inner surface.

22. The method of claim 21 , wherein forming the recess comprises forming a circular recess.

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