Intravascular needle with flexible circuit

Abstract

Ablation and diagnostic tools are provided that include a wrapped flexible circuit. The wrapped flexible circuit can include one or more electrodes on a surface layer, one or more conductive traces on one or more underlying layers, and an electrically insulating substrate. The surface layer can be patterned to include multiple electrodes. The underlying layer(s) can include electrode contact trace(s) and / or traces for forming thermocouple junctions. The wrapped flexible circuit can be secured to an outer surface of a metal tube. The electrodes can be electrically insulated from the metal tube. The metal tube can have a sharp end for piercing tissue during an ablation or intravascular diagnostic procedure. Additionally or alternatively, the wrapped flexible circuit can have a sharp end and sufficient structural integrity to pierce tissue during an ablation or intravascular diagnostic procedure without the support of a metal tube.

Description

[Technical field]

[0001] The present invention relates generally to intravascular catheter systems, and more particularly to intravascular ablation and / or diagnostic electrodes. [Background technology]

[0002] A variety of catheters are available that deliver electrodes to the heart or other tissues of the body for purposes of ablation, diagnosis, and other functions to assist in medical procedures.

[0003] Electrodes used for ablation may be configured to deliver focused radio frequency (RF) current to tissue to generate thermal damage to tissue in contact with the electrode. While insufficient heating may result in insufficient sized lesions, overheating of the electrode may cause evaporation of tissue or blood water and formation of vapor bubbles that may cause the tissue to rupture in an uncontrollable and undesirable manner. Accurate temperature measurement during ablation may be difficult due to placement of a thermocouple relative to the electrode. In some applications, it may be advantageous to puncture the tissue so that the electrode may be placed within the tissue. However, a steeply angled electrode shape shaped to puncture the tissue may result in non-uniform current distribution during ablation, which may lead to hot spots. To avoid inadvertently puncturing tissue with a sharp electrode, the electrode may be coated during intravascular delivery. However, it may be difficult to ascertain whether the electrode is properly coated when the electrode is in the patient. Thus, applicants have recognized a need for improved intravascular ablation tools and methods.

[0004] The electrodes used for diagnosis are typically positioned as spaced apart rings along the atraumatic shaft at the distal end of the catheter. The atraumatic shaft can be shaped to allow the rings to contact tissue. In some applications, such diagnostic catheters can be used to effectively map the intravascular system and the heart. For example, for the treatment of arrhythmias, catheter-delivered electrodes can be used to map electrical properties from within the heart to identify the conduction pathway of the signal causing the arrhythmia. Challenges associated with diagnostic catheter electrodes include increasing the number of counting electrodes and capturing subcutaneous data. Increasing the number of counting electrodes means increasing the number of electrodes and wiring to each electrode, which can increase the size of the diagnostic catheter. Larger catheters can be less flexible and / or larger in diameter, increasing the difficulty of delivering and positioning the catheter during the procedure. Subcutaneous data can be captured by a structure similar to the ablation needle described above. However, the needle structure includes only a single electrode (needle). Furthermore, the needle structure is preferably covered during delivery to avoid inadvertent puncture of tissue, a sheath further increasing the size of the diagnostic catheter. Summary of the Invention [Problem to be solved by the invention]

[0005] Accordingly, Applicants have recognized a need for improved intravascular diagnostic electrode tools and methods. [Means for solving the problem]

[0006] According to some embodiments of the present disclosure, a device for lancing intravascular tissue is provided that includes a tubular electrical circuit and a sharp end. The circuit has an outer surface that defines a tubular shape disposed about a longitudinal axis and extending along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit. The circuit includes an electrically insulating substrate film, a patterned layer disposed on the substrate film and including conductive traces, an electrically insulating separator film disposed on the patterned layer and including one or more vias extending therethrough, and one or more electrodes disposed on the separator film and on the outer surface of the tubular shape. The sharp end is secured proximate to the first end of the tubular shape of the circuit.

[0007] In some embodiments, the device includes a needle surrounded by the circuit and secured to the circuit such that the sharp end of the device includes the tip of the needle, hi some embodiments, each of the one or more electrodes is electrically insulated from the needle.

[0008] In some embodiments, the circuit has a sharp tip proximate the first end of the tubular shape such that the sharp end comprises a point. Embodiments including a circuit with a sharp tip may or may not include a needle, metal sheet, or other structural support to maintain the tubular shape during use of the device. In some embodiments, the tubular shape of the circuit has sufficient columnar stiffness to lance intravascular tissue with the sharp tip without relying on additional structural support to the tubular shape circuit.

[0009] In some embodiments, the electrically insulating substrate film forms a lumen through the tubular shape and is positioned on an inner surface of the lumen, which lumen through the tubular shape can function as a passageway for irrigation fluid without additional structure between the insulating substrate and the irrigation passageway.

[0010] In some embodiments, the circuit further comprises a metal sheet beneath the electrically insulating substrate. The metal sheet comprises a sharp end proximate the first end of the tubular circuit. The sharp end comprises a sharp end of the metal sheet. The metal sheet is disposed on an interior surface of the tubular shape. The tubular shape comprises the metal sheet, the tubular shape having sufficient columnar stiffness to lance intravascular tissue.

[0011] In some embodiments, at least one of the one or more electrodes each includes a gold band that circumscribes the tubular shape.

[0012] In some embodiments, the circuit further includes solder pads each electrically connected to a respective one of the conductive traces on the patterned layer, and the one or more vias are positioned such that the one or more electrodes are each electrically connected to a respective trace.

[0013] In some embodiments, the solder pads are located within a proximal portion of the circuit.

[0014] In some embodiments, the device further comprises a sheath that surrounds the electrical circuitry and the sharpened end, the electrical circuitry and the sharpened end being slidable to extend the sharpened end from the sheath.

[0015] In some embodiments, the sharp end is electrically insulated from the one or more electrodes.

[0016] In some embodiments, the device includes one or more electrodes and one or more vias, each electrode electrically connected to a respective conductive trace on the patterned layer through a respective via, and each electrode electrically isolated from all other electrodes.

[0017] In some embodiments, the circuit includes one or more thermocouple junctions.

[0018] In some embodiments, the device includes a thermocouple junction positioned in the via. The thermocouple junction includes a portion of an electrode and a portion of a trace on the patterned layer, the portion of the electrode and the portion of the trace being in electrical contact with each other. In some embodiments, the thermocouple electrode includes gold and the thermocouple trace includes constantan.

[0019] In some embodiments, the device includes a thermocouple junction present in the patterned layer, the thermocouple junction including respective portions of two traces on the patterned layer such that the respective portions of the two traces are in electrical contact.

[0020] In some embodiments, the device includes a needle having a thermocouple junction and an exterior surface. The thermocouple junction is electrically insulated from the needle. The thermocouple junction is positioned on the exterior surface of the needle.

[0021] In some embodiments, the devices include pure gold electrodes having a thickness of about 0.001 inches (about 25 micrometers).

[0022] In some embodiments, the device includes one or more electrodes and one or more thermocouple junctions, each thermocouple junction positioned to be heated by a respective electrode, some or all of the thermocouple junctions including a portion of a respective electrode, Additionally or alternatively, some or all of the thermocouple junctions are each positioned in the patterned layer below and electrically insulated from a respective electrode.

[0023] In some embodiments, the device further includes a navigation sensor positioned to detect movement of one or more electrodes.

[0024] In some embodiments, the navigation sensor is positioned to detect movement of at least two of the one or more electrodes relative to the navigation sensor.

[0025] In some embodiments, the device further includes a catheter having a distal end, a needle assembly including circuitry and a sharpened end, and a navigation sensor. The needle assembly is translatable in one dimension relative to the navigation sensor. The navigation sensor is fixed proximate to the distal end of the catheter. The navigation sensor is positioned to detect movement of the one or more electrodes relative to the navigation sensor.

[0026] In some embodiments, the device includes one or more electrodes, one or more vias, and one or more conductive traces. The circuit further includes solder pads. Each of the electrodes is electrically connected to a respective trace through a respective via. Each of the solder pads is electrically connected to a respective conductive trace.

[0027] In some embodiments, at least one of the electrodes is electrically isolated from all other electrodes.

[0028] In some embodiments, the one or more electrodes are configured to measure voltage and / or impedance.

[0029] In some embodiments, the electrodes include ring electrodes, each ring electrode circumferentially surrounding the tubular shape of the circuit.

[0030] In some embodiments, the ring electrodes are spaced a predetermined distance from the sharp edge, and each ring electrode is insulated from every other ring electrode at the exterior surface of the tubular shape defined by the circuit.

[0031] In some embodiments, the ring electrodes are limited to a distance of about 9 mm as measured from the tip of the sharp end.

[0032] In some embodiments, the circuit includes about 6 ring electrodes to about 10 ring electrodes.

[0033] In some embodiments, the ring electrodes are spaced apart from each adjacent ring electrode by an edge-to-edge spacing of about 2 mm to about 4 mm.

[0034] According to some embodiments of the present disclosure, there is further provided a system including a circuit, a sharp end, a navigation sensor, and a processing device. The circuit defines an outer surface disposed about a longitudinal axis to define a tubular shape extending along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit. The sharp end is fixed proximate to the first end of the tubular shape. The circuit includes an electrically insulating substrate film, a patterned layer disposed on the substrate film, an electrically insulating separator film disposed on the patterned layer, and a plurality of electrodes disposed on the insulating film and on the outer surface of the tubular shape. The patterned layer includes conductive traces. The electrically insulating separator film includes one or more vias passing therethrough. The navigation sensor is positioned to detect movement of one of the one or more electrodes relative to the navigation sensor. The processing device is configured to extract electrical measurements from the plurality of electrodes and use the navigation sensor to determine a position of each of the plurality of electrodes relative to the intracardiac tissue.

[0035] In some embodiments, the one or more electrodes include a plurality of ring electrodes. The processing device is further configured to determine impedance of the endocardial tissue at a plurality of depths in the tissue in response to lancing the endocardial tissue with a sharp end of the device and inserting the plurality of ring electrodes into the endocardial tissue.

[0036] In some embodiments, the system includes a catheter, conductive wires, and a radio frequency generator. The conductive wires are each electrically connected to a respective conductive trace. The conductive wires extend through the catheter. The radio frequency generator is electrically connected to at least one of the conductive wires.

[0037] According to some embodiments of the present disclosure, there is further provided a system including a circuit, a sharp end, a catheter, a conductive wire, and a radio frequency generator. The circuit defines a tubular shape having an outer surface disposed about a longitudinal axis. The tubular shape extends along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit. The sharp end is secured proximate to the first end of the tubular shape defined by the circuit. The circuit includes an electrically insulating substrate film, a patterned layer disposed on the substrate film, an electrically insulating separator film disposed on the patterned layer, and a plurality of electrodes disposed on the insulating film and on the outer surface of the tubular shape. The patterned layer includes conductive traces. The insulating separator film disposed on the patterned layer includes one or more vias passing therethrough. Each of the conductive wires is electrically connected to a respective conductive trace. The conductive wires extend through the catheter. The radio frequency generator is electrically connected to at least one of the conductive wires.

[0038] In some embodiments, each respective conductive trace is further electrically connected to a respective electrode. The radio frequency generator, and potentially multiple radio frequency generators, are electrically connected to one or more of the conductive wires, such that the one or more radio frequency generators are each electrically connected to a respective electrode by a connection of the RF generator(s) to the conductive wires and a connection of the conductive wires to the one or more electrodes.

[0039] In some embodiments, the system includes an electrical measurement tool electrically connected to a first portion of the plurality of electrodes, while the one or more radio frequency generators are electrically connected to a second portion of the plurality of electrodes, the electrical measurement tool including a voltmeter, an ohmmeter, and / or an ammeter.

[0040] There is further provided, in accordance with some embodiments of the present disclosure, an ablation tool having a sharpened end and an ablation electrode electrically insulated from the sharpened end.

[0041] There is further provided, in accordance with some embodiments of the present disclosure, an ablation tool having an ablation electrode and a thermocouple comprising a portion of the ablation electrode.

[0042] There is further provided, in accordance with an embodiment of the present invention, a system comprising a catheter, a navigation sensor, and a needle assembly. The navigation sensor is disposed proximate a distal end of the shaft. The needle assembly includes an electrode thereon and a sharpened end. The needle assembly is translatable in one dimension relative to the navigation sensor. The needle assembly is translatable through the distal end of the catheter to move the sharpened end out of the catheter. The navigation sensor is positioned to detect movement of the electrode relative to the navigation sensor.

[0043] According to some embodiments of the present disclosure, there is further provided a method of endovascular treatment, the method including one or more of the following steps: delivering an electrode needle assembly into a blood vessel via a catheter; lancing tissue in or around the heart with the electrode needle assembly and moving a first electrode of the electrode needle assembly to a first depth while moving a second electrode of the electrode needle assembly to a position above the tissue or to a second depth within the tissue that is shallower than the first depth.

[0044] In some embodiments, the method further includes detecting a first electrical signal at a first depth within the tissue by the first electrode, the first electrical signal indicative of at least one of a tissue voltage and a tissue impingement.

[0045] In some embodiments, the method further includes applying a radio frequency electrical signal to at least one of the first electrode and the second electrode.

[0046] In some embodiments, the method further includes injecting a conductive fluid into the tissue via a lumen in the electrode needle assembly while the first electrode is positioned at the first depth.

[0047] In some embodiments, the method further includes positioning the electrode needle assembly in or around the heart while covered, positioning a navigation sensor in or around the heart, exposing the electrode needle assembly while positioned in or around the heart, and detecting movement of at least one of the first electrode and the second electrode as a result of the exposure of the electrode needle assembly with the navigation sensor.

[0048] In some embodiments, the method further includes sensing a temperature proximate at least one of the first electrode and the second electrode.

[0049] According to some embodiments of the present disclosure, there is further provided a method for ablating tissue in or around the heart, the method including one or more of the following steps: delivering an electrode needle assembly into a blood vessel via a catheter; lancing tissue in or around the heart with a sharp end of the electrode needle assembly; moving an electrode electrically insulated from the sharp end into the tissue; and ablating the tissue by applying electrical energy to the electrode.

[0050] In some embodiments, ablating tissue by applying electrical energy to the electrode further comprises delivering an electrical current from an annular surface of the electrode to the tissue such that the current comprises a substantially uniform current density across the annular surface.

[0051] According to some embodiments of the present disclosure, there is further provided a method for constructing a device for lancing intravascular tissue, the method including one or more of the following steps: applying a conductive trace to a first electrically insulating flexible film; positioning an opening in a second electrically insulating flexible film; securing the second electrically insulating flexible film to the conductive trace and the first electrically insulating flexible film such that the opening is positioned over the conductive trace; applying an electrode to the second electrically insulating flexible film such that the electrode contacts the conductive trace through the opening in the second electrically insulating flexible film; and wrapping the first electrically insulating flexible film, the conductive trace, the second electrically insulating flexible film, and the electrode to define a tubular shape extending along a longitudinal axis and securing a sharp end proximate a first end of the tubular shape.

[0052] In some embodiments, the method may further include securing an inner surface of the tubular shape to the needle such that the needle includes a sharpened end secured proximate to a first end of the tubular shape.

[0053] In some embodiments, the method may further include electrically isolating each of the one or more electrodes from the needle.

[0054] In some embodiments, the method may further include positioning a thermocouple junction on an exterior surface of the needle and electrically isolating the thermocouple junction from the needle.

[0055] In some embodiments, the method may further include forming a point at the first end of the tubular shape such that the sharp end comprises a point.

[0056] In some embodiments, the method further includes forming a sharp tip at a first end of the tubular shape such that the sharp end includes a point and forms the tubular shape with sufficient columnar stiffness to lance intravascular tissue.

[0057] In some embodiments, the method may further include securing a metal sheet under the first electrically insulating flexible film, wrapping the metal sheet to define an inner surface of a tubular shape, and forming a point on the metal sheet proximate to the first end of the tubular shape such that the sharp end comprises a point.

[0058] In some embodiments, the method may further include applying a liner electrode comprising gold to a second insulating flexible film and wrapping the linear electrode to form a band surrounding the tubular shape.

[0059] In some embodiments, the method may further include electrically connecting a solder pad to each of the conductive traces, and positioning openings in the second electrically insulating flexible film such that the electrodes are each electrically connected to a respective one of the conductive traces.

[0060] In some embodiments, the method may further include enclosing the tubular shape and the sharpened end with a sheath such that the tubular shape and the sharpened end are slidable to extend the sharpened end from the sheath.

[0061] In some embodiments, the method may further include electrically insulating the sharp end from the electrode.

[0062] In some embodiments, the method may further include electrically isolating each electrode from the remainder of the electrode.

[0063] In some embodiments, the method may further include positioning the thermocouple junction in the opening of the second electrically insulating flexible film such that the thermocouple junction includes a portion of one of the electrodes in contact with one of the conductive traces in the opening.

[0064] In some embodiments, the method may further include forming the electrodes of the thermocouple junction to comprise gold and forming the conductive traces of the thermocouple junction to comprise constantan.

[0065] In some embodiments, the method may further include positioning a second thermocouple junction between the first electrically insulating flexible film and the second electrically insulating film such that the second thermocouple junction includes an overlapping portion of two of the conductive traces.

[0066] In some embodiments, the method may further include applying a pure gold electrode having a thickness of about 0.001 inches (about 25 micrometers) to the second electrically insulating film.

[0067] In some embodiments, the method may further include positioning the thermocouple junction so that it is heated by all of the electrodes.

[0068] In some embodiments, the method may further include positioning a navigational sensor to detect movement of one or more of the electrodes.

[0069] In some embodiments, the method can further include positioning a navigation sensor to detect movement of two or more of the electrodes.

[0070] In some embodiments, the method may further include securing a navigation sensor proximate a distal end of the catheter and positioning a needle assembly, including a tubular shape and a sharpened end, through the catheter such that the needle assembly is constrained to move in only one dimension relative to the navigation sensor.

[0071] In some embodiments, the method may further include electrically isolating each of the electrodes from the remainder of the electrodes.

[0072] In some embodiments, the method may further include configuring the electrodes to measure voltage and / or impedance.

[0073] In some embodiments, the method may further include wrapping the electrodes around a circumference of the tubular shape.

[0074] In some embodiments, the method may further include spacing each of the electrodes a predetermined distance from the sharp edge to electrically insulate each electrode from the remainder of the electrode.

[0075] In some embodiments, the method can further include positioning the electrode limited to a distance of about 9 mm, as measured from the tip of the sharp end.

[0076] In some embodiments, applying electrodes to the second electrically insulating flexible film can further include applying about 6 to about 10 linear electrodes. The method can further include wrapping each of the linear electrodes to form about 6 to about 10 ring electrodes.

[0077] In some embodiments, the method may further include spacing each adjacent ring electrode from each other with an edge-to-edge spacing of between about 2 mm and about 4 mm.

[0078] According to some embodiments of the present disclosure, there is further provided a method for configuring a system for endovascular treatment, the method can include one or more of the following: selecting a flexible circuit, wrapping the flexible circuit to form a tubular shape, positioning a navigation sensor, and configuring a processing device. The flexible circuit is selected to have an electrically insulating substrate film, a conductive trace disposed on the substrate film, an electrically insulating separation film disposed on the conductive trace, the electrically insulating film including a via passing therethrough, and an electrode is disposed on the insulating film and connected to at least a portion of the conductive trace through the via. The flexible circuit is wrapped such that the electrode is shaped as a ring electrode that avoids an exterior surface of the tubular shape. A sharp end is fixed proximate to a first end of the tubular shape. The navigation sensor is positioned to detect movement of one or more of the ring electrodes relative to the navigation sensor. The processing device is configured to extract electrical measurements from the electrodes and use the navigation sensor to determine a position of each of the electrodes relative to the endocardial tissue.

[0079] In some embodiments, the method further includes further configuring the processing device to determine impedance of the intracardiac tissue at multiple depths in the tissue in response to lancing the sharp end and the intracardiac tissue with the ring electrode and inserting the ring electrode into the intracardiac tissue.

[0080] In some embodiments, the method further includes selecting a catheter, electrically connecting a conductive wire to each of the conductive traces, extending the conductive wires through the catheter, and electrically connecting a frequency generator to at least one of the conductive wires.

[0081] In some embodiments, the method further includes electrically connecting an electrical measurement tool to a first portion of the electrodes and electrically connecting a radio frequency generator to a second portion of the plurality of electrodes.

[0082] In some embodiments, the electrical measurement tool includes one or more of a voltmeter, an ohmmeter, and an ammeter.

[0083] According to some embodiments of the present disclosure, there is further provided a method for configuring a system for endovascular treatment, which may include one or more of the following: selecting a flexible circuit, winding the flexible circuit to form a tubular shape, securing a sharp end proximate a first end of the tubular shape, selecting a catheter, electrically connecting conductive wires each to a respective conductive trace on the flexible circuit, and electrically connecting a radio frequency generator to at least one of the conductive wires. The flexible circuit is selected to have an electrically insulating substrate film, conductive traces disposed on the substrate film, and an electrically insulating separation film disposed over the conductive traces, the electrically insulating film including vias therethrough, and an electrode is disposed on the insulating film and connected to at least a portion of the conductive traces through the vias.

[0084] According to some embodiments of the present disclosure, there is further provided a method of constructing an ablation tool, which may include one or more of the following: forming an ablation electrode; forming a sharp end secured to the ablation electrode; and electrically insulating the ablation electrode from the sharp end.

[0085] According to some embodiments of the present disclosure, there is further provided a method of constructing an ablation tool, which may include one or more of the following: forming an ablation electrode; and forming a thermocouple junction such that the thermocouple junction includes a portion of the ablation electrode.

[0086] According to some embodiments of the present disclosure, there is further provided a method of constructing an ablation tool, which may include one or more of the following: selecting a catheter; securing a navigation sensor proximate a distal end of the catheter; positioning a needle assembly having an electrode thereon and a sharpened end within the catheter such that the needle assembly is translatable in one dimension relative to the navigation sensor, the needle assembly being translatable to move the sharpened end out of the catheter through the distal end of the catheter; and configuring the navigation sensor to detect movement of the electrode relative to the navigation sensor.

[0087] A more complete understanding of the present disclosure will be obtained from the following detailed description of the embodiments of the invention when read in conjunction with the drawings. [Brief description of the drawings]

[0088] [Figure 1] 1 is a diagram of an ablation tool, according to some embodiments of the present invention. [Figure 2A] 2 is a diagram of a flexible circuit of the ablation tool of FIG. 1 in a flat configuration, according to some embodiments of the present disclosure. [Figure 2B] 2 is a diagram of a flexible circuit of the ablation tool of FIG. 1 in a tubular shape, according to some embodiments of the present disclosure. [Diagram 3] 1 is a diagram of an ablation tool, according to some embodiments of the present invention. [Figure 4A] 4 is a diagram of a flexible circuit of the ablation tool of FIG. 3 in a flat configuration, according to some embodiments of the present disclosure. [Figure 4B] 4 is a diagram of a flexible circuit of the ablation tool of FIG. 3 in a tubular shape, according to some embodiments of the present disclosure. [Diagram 5] 1A-1C are diagrams of flexible circuits in a tubular shape including pointed ends, according to some embodiments of the present disclosure. [Figure 6]FIG. 2 is a diagram of a flexible circuit having a metal sheet secured thereto, forming the flexible circuit and the metal sheet into a tubular shape and including a pointed end, according to some embodiments of the present disclosure. [Figure 7] 7 is a diagram of the flexible circuit of FIG. 5 or FIG. 6 in a flat configuration according to some embodiments of the present disclosure. [Figure 8A] 7 is a diagram of the metal sheet of FIG. 6 in a flat configuration, according to some embodiments of the present disclosure. [Figure 8B] FIG. 7 is a diagram of the metal sheet of FIG. 6 in a tubular shape, according to some embodiments of the present disclosure. [Figure 9] 1 is a diagram of a diagnostic electrode tool, according to some embodiments of the present invention. [Figure 10A] 10 is a diagram of a flexible circuit of the diagnostic electrode tool of FIG. 9 in a flat configuration according to some embodiments of the present disclosure. [Figure 10B] 10 is a diagram of a flexible circuit of the diagnostic electrode tool of FIG. 9 in a tubular shape, according to some embodiments of the present disclosure. [Figure 11] 1A-1C are diagrams of layers of a flexible circuit usable for an ablation tool and / or a diagnostic tool according to some embodiments of the present disclosure. [Figure 12] FIG. 1 illustrates a flexible circuit including a thermocouple that includes a portion of an electrode, according to some embodiments of the present disclosure. [Figure 13] FIG. 1 is a diagram of a flexible circuit including a thermocouple electrically isolated from the electrodes. [Figure 14] 1A-1D are diagrams of sharpened edges that can be used for ablation and / or diagnostic tools, according to some embodiments of the present disclosure. [Figure 15] 1 is a diagram of a dome end of an ablation tool as known. [Figure 16] 1A-1D are diagrams of a needle assembly, according to some embodiments of the present invention. [Figure 17] 1 is a diagram of an ablation or diagnostic tool according to an embodiment of the present invention. [Figure 18] FIG. 1 is a flow diagram of a method of treatment using an ablation or diagnostic tool according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0089] As used herein, the term "about" or "approximately" in relation to any numerical value or range indicates a suitable dimensional tolerance that enables a portion of a component or a collection 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 ​​of ±20% of the recited value, e.g., "about 90%" may refer to a range of values ​​of 71% to 99%.

[0090] As used herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular structure or system is generally illustrated as a substantially right cylindrical structure. However, a tubular system can have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0091] The term "computing system" is intended to include a stand-alone machine or device and / or combinations of machines, components, modules, systems, servers, processors, memories, detectors, user interfaces, computing device interfaces, network interfaces, hardware elements, software elements, firmware elements, and other computer-related units. By way of example and not limitation, a computing system may include one or more of a general purpose computer, a special purpose computer, a processor, a portable electronic device, a portable electronic medical device, a stationary or semi-stationary electronic medical device, or other electronic data processing device.

[0092] Terms such as "component," "module," "system," "server," "processor," "memory," and the like are intended to include one or more computer-related units, including but not limited to running hardware, firmware, a combination of hardware and software, software, or software. For example, a component may be, but is not limited to, a processor, an object, an executable, a thread of execution, a program, and / or a process running on a computer. By way of example, both an application running on a computing device and the computing device may be a component. One or more components may reside within a process and / or thread of execution, and a component may be localized on one computer and / or distributed among two or more computers. Furthermore, these components may execute from various computer-readable media having various data structures stored thereon. A component may communicate via local and / or remote processes, such as according to a signal having one or more data packets, such as data from one component interacting with another component over a network, such as the Internet, in a local system, a distributed system, and / or with other systems via a signal. A computer-readable medium may be non-transitory. The term "non-transitory computer-readable medium" includes, but is not limited to, random access memory (RAM), read-only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory or other memory technology, compact disc ROM (CD-ROM), digital versatile disk (DVD) or other optical storage device, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage device, or any other tangible physical medium that can be used to store computer-readable instructions and / or data.

[0093] FIG. 1 is a diagram of an ablation tool including a needle assembly 100a retractable or otherwise covered within a catheter 200. The needle assembly 100a may include a sharpened end 110a and a flexible circuit 120a. The needle assembly 100a may include a hollow needle 102a having a tip 104a and a hollow lumen 106. During the ablation process, a conductive fluid may be delivered through the lumen 106. Lesion size may be increased by increasing the thermal conductivity of tissue by delivering a fluid through the needle assembly 100a in a manner similar to that disclosed in U.S. Pat. No. 9,326,813, which is incorporated herein by reference in its entirety as if set forth in its entirety and is attached as an appendix to priority application U.S. Pat. No. 62 / 943,552. During treatment, the distal tip 104a of the hollow needle 102a can be introduced into tissue, a conductive fluid can be injected through the needle into the tissue, and the tissue can be ablated after and / or during the introduction of the fluid into the tissue. The fluid conducts ablation energy into the tissue to create a larger lesion than would be created without the introduction of the fluid. During ablation, electrical current can be delivered to the tissue via one or more electrodes 136a on the flexible circuit 120a. The flexible circuit 120a can include an electrically insulating flexible substrate. The flexible circuit 120a can be wrapped around the needle 102a to define a tubular shape. Once secured to the needle 102a, the flexible circuit 120a is no longer flexible. This means that the circuit 120a is fixed relative to the needle 102a. The electrode 136a(s) may be electrically insulated from the needle 102a at least by the insulating properties of the flexible substrate in addition to any intermediate insulating layers of the flexible circuit 120a.

[0094] The needle assembly 100a may be slidably translatable relative to a catheter or sheath 200 (referred to herein for simplicity as a "catheter"). The catheter 200 is further shown in FIG. 17. With collective reference to FIGS. 1 and 17, the needle assembly 100a may be slidably retracted into an opening 204 in the catheter 200 when the needle assembly 100a is manipulated pre- and post-treatment. The needle assembly 100a may be sheathed to reduce the risk of inadvertently puncturing tissue. The navigation sensor 70 may be positioned within the catheter 200 proximate a distal end of the catheter 200. The navigation sensor 70 may be positioned or otherwise configured to detect movement of the needle assembly 100a relative to the catheter 200. The navigation sensor may be configured to detect whether the needle assembly 100a is fully sheathed within the catheter 200. The sensor 70 may be in a fixed position at the catheter tip. In some applications, the sensor 70 can be configured to provide a signal to an electrode mapping system, which can determine the relative position of the needle assembly 100a based on the signal from the sensor 70. The electrode mapping system can thereby provide data indicative of the status of the needle assembly 100a, such as covered / exposed, as well as data indicative of the intradermal signal location. So configured, the electrode mapping system can provide the z-component of the position of the needle assembly 100a in addition to the x and y positions.

[0095] Figure 2A is a diagram of the flexible circuit 120a of the ablation tool of Figure 1 in a flat configuration, and Figure 2B is a diagram of the flexible circuit 120a of the ablation tool of Figure 1 in a tubular shape.

[0096] 1, 2A, and 2B collectively, the flexible circuit 120a may include a rectangular flexible circuit having a surface 130 at least partially covered by a sputtered gold electrode surface 136a. The rectangular flexible circuit 120a may be attached by wrapping around the hollow needle 102a using adhesive and / or heat processing. The flexible circuit 120a may be electrically insulated from the needle 102a. The flexible circuit 120a may be further electrically insulated from all other conductive surfaces of the ablation tool. The needle assembly 100a may include an insulated trace(s) routed from the ablation electrode zone 136a to a solder pad 122 near the proximal edge 132 of the flexible circuit 120a. One or more leads may be attached to connect back through the catheter 200, such that the leads eventually connect to an RF generator. The needle 102a may be electrically insulated from the RF circuit. When the needle 102a is electrically isolated from the ablation energy from the RF generator, the tip 104a of the needle 102a can have a sharp point (see also FIG. 14). When the needle 102a is not electrically isolated from the ablation energy from the RF generator, the tip 104a of the needle 102a can have rounded edges to reduce non-uniform current distribution and heating during ablation (see also FIG. 15). A sharper needle generally requires less force to pierce cardiac tissue. Thus, advantages of insulating the needle tip 104a from the electrode 136a can include a sharper needle tip 104a to more easily pierce tissue, as well as the ability to have an electrode geometry shaped to further reduce the effects of non-uniform current distribution and heating during ablation.

[0097] During ablation, RF energy may be delivered from the generator to the solder pad 132, from the solder pad 132 to the flexible circuit electrode 136a, from the flexible circuit electrode 136a to tissue adjacent to the electrode 136a, and back through a system return electrode (not shown). The system return electrode may be configured in a manner similar to the predictive device. In some applications, RF energy may be delivered from the ablation zone 136a such that leakage to adjacent catheter structures, such as domes and needles, is minimized. The tool need not include irregular structures on the electrode surface 136a, so that the current density across the ablation surface 136a may be substantially uniform.

[0098] With reference to FIG. 2A, the flexible circuit can be fabricated in a rectangular shape. The flexible circuit 120a can have a substantially uniform thickness over the area of ​​the electrode 136a. The rectangular shape can be wrapped to define a tubular shape, as shown in FIG. 2B and FIG. 1. In the tubular shape, the flexible circuit 120a can maintain a substantially uniform thickness in the area of ​​the electrode 136a. The rectangular shape can be wrapped such that the longitudinal sides 126, 128 of the circuit are adjacent to create a smooth transition between the edges 126, 128 in the electrode area 136a when in the tubular shape. So configured, the electrode 136a can be substantially radially symmetric about the longitudinal axis 10. The radial electrode symmetry can provide more predictable and reproducible lesions as compared to needle assemblies that use needles as electrodes. Radial electrode symmetry can provide lesions that are less affected by the orientation of the needle assembly 100a relative to the target tissue surface (e.g., angled lancet incision versus vertical incision) compared to needle assemblies that use needles as electrodes.

[0099] The risk of current leakage from the electrode 136a through tissue or fluid to the sharp end 110a or another needle surface can be mitigated by physically offsetting the ablation zone 136a from the sharp end 110a and the needle surface. The ablation zone 136a can be physically offset by positioning the distal edge of the ablation zone a predetermined distance from the distal end 124 of the flexible circuit 120a. The needle assembly 100a can thereby be configured to deliver essentially all of the ablation energy to the target tissue.

[0100] 1, 2A, and 2B collectively, the flexible circuit 120a may have an exterior surface 130 including an electrode surface 136a and an insulating surface 134 positioned proximally relative to the electrode surface 136a. The insulating surface 134 may electrically insulate the needle assembly 100a from the catheter 200 during ablation. The insulating surface 130 may further cover one or more electrical traces connecting the electrodes 136a to the solder pads 132.

[0101] FIG. 3 is a diagram of an ablation tool including a needle assembly 100b having multiple electrodes 136b-f and solder pads 132. The electrodes 136b-f may be electrically insulated from one another. The electrodes 136b-f may each be electrically insulated from the sharp end 110a. The multiple solder pads 132 may each be electrically connected to some or all of the electrodes 136b-f, respectively. The electrodes 136b-f may be connected to the solder pads 132 in a one-to-one manner. Alternatively, the electrodes 136b-f may be connected to multiple solder pads 132, the solder pads 132 may be connected to multiple electrodes 136b-f, and / or the electrodes 136b-f may be floating and lacking connections to solder pads. RF ablation energy may be applied separately at each electrode 136b-f to provide different ablation energies at different tissue depths. Additionally or alternatively, one or more of the electrodes 136b-f may be connected to an electrical measurement tool.

[0102] Figure 4A is a diagram of the flexible circuit 100b of the ablation tool of Figure 3 in a flat configuration. In the flat configuration, the electrodes 136b-f can be substantially linear and extend between the longitudinal edges 126, 128. The solder pads 132 can be substantially linear and extend between the longitudinal edges 126, 128.

[0103] Figure 4B is an illustration of the flexible circuit 120b of the ablation tool of Figure 3 in a tubular shape. The linear electrodes 136b-f in a flat configuration can become ring electrodes 136b-f when the flexible circuit 120b is wrapped into a tubular shape.

[0104] The ablation system, needle assembly 100b, and its component parts shown in Figures 3, 4A, and 4B may be constructed in other manners and include the functionality and features described in connection with the ablation system, needle assembly 100a, and its component parts as shown and described in connection with Figures 1, 2A, and 2B.

[0105] FIG. 5 is a diagram of a needle assembly 100c including a circuit 120c in a tubular shape including a tip 110b. The circuit 120c can be a flexible circuit board wrapped into the illustrated tubular shape. Once in the tubular shape, the circuit 120c can have sufficient structural stability and columnar rigidity to pierce tissue during ablation without substantial deformation. In some embodiments, the needle assembly 100c does not need to include structural support within the lumen 176 of the tubular circuit 120c. The surface of the lumen 176 can correspond to the bottom surface 174 of the electrically insulating substrate film of the flexible circuit board 120c (see also FIG. 11). The lumen 176 of the circuit 120c can be further sized and otherwise configured to provide a fluid path to assist in the ablation of the conductive fluid. The sides 126, 128 of the tubular circuit 120c can be fused together or otherwise joined to create a fluid impermeable connection.

[0106] The ablation system, needle assembly 100c, and its component parts shown in Figure 5 may be constructed in other manners and include the functionality and features described in connection with the ablation system, needle assembly 100a, and its component parts as illustrated and described in connection with Figures 1, 2A, and 2B. Additionally, the needle assembly 100c shown in Figure 5 may include multiple electrodes within electrode region 130 as shown and described in connection with Figures 3, 4A, and 4B.

[0107] FIG. 6 is a diagram of a needle assembly 100d including a circuit 120c having a metal sheet 140 secured thereto. The circuit 120c and metal sheet 140 are shown in a tubular shape including a tip 110c. The metal sheet 140 can provide additional columnar rigidity to support the tubular circuit 120c. Thus, the circuit 120c can have sufficient columnar rigidity to lance tissue without significant deformation without the metal sheet 140, but is not required to do so. The circuit 120c shown in FIG. 6 may be constructed in other manners and includes functionality and features as described in connection with the circuit 120c shown in FIG. 5.

[0108] Figure 7 is a diagram of the circuit 120c of Figure 5 or Figure 6 in a flat configuration. The circuit 120c can have a triangular shape proximate the distal end 114 of the flat circuit 120c such that when the circuit 120c is wrapped to form a tube, the triangular shape forms part of the sharpened end 110b shown in Figure 5 or the sharpened end 110c shown in Figure 6. The outer surface 130 of the circuit 120c can be insulating within the triangular shape.

[0109] Figure 8A is a diagram of the metal sheet 140 of Figure 6 in a flat configuration. The metal sheet can have lateral edges 126, 128 that can overlap when the metal sheet 140 is formed into a tubular shape.

[0110] Figure 8B is an illustration of a tubular shape of the metal sheet 140 of Figure 6. The metal sheet 140 can be secured to the flexible circuit board 120c in either a flat shape or a tubular shape. The metal sheet 140 can include perforations to reduce the weight of the metal sheet 140.

[0111] 9 is a diagram of a diagnostic electrode tool including a diagnostic needle assembly 100e having a plurality of electrodes 136g-p. Needle assembly 100e may include a flexible circuit 120d.

[0112] Figure 10A is a diagram of the flexible circuit 120d of the ablation tool of Figure 9 in a flat configuration. In the flat configuration, the electrodes 136g-p may be substantially linear and extend between the longitudinal edges 126, 128 of the circuit board 120d. The solder pads 132 may be substantially linear and extend between the longitudinal edges 126, 128 of the circuit board 120d. In other words, when flat, the flexible circuit 120d may be rectangular with portions of its outer surface 130 covered with rectangular bands 136g-p of sputtered gold.

[0113] Figure 10B is a diagram of the flexible circuit 120d of the ablation tool of Figure 9 in a tubular shape. When the flexible circuit 120d is wrapped around the tubular shape, the linear electrodes 136g-p in the flat configuration can become ring electrodes 136g-p. In other words, when tubular, the rectangular bands of sputtered gold 136g-p can form rings that surround the circumference of the tubular shape.

[0114] 9, 10A, and 10B collectively, the needle assembly 100e may further include a needle 102b. A flexible circuit 120d may be wrapped around the needle 102b. The flexible circuit 120d may be secured to the needle 102b using adhesives, heat treatments, or other means, as will be appreciated and understood by those skilled in the art. Once formed, the bands 136g-p may form a series of spaced apart insulated ring electrodes wrapped laterally around the needle frame (wrapped circumferentially around the longitudinal axis 10). Each electrode 136g-p may be electrically insulated and coupled to a solder pad 132 by a trace on the circuit board 120d. Leads may be attached to the solder pads 132 for coupling to a diagnostic system.

[0115] The ring electrodes 136g-p may be configured to detect bipolar electrocardiogram (ECG) signals, unipolar ECG signals, impedance, activation voltage, and other electrically detectable signals, as will be recognized and understood by those skilled in the art. The array of ring electrodes 136g-p may be further configured to observe electrical properties of the myocardium at depth. For example, the diagnostic electrode tool catheter 200 may include a navigation sensor paired with CARTO mapping and diagnostic software (or similar software, as will be recognized and understood by those skilled in the art).

[0116] In some embodiments, the diagnostic electrode tool may be configured to function as a lesion assessment tool. The needle assembly 100e may be moved to penetrate a known lesion location or a suspected leak area within the lesion. Once at least some of the electrodes 136g-p are positioned within the tissue, a physician or other user may utilize the electrodes to determine the relative tissue impedance at depth. The relative tissue impedance may be used to determine lesion depth, lesion quality, and / or sublesion signal propagation. Such data may direct additional focused analysis (e.g., RF analysis). Such a lesion assessment tool may be used in some applications to provide a physician with a means to directly verify lesion quality or to find and resolve electrically leaky lesions as an alternative to indirect measurements using clinical design validation models or surface diagnostics.

[0117] In some embodiments, the diagnostic electrode tool may be configured to function as a subsurface diagnostic tool. The needle assembly 100e may be moved to penetrate the myocardial tissue at multiple locations. At each location, a physician or other user may utilize the electrode to obtain electrical measurements of the myocardial tissue at multiple depths. The multiple depth readings of the myocardial tissue may be overlaid against the marker signal to match individual observation points. A computing system with the multiple depth readings and the marker signal may be configured to partially integrate together one or more 3D models of electrical signal propagation, electrical signal activation, and / or impedance. Triangular boundary conditions may be utilized to identify potential activation points for ablation that would not be apparent when performing a similar analysis using a surface contact diagnostic device lacking depth readings.

[0118] In some embodiments, a diagnostic electrode tool can serve as an alternative to using a needle ablation catheter as a diagnostic tool. A diagnostic electrode tool with multiple electrodes 136g-p can provide greater granularity in electrical signal modeling compared to a needle ablation catheter with a single ablation electrode. Multiple electrodes 136g-p can essentially function as an antenna array as opposed to one larger antenna in a single electrode tool.

[0119] Electrode spacing, electrode surface area, and electrode quantity may be configured according to the needs of a given diagnostic application (e.g., to create a clinically useful signal profile). In some embodiments, the circuit board 120d may include about 5 bipolar pairs (about 10 electrodes total). Alternatively, the circuit board 120d may include about 6 electrodes. In some embodiments, the electrodes may be evenly spaced with uniform spacing from edge to edge. Alternatively, the electrodes may be unevenly spaced from edge to edge (e.g., 2mm to 4mm to 2mm to 4mm to 2mm...), and in some embodiments, each of the electrodes may be spaced over a penetration depth of about 9mm as measured from the tip 104b of the needle 102b along the longitudinal axis 10.

[0120] FIG. 11 is a diagram of layers of a flexible circuit 120 that can be used in an ablation tool and / or a diagnostic tool. Flexible circuits 120a-f as otherwise illustrated and described herein can be constructed similarly to that shown in and described in connection with FIG. 11. The flexible circuit 120 can include a substrate layer 172, an adhesive layer 170, a trace array layer 160, an intermediate electrical insulation layer 150, electrodes 136q-r, and solder pads 132. The flexible circuit 120 can have a bottom surface 174 that includes a bottom side of the substrate layer 172. The flexible circuit 120 can have a top surface 130 that includes top surfaces of the electrodes 136q-r, portions of the top surface of the intermediate electrical insulation layer 150, and top surfaces of the solder pads 132.

[0121] The electrodes 136q-r may include gold. The electrodes 136q-r may be pure gold. The electrodes may have a thickness of about 1 micrometer to about 2 micrometers. The electrodes may have an edge-to-edge spacing D. The edge-to-edge spacing D between the electrodes may be uniform. Alternatively, the edge-to-edge spacing D may vary from one pair of electrodes to the next pair of electrodes. The minimum edge-to-edge spacing D between the electrodes may be determined by applying certain factors, such as potential electrical interference between the electrodes and manufacturing limitations. Maintaining electrical isolation between adjacent electrodes may be a factor in determining the minimum edge-to-edge spacing. In some applications, an edge-to-edge spacing of about 0.05 mm may be achievable with the present manufacturing techniques and may be sufficient to maintain electrical isolation. In some applications, achieving a minimum edge-to-edge spacing may not be an objective.

[0122] For purposes of ablation and / or sensing as described herein, the following spacings may be advantageously used: The circuit board 120 may be positioned with an edge-to-edge spacing D of 2 mm to 4 mm to 2 mm to 4 mm to 2 mm. The circuit board 120 may include about 10 to about 6 electrodes. The electrodes 136q-r may be spaced apart from the distal end 124 of the flexible circuit 120 over a length of about 7 millimeters to about 9 millimeters. The electrodes 136s-r may have a rectangular shape that extends linearly across the width of the flexible circuit 120. The flexible circuit 120 with linear (rectangular) electrodes 136s-r may be wrapped to form ring electrodes 136s-r.

[0123] The intermediate electrical insulation layer 150 may include a polymer such as flexible polyimide. The intermediate electrical insulation layer 150 may include Felios RF775 Polyimide Flex with copper removed. The intermediate electrical insulation layer 150 may have a thickness of about 25 micrometers. Alternatively, the intermediate electrical insulation layer 150 may have a thickness and / or material configuration sufficient to achieve the structural and electrical functions as described herein. For example, the intermediate electrical insulation layer may include an electrically insulating flexible sheet having a thickness of about 12.5 micrometers or 50 micrometers, as currently commercially available. The intermediate electrical insulation layer 150 may include openings 152a-c for providing connections between the electrodes 136q-r for the traces on the trace array layer 160 and the solder pads 132 for the traces on the trace array layer 160. The openings 152a-c may be filled with a conductive material. The openings 152a-c may function as vias.

[0124] The trace array layer 160 can include conductive traces 162a-d, 166a-b (see also Figures 12 and 13). The traces 162a-d, 166a-b can have a thickness of from about 1 micrometer to about 2 micrometers.

[0125] Adhesive layer 170 can have a thickness of about 25 micrometers or less, preferably a minimum thickness sufficient to maintain sufficient adhesion. A thickness of about 12 micrometers to about 13 micrometers is preferred. In needle assembly embodiments lacking an inner tube (e.g., needle or metal sheet) for structural support, adhesive layer 170 can be thicker because the lack of needle wall thickness allows more room for other layers without affecting the overall size of the needle assembly. Adhesive layer 170 can include an acrylic adhesive. The adhesive can be coated on a release paper. Adhesive layer 170 can include Dupont Pyralux LF sheet adhesive, such as LF0100 or a similar product.

[0126] The substrate layer 172 can have a thickness of about 12 micrometers to about 13 micrometers. Alternatively, the intermediate electrically insulating layer 150 can have a thickness and / or material configuration sufficient to achieve the structural and electrical functions as described herein. For example, the intermediate electrically insulating layer can include an electrically insulating flexible sheet having a thickness of about 12.5 micrometers or 50 micrometers, as currently commercially available. The substrate layer 172 can include an acrylic adhesive. The substrate layer can include a polyamide film. The substrate layer 172 can be a composite of acrylic, polyamide film, and / or other insulating flexible materials. The substrate layer 172 can include a Dupont Pyralus LF coverlay, such as LF7001.

[0127] 12 is a diagram of a flexible circuit 120e including a thermocouple 168a including an electrode 136t and a portion of a trace 166a on a patterned layer 160. The trace 166a may include constantan. The trace 166a may contact the electrode 136t through a via 152g. So configured, the thermocouple junction 168a may be separated from the tissue ablation surface by the sum of the thickness of the electrode 136t and the thickness of the intermediate insulating layer 150 (e.g., about 26 micrometers). The thermocouple 168a may thereby be in direct contact with the electrode 136t.

[0128] The trace array layer 160 can further include traces 162a-c of the same material as the electrodes 136s-v. The electrode traces 162a-c can each contact a respective electrode 136s-v through a respective via 152d-f. Some or all of the electrode traces 162a-c can each provide a path for ablation current to a respective electrode 136s-u. Additionally or alternatively, some or all of the electrode traces 162a-c can provide a path for measuring electrical signals from a respective electrode 136s-u.

[0129] Each of the traces 162 a - c , 166 a can be connected to a respective solder pad 132 .

[0130] FIG. 13 is a diagram of a flexible circuit 120f including a thermocouple 168b electrically isolated from the electrodes 136w-z. The thermocouple 168b may be confined to the trace array layer 160. The thermocouple 168b may include a constant trace 166b and a gold trace 164. The trace array layer 160 may further include electrode traces 162d-e that contact the electrodes 136x-y through vias 152h-i. Each of the traces 162d-e, 164, 166b may be connected to a respective solder pad 132. Some or all of the electrode traces 162d-e may each provide a path for an ablation current to a respective electrode 136x-y. Additionally or alternatively, some or all of the electrode traces 162d-e may provide a path for electrical signal measurement from a respective electrode 136x-y.

[0131] 11 and 12 collectively, needle assemblies 100, 100a-e including flexible circuits 120e-f having thermocouples 168a-b integrated therein can be configured to perform temperature controlled ablation through automatic temperature feedback from the thermocouples 168a-b.

[0132] Any of the flexible circuits 120, 120a-f shown herein may include electrodes configured to extract electrical signals for diagnostic purposes in addition to electrodes configured to provide current for ablation. In some embodiments, one or more diagnostic electrodes may be positioned distally and / or proximally relative to each ablation electrode. Positioned in this manner, the diagnostic electrodes may be configured to provide data to a computing device configured to determine, based on the provided data, whether each respective diagnostic electrode is in contact with scar tissue or activated tissue. The computing device may be further configured to control the current output from each ablation electrode to target the activated tissue. As shown in FIGS. 12 and 13, the electrodes 136t, 136x proximate the thermocouple junctions 168a-b may be configured for ablation, while the electrodes 136s, 136u, 136w, 136y on either side of the ablation electrodes 136t, 136x may be configured as diagnostic electrodes.

[0133] The thermocouples 168a-b can be positioned relative to the electrode 136t, 136x surface. Assuming a uniform thickness and shape of the ablation electrodes 136t, 136x, the thermocouples 168a-b can be positioned at the center of the ablation surface to represent the temperature of the entire surface. Additionally or alternatively, the thermocouples 168a-b can be positioned proximate the edges of the electrodes 136t, 136x to capture boundary temperatures. Multiple ablation zones can be accommodated by shorting to multiple individual or shared constant traces. Alternatively, the constant traces can be electrically isolated from the remainder of the constant trace. In some applications, the thermocouple 168a in electrical contact with the electrode 136t can have improved thermal performance compared to the insulated thermocouple 168b separated from the ablation electrode 136x by the thickness of the intermediate electrical insulation layer 150. Thermocouple 168b, which is insulated from electrode 136x, can reduce signal noise as compared to thermocouple 168a, which is in electrical contact with electrode 136t.

[0134] The thermocouples 168a-b may have a greater thermal conductivity to the ablation electrodes 136t, 136x as compared to the thermal conductivity to the fluid flow through the needle assembly lumens 106, 146, 176.

[0135] 14 is an illustration of a sharpened end 104a of a needle 102a that can be used in an ablation and / or diagnostic tool in accordance with the teachings of the present disclosure. The end 104a can have a blade edge. The end 104a can be electrically insulated from the electrodes 136a-z so that it should not be of a sharp configuration that results in a current concentration. Similarly, the needle 102b of the diagnostic tool can include a pointed end 104b in accordance with the teachings of the present disclosure.

[0136] 15 is an illustration of a rounded end 104c of a needle 102c that can be used in an ablation and / or diagnostic tool where the needle 102c functions as an ablation electrode as known in the art. The end 104c is rounded to reduce the effects of current crowding and hot spots during ablation.

[0137] 16 is a cross-sectional view of a needle electrode assembly 46 including a needle assembly 100, an outer tube 48, a proximal tube 33, a joining tube 45, a spacer 51, and wire 138. Any of the needle assemblies 100a-e shown and otherwise described herein may be secured as part of a needle electrode assembly such as that illustrated in connection with the needle electrode assembly 46 of FIG.

[0138] The needle electrode assembly 46 may be aligned along the longitudinal axis 10. The spacer 51 may inhibit bodily fluids from entering the needle electrode assembly 46. A portion of the flexible circuit 120 may be positioned within the outer tube 48. The flexible circuit 120 may be configured as any of the flexible circuits 120a-f otherwise described and illustrated herein. An electrode section 136 of the flexible circuit 120 may be secured to the exterior of the outer tube 48 such that the electrode is positioned to enter tissue upon penetration by the needle assembly 100. A wire 138 may extend through the outer tube 48 and may be accessible to a physician or other user during treatment. The wire 138 may be connected to an RF generator, other ablation energy source, a voltmeter, an ohmmeter, an ammeter, and / or other electrical measurement tool.

[0139] 17 is a diagram of an ablation or diagnostic tool. A needle electrode assembly 46 including a needle assembly 100 may be slidably positioned within a protective tube or sheath 47 that is stationary and fixed relative to a catheter 200. The needle electrode assembly 46 may be retracted such that a sharpened end 110 of the needle assembly 100 is retracted within the sheath 47. The sharpened end 110 may be configured as any of the sharpened ends 110a-d otherwise described and shown herein. The catheter 200 may include an infusion lumen 24 in fluid communication with the lumens 106, 146, 176 of the needle assemblies 100, 100a-e.

[0140] The catheter 200 may include a navigational sensor 70. The navigational sensor 70 may be housed within the catheter 200 proximate a distal end of the catheter 200. The navigational sensor 70 may be used to detect movement of the electrodes 136a-z of the needle assembly 100 relative to the distal end of the catheter 200. The navigational sensor 70 may further be used to determine the coordinates of the distal end of the catheter 200. The navigational sensor 70 may be connected to a sensor cable 72. The sensor cable 72 may extend through the lumen 28 of the catheter 200 and may be connected to an electrical measurement tool.

[0141] The catheter 200 may include a tip electrode 32. The tip electrode 32 may include a passageway 56 through which the sheath 47 extends. The tip electrode 32 may be connected to the tube 19 by a plastic housing 34. The tip electrode 32 may be configured to measure electrical signals at a tissue surface. The catheter 200 may further include a ring electrode 38 configured to measure electrophysiology. The tip electrode 32 and the ring electrode 38 may each be connected to a separate lead wire 40. The wire 40 may be connected to an electrical measurement tool.

[0142] The combination of the navigational sensor 70 and the electrodes 32, 38 allows a physician or other user to simultaneously map the contour or shape of the heart chamber, the electrical activity of the chambers, and the degree of displacement of the catheter 200.

[0143] 18 is a flow diagram illustrating a method 300 of treatment using an ablation or diagnostic tool. The method 300 may include one or more of the following steps, which are not presented in any particular order. The exemplary method 300 may include additional steps that will be recognized and understood by one of ordinary skill in the art. The exemplary method may be performed by a physician or other user utilizing the exemplary diagnostic and / or ablation tools including the needle assemblies 100, 100a-e shown and disclosed herein, variations thereof, or variations thereof as will be recognized and understood by one of ordinary skill in the art.

[0144] In step 302, a shielded needle assembly may be delivered to a treatment site. The needle assembly may be a needle assembly 100, 100a-e as illustrated and disclosed herein, variations thereof, or alternatives thereof as would be understood and appreciated by one of ordinary skill in the art. The needle assembly may be shielded within a catheter or other sheath, such as catheter 200 as illustrated and disclosed herein, variations thereof, or alternatives thereof as would be understood and appreciated by one of ordinary skill in the art.

[0145] At step 304, the needle assembly may be exposed. The needle assembly may be exposed by sliding the needle assembly out of an opening in the distal end of a catheter or other sheath. For example, the needle assembly 100, 100a-e may be slid out of an opening 204 in the catheter 200 as shown and disclosed herein, variations thereof, or alternatives thereof as will be recognized and understood by those skilled in the art.

[0146] At step 306, movement of the needle assembly relative to the sheath can be detected. For example, the catheter can include a navigational sensor, such as navigational sensor 70 as illustrated and disclosed herein, variations thereof, or alternatives thereof as will be understood and appreciated by those of skill in the art. The navigational sensor can be configured to detect movement of the needle assembly relative to the navigational sensor. The needle assembly can be configured to move in only one dimension relative to the navigational sensor.

[0147] At step 308, tissue in or around the heart may be lanced with a needle assembly. The needle assembly may include a sharpened end shaped to lance tissue, such as sharpened ends 110, 110a-d as shown and disclosed herein, variations thereof, or alternatives thereof as will be recognized and understood by those of skill in the art.

[0148] At step 310, one or more electrodes insulated from the sharp end of the needle assembly can be moved into the tissue.

[0149] In step 312, one or more electrodes may be used to ablate and / or sense tissue.

[0150] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of ablation and diagnostic tools, including alternative numbers of electrodes, alternative combinations of electrodes, combinations of components shown in separate figures, alternative materials, alternative component shapes, and alternative component arrangements. Variations and modifications that are obvious to those skilled in the art following the teachings of the present disclosure are intended to be within the scope of the following claims.

[0151] [Embodiment] (1) A device for lancing intravascular tissue, the device comprising: a circuit defining an outer surface defining a tubular shape disposed about a longitudinal axis and extending along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit, the circuit comprising: an electrically insulating substrate film; a patterned layer disposed on the substrate film and including conductive traces; an electrically insulating separator film disposed on the patterned layer and including one or more vias therethrough; one or more electrodes disposed on the release film and on the exterior surface of the tubular shape; a sharp end secured proximate to the first end of the tubular shape. (2) The device of embodiment 1, wherein the sharp end is electrically insulated from the one or more electrodes. (3) The device of embodiment 1, further comprising a needle surrounded by and secured to the circuit, the sharp end comprising a tip of the needle, and each of the one or more electrodes being electrically insulated from the needle. (4) the circuit has a tip proximate the first end of the circuit; the sharp end comprises the pointed tip; 2. The device of embodiment 1, wherein the tubular shape comprises sufficient columnar stiffness to lance intravascular tissue. (5) the circuit further comprises a metal sheet under the substrate film; the metal sheet includes a pointed end proximate the first end of the circuit; the sharp edge comprises the pointed end of the metal sheet; the metal sheet is disposed on an inner surface of the tubular shape; the tubular shape comprises the metal sheet; 2. The device of embodiment 1, wherein the tubular shape comprises columnar stiffness sufficient to lance intravascular tissue.

[0152] (6) The device of embodiment 1, wherein at least one of the one or more electrodes each comprises a gold band surrounding the tubular shape. (7) The device of embodiment 1, further comprising a sheath surrounding the circuit and the sharpened end, the circuit and the sharpened end being slidable from and through the sheath to allow the sharpened end to extend therethrough. (8) the circuit further comprises a thermocouple junction positioned in the via; the thermocouple junction includes a portion of a first electrode of the one or more electrodes in contact with a first trace of the conductive traces; the first electrode comprises gold; 2. The device of embodiment 1, wherein the first trace comprises constantan. (9) the circuit further comprises a thermocouple junction present in the patterned layer; the thermocouple junction includes a portion of a second one of the conductive traces and a portion of a third one of the conductive traces; 2. The device of embodiment 1, wherein the portion of the second trace and the portion of the third trace are in electrical contact. (10) The device of embodiment 1, further comprising a navigation sensor positioned to detect movement of one or more of the electrodes.

[0153] (11) a catheter having a distal end; The device of embodiment 10, further comprising a needle assembly comprising the circuit and the sharp end, the needle assembly being translatable in one dimension relative to the navigation sensor, the navigation sensor being fixed adjacent to the distal end of the catheter. (12) The one or more electrodes comprises a plurality of electrodes; each of the electrodes of the plurality of electrodes is electrically connected to a respective one of the conductive traces through a respective one of the vias and configured to measure voltage and / or impedance; 2. The device of any preceding embodiment, wherein the circuitry comprises solder pads each electrically connected to a respective one of the conductive traces. (13) The plurality of electrodes comprises a plurality of ring electrodes, each ring electrode circumferentially surrounds the tubular shape of the circuit; each ring electrode is spaced a predetermined distance from the sharp end; 13. The device of embodiment 12, wherein each ring electrode is insulated from all other ring electrodes of the plurality of electrodes at the outer surface. (14) A system comprising: a circuit defining an outer surface defining a tubular shape disposed about a longitudinal axis and extending along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit, the circuit comprising: an electrically insulating substrate film; a patterned layer disposed on the substrate film and including conductive traces; an electrically insulating separator film disposed on the patterned layer and including one or more vias therethrough; a circuit comprising: a plurality of electrodes disposed on the release film and on the exterior surface of the tubular shape and electrically connected to conductive traces on the patterned layer; a sharpened end secured adjacent to the first end of the tubular shape; a catheter extending distally from the circuit; conductive wires each electrically connected to a respective one of the conductive traces, the conductive wires extending through the catheter; a radio frequency generator electrically connected to at least one of the conductive wires. (15) further comprising an electrical measurement tool electrically connected to a first portion of the plurality of electrodes; 15. The system of embodiment 14, wherein the high frequency generator is electrically connected to a second portion of the plurality of electrodes.

[0154] (16) The system of claim 15, wherein the electrical measurement tool includes one or more of a voltmeter, an ohmmeter, and an ammeter. (17) The system of embodiment 15, wherein the circuit further comprises a thermocouple junction. (18) The system of embodiment 15, further comprising a navigation sensor positioned proximate to the distal end of the catheter. (19) A method of endovascular treatment, comprising: delivering an electrode needle assembly into a blood vessel via a catheter; lancing tissue within or around the heart with the electrode needle assembly; moving a first electrode of the electrode needle assembly to a first depth while moving a second electrode of the electrode needle assembly to a second depth shallower than the first depth within the tissue. (20) The method of embodiment 19, further comprising applying a high frequency electrical signal to at least one of the first electrode and the second electrode.

Claims

1. 1. A device for puncturing intravascular tissue, the device comprising: a circuit defining an outer surface defining a tubular shape disposed about a longitudinal axis and extending along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit, the circuit comprising: an electrically insulating substrate film; a patterned layer disposed on the electrically insulating substrate film and including conductive traces; an electrically insulating separator film disposed on the patterned layer and including one or more vias therethrough; one or more electrodes disposed on the electrically insulating separator film and on the exterior surface of the tubular shape; a sharpened end secured adjacent to the first end of the tubular shape; a needle surrounded by and secured to the circuit, the sharp end including a tip of the needle, and each of the one or more electrodes being electrically insulated from the needle.

2. 1. A device for puncturing intravascular tissue, the device comprising: a circuit defining an outer surface defining a tubular shape disposed about a longitudinal axis and extending along the longitudinal axis from a first end of the circuit to a proximal portion of the circuit, the circuit comprising: an electrically insulating substrate film; a patterned layer disposed on the electrically insulating substrate film and including conductive traces; an electrically insulating separator film disposed on the patterned layer and including one or more vias therethrough; one or more electrodes disposed on the electrically insulating separator film and on the exterior surface of the tubular shape; a sharpened end secured adjacent to the first end of the tubular shape; a metal sheet beneath the electrically insulating substrate film, the metal sheet including a pointed end proximate the first end of the circuit, the sharp end comprising the pointed end of the metal sheet, the metal sheet disposed on an inner surface of the tubular shape and formed into a tubular shape, the circuit having sufficient columnar stiffness to puncture intravascular tissue.

3. The device of claim 1 , wherein the one or more electrodes are physically spaced from the sharp end and the surface of the needle.

4. The device of claim 2 , wherein the metal sheet includes a plurality of perforations.

5. The device of claim 1 or 2, wherein the sharp end is electrically insulated from the one or more electrodes.

6. The device of claim 1 or 2, wherein at least one of the one or more electrodes comprises a gold band that respectively circumscribes the tubular shape.

7. 3. The device of claim 1 or 2, further comprising a sheath surrounding the circuit and the sharpened end, the circuit and the sharpened end being slidable through the sheath to extend the sharpened end from the sheath.

8. the circuit further comprising a thermocouple junction positioned in the via; the thermocouple junction includes a portion of a first electrode of the one or more electrodes in contact with a first trace of the conductive traces; the first electrode comprises gold; The device of claim 1 or 2, wherein the first trace comprises constantan.

9. the circuit further comprising a thermocouple junction present in the patterned layer; the thermocouple junction includes a portion of a second one of the conductive traces and a portion of a third one of the conductive traces; The device of claim 1 or 2, wherein the portion of the second trace and the portion of the third trace are in electrical contact.

10. The device of claim 1 or 2, further comprising a navigation sensor positioned to detect movement of the one or more electrodes.

11. a catheter having a distal end; The device of claim 10 , wherein the circuitry and sharp end are translatable in one dimension relative to the navigation sensor, the navigation sensor being fixed proximate the distal end of the catheter.

12. the one or more electrodes comprises a plurality of electrodes; each of the plurality of electrodes is electrically connected to a respective one of the conductive traces through a respective one of the vias and configured to measure voltage and / or impedance; 3. The device of claim 1, wherein the circuitry comprises solder pads each electrically connected to a respective one of the conductive traces.

13. the plurality of electrodes comprises a plurality of ring electrodes; each said ring electrode circumferentially surrounds said tubular shape of said circuit; each said ring electrode being spaced a predetermined distance from said sharp end; The device of claim 12 , wherein each ring electrode is insulated from all other ring electrodes of the plurality of electrodes at the outer surface.

14. 1. A system comprising: A device according to claim 1 or 2; an outer tube to which the device is secured such that a proximal portion of the circuit is positioned within the outer tube and a distal portion of the circuit and the sharp end are positioned outside of the outer tube; a conductive wire electrically connected to each of the conductive traces, the conductive wires extending through the outer tube; a radio frequency generator electrically connected to at least one of the conductive wires.

15. and an electrical measurement tool electrically connected to a first portion of the one or more electrodes. The system of claim 14 , wherein the radio frequency generator is electrically connected to a second portion of the one or more electrodes.

16. The system of claim 15 , wherein the electrical measurement tool comprises one or more of a voltmeter, an ohmmeter, and an ammeter.

17. The system of claim 15 , wherein the circuit further comprises a thermocouple junction.

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