Two-sided encapsulated planar catheter with encapsulation polymer

Abstract

An end effector for a cardiac mapping catheter, the end effector comprising a flexible circuit comprising a plurality of electrodes, each electrode of the plurality of electrodes comprising a contact surface. The flexible circuit may be disposed on an insulating material. The insulating material may abut the contact surface such that only the contact surface of at least a portion of the plurality of electrodes is exposed to an ambient environment.

Description

[0001] This application claims priority to U.S. patent application No. 63 / 516,196 (Agent Docket No. 253757.000421 (BIO6876USPSP1)) previously filed on July 28, 2023, which is hereby incorporated by reference in its entirety. Technical Field

[0002] The present invention relates generally to minimally invasive medical devices, and in particular to sensing catheters, and further, but not exclusively, to cardiac mapping catheters and their manufacture. Background Art

[0003] Arrhythmias such as atrial fibrillation occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue, disrupting the normal cardiac cycle and causing an irregular heartbeat. The source of the unwanted signals can be located in the tissue of the atria or ventricles. The unwanted signals are conducted through cardiac tissue to other locations where they can initiate or perpetuate the arrhythmia.

[0004] Procedures used to treat cardiac arrhythmias involve surgically disrupting the source of the signals that cause the arrhythmia, as well as disrupting the conduction pathways used for such signals. Recently, it has been discovered that by mapping the electrical properties of the endocardium and cardiac volumes, and selectively ablating cardiac tissue by applying energy, it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. Ablation methods destroy unwanted electrical pathways by creating non-conductive lesions.

[0005] In this two-step procedure (which includes mapping and ablation), electrical activity at various points in the heart is sensed and measured, typically by advancing a catheter containing one or more electrical sensors into the heart and acquiring data at multiple points. This data is then used to select a target area to be ablated.

[0006] In order to obtain higher mapping resolution, it is expected that the mapping catheter can fit closely with the target anatomical structure. For mapping within the atria or ventricles (e.g., the apex of the ventricle), it is expected that the catheter can collect a larger amount of data signals in a shorter time span. It is also expected that such catheters can allow electrodes to fully contact different tissue surfaces, for example, flat, curved, irregular or non-planar surface tissues, and can be retracted to be non-invasively advanced and withdrawn through the patient's vascular system. Existing catheters generally require hard internal structural components to ensure that a predetermined configuration is maintained. However, this hardness is disadvantageous when operating within human organs because it prevents the electrodes from contacting the tissue.

[0007] Other catheters may include flexible end effectors designed to overcome this disadvantage. These catheters may include layered components that are time-consuming, complex, and expensive to manufacture and assemble. Many times, the electrode contact surfaces of these end effectors must be exposed via laser cutting or mechanical removal through the packaging material, both of which increase labor time and production costs. Summary of the invention

[0008] In order to achieve time- and cost-effective manufacturing of end effectors that enhance the functionality of the mapping and ablation catheters mentioned in the background technology section, the present disclosure relates to easy-to-manufacture end effectors, as well as fixation devices and methods for manufacturing the end effectors having enhanced aspects of mapping and ablation catheter performance (including but not limited to mapping resolution, contact of electrodes with target anatomical structures, delivery of end effectors to target anatomical structures, biocompatibility, end effector stiffness and non-traumaticity).

[0009] According to one embodiment of the present invention, an end effector is provided. The end effector may include a flexible circuit, the flexible circuit including a plurality of electrodes, each of the plurality of electrodes including a contact surface. The flexible circuit may be disposed on an insulating material. The insulating material may be adjacent to the contact surface such that only the contact surface of at least a portion of the plurality of electrodes is exposed to the surrounding environment.

[0010] The disclosed technology includes a method of manufacturing an end effector for a medical catheter. The method may include: placing a flexible circuit including a plurality of electrodes in a mold, each of the plurality of electrodes including a contact surface; placing a sheet of insulating material in contact with the flexible circuit; and molding the flexible circuit and the insulating material so that the insulating material flows at least partially around the flexible circuit into abutment with the contact surface, so that only the contact surface of at least a portion of the electrodes in the plurality of electrodes is exposed to the surrounding environment.

[0011] The disclosed technology includes a fixture for forming an end effector for a package of a medical catheter. The fixture may include a plurality of components stacked approximately in parallel along a vertical axis of the fixture. The plurality of components may include: a first compression surface; a second compression surface, the second compression surface being arranged opposite to the first compression surface and being configured to translate from an expanded configuration to a compressed configuration relative to the first compression surface along the vertical axis; and a first flexible heat-resistant sheet, the first flexible heat-resistant sheet being arranged adjacent to the first compression surface and having a hardness such that when compression is applied to the first compression surface and the second compression surface, contact surfaces of a first plurality of electrodes extending from a first flexible circuit protrude a first distance into the first flexible heat-resistant sheet. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1is a schematic pictorial illustration of a medical system including a planar catheter according to an embodiment of the present invention;

[0013] Figure 2 is an illustration of a perspective view of an end effector according to an embodiment of the present invention;

[0014] Figure 3 yes Figure 2 an exploded perspective view of an end effector;

[0015] Figure 4A is an illustration of a cross-section of an end effector according to an embodiment of the present invention;

[0016] Figure 4B is an illustration of a cross-section of an end effector according to an embodiment of the present invention;

[0017] Figure 4B1 yes Figure 4B A variation in which the frame is not encapsulated into the insulating material but is contiguous thereto;

[0018] Figure 4C is an illustration of a cross-section of an end effector according to an embodiment of the present invention;

[0019] Figure 5A is an illustration of a cross-section of a fixture for making an end effector according to an embodiment of the present invention;

[0020] Figure 5B is a detailed view of a cross section of a fixture for making an end effector according to an embodiment of the present invention;

[0021] Figure 5C is a detailed view of a cross section of a fixture for making an end effector according to an embodiment of the present invention;

[0022] Fig. 6A is an illustration of a cross-section of a fixture for making an end effector according to an embodiment of the present invention;

[0023] Figure 6B is a detailed view of a cross section of a fixture for making an end effector according to an embodiment of the present invention;

[0024] Figure 6C is a detailed view of a cross section of a fixture for making an end effector according to an embodiment of the present invention;

[0025] Fig.6D shows a cross-sectional view of an end effector removed from a fixture showing an electrode contact surface flush with an insulating substrate, according to an embodiment of the present invention;

[0026] Fig. 6E and Fig. 6F An alternative embodiment to that according to the invention is shown, in which the electrode contact surface need not be flush with the insulating surface and may be variable;

[0027] Fig. 7A is an illustration of a perspective view of a fixture for making an end effector according to an embodiment of the present invention;

[0028] Figure 7B is an illustration of a perspective view of a fixture for making an end effector according to an embodiment of the present invention;

[0029] Figure 8 is an illustration of a catheter assembly according to an embodiment of the present invention;

[0030] Fig.9A is a flow chart of a method of manufacturing an end effector for a medical catheter according to an example of the present invention; and

[0031] Fig. 9B is a flow chart of a method of manufacturing an end effector for a medical catheter according to an example of the present invention. DETAILED DESCRIPTION

[0032] The following specific embodiments should be read in conjunction with the accompanying drawings, wherein the same elements are labeled the same in different drawings. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including the best modes currently believed to be implemented in the invention.

[0033] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0034] As discussed herein, references to a "patient," "recipient," "user," and "subject" tissue, vasculature, or organ may be references to a human or any animal tissue, vasculature, or organ. It should be understood that the animal may be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal may be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject may be, for example, any suitable human patient.

[0035] As discussed herein, a "physician" may include a doctor, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0036] As discussed herein, the term "ablation" when referring to the devices and corresponding systems of the present disclosure refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells. For example, by utilizing thermal energy such as radiofrequency (RF) ablation, or non-thermal energy such as irreversible electroporation (IRE), IRE may be interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA) throughout this disclosure. "Ablation" as used throughout this disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to thermal ablation or non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

[0037] As discussed herein, the terms "tubular" and "tube" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross-section or a uniform cross-section throughout their length. For example, tubular structures are often illustrated as structures that are substantially perfect cylinders. However, tubular structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0038] The present disclosure relates to systems, methods or uses and devices for mapping and ablating cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at the distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0039] Ablation of cardiac tissue to correct a malfunctioning heart using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations of the myocardium. In addition, temperature measurements during ablation provide data that can achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods may have the risk of causing tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0040] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout the present disclosure, IRE may be referred to interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. In order to ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. Biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, in order to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells in the treatment area indiscriminately. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0041] refer to Figure 1 , which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are inserted into the chambers or vascular structures of the heart 12 by a physician 24 through the vascular system of a patient 23 through the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, multiple catheters can be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An example catheter 14 constructed for sensing IEGM is shown herein. The physician 24 brings the catheter shaft 90 having the distal end of the catheter 14 (i.e., the multi-layer end effector 100) into contact with the heart wall for sensing a target site in the heart 12. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0042] The catheter 14 is an exemplary catheter including one and preferably a plurality of electrodes 26, optionally distributed over the end effector 100, coupled to the catheter shaft 90 and configured to sense IEGM signals, as described in more detail below. The catheter 14 may further include a position sensor (e.g., a position sensor embedded in or near the end effector 100) for tracking the position and orientation of the end effector 100. Figure 1 Optionally and preferably, the position sensor is a magnetic-based position sensor comprising a plurality of magnetic coils for sensing three-dimensional (3D) position and orientation.

[0043] The magnetic-based position sensor can operate with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the end effector 100 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patents 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, 6,892,091, each of which is incorporated herein by reference.

[0044] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0045] Recorder 11 displays electrograms 21 captured using surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0046] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more of the electrodes 26 at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0047] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0048] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (5) displaying on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTO TM 3 System was purchased from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0049] Figure 2An end effector 100 according to an embodiment of the present disclosure is provided to achieve ease of manufacturing, reduced cost, and enhanced end effector characteristics, such as desired stiffness, mapping resolution, electrode contact with target anatomical structures, and conformity of the end effector disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found in target anatomical structures. The end effector 100 may include a flexible circuit 110, the flexible circuit including a plurality of electrodes 112, each of the plurality of electrodes 112 including a contact surface 112c. As used herein, the term "flexible circuit" includes thin film circuits, flexible printed circuit boards, printed circuit boards, printed circuit boards, and printed circuit boards fabricated via photolithography and etching processes on a substrate such as polyimide, copper, LCP (e.g., Panasonic FELIOS TM SERIES flexible circuit board) substrate, Nitinol substrate or directly on a polymer substrate such as Panasonic BEYOLEX TM PRINTED ELECTRONICS SUBSTRATE Series, as shown and described in the attached technical references incorporated herein by appendix. In some examples, the flexible circuits described herein may be made primarily of polyimide. In other examples, they may be made of any of biocompatible polyimide, glass reinforced epoxy laminate, copper or graphene, alone or in combination. The first flexible circuit 110 and the second flexible circuit 140 may include conductive traces formed directly on a polymer substrate, wherein the electrodes include a substantially thicker trace form, such that a typical polyimide substrate is no longer required. In some examples, the electrodes described herein may include at least one mapping electrode and / or at least one ablation electrode, and may be configured to detect electrophysiological signals or transmit ablation energy AC or DC from an energy generator to tissue according to the various ablation methods previously described (e.g., RF, IRE, etc.).

[0050] The flexible circuit 110 may be disposed on the insulating material 120. The insulating material 120 may be adjacent to the contact surface 112c such that only the contact surface 112c of at least a portion of the plurality of electrodes 112 is exposed to the surrounding environment. As used herein, the term "contact surface" includes a portion of an electrode having a generally flat surface and one or more edges immediately surrounding the flat surface. When the end effector 100 is placed against tissue, the electrode 112 may have slightly rounded, filleted, or chamfered edges and a generally flat surface that contact the tissue. As used herein, "surrounding environment" refers to the external environment, such as an organ in which the end effector 100 is deployed or an organ in an operating room prior to deployment in a biological organ.

[0051] It should be noted that not all electrodes on the end effector 100 described herein need to be exposed through the insulating material 120, as these unexposed electrodes can be used to sense far-field signals for noise reduction near the tissue contacting electrodes. Similarly, for the entire end effector having a reference electrode that is not in contact with the tissue but only in contact with the blood, far-field signals including noise or artifacts can be reduced or eliminated. Flushing can be provided using a flushing port 163a on one side and a flushing port 162b on the other side that are in fluid communication with an unshown flushing line disposed in the catheter shaft 90. Instead of a flushing line separated from the catheter shaft 90, an inner cavity can be formed by extruding the catheter shaft 90 to provide an inner cavity channel. It should be noted that the port 163a or 162b can be configured to have sufficient flow diverter characteristics to allow the flushing fluid to cover the mapping electrode during the flushing flow in order to prevent or reduce thrombosis.

[0052] The flexible circuit 110 may also include a frame 130 adjacent to or within the insulating material. In examples where the flexible circuit 110 includes the frame 130, the frame 130 may be disposed directly on the flexible circuit 110 with no or very little insulating material 120 therebetween.

[0053] In other words, one aspect of the present disclosure provides an end actuator 100 having a planar frame 130 that bisects two flat heat-formed portions 120a, 120b of a flexible insulating block 120, wherein at least one flexible circuit 110 is disposed on one side of the frame 130, and wherein a contact surface 112c of an electrode 112 extends up to or slightly beyond the outside of the flexible insulating block 120.

[0054] Figure 3 An exploded view of the end effector 100 is shown, with its components exploded vertically along a vertical axis VV. The flexible circuit 110 can be a first flexible circuit 110, and the plurality of electrodes 112 can be a first plurality of electrodes 112, wherein each first electrode 112 includes a first contact surface 112c. The end effector 100 can also include a second flexible circuit 140 having a second plurality of electrodes 142. The first flexible circuit 110 can be spaced apart from the second flexible circuit 140, and each electrode of the second plurality of electrodes 142 can have a second contact surface 142c.

[0055] In an example having a first flexible circuit 110 and a second flexible circuit 140, an insulating material 120 may be disposed between the first flexible circuit 110 and the second flexible circuit 140, and the insulating material 120 may be adjacent to the second contact surface 142c such that only the contact surface 142c of each second electrode 142 is exposed to the surrounding environment, and the first electrode 112 is disposed in the insulating material and exposed through the insulating material in a similar manner.

[0056] Electrodes 112, 142 can sense tissue signals or transmit energy AC or DC from an energy generator to tissue. In some examples, there are about 92 electrodes. In some examples, there are about 48 electrodes. In some examples, there are about 64 electrodes. In some examples, there are about 72 electrodes. In some examples, there are about 98 electrodes. Details of the spacing relationship between each pair of electrodes and the discrete set of electrode pairs can be found in U.S. Provisional Patent Application SN63 / 406,673 (Agent Docket No. BIO6749USPSP3) filed on September 14, 2022, and are included in the Appendix for reference.

[0057] In an example, the end effector 100 includes a frame 130 disposed between a first flexible circuit 110 and a second flexible circuit 140 .

[0058] The frame 130 may be a component of the end effector 100 that is separate and distinct from the first flexible circuit 110 and disposed proximate to the first flexible circuit 110. In this case, the insulating material 120 may be further disposed between the frame 130 and the second flexible circuit 140. The frame 130 may be formed from a planar or cylindrical raw material using any suitable method. For example, the frame 130 may be formed by cutting, laser cutting, stamping, etc.

[0059] The insulating material 120 may include a first sheet of insulating material 120a and a second sheet of insulating material 120b that are fused together near the frame 130 into a single, contiguous, generally planar insulating block 120. The insulating material 120 also serves to enhance the atraumatic nature of the end effector 100 and protect the subject from sharp edges. The insulating material 120 may include a polymer. As described later with respect to Fig.9A and Fig. 9B As discussed, the insulating material 120 may be thermoformed around the frame 130 and at least a portion of the first and second flexible circuits 110, 140. The polymer may include thermoplastic polyurethane (TPU) or other thermoforming or shaping material suitable for such thermoforming.

[0060] In addition, although the insulating material 120 is shown as flat in these figures, the insulating material 120 can be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured so that the overall profile of the insulating material 120 produces the physical and / or mechanical properties required by the end actuator 100 as mentioned above, such as rigidity and deflection along multiple axes.

[0061] Figure 4A It shows that Figure 3The first contact surface 112c is substantially parallel to the first outer surface 122a of the insulating block 120. The first plurality of electrodes 112 extend vertically and outwardly from the first outer surface by a first distance D1. Similarly, the second contact surface 142c may be substantially parallel to the second outer surface 122b of the insulating block 120 and extend vertically and outwardly from the second outer surface by a second distance D2. As will be described later with respect to FIG. 5A to FIG. 7B and FIG. 9A to FIG. 9B As discussed with reference to the illustrated fixture 500 , the first distance D1 and the second distance D2 may be determined by aspects of the fixture 500 and / or the method 900 .

[0062] Figure 4B 1 shows a similar cross section, but from an example end effector 100 without the second flexible circuit 140. That is, with the electrodes on the opposite side Figure 4A Compared with the end effector (or double-sided end effector), Figure 4B The end effector in has an electrode on only one side (single-sided end effector). Figure 4B1 Shows Figure 4B A variation in which the frame 130 is not encapsulated in the insulating material but is disposed outside the insulating material 120.

[0063] Figure 4C Shows something like Figure 4A 1, but from an example end effector 100 without the frame 130. It should be noted that while the frame 130 is shown as a rectangle in cross-section, the frame 130 is not limited to such a cross-section and any suitable cross-section may be utilized.

[0064] Importantly, an end effector 100 having flush or outwardly protruding electrode contact surfaces 112c, 142c may be manufactured via the methods and / or fixtures described in greater detail below without requiring removal of material in order to expose the electrode contact surfaces 112c, 142c.

[0065] In other examples, the first contact surface 112 c may lie substantially coplanar with the first outer surface 122 a of the insulating block 120 , and the second contact surface 142 c may lie coplanar with the second outer surface 122 b of the insulating block 120 .

[0066] FIG. 5A to FIG. 6A An end effector for forming a package for a medical catheter such as Figures 2 to 4C It should be noted that the fixing device 500 is formed as a component of the end effector 100. Figure 5A The sorting in is similar to Figure 3When in the expanded configuration 500a, the first compression surface 510, the second compression surface 520, and the sidewall 550 are configured to accommodate therebetween: the first flexible circuit 110, the first insulating material sheet 120a, the frame 130, the second insulating material sheet 120b, and the second flexible circuit 140.

[0067] Fixture 500 may include a plurality of components stacked substantially in parallel. The plurality of components may include a first compression surface 510 and a second compression surface 520 disposed opposite to first compression surface 510 and configured to translate vertically from an expanded configuration 500a to a compressed configuration 500b relative to first compression surface 510.

[0068] The fixture 500 may include a first flexible heat-resistant sheet 530 disposed proximate to the first compression surface 510 .

[0069] exist Figure 5B In the detail shown, the electrode 112 does not protrude into the first flexible heat-resistant sheet 530 because the first compression surface 510 and the second compression surface 520 are not compressed toward each other, ie, the fixture 500 is in the expanded configuration 500a.

[0070] The plurality of components may further include a second flexible heat-resistant sheet 540 similar to the first flexible heat-resistant sheet 530. The second flexible heat-resistant sheet 540 may be disposed proximate to the second compression surface 520.

[0071] exist FIG. 5A to FIG. 5C , the first insulating material sheet 120a and the second insulating material sheet 120b are substantially flat because they have not been molded. Similar to the masking process, the first flexible heat-resistant sheet 530 covers the contact surface 112c of the electrode 112. After molding, when the contact surface 112c is no longer compressed into the first flexible heat-resistant sheet 530, the contact surface 112c is exposed to the surrounding environment, while the rest of the end effector 100 is encapsulated in the material 120. As used herein, the term "molding" includes molding using heat, molding using pressure, or molding using both heat and pressure.

[0072] In brief, the fixture 500 is a mold having at least one flexible portion 540 configured to allow the electrode contact surface 112c to protrude into the flexible portion 540 so that the electrode contact surface 112c is not covered by the insulating material sandwiched between the compression plates 510, 520 and over the components of the end effector 100 including at least the first flexible circuit 110, and may include a portion of the electrode 112. The fixture 500 may also include another flexible portion 540 that provides the same function for the second electrode contact surface 142c of the second flexible circuit 140.

[0073] Fig. 6A The compressed configuration 500b is shown. The first compression surface 510 is configured to cause the first insulating material sheet 120a to flow at least partially around the frame 130 and the first flexible circuit 110 to extend until approximately in front of the contact surface 112c of the first plurality of electrodes 112 when in the compressed configuration 500b. The sidewall 550 is configured to constrain the first compression surface 510 when the fixture 500 translates from the expanded configuration 500a to the compressed configuration 500b. Figure 6B As seen in the detailed view shown, the first flexible heat-resistant sheet 530 may have a hardness such that when compression is applied to the first compression surface 510 and the second compression surface 520, the contact surface 112c of the first plurality of electrodes 112 extending from the first flexible circuit 110 protrudes into the first flexible heat-resistant sheet 530 by a first distance D1. Figure 6C In the embodiment, the second flexible heat-resistant sheet 540 may have a hardness such that when compression is applied, the contact surfaces 142c of the second plurality of electrodes 142 extending from the second flexible circuit 140 protrude into the second flexible heat-resistant sheet 540 by a second distance D2.

[0074] Compared to FIG. 5A to FIG. 5C , FIG. 6A to FIG. 6C The first and second insulating material sheets 120a, 120b are shown as having been molded and are therefore no longer flat but form a packaged block of material 120, wherein the first and second sheets are not necessarily distinguishable from one another. Note that while the top electrodes 112 and 142 are shown separately, alternative embodiments may have the flexible printed circuit substrate 110 as part of the top electrode 112 and the flexible printed circuit substrate 140 as part of the bottom electrode 142 ( Figure 5B and Figure 5C ).

[0075] Although the first compression surface 510 and the second compression surface 520 are shown in the figures as being generally flat, the surfaces 510, 520 may be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured so that the overall profile of the encapsulation block 120 produces the physical and / or mechanical properties required of the end actuator 100 mentioned above, such as rigidity and deflection along multiple axes.

[0076] In other words, the first compression surface 510 and the second compression surface 520 can be configured to cause the first insulating material sheet 120a and the second insulating material sheet 120b to melt near the frame 130 and flow at least partially around the frame 130 when in the compression configuration 500b, and the first flexible circuit 110 and the second flexible circuit 140 extend until approximately before the contact surface 112c of the first plurality of electrodes 112 and the contact surface of the second plurality of electrodes 142.

[0077] In some examples, the first distance D1 may be equal to the second distance D2. In some examples, the first distance D1 may be approximately equal to 5 microns. The second distance D2 may be approximately equal to 5 microns.

[0078] In an example where the fixture 500 does not include the heat-resistant sheets 530, 520, the electrode contact surfaces 112c, 142c may be placed in direct contact with the first compression surface 510 and the second compression surface 520. This results in the first contact surface 112c being substantially coplanar with the first outer surface 122a of the insulating block 120, and the second contact surface 142c being coplanar with the second outer surface 122b of the insulating block 120.

[0079] The fixture 500 may also include a heating element (not shown) configured to apply heat to the first and second insulating material sheets 120a, 120b so as to thermally form them into the contiguous block 120 discussed above. As previously mentioned, a thermoplastic elastomer such as TPU may be used. Although the first and second insulating material sheets 120a, 120b are melted into the contiguous block 120, the block 120 need not be homogeneous. The characteristics of the final end effector 100 produced using the fixture 500 may be changed based on the compositional differences between the first and second insulating material sheets 120a, 120b or preventing additives therebetween and / or on the fixture 500.

[0080] The first flexible heat-resistant sheet 530 and the second flexible heat-resistant sheet 540 may be made of a material having properties that enable them to remain stable at temperatures that cause the insulating material 120 to melt / flow. In addition, the heat-resistant sheets 530, 520 may include material properties that facilitate easy release from the fixture 500. The fixture 500 may be configured to facilitate easy replacement of the heat-resistant sheets 530, 520, as they may be subject to more wear than other components of the fixture 500.

[0081] refer to Fig. 6A , heat or pressure (indicated by the symbol "F") is applied, and the insulating materials 120a and 120b begin to fuse together into a single material 120 that flows around the electrodes 112 and 142. When the top compression surface 510 and the bottom compression surface 520 are brought together and make contact on the corresponding top electrode 112 and bottom electrode 142, the insulating material 120 cannot flow around the electrode contact surfaces 112c and 142c. That is, the insulating material 120 cannot extend beyond the boundaries defined by the top compression surface 510 and the bottom compression surface 520. Fig.6D, where the insulating material 120 is now flush with the contact surface 112c (of the top electrode 112) and flush with the contact surface 142c of the bottom electrode 142. Although the preferred embodiment has the electrode contact surface 112c or 142c flush with the insulating surface 121a or 121b, in some applications the contact surface need not be as flush. Fig. 6E and Fig. 6F As shown, the electrodes 114 may be flush with each other, wherein the electrodes 114 may protrude at different levels (such as Fig. 6E The low protrusion for the electrode 113 and the high protrusion for the electrode 114) protrude beyond the insulating surface 121a. Fig. 6E , different levels of protrusion are defined by compression members 510 ′ and 520 ′ having dimples 512 and 514 .

[0082] In applications where the electrode contact surface will extend beyond the plane 121a or 121b defined by the insulating material 120, the top compression surface 510' and the bottom compression surface 520' may be provided with openings 512 and 514 that fit directly into the recesses of the corresponding electrodes so that the electrodes 112 and 142 will protrude above the top surface 121a and the bottom surface 121b of the insulating material 120 by a predetermined distance, as shown in FIG. Fig. 6E As shown. Fig. 6E As can be seen in the figures, by varying the openings of the mating recesses in the compression surfaces 510' and 520', different protrusion heights can be achieved so that the electrode 114 extends to the uppermost position above the top surface 121a of the insulating material 120. Similarly, the recess 514 of the compression plate 520' will allow the protrusion of the electrode 142 to extend further than the top or bottom surface 121a or 121b of the insulating material 120.

[0083] Fig. 6F Yet another embodiment within the scope of the present invention is shown, where the electrode contact surface may be deeply recessed below the top or bottom surface 121a, such as shown by electrode 112; flush with the top or bottom surface 121a, such as in electrode 113; protrude beyond the top surface 121a and electrode 113 is flush with the top surface 121a. Although the top and bottom surfaces 121a and 121b are shown as flat or planar surfaces, it is within the scope of the present invention that the top and bottom surfaces of the insulating material 120 do not have to be flat or planar, and may include compound curved or curved surfaces, depending on the actual geometry of the compression surface 511 of the plate 510. In all of these examples, it should be mentioned that the contact surface of the electrode is not limited to its top surface, but any surface of the electrode that is not covered by the insulating material.

[0084] Fig. 7AA perspective view of a first compression surface 510 is shown, configured as a cap having a lip that acts as a stop to prevent compression beyond compression configuration 500b.

[0085] Figure 7B A perspective view of a fixture 500 with a completed end effector therein is shown. In this figure, there is a Teflon sheet 502 configured to allow release of the completed end effector, however, a liquid, spray or powdered release agent may be used.

[0086] The fixture 500 may include notches, dovetails, keys, injection / exhaust ports, frames, plates, clamps, and other components used in molds as understood by those skilled in the relevant art.

[0087] The present disclosure provides Figure 8 The catheter assembly 200 shown may include a tubular member 230 extending along the longitudinal axis LL and configured to deliver the end effector 100 outside the sheath 210. The physician 24 can manipulate the catheter 200 using the handle 220. Suitable examples of the catheter assembly 200 and its subcomponents such as the handle 220, the sheath 210, the tubular member 230, and other components not mentioned herein are described in U.S. Patent Publication No. 2021 / 0369339, which is incorporated herein by reference and included in the attached appendix.

[0088] FIG. 9A to FIG. 9B A method 900 of manufacturing an end effector for a medical catheter is shown. In some examples, the method 900 can be implemented using the fixture 500, and the end effector 100 as described above and all of their components and subcomponents can be manufactured.

[0089] like Fig.9A As shown, method 900 may include: placing 902 a flexible circuit including a plurality of electrodes in a mold; placing 904 a sheet of insulating material in contact with the flexible circuit; and molding 912 the flexible circuit and the insulating material so that the insulating material flows at least partially around the flexible circuit to be adjacent to the contact surface, so that only the contact surfaces of at least a portion of the electrodes in the plurality of electrodes are exposed to the surrounding environment.

[0090] The method 900 may also include, prior to molding: placing 906a a second sheet of insulating material in contact with the first flexible circuit or the sheet of insulating material; placing 908a a second flexible circuit on the second sheet of insulating material opposite the first flexible circuit, the second flexible circuit comprising a second plurality of electrodes and each of the plurality of electrodes comprising a second contact surface. The method 900 may also include placing 910a a second molding surface in contact with the second contact surfaces of the second plurality of electrodes. The method may include molding 914a the second flexible circuit and the second insulating material so that the second insulating material flows at least partially around the second flexible circuit, the insulating material extending until approximately in front of the second contact surface.

[0091] Molding 912 the first sheet of insulating material and molding 914a the second sheet of insulating material may include applying heat to the first sheet of insulating material and the second sheet of insulating material, such as by the previously mentioned heating element of the fixture 500. Applying heat may include heating the first sheet of insulating material and heating the second sheet of insulating material to approximately 400 degrees Fahrenheit, which is sufficient to cause the TPU to flow within the fixture 500. As one skilled in the art will appreciate, the target temperature for heating the insulating material may vary depending on the particular material.

[0092] Molding 912 the first sheet of insulating material and molding 914a the second sheet of insulating material may include melting the first sheet of insulating material to the second sheet of insulating material proximate the first flexible circuit and the second flexible circuit. This may create an abutment block 120. Molding 912 the first sheet of insulating material and molding 914a the second sheet of insulating material may include applying heat and compression to the first contact surface of the first plurality of electrodes and the second contact surface of the second plurality of electrodes, such as by the first compression surface 510 and the second compression surface 520 of the fixture 500.

[0093] like Fig. 9B As shown, method 900 may include: placing 902 a flexible circuit including a plurality of electrodes in a mold; placing 904 a sheet of insulating material in contact with the flexible circuit; placing 905 a frame in contact with the sheet of insulating material; and molding 912 the flexible circuit and insulating material so that the insulating material flows at least partially around the flexible circuit and the frame to be adjacent to the contact surface, so that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the surrounding environment.

[0094] The method 900 may also include, prior to molding: placing 906b a second sheet of insulating material in contact with the frame; placing 908b a second flexible circuit on the second sheet of insulating material opposite the frame, the second flexible circuit comprising a second plurality of electrodes and each of the plurality of electrodes comprising a second contact surface. The method 900 may also include placing 910b a second molding surface in contact with the second contact surfaces of the second plurality of electrodes. The method may include molding 914b the second flexible circuit, the second insulating material, and the frame so that the second insulating material flows around the frame and at least partially around the second flexible circuit, the insulating material extending until approximately in front of the second contact surface.

[0095] Molding 912 the first sheet of insulating material and molding 914b the second sheet of insulating material may include applying heat to the first sheet of insulating material and the second sheet of insulating material, such as by the previously mentioned heating element of the fixture 500. Applying heat may include heating the first sheet of insulating material and heating the second sheet of insulating material to approximately 400 degrees Fahrenheit, which is sufficient to cause the TPU to flow within the fixture 500. As one skilled in the art will appreciate, the target temperature for heating the insulating material may vary depending on the particular material.

[0096] Molding 912 the first sheet of insulating material and molding 914b the second sheet of insulating material may include melting the first sheet of insulating material to the second sheet of insulating material near the frame. This may create abutment block 120. Molding 912 the first sheet of insulating material and molding 914b the second sheet of insulating material may include applying heat and compression to the first contact surface of the first plurality of electrodes and the second contact surface of the second plurality of electrodes, such as by first compression surface 510 and second compression surface 520 of fixture 500.

[0097] In other words, the process 900 for making an end effector includes protecting the electrode contact surface by allowing it to extrude into a flexible sheet and then molding a flexible insulating material over the components of the end effector, such as a flexible circuit having electrodes disposed thereon and a frame.

[0098] It should be understood that the method 900 just described may include more or fewer steps or features than those described. In addition, these steps or features may be performed in different orders and should not be interpreted as requiring execution in any particular order.

[0099] The disclosed technology described herein can be further understood according to the following terms:

[0100] Item 1: An end actuator comprising: a flexible circuit, the flexible circuit comprising a plurality of electrodes, the flexible circuit being disposed on an insulating material, and each of the plurality of electrodes comprising a contact surface; and the insulating material, the insulating material being adjacent to the contact surface such that only the contact surface of at least a portion of the plurality of electrodes is exposed to the surrounding environment.

[0101] Item 2: According to the end actuator described in Item 1, the flexible circuit also includes a frame, the frame is adjacent to the insulating material, or a portion of the frame is encapsulated in the insulating material, and wherein the contact surface of the electrode includes an area of ​​the contact electrode that is not covered by the insulating material.

[0102] Item 3: According to the end actuator described in Item 1, the flexible circuit includes a first flexible circuit, and the plurality of electrodes include a first plurality of electrodes, each of the first plurality of electrodes includes a first contact surface, and the end actuator also includes: a second flexible circuit, the second flexible circuit includes a second plurality of electrodes, the second flexible circuit is separated from the first flexible circuit, and each electrode of the second plurality of electrodes includes a second contact surface, the insulating material is further arranged between the first flexible circuit and the second flexible circuit, the insulating material is adjacent to the second contact surface, so that only the contact surface of each electrode is exposed to the surrounding environment.

[0103] Clause 4: The end effector of clause 3, further comprising a frame disposed between the first flexible circuit and the second flexible circuit.

[0104] Clause 5: The end effector of any of clauses 3 to 4, wherein the insulating material is heat formed around the frame and at least a portion of the first and second flexible circuits.

[0105] Item 6: According to the end actuator described in Item 1, the flexible circuit includes a first flexible circuit, and the plurality of electrodes include a first plurality of electrodes, each of the first plurality of electrodes includes a first contact surface, and the end actuator also includes: a frame, the frame is arranged to be close to the first flexible circuit; a second flexible circuit, the second flexible circuit includes a second plurality of electrodes, the second flexible circuit is spaced apart from the frame on a side of the frame opposite to the first flexible circuit, and each electrode of the second plurality of electrodes includes a second contact surface, the insulating material is further arranged between the frame and the second flexible circuit, and the insulating material is thermally formed around at least a portion of the second flexible circuit and the frame.

[0106] Clause 7: The end effector according to any one of clauses 2 to 6, wherein the insulating material comprises a first sheet of insulating material and a second sheet of insulating material, wherein the first sheet of insulating material and the second sheet of insulating material are fused together adjacent the frame into a single, contiguous, generally planar insulating block.

[0107] Clause 8: The end effector of clause 7, the first contact surface lying parallel to a first outer surface of the insulating block, the first plurality of electrodes extending vertically and outwardly a first distance from the first outer surface.

[0108] Clause 9: The end effector of clause 7, the first contact surface lying coplanar with the first outer surface of the insulating block.

[0109] Clause 10: The end effector of any of clauses 7 to 9, the second contact surface lying substantially parallel to a second outer surface of the insulating block, the second plurality of electrodes extending substantially vertically and outwardly a second distance from the second outer surface.

[0110] Clause 11: The end effector of any of clauses 7 to 9, the second contact surface lying coplanar with the second outer surface of the insulating block.

[0111] Clause 12: The end effector of any of clauses 1 to 11, wherein the insulating material comprises a polymer.

[0112] Clause 13: The end effector of clause 12, wherein the polymer comprises thermoplastic polyurethane (TPU).

[0113] Item 14: A method of manufacturing an end effector for a medical catheter, the method comprising: placing a flexible circuit comprising a plurality of electrodes in a mold, each of the plurality of electrodes comprising a contact surface; placing a sheet of insulating material in contact with the flexible circuit; and molding the flexible circuit and the insulating material so that the insulating material flows at least partially around the flexible circuit to be adjacent to the contact surface, so that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the surrounding environment.

[0114] Item 15: According to the method of Item 14, the insulating material sheet includes a first flexible material sheet, the flexible circuit includes a first flexible circuit and includes a frame, and the plurality of electrodes include a first plurality of electrodes, the first plurality of electrodes include a first contact surface, the method also includes before the molding: placing a second insulating material sheet in contact with the frame; placing a second flexible circuit on the second insulating material sheet opposite to the frame, the second flexible circuit including a second plurality of electrodes, each of the plurality of electrodes including a second contact surface; placing a second molding surface in contact with the second contact surfaces of the second plurality of electrodes; and molding the second flexible circuit, the second insulating material and the frame so that the second insulating material flows around the frame and at least partially around the second flexible circuit, the insulating material extending until approximately in front of the second contact surface.

[0115] Item 16: According to the method of Item 14, the insulating material sheet includes a first flexible material sheet, the flexible circuit includes a first flexible circuit and includes a frame, and the plurality of electrodes include a first plurality of electrodes, the first plurality of electrodes include a first contact surface, the method also includes before the molding: placing a second insulating material sheet in contact with the frame; placing a second flexible circuit on the second insulating material sheet opposite to the frame, the second flexible circuit including a second plurality of electrodes, each of the plurality of electrodes including a second contact surface; placing a second molding surface in contact with the second contact surfaces of the second plurality of electrodes; and molding the second flexible circuit, the second insulating material and the frame so that the second insulating material flows around the frame and at least partially around the second flexible circuit, the insulating material extending until approximately in front of the second contact surface.

[0116] Clause 17: The method of any of clauses 15-16, wherein molding the first sheet of insulating material and molding the second sheet of insulating material comprises applying heat to the first sheet of insulating material and the second sheet of insulating material.

[0117] Clause 18: The method of clause 17, applying heat comprises heating the first sheet of insulating material and heating the second sheet of insulating material to approximately 400 degrees Fahrenheit.

[0118] Clause 19: The method of any of clauses 15 to 18, molding the first sheet of insulating material and molding the second sheet of insulating material comprising melting the first sheet of insulating material to the second sheet of insulating material proximate the framework.

[0119] Clause 20: A method according to any one of clauses 17 to 19, wherein the first sheet of insulating material and the second sheet of insulating material comprise a thermoplastic elastomer, and wherein molding the first sheet of insulating material and molding the second sheet of insulating material comprise applying heat and compression to the first contact surface of the first plurality of electrodes and the second contact surface of the second plurality of electrodes.

[0120] Clause 21: According to the method described in any one of clauses 15 to 20, the first molding surface includes a first flexible heat-resistant sheet, which is configured to conform to each of the contact surfaces of the first plurality of electrodes, and the second molding surface includes a second flexible heat-resistant sheet, which is configured to conform to each of the contact surfaces of the second plurality of electrodes.

[0121] Clause 22: The method of clause 21, wherein the first flexible heat-resistant sheet comprises a material having a hardness such that when the compression is applied, the first plurality of electrodes extend a first distance into the first flexible heat-resistant sheet.

[0122] Clause 23: The method of clause 22, wherein the first distance comprises approximately 5 microns.

[0123] Clause 24: The method of any one of clauses 21 to 23, wherein the second flexible heat-resistant sheet comprises a material having a hardness such that upon application of the compression, the second plurality of electrodes extend into the second flexible heat-resistant sheet a second distance.

[0124] Clause 25: The method of clause 24, wherein the second distance comprises approximately 5 microns.

[0125] Item 26: A fixture for forming an end actuator for a package of a medical catheter, the fixture comprising a plurality of components stacked approximately in parallel along a vertical axis of the fixture, the plurality of components comprising: a first compression surface; a second compression surface, the second compression surface being disposed opposite to the first compression surface and being configured to translate from an expanded configuration to a compressed configuration along the vertical axis relative to the first compression surface; and a first flexible heat-resistant sheet, the first flexible heat-resistant sheet being disposed proximate to the first compression surface and comprising a hardness such that when compression is applied to the first compression surface and the second compression surface, contact surfaces of a first plurality of electrodes extending from a first flexible circuit protrude a first distance into the first flexible heat-resistant sheet.

[0126] Item 27: According to the fixing device described in Item 26, the multiple components also include: a second flexible heat-resistant sheet, which is arranged to be close to the second compression surface and includes a hardness so that when the compression is applied, the contact surfaces of the second multiple electrodes extending from the second flexible circuit protrude a second distance into the second flexible heat-resistant sheet.

[0127] Clause 28: The fixture of clause 27, the first compression surface and the second compression surface configured to accommodate therebetween: the first flexible circuit, a first sheet of insulating material, a frame, a second sheet of insulating material, and the second flexible circuit when in the expanded configuration.

[0128] Clause 29: A fixture according to any of clauses 26 to 28, the first compression surface being configured to cause the first sheet of insulating material to flow at least partially around the frame when in the compression configuration, and the first flexible circuit extending until approximately in front of the contact surface of the first plurality of electrodes.

[0129] Item 30: According to a fixing device described in any one of items 27 to 29, the first compression surface and the second compression surface are configured to cause the first insulating material sheet and the second insulating material sheet to melt close to the frame and flow at least partially around the frame when in the compression configuration, and the first flexible circuit and the second flexible circuit extend until approximately in front of the contact surface of the first plurality of electrodes and the contact surface of the second plurality of electrodes.

[0130] Clause 31: The fixture of any one of clauses 27 to 30, wherein the first distance is equal to the second distance.

[0131] Clause 32: The fixture of any one of clauses 26 to 31, wherein the first distance is approximately equal to 5 micrometers.

[0132] Clause 33: The fixture of any one of clauses 27 to 32, wherein the second distance is approximately equal to 5 micrometers.

[0133] Clause 34: The fixture of any of clauses 27 to 33, further comprising a heating element configured to apply heat to the first and second sheets of insulating material.

Claims

1. An end effector, comprising: a flexible circuit comprising a plurality of electrodes, the flexible circuit being disposed on an insulating material, and each of the plurality of electrodes comprising a contact surface; and The insulating material is adjacent to the contact surface such that only the contact surface of at least a portion of the plurality of electrodes is exposed to an ambient environment.

2. The end effector of claim 1, wherein the flexible circuit further comprises a frame, wherein the frame is adjacent to the insulating material, or wherein a portion of the frame is encapsulated within the insulating material, and wherein, The contact surface of an electrode of the plurality of electrodes includes an area of ​​the electrode not covered by the insulating material.

3. The end effector of claim 2, the flexible circuit comprising a first flexible circuit, and the plurality of electrodes comprising a first plurality of electrodes, the first plurality of electrodes each comprising a first contact surface, the end effector further comprising: a second flexible circuit, the second flexible circuit comprising a second plurality of electrodes, the second flexible circuit being spaced apart from the first flexible circuit, and each of the second plurality of electrodes comprising a second contact surface, the insulating material being further disposed between the first flexible circuit and the second flexible circuit, the insulating material being adjacent to the second contact surface such that only the contact surface of each electrode is exposed to the surrounding environment.

4. The end effector of claim 3, further comprising a frame disposed between the first flexible circuit and the second flexible circuit.

5. The end effector of claim 3, said insulating material being heat formed around said frame, said second flexible circuit, and at least a portion of said first flexible circuit.

6. The end effector of claim 1, the flexible circuit comprising a first flexible circuit, and the plurality of electrodes comprising a first plurality of electrodes, the first plurality of electrodes each comprising a first contact surface, the end effector further comprising: a frame disposed proximate to the first flexible circuit; a second flexible circuit, the second flexible circuit comprising a second plurality of electrodes, the second flexible circuit being spaced apart from the frame on a side of the frame opposite the first flexible circuit, and each of the second plurality of electrodes comprising a second contact surface, the insulating material being further disposed between the frame and the second flexible circuit, the insulating material being thermally formed around at least a portion of the second flexible circuit and the frame.

7. The end effector of claim 6, wherein the insulating material comprises a first sheet of insulating material and a second sheet of insulating material, the first sheet of insulating material and the second sheet of insulating material being fused together adjacent the frame into a single, contiguous, generally planar insulating block.

8. The end effector of claim 7, the first contact surface lying parallel to a first outer surface of the insulating block, the first plurality of electrodes extending vertically and outwardly a first distance from the first outer surface.

9. A method of manufacturing an end effector for a medical catheter, the method comprising: placing a flexible circuit comprising a plurality of electrodes in the mold, each electrode of the plurality of electrodes comprising a contact surface; placing a sheet of insulating material in contact with the flexible circuit; as well as The flexible circuit and the insulating material are molded to cause the insulating material to flow at least partially around the flexible circuit into abutment with the contact surface such that only the contact surface of at least a portion of the electrodes of the plurality of electrodes is exposed to an ambient environment.

10. The method of claim 9, wherein the sheet of insulating material comprises a first sheet of flexible material, the flexible circuit comprises a first flexible circuit, and the plurality of electrodes comprises a first plurality of electrodes, the first plurality of electrodes comprising a first contact surface, the method further comprising, prior to the molding: placing a second sheet of insulating material in contact with the first flexible circuit; placing a second flexible circuit on the second sheet of insulating material opposite the first flexible circuit, the second flexible circuit comprising a second plurality of electrodes, each electrode of the plurality of electrodes comprising a second contact surface; placing a second molding surface in contact with the second contact surfaces of the second plurality of electrodes; as well as The second flexible circuit and the second insulating material are molded so that the second insulating material flows at least partially around the second flexible circuit, the insulating material extending until approximately in front of the second contact surface.

11. The method of claim 9, the sheet of insulating material comprising a first sheet of flexible material, the flexible circuit comprising a first flexible circuit and comprising a frame, and the plurality of electrodes comprising a first plurality of electrodes, the first plurality of electrodes comprising a first contact surface, the method further comprising, prior to the molding: placing a second sheet of insulating material in contact with the frame; placing a second flexible circuit on the second sheet of insulating material opposite the frame, the second flexible circuit comprising a second plurality of electrodes, each electrode of the plurality of electrodes comprising a second contact surface; placing a second molding surface in contact with the second contact surfaces of the second plurality of electrodes; as well as The second flexible circuit, the second insulating material, and the frame are molded so that the second insulating material flows around the frame and at least partially around the second flexible circuit, the insulating material extending until approximately in front of the second contact surface.

12. The method according to claim 11, wherein: Molding the first sheet of insulating material and molding the second sheet of insulating material include applying heat to the first sheet of insulating material and the second sheet of insulating material.

13. The method of claim 12, applying heat comprises heating the first sheet of insulating material and heating the second sheet of insulating material to approximately 400 degrees Fahrenheit.

14. The method of claim 11, molding the first sheet of insulating material and molding the second sheet of insulating material comprising melting the first sheet of insulating material to the second sheet of insulating material proximate the framework.

15. The method of claim 14, the first and second sheets of insulating material comprising a thermoplastic elastomer, and in, Molding the first sheet of insulating material and molding the second sheet of insulating material include applying heat and compression to the first contact surfaces of the first plurality of electrodes and the second contact surfaces of the second plurality of electrodes.

16. The method of claim 11, the first molding surface comprising a first flexible heat-resistant sheet configured to conform to each of the contact surfaces of the first plurality of electrodes, and The second molding surface includes a second flexible heat-resistant sheet configured to conform to each of the contact surfaces of the second plurality of electrodes.

17. The method according to claim 16, wherein: The first flexible heat-resistant sheet includes a material having a hardness such that upon application of compression, the first plurality of electrodes extend into the first flexible heat-resistant sheet a first distance.

18. A fixture for forming a packaged end effector for a medical catheter, the fixture comprising a plurality of components stacked generally in parallel along a vertical axis of the fixture, the plurality of components comprising: a first compression surface; a second compression surface disposed opposite the first compression surface and configured to translate relative to the first compression surface along the vertical axis from an expanded configuration to a compressed configuration; and A first flexible heat-resistant sheet is disposed proximate to the first compression surface and includes a hardness such that when compression is applied to the first compression surface and the second compression surface, contact surfaces of a first plurality of electrodes extending from the first flexible circuit protrude a first distance into the first flexible heat-resistant sheet.

19. The fixing device according to claim 18, wherein the plurality of components further comprises: A second flexible heat-resistant sheet is disposed proximate to the second compression surface and includes a hardness such that, when the compression is applied, contact surfaces of a second plurality of electrodes extending from the second flexible circuit protrude a second distance into the second flexible heat-resistant sheet.

20. The fixture of claim 19, the first compression surface and the second compression surface configured to accommodate therebetween: the first flexible circuit, a first sheet of insulating material, a frame, a second sheet of insulating material, and the second flexible circuit when in the expanded configuration.

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