Double-sided encapsulated planar catheter with encapsulating polymer

Abstract

To provide an end effector.SOLUTION: An end effector for a cardiac mapping catheter includes a flexible circuit including a plurality of electrodes, each electrode of the plurality of electrodes including a contact surface. The flexible circuit can be disposed on an insulative material. The insulative material can be contiguous to the contact surfaces so that only the contact surfaces of at least a portion of the plurality of electrodes are exposed to the ambient environment.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] (Priority Claim) This application claims priority to prior application U.S. Patent Application No. 63 / 516,196, filed July 28, 2023 (Attorney Docket No. 253757.000421 (BIO6876USPSP1)), which is incorporated by reference herein as if fully set forth.

[0002] FIELD OF THEINVENTION The present invention relates generally to minimally invasive medical devices and particularly, but not exclusively, to sensing catheters and further to cardiac mapping catheters and their manufacture. [Background technology]

[0003] Cardiac arrhythmias, such as atrial fibrillation, occur when electrical signals are abnormally conducted from an area of ​​cardiac tissue to adjacent tissue, disrupting the normal cardiac cycle and causing an asynchronous rhythm. The source of the unwanted signals may be located in the tissue of the atria or ventricles. The unwanted signals may be conducted through the cardiac tissue to other locations and cause or perpetuate the arrhythmia.

[0004] Procedures for treating arrhythmias include surgically disrupting the source of the signals that cause the arrhythmia and disrupting the conduction pathways of such signals. More recently, it has been found that it is possible to interrupt or modify the propagation of undesired electrical signals from one part of the heart to another by mapping the electrical properties and cardiac volumes of the endocardium and selectively ablating cardiac tissue through the application of energy. The ablation process disrupts the undesired electrical pathways by the formation of non-conducting foci.

[0005] In this two-step procedure, which involves mapping followed by ablation, electrical activity at points within the heart is sensed and measured, typically by advancing a catheter equipped with one or more electrical sensors into the heart and acquiring data at multiple points, which are then used to select a target area where ablation will be performed.

[0006] For higher mapping resolution, it is desirable for the mapping catheter to closely conform to the target anatomy. For mapping within the atria or ventricles (e.g., the apex of the ventricles), it is desirable for the catheter to collect more data signals in a shorter time. It is also desirable for such catheters to enable sufficient electrode contact with various tissue surfaces, e.g., flat, curved, irregular, or non-planar surface tissue, and be foldable for non-invasive advancement and retraction through the patient's vascular system. Existing catheters generally require stiff internal structural members to ensure that a predetermined configuration is maintained. Rigidity is a disadvantage during manipulation within a body organ, as it can prevent 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 can be time-consuming, complex, and expensive to manufacture and assemble. Often, the electrode contact surfaces of these end effectors must be exposed through the encapsulating material via laser cutting or mechanical removal, and both the layered components and the electrode contact surfaces increase labor hours and production costs. Summary of the Invention [Means for solving the problem]

[0008] To enable time and cost efficient production of end effectors that enhance the functionality of the mapping and ablation catheters mentioned in the Background section, the present disclosure relates to easily manufacturable end effectors, as well as fixtures and methods for manufacturing such end effectors having enhanced aspects of mapping and ablation catheter performance including, but not limited to, mapping resolution, electrode contact with the target anatomy, delivery of the end effector to the target anatomy, biocompatibility, end effector stiffness, and atraumaticity.

[0009] An end effector according to an embodiment of the present invention is provided. The end effector can include a flexible circuit including a plurality of electrodes, each electrode of the plurality of electrodes including a contact surface. The flexible circuit can be disposed on an insulating material. The insulating material can be continuous with the contact surfaces such that only the contact surfaces of at least a portion of the plurality of electrodes are exposed to the surrounding environment.

[0010] The disclosed technology includes a method of manufacturing a medical catheter end effector, the method including placing a flexible circuit including a plurality of electrodes in a mold, each electrode 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 such that the insulating material flows at least partially around the flexible circuit continuous with the contact surfaces such that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the surrounding environment.

[0011] The disclosed technology includes a fixture for forming an encapsulated end effector for a medical catheter. The fixture can include a plurality of components stacked generally parallel along a vertical axis of the fixture. The plurality of components can include a first compression surface, a second compression surface disposed opposite the first compression surface and configured to translate along the vertical axis relative to the first compression surface from an expanded configuration to a compressed configuration, and a first flexible, heat-resistant sheet disposed proximate the first compression surface, the first flexible, heat-resistant sheet having a durometer such that upon application of compression 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. [Brief description of the drawings]

[0012] [Figure 1] 1 is a schematic, pictorial illustration of a medical system including a planar catheter, in accordance with an embodiment of the present invention; [Diagram 2] 1 illustrates a perspective view of an end effector, in accordance with one embodiment of the present invention; [Diagram 3] 3 illustrates an exploded perspective view of the end effector of FIG. 2; [Figure 4A] 1 illustrates a cross section of an end effector according to one embodiment of the present invention. [Figure 4B] 1 illustrates a cross section of an end effector according to one embodiment of the present invention. [Figure 4B1] A variation of FIG. 4B in which the framework is not encapsulated within the insulating material, but is continuous with it. [Figure 4C] 1 illustrates a cross section of an end effector according to one embodiment of the present invention. [Figure 5A] 1 illustrates a cross section of a fixture for creating an end effector, according to one embodiment of the present invention. [Figure 5B] FIG. 13 is a detailed cross-sectional view of a fixture for making an end effector, according to one embodiment of the present invention. [Figure 5C]FIG. 13 is a detailed cross-sectional view of a fixture for making an end effector, according to one embodiment of the present invention. [Figure 6A] 1 illustrates a cross section of a fixture for creating an end effector, according to one embodiment of the present invention. [Figure 6B] FIG. 13 is a detailed cross-sectional view of a fixture for making an end effector, according to one embodiment of the present invention. [Figure 6C] FIG. 13 is a detailed cross-sectional view of a fixture for making an end effector, according to one embodiment of the present invention. [Figure 6D] 1 illustrates a cross-sectional view of the end effector removed from the fixture showing the electrode contact surface flush with the insulating substrate, according to one embodiment of the present invention. [Figure 6E] 13 illustrates an alternative embodiment in which the electrode contact surface does not have to be flush with the insulating surface, but can be modified, according to one embodiment of the present invention. [Figure 6F] 13 illustrates an alternative embodiment in which the electrode contact surface does not have to be flush with the insulating surface, but can be modified, according to one embodiment of the present invention. [Figure 7A] 1 illustrates a perspective view of a fixture for creating an end effector, in accordance with one embodiment of the present invention; [Figure 7B] 1 illustrates a perspective view of a fixture for creating an end effector, in accordance with one embodiment of the present invention; [Figure 8] 1 illustrates a catheter assembly, according to one embodiment of the present invention. [Figure 9A] 1 is a flow chart of a method of manufacturing an end effector for a medical catheter, according to an example of the present invention. [Figure 9B] 1 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 OF THE PREFERRED EMBODIMENTS

[0013] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.

[0014] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates suitable dimensional tolerances that allow a portion or collection of components to function for the intended purpose 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 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in a human patient represents a preferred embodiment, it is not intended to limit the system or method to human use. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.

[0015] As discussed herein, the tissues, vasculature, or organs of a "patient," "host," "user," and "subject" may be human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient.

[0016] As discussed herein, a "physician" may include a physician, surgeon, engineer, scientist, operator, or any other individual or delivery instrument involved in the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0017] As discussed herein, the term "ablate" or "ablation" refers to components and structural features that are configured to reduce or prevent the occurrence of irregular cardiac signals within cells, for example by utilizing thermal energy, such as radio frequency (RF) ablation, or non-thermal energy, such as irreversible electroporation (IRE), throughout this disclosure, which are interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA). When referring to the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout this disclosure to refer to thermal or non-thermal ablation of cardiac tissue for specific conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.

[0018] As discussed 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 is generally illustrated as a substantially right cylindrical structure. However, a tubular structure may have a tapered or curved exterior surface without departing from the scope of the present disclosure.

[0019] The present disclosure relates to systems, methods, or uses and devices for mapping and ablation of cardiac tissue to treat cardiac arrhythmias. Ablation energy is typically delivered to the cardiac tissue by a distal portion of a catheter that can deliver the ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to administer the ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy.

[0020] Ablation of cardiac tissue applying radio frequency (RF) energy and thermal techniques such as cryoablation to improve a failing heart is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF approaches may have risks that may lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation. Thus, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0021] The present disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). IRE may be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA) throughout this disclosure. IRE as discussed in this disclosure is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures in the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to the target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which may be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses may be utilized.

[0022] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cavity or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. The multiple catheters can then 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 exemplary catheter 14 configured to sense IEGMs is illustrated herein. The physician 24 brings a catheter shaft 90 (i.e., a multi-layered end effector 100) with a distal tip of the catheter 14 into contact with the heart wall to sense a target site within the heart 12. For ablation, the physician 24 similarly brings a distal end of an ablation catheter to a target site for ablation.

[0023] The catheter 14 is an exemplary catheter that includes one, and preferably multiple, electrodes 26 optionally distributed over an end effector 100 coupled to a catheter shaft 90 and configured to sense IEGM signals, as described in more detail below. The catheter 14 may further include a position sensor (shown in FIG. 2B ) embedded in or near the end effector 100 for tracking the position and orientation of the end effector 100. Optionally and preferably, the position sensor is a magnetic-based position sensor including multiple magnetic coils for sensing three-dimensional (3D) position and orientation.

[0024] The magnetic-based position sensor may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector 100 of the catheter 14 may be tracked based on the magnetic field generated by the location pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 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, and 6,892,091, each of which is incorporated herein by reference.

[0025] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the position of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0026] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0027] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more 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 unipolar or bipolar high voltage direct current pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0028] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities to implement real-time calculations of the catheter positions and perform ECG calculations.

[0029] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 55 may optionally provide multiple functions including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual display or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (5) displaying sites of interest, such as where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0030] 2 provides an end effector 100 according to an embodiment of the present disclosure to achieve ease of manufacture, reduced cost, and enhanced end effector properties such as desired stiffness, mapping resolution, electrode contact with the target anatomy, and conformability of the end effectors disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found within the target anatomy. The end effector 100 can include a flexible circuit 110 including a plurality of electrodes 112, each electrode 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, polyimide, copper wire, thin film deposition via lithography and etching processes onto substrates such as LCP (e.g., Panasonic FELIOS™ SERIES of Flexible Circuit Boards), Nitinol substrates, or direct deposition onto polymer substrates such as Panasonic BEYOLEX™ PRINTED ELECTRONICS SUBSTRATE Series, as shown and described in the accompanying technical literature incorporated herein by appendix. In some examples, the flexible circuit layer described herein can be made primarily of polyimide. In other examples, it can be made of either biocompatible polyimide, glass reinforced epoxy laminate material, copper, or graphene, either alone or in combination. The first flexible circuit 110 and the second flexible circuit 140 can include conductive traces formed directly on the polymer substrate, with the electrodes comprising substantially much thicker versions of the traces such that a typical polyimide substrate is no longer required. In some examples, the electrodes described herein can include at least one mapping electrode and / or at least one ablation electrode and can be configured to detect electrophysiological signals or deliver ablation energy AC or DC from the energy generator to the tissue according to various ablation methods mentioned above, e.g., RF, IRE, etc.

[0031] The flexible circuit 110 may be disposed on an insulating material 120. The insulating material 120 may be continuous with the contact surface 112c such that only the contact surface 112c of at least a portion of the 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 an edge or edges immediately surrounding the flat surface. The electrodes 112 may have slightly rounded, rounded, or chamfered edges that contact tissue with the generally flat surface when the end effector 100 is placed in contact with tissue. As used herein, "surrounding environment" refers to the organ in which the end effector 100 is placed, or the external environment, such as an operating room, prior to placement within a biological organ.

[0032] It should be noted that not all of the electrodes on the end effector 100 described herein need to be exposed through the insulating material 120, as these unexposed electrodes may be used to sense far-field signals for noise reduction in proximity to the tissue-contacting electrodes. Similarly, far-field signals, including noise or artifacts, may be reduced or cancelled for an entire end effector having a reference electrode that does not contact tissue, but only blood. Irrigation may be provided using an irrigation port 163a on one side and an irrigation port 162b on the other side, which are in fluid communication with an irrigation line (not shown) disposed within the catheter shaft 90. Instead of an irrigation line separate from the catheter shaft 90, a lumen may be formed by extrusion of the catheter shaft 90 to provide a lumen channel. It should be noted that the ports 163a or 162b may be configured to have sufficient diverter properties to allow the irrigation fluid to cover the mapping electrodes during irrigation flow to prevent or reduce clot formation.

[0033] The flexible circuit 110 may further include a framework 130 that is contiguous with or within the insulating material. In examples in which the flexible circuit 110 includes the framework 130, the framework 130 may be disposed directly on the flexible circuit 110 with little or no insulating material 120 disposed between the two.

[0034] Stated another way, one aspect of the present disclosure provides an end effector 100 having a planar framework 130 that bisects two flat thermoformed portions 120a, 120b of a flexible insulating material 120, with at least one flexible circuit 110 disposed on one side of the framework 130 and with the contact surface 112c of the electrode 112 extending to or slightly beyond the outer surface of the flexible insulating material 120.

[0035] 3 shows an exploded view of the end effector 100, with its components vertically exploded 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, with each first electrode 112 including a first contact surface 112c. The end effector 100 can further include a second flexible circuit 140 having a second plurality of electrodes 142. The second flexible circuit 140 can be spaced apart from the first flexible circuit 110, and each electrode of the second plurality of electrodes 142 can have a second contact surface 142c.

[0036] In an example having a first flexible circuit 110 and a second flexible circuit 140, the 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 continuous to the second contact surface 142c such that only the contact surface 142c of each second electrode 142 is exposed to the surrounding environment, similar to the manner in which the first electrode 112 is disposed within and exposed through the insulating material.

[0037] The electrodes 112, 142 can sense tissue signals or deliver energy AC or DC from an energy generator to the 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 of each pair of electrodes relative to the spacing between separate sets of electrode pairs can be found in U.S. Provisional Patent Application No. 63 / 406,673, filed September 14, 2022 (Attorney Docket No. BIO6749USPSP3), and are included in the appendix, which is incorporated by reference.

[0038] In an example, the end effector 100 includes a framework 130 disposed between a first flexible circuit 110 and a second flexible circuit 140.

[0039] The framework 130 may be a component of the end effector 100 that is separate and distinct from and disposed proximate to the first flexible circuit 110. In this case, the insulating material 120 may further be disposed between the framework 130 and the second flexible circuit 140. The framework 130 may be formed from a planar or cylindrical stock of material using any suitable method. For example, the framework 130 may be formed by cutting, laser cutting, stamping, etc.

[0040] The insulating material 120 can include a first sheet 120a and a second sheet 120b of insulating material, which are fused together adjacent the framework 130 to form a single continuous, generally planar insulating mass 120. The insulating material 120 also serves to enhance the atraumatic nature of the end effector 100 and to protect the subject from sharp edges. The insulating material 120 can include a polymer. As discussed below in connection with FIGS. 9A and 9B, the insulating material 120 can be thermoformed around at least a portion of the first flexible circuit 110, the second flexible circuit 140, and the framework 130. The polymer can include thermoplastic polyurethane (TPU) or other thermoforming or molding material suitable for such thermoforming.

[0041] Additionally, although the insulating material 120 is shown as flat in these figures, the insulating material 120 may be shaped, corrugated, ribbed, raised, concave, convex, or otherwise configured such that the overall contour of the insulating material 120 provides the physical and / or mechanical properties, such as stiffness and flexure along multiple axes, required by the end effector 100 referenced above.

[0042] FIG. 4A illustrates a cross-section obtained as shown in FIG. 3. The first contact surface 112c lies substantially parallel to the first outer surface 122a of the insulating mass 120. The first plurality of electrodes 112 extends vertically outwardly a first distance D1 from the first outer surface. Similarly, the second contact surface 142c can lie substantially parallel to the second outer surface 122b of the insulating mass 120 and extend substantially vertically outwardly a second distance D2 from the second outer surface. As discussed below in connection with the fixture 500 illustrated in FIGS. 5A-7B and 9A-9B, the first distance D1 and the second distance D2 can be determined by aspects of the fixture 500 and / or method 900.

[0043] Figure 4B shows a similar cross section taken from an exemplary end effector 100 without the second flexible circuit 140. That is, the end effector of Figure 4B has electrodes on only one side (a single-sided end effector) compared to the end effector of Figure 4A having electrodes on both sides (or a double-sided end effector). Figure 4B1 shows a variation of Figure 4B in which the framework 130 is not encapsulated within the insulating material, but is disposed outside the insulating material 120.

[0044] Figure 4C shows a cross-section from an exemplary end effector 100 similar to that of Figure 4A, but without the framework 130. It should be noted that although the framework 130 is shown as rectangular in cross-section, the framework 130 is not limited to such a cross-section and any suitable cross-section may be utilized.

[0045] Importantly, end effectors 100 having flush or outwardly protruding electrode contact surfaces 112c, 142c can be manufactured without having to remove material to expose the electrode contact surfaces 112c, 142c via methods and / or fixtures described in more detail below.

[0046] In another example, the first contact surface 112c can be located substantially flush with the first outer surface 122a of the insulating mass 120, and the second contact surface 142c can be located flush with the second outer surface 122b of the insulating mass 120.

[0047] 5A-6A show a fixture 500 for forming an encapsulated end effector for a medical catheter, such as the end effector 100 of FIGS. 2-4C. Note that the components formed by the fixture 500 in the end effector 100 are in the same ordered order as the components in FIG. 5A. The first compression surface 510, the second compression surface 520, and the sidewall 550 are configured to receive the first flexible circuit 110, the first sheet of insulating material 120a, the framework 130, the second sheet of insulating material 120b, and the second flexible circuit 140 between the first compression surface 510, the second compression surface 520, and the sidewall 550 when in the expanded configuration 500a.

[0048] The fixture 500 can include a plurality of generally parallel stacked components. The plurality of components can include a first compression surface 510 and a second compression surface 520 disposed opposite the first compression surface 510 and configured to translate perpendicularly relative to the first compression surface 510 from the expanded configuration 500a to the compressed configuration 500b.

[0049] The fixture 500 may include a first flexible heat resistant sheet 530 disposed proximate to the first compression surface 510 .

[0050] In the detailed view shown in FIG. 5B, 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, i.e., the fixture 500 is in the expanded configuration 500a.

[0051] 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.

[0052] 5A-5C, the first sheet 120a and the second sheet 120b of insulating material are generally flat since they have not yet been formed. The first flexible heat-resistant sheet 530 covers the contact surface 112c of the electrode 112, similar to a masking process. After forming, when the contact surface 112c is no longer compressed within the first flexible heat-resistant sheet 530, the contact surface 112c is exposed to the surrounding environment, while the remainder of the end effector 100 is encapsulated within the material 120. As used herein, the term "forming" includes forming using heat, forming using pressure, or forming using both heat and pressure.

[0053] Briefly, 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 such that the electrode contact surface 112c is not covered by an insulating material that is sandwiched between compression plates 510, 520 and covers 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 further include another flexible portion 540 that serves the same function for the second electrode contact surface 142c of the second flexible circuit 140.

[0054] 6A illustrates a compressed configuration 500b. The first compression surface 510 is configured to at least partially flow the first sheet of insulating material 120a around the framework 130 when in the compressed configuration 500b, and the first flexible circuit 110 extends to approximately short of the contact surface 112c of the first plurality of electrodes 112. The sidewalls 550 are configured to constrain the first compression surface 510 as the fixture 500 is translated from the expanded configuration 500a to the compressed configuration 500b. As seen in the detailed view illustrated in FIG. 6B, the first flexible heat-resistant sheet 530 can have a durometer 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. Similarly, in FIG. 6C, the second flexible heat-resistant sheet 540 can have a durometer such that, upon application of compression, the contact surfaces 142c of the second plurality of electrodes 142 extending from the second flexible circuit 140 protrude a second distance D2 into the second flexible heat-resistant sheet 540.

[0055] In contrast to Figures 5A-5C, the first and second sheets of insulating material 120a, 120b shown in Figures 6A-6C are shaped and thus are no longer flat, but rather form an encapsulation 120 of material in which the first and second sheets are not necessarily distinguishable from one another. It should be noted that while the top electrodes 112 and 142 are shown alone, alternative embodiments may have a flexible printed circuit board 110 as part of the top electrode 112 and a flexible printed circuit board 140 as part of the bottom electrode 142 (Figures 5B and 5C).

[0056] While 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, corrugated, ridged, raised, concave, convex, or otherwise configured such that the overall contour of the encapsulant 120 provides the physical and / or mechanical properties, such as stiffness and flexure along multiple axes, required by the end effector 100 referred to above.

[0057] In other words, the first compression surface 510 and the second compression surface 520, when in the compressed configuration 500b, can be configured to fuse the first sheet of insulating material 120a and the second sheet of insulating material 120b proximate to the framework 130 and at least partially flow around the framework 130, such that the first flexible circuit 110 and the second flexible circuit 140 extend almost to the contact surfaces 112c of the first plurality of electrodes 112 and the contact surfaces of the second plurality of electrodes 142.

[0058] In some examples, the first distance D1 can be equal to the second distance D2. In some examples, the first distance D1 can be about 5 micrometers. The second distance D2 can be approximately equal to 5 micrometers.

[0059] In examples where the fixture 500 does not include 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 such that the first contact surface 112c is substantially flush with the first outer surface 122a of the insulating mass 120 and the second contact surface 142c is flush with the second outer surface 122b of the insulating mass 120.

[0060] The fixture 500 may further include a heating element (not shown) configured to apply heat to the first sheet of insulating material 120a and the second sheet of insulating material 120b to thermoform them into the continuous mass 120 discussed above. As mentioned above, a thermoplastic elastomer such as TPU may be used. The first sheet of insulating material 120a and the second sheet of insulating material 120b fuse into a continuous mass 120, which is not necessarily homogenous. The properties of the finished end effector 100 fabricated using the fixture 500 may be altered based on compositional differences between the first sheet of insulating material 120a and the second sheet of insulating material 120b, or additives disposed therebetween and / or on the fixture 500.

[0061] The first flexible heat resistant sheet 530 and the second flexible heat resistant sheet 540 may be made of a material that has properties that allow them to remain stable at temperatures that melt / flow the insulating material 120. Additionally, the heat resistant sheets 530, 520 may include material properties that facilitate easy removal from the fixture 500. The fixture 500 may be configured to facilitate replacement of the heat resistant sheets 530, 520, as the heat resistant sheets 530, 520 may be subject to more severe wear than other components of the fixture 500.

[0062] 6A, upon application of heat or pressure (indicated by the symbol "F"), insulating materials 120a and 120b begin to melt together as a single material 120 that flows around electrodes 112 and 142. As upper compression surface 510 and lower compression surface 520 approach each other and contact upper electrode 112 and lower electrode 142, respectively, insulating material 120 is unable to flow around electrode contact surfaces 112c and 142c. That is, insulating material 120 is unable to extend beyond the boundaries defined by upper compression surface 510 and lower compression surface 520. The product after heat or pressure forming is shown in FIG. 6D, where insulating material 120 is now flush with contact surface 112c (of upper electrode 112) and flush with contact surface 142c of lower electrode 142. Although preferred embodiments have electrode contact surface 112c or 142c flush with insulating surface 121a or 121b, in some applications the contact surface need not be flush as shown in Figures 6E and 6F and electrode 114 can protrude beyond insulating surface 121a at various levels of protrusion, such as a low protrusion for electrode 113 and a high protrusion for electrode 114 in Figure 6E. In Figure 6E, the various levels of protrusion are defined by compression members 510' and 520' having recessed pockets 512 and 514.

[0063] In applications where the electrode contact surfaces extend beyond the planes 121a or 121b defined by the insulating material 120, the upper and lower compression surfaces 510' and 520' can be provided with recessed openings 512 and 514 that fit directly into the respective electrodes such that the electrodes 112 and 142 project a predetermined distance above the top and bottom surfaces 121a and 121b of the insulating material 120, as shown here in FIG. 6E. In FIG. 6E, it can be seen that different projection heights can be obtained by modifying the mating recessed openings in the compression surfaces 510' and 520' such that the electrode 114 extends all the way to the top of the top surface 121a of the insulating material 120. Similarly, the recessed pockets 514 in the compression plate 520' allow the projection of the electrode 142 to extend further than the top or bottom surfaces 121a and 121b of the insulating material 120.

[0064] 6F illustrates yet another embodiment within the scope of the present invention, where the electrode contact surface may be deeply recessed below the top or bottom surface 121a, as shown by electrode 112, and may be flush with the top or bottom surface 121a, as shown by electrode 113, and may protrude beyond the top or bottom surface 121a and the electrode 113, which is flush with the top surface 121a. Although the top surface 121a and bottom surface 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 need not be flat or planar, but may include compound curves or curved surfaces depending on the actual geometry of the compression surface 511 of the plate 510. It should be noted that in all these examples, 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.

[0065] FIG. 7A shows a perspective view of a first compression surface 510 configured as a cap with a lip that acts as a stop to prevent compression beyond the compressed configuration 500b.

[0066] 7B shows a perspective view of fixture 500 with a completed end effector therein. In this view, there is a Teflon sheet 502 configured to allow for release of the completed end effector, although a liquid, spray, or powder release agent could be used.

[0067] The fixture 500 can include notches, dovetails, keys, inlet / outlet ports, frames, plates, clamps, and other components used in molds as would be understood by one of ordinary skill in the art.

[0068] The present disclosure provides a catheter assembly 200, as shown in FIG. 8, which may include a tubular member 230 extending along a longitudinal axis LL and configured to deliver the end effector 100 out of a sheath 210. A physician 24 can manipulate the catheter 200 using a 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 others not mentioned herein, are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference, and is included in the appendix attached hereto.

[0069] 9A-9B illustrate a method 900 of manufacturing an end effector for a medical catheter. The method 900, in some examples, can be performed using a fixture 500 to manufacture the end effector 100 as detailed above, along with all of its components and subcomponents.

[0070] As shown in FIG. 9A , method 900 can 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 such that the insulating material flows at least partially around the flexible circuit continuous with the contact surface such that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the ambient environment.

[0071] The method 900 may further include placing 906a a second sheet of insulating material in contact with the first flexible circuit or sheet of insulating material prior to molding, and placing 908a the 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. The method 900 may further include placing 910a a second molding surface in contact with a second contact surface of the second plurality of electrodes. The method may include molding 914a the second flexible circuit and the second insulating material to flow the second insulating material at least partially around the second flexible circuit, the insulating material extending approximately short of the second contact surface.

[0072] Forming the first sheet of insulating material 912 and forming the second sheet of insulating material 914a can include applying heat to the first sheet of insulating material and the second sheet of insulating material, such as by a heating element of the fixture 500 referenced above. Applying heat can include heating the first sheet of insulating material and heating the second sheet of insulating material to approximately 400 degrees Fahrenheit sufficient to cause the TPU to flow within the fixture 500. As will be appreciated by one of ordinary skill in the art, the target temperature for heating the insulating material can vary depending on the particular material.

[0073] Forming the first sheet of insulating material 912 and forming the second sheet of insulating material 914a can include fusing the first sheet of insulating material to the second sheet of insulating material in proximity to the first and second flexible circuits. This can result in a continuous mass 120. Forming the first sheet of insulating material 912 and forming the second sheet of insulating material 914a can include applying heat and compression, such as by a first compression surface 510 and a second compression surface 520 of a fixture 500, to a first contact surface of the first plurality of electrodes and a second contact surface of the second plurality of electrodes.

[0074] As shown in FIG. 9B, method 900 can 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 framework in contact with the sheet of insulating material, and molding 912 the flexible circuit and the insulating material such that the insulating material flows at least partially around the flexible circuit and framework continuous with the contact surfaces such that only the contact surfaces of at least a portion of the plurality of electrodes are exposed to the ambient environment.

[0075] The method 900 may further include placing 906b a second sheet of insulating material in contact with the framework and placing 908b a second flexible circuit on the second sheet of insulating material opposite the framework, the second flexible circuit comprising a second plurality of electrodes, each electrode of the plurality of electrodes comprising a second contact surface. The method 900 may further include placing 910b a second molding surface in contact with a second contact surface of the second plurality of electrodes. The method may include molding 914b the second flexible circuit, the second insulating material, and the framework such that the second insulating material flows around the framework and at least partially around the second flexible circuit, the insulating material extending substantially short of the second contact surface.

[0076] Forming the first sheet of insulating material 912 and forming the second sheet of insulating material 914b can include applying heat to the first sheet of insulating material and the second sheet of insulating material, such as by a heating element of the fixture 500 referenced above. Applying heat can include heating the first sheet of insulating material and heating the second sheet of insulating material to approximately 400 degrees Fahrenheit sufficient to cause the TPU to flow within the fixture 500. As will be appreciated by one of ordinary skill in the art, the target temperature for heating the insulating material can vary depending on the particular material.

[0077] Shaping the first sheet of insulating material 912 and forming the second sheet of insulating material 914b can include fusing the first sheet of insulating material to the second sheet of insulating material proximate the framework, which can result in a continuous mass 120. Shaping the first sheet of insulating material 912 and forming the second sheet of insulating material 914b can include applying heat and compression, such as by a first compression surface 510 and a second compression surface 520 of a fixture 500, to first contact surfaces of the first plurality of electrodes and second contact surfaces of the second plurality of electrodes.

[0078] In other words, the process 900 for making the end effector includes protecting the electrode contact surfaces by allowing them to be crushed into a flexible sheet, and then molding a flexible insulating material to cover the components of the end effector, such as the flexible circuit and framework on which the electrodes are disposed.

[0079] It should be understood that the method 900 described herein may include more or less steps or features than those described. Additionally, the steps or features may be performed in different orders and should not be construed as requiring performance in any particular order.

[0080] The techniques of the present disclosure described herein can be further understood according to the following sections.

[0081] Item 1: An end effector comprising a flexible circuit having a plurality of electrodes, the flexible circuit being disposed on an insulating material, each electrode of the plurality of electrodes having a contact surface, the insulating material being continuous with the contact surfaces such that only the contact surfaces of at least a portion of the plurality of electrodes are exposed to the surrounding environment.

[0082] Clause 2: An end effector as described in clause 1, wherein the flexible circuit further comprises a framework continuous with the insulating material or a portion of the framework is encapsulated within the insulating material, and the contact surface of the electrode includes an area of ​​the contact electrode that is not covered by the insulating material.

[0083] Clause 3: The end effector of clause 1, wherein the flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes each having a first contact surface, and the end effector further comprises a second flexible circuit comprising a second plurality of electrodes, the second flexible circuit being spaced apart from the first flexible circuit, each electrode of the second plurality of electrodes having a second contact surface, and an insulating material is further disposed between the first flexible circuit and the second flexible circuit, the insulating material being continuous with the second contact surface such that only the contact surface of each electrode is exposed to the surrounding environment.

[0084] Clause 4: The end effector of clause 3, wherein the end effector further comprises a framework disposed between the first flexible circuit and the second flexible circuit.

[0085] Clause 5: An end effector described in any of clauses 3 to 4, wherein an insulating material is thermoformed around the first flexible circuit, the second flexible circuit, and at least a portion of the framework.

[0086] Clause 6: The end effector of clause 1, wherein the flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes each having a first contact surface, and the end effector further comprises a framework disposed proximate to the first flexible circuit and a second flexible circuit comprising a second plurality of electrodes, the second flexible circuit being spaced apart from the framework on a side of the framework opposite the first flexible circuit, each electrode of the second plurality of electrodes comprising a second contact surface, and an insulating material is further disposed between the framework and the second flexible circuit, the insulating material being thermoformed around at least a portion of the framework and the second flexible circuit.

[0087] Clause 7: An end effector described in any of clauses 2 to 6, wherein the insulating material includes a first sheet of insulating material and a second sheet of insulating material fused together into a single continuous, generally planar insulating mass adjacent the framework.

[0088] Clause 8: An end effector as described in clause 7, wherein the first contact surface lies parallel to a first outer surface of the insulating mass, and the first plurality of electrodes extend perpendicularly and outwardly from the first outer surface a first distance.

[0089] Clause 9: An end effector as described in clause 7, wherein the first contact surface is flush with the first exterior surface of the insulating mass.

[0090] Clause 10: An end effector described in any of clauses 7 to 9, wherein the second contact surface is positioned substantially parallel to the second outer surface of the insulating mass, and the second plurality of electrodes extends substantially perpendicularly and outwardly from the second outer surface a second distance.

[0091] Item 11: An end effector described in any one of items 7 to 9, wherein the second contact surface is positioned flush with the second outer surface of the insulating mass.

[0092] Item 12: An end effector described in any one of items 1 to 11, wherein the insulating material includes a polymer.

[0093] Item 13: The end effector of item 12, wherein the polymer comprises thermoplastic polyurethane (TPU).

[0094] Clause 14: A method of manufacturing an end effector for a medical catheter, the method comprising: placing a flexible circuit having a plurality of electrodes in a mold, each electrode of the plurality of electrodes having a contact surface; placing a sheet of insulating material in contact with the flexible circuit; and molding the flexible circuit and the insulating material such that the insulating material flows at least partially around the flexible circuit continuous with the contact surface such that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the ambient environment.

[0095] Clause 15: The method of clause 14, wherein the sheet of insulating material comprises a first flexible sheet of material, the flexible circuit comprises a first flexible circuit and comprises a framework, and the plurality of electrodes comprises a first plurality of electrodes comprising a first contact surface, and the method further comprises, prior to the molding, placing a second sheet of insulating material in contact with the framework, placing a second flexible circuit on the second sheet of insulating material opposite the framework, 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, and molding the second flexible circuit, the second insulating material, and the framework to flow the second insulating material around the framework and at least partially around the second flexible circuit, wherein the insulating material extends approximately short of the second contact surface.

[0096] Clause 16: The method of clause 14, wherein the sheet of insulating material comprises a first flexible sheet of material, the flexible circuit comprises a first flexible circuit and comprises a framework, and the plurality of electrodes comprises a first plurality of electrodes comprising a first contact surface, and the method further comprises, prior to the molding, placing a second sheet of insulating material in contact with the framework, placing a second flexible circuit on the second sheet of insulating material opposite the framework, 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 second contact surfaces of the second plurality of electrodes, and molding the second flexible circuit, the second insulating material, and the framework to flow the second insulating material around the framework and at least partially around the second flexible circuit, the insulating material extending approximately short of the second contact surface.

[0097] Clause 17: The method of any one of clauses 15 to 16, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises applying heat to the first sheet of insulating material and the second sheet of insulating material.

[0098] Clause 18: The method of clause 17, wherein applying heat includes heating the first sheet of insulating material and heating the second sheet of insulating material to about 400 degrees Fahrenheit.

[0099] Clause 19: The method of any of clauses 15 to 18, wherein forming the first sheet of insulating material and forming the second sheet of insulating material includes fusing the first sheet of insulating material to the second sheet of insulating material in proximity to a framework.

[0100] Clause 20: The method of any of clauses 17 to 19, wherein the first sheet of insulating material and the second sheet of insulating material comprise a thermoplastic elastomer, and molding the first sheet of insulating material and molding the second sheet of insulating material comprise applying heat and compression to first contact surfaces of the first plurality of electrodes and second contact surfaces of the second plurality of electrodes.

[0101] Clause 21: The method of any of clauses 15 to 20, wherein the first shaped surface comprises a first flexible, heat-resistant sheet configured to conform to each of the contact surfaces of the first plurality of electrodes, and the second shaped surface comprises a second flexible, heat-resistant sheet configured to conform to each of the contact surfaces of the second plurality of electrodes.

[0102] Clause 22: The method of clause 21, wherein the first flexible heat-resistant sheet comprises a material having a durometer such that upon application of compression, the first plurality of electrodes extend a first distance into the first flexible heat-resistant sheet.

[0103] Clause 23: The method of clause 22, wherein the first distance comprises about 5 micrometers.

[0104] Clause 24: The method of any of clauses 21 to 23, wherein the second flexible heat-resistant sheet comprises a material having a durometer such that upon application of compression, the second plurality of electrodes extend a second distance into the second flexible heat-resistant sheet.

[0105] Clause 25: The method of clause 24, wherein the second distance comprises about 5 micrometers.

[0106] Clause 26: A fixture for forming an encapsulated end effector for a medical catheter, the fixture comprising a plurality of components stacked generally parallel along a vertical axis of the fixture, the plurality of components including: a first compression surface; a second compression surface disposed opposite the first compression surface and configured to translate along the vertical axis relative to the first compression surface from an expanded configuration to a compressed configuration; and a first flexible, heat-resistant sheet disposed proximate to the first compression surface, the first flexible, heat-resistant sheet having a durometer such that application of compression to the first compression surface and the second compression surface causes contact surfaces of a first plurality of electrodes extending from the first flexible circuit to protrude a first distance into the first flexible, heat-resistant sheet.

[0107] Clause 27: The fixture of clause 26, wherein the plurality of components further comprises a second flexible, heat-resistant sheet disposed proximate to the second compression surface, the second flexible, heat-resistant sheet having a durometer such that upon application of compression, 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.

[0108] Clause 28: The fixture of clause 27, wherein the first compression surface and the second compression surface are configured to accommodate the first flexible circuit, the first sheet of insulating material, the framework, the second sheet of insulating material, and the second flexible circuit between the first compression surface and the second compression surface when in the expanded configuration.

[0109] Clause 29: A fixture as described in any of clauses 26 to 28, wherein the first compression surface is configured to flow the first sheet of insulating material at least partially around the framework when in a compressed configuration, and the first flexible circuit extends generally in front of the first plurality of electrodes of the contact surface.

[0110] Clause 30: A fixture as described in any of clauses 27 to 29, wherein the first compression surface and the second compression surface are configured, when in a compressed configuration, to fuse the first sheet of insulating material and the second sheet of insulating material proximate to the framework and at least partially flow around the framework, and the first flexible circuit and the second flexible circuit extend approximately short of the contact surfaces of the first and second plurality of electrodes.

[0111] Clause 31: A fastener according to any one of clauses 27 to 30, wherein the first distance is equal to the second distance.

[0112] Item 32: A fixture described in any one of items 26 to 31, wherein the first distance is approximately equal to 5 micrometers.

[0113] Item 33: A fixture described in any one of items 27 to 32, wherein the second distance is approximately equal to 5 micrometers.

[0114] Item 34: The fixture of any one of items 27 to 33, further comprising a heating element configured to apply heat to the first sheet of insulating material and the second sheet of insulating material.

[0115] [Embodiment] (1) An end effector, comprising: a flexible circuit comprising a plurality of electrodes, the flexible circuit being disposed on an insulating material, each electrode of the plurality of electrodes comprising a contact surface; The end effector, wherein the insulating material is continuous with the contact surfaces such that only the contact surfaces of at least a portion of the plurality of electrodes are exposed to the surrounding environment. (2) An end effector as described in embodiment 1, wherein the flexible circuit further comprises a framework continuous with the insulating material or a portion of the framework is encapsulated within the insulating material, and the contact surface of one of the multiple electrodes comprises an area of ​​the electrode that is not covered by the insulating material. (3) the flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes each having a first contact surface, and the end effector comprises: 3. An end effector as described in embodiment 2, further comprising a second flexible circuit having a second plurality of electrodes, the second flexible circuit being spaced apart from the first flexible circuit, each electrode of the second plurality of electrodes having a second contact surface, the insulating material being further disposed between the first flexible circuit and the second flexible circuit, the insulating material being continuous with the second contact surface such that only the contact surface of each electrode is exposed to the surrounding environment. (4) The end effector of embodiment 3, further comprising a framework disposed between the first flexible circuit and the second flexible circuit. (5) The end effector of embodiment 3, wherein the insulating material is thermoformed around the first flexible circuit, the second flexible circuit, and at least a portion of the framework.

[0116] (6) The flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes each having a first contact surface, and the end effector comprises: a framework disposed proximate to the first flexible circuit; 2. The end effector of claim 1, further comprising: a second flexible circuit having a second plurality of electrodes, the second flexible circuit being spaced apart from the framework on a side of the framework opposite the first flexible circuit, each electrode of the second plurality of electrodes having a second contact surface, the insulating material being further disposed between the framework and the second flexible circuit, the insulating material being thermoformed around at least a portion of the framework and the second flexible circuit. (7) The end effector of claim 6, wherein the insulating material includes a first sheet of insulating material and a second sheet of insulating material fused together into a single continuous, generally planar insulating mass adjacent the framework. (8) The end effector of embodiment 7, wherein the first contact surface lies parallel to a first outer surface of the insulating mass and the first plurality of electrodes extend perpendicularly and outwardly from the first outer surface a first distance. (9) A method of manufacturing an end effector for a medical catheter, the method comprising: placing a flexible circuit comprising a plurality of electrodes within a mold, each electrode 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 to flow at least partially around the flexible circuit continuous with the contact surfaces such that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the surrounding environment. (10) A method according to any one of the preceding claims, wherein the sheet of insulating material comprises a first flexible sheet of material, the flexible circuit comprises a first flexible circuit, and the plurality of electrodes comprises a first plurality of electrodes having a first contact surface, and wherein the method further comprises, prior to the forming, placing a second sheet of insulating material in contact with the first flexible circuit; disposing 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 shaped surface in contact with the second contact surfaces of the second plurality of electrodes; 10. The method of claim 9, further comprising molding the second flexible circuit and the second insulating material to flow the second insulating material at least partially around the second flexible circuit, the insulating material extending approximately short of the second contact surface.

[0117] (11) A method for manufacturing a semiconductor device comprising the steps of: the sheet of insulating material comprising a first flexible sheet of material; the flexible circuit comprising a first flexible circuit and a framework; and the plurality of electrodes comprising a first plurality of electrodes having a first contact surface; and the method further comprising, prior to the forming, placing a second sheet of insulating material in contact with the framework; disposing a second flexible circuit on the second sheet of insulating material opposite the framework, 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 shaped surface in contact with the second contact surfaces of the second plurality of electrodes; 10. The method of claim 9, further comprising: molding the second flexible circuit, the second insulating material, and the framework to cause the second insulating material to flow around the framework and at least partially around the second flexible circuit, wherein the insulating material extends approximately short of the second contact surface. 12. The method of claim 11, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises applying heat to the first sheet of insulating material and the second sheet of insulating material. 13. The method of claim 12, wherein applying heat includes heating the first sheet of insulating material and heating the second sheet of insulating material to about 400 degrees Fahrenheit. 14. The method of claim 11, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises fusing the first sheet of insulating material to the second sheet of insulating material in proximity to the framework. (15) The first insulating material sheet and the second insulating material sheet each contain a thermoplastic elastomer, 15. The method of claim 14, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises applying heat and compression to first contact surfaces of the first plurality of electrodes and second contact surfaces of the second plurality of electrodes.

[0118] (16) The method of claim 1, wherein the first shaped surface comprises a first flexible heat resistant sheet configured to conform to each of the contact surfaces of the first plurality of electrodes; 12. The method of claim 11, wherein the second shaped surface comprises a second flexible heat resistant sheet configured to conform to each of the contact surfaces of the second plurality of electrodes. (17) The method of claim 16, wherein the first flexible heat-resistant sheet comprises a material having a durometer such that upon application of compression, the first plurality of electrodes extend a first distance into the first flexible heat-resistant sheet. (18) A fixture for forming an encapsulated end effector for a medical catheter, the fixture comprising a plurality of components stacked generally 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 along the perpendicular axis relative to the first compression surface from an expanded configuration to a compressed configuration; a first flexible, heat-resistant sheet disposed proximate to the first compression surface, the first flexible, heat-resistant sheet having a durometer such that upon application of compression 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. (19) The plurality of components include 19. The fastener of claim 18, further comprising a second flexible heat-resistant sheet disposed proximate to the second compression surface, the second flexible heat-resistant sheet having a durometer such that upon application of the compression, 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 embodiment 19, wherein the first compression surface and the second compression surface are configured to receive the first flexible circuit, the first sheet of insulating material, the framework, the second sheet of insulating material, and the second flexible circuit between the first compression surface and the second compression surface when in the expanded configuration.

Claims

1. An end effector, a flexible circuit comprising a plurality of electrodes, the flexible circuit being disposed on an insulating material, each electrode of the plurality of electrodes comprising a contact surface; The end effector, wherein the insulating material is continuous with the contact surfaces such that only the contact surfaces of at least a portion of the plurality of electrodes are exposed to the surrounding environment.

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

3. the flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes each having a first contact surface, and the end effector comprises:

3. The end effector of claim 2, further comprising a second flexible circuit comprising a second plurality of electrodes, the second flexible circuit being spaced apart from the first flexible circuit, each electrode 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 continuous with the second contact surface such that only the contact surface of each electrode is exposed to the ambient environment.

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

5. The end effector of claim 3 , wherein the insulating material is thermoformed around the first flexible circuit, the second flexible circuit, and at least a portion of the framework.

6. the flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes each having a first contact surface, and the end effector comprises: a framework disposed proximate to the first flexible circuit; 2. The end effector of claim 1, further comprising: a second flexible circuit comprising a second plurality of electrodes, the second flexible circuit being spaced apart from the framework on a side of the framework opposite the first flexible circuit, each electrode of the second plurality of electrodes comprising a second contact surface, the insulating material being further disposed between the framework and the second flexible circuit, the insulating material being thermoformed around at least a portion of the framework and the second flexible circuit.

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 fused together into a single continuous, generally planar insulating mass adjacent the framework.

8. 8. The end effector of claim 7, wherein the first contact surface lies parallel to a first exterior surface of the insulating mass and the first plurality of electrodes extend perpendicularly and outwardly a first distance from the first exterior surface.

9. 1. A method of manufacturing an end effector for a medical catheter, the method comprising: placing a flexible circuit comprising a plurality of electrodes within a mold, each electrode 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 to flow at least partially around the flexible circuit continuous with the contact surfaces such that only the contact surfaces of at least a portion of the electrodes of the plurality of electrodes are exposed to the surrounding environment.

10. The sheet of insulating material comprises a first flexible sheet of material, the flexible circuit comprises a first flexible circuit, the plurality of electrodes comprises a first plurality of electrodes having a first contact surface, and the method further comprising, prior to the forming, placing a second sheet of insulating material in contact with the first flexible circuit; disposing 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 shaped surface in contact with the second contact surfaces of the second plurality of electrodes; 10. The method of claim 9, further comprising molding the second flexible circuit and the second insulating material to flow the second insulating material at least partially around the second flexible circuit, the insulating material extending approximately short of the second contact surface.

11. The sheet of insulating material comprises a first flexible sheet of material, the flexible circuit comprises a first flexible circuit and comprises a framework, the plurality of electrodes comprises a first plurality of electrodes having a first contact surface, and the method further comprises, prior to the forming, placing a second sheet of insulating material in contact with the framework; disposing a second flexible circuit on the second sheet of insulating material opposite the framework, 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 shaped surface in contact with the second contact surfaces of the second plurality of electrodes; 10. The method of claim 9, further comprising: molding the second flexible circuit, the second insulating material, and the framework to cause the second insulating material to flow around the framework and at least partially around the second flexible circuit, wherein the insulating material extends approximately short of the second contact surface.

12. 12. The method of claim 11, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises applying heat to the first sheet of insulating material and the second sheet of insulating material.

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

14. 12. The method of claim 11, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises fusing the first sheet of insulating material to the second sheet of insulating material in proximity to the framework.

15. the first sheet of insulating material and the second sheet of insulating material comprise a thermoplastic elastomer; 15. The method of claim 14, wherein forming the first sheet of insulating material and forming the second sheet of insulating material comprises 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 first shaped surface comprising a first flexible heat resistant sheet configured to conform to each of the contact surfaces of the first plurality of electrodes; The method of claim 11 , wherein the second shaped surface comprises a second flexible heat resistant sheet configured to conform to each of the contact surfaces of the second plurality of electrodes.

17. 17. The method of claim 16, wherein the first flexible heat resistant sheet comprises a material having a durometer such that upon application of compression, the first plurality of electrodes extend a first distance into the first flexible heat resistant sheet.

18. 1. A fixture for forming an encapsulated end effector for a medical catheter, the fixture comprising a plurality of components stacked generally parallel along a vertical axis of the fixture, the plurality of components comprising: a first compression surface; and a second compression surface disposed opposite the first compression surface and configured to translate along the perpendicular axis relative to the first compression surface from an expanded configuration to a compressed configuration; a first flexible, heat-resistant sheet disposed proximate to the first compression surface, the first flexible, heat-resistant sheet having a durometer such that upon application of compression 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.

19. The plurality of components are 20. The fixture of claim 18, further comprising a second flexible, heat-resistant sheet disposed proximate to the second compression surface, the second flexible, heat-resistant sheet having a durometer such that upon application of the compression, contact surfaces of a second plurality of electrodes extending from a second flexible circuit protrude a second distance into the second flexible, heat-resistant sheet.

20. 20. The fixture of claim 19, wherein the first compression surface and the second compression surface are configured to contain the first flexible circuit, a first sheet of insulating material, a framework, a second sheet of insulating material, and the second flexible circuit between the first compression surface and the second compression surface when in the expanded configuration.

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