Curved end effector for medical catheters

Abstract

To provide end-effectors. [Solution] The technology of the present disclosure includes an end effector comprising a plurality of spines extending along a longitudinal axis and defining a basket assembly, wherein the plurality of spines are configured to bend radially outward from the longitudinal axis to define a radius of curvature with respect to the longitudinal axis and to transition between an extended configuration and a folded configuration. Each of the plurality of spines may include a section extending radially outward from the radius of curvature defined by the remainder of the spine. The end effector may further include at least one electrode disposed on the section for each of the plurality of spines.

Description

Technical Field

[0001] The present invention generally relates to minimally invasive medical devices, specifically, sensing catheters, and further relates to, but is not exclusive to, cardiac mapping catheters and their manufacture.

Background Art

[0002] Cardiac arrhythmias such as atrial fibrillation occur when electrical signals abnormally conduct from a region of cardiac tissue to adjacent tissue, thereby disrupting the normal cardiac cycle and causing asynchronous rhythm. The undesired signal source may be located in atrial or ventricular tissue. The unwanted signals may conduct through the cardiac tissue to other locations, causing or continuing an arrhythmia.

[0003] Treatments for treating arrhythmias include surgically interfering with the signal source causing the arrhythmia and interfering with the conduction path of such signals. More recently, it has been found that by mapping the electrical properties and cardiac volume of the endocardium and selectively ablating cardiac tissue by applying energy, it is possible to interrupt or modify the propagation of unwanted electrical signals from one part of the heart to another. The ablation process breaks the unwanted electrical path by forming a non-conductive lesion.

[0004] In this two-step procedure, including mapping and subsequent ablation, a catheter equipped with one or more electrical sensors is usually advanced into the heart, and by acquiring data at a number of points, the electrical activity at each point within the heart is sensed and measured. Then, using these data, the target area where ablation is to be performed is selected.

[0005] For higher mapping resolution, it is desirable that the mapping catheter closely conforms to the target anatomical structure. For mapping within the atria or ventricles (e.g., the apex of the ventricle), it is desirable that the catheter collects more data signals in a shorter time. Furthermore, it is desirable that such a catheter allows sufficient electrode contact with various tissue surfaces, e.g., flat, curved, irregular, or non-planar surface tissues, and is foldable for non-invasive advancement and retreat through the patient's vascular system. Existing catheters generally require rigid internal structural members to ensure that the predetermined configuration is maintained. This rigidity is disadvantageous during manipulation within body organs, as it can hinder electrode contact with tissue.

[0006] Other catheters may include flexible end-effectors designed to overcome this disadvantage. These catheters may contain layered components, which 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 encapsulation material via laser cutting or mechanical removal, and both the layered components and the electrode contact surfaces increase labor time and production costs. [Overview of the Initiative] [Means for solving the problem]

[0007] To enable the time- and cost-efficient manufacturing of end effectors that enhance the functionality of mapping and ablation catheters as mentioned in the background section, this 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 target biostructure, delivery of the end effector to the target biostructure, biocompatibility, end effector rigidity, and non-traumaticity.

[0008] An end effector is provided according to the art of this disclosure, having a length extending along a longitudinal axis from a proximal end to a distal end, a width extending along a horizontal axis perpendicular to the longitudinal axis, and a thickness extending along a vertical axis perpendicular to the longitudinal and horizontal axes. The end effector may include a flexible circuit comprising a plurality of electrodes. The flexible circuit may be arranged on an insulating material, and each of the plurality of electrodes may include a contact surface. The insulating material may be continuous with the contact surfaces such that only at least some of the contact surfaces of the plurality of electrodes are exposed to the ambient environment. The framework may be at least partially enclosed within the insulating material and may be curved along the width in a direction along the vertical axis such that the end effector includes curvature along its width from around the proximal end to around the distal end.

[0009] The technology of this disclosure may include an end effector comprising a flexible circuit having a plurality of electrodes. The flexible circuit may be disposed within a first insulating layer of an insulating material, and each of the plurality of electrodes may include a contact surface. The insulating material may be continuous with the contact surfaces such that only at least some of the contact surfaces of the plurality of electrodes are exposed to the ambient environment. The framework may be at least partially enclosed within the first insulating layer, and the lumen may be defined within the insulating material.

[0010] The technology of this disclosure may further include a method for manufacturing an end effector of a medical catheter. The method may include encapsulating a framework within a first insulating layer. The framework may include a shape memory material configured to curve along the width of the framework from around the proximal end of the framework to around the distal end of the framework. The method may further include arranging a flexible circuit having a plurality of electrodes on a first side of the first insulating layer, each of the plurality of electrodes including a contact surface. The method may further include arranging an insulating material sheet in contact with the flexible circuit. The insulating material sheet may be bonded to the outer surface of the first insulating layer to seal the flexible circuit between the insulating material sheet and the first insulating layer.

[0011] Additional features, functions, and applications of the technology disclosed herein are discussed in more detail herein. [Brief explanation of the drawing]

[0012] [Figure 1] This is a schematic diagram of a medical system, including a medical device, based on the technology disclosed herein. [Figure 2] This is a schematic diagram of a perspective view of an end effector using the technology disclosed herein. [Figure 3] Figure 2 is a schematic diagram showing an exploded perspective view of the end effector. [Figure 4] This is a schematic diagram of a cross-section of an end effector along line 4-4 in Figure 2, based on the technology of this disclosure. [Figure 5A] This is a schematic diagram of a perspective view of an end effector using the technology disclosed herein. [Figure 5B] This is a schematic diagram of a perspective view of an end effector using the technology disclosed herein. [Figure 5C] This is a schematic diagram of a perspective view of an end effector showing the radius of curvature, based on the technology disclosed herein. [Figure 5D] This is a schematic diagram of a perspective view of an end effector showing the radius of curvature, based on the technology disclosed herein. [Figure 6] This is a schematic diagram of a cross-section of an alternative configuration for an end effector using the technology disclosed herein. [Figure 7] This is a schematic diagram of a cross-section of an alternative configuration for an end effector using the technology disclosed herein. [Figure 8A] This is a schematic diagram of a cross-section of an alternative configuration for an end effector using the technology disclosed herein. [Figure 8B] This is a schematic drawing of the cross-sectional detail view of Figure 8A, based on the technology disclosed herein. [Figure 8C] This is a schematic diagram of a cross-section of an alternative configuration for an end effector using the technology disclosed herein. [Figure 8D] This is a schematic drawing of the cross-sectional detail view of Figure 8C, based on the technology disclosed herein. [Figure 8E]A schematic drawing of the cross-sectional detail view of FIG. 8D according to the technology of the present disclosure. [Figure 9A] A schematic drawing of a cross-section of another alternative configuration of an end effector according to the technology of the present disclosure. [Figure 9B] A schematic drawing of a cross-section of another alternative configuration of an end effector according to the technology of the present disclosure. [Figure 10] A flowchart of a method for manufacturing an end effector for a medical device according to the technology of the present disclosure. [Figure 11] A schematic drawing of a medical device assembly according to the technology of the present disclosure. [Figure 12] A schematic drawing of a top view of an end effector folded within a sheath according to the technology of the present disclosure.

Mode for Carrying Out the Invention

[0013] The following detailed description should be read with reference to the drawings, and like elements in different drawings are assigned the same numbers. The drawings are not necessarily to scale and depict selected embodiments and are not intended to limit the scope of the present invention. The detailed description is illustrative, not limiting, and exemplifies the principles of the present invention. This specification describes some embodiments, adaptations, variations, alternatives, and uses of the present invention, including what is currently considered to be the best mode for carrying out the present invention, which will clearly enable those skilled in the art to make and use the present invention.

[0014] As used herein, the terms "about" or "approximately" with respect to any numerical value or range indicate a suitable dimensional tolerance that allows a component or collection to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values that are ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%. Additionally, as used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject, and the use of the present invention in human patients represents a preferred embodiment, but is not intended to limit the system or method to human use. Similarly, the term "proximal" indicates a position closer to the operator or physician, while "distal" indicates a position farther from the operator or physician.

[0015] When considered herein, the tissues, vasculature, or organs of "patients", "hosts", "users", and "subjects" can be those of humans or any animals. It should be understood that the animals can be of various arbitrary applicable types, including but not limited to mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain properties similar to humans. It should be understood that the subject can be, for example, any applicable human patient.

[0016] As discussed herein, "physician" can include physicians, surgeons, technicians, scientists, operators, or any other individual or delivery instrument related to the delivery of a multi-electrode medical device for the treatment of drug refractory atrial fibrillation to a subject.

[0017] As discussed herein, the terms “to ablate” or “ablation” refer to the devices and corresponding systems of this disclosure and to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells. Throughout this disclosure, these terms are interchangeable with pulsed electric field (PEF) and pulsed field ablation (PFA), for example, by utilizing thermal energy such as radio frequency (RF) ablation or non-thermal energy such as irreversible electroporation (IRE). In relation to the devices and corresponding systems of this disclosure, “to ablate” or “ablation” is used throughout this disclosure to refer to thermal or non-thermal ablation of cardiac tissue in specific conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The terms “to ablate” or “ablation” also include known methods, devices, and systems for achieving various forms of body tissue ablation, as 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 a right cylindrical structure, a structure with a strictly circular cross-section, or a structure with a uniform cross-section over its entire 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 outer surface without departing from the scope of this disclosure.

[0019] This disclosure relates to systems, methods, or uses and devices for mapping and ablation of cardiac tissue for the treatment of cardiac arrhythmias. Ablation energy is typically delivered to cardiac tissue by the tip of a medical device (e.g., a medical probe or catheter) that can deliver the ablation energy along with the tissue being ablated. Some exemplary catheters include a three-dimensional structure in their tip and are configured to manage ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy.

[0020] Cardiac tissue ablation, which involves applying radiofrequency (RF) energy and thermal techniques such as cryoablation, is a well-known procedure for improving a dysfunctional heart. Typically, to successfully ablate using thermal techniques, it is necessary to measure electrocardiograms at various locations in the myocardium. In addition, temperature measurements during ablation provide data that enables the effectiveness of the ablation. In ablation procedures using thermal techniques, electrode potentials and temperature are usually measured before, during, and after the actual ablation. RF approaches can carry risks that can lead to tissue carbonization, combustion, 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 cryoablation devices and selectively applying cryoablation is generally more difficult than RF ablation. Therefore, cryoablation is not feasible in certain anatomical shapes that can be reached by electroablation devices.

[0021] This disclosure may include electrodes configured for RF ablation, cryoablation, and / or irreversible electroporation (IRE). Throughout this disclosure, IRE may be interchangeably referred to as pulsed field (PEF) ablation and pulsed field ablation (PFA). The IRE considered in this disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. To ablate using IRE / PEF, a biphasic voltage pulse is applied to destroy the cellular structure of the myocardium. The biphasic pulse is a non-sinusoidal waveform 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 save adjacent heat-sensitive structures or tissues, which would be beneficial in reducing the potential complications known in ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0022] Refer to Figure 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 into a lumen or vascular structure of the heart 12 through the vascular system of the patient 23. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location in the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include a catheter dedicated to sensing intracardiac electrophysiological (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGM is illustrated herein. To sense a target site in the heart 12, the physician 24 brings the catheter shaft (i.e., multilayer end effector 100) with the distal tip 28 of the catheter 14 into contact with the heart wall. For ablation, the physician 24 similarly brings the distal end of the ablation catheter to the target site for ablation.

[0023] Catheter 14 is an exemplary catheter comprising one, preferably more electrodes, optionally distributed across an end effector 100 coupled to a catheter shaft and configured to sense IEGM signals, as will be described in more detail below. Catheter 14 may additionally include a position sensor embedded in or near the end effector 100 to track the position and orientation of the end effector 100. Optionally and preferably, the position sensor is a magnetic-based position sensor comprising multiple magnetic coils for sensing three-dimensional (3D) position and orientation.

[0024] A magnetic-based position sensor may operate in conjunction with a position pad 25 which includes a plurality of magnetic coils 32 configured to generate a magnetic field within a given 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 position pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patents No. 5,391,199, No. 5,443,489, No. 5,558,091, No. 6,172,499, No. 6,239,724, No. 6,332,089, No. 6,484,118, No. 6,618,612, No. 6,690,963, No. 6,788,967, and No. 6,892,091, each of which is incorporated herein by reference.

[0025] System 10 includes one or more electrode patches 38 placed for skin contact on a patient 23 to establish a position reference for the position pad 25 and impedance-based tracking of the electrodes. For impedance-based tracking, current is directed to the electrodes and sensed in the electrode skin patches 38, thereby allowing the position of each electrode to be triangulated through the electrode patches 38. Details of the impedance-based location tracking technology 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.

[0026] The recorder 11 displays the electromagnetism 21 captured by the surface ECG electrodes 18 and the intracardiac electromagnetism (IEGM) captured by the electrodes of the catheter 14. The recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to a standalone pacer.

[0027] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes 26 located at the distal tip 28 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, pulsed-field ablation (PFA) energy including unipolar or bipolar high-voltage DC pulses that can be used to perform irreversible electroporation (IRE), or a combination thereof.

[0028] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheter, the electrophysiological equipment, the power supply, and the workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, position pads 25, 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 for implementing real-time calculation of catheter position and performing ECG calculations.

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

[0030] Figure 2 shows an example of an end effector 100 according to the present disclosure to achieve ease of manufacture, cost reduction, and enhancement of end effector characteristics such as desired foldability, operability, robustness, rigidity, mapping resolution, electrode contact with the target anatomical structure, and the suitability of the end effector 100 disclosed herein to flat, curved, irregular, and / or non-planar tissue surfaces found within the target anatomical structure. The end effector 100 may comprise a length L extending along a longitudinal axis LL from a proximal end to a distal end, a width W extending along a horizontal axis HH perpendicular to the longitudinal axis, and a thickness T extending along a vertical axis VV perpendicular to the longitudinal and horizontal axes.

[0031] The end effector 100 may include a flexible circuit 110 comprising a plurality of electrodes 112, each electrode comprising a contact surface 112c. As used herein, the term “flexible circuit” includes thin-film circuits, flexible printed circuit boards, and thin-film deposition by lithography and etching processes on substrates such as polyimide, copper, LCP (e.g., Panasonic FELIOS™ series of flexible circuit boards), nitinol substrates, or polymer substrates such as Panasonic BEYOLEX™ PRINTED ELECTRONICS SUBSTRATE Series. In some embodiments, the flexible circuits described herein may be fabricated primarily from polyimide. In other embodiments, they may be fabricated using biocompatible polyimide, glass-reinforced epoxy laminates, copper, or graphene, either 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, with electrodes having substantially much thicker versions of the traces, such that a typical polyimide substrate is no longer required. In some embodiments, the electrodes described herein may include at least one mapping electrode and / or at least one ablation electrode, and may be configured to detect an electrophysiological signal or to transmit ablation energy AC or DC from an energy generator to the tissue according to various ablation methods mentioned herein, such as RF, IRE, etc.

[0032] The flexible circuit 110 can be placed on an insulating material 120 (also known as an insulating material). The insulating material 120 can be continuous with the contact surfaces 112c such that only at least some of the contact surfaces 112c of the plurality of electrodes 112 are exposed to the ambient environment. As used herein, the term “contact surface” includes portions of electrodes having a substantially flat surface and one or more edges directly surrounding the flat surface. The electrodes 112 may have slightly rounded, rounded, or chamfered edges that contact the tissue along with the substantially flat surface when the end effector 100 is placed in contact with the tissue. As used herein, “ambient environment” refers to the external environment, such as an operating room, before the end effector 100 is placed in the organ or biological organ.

[0033] It should be noted that all electrodes 112 on the end effector 100 described herein do not 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 contact electrodes. Similarly, far-field signals containing noise or artifacts can be reduced or offset against the entire end effector having a reference electrode that does not come into contact with tissue and only with blood. Irrigation can be provided using irrigation ports 163a on one side and 162b on the other side, which are in fluid communication with an irrigation line (not shown) located within the catheter shaft 210. Instead of a separate irrigation line from the catheter shaft 210, a lumen can be formed by extrusion molding of the catheter shaft 210 to provide a lumen channel. It should be noted that the port 163a or 162b may be configured to have sufficient flow-shattering properties so that the irrigation fluid covers the mapping electrode in the irrigation flow to prevent or reduce thrombus formation.

[0034] The end effector 100 may further include a framework 130 that is continuous with or at least partially enclosed within the insulating material 120. In an example where the end effector 100 includes a framework 130, the framework 130 may be separated from the flexible circuit 110 by a portion of the insulating material 120 that lies between them.

[0035] Figure 3 shows an exploded view of the end effector 100, where its components are vertically separated along the vertical axis VV (also referred to as the height direction) of the end effector 100. The flexible circuit 110 may be a first flexible circuit 110, and the plurality of electrodes 112 may be a plurality of first electrodes 112, each first electrode 112 including a first contact surface 112c. The end effector 100 may further include a second flexible circuit 140 having a plurality of second electrodes 142. The second flexible circuit 140 may be spaced apart from the first flexible circuit 110, but each electrode of the second plurality of electrodes 142 may have a second contact surface 142c. The contact surfaces 112c, 142c are configured to be in contact with tissue or located proximal to tissue during use. Furthermore, each flexible circuit 110, 140 includes a tine that extends along the longitudinal axis LL, and the tine supports its respective electrode.

[0036] In embodiments having a first flexible circuit 110 and a second flexible circuit 140, the insulating material 120 may be placed between the first flexible circuit 110 and the second flexible circuit 140, but the insulating material 120 may be continuous with 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 how the first electrode 112 is placed within the insulating material and exposed through the insulating material 120.

[0037] Electrodes 112 and 142 can sense tissue signals or transmit AC or DC energy from an energy generator to the tissue. In some embodiments, there are about 92 electrodes. In some embodiments, there are about 48 electrodes. In some embodiments, there are about 64 electrodes. In some embodiments, there are about 72 electrodes. In some embodiments, there are about 98 electrodes. However, those skilled in the art will understand that various numbers of electrodes 112 and 142 can be used without departing from the spirit and scope of this disclosure.

[0038] In the examples herein, the end effector 100 includes a framework 130 positioned between a first flexible circuit 110 and a second flexible circuit 140. The framework 130 may be a component of the end effector 100 that is separated from and distinct from the first flexible circuit 110, and positioned in close proximity to the first flexible circuit 110. In this case, insulating material 120 may be further positioned 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 preferred method. For example, the framework 130 may be formed by cutting, laser cutting, stamping, etc.

[0039] The framework includes multiple spines extending along the longitudinal axis LL. The tines of the flexible circuits 110, 140 may be approximately aligned with one or more of the spines, so that the spine 132 provides support to them.

[0040] The insulating material 120 may include a first insulating material sheet 120a and a second insulating material sheet 120b, which are fused together in close proximity to the framework 130 to form a single, continuous, generally planar insulating material 120. This insulating material 120 also serves to enhance the non-traumatic properties of the end effector 100 and to protect the object from sharp edges.

[0041] Figure 4 shows a cross-sectional view of the end effector 100. As seen in Figure 4, the insulating material 120 includes opposing outer surfaces 122a (referred to herein as the first insulating surface 122a) and 122b (referred to herein as the second insulating surface 122b). In some embodiments, the first and second outer surfaces 122a and 122b extend in substantially parallel planes.

[0042] The insulating material 120 may include a polymer. The insulating material 120 can be thermoformed around the first flexible circuit 110, the second flexible circuit 140, and at least a portion of the framework 130. The polymer may include, but is not limited to, thermoplastic polyurethane (TPU), or other thermoforming or molding materials suitable for such thermoforming, such as silicone or siloxane.

[0043] Figures 5A to 5D show curved end effectors in several examples. In some embodiments, the framework 130 may be curved along the horizontal axis HH and in the direction along the vertical axis, such that the end effector 100 has curvature along its width W from the proximal end to the distal end. The curvature can help reduce insertion force and reduce shear risk.

[0044] In some embodiments, as shown in Figure 5C, the curvature may be uniform throughout the entire length of the paddle. In some embodiments, the curvature may include a radius R of about 8 mm to about 15 mm. In some embodiments, the curvature may start with an initial radius, for example about 4 mm, at the first end 103 and gradually open to a flat paddle at the second end 104. The curvature may be provided to facilitate contact of the electrode of the end effector 100 with the tissue surface being treated.

[0045] In some embodiments, the curvature may be applied along the horizontal axis HH, along the longitudinal axis LL, and along the length L of the end effector. Similar to the curvature along the width W, the curvature along the length may include a constant radius or an increasing radius. For example, the curvature may begin at the proximal end 101 with an initial radius, e.g., 4 mm, and gradually open to a flat paddle at the distal end 102. In some embodiments, the end effector may be curved along both its width W and length L.

[0046] In some embodiments, the curvature can be created by a set of shapes within the framework 130. In some embodiments, the curvature can be created by fixing a flat framework 130 in a curved configuration to components such as inserts, tubes, or tethers. In some embodiments, the framework 130 includes a shape memory material. In some embodiments, the shape memory material is configured to return to a predetermined shape with curvature at an activation temperature. This can facilitate the movement of the end effector 100 through the sheath before being activated to return to the set shape in the patient's body. In some embodiments, the activation temperature of the shape memory material is about 37°C. The shape memory material may include nitinol, or similar biocompatible shape memory materials such as copper-aluminum-nickel alloys, titanium-niobium alloys, titanium-tantalum alloys, titanium-molybdenum alloys, and titanium-zirconium alloys.

[0047] Referring to Figure 6, in some embodiments, the outer surfaces 122a, 122b of the insulating material 120 may have a number of folds 127 along the length L of the end effector 100. The folds 127 can facilitate the folding or winding of the end effector 100 when it moves through or is inserted into the sheath, as shown in Figure 12. The folds 127 can provide predetermined folds and wrinkle lines or zones. The folds 127 can reduce stress concentration in the insulating material 120 or critical components (such as electrical traces) when the end effector is folded, thereby preventing breakage or damage to the insulating material 120. In some embodiments, the folds 127 are provided on the outer surfaces 122a, 122b of the insulating material 120. In some embodiments, the fold 127 may be provided on only one side of the end effector, resulting in only the first outer surface 122a or the second outer surface 122b of the insulating material 120 containing the fold 127, while the opposite outer surface is substantially flat. An additional fold 127 may be added to one side to facilitate folding in a particular direction at a particular location. In some embodiments, forming the fold 127 involves at least one of laser drilling, chemical etching, or stamping. In some embodiments, a separate component having the fold 127 (e.g., a folded polyimide layer) can be laminated to form part of the end effector assembly.

[0048] In some embodiments, the insulating material 120 may be shaped, corrugated, undulating, raised, concave, convex, or otherwise configured such that the overall shape of the insulating material 120 gives physical and / or mechanical properties such as rigidity and flexibility along multiple axes required by the end effector 100 mentioned above.

[0049] Referring to Figure 7, in some embodiments, the outer surfaces 122a, 122b of the insulating material 120 may have a plurality of inclined edges. In some embodiments, as shown in Figure 11, the medical probe assembly 200 includes a tubular member 230 extending along the longitudinal axis LL, configured to deliver one of the aforementioned end effectors 100 to and from the sheath 250, and / or return to the sheath. Particularly as seen in Figure 12, when the end effector 100 is folded into the lumen 212 of the sheath 250, the sides of the end effector 100 can come into contact with each other and be compressed against each other until one side slides inward, allowing the paddle to roll on itself. By providing inclination on the edges, sliding can be facilitated, which can facilitate the early rolling of the end effector 100, thereby reducing resistance when the end effector 100 is folded into the sheath or insertion tool. In some embodiments, the inclined edges are imprinted with lamination fixtures.

[0050] Figures 8A to 8E show cross-sectional views of a multilayer end effector 100 including a first flexible circuit 110, a first electrode 112, an insulating material, a framework 130, a second flexible circuit 140, and a second electrode 142. The insulating material encloses and / or separates the components of the end effector 100, as discussed in previous embodiments. In this configuration, the insulating material is formed from three insulating sheets, namely a first sheet 120a, a second sheet 120b, and a third sheet 120c. A boundary layer 123 is formed where the second sheet 120b abuts against the first sheet 120a, and where the third sheet 120c abuts against the first sheet 120a. The framework 130 is at least partially enclosed by a first insulating material sheet 120a, the first flexible circuit 110 is at least partially enclosed by a second insulating material sheet 120b, and the second flexible circuit 140 is at least partially enclosed by a third insulating material sheet 120c. The flexible circuits 110 and 140 may be provided on or adjacent to the boundary layer 123.

[0051] In some embodiments, a gap 125 is provided between at least one surface of the flexible circuits 110, 140 and the respective sheets 120b, 120c of the insulating material. The gap 125 provides separation between the flexible circuits 110, 140, and the insulating material provides additional flexibility of the end effector 100 when, for example, the end effector 100 is bent relative to the horizontal axis HH.

[0052] Referring to Figure 8A, the gap 125 may be provided between at least one surface of the flexible circuits 110, 140 along the length of the end effector 100. In some embodiments, the gap 125 is provided around three surfaces, the top surface and two sides of the flexible circuits 110, 140. As shown in Figure 8E, a separation distance d1 can be provided between the side of the flexible circuit and the insulating material, and a separation distance d2 can be provided between the top surface of the flexible circuit and the insulating material. In some embodiments, separation distances d1 and d2 are equal. Figure 8C shows a cross-sectional view at the location where electrodes 112, 142 are provided on the flexible circuit, with the gap 125 provided around the flexible circuits 110, 140, although the insulating material may be in contact with electrodes 112, 114. The figure shows flexible circuits 110, 140 having a rectangular cross-section, but it can be understood that a similar gap 125 may be applied to flexible circuits having alternative shapes.

[0053] Figures 9A and 9B illustrate other embodiments of the present disclosure. Irrigation is typically required in medical catheters for various reasons, including, but not limited to, cooling and / or temperature control (e.g., during ablation), and prevention of blood clot formation. The designs shown in these figures can employ similar (or the same) concepts as those described above (e.g., folds, curved end effectors, flexible circuits 110, 140, and electrodes 112, 142). In some embodiments, at least one lumen is formed within the insulating material 120.

[0054] Figure 9A shows a cross-sectional view of a multilayer end effector 100 including a first flexible circuit 110, a first electrode 112, an insulating material 120, a framework 130, a second flexible circuit 140, and a second electrode 142. The insulating material 120 similarly encapsulates and / or separates the components of the end effector 100, as discussed in previous embodiments. In this configuration, the insulating material 120 is formed from four insulating sheets, namely a first sheet 120a, a second sheet 120b, a third sheet 120c, and a fourth sheet 120d, which are thermoformed together to form a single continuous mass. In some embodiments, a boundary layer 123 is formed where the insulating sheets abut each other. The framework 130 is placed on the first insulating sheet 120a and the second insulating sheet 120b and sandwiched between the first insulating sheet 120a and the second insulating sheet 120b. Although the flexible circuits 110 and 140 are shown as being placed on a third insulating sheet 120c and a fourth insulating sheet 120d, respectively, as will be understood by those skilled in the art, the flexible circuits 110 and 140 may be placed on any suitable layer / sheet of insulating material 120 without departing from the spirit and scope of the present disclosure.

[0055] The insulating material 120 defines one or more first lumens 124a formed between adjacent first sheets 120a and third sheets 120c. Depending on the irrigation requirements of the system, one or more second lumens 124b may be additionally formed between adjacent second sheets 120b and fourth sheets 120d. These lumens 124a, 124b may extend from the proximal end to the distal end of the end effector 100 and / or may include channels formed through the outermost sheets 120c, 120d at predetermined locations along the longitudinal axis LL. Methods for forming these lumens 124, 126 are discussed in more detail herein.

[0056] In some embodiments, one or more first lumens 124a are formed by recesses provided in the third sheet 120c such that the first lumens 124a are defined in a boundary layer 123 where the first insulating sheet 120a and the third insulating sheet are joined. Similarly, one or more second lumens 124a may be formed by recesses provided in the fourth sheet 120d such that the second lumens 124b are defined in a boundary layer 123 where the second insulating sheet 120b and the fourth insulating sheet are joined.

[0057] Figure 9B shows a similar concept to Figure 9A, but with a different configuration of insulating material 120 and lumen 124, illustrating an alternative approach that employs the concept discussed herein. In this example, a first sheet 120a and a second sheet 120b are formed together to form an insulating material / insulating material 120 that at least partially encloses the framework. A single lumen 124 is formed by recesses provided in the first sheet 120a and the second sheet 120b, which, when formed together, collectively define the lumen 124. In this example, the lumen 124 is positioned laterally with respect to the framework 130 and flexible circuits 110, 140. An additional insulating sheet may be provided on the outer surface 122a1 of the first sheet 120a to partially enclose an electrode 112. Similarly, an additional insulating sheet may be provided on the outer surface 122b1 of the second sheet 120a to partially enclose an electrode 142.

[0058] As discussed herein, insulating sheets can be joined by any suitable process, such as thermal, mechanical, or laser forming processes. In some embodiments, lumens can be formed by selectively leaving one or more areas of the insulating material 120 in an unlaminated state (i.e., not thermoformed or laser welded), and leaving some areas in an unlaminated state provides a tunnel for the irrigation fluid. In some embodiments, lumens can be formed by selectively laminating a first sheet and a second sheet such that the unlaminated sections of the first and second sheets define the lumen. For example, the end effector 100 of Figure 9A may have a lumen 124a fabricated by selectively laminating sheets 120a, 120c at their contact surfaces 123 (e.g., via laser welding), where the unlaminated sections form a void that functions as the irrigation lumen 124a.

[0059] As discussed herein, laser welding can be used to selectively bond various layers of a TPU / thermoplastic polymer matrix that form an insulating sheet. This may allow for complete sealing of components within the polymer matrix, while also giving some freedom of movement / shift to the flexible circuit. In another example, a hot press with dedicated hot zones (through bosses, cooling lines, various conductive and nonconductive materials) can also be used for selective lamination, leaving one or more areas of the insulating material 120 in an unlaminated state (i.e., not thermoformed), thereby providing tunnels for irrigation fluids.

[0060] In some embodiments, the lumen is formed by creating a recess in one of the sheets (e.g., the first sheet). This can be done by any suitable process, such as laser cutting.

[0061] In some embodiments, the lumen is formed by partially positioning a second material having a higher melting point than the insulating material between a first sheet and a second sheet. For example, the second material may include, but is not limited to, polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), and polyimide. In addition to the tubular shape, a rectangular lumen can be formed by positioning two or more flat / rectangular strips with gaps between them.

[0062] In some embodiments where a second material (e.g., polyetheretherketone (PEEK), polished stainless steel, etc.) is used, two sheets can be laminated, and then the second material can be removed, leaving a void as a lumen. In other words, the second material is only temporarily part of the structure of the end effector 100 as part of the manufacturing process.

[0063] Figure 10 shows an exemplary method 1000 for manufacturing an end effector 100 for a medical catheter. In some embodiments, the method includes, in step 1002, encapsulating a framework 130 within a first insulating layer. In some embodiments, in step 1004, a first flexible circuit including a plurality of electrodes is positioned on the first side of the first insulating layer. In some embodiments, the method further includes, in step 1008, positioning an insulating material sheet in contact with the first flexible circuit. In some embodiments, in step 1012, the insulating material sheet is bonded to the outer surface of the first insulating layer to seal the first flexible circuit between the insulating material sheet and the first insulating layer. The method may further include, in step 1006, positioning a second flexible circuit including a plurality of electrodes on the second side of the first insulating layer. In some embodiments, the method further includes, in step 1010, positioning a second insulating material sheet in contact with the second flexible circuit. In some embodiments, step 1014 involves bonding a second insulating material sheet to the first insulating layer to seal the second flexible circuit between the second insulating material sheet and the first insulating layer. The method may further include the step of exposing the contact surfaces of each electrode 112 by laser cutting the insulating material sheet around the contact surfaces 112c of each electrode 112.

[0064] The technologies of this disclosure described herein can be further understood in accordance with the following provisions. Clause 1: An end effector having a length extending along a longitudinal axis from a proximal end to a distal end, a width extending along a horizontal axis perpendicular to the longitudinal axis, and a thickness extending along a vertical axis perpendicular to the longitudinal axis and the horizontal axis, comprising a flexible circuit having a plurality of electrodes, the flexible circuit being arranged on an insulating material, each of the plurality of electrodes having a contact surface, the insulating material being continuous with the contact surfaces such that only at least a portion of the contact surfaces of the plurality of electrodes are exposed to the ambient environment; and a framework at least partially enclosed within the insulating material, the framework being curved along the width in a direction along the vertical axis such that the end effector has curvature along its width from around the proximal end to around the distal end.

[0065] Clause 2: The curvature of the end effector as described in Clause 1 includes a radius of approximately 8 mm to approximately 15 mm.

[0066] Clause 3: The radius of curvature is uniform throughout the entire length of the end effector, as described in Clause 1.

[0067] Clause 4: The radius of curvature increases from the proximal end to the distal end, as described in Clause 1.

[0068] Clause 5: The radius of curvature at the proximal end is approximately 4 millimeters, as described in Clause 4 for the end effector.

[0069] Clause 6: The end effector according to Clause 1, wherein the framework includes a shape memory material configured to return to a predetermined shape having curvature at an activation temperature.

[0070] Clause 7: The activation temperature of the end effector described in Clause 6 is approximately 37°C.

[0071] Clause 8: The end effector described in Clause 6, wherein the shape memory material contains nitinol.

[0072] Clause 9: The end effector described in Clause 1, wherein the outer surface of the insulating material has multiple folds along the length of the end effector.

[0073] Clause 10: The outer surface of the insulating material is sloped between adjacent spines of the framework, as described in Clause 1.

[0074] Clause 11: The end effector as described in Clause 1, wherein the insulating material further defines a gap between at least one surface of the flexible circuit and the inner surface of the insulating material.

[0075] Clause 12: The end effector according to Clause 1, further comprising a lumen formed within an insulating material.

[0076] Clause 13: The lumen is located adjacent to the spine of the framework, as described in Clause 12.

[0077] Clause 14: A method for manufacturing an end effector for a medical catheter, comprising: encapsulating a framework within a first insulating layer, the framework comprising a shape memory material configured to curve along the width of the framework from around the proximal end of the framework to around the distal end of the framework; arranging a flexible circuit comprising a plurality of electrodes on a first side of the first insulating layer, each of the plurality of electrodes comprising a contact surface; arranging an insulating material sheet so as to be in contact with the flexible circuit; and bonding the insulating material sheet to the outer surface of the first insulating layer to seal the flexible circuit between the insulating material sheet and the first insulating layer.

[0078] Clause 15: The method according to Clause 14, further comprising the step of exposing the contact surface of each electrode by laser cutting an insulating material sheet around the contact surface of each electrode.

[0079] Clause 16: Bonding an insulating material sheet to the outer surface of the first insulating layer is the method according to Clause 14, including laser bonding.

[0080] Clause 17: Bonding an insulating material sheet to the outer surface of the first insulating layer, including thermal bonding, as described in Clause 14.

[0081] Clause 18: The method of Clause 14, wherein the end effector defines the gap between the point where the insulating material sheet is welded to the outer surface and the flexible circuit.

[0082] Clause 19: The method according to Clause 14, further comprising forming folds in an insulating material sheet.

[0083] Clause 20: The method according to Clause 19, wherein forming a fold includes at least one of laser perforation, chemical etching, or stamping.

[0084] Clause 21: The method according to Clause 14, further comprising forming a lumen within the first insulating layer.

[0085] Clause 22: The method according to Clause 14, further comprising forming a first lumen between a first insulating layer and an insulating material sheet.

[0086] Clause 23: End effector comprising: a flexible circuit having a plurality of electrodes, the flexible circuit being arranged on a first insulating layer on an insulating material, each of the plurality of electrodes having a contact surface, and the insulating material being continuous with the contact surfaces such that only at least a portion of the contact surfaces of the plurality of electrodes are exposed to the ambient environment; a framework at least partially enclosed in the first insulating layer; and a lumen defined within the insulating material.

[0087] Clause 24: The end effector described in Clause 23, wherein the lumen is formed within the first insulating layer.

[0088] Clause 25: The end effector according to Clause 23, further comprising a first insulating material sheet attached to the first insulating layer, wherein the lumen is formed between the first insulating layer and the first insulating material sheet.

[0089] The embodiments described above are cited as examples, and the technology of this disclosure is not limited to those specifically illustrated and described in the above specification. Rather, the scope of the technology of this disclosure includes both combinations and partial combinations of the various features described above, as well as variations and modifications thereof not disclosed in the prior art, which a person skilled in the art would conceive of by reading the above description.

[0090] [Implementation Method] (1) An end effector having a length extending along a longitudinal axis from a proximal end to a distal end, a width extending along a horizontal axis perpendicular to the longitudinal axis, and a thickness extending along a vertical axis perpendicular to the longitudinal axis and the horizontal axis, wherein the end effector is A flexible circuit comprising multiple electrodes, wherein the flexible circuit is arranged on an insulating material (120), each of the multiple electrodes has a contact surface, and the insulating material is continuous with the contact surfaces such that at least some of the contact surfaces of the multiple electrodes are exposed to the surrounding environment. An end effector comprising: a framework that is at least partially encapsulated within the insulating material and curved along the width in a direction along the vertical axis such that the end effector has curvature along its width from around the proximal end to around the distal end. (2) The end effector according to Embodiment 1, wherein the curvature includes a radius (R) of about 8 mm to about 15 mm. (3) The end effector according to Embodiment 1, wherein the radius of the curvature is uniform over the entire length of the end effector. (4) The end effector according to Embodiment 1, wherein the radius of curvature increases from the proximal end to the distal end. (5) The end effector according to Embodiment 4, wherein the radius of curvature at the proximal end is approximately 4 millimeters.

[0091] (6) The end effector according to Embodiment 1, wherein the framework includes a shape memory material configured to return to a predetermined shape having the curvature at an activation temperature. (7) The end effector according to Embodiment 6, wherein the activation temperature is approximately 37°C. (8) The end effector according to Embodiment 6, wherein the shape memory material contains nitinol. (9) The end effector according to Embodiment 1, wherein the outer surface of the insulating material has a plurality of folds along the length of the end effector. (10) The end effector according to Embodiment 1, wherein the outer surface of the insulating material is sloped between adjacent spines of the framework.

[0092] (11) The end effector according to Embodiment 1, wherein the insulating material further defines a gap between at least one surface of the flexible circuit and the inner surface of the insulating material. (12) The end effector according to Embodiment 1, further comprising a lumen formed within the insulating material. (13) The end effector according to embodiment 12, wherein the lumen is located adjacent to the spine of the framework. (14) A method for manufacturing an end effector for a medical catheter, wherein the method is The encapsulation involves encapsulating a framework within a first insulating layer, wherein the framework includes a shape memory material configured to curve along the width of the framework from around the proximal end to around the distal end. The arrangement involves arranging a flexible circuit having a plurality of electrodes on the first side of the first insulating layer, wherein each of the plurality of electrodes includes a contact surface. The insulating material sheet is placed in contact with the flexible circuit, A method comprising bonding the insulating material sheet to the outer surface of the first insulating layer to seal the flexible circuit between the insulating material sheet and the first insulating layer. (15) The method according to embodiment 14, further comprising the step of exposing the contact surface of each electrode by laser cutting the insulating material sheet around the contact surface of each electrode.

[0093] (16) The method according to embodiment 14, wherein bonding the insulating material sheet to the outer surface of the first insulating layer includes laser bonding. (17) The method according to embodiment 14, wherein the end effector defines a gap between the point where the insulating material sheet is welded to the outer surface and the flexible circuit. (18) The method according to embodiment 14, further comprising forming folds in the insulating material sheet. (19) The method according to embodiment 14, further comprising forming a lumen within the first insulating layer. (20) The method according to embodiment 14, further comprising forming a first lumen between the first insulating layer and the insulating material sheet.

Claims

1. An end effector having a length extending along a longitudinal axis from a proximal end to a distal end, a width extending along a horizontal axis perpendicular to the longitudinal axis, and a thickness extending along a vertical axis perpendicular to the longitudinal axis and the horizontal axis, wherein the end effector is A flexible circuit comprising multiple electrodes, wherein the flexible circuit is arranged on an insulating material (120), each of the multiple electrodes has a contact surface, and the insulating material is continuous with the contact surfaces such that at least some of the contact surfaces of the multiple electrodes are exposed to the surrounding environment. An end effector comprising: a framework that is at least partially encapsulated within the insulating material and curved along the width in a direction along the vertical axis such that the end effector has curvature along its width from around the proximal end to around the distal end.

2. The end effector according to claim 1, wherein the curvature includes a radius (R) of about 8 millimeters to about 15 millimeters.

3. The end effector according to claim 1, wherein the radius of the curvature is uniform over the entire length of the end effector.

4. The end effector according to claim 1, wherein the radius of the curvature increases from the proximal end to the distal end.

5. The end effector according to claim 4, wherein the radius of curvature at the proximal end is approximately 4 millimeters.

6. The end effector according to claim 1, wherein the framework includes a shape memory material configured to return to a predetermined shape having the curvature at an activation temperature.

7. The end effector according to claim 6, wherein the activation temperature is approximately 37°C.

8. The end effector according to claim 6, wherein the shape memory material contains nitinol.

9. The end effector according to claim 1, wherein the outer surface of the insulating material has a plurality of folds along the length of the end effector.

10. The end effector according to claim 1, wherein the outer surface of the insulating material is sloped between adjacent spines of the framework.

11. The end effector according to claim 1, wherein the insulating material further defines a gap between at least one surface of the flexible circuit and the inner surface of the insulating material.

12. The end effector according to claim 1, further comprising a lumen formed within the insulating material.

13. The end effector according to claim 12, wherein the lumen is positioned adjacent to the spine of the framework.

14. A method for manufacturing an end effector for a medical catheter, wherein the method is The encapsulation involves encapsulating a framework within a first insulating layer, wherein the framework includes a shape memory material configured to curve along the width of the framework from around the proximal end to around the distal end. The flexible circuit having a plurality of electrodes is arranged on the first side of the first insulating layer, wherein each of the plurality of electrodes includes a contact surface. The insulating material sheet is placed in contact with the flexible circuit, A method comprising bonding the insulating material sheet to the outer surface of the first insulating layer, thereby sealing the flexible circuit between the insulating material sheet and the first insulating layer.

15. The method according to claim 14, further comprising the step of exposing the contact surfaces of each electrode by laser cutting the insulating material sheet around the contact surfaces of each electrode.

16. The method according to claim 14, wherein bonding the insulating material sheet to the outer surface of the first insulating layer includes laser bonding.

17. The method according to claim 14, wherein the end effector defines a gap between the point where the insulating material sheet is welded to the outer surface and the flexible circuit.

18. The method according to claim 14, further comprising forming folds in the insulating material sheet.

19. The method according to claim 14, further comprising forming a lumen within the first insulating layer.

20. The method according to claim 14, further comprising forming a first lumen between the first insulating layer and the insulating material sheet.

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