Encapsulated catheter with friction-reducing skid

Abstract

To provide end effectors for medical devices. [Solution] The end effector includes a framework, a flexible circuit including electrodes, an insulating material, and skids. The framework and flexible circuit are placed on the insulating material. The insulating material includes a first surface located at a first height from the framework in the height direction of the end effector and includes a first coefficient of dynamic friction. The skids are placed on the insulating material, and each skid includes a second surface located at a second height from the framework in the height direction and including a second coefficient of dynamic friction lower than the first coefficient of dynamic friction. The first surface and skids are positioned in the height direction such that the first height and each of the second heights are equal, or each of the second heights is greater than the first height.

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 rhythms. 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 the arrhythmia.

[0003] Procedures 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 pathway 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 data is acquired at a number of points to sense and measure the electrical activity at each point within the heart. Then, these data are used to select the target area where ablation is to be performed.

Summary of the Invention

Problems to be Solved by the Invention

[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, such catheters should allow sufficient electrode contact with various tissue surfaces, e.g., flat, curved, irregular, or non-planar surface tissues, and should be 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. [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 for a medical device is provided according to the technology of this disclosure. The end effector includes a framework, a flexible circuit, an insulating material, and a plurality of skids. The flexible circuit comprises a plurality of electrodes. The framework and the flexible circuit are arranged on the insulating material. The insulating material includes a first surface that (i) is positioned at a first height from the framework in the height direction of the end effector and (ii) has a first coefficient of dynamic friction. The plurality of skids are arranged on the insulating material, and each skid includes a second surface that (i) is positioned at a second height from the framework in the height direction and (ii) has a second coefficient of dynamic friction lower than the first coefficient of dynamic friction. The first surface and the plurality of skids are arranged in the height direction such that the first height and each of the second heights are equal, or each of the second heights is greater than the first height.

[0009] An end effector for a medical device is further provided according to the technology of the present disclosure. The end effector comprises a framework, a flexible circuit, and an insulating material. The flexible circuit comprises a plurality of electrodes. The insulating material defines a first lumen, and the framework and the flexible circuit are arranged on the insulating material. The insulating material comprises a first insulating material sheet having a first surface and a second surface, and a second insulating material sheet having a first surface and a second surface. The second surface of the first sheet and the second surface of the second sheet are joined such that the first lumen is at least partially defined by the second surface of the first sheet and the second surface of the second sheet.

[0010] The present disclosure further provides a method for forming an end effector of a medical device. This method includes laminating a first insulating material sheet and a second insulating material sheet such that a framework and a flexible circuit are at least partially enclosed therein. This method includes forming a lumen at least partially defined by the first sheet and the second sheet.

[0011] An end effector for a medical device is further provided according to the technology of the present disclosure. The end effector comprises a first framework, a second framework, a first flexible circuit, and an insulating material. The first flexible circuit is positioned between the first framework and the second framework and comprises a plurality of first electrodes. The first framework, the second framework, and the first flexible circuit are at least partially enclosed by the insulating material. [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 cross-section of an end effector along line 5A-5A in Figure 2, based on the technology of this disclosure. [Figure 5B] This is a schematic drawing of the detailed view A of Figure 5A, based on the technology disclosed herein. [Figure 6] This is a schematic diagram of a medical device assembly using the technology disclosed herein. [Figure 7] This is a schematic drawing of a top view of an end effector folded within a sheath, according to the technology of this disclosure. [Figure 8] This is a schematic diagram of a cross-section of an alternative configuration for an end effector using the technology disclosed herein. [Figure 9A] This is a schematic diagram of a cross-section of another alternative configuration of an end effector using the technology of the present disclosure. [Figure 9B] This is a schematic cross-sectional view of an alternative configuration for the end effector shown in Figure 9A, based on the technology disclosed herein. [Figure 10]This is a flowchart of a method for manufacturing an end effector for a medical device using the technology disclosed herein. [Figure 11] This is a schematic diagram of a cross-section of yet another alternative configuration of an end effector using the technology of the present disclosure. [Modes for carrying out the invention]

[0013] The following detailed description should be read in reference to the drawings, where similar elements in different drawings are numbered identically. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is illustrative of the principles of the invention, not limiting, but illustrating them as examples. This specification describes several embodiments, adaptations, modifications, alternatives, and uses of the invention, including those that are currently considered to be the best modes for carrying out the invention, which will make it obvious to those skilled in the art how to make and use the invention.

[0014] Where used herein, the terms “approximately” or “about” for any number or range indicate a preferred dimensional tolerance that enables some or all of the components to function for the intended purposes described herein. More specifically, “about” or “nearly” may refer to a range of values ​​within ±20% of the enumerated values, while “about 90%” may refer to a range of values ​​between 71% and 110%. In addition, where used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject, and while the use of the present 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” indicates a location closer to the operator or physician, while “distal” indicates a location further away from the operator or physician.

[0015] As contemplated herein, the tissues, vasculature, or organs of "patients", "hosts", "users", and "subjects" can be those of humans or any animal. It should be understood that the animals can be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. By way of example, the animal can be a laboratory 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 contemplated herein, a "physician" can include a physician, surgeon, technician, scientist, operator, or any other individual or delivery device associated with 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] The present disclosure relates to systems, methods, or uses and devices for mapping and ablation of cardiac tissue for treating cardiac arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a medical device (e.g., a medical probe or catheter) capable of delivering ablation energy with the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion 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] To improve a malfunctioning heart, ablation of cardiac tissue applying thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, to successfully ablate using thermal techniques, it is necessary to measure cardiac potentials at various locations in the myocardium. In addition, temperature measurements during ablation provide data enabling the effectiveness of ablation. Usually, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation. The RF approach can have risks leading to tissue carbonization, burning, steam pops, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. 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 compared to RF ablation. Thus, cryoablation is not feasible in certain anatomical shapes that can be reached by electrical ablation 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 90 (i.e., multilayer end effector 100) with the distal end 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 multiple, electrodes 26 optionally distributed across an end effector 100 connected to a catheter shaft 90 and configured to sense IEGM signals, as will be described in more detail below. Catheter 14 may further include a position sensor (shown in Figure 2B) 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 positioned for skin contact on a patient 23 to establish a position reference for the position pad 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 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 electrode 18 and the intracardiac electromagnetism (IEGM) captured by the electrode 26 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 provides an end effector 100 according to an example of 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 include a flexible circuit 110 extending along a longitudinal axis LL and comprising a plurality of electrodes 112, each electrode of the plurality of electrodes 112 comprising a contact surface 112c. As used herein, the term “flexible circuit” includes thin-film circuits, flexible printed circuit boards, thin-film deposition via lithography and etching processes on substrates such as polyimide, copper wire, LCP (e.g., Panasonic FELIOS® SERIES of Flexible Circuit Boards), and nitinol substrates, or direct deposition on polymer substrates such as Panasonic BEYOLEX® PRINTED ELECTRONICS SUBSTRATE Series, as illustrated and described in the accompanying technical literature incorporated herein by the Appendix. In some embodiments, the flexible circuit layers described herein can be made primarily from polyimide. In other embodiments, they can be made from 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, and the electrodes have substantially much thicker versions of the traces so 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.

[0031] 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 organ in which the end effector 100 is placed, or the external environment such as an operating room before it is placed inside a biological organ.

[0032] It should be noted that all electrodes 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 90. Instead of a separate irrigation line from the catheter shaft 90, a lumen channel can be provided by forming a lumen by extrusion molding of the catheter shaft 90. 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.

[0033] 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.

[0034] In other words, 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, wherein at least one flexible circuit 110 is positioned on one side of the framework 130, and the contact surface 112c of an electrode 112 extends to the outer surface of the flexible insulating material 120, slightly beyond the outer surface, or slightly recessed (coplanar with the outer surface, as seen in Figure 4).

[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 its respective tine 111, 141 extending along the longitudinal axis LL, and the tines 111, 141 support their respective electrodes 112, 142 (see, for example, Figure 4).

[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 132, 134, 136, and 138 extending along the longitudinal axis LL. The tines 111, 141 of the flexible circuits 110, 140 can be substantially aligned with one or more of the spines 132, 134, 136, and 138, so that the spines 132, 134, 136, and 138 provide 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] Figures 4 to 5B show various cross-sectional and detailed views of the end effector 100. As seen in Figures 4 to 5A, 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. Both the first surface 122a and the second surface 122b are positioned along the vertical axis VV at a first height H1 (Figure 5B) from the framework 130 and the longitudinal axis LL.

[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 thermoplastic polyurethane (TPU), or other thermoforming or molding materials suitable for such thermoforming, such as but not limited to silicone or siloxane. In the examples described herein, the insulating material 120 includes a high-friction material. As used herein, the term “high-friction material” is used to distinguish other materials from a given material / object (e.g., a sheath or vascular structure) whose coefficient of dynamic friction is lower than that of the high-friction material. The term “low-friction material” (described in more detail below with respect to skid 150) is used herein to describe other materials that have a lower coefficient of friction compared to the high-friction material when measured in contact with the same given material / object. In some embodiments, the outer surfaces 122a, 122b of the insulating material 120 and the sheath 210 (Figure 6, described in more detail below, is an example of a given object, also called an introducer tool in the art) have a dynamic friction coefficient of about 0.02 to 0.6, or a median of about 0.31. As an example, the sheath can be made from any number of low-friction materials such as high-density polyethylene, low-density polyethylene, polyether block amide (known by trade name Pebax®) with a lubricating layer (e.g., using EverGlide®), polytetrafluoroethylene, etc.

[0043] Furthermore, although the insulating material 120 is shown as flat in these figures, 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 provides physical and / or mechanical properties such as rigidity and flexibility along multiple axes required by the end effector 100 mentioned above.

[0044] Continuing to refer to Figures 2 to 5B, the end effector 100 further includes skids 150. The framework 130, flexible circuits 110 and 140, and skids 150 are stacked along the height / vertical axis VV. The framework 130 and flexible circuits 110 and 140 are at least partially enclosed by insulating material 120, and the skids 150 are placed on the outer surface of the insulating material 120 or partially enclosed by the insulating material 120. For example, as seen in Figures 5A to 5B, the inner surface of each skid 150 can be placed directly on one of the flexible circuits 110 and 140 and extend away from there along the height direction.

[0045] In addition to the above, the skid 150 may be provided along one or more of the tines 111, 141 of each flexible circuit 110, 140, as shown in Figure 5A. In the illustrated example, each tine 111, 141 is provided with a corresponding skid 150, and each skid 150 is discontinuous so that the electrodes 112, 142 are not covered by the skid 150. However, those skilled in the art will understand that the skid 150 can take any suitable configuration without departing from the spirit and scope of the present disclosure. For example, the skid 150 may be provided on separate tines 111, 141 that do not include electrodes (i.e., those tines 111, 141 are specifically provided to engage with and support the skid 150). Alternatively, the skid 150 may be encapsulated / connected (e.g., overlaid or embedded) in insulating material 120 in a manner that does not use direct connection to the flexible circuits 110, 140.

[0046] The skid 150 is configured to create a reduced friction contact surface for the end effector 100 during insertion into the patient's body, retraction into the sheath 210 (Figure 7), and manipulation and storage of the catheter 14. In doing so, the amount of force required to control the movement of the end effector 100 can be reduced.

[0047] Each skid 150 has an outer surface 152 positioned at a second height H2 (Figure 5B) from the framework 130 and the longitudinal axis LL. The second height H2 is greater than or equal to the first height H1, so that the outer surface 152 of each skid 150 is either coplanar with the outer surfaces 122a, 122b of the insulating material 120, or protrudes from the outer surfaces 122a, 122b. For example, a skid 150 can be positioned directly on one of the respective flexible circuits 110, 140, extend in the height direction VV through one of the outer surfaces 122a, 122b of the insulating material 120, and terminate at the skid outer surface 152.

[0048] The number of skids 150 that protrude from or are coplanar with the outer surfaces 122a, 122b of the insulating material may vary according to the art of this disclosure, depending on the design requirements of the end effector. If at least some of the skids 150 protrude from the outer surface (i.e., H2 is greater than H1), the amount of protrusion may range from almost no protrusion (i.e., the difference between H2 and H1 is almost zero) to about 5 to 20 microns, since the intention of the skids 150 is to change the surface interaction between the end effector 100 and a given object / material, and not to increase the material. In some embodiments, all of the skids 150 are coplanar with the outer surfaces 122a, 122b of the insulating material 120 (i.e., H2 is equal to H1). In some embodiments, all of the skids 150 protrude from the outer surfaces 122a, 122b of the insulating material 120 (i.e., H2 is greater than H1). In some embodiments, there is a mixture of skids 150 that are coplanar with the outer surfaces 122a and 122b of the insulating material 120 and protrude from there.

[0049] Furthermore, each skid 150 is formed from a low-friction material such that the contact between the outer surface 152 of each skid and the predetermined object / material (e.g., sheath 210) results in a lower dynamic friction coefficient than that between the insulating material 120 and the predetermined object / material. In some embodiments, the outer surface 152 of the skid 150 and the sheath 210 (an example of the predetermined object, described in more detail below in Figure 6) have a dynamic friction coefficient at the lower end of the range described above with respect to the insulating material 120 and the predetermined material / object. For example, the dynamic coefficient between the skid 150 and the predetermined material / object may be about 0.02 to 0.3, which is reduced with respect to the range of friction coefficients of the insulating material 120. In other words, the median of this range (e.g., about 0.16) is smaller than the median of the range of values ​​for the dynamic coefficient of the insulating material 120 (e.g., about 0.31 as described above). Generally, skids 150 are designed such that their coefficient of kinetic friction (or range of their coefficients of kinetic friction) is lower than that of insulating material 120 for their contact with the same material / object.

[0050] In some embodiments, the low-friction material for each skid 150 may include polyimide, liquid crystal polymer (LCP), ethylene tetrafluoroethylene (ETFE), polyether ether ketone (PEEK), and combinations thereof. However, those skilled in the art will understand that the low-friction material may include any suitable biocompatible material having low-friction properties (other than or in combination with the materials listed in the preceding sentence) without departing from the spirit and scope of this disclosure.

[0051] Since the skid is either coplanar with the insulating material 120 or protrudes from the insulating material 120, the overall frictional force applied to the end effector can be reduced, along with the use of a material with low friction relative to the insulating material 120.

[0052] Exemplary use cases are shown in Figures 6 and 7, which illustrate the medical probe assembly 2000. The medical probe assembly 2000 includes a tubular member 2300 extending along the longitudinal axis 60, configured to deliver one of the aforementioned end effectors 100 into and out of the sheath 2100, and / or return to the sheath 2100. As the end effector 100 moves into the lumen 2120 of the sheath 2100, particularly as seen in Figure 7, the skid 150 engages with the wall of the lumen 2120, thereby providing a low-friction interface with the wall of the lumen 2120 to facilitate the folding of the end effector 100. The skid 150 also helps to allow the lateral end of the end effector 100 to move. Furthermore, it should be noted that a physician 24 can operate the medical probe assembly 2000 using the handle 2200. Suitable examples of the catheter assembly 2000, as well as its subcomponents such as the handle 2200, the sheath 2100, the tubular member 2300, and others not mentioned herein, are described in U.S. Patent Application Publication No. 2021 / 0369339, which is incorporated herein by reference.

[0053] Figures 8 to 9B illustrate other aspects 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 be employed in the same (or identical) concepts as those described above (e.g., together with the skid 150, flexible circuits 110, 140, and electrodes 112, 142). Therefore, this section will focus on details specific to the configurations shown in Figures 8 to 9B.

[0054] Figure 8 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. The framework 130 is placed on and sandwiched between the second flexible circuit 120b and the fourth flexible circuit 120d. Although the flexible circuits 110 and 140 are shown as being positioned on the second flexible circuit 120b and the fourth flexible circuit 120d, respectively, as will be understood by those skilled in the art, the flexible circuits 110 and 140 may be positioned on any suitable layer / sheet of the insulating material 120 without departing from the spirit and scope of this disclosure.

[0055] The insulating material 120 defines one or more first lumens 124 formed between adjacent first sheets 120a and second sheets 120b. Depending on the irrigation requirements of the system, one or more second lumens 126 may be additionally formed between adjacent third sheets 120c and fourth sheets 120d. These lumens 124, 126 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 120a, 120c at predetermined locations along the longitudinal axis LL. Methods for forming these lumens 124, 126 will be discussed in more detail with respect to Figure 10.

[0056] The first sheet 120a has a first surface 122a1 and a second surface 122a2 on the opposite side. The second sheet 120b has a first surface 122b1 and a second surface 122b2 on the opposite side. The third sheet 120c has a first surface 122c1 and a second surface 122c2 on the opposite side. The fourth sheet 120d has a first surface 122d1 and a second surface 122d2 on the opposite side. The second surface 122a2 of the first sheet 120a and the second surface 122b2 of the second sheet 120b are joined so that the first lumen 124 is at least partially defined by the second surface 122a2 of the first sheet 120a and the second surface 122b2 of the second sheet 120b. Similarly, the second lumen 126 is at least partially formed by the joined second surfaces 122c2, 122d2 of the third and fourth sheets 120c, 120d.

[0057] In this embodiment, the tubular lumen 124, 126 are formed as recesses in one of the second surfaces 122a2, 122b2, 122c2, 122d2. They can be formed by any suitable process, such as a mechanical or laser forming process. Alternatively, the tubular lumen 124, 126 can be formed by selectively leaving one or more regions of the insulating material 120 unlaminated (i.e., unthermoformed).

[0058] 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 described herein. In this example, three sheets 120a, 120b, and 120c are thermoformed together to form the insulating material / insulating material 120. A single lumen 124 is formed by recesses 122a3, 122b3, and 122c3 formed on the second surfaces 122a2, 122b2, and 122c2 of each of the three sheets 120a, 120b, and 120c, such that the three sheets 120a, 120b, and 120c 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.

[0059] Figure 10 shows a flowchart of one or more methods 1000 for forming an end effector. Method 1000 may include the following steps: A first insulating material sheet and a second insulating material sheet are laminated such that a framework and a flexible circuit are at least partially enclosed therein (1002). A lumen is formed which is at least partially defined by the first and second sheets (1004).

[0060] In some embodiments, the lumen is formed by selectively laminating the first and second sheets such that the non-laminated sections of the first and second sheets define the lumen (1004). For example, the end effector 100 in Figure 8 may have a lumen 124 fabricated by selectively laminating sheets 120a, 120b at their contact surfaces 122a2, 122b2 (e.g., via laser welding), where the non-laminated sections form a void that functions as an irrigation lumen 124.

[0061] In some embodiments, the lumen is formed by creating a recess in one of the sheets (e.g., the first sheet) (1004). This can be done by any suitable process, such as laser cutting. See, for example, the recess formed in Figure 8.

[0062] In some embodiments, the lumen is formed in part by positioning a second material having a higher melting point than the insulating material between the first and second sheets (1004). For example, the second material may include, but is not limited to, polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), polyimide, etc. Figures 9A and 9B illustrate an example of this process, in which a hollow cylindrical and / or tubular second material is used to form a cylindrical irrigation lumen 124 at the boundary where the first and second sheets 120a, 120b are joined. In addition to the tubular shape, a rectangular lumen can be formed by positioning two or more flat / rectangular strips with gaps between them.

[0063] 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.

[0064] Figure 11 illustrates yet another aspect of the present disclosure. As described above, the end effector 100 is subjected to many forces during its use. The end effector 200 shown in Figure 11 uses frameworks 230a and 230b with an inverse configuration relative to the flexible circuits 210 and 240. The designs shown in these figures can be used with similar (or the same) concepts as those described above (for example, the skid 150, the lumen 124, and planar frameworks in the form of tines as seen in Figure 3). Therefore, this section will focus on the details specific to the configuration shown in Figure 11.

[0065] The end effector includes a first framework 230a, a second framework 230b, a first flexible circuit 210, a second flexible circuit 240, and an insulating material 220. The frameworks 230a and 230b can be formed from a superelastic material such as Nitinol. The first flexible circuit 210 is positioned between the first framework 230a and the second framework 230b along a vertical axis VV and includes a plurality of first electrodes 212. The second flexible circuit 240 is also positioned between the first framework 230a and the second framework 230b along the aforementioned vertical axis and includes a plurality of second electrodes 242. The insulating material 220 at least partially encloses the first framework 230a, the second framework 230b, the first flexible circuit 210, and the second flexible circuit 240. In this example, the framework is configured as two framework sections 230a and 230b positioned further away from the center of the insulating material 220 (and end effector 200) along the vertical axis VV than the flexible circuits 210 and 240, so that the frameworks 230a and 230b can protect the end effector 200 from the high bending forces it may experience during use.

[0066] Furthermore, multiple first gaps 221a are formed in the insulating material 220. Each first gap 221a extends from the outer surface 222a of the insulating material 220 through the tines of the first framework 230a, aligning with and exposing one of the first electrodes 212. Similarly, on the opposite side of the end effector 200, multiple second gaps 221b are formed within the insulating material 220. Each second gap 221b extends from another outer surface 222b of the insulating material 220 (opposite the outer surface on which the first gaps 221a extend) through the tines of the second framework 230b, aligning with and exposing one of the second electrodes 242. These gaps 221a, 221b allow the electrodes 212, 242 to be exposed to the external environment for cardiac mapping and / or ablation.

[0067] The technologies of this disclosure described herein can be further understood in accordance with the following provisions.

[0068] Clause 1. An end effector for a medical device, comprising: a framework; a flexible circuit comprising a plurality of electrodes; an insulating material on which the framework and the flexible circuit are arranged, the insulating material comprising: (i) a first surface located at a first height from the framework in the height direction of the end effector and (ii) a first coefficient of dynamic friction; and a plurality of skids arranged on the insulating material, each skid comprising: (i) a second surface located at a second height from the framework in the height direction and (ii) a second coefficient of dynamic friction lower than the first coefficient of dynamic friction, wherein the first surface and the plurality of skids are arranged in the height direction such that the first height and each second height are equal to the first height, or each second height is greater than the first height.

[0069] Clause 2. An end effector as described in Clause 1, wherein at least some of the second heights are greater than the first height.

[0070] Clause 3. An end effector as described in Clause 2, where all of the second heights are greater than the first height.

[0071] Clause 4. An end effector as described in Clause 2 or 3, wherein the difference between the second height and the first height is within the range of 5 to 20 microns.

[0072] Clause 5. At least some of the second heights are equal to the first height, as described in Clause 1.

[0073] Clause 6. An end effector as described in Clause 5, where the entirety of the second height is equal to the first height.

[0074] Clause 7. The coefficient of dynamic friction of the first surface is the end effector as described in any one of Clauses 1 to 6, including a maximum value of approximately 0.6.

[0075] Clause 8. The end effector described in Clause 7, wherein the coefficient of dynamic friction of each of the second surfaces is approximately 0.02 to 0.3 and is less than the value of the coefficient of dynamic friction of the first surface.

[0076] Clause 9. The insulating material comprises at least one of thermoplastic polyurethane, silicone, or siloxane, as described in any one of Clauses 1 to 8.

[0077] Clause 10. An end effector as described in any one of Clauses 1 to 9, wherein the framework, flexible circuitry, and skid are stacked along the height direction, and the framework and flexible circuitry are at least partially enclosed by insulating material.

[0078] Clause 11. The skid is at least partially enclosed by insulating material, as described in any one of Clauses 1 to 10.

[0079] Clause 12. Each skid is positioned on a flexible circuit, extends from the flexible circuit in the height direction through a first surface, and terminates on a second surface, as described in any one of Clauses 1 to 11.

[0080] Clause 13. An end effector according to any one of Clauses 1 to 12, wherein the first and second dynamic friction coefficients each include a value or range of values ​​configured to be determined by the dynamic contact between the insulating material and the given object, and the dynamic contact between each skid and the given object.

[0081] Clause 14. An end effector as described in Clause 13, wherein the specified object includes a sheath.

[0082] Clause 15. End effector of a medical device, the end effector comprising: a framework; a flexible circuit comprising a plurality of electrodes; and an insulating material defining a first lumen, wherein the framework and the flexible circuit are arranged on the insulating material, and the insulating material comprises: a first insulating material sheet comprising a first surface and a second surface; and a second insulating material sheet comprising a first surface and a second surface, wherein the second surface of the first sheet and the second surface of the second sheet are joined such that the first lumen is at least partially defined by the second surface of the first sheet and the second surface of the second sheet.

[0083] Clause 16. The end effector according to Clause 15, wherein the second surface of the first sheet comprises a recess, the recess defining a portion of the first lumen.

[0084] Clause 17. The end effector according to Clause 15 or 16, wherein the second surface of the second sheet comprises a recess, the recess defining a portion of the first lumen.

[0085] Clause 18. An end effector according to any one of Clauses 15 to 17, wherein the insulating material comprises a third insulating material sheet having a first surface and a second surface, and a fourth insulating material sheet having a first surface and a second surface, further defining a second lumen, the second surface of the third sheet and the second surface of the fourth sheet being joined such that the second lumen is defined by the second surface of the first sheet and the second surface of the second sheet.

[0086] Clause 19. The end effector according to any one of Clauses 15 to 17, wherein the insulating material further comprises a third insulating material sheet having a first surface and a second surface, and the first lumen is at least partially defined by the second surface of the third sheet.

[0087] Clause 20. An end effector according to any one of Clauses 15 to 19, further comprising a plurality of skids arranged on an insulating material, each skid having a second surface having a second coefficient of dynamic friction lower than the first coefficient of dynamic friction of the first surface of the first sheet.

[0088] Clause 21. An end effector as described in any one of Clauses 15 to 20, wherein the first lumen is configured to deliver an irrigation fluid through it.

[0089] Clause 22. A method for forming an end effector of a medical device, comprising laminating a first insulating material sheet and a second insulating material sheet such that a framework and a flexible circuit are at least partially enclosed inside, and forming a lumen at least partially defined by the first sheet and the second sheet.

[0090] Clause 23. The method according to Clause 22, wherein forming a lumen comprises selectively laminating the first sheet and the second sheet such that the non-laminated sections of the first sheet and the second sheet define a lumen.

[0091] Clause 24. The method according to Clause 22, wherein forming a lumen includes forming a recess within a first sheet that at least partially defines the lumen.

[0092] Clause 25. Forming a recess is the method of Clause 24, which includes forming a recess by laser cutting a first sheet.

[0093] Clause 26. The method according to Clause 22, wherein forming a lumen involves positioning a second material having a higher melting point than an insulating material between a first sheet and a second sheet.

[0094] Clause 27. The second material is the method according to Clause 26, having a tubular shape.

[0095] Clause 28. The method according to Clause 26, wherein the second material comprises a pair of flat strips defining a gap between them.

[0096] Clause 29. The method according to Clause 26, further comprising laminating a first insulating material sheet and a second insulating material sheet, followed by removing the second material to define the lumen.

[0097] Clause 30. An end effector for a medical device, the end effector comprising: a first framework; a second framework; a first flexible circuit disposed between the first framework and the second framework and comprising a plurality of first electrodes; and an insulating material, wherein the first framework, the second framework, and the first flexible circuit are at least partially enclosed by the insulating material.

[0098] Clause 31. The first and second frameworks are end effectors as described in Clause 30, including a superelastic material.

[0099] Clause 32. The end effector according to Clause 30 or 31, further comprising a plurality of first gaps formed in an insulating material and extending through a first framework, each first gap being aligned with its respective first electrode.

[0100] Clause 33. The end effector according to any one of Clauses 30 to 32, further comprising a second flexible circuit positioned between the first framework and the second framework and having a plurality of second electrodes.

[0101] Clause 34. The end effector according to Clause 33, further comprising a plurality of second gaps formed within an insulating material and extending through a second framework, each second gap being aligned with its respective second electrode.

[0102] Clause 35. An end effector according to any one of Clauses 30 to 34, further comprising a plurality of skids disposed on an insulating material, each skid having a second surface having a second coefficient of dynamic friction lower than a first coefficient of dynamic friction of the first surface of the insulating material.

[0103] 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.

[0104] [Implementation Method] (1) An end effector for a medical device, Framework and A flexible circuit equipped with multiple electrodes, An insulating material wherein the framework and the flexible circuit are arranged on the insulating material, and the insulating material includes (i) a first surface that is positioned at a first height from the framework in the height direction of the end effector, and (ii) a first coefficient of dynamic friction, A plurality of skids disposed on the insulating material, each skid comprising: (i) a skid positioned at a second height from the framework in the height direction, and (ii) a skid including a second surface having a second coefficient of dynamic friction lower than the first coefficient of dynamic friction; An end effector in which the first surface and the plurality of skids are arranged in the height direction such that the first height and each of the second heights are equal, or each of the second heights is greater than the first height. (2) The end effector according to Embodiment 1, wherein at least some of the second heights are greater than the first height. (3) The end effector according to Embodiment 2, wherein all of the second heights are greater than the first height. (4) The end effector according to Embodiment 2, wherein the difference between the second height and the first height is in the range of 5 to 20 μm (5 to 20 microns). (5) The end effector according to Embodiment 1, wherein at least some of the second heights are equal to the first height.

[0105] (6) The end effector according to Embodiment 5, wherein the entirety of the second height is equal to the first height. (7) The end effector according to Embodiment 1, wherein the coefficient of dynamic friction of the first surface includes a maximum value of about 0.6. (8) The end effector according to Embodiment 7, wherein the coefficient of dynamic friction of each of the second surfaces is about 0.02 to 0.3 and is smaller than the value of the coefficient of dynamic friction of the first surface. (9) The end effector according to Embodiment 1, wherein the framework, the flexible circuit and the skid are stacked along the height direction, and the framework and the flexible circuit are at least partially enclosed by the insulating material. (10) The end effector according to Embodiment 1, wherein the skid is at least partially enclosed by the insulating material.

[0106] (11) The end effector according to Embodiment 1, wherein each skid is arranged on the flexible circuit, extends from the flexible circuit through the first surface in the height direction, and terminates on the second surface. (12) The end effector according to Embodiment 1, wherein the first and second dynamic friction coefficients each include a value or range of values ​​configured to be determined by the dynamic contact between the insulating material and a predetermined object and the dynamic contact between each skid and the predetermined object. (13) The end effector according to embodiment 12, wherein the predetermined object includes a sheath. (14) End effector of a medical device, wherein the end effector is Framework and A flexible circuit equipped with multiple electrodes, An insulating material defining a first lumen, wherein the framework and the flexible circuit are arranged on the insulating material, and the insulating material is A first insulating material sheet including a first surface and a second surface, A second insulating material sheet including a first surface and a second surface, An end effector comprising an insulating material, wherein the second surface of the first sheet and the second surface of the second sheet are joined such that the first lumen is at least partially defined by the second surface of the first sheet and the second surface of the second sheet. (15) The end effector according to embodiment 14, wherein the second surface of the first sheet is provided with a recess, the recess defining a portion of the first lumen.

[0107] (16) The end effector according to embodiment 14, wherein the second surface of the second sheet comprises a recess, the recess defining a portion of the first lumen. (17) The end effector according to Embodiment 15, further comprising a plurality of skids disposed on the insulating material, wherein each skid includes a second surface having a second coefficient of dynamic friction lower than the first coefficient of dynamic friction of the first surface of the first sheet. (18) An end effector of a medical device, wherein the end effector is The first framework, The second framework, A first flexible circuit, positioned between the first framework and the second framework, comprising a plurality of first electrodes, Equipped with an insulating material, An end effector in which the first framework, the second framework, and the first flexible circuit are at least partially enclosed by the insulating material. (19) The end effector according to embodiment 18, further comprising a plurality of first gaps formed in the insulating material and extending through the first framework, each first gap being aligned with its respective first electrode. (20) The end effector according to Embodiment 18, further comprising a plurality of skids disposed on the insulating material, each skid having a second surface having a second coefficient of dynamic friction lower than a first coefficient of dynamic friction of the first surface of the insulating material.

Claims

1. It is an end effector for a medical device, Framework and A flexible circuit equipped with multiple electrodes, An insulating material wherein the framework and the flexible circuit are arranged on the insulating material, and the insulating material includes (i) a first height from the framework in the height direction of the end effector, and (ii) a first surface having a first coefficient of dynamic friction, A plurality of skids disposed on the insulating material, each skid comprising: (i) a skid positioned at a second height from the framework in the height direction, and (ii) a skid having a second surface having a second coefficient of dynamic friction lower than the first coefficient of dynamic friction; An end effector in which the first surface and the plurality of skids are arranged in the height direction such that the first height and each of the second heights are equal, or each of the second heights is greater than the first height.

2. The end effector according to claim 1, wherein at least some of the second heights are greater than the first height.

3. The end effector according to claim 2, wherein all of the second heights are greater than the first height.

4. The end effector according to claim 2, wherein the difference between the second height and the first height is in the range of 5 to 20 μm (5 to 20 microns).

5. The end effector according to claim 1, wherein at least some of the second heights are equal to the first height.

6. The end effector according to claim 5, wherein the entirety of the second height is equal to the first height.

7. The end effector according to claim 1, wherein the coefficient of dynamic friction of the first surface includes a maximum value of about 0.

6.

8. The end effector according to claim 7, wherein the coefficient of dynamic friction of each of the second surfaces is about 0.02 to 0.3 and is smaller than the value of the coefficient of dynamic friction of the first surface.

9. The end effector according to claim 1, wherein the framework, the flexible circuit, and the skid are stacked along the height direction, and the framework and the flexible circuit are at least partially enclosed by the insulating material.

10. The end effector according to claim 1, wherein the skid is at least partially enclosed by the insulating material.

11. The end effector according to claim 1, wherein each skid is arranged on the flexible circuit, extends from the flexible circuit through the first surface in the height direction, and terminates on the second surface.

12. The end effector according to claim 1, wherein the first and second dynamic friction coefficients each include a value or range of values ​​configured to be determined by the dynamic contact between the insulating material and a predetermined object and the dynamic contact between each skid and the predetermined object.

13. The end effector according to claim 12, wherein the predetermined object includes a sheath.

14. An end effector for a medical device, wherein the end effector is Framework and A flexible circuit equipped with multiple electrodes, An insulating material defining a first lumen, wherein the framework and the flexible circuit are arranged on the insulating material, and the insulating material is A first insulating material sheet including a first surface and a second surface, A second insulating material sheet including a first surface and a second surface, An end effector comprising an insulating material, wherein the second surface of the first sheet and the second surface of the second sheet are joined such that the first lumen is at least partially defined by the second surface of the first sheet and the second surface of the second sheet.

15. The end effector according to claim 14, wherein the second surface of the first sheet is provided with a recess, the recess defining a portion of the first lumen.

16. The end effector according to claim 14, wherein the second surface of the second sheet is provided with a recess, the recess defining a portion of the first lumen.

17. The end effector according to claim 15, further comprising a plurality of skids disposed on the insulating material, wherein each skid includes a second surface having a second coefficient of dynamic friction lower than the first coefficient of dynamic friction of the first surface of the first sheet.

18. An end effector for a medical device, wherein the end effector is The first framework, The second framework, A first flexible circuit is positioned between the first framework and the second framework and comprises a plurality of first electrodes, Equipped with an insulating material, An end effector in which the first framework, the second framework, and the first flexible circuit are at least partially enclosed by the insulating material.

19. The end effector according to claim 18, further comprising a plurality of first gaps formed in the insulating material and extending through the first framework, each first gap being aligned with its respective first electrode.

20. The end effector according to claim 18, further comprising a plurality of skids disposed on the insulating material, each skid having a second surface having a second coefficient of dynamic friction lower than a first coefficient of dynamic friction of the first surface of the insulating material.

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