Medical device with end effector including connecting hubs and electrode array

Abstract

To provide a connecting hub used with an end effector of a medical device.SOLUTION: The disclosed technology includes a connecting hub used with an end effector of a medical probe. The connecting hub is generally cylindrical in form and defines a hub lumen extending along a longitudinal axis between its terminal ends. Recesses are disposed about an outer circumferential surface of the cylindrical body and extend parallel to the longitudinal axis. Each recess is open along the longitudinal axis at or proximal the first terminal end and mates with a proximal end or a distal end of a spine of the end effector.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present technology relates generally to medical devices, particularly to medical probes having electrodes, and further, but not exclusively, to medical probes suitable for use to induce irreversible electroporation (IRE) of cardiac tissue. [Background technology]

[0002] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an asynchronous rhythm. Certain procedures that exist for treating arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. By selectively ablating cardiac tissue with the application of energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0003] Many current ablation approaches in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain risks associated with thermal heating that can lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula.

[0004] Cryoablation is an alternative approach to RF ablation that reduces the thermal risks typically associated with RF ablation. However, operating a cryoablation apparatus and selectively applying cryoablation is generally more difficult compared to RF ablation, and thus cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0005] Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers short pulses of high voltage to tissue, causing irreversible permeabilization of cell membranes. Delivery of IRE energy to tissue using multi-electrode probes has been previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), each of which is incorporated herein by reference. Summary of the Invention [Problem to be solved by the invention]

[0006] Basket-type end effectors contain spines that must be held in place at their distal portions for their proper function. Improved techniques for holding the distal / proximal portions of the spines are needed. There is also a need for larger basket catheters for pulmonary vein isolation (PVI) with IRE. [Means for solving the problem]

[0007] According to the disclosed technology, an end effector for a medical device is provided. The end effector can include a plurality of spines extending along a longitudinal axis and configured to move between an expanded configuration and a collapsed configuration. Each spine includes a proximal end and a distal end. The end effector can include a plurality of electrodes connected to each spine. The end effector can include a connection hub defining a hub lumen and including a first end, a second end, and a plurality of recesses. The plurality of recesses are radially disposed about an outer circumferential surface of the connection hub and extend parallel to the longitudinal axis. Each recess is open along the longitudinal axis at or proximal to the first end. Each recess mates with one of the proximal and distal ends of a respective spine of the plurality of spines to prevent relative movement between the connection hub and the spine. The end effector may further include an actuator member connected to the connection hub and the multiple spines such that translation of the actuator member along the longitudinal axis moves the spines from the expanded configuration to the collapsed configuration.

[0008] The disclosed technology further provides a connection hub for use with an end effector of a medical device. The connection hub may include a first end, a second end opposite the first end, a cylindrical body, and a plurality of recesses. The cylindrical body defines a hub lumen and extends from the first end to the second end along a longitudinal axis. The plurality of recesses are radially disposed around an outer circumferential surface of the cylindrical body and extend parallel to the longitudinal axis. Each recess opens along the longitudinal axis at or proximal to the first end, and each recess is configured to mate with a proximal or distal end of a spine of the end effector. [Brief description of the drawings]

[0009] [Figure 1] 1 is a schematic, pictorial diagram of a medical system including a medical device having a distal end including a medical probe having electrodes, in accordance with the disclosed technology; [Diagram 2] FIG. 1 is a schematic, pictorial diagram showing a perspective view of an end effector of a medical device in accordance with the disclosed technology; [Diagram 3] FIG. 2 is a schematic, pictorial diagram showing a detailed perspective view of a distal end of an end effector with coils and rings removed for clarity, in accordance with the disclosed technology; [Figure 4] FIG. 4 is a schematic, pictorial diagram illustrating a detailed cross-sectional view of the distal end shown in FIG. 3 taken relative to a vertical plane intersecting the longitudinal axis, in accordance with the disclosed technology. [Diagram 5] FIG. 2 is a schematic, pictorial diagram showing a detailed perspective view of a proximal end of an end effector with sleeve removed for clarity, in accordance with the disclosed technology; [Figure 6] FIG. 6 is a schematic, pictorial diagram showing a detailed cross-sectional view of the proximal end shown in FIG. 5 taken relative to a vertical plane intersecting the longitudinal axis, in accordance with the disclosed technology. [Figure 7] FIG. 4 is a schematic, pictorial diagram showing an enlarged detailed perspective view of the proximal end shown in FIG. 3 with tubing removed for clarity, in accordance with the disclosed technology. [Figure 8] FIG. 1 is a schematic, pictorial diagram showing a perspective view of a second end effector in accordance with the disclosed technology; [Figure 9] FIG. 10 is a schematic pictorial diagram illustrating a cross-sectional detail of the second end effector shown in FIG. 9 cut against a vertical plane intersecting the longitudinal axis, with the outer region of the second end effector not shown, in accordance with the disclosed technology. [Figure 10] FIG. 13 is a schematic, pictorial diagram showing a perspective view of a third end effector in accordance with the disclosed technology; [Figure 11] FIG. 11 is a schematic, pictorial diagram showing a perspective view of a third end effector similar to FIG. 10 with the elongated shaft, ring, and coil removed for clarity, in accordance with the disclosed technology. [Figure 12] 12 is a schematic, pictorial diagram illustrating a cross-sectional detail view of the third end effector shown in FIG. 11 taken relative to a vertical plane intersecting the longitudinal axis in accordance with the disclosed technology; FIG. [Figure 13] FIG. 1 is a schematic, pictorial diagram showing a perspective detailed view of a proximal end of a third end effector, with the sleeve and some spines removed for clarity, in accordance with the disclosed technology; [Figure 14]FIG. 13 is a schematic, pictorial diagram showing an exploded detailed view of the proximal hub of a third end effector in accordance with the disclosed technology; [Figure 15] FIG. 13 is a schematic, pictorial diagram showing a detailed perspective view of a proximal hub of a third end effector in accordance with the disclosed technology; [Figure 16] FIG. 13 is a schematic, pictorial diagram showing a detailed elevation view of the proximal hub of a third end effector in accordance with the disclosed technology; [Figure 17] FIG. 13 is a schematic, pictorial diagram illustrating a detailed perspective view of yet another connection hub in accordance with the disclosed technology; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected examples, and are not intended to limit the scope of the present disclosure. The detailed description illustrates, by way of example, but not by way of limitation, the principles of the disclosed technology. This description clearly enables a person skilled in the art to make and use the disclosed technology, and describes several embodiments, adaptations, variations, alternatives, and uses of the disclosed technology, including what is currently contemplated to be the best mode for carrying out the disclosed technology.

[0011] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates suitable dimensional tolerances that allow a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, e.g., "about 90%" may refer to a range of values ​​of 71% to 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the subject technology in human patients represents a preferred embodiment, it is not intended to limit the system or method to human use. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.

[0012] As discussed herein, the vascular system of a "patient," "host," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient.

[0013] As discussed herein, an "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrument associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation to a subject.

[0014] As discussed herein, the term "ablate" or "ablation", in the context of the devices and corresponding systems of the present disclosure, refers to components and structural features that are configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy, such as irreversible electroporation (IRE), interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA), throughout this disclosure. In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout this disclosure with reference to non-thermal ablation of cardiac tissue in certain conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.

[0015] As discussed herein, the terms "bipolar" and "monopolar", when used to refer to ablation schemes, describe different ablation schemes with respect to current paths and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes a current path between two electrodes, both of which are placed at the treatment site. The current density and electric flux density are typically approximately equal at each of the two electrodes. "Monopolar" refers to an ablation scheme that utilizes a current path between two electrodes, where one electrode with a high current density and high electric flux density is positioned at the treatment site, and a second electrode with a relatively low current density and lower electric flux density is positioned remotely from the treatment site.

[0016] As discussed herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or that are of uniform cross section throughout their length. For example, a tubular / shaft structure is generally illustrated as a substantially right cylindrical structure. However, a tubular / shaft structure may have a tapered or curved exterior surface without departing from the scope of the present disclosure.

[0017] The present disclosure relates to a system, method, or use and device for IRE ablation of cardiac tissue to treat cardiac arrhythmia. Ablation energy is typically delivered to cardiac tissue by a distal portion of a catheter that can deliver the ablation energy along the tissue to be ablated. Some exemplary catheters include a three-dimensional structure at the distal portion and are configured to administer the ablation energy from various electrodes positioned on the three-dimensional structure. Ablation procedures incorporating such exemplary catheters can be visualized using X-ray fluoroscopy.

[0018] Ablation of cardiac tissue applying radio frequency (RF) energy and thermal techniques such as cryoablation to improve a failing heart is a well-known procedure. Typically, to successfully ablate using thermal techniques, cardiac potentials must be measured at various locations in the myocardium. In addition, temperature measurements during ablation provide data that allows for the effectiveness of the ablation. Typically, in ablation procedures using thermal techniques, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF approaches may have risks that may lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistula. Cryoablation is an alternative approach to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, operating a cryoablation device and selectively applying cryoablation is generally more difficult compared to RF ablation. Thus, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0019] The present disclosure may include electrodes configured for irreversible electroporation (IRE), RF ablation, and / or cryoablation. IRE may be interchangeably referred to as pulsed electric field (PEF) ablation and pulsed field ablation (PFA) throughout this disclosure. IRE as discussed in this disclosure is a non-thermal cell death technique that can be used to ablate atrial arrhythmias. To ablate using IRE / PEF, biphasic voltage pulses are applied to destroy cellular structures of the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to the target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which would be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses can be utilized.

[0020] Electroporation can be induced by applying a pulsed electric field to biological cells to cause the reversible (temporary) or irreversible (permanent) creation of pores in the cell membrane. Cells have a transmembrane electrostatic potential that increases above the resting potential upon application of the pulsed electric field. While the transmembrane electrostatic potential remains below a threshold potential, electroporation is reversible, meaning that the pores can close when the applied pulsed electric field is removed and the cell can self-repair and survive. If the transmembrane electrostatic potential increases above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. As a result, the cell dies due to loss of homeostasis, typically by apoptosis. In general, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of nearly 500V / cm, while bone has a threshold potential of 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on threshold potential.

[0021] The technology of the present disclosure includes systems and methods for applying electrical signals from a catheter electrode positioned in the vicinity of myocardial tissue to generate ablation energy for ablation of the myocardial tissue. In some examples, the systems and methods may be effective for ablating target tissue by inducing irreversible electroporation. In some examples, the systems and methods may be effective for inducing reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when electricity applied at the electrode falls below the electric field threshold of the target tissue, allowing cells to repair. Reversible electroporation does not kill cells, but allows the physician to see the effect of reversible electroporation on the electrical activation signal in the vicinity of the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Application Publication No. 2021 / 0162210, which is incorporated by reference in its entirety.

[0022] The pulsed electric field and its effectiveness in inducing reversible and / or irreversible electroporation can be influenced by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters can include electrode contact area, electrode spacing, electrode shape, etc. The examples presented herein generally include physical parameters adapted to effectively induce reversible and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal can include voltage amplitude, pulse duration, pulse interphase delay, interpulse delay, total application time, delivered energy, etc. In some examples, the parameters of the electrical signal can be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various systems and methods of ablation, including IRE, are provided in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), the entireties of each of which are incorporated by reference herein.

[0023] Please refer to FIG. 1, which illustrates an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cavity or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. The multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary medical device / probe, e.g., catheter 14, configured to sense IEGMs is illustrated herein. The physician 24 brings the distal tip of the catheter 14 (i.e., in this case, basket assembly 28) into contact with the heart wall to sense a target site within the heart 12. The catheter 14 with a distal basket assembly may be referred to as a basket catheter. For ablation, physician 24 similarly delivers the distal end of an ablation catheter to the target site for ablation.

[0024] The catheter 14 is an exemplary catheter including one, and preferably multiple, electrodes 26 optionally distributed across multiple spines 104 in the basket assembly 28 and configured to sense IEGM signals. The catheter 14 may further include a position sensor embedded in or near the basket assembly 28 for tracking the position and orientation of the basket assembly 28. Optionally and preferably, the position sensor is a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0025] The magnetic-based position sensor may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the basket assembly 28 of the catheter 14 may be tracked and sensed by the magnetic-based position sensor based on the magnetic field generated by the location pad 25. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference.

[0026] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0027] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0028] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more of the electrodes at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including unipolar or bipolar high-voltage DC pulses, such as may be used to effect irreversible electroporation (IRE), or combinations thereof.

[0029] Patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, electrophysiological equipment, a power source, and a workstation 55 that controls the operation of system 10. The electrophysiological equipment of system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities to implement real-time calculations of catheter positions and perform ECG calculations.

[0030] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with suitable operating software, and a user interface function. The workstation 55 may optionally provide multiple functions, including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual display or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (5) displaying sites of interest, such as where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system (10) is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0031] FIG. 2 is a schematic pictorial diagram showing a perspective view of an end effector of a medical device 14, such as a medical probe having an electrode 26. The medical device 14 includes an end effector 100 at its distal tip 28. The end effector 100 in the currently described example takes the form of a basket assembly including at least one spine 104. The spine 104 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross section and may include a flexible elastic material (e.g., a shape memory alloy such as nickel-titanium, also known as Nitinol) forming a strut. The spine 104 may be formed from a planar or cylindrical stock of material using any suitable method. For example, the spine 104 may be formed by cutting, laser cutting, stamping, etc. The spine 104 has a distal end 104A (FIG. 4) and a proximal end 104B (FIG. 6) and extends along a longitudinal axis A1. The spine 104 is movable between an expanded configuration and a collapsed configuration via an actuator member. The actuator member is connected / coupled to the spine such that translation of the actuator member along the longitudinal axis moves the spine from the extended position to the collapsed position.

[0032] In the examples described herein, the electrodes 26 can be configured to deliver ablation energy (IRE and / or RF) to tissue within the heart 12. In FIG. 2 , each spine 104 has a midpoint (e.g., the approximate point where the spine 104 bends from extending away from the longitudinal axis A1 toward it), and there are four electrodes 26 connected to each spine. A first two of the four electrodes 26 are disposed on a first side of the midpoint of each spine 104, and a second two of the four electrodes 26 are disposed on a second side of the midpoint of each spine 104. In addition to using the electrodes 26 to deliver ablation energy, the electrodes 26 can also be used to determine the position of the end effector 100 and / or measure physiological properties, such as local surface potentials, at respective locations on the tissue within the heart 12. The electrode 26 can be biased so that a majority of the electrode 26 faces outward from the end effector 100, such that the electrode 26 delivers a greater amount of electrical energy outwardly away from the end effector 100 (i.e., toward the tissue of the heart 12) than inwardly toward the end effector 100.

[0033] Examples of materials that are ideally suited for forming the electrodes 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows the minimal heat generated on the tissue (i.e., due to the ablation energy delivered to the tissue) to be conducted through the electrode to the back side of the electrode (i.e., the portion of the electrode inside the spine) and then to the blood pool within the heart 12.

[0034] The end effector 100 is connected to the remainder of the medical probe 14 via an elongated shaft 102. The elongated shaft 102 connects the end effector 100 to a handle that can be manipulated by the operator 24 during use. The elongated shaft 102 may be tubular in shape and flexible, with certain portions being more flexible than other portions. For example, a tip portion thereof may be made more flexible than the remainder to allow the end effector 100 to be easily deflected. The elongated shaft 102 may be made from a flexible biocompatible electrically insulating material such as polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), urethane, polyimide, parylene, silicone, or the like. In some examples, the insulating material may include biocompatible polymers including, but not limited to, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydrides, with the ratio of particular polymers selected to control the degree of inflammatory response. Additionally, a flexible sleeve 120 is provided on the proximal end of the end effector 100 to further enhance the atraumatic nature of the end effector 100.

[0035] A connector tube or rod 118 is connected to the distal end 104A of the spine. In some examples, the connector tube 118 functions as an actuator member to facilitate the expansion and collapse of the spine 104. For example, as described above, the connector tube 118 can be translated along the longitudinal axis A1 to expand / collapse the spine 104. In the expanded configuration (e.g., FIG. 2) as well as the collapsed configuration, one or more spines 104 can bend radially outward from the longitudinal axis A1. Alternatively, another actuator member (e.g., a pull wire) can be used in conjunction with the connector tube 118, and the connector tube / rod 118 is used for other purposes, such as to route irrigation. For example, the connector tube 118 can include multiple irrigation holes along its length or provide a passage for other irrigation tubes. The connector tube can also include a reference or return electrode connected thereto. The spine(s) 104, elongate shaft 102, and connector tube 118 are disposed generally along (i.e., parallel to or coaxial with) longitudinal axis A1 when elongate shaft 200 is unbent. Connector tube 118 also defines a lumen 118A (FIG. 3) that is coaxial with longitudinal axis A1 and through which, in use, various medical devices, such as a mapping catheter or a guidewire, can be extended.

[0036] The atraumatic collar 114 and the coil 116 are connected to the distal end 104A of the spine 104. In some examples, the coil 116 can include a single-axis sensor (SAS). In other examples, the coil 116 can include a dual-axis sensor (DAS) or a triaxial sensor (TAS). The coil 116 can include a conductive material wound around a coil, or a coil formed into a flexible circuit. The coil 116 can include a conductor for conducting a current induced on the coil to the patient interface unit 30. As will be appreciated, by attaching the coil 116 to the distal end of the end effector 100, it is possible to detect its position. In this manner, the physician 24 can more accurately determine the position of the distal end of the end effector 100 before applying ablation energy to tissue.

[0037] An insulating material, referred to herein as a jacket 106, is provided over each spine 104. Each jacket 106 functions to enhance the atraumatic nature of the end effector 100, to protect the subject from sharp edges, and for irrigation purposes, as described in more detail below. The jacket 106 may include a polymer. For example, the jacket 106 may be made from a flexible biocompatible electrically insulating material, such as polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), urethane, polyimide, parylene, silicone, or the like. In some examples, the insulating material may comprise a biocompatible polymer, including but not limited to polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-co-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, with the ratio of specific polymers selected to control the degree of inflammatory response. Additionally, although the jacket 106 is shown in these figures as being tubular, the jacket 106 may be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured such that the overall contour of the jacket 106 provides the physical and / or mechanical properties, such as stiffness and flexure along multiple axes, required for the end effector 100 described above.

[0038] Figure 3 is a schematic, pictorial diagram showing a detailed perspective view of the distal end of end effector 100, with coil 116 and ring 114 removed for clarity. Figure 4 is a schematic, pictorial diagram showing a detailed cross-sectional view of the distal end as shown in Figure 3, taken against a vertical plane intersecting longitudinal axis A1.

[0039] 3 and 4, the spines 104 are connected at their distal ends 104A to a distal hub 108, also referred to herein as a connection hub. The distal hub 108 is a monolithic cylinder that defines a distal hub lumen 108 that connects with a connector tube 118. The distal hub 108 can be made of Nitinol or any other suitable biocompatible material. The distal hub 108 extends from a first end (i.e., the left-most end of the distal hub 108 along the longitudinal axis A1 with respect to FIG. 3) to a second end opposite the first end (i.e., the right-most end of the distal hub 108 along the longitudinal axis A1 with respect to FIG. 3).

[0040] Furthermore, the distal hub 108 is radially symmetrical and defines a plurality of inverted T-shaped recesses 108A disposed about and defined within the outer circumferential surface of the distal hub 110 and extending parallel to the longitudinal axis A1. As seen in the cross-sectional view of FIG. 4, each recess 110A is open along the longitudinal axis A1 at a first end and a second end (i.e., there is no material at these ends defining termination points for these recesses 110A). In other words, each recess 110A extends the entire length of the distal hub 108. Furthermore, each recess 110A receives and mates with a distal end 104A of a respective spine 104 to prevent relative movement between the distal hub 108 and the spine 104. The distal end 104A is mated with the distal hub 108 by sliding into the recess 110A in a direction parallel to the longitudinal axis A1.

[0041] 3 and 4, adjacent recesses 110A have an inverted T-shape therebetween and define a T-formation 110 therebetween. The recesses 110A space the T-formations 110 from one another. The tops of adjacent T-formations 110 engage the outer surface of each respective spine 104 to prevent relative movement therebetween.

[0042] Figure 5 is a schematic, pictorial diagram showing a detailed perspective view of the proximal end of end effector 100 with sleeve 120 removed for clarity. Figure 6 is a schematic, pictorial diagram showing a detailed cross-sectional view of the proximal end as shown in Figure 5, taken about a vertical plane intersecting longitudinal axis A1. Figure 7 is a schematic, pictorial diagram showing an enlarged detailed perspective view of the proximal end shown in Figure 3 with tube 136 removed for clarity (tube 136 is discussed in more detail below).

[0043] Referring primarily to FIGS. 5-7, the spines 104 are connected at their proximal ends 104B to a proximal hub 122, also referred to herein as a connection hub. The proximal hub 122 is a monolithic cylinder defining a proximal hub lumen 126 that indirectly connects with the connector tube 118. The proximal hub 122 may be made of Nitinol or any other suitable biocompatible material. The proximal hub 122 extends from a first end (i.e., the left-most end of the proximal hub 122 along the longitudinal axis A1, relative to FIG. 6) to a second end opposite the first end (i.e., the right-most end of the proximal hub 122 along the longitudinal axis A1, relative to FIG. 6).

[0044] Additionally, like the distal end, the proximal hub 122 is radially symmetrical and defines a plurality of inverted T-shaped recesses 124A disposed about and defined within the outer periphery of the proximal hub 122 and extending parallel to the longitudinal axis A1. As seen in the cross-sectional view of FIG. 6, each recess 124A (not explicitly labeled in FIG. 6 because the proximal end 104B is disposed within the recess 124A, see FIG. 7) is open along the longitudinal axis A1 at a first end and a second end (i.e., there is no material at these ends defining a termination point to these recesses 124A). In other words, each recess 124A extends the entire length of the proximal hub 122. Additionally, each recess 124A receives and mates with the proximal end 104A of a respective spine 104 to prevent relative movement between the proximal hub 122 and the spine 104. The proximal end 104B is mated with the proximal hub 122 by sliding it into the recess 124A in a direction parallel to the longitudinal axis A1. They are held in place in any suitable manner (e.g., friction fit, fasteners, adhesive, etc.).

[0045] 5 and 6, adjacent recesses 124A have an inverted T-shape therebetween and define a T-formation 124 therebetween. The recesses 124A space the T-formations 124 from one another. The tops of adjacent T-formations 124 engage the outer surface of each respective spine 104 to prevent relative movement therebetween.

[0046] In some examples, the proximal hub 122 and the distal hub 108 are designed identically to increase the modularity of the connection hub. In the currently shown example, as shown particularly in FIG. 7, the opposing upper surfaces of each T-forming portion 124 each define a groove 124B. Adjacent grooves 124B of adjacent T-forming portions 124 form a groove pair. As best seen in FIG. 7, each groove pair is disposed above a respective recess 124A that separates each adjacent T-forming portion 124. In other words, the groove pair and the recess 124A are substantially radially aligned with one another.

[0047] Additionally, at the proximal end of the end effector 100 is a proximal tubular housing 128 that mates with the proximal hub 122 along the longitudinal axis A1. The tubular housing 128 defines a housing lumen 130 through which the connector tube 118 passes. The proximal hub 122 slides over a distal portion of the tubular housing 128 such that the tubular housing 128 extends through the hub lumen 126 of the proximal hub 122. As also seen in FIG. 7, the outer surface of the distal portion of the tubular housing 128 is a housing groove 128A that aligns with the hub groove 124B along the longitudinal axis A1. With reference to FIGS. 5 and 7, each hub groove pair 124B and the aligned housing groove 128A cooperatively receive a conduit 136 through which a wire / connection can be routed to electrically connect the end effector 100 to the rest of the system.

[0048] FIG. 8 is a schematic pictorial diagram showing a perspective view of the second end effector 200. FIG. 9 is a schematic pictorial diagram showing a cross-sectional detail view of the second end effector 200 shown in FIG. 3 cut against a vertical plane intersecting the longitudinal axis A1. The following description focuses on details specific to the second end effector 200 as contrasted with the first end effector 100. It will be understood that many of the features described with respect to the first end effector 100 can be suitably incorporated into the second end effector 200 and vice versa. By way of example, the second end effector 200 can have a similarly or identically designed elongated shaft 202, a spine 204 having a distal end 204A and a proximal end 204B, a distal hub 208, a distal hub lumen 212, an annulus 214, a coil 216, a proximal sleeve 220, a proximal hub 222, and a proximal tubular housing 228.

[0049] In Figure 8, each spine 204 has three electrodes 26 arranged thereon such that each of the three electrodes 26 on each respective spine are aligned with one another from spine 204 to spine 204. In other words, each spine 204 has electrodes 26 arranged at the same location along their length. With three electrodes 26 on a spine, the electrodes 26 have sufficient total tissue contact surface area to safely deliver a PFA pulse of approximately 2000V.

[0050] In addition to the above, the second end effector 200 differs primarily in the actuator member 218 that actuates the spine between the collapsed and extended configurations and / or provides irrigation around the end effector 200. The actuator member 218 exhibits a pull wire 218A and includes an irrigation tube 218B. The irrigation tube 218B extends along the longitudinal axis A1. The irrigation tube 218B also includes pores 218C to allow irrigation fluid, such as saline, to be distributed around each electrode 26. The pull wire 218A extends through the irrigation tube 218B and connects with the spine 104, thereby allowing the spine 104 to be moved between the expanded and collapsed configurations. More specifically, distal hub fastener 208A (to which pull wire 218A is attached) is connected within distal hub lumen 212 to distal hub 208, which mates with distal end 204A of spine 204, as described above with respect to end effector 100. Proximal to end effector 200 within proximal tubular housing 228 are one or more O-rings 228. The O-rings are configured to maintain radial positioning of pull wire 218A relative to longitudinal axis A1 and allow pull wire 218A to translate back and forth in a stable manner to actuate spine 204.

[0051] FIG. 10 is a schematic pictorial diagram showing a perspective view of the third end effector 300. FIG. 11 is a schematic pictorial diagram showing a perspective view of the third end effector 300 similar to FIG. 10, with the elongated shaft 302, ring 314, and coil 316 removed for clarity. FIG. 12 is a schematic pictorial diagram showing a cross-sectional detail view of the third end effector 200 shown in FIG. 11, cut against a vertical plane intersecting the longitudinal axis A1. The following description focuses on details unique to the third end effector 300 as contrasted with the first end effector 100 and the second end effector 200. It will be understood that many of the features discussed with respect to the end effectors 100, 200 discussed above may be suitably incorporated into the third end effector 300, and vice versa. By way of example, the third end effector 300 can have a similarly or identically designed elongate shaft 302, spine 304 having distal end 304A and proximal end 304B, distal hub 308, distal hub lumen 312, annulus 314, coil 316, and proximal sleeve 320. With reference to FIGURE 12, the actuator member 318 of the third end effector 300 includes an actuator rod 318 and an irrigation tube 318, which are differently configured and function in similar manners as described above.

[0052] FIG 13 is a schematic, pictorial diagram showing a detailed perspective view of the proximal end of the third end effector 300 with the sleeve 320 and some of the spines 304 removed for clarity. FIG 14 is a schematic, pictorial diagram showing an exploded detail view of the proximal hub 322 of the third end effector 300. FIG 15 is a schematic, pictorial diagram showing a detailed perspective view of the proximal hub 322 of the third end effector 300. FIG 16 is a schematic, pictorial diagram showing a detailed elevation view of the proximal hub 322 of the third end effector 300.

[0053] 13-16, the proximal hub 322, also referred to herein as the connecting hub, to which the proximal end 304B of the spine 304 is connected, is formed from multiple components. The proximal hub 322 may be made from Nitinol or any other suitable biocompatible material. Similar to the other described hubs, the proximal hub 322 includes a cylindrical body 322A that defines a proximal hub lumen 326 that connects directly or indirectly with the irrigation tube 318B. The cylindrical body 322A extends from a first end (i.e., the left-most end of the proximal hub 322 along the longitudinal axis A1 with respect to FIG. 11) to a second end opposite the first end (i.e., the right-most end of the proximal hub 322 along the longitudinal axis A1 with respect to FIG. 11). The cylindrical body 322A is provided with fins 322B that are radially disposed on the cylindrical body 322A and protrude from the outer circumferential surface of the cylindrical body 322A. Receiving channels 322C are defined between adjacent fins 322B and function in a manner described in more detail below.

[0054] As in the previous example, a plurality of recesses 324A are also provided, radially disposed around the outer periphery of the cylinder 322A and extending parallel to the longitudinal axis A1. However, in this example, the recesses 324A are formed in a spine coupler 324 that is partially cuboid in shape and has arcuate upper and lower surfaces and tapered sides (see FIG. 16 for reference). On its proximal side, the spine coupler 324 includes a stop 324B that projects toward the longitudinal axis and engages with a first end of the cylinder 322A when engaged with the cylinder 322A (FIG. 15) (e.g., the spine coupler 324 can be slid onto the cylinder A in the direction indicated by the arrow in FIG. 14). As a result, the spine coupler 324 is partially offset from the cylinder 322A along the longitudinal axis A1 such that the stop 324B overhangs the cylinder 322A.

[0055] Stops 324B maintain spine coupler 324 in place relative to barrel 322A and prevent spine 304 from pulling coupler 324 past barrel 322A. In other words, stops 324B prevent longitudinal translation in at least one direction of spine coupler 324 relative to barrel 322A. As can be seen particularly in Figures 15 and 16, spine coupler 322C sits within receiving channel 322C and is laterally restrained by fins 322B.

[0056] Furthermore, the recesses 324A formed in the upper surface of the spine coupler 324 are shaped to fit the shape of the proximal ends 304B of the spines 304 (FIG. 13). Thus, to mate the recesses 324A and the proximal ends 304B, each proximal end 304B is slid into its respective recess 324A in a direction perpendicular to the longitudinal axis A1. The recesses 324A have an open end that terminates proximally (but not flush) with the second end of the cylinder 322A (see, for example, the right side of FIG. 15) due to the offset between the spine coupler 324 and the cylinder 322A. Also, as seen in FIG. 15, the end of the recess 324A opposite the open end is closed because it fits the shape of the distal tip of the spine 304 it receives.

[0057] 17 is a schematic pictorial diagram showing a detailed perspective view of yet another connection hub 422. It is similar in construction to the previously described proximal hub 322, but is formed as a monolithic hub rather than as separate components.

[0058] The techniques of the present disclosure described herein can be further understood according to the following sections. Clause 1. An end effector for a medical device, the end effector comprising: a plurality of spines extending along a longitudinal axis and configured to move between an expanded configuration and a collapsed configuration, each spine having a proximal end and a distal end; a plurality of electrodes connected to the respective spines; a connection hub defining a hub lumen, the connection hub including a first end, a second end, and a plurality of recesses disposed radially around an outer circumferential surface of the connection hub and extending parallel to the longitudinal axis, each recess opening along the longitudinal axis at or proximal to the first end, each recess mating with one of the proximal and distal ends of a respective spine of the plurality of spines to prevent relative movement between the connection hub and the spine; and an actuator member connected to the connection hub and the plurality of spines such that translation of the actuator member along the longitudinal axis moves the spines from the expanded configuration to the collapsed configuration. Clause 2. An end effector as described in clause 1, wherein when each recess receives one of the proximal end and the distal end, the one of the proximal end and the distal end slides into the respective recess in a direction parallel to the longitudinal axis. Clause 3. An end effector as described in clause 1, wherein when the recess receives one of the proximal end and the distal end, the one of the proximal end and the distal end slides into the respective recess in a direction perpendicular to the longitudinal axis. Clause 4. An end effector described in any one of clauses 1 to 3, further comprising a connector tube extending parallel to the longitudinal axis and through the hub lumen from the proximal ends of the plurality of spines to the distal ends of the plurality of spines, the connector tube defining a connector tube lumen. Clause 5. The end effector of clause 4, wherein the connector tube defines a plurality of irrigation holes. Clause 6. The end effector of clause 1, further comprising an irrigation tube extending along the longitudinal axis, the actuator member comprising a pull wire extending through the irrigation tube and connected to distal ends of the plurality of spines, the pull wire configured to move the plurality of spines between an expanded configuration and a collapsed configuration. Clause 7. The end effector of clause 1, further comprising an irrigation tube extending along the longitudinal axis, the actuator member comprising an actuator rod extending through the irrigation tube and connected to distal ends of the plurality of spines, the actuator rod configured to move the plurality of spines between an extended configuration and a collapsed configuration. Clause 8. The end effector of clause 7, wherein the actuator rod comprises a reference or return electrode. Clause 9. An end effector described in any one of clauses 7 to 8, wherein the actuator rod defines an actuator rod lumen configured to pass a guidewire or mapping catheter therethrough. Clause 10. An end effector described in any one of clauses 6 to 9, wherein the irrigation tube is provided with holes to allow saline to be distributed around each of the multiple electrodes. Clause 11. An end effector described in any one of clauses 1 to 10, further comprising a proximal tubular housing that mates with the connection hub along the longitudinal axis. Clause 12. The end effector of clause 11, wherein the proximal tubular housing extends through the hub lumen. Clause 13. An end effector described in any one of clauses 11-12, wherein the connection hub defines a plurality of hub grooves and the proximal tubular housing has a plurality of housing grooves aligned with the plurality of hub grooves along the longitudinal axis. Clause 14. The end effector of clause 13, further comprising a plurality of electrical tubes each respectively received in the aligned plurality of housing grooves and the plurality of hub grooves. Clause 15. An end effector described in any one of clauses 1 to 14, wherein the plurality of electrodes comprises three electrodes connected to each spine, each of the three electrodes on each spine being aligned laterally with respect to one another, and the plurality of electrodes has a total tissue contact surface area sufficient to deliver a pulsed field ablation (PFA) pulse of 2000V. Clause 16. An end effector described in any one of clauses 1 to 14, wherein each spine has a midpoint and the plurality of electrodes includes four electrodes connected to each spine, a first two of the four electrodes being on a first side of the midpoint of each spine and a second two of the four electrodes being on a second side of the midpoint of each spine. Clause 17. An end effector described in any one of clauses 1 to 16, further comprising a magnetic position sensor connected to the distal ends of the plurality of spines. Clause 18. A connection hub for use with an end effector of a medical device, the connection hub including a first end, a second end opposite the first end, a cylindrical body defining a hub lumen and extending along a longitudinal axis from the first end to the second end, and a plurality of recesses disposed radially around an outer circumferential surface of the cylindrical body and extending parallel to the longitudinal axis, each recess opening along the longitudinal axis at or proximal to the first end, each recess configured to mate with a proximal or distal end of a spine of the end effector. Clause 19. A connection hub as described in clause 18, wherein each recess is defined in an outer circumferential surface of the cylindrical body. Clause 20. A connection hub as described in any one of clauses 18 to 19, wherein each recess extends the entire length of the cylindrical body. Clause 21. A connection hub as described in any one of clauses 18 to 20, wherein adjacent recesses define a T-formation therebetween, each recess spacing adjacent T-formations apart. Clause 22. A connection hub as described in clause 21, wherein opposing upper surfaces of each T-shaped formation respectively define a groove, and adjacent grooves of adjacent T-shaped formations form a groove pair configured to cooperatively receive an electrical conduit. Clause 23. A connection hub as described in clause 22, wherein each pair of grooves is disposed above a respective recess that separates each adjacent T-forming portion. Clause 24. A connection hub as described in any one of clauses 18 to 23, wherein the connection hub is cylindrical. Clause 25. The connection hub of clause 18, further comprising a plurality of spine couplers each engaging an outer circumferential surface of the cylindrical body, the plurality of spine couplers comprising a plurality of recesses. Clause 26. A connection hub as described in clause 25, wherein each spine coupler includes a stop protruding toward the longitudinal axis, the stop preventing longitudinal translation of the spine coupler relative to the cylinder in a first direction. Clause 27. A connection hub as described in any one of clauses 25-26, wherein each spine coupler is partially offset from the cylindrical body along the longitudinal axis such that each spine coupler overhangs the cylindrical body. Clause 28. A connection hub as described in any one of clauses 25 to 27, wherein the cylindrical body has a plurality of fins arranged radially around the outer circumferential surface of the cylindrical body, adjacent fins receiving respective spine couplers therebetween. Clause 29. A connection hub as described in any one of clauses 18 to 28, wherein the multiple recesses are shaped to correspond to the shape of the proximal or distal end of the spine of the end effector.

[0059] The above-described embodiments are cited as examples, and the disclosed technology is not limited to what has been specifically shown and described in the above specification. Rather, the scope of the disclosed technology includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that would occur to one skilled in the art upon reading the foregoing description and that are not disclosed in the prior art.

[0060] [Embodiment] (1) An end effector for a medical device, the end effector comprising: a plurality of spines extending along a longitudinal axis and configured to move between an expanded configuration and a collapsed configuration, each spine having a proximal end and a distal end; A plurality of electrodes connected to each spine; a connection hub defining a hub lumen, the connection hub including a first end, a second end, and a plurality of recesses radially disposed about an outer periphery of the connection hub and extending parallel to the longitudinal axis, each recess opening along the longitudinal axis at or proximal to the first end, each recess mating with one of the proximal and distal ends of a respective spine of a plurality of spines to prevent relative movement between the connection hub and the spine; an actuator member connected to the connection hub and to the plurality of spines such that translation of the actuator member along the longitudinal axis moves the spines from the expanded configuration to the collapsed configuration. (2) An end effector as described in embodiment 1, wherein the one of the proximal end and the distal end slides into the respective recess in a direction parallel to the longitudinal axis when the respective recess receives the one of the proximal end and the distal end. (3) An end effector as described in embodiment 1, wherein the one of the proximal end and the distal end slides into the respective recess in a direction perpendicular to the longitudinal axis when the respective recess receives the one of the proximal end and the distal end. (4) The end effector of embodiment 1, further comprising a connector tube extending parallel to the longitudinal axis and through the hub lumen from the proximal ends of the plurality of spines to the distal ends of the plurality of spines, the connector tube defining a connector tube lumen. (5) further comprising an irrigation tube extending along the longitudinal axis; An end effector as described in embodiment 1, wherein the actuator member comprises a puller wire extending through the irrigation tube and connected to the distal ends of the plurality of spines, the puller wire configured to move the plurality of spines between the expanded configuration and the collapsed configuration.

[0061] (6) further comprising an irrigation tube extending along the longitudinal axis; An end effector as described in embodiment 1, wherein the actuator member comprises an actuator rod extending through the irrigation tube and connected to the distal ends of the plurality of spines, the actuator rod being configured to move the plurality of spines between the expanded configuration and the collapsed configuration. (7) An end effector as described in embodiment 6, wherein the actuator rod defines an actuator rod lumen configured to pass a guidewire or mapping catheter therethrough. (8) The end effector of embodiment 1, further comprising a proximal tubular housing mating with the connection hub along the longitudinal axis. (9) The end effector of embodiment 8, wherein the proximal tubular housing extends through the hub lumen. (10) The end effector of embodiment 8, wherein the connection hub defines a plurality of hub grooves and the proximal tubular housing has a plurality of housing grooves aligned with the plurality of hub grooves along the longitudinal axis.

[0062] (11) A connection hub for use with an end effector of a medical device, the connection hub comprising: A first end; a second end opposite the first end; and a cylindrical body defining a hub lumen and extending along a longitudinal axis from the first end to the second end; a plurality of recesses disposed radially around an outer circumferential surface of the cylinder and extending parallel to the longitudinal axis, each recess opening along the longitudinal axis at or proximal to the first end, each recess configured to mate with a proximal or distal end of a spine of the end effector. (12) The connection hub of embodiment 11, wherein each recess is defined in the outer circumferential surface of the cylindrical body. (13) A connection hub as described in embodiment 11, wherein adjacent recesses define T-shaped formations therebetween, and each recess spaces adjacent T-shaped formations apart. (14) A connection hub as described in embodiment 13, wherein opposing upper surfaces of each T-shaped formation define a groove, and adjacent grooves of adjacent T-shaped formations cooperate to form a groove pair configured to receive an electrical tube. (15) A connection hub as described in embodiment 14, wherein each pair of grooves is disposed above a respective recess that separates each adjacent T-shaped formation.

[0063] (16) The connection hub of embodiment 11, further comprising a plurality of spine couplers each engaging with the outer circumferential surface of the cylindrical body, the plurality of spine couplers comprising the plurality of recesses. (17) A connection hub as described in embodiment 16, wherein each spine coupler includes a stop protruding toward the longitudinal axis, the stop preventing longitudinal translation of the spine coupler in a first direction relative to the cylinder. (18) A connection hub as described in embodiment 16, wherein each spine coupler is partially offset from the cylindrical body along the longitudinal axis such that each spine coupler overhangs the cylindrical body. (19) A connection hub as described in embodiment 16, wherein the cylindrical body includes a plurality of fins radially arranged about the outer circumferential surface of the cylindrical body, adjacent fins receiving a respective spine coupler therebetween. (20) The connection hub of embodiment 11, wherein the plurality of recesses are shaped to correspond to a shape of the proximal end or the distal end of the spine of the end effector.

Claims

1. 1. An end effector for a medical device, the end effector comprising: a plurality of spines extending along a longitudinal axis and configured to move between an expanded configuration and a collapsed configuration, each spine having a proximal end and a distal end; A plurality of electrodes connected to each spine; a connection hub defining a hub lumen, the connection hub including a first end, a second end, and a plurality of recesses radially disposed about an outer circumferential surface of the connection hub and extending parallel to the longitudinal axis, each recess opening along the longitudinal axis at or proximal to the first end, each recess mating with one of the proximal and distal ends of a respective spine of a plurality of spines to prevent relative movement between the connection hub and the spine; an actuator member connected to the connection hub and to the plurality of spines such that translation of the actuator member along the longitudinal axis moves the spines from the expanded configuration to the collapsed configuration.

2. The end effector of claim 1 , wherein the one of the proximal and distal ends slides into the respective recess in a direction parallel to the longitudinal axis when the respective recess receives the one of the proximal and distal ends.

3. The end effector of claim 1 , wherein the one of the proximal and distal ends slides into the respective recess in a direction perpendicular to the longitudinal axis when the respective recess receives the one of the proximal and distal ends.

4. The end effector of claim 1 , further comprising a connector tube extending parallel to the longitudinal axis and through the hub lumen from the proximal ends of the plurality of spines to the distal ends of the plurality of spines, the connector tube defining a connector tube lumen.

5. an irrigation tube extending along the longitudinal axis; 2. The end effector of claim 1, wherein the actuator member comprises a puller wire extending through the irrigation tube and connected to the distal ends of the plurality of spines, the puller wire configured to move the plurality of spines between the expanded configuration and the collapsed configuration.

6. an irrigation tube extending along the longitudinal axis; 2. The end effector of claim 1, wherein the actuator member comprises an actuator rod extending through the irrigation tube and connected to the distal ends of the plurality of spines, the actuator rod configured to move the plurality of spines between the expanded configuration and the collapsed configuration.

7. The end effector of claim 6 , wherein the actuator rod defines an actuator rod lumen configured for a guidewire or mapping catheter to pass therethrough.

8. The end effector of claim 1 , further comprising a proximal tubular housing mating with the connection hub along the longitudinal axis.

9. The end effector of claim 8 , wherein the proximal tubular housing extends through the hub lumen.

10. The end effector of claim 8 , wherein the connection hub defines a plurality of hub grooves, and the proximal tubular housing includes a plurality of housing grooves aligned with the plurality of hub grooves along the longitudinal axis.

11. 1. A connection hub for use with an end effector of a medical device, the connection hub comprising: a first end; and a second end opposite the first end; and a cylindrical body defining a hub lumen and extending along a longitudinal axis from the first end to the second end; a plurality of recesses disposed radially around an outer circumferential surface of the cylinder and extending parallel to the longitudinal axis, each recess opening along the longitudinal axis at or proximal to the first end, each recess configured to mate with a proximal or distal end of a spine of the end effector.

12. The connection hub of claim 11 , wherein each recess is defined in the outer circumferential surface of the cylindrical body.

13. The connection hub of claim 11 , wherein adjacent recesses define a T-formation therebetween, each recess spacing adjacent T-formations apart.

14. 14. The connection hub of claim 13, wherein opposing upper surfaces of each T-forming portion define a respective groove, and adjacent grooves of adjacent T-forming portions cooperate to form a groove pair configured to receive an electrical tube.

15. The connection hub of claim 14 , wherein each pair of grooves is disposed above a respective recess that separates the respective adjacent T-formations.

16. The connection hub of claim 11 , further comprising a plurality of spine couplers respectively engaging the outer circumferential surface of the cylindrical body, the plurality of spine couplers comprising the plurality of recesses.

17. The connection hub of claim 16 , wherein each spine coupler includes a stop protruding toward the longitudinal axis, the stop preventing longitudinal translation of the spine coupler relative to the barrel in a first direction.

18. The connection hub of claim 16 , wherein each spine coupler is partially offset from the cylindrical body along the longitudinal axis such that each spine coupler overhangs the cylindrical body.

19. The connection hub of claim 16 , wherein the cylindrical body includes a plurality of fins radially disposed about the outer circumferential surface of the cylindrical body, adjacent fins receiving a respective spine coupler therebetween.

20. The connection hub of claim 11 , wherein the plurality of recesses are shaped to correspond to a shape of the proximal end or the distal end of the spine of the end effector.

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