Medical device with tactile feedback for the deployment

Abstract

To provide a medical device.SOLUTION: The disclosed technology includes an actuator subsystem for a medical probe, including an actuator, a detent, and at least one catch. The actuator is designed to move an end effector between expanded and collapsed configurations. As the actuator is moved, the catches, in conjunction with the detent, provide tactile feedback regarding a position of an end effector of the medical device.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to earlier U.S. Provisional Patent Application No. 63 / 581,435, filed September 8, 2023 (Attorney Docket No. BIO6817USPSP1-253757.000426), the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION 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]

[0003] 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.

[0004] 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 fistulas.

[0005] Cryoablation is an alternative approach to RF ablation that reduces the thermal risks typically associated with RF ablation. However, manipulating cryoablation devices 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.

[0006] 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.

[0007] Regions of cardiac tissue can be mapped by the catheter to identify abnormal electrical signals. Ablation can be performed using the same or a different medical device. Some exemplary probes include multiple spines with electrodes positioned on them. These probes must be able to ablate the inner bellmouth of the pulmonary veins (PV) and the ostial surfaces of the PV without excessively retracting the spines. Additionally, these catheters must be able to fit within a 13.5 French (Fr) sheath. Summary of the Invention [Means for solving the problem]

[0008] In accordance with the disclosed technology, an end effector for a medical device is provided. The end effector can include a one-piece spine frame. The one-piece spine frame can include a proximal end, a distal end with a crown, and a plurality of spines integral with the crown. The plurality of spines are configured to bend radially outward from the longitudinal axis and move between an expanded configuration and a folded configuration. The one-piece frame is a teardrop-shaped profile in the folded configuration. The teardrop-shaped profile has a bulbous distal region that tapers toward a proximal region. The bulbous distal region includes a plurality of spines that extend outward from the crown to the longitudinal axis in a proximal direction, the plurality of spines tapering toward the longitudinal axis for a smaller proximal region, and a transition region is between the bulbous region and the subsequent region. At least one electrode is disposed on each spine in the bulbous distal region. At least two electrodes are disposed on each spine of the subsequent region.

[0009] According to the disclosed technology, there is further provided a housing assembly for a medical device. The housing assembly may include a shell, an actuator, a detent, and a first catch. The shell defines a cavity. The actuator is slidable within the cavity along a longitudinal axis and configured to move the end effector between an extended configuration and a folded configuration. The detent is engaged with one of the shell and the actuator. The first catch is integral with the other of the shell and the actuator and configured to selectively engage the detent. Engagement of the detent with the first catch provides tactile feedback regarding the folded, intermediate, or extended configuration of the end effector.

[0010] According to an embodiment of the disclosed technology, a medical device is further provided. The medical device can include a first shaft, an end effector, and a housing assembly. The first shaft extends along a longitudinal axis and is attached to an actuator. The end effector is attached to the first shaft at a proximal end of the end effector and configured to move between an extended configuration, an intermediate configuration, and a folded configuration. The housing assembly can include an actuator, a detent, and a first catch. The actuator is attached to the first shaft and slidable along the longitudinal axis. Sliding motion of the actuator causes the first shaft and the proximal end of the end effector to slide. The first catch is configured to selectively engage the detent. The first catch is configured to provide tactile feedback that the end effector is in one of the extended configuration, the intermediate configuration, and the folded configuration. [Brief description of the drawings]

[0011] [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 a medical device with a portion of the elongate shaft cut away, in accordance with the disclosed technology. [Diagram 3] FIG. 1 is a schematic pictorial diagram showing a detailed schematic view of a portion of a handle, in accordance with the disclosed technology. [Figure 4] FIG. 2 is a schematic pictorial diagram showing a detailed cross-sectional view of a portion of a handle and actuator subsystem in accordance with the disclosed technology. [Diagram 5] 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; [Figure 6] 1 is a schematic pictorial diagram showing a medical device from a distal end in accordance with the disclosed technology. [Figure 7] FIG. 1 is a schematic, pictorial representation of a side view of an end effector disposed within a sheath in accordance with the disclosed technology; [Figure 8] FIG. 1 is a schematic pictorial diagram of a side view of an integrated spine frame in accordance with the disclosed technology; [Figure 9] FIG. 1 is a schematic, pictorial representation of a detailed cross-sectional side view of a distal end of an end effector in accordance with the disclosed technology; [Figure 10] FIG. 1 is a schematic, pictorial illustration of a perspective view of a distal end of an end effector in accordance with the disclosed technology; [Figure 11] FIG. 1 is a schematic, pictorial illustration of an end effector ring in accordance with the disclosed technology; [Figure 12] FIG. 13 is a schematic pictorial diagram of a detailed perspective view of the proximal end of the end effector with the spine retaining collar removed in accordance with the disclosed technology; [Figure 13] FIG. 1 is a schematic, pictorial diagram illustrating an end effector in a position immediately after actuation of the actuator subsystem has begun, in accordance with the disclosed technology. [Figure 14] 1 is a schematic pictorial diagram illustrating an end effector in a position intermediate a collapsed configuration and an extended configuration in accordance with the disclosed technology; [Figure 15] FIG. 1 is a schematic, pictorial diagram illustrating an end effector in an extended configuration, in accordance with the disclosed technology; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] 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.

[0013] 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 disclosed 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.

[0014] 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.

[0015] 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.

[0016] 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 in 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.

[0017] 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.

[0018] As discussed herein, the terms "tubular," "tube," and "shaft" are intended to be broadly construed and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular / shaft structure is generally illustrated as a substantially right cylindrical structure. However, a tubular / shaft structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0019] The present disclosure relates to systems, methods, or uses and devices for IRE ablation of cardiac tissue to treat cardiac arrhythmias. 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.

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

[0021] The present disclosure may include electrodes configured for 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 in the myocardium. The biphasic pulses are non-sinusoidal waveforms and can be tailored to the target cells based on the electrophysiology of the cells. In contrast, to ablate using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area, indiscriminately heating all cells within the treatment area. Thus, IRE has the ability to spare adjacent heat-sensitive structures or tissues, which may be beneficial in reducing possible complications known with ablation or isolation modalities. Additionally or alternatively, monophasic pulses may be utilized.

[0022] Electroporation can be induced by applying a pulsed electric field to biological cells to cause the reversible (temporary) or irreversible (permanent) generation 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 approximately 500V / cm, while bone has a threshold potential of 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on the threshold potential.

[0023] The technology of the present disclosure includes systems and methods for applying electrical signals from a catheter electrode positioned near 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 near 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.

[0024] 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.

[0025] Please refer to FIG. 1, which shows an exemplary catheter-based electrophysiology 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 probe, such as a catheter 14, configured to sense an IEGM is illustrated herein. The physician 24 brings a distal tip of the catheter 14 (i.e., in this case, a 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.

[0026] 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.

[0027] 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.

[0028] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the position of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking 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.

[0029] 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.

[0030] 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.

[0031] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities to implement real-time calculations of the catheters' positions and perform ECG calculations.

[0032] 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, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0033] 2 is a schematic pictorial diagram showing a perspective view of a medical device 14 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 examples takes the form of a basket assembly including one or more spines 104. In some examples, the one or more spines 104 may be integrally formed with a crown 108 to form a one-piece / monolithic spine frame 102.

[0034] The one or more spines 104 are movable between an extended configuration and a folded configuration. Such movement can be accomplished by an actuator subsystem 200, including, among other elements, an actuator 210 and an elongated shaft 200, as described further below. The elongated shaft 202 connects the end effector 100 to a handle that can be manipulated by an operator 24 in use. The elongated shaft 202 may also be referred to as an actuator shaft when the shaft 202 is fixed to a distal end of the basket and connected to an actuator at a proximal handle 300 for translation along the longitudinal axis A1. FIG. 7 is a schematic pictorial diagram showing a side view of the end effector 100 within a sheath 400 in a folded configuration. In the extended configuration (FIG. 15) as well as the folded configuration, the one or more spines 104 bend radially outward. As seen in FIGS. 2 and 5, the spine frame 102 may be a teardrop-shaped profile in the folded configuration. The spine 104, elongate shaft 202, and handle 300 are aligned generally along a longitudinal axis A1 when the elongate shaft 210 is unbent.

[0035] 3 is a schematic pictorial diagram showing a detailed schematic view of a portion of a handle 300. The handle 300 is also referred to herein as a housing assembly. As shown, the handle 300 may have a clamshell design defining a cavity 302. In FIG. 3, a portion of the clamshell has been removed to diagrammatically show an exemplary interior thereof. As shown, a portion of the actuator subsystem 200 is housed within the handle 300 and extends parallel to and along a longitudinal axis A1.

[0036] FIG. 4 is a schematic pictorial diagram showing a detailed cross-sectional view of a portion of the handle 300 and the actuator subsystem 200. In addition to the above, the actuator 210 can take the form of a push / pull rod with an enlarged head (on the right side of FIG. 4) for manipulation by the operator 24. The proximal end of the elongated shaft 202, also referred to herein as the first elongated shaft, is connected to the distal end of the actuator 210 to allow for simultaneous translation of both when the actuator 210 is manipulated, as will be described in more detail below. The distal end of the elongated shaft 202 (FIG. 5) can be connected to the end effector 100 via a collar 102A. The elongated shaft 202 defines a lumen 204 therethrough that receives another elongated shaft 206, also referred to herein as the second elongated shaft 206. The second elongated shaft 206 can be routed through the handle 300 and the first elongated shaft 202 and secured at its distal end to the distal end of the end effector 100 (FIG. 9). The first elongate shaft 202 is slidable relative to the second elongate shaft 206, which will be described in more detail below. The second elongate shaft 206 may be used in part to deliver irrigation to the end effector 100 through its lumen 208. For example, the second elongate shaft 206 may be provided with irrigation holes in its distal portion. Both the first elongate shaft 202 and the second elongate shaft 206 may be formed 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 the particular polymers being selected to control the degree of inflammatory response.

[0037] 3 and 4, a pill-shaped relief 212 may be formed in the wall of the actuator 210 disposed within the handle 300. Within the relief 212 are a number of protrusions 214 for providing tactile feedback to the operator 14, as will be described in more detail below. For example, the number of protrusions / ribs 214 may include a first set of protrusions / ribs 214A that function as a first catch, a second set of protrusions / ribs 214B that function as a second catch, and a third set of protrusions / ribs 214C that function as a third catch. Of course, any number of catches may be used without departing from the spirit and scope of the present disclosure. The protrusions 214 are used in conjunction with detents 216 that may be connected to or otherwise integrated with the housing 300. In the currently depicted example, the detent 216 comprises a hollow pin 216 with a spring 222 provided within a cavity in the pin 216 to bias the ball 220 away from the cavity and towards the relief 212 and protrusion 214. The detent 216 may be movable towards and away from the protrusion / catch 214 in a direction perpendicular to the longitudinal axis A1, which has the effect of adjusting the force applied by the detent 216 to the protrusion 214. This may be achieved, for example, by threading the detent 216 into the housing 300.

[0038] Of course, other configurations of this portion of the actuator subsystem may be used. For example, a different structural configuration of the detent 216 may be used. Additionally, the protrusion 214 may alternatively be provided on the handle 300 and the detent 216 may be connected to the actuator 210. Operation of the actuator subsystem is described in more detail below in conjunction with Figures 13-15.

[0039] FIG. 5 is a schematic pictorial diagram showing a perspective view of an end effector 100 of a medical device according to the disclosed technology. FIG. 6 is a schematic pictorial diagram showing the medical device from its distal end. FIG. 7 is a schematic pictorial diagram of a side view of the end effector 100 disposed within a sheath 400. FIG. 8 is a schematic pictorial diagram of a side view of an integrated spine frame 102. Referring to FIGS. 5-8, an integrated spine frame 102 may be used as described above. The frame 102 may include one or more flexible spines 104 connected at its proximal portion 104B to a first elongate shaft 202 and at its distal portion 104A to a second elongate shaft 206. During a medical procedure, the operator 24 may deploy the end effector 100 from a sheath 400 having a diameter D1 (e.g., a diameter of 12 Fr or 13.5 Fr, see FIG. 7). Extending the shafts 202, 206 through the sheath 400 allows the end effector 100 to exit the sheath 400, at which point it can transition to an expanded configuration (described in more detail below). The spine 104 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and may include a flexible, resilient material (e.g., a shape memory alloy such as nickel-titanium, also known as Nitinol) that forms struts.

[0040] In FIG. 7, it can be seen that the spines define a teardrop-shaped profile, with the spines flaring outward from the longitudinal axis in a proximal direction. The spines (126 and 136) can be seen to expand outward for a length L2, at which point the spine expansion stops and the spine essentially becomes tangent to the inner surface of the tubular member 400. This profile of the spine over L2 is considered to be the "bulbous region" of the end effector. The spine then tapers inward (towards the longitudinal axis) for a length L1 that extends toward near the proximal 130. This profile over L1 is considered to be the "subsequent region." Between the "bulbous region" and the "subsequent region" is a "transition region" where the spine abuts the inner surface of the tubular member 400. The inventors have devised a unique arrangement of electrodes for the bulbous region and the subsequent region for what they believe to be the optimal ablation electrode placement in a pulmonary vein ablation procedure. In particular, at least one electrode must be disposed on at least one spine in the bulbous region, and at least two electrodes must be disposed in the subsequent region. Similarly, every other spine in the plurality of spines must have one electrode disposed in the transition region (i.e., the region of greatest outer diameter defined by the spines adjacent the tubular interior surface of member 400). It can be seen that in the exemplary spine 126, this requirement of at least one electrode 26 in the bulbous region is met by electrode 26a, and the requirement of at least two electrodes disposed in the subsequent region is met by electrodes 26b and 26c. The requirement of one electrode on the transition region is met by electrode 26e.

[0041] Referring back to FIG. 8, the position of each of the spines 104, and therefore the overall shape of the basket, can be determined through the use of a magnetic field sensor in the form of multiple loops formed of a helical loop of wire with two leads 300a and 300b, with the wire loop around the spine (shown as a dashed line) forming a loop around each of the multiple spines. Alternatively, a flat loop can also be defined by a single wire with two leads 300a and 300b. Each spine has a wire loop in the form of a helix (central spine) or a flat loop shown in the lower spine. The support of the magnetic position sensor and the shape determination of this sensor can be understood from US Patent Application Publication Nos. 20180344202 (A1), 20220265194 (A1), or 10687761 (B2), each of which is incorporated by reference with a copy provided in the appendix of priority application No. 63 / 581435.

[0042] As will be appreciated, the spine 104 may be electrically insulated from the electrode 26 to prevent arcing from the electrode 26 to the spine 104. For example, an insulating jacket may be positioned between the spine 104 and the electrode 26, although one of ordinary skill in the art will appreciate that other insulating coverings are contemplated. For example, an insulating coating may be applied to the spine 104, the electrode 26, or both. The insulating jacket may be made from a 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. The insulating jacket 106 may also include one or more additives or fillers, such as, for example, polytetrafluoroethylene (PTFE), boron nitride, silicon nitride, silicon carbide, aluminum oxide, aluminum nitride, zinc oxide, and the like.

[0043] In the embodiments described herein, the electrodes 26 may be configured to deliver ablation energy (IRE and / or RF) to tissue within the heart 12. In addition to using the electrodes 26 to deliver ablation energy, the electrodes 26 may 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 electrodes 26 may be biased such that a majority of the electrodes 26 face outward from the end effector 100 such that the electrodes 26 deliver a greater amount of electrical energy outward from the end effector 100 (i.e., toward the tissue of the heart 12) than inward toward the end effector 100.

[0044] 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.

[0045] At least three electrodes 26 can be attached to each spine 104, as shown in particular in Figures 5 and 6. For example, four electrodes 26 can be attached to each spine 104, with at least ten spines 104 arranged radially around the end effector 100, such that 30-40 electrodes can be provided on the basket assembly that is sized and designed in conjunction with the second elongate shaft 206 while still fitting within a 12 Fr or 13.5 Fr sheath. As shown in particular in Figures 5-7, the electrodes 26 are staggered relative to the electrodes 26 on adjacent spines 104 along the longitudinal axis A1. In other embodiments, the electrodes 26 do not necessarily need to be staggered to still fit within a 12 Fr or 13.5 Fr sheath. Also, as seen in particular in Figure 7, the electrodes 28 are also generally weighted / positioned on the spines 104 toward the distal portion 104A such that there are no electrodes 28 at the proximal portion 104B of the end effector 100. The reference electrode 31 may be located in the region between L1 and L2 in FIG. 7 such that the reference electrode is approximately isocentric with respect to the electrode 28 located between the region defined by L1 and L2.

[0046] FIG. 9 is a schematic pictorial view of a detailed cross-sectional side view of the distal end of the end effector 100. FIG. 10 is a schematic pictorial view of a perspective view of the distal end of the end effector 100 with the coil 124 removed for clarity. FIG. 11 is a schematic pictorial view of the ring 114 of the end effector 100. With reference to FIGS. 9-11, as described above, a second elongated shaft 206 is connected to the distal end of the end effector. Specifically, the end effector 100 includes a ring 114 having a lumen 114A in which the second elongated shaft 206 is secured. The ring includes a rounded atraumatic tip 116, a friction ring intermediate portion 118, a locking protrusion 120 radially disposed around the friction ring intermediate portion 118, and a ring shaft 122 opposite the atraumatic tip 116. The annulus 114A is axially aligned with the second elongate shaft lumen 208 such that various medical devices, such as a mapping catheter or guidewire, can extend therethrough in use. The annulus 114 is connected to and extends through the distal end 108 of the integral spine frame 102, which is also referred to herein as the crown 108. As seen particularly in FIG. 10, the crown 108 is provided with a number of notches 110 radially disposed about its circumference into which the locking protrusions 120 engage to lock the crown 108 to the annulus 114. Additionally, the friction ring intermediate portion 118 frictionally engages with the inner annular surface of the crown 108 to help prevent disengagement. The annulus shaft 122 engages the outer surface of the second elongate shaft 206.

[0047] 7 and 9, a first coil 124 is integrated with or connected to the ring 114. The first coil 124 can be configured to generate a current when subjected to a magnetic field. In some examples, the first coil 124 can include a single axis sensor (SAS). In other examples, the coil 124 can include a dual axis sensor (DAS) or a triaxial sensor (TAS). The first coil 124 can include a conductive material wound around a coil, or a coil formed into a flex circuit. The first coil 124 can include a conductor for conducting a current induced on the first coil 124 to the patient interface unit 30. As can be appreciated, by attaching the first coil 124 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.

[0048] Also provided on the end effector 100 are one or more second coils 126 (FIG. 7) disposed within the jacket 106 and / or spine 104. In some examples, the second coil 126 can include a SAS. In other examples, the second coil 126 can include a DAS or a TAS. The second coil 126 can include a conductive material wound on a coil, or a coil formed in a flex circuit. The second coil(s) 126 can include a conductor for conducting a current induced on the second coil(s) 126 to the patient interface unit 30. As will be appreciated, by attaching the second coil 126 to one or more of the spines 104, it is possible to detect its location. In this manner, similar to the first coil 124, the physician 24 can more accurately determine the location of the spine 104 of the end effector 100 before applying ablation energy to tissue.

[0049] Further provided on or adjacent to the end effector 100 at its proximal end is a third coil 128 (FIGS. 5 and 7) sandwiched between the collar 202A of the first elongate shaft 202 and the spine retaining collar 130. In some examples, the third coil 128 can comprise a DAS or a TAS. In other examples, the third coil 128 can comprise a SAS. The third coil 128 can comprise a conductive material wound on a coil, or a coil formed into a flex circuit. The third coil 128 can comprise a conductor for conducting a current induced on the third coil 128 to the patient interface unit 30. As will be appreciated, by attaching the third coil 128 to the proximal end of the end effector 100, it is possible to detect its position. In this manner, similar to the first coil 124 and the second coil 126, the physician 24 can more accurately determine the position of the proximal end of the end effector 100 before applying ablation energy to tissue.

[0050] 12 is a schematic pictorial diagram of a detailed perspective view of the proximal end of end effector 100 with spine retaining collar 130 removed for clarity. The proximal end 112 of spine 104 has a tab shaped to engage with a spine coupler 132. The spine coupler connects to an irrigation manifold 134 that provides irrigation to end effector 100. In the illustrated example, the engagement may be via a method similar to how ring 114 and crown 108 mate.

[0051] The actuator subsystem 200 will now be described in more detail with particular reference to Figures 4, 7, and 13-15. Due to the teardrop-shaped profile shape of the spine frame 102 in the folded configuration, the spine frame 102 has a maximum diameter D1 at a first location 136 along the spine 104 that is offset from the center of the spine frame 102. More specifically, the first location 136 is toward the distal portion 104A of the end effector 100 at a distance L1 from the proximal end of the spine 104 and / or crown 108 and a distance L2 to the distal end of the spine 104. To allow for maneuverability within the heart, the sum of L1 and L2 is minimized in the disclosed technology. For example, the sum of L1 and L2 can fall within the range of 30-50 millimeters. In the folded configuration, the detent 216 engages the first catch 214A. In some examples, the detent 216 can be adjusted to lock it with the first catch 214A (as well as the other catches 214B, 214C). This feature allows the operator 24 to maintain the exact intended geometry of the end effector 100, which changes as the end effector 100 is extended.

[0052] 13 is a schematic pictorial diagram showing the end effector 100 in a position immediately after actuation of the actuator subsystem 200 has begun. This conical shape allows for easy placement within the pulmonary vein of the patient 23. More specifically, when the actuator 210 is pulled along the longitudinal axis A1 with sufficient force toward the end effector 100 so as to protrude further from the handle 300, the detents 216 leave engagement with the first catch 214A, providing tactile feedback to the operator 24 that the end effector 100 is no longer in the collapsed configuration. As this movement of the actuator 210 occurs, the spine 104 begins to bend further radially outward (relative to the collapsed configuration). This motion is telescopically accomplished by the sliding motion of the first elongated shaft 202 (sliding due to its connection to the actuator 210) relative to the second elongated shaft 206, such that the first elongated shaft 202 moves along the second elongated shaft 206.

[0053] 7, three reference electrodes 31a, 31b, and 31c can be disposed on the actuator shaft 206. By having three reference electrodes 31, this example ensures that at least one reference electrode 31 is always exposed to the blood medium so that far-field signals (e.g., noise) can be sensed or collected for noise cancellation to near-field signals collected by the tissue-contacting electrode 28.

[0054] 14 is a schematic pictorial diagram showing the end effector 100 in a position intermediate between the collapsed and extended configurations. In this intermediate configuration, the spine 104 bends radially outward further as the first elongate shaft slides closer to the annulus 114. Additionally, the detent 216 engages the second catch 214B to provide tactile feedback to the operator 24 that the end effector is in the intermediate configuration. As alluded to above, the detent 216 can be provided as threadably adjustable such that the detent 216 can be moved toward the catch 214B to lock into the intermediate position if the operator 24 needs to maintain this position for a period of time or if the extended configuration is not required for a particular treatment area. To unlock and / or continue movement of the actuator 210, the detent 216 can be adjusted away from the catch 214B to reduce the force it applies to the second catch 214B, and sufficient force from the operator 24 allows the detent 216 to leave engagement with the second catch 214B.

[0055] FIG. 15 is a schematic drawing showing the end effector 100 in an extended configuration, with the spine 104 fully bent outward / expanded and the maximum diameter D2 being greater than the maximum diameter D1 in the collapsed configuration. In this position, the distal end of the first elongate shaft 202 is disposed proximal to the annulus 114 and the spine 104 resembles a petal. In some examples, the proximal and distal ends of the end effector 100 can abut or substantially abut one another in the extended configuration (i.e., there is no space separating the ends or only a gap of a few millimeters (e.g., 1-3 millimeters) separating them). To form a teardrop shape, the proximal and distal ends of the end effector can be spaced apart, for example, about 25 mm. When the actuator 210 reaches its range of travel, the detent engages the third catch 214C, thus providing tactile feedback to the operator 24 that the end effector 100 is fully extended. As described above with respect to the other catches, the operator 24 can also manipulate the detent 216 to engage the third catch 214C.

[0056] In the expanded configuration, the approximate point along the spine 104 of the widest diameter D2 is the second location 138 depicted in FIG. 7. When the petal-shaped geometry of the spine frame 102 is in the expanded configuration, the maximum diameter D2 at the second location 138 along the spine 104 is closer to the proximal end of the end effector 100 than the first location 136. More specifically, the second location 136 has a distance of L3 (less than L1) from the proximal end of the spine 104 and a distance of L4 (more than L2) to the distal end of the spine 104. In some examples, the ratio of L1 to L2 is about 10 to 3, and the ratio of L3 to L4 is about 1 to 1. In some examples, the ratio of the sum of L1 and L2 (and thus L3+L4) to D2 can be about 1.2:1. In this position, the positioning of the electrode 26 toward the distal end of the spine 104 allows the electrode 26 to face substantially forward (i.e., toward the distal end of the end effector) and ablate the entrance surface of the PV without excessive pullback at the distal tip of the end effector 100.

[0057] As will be appreciated, movement of the actuator 210 in a direction opposite to that illustrated will cause the end effector 100 to fold into a folded configuration, with the catches 214A, 214B, 214C providing tactile feedback along the path of travel of the actuator to provide an indication of the configuration of the end effector 100. As noted above, although only three catches 204 are illustrated, any number may be used without departing from the spirit and scope of the present disclosure.

[0058] Additionally, an alternative embodiment of the actuator 210 includes a pull wire, which may be used in a similar manner as described above. Rather than pushing on the elongate shaft 202, the pull wire may be routed, for example, around the ring 214 and connected to the proximal end of the end effector 100, thus allowing for similar configurations as described above.

[0059] The techniques of the present disclosure described herein can be further understood according to the following sections.

[0060] Clause 1. An end effector for a medical device, the end effector comprising: a one-piece spine frame having a proximal end, a distal end with a crown, and a plurality of spines integral with the crown, the plurality of spines configured to bend radially outward from a longitudinal axis and move between an expanded configuration and a folded configuration, the one-piece frame defining a teardrop-shaped profile in the folded configuration, the teardrop-shaped profile having a bulbous distal region that tapers toward a proximal region, the bulbous distal region including a plurality of spines that extend outward relative to the longitudinal axis in a proximal direction from the crown, the plurality of spines tapering toward the longitudinal axis for a smaller proximal region, a transition region being between the bulbous distal region and a subsequent proximal region; and at least one electrode disposed on each spine at the bulbous distal region and at least two electrodes disposed on each spine in the subsequent region.

[0061] Clause 2. An end effector as described in clause 1, wherein each spine is movable such that in a folded configuration, the widest diameter of the plurality of spines is located at a first position along the longitudinal axis that is more proximal to the crown than the proximal end, and in an expanded configuration, the widest diameter of the plurality of spines is located at a second position along the longitudinal axis spaced from the first position.

[0062] Clause 3. The end effector of clause 2, wherein the second position is spaced from the first position in a direction toward the proximal end.

[0063] Clause 4. An end effector as described in clause 2 or 3, wherein the proximal end and the first location are spaced apart by a first length, and the first location and the crown are spaced apart by a second length, and the ratio of the first length to the second length is approximately 10:3.

[0064] Clause 5. An end effector described in any one of clauses 2 to 4, wherein the proximal end and the second position are spaced apart by a third length, the second position and the crown are spaced apart by a fourth length, and the ratio of the third length to the fourth length is approximately 1 to 1.

[0065] Clause 6. An end effector described in any one of clauses 1 to 5, wherein the plurality of spines is at least 10 spines.

[0066] Clause 7. An end effector described in any one of clauses 1 to 6, further comprising at least three electrodes attached to each spine.

[0067] Clause 8. The end effector of clause 7, wherein at least three electrodes of each spine are attached towards a distal end.

[0068] Clause 9. An end effector described in any one of clauses 7 to 8, wherein at least three electrodes of one spine are staggered with respect to at least three electrodes of an adjacent spine.

[0069] Clause 10. An end effector described in any one of clauses 1 to 9, further comprising a ring extending at least partially through the crown and covering a terminal portion of the crown.

[0070] Clause 11. The end effector of clause 10, wherein the ring has a rounded outermost surface.

[0071] Clause 12. The end effector of clause 10 or 11, wherein the ring comprises at least one ring protrusion that engages with at least one slot in the crown.

[0072] Clause 13. An end effector described in any one of clauses 1 to 12, further comprising a first single-axis sensor attached to the crown.

[0073] Clause 14. An end effector described in any one of clauses 1 to 13, further comprising a second single-axis sensor disposed within one of the plurality of spines.

[0074] Clause 15. An end effector described in any one of clauses 1 to 14, further comprising a dual-axis sensor, a flex circuit, or a triple-axis sensor positioned proximal to the proximal end.

[0075] Clause 16. An end effector described in any one of clauses 1 to 16, wherein the proximal end of each spine is provided with a tab that engages with a complementary shaped recess in the spine coupler.

[0076] Clause 17.13.5 An end effector as described in any one of clauses 1 to 16, configured to fit within a French sheath.

[0077] Clause 18. An end effector described in any one of clauses 1 to 17, further comprising an actuator shaft connected to a distal portion of the spine and coupled to the actuator, and at least one reference electrode disposed on the actuator shaft.

[0078] Clause 19. The end effector of clause 18, wherein the at least one reference electrode includes three reference electrodes positioned at three separate locations on the actuator shaft.

[0079] Clause 20. An end effector described in any one of clauses 1 to 16, further comprising a wire loop extending along each of the plurality of spines to define a magnetic field position sensor for each spine.

[0080] Clause 21. An end effector as described in clauses 1 to 16, further comprising at least one wire helically looped around each of the plurality of spines to define a magnetic field position sensor.

[0081] Clause 22. A housing assembly for a medical device comprising: a shell defining a cavity; an actuator slidable within the cavity along a longitudinal axis and configured to move an end effector between an extended configuration and a folded configuration; a detent engaged with one of the shell and the actuator; and a first catch integral with the other of the shell and the actuator and configured to selectively engage the detent, wherein engagement of the detent with the first catch provides tactile feedback regarding the folded configuration, an intermediate configuration, or an extended configuration of the end effector.

[0082] Clause 23. The housing assembly of clause 22, further comprising a second catch integral with the other of the shell and the actuator and configured to selectively engage the detent.

[0083] Clause 24. The housing assembly of clause 23, further comprising a third catch integral with the other of the shell and the actuator and configured to selectively engage the detent.

[0084] Clause 25. A housing assembly as described in clause 24, wherein the first catch is configured to provide tactile feedback that the end effector is in a folded configuration, the second catch is configured to provide tactile feedback that the end effector is in an intermediate configuration, and the third catch is configured to provide tactile feedback that the end effector is in an extended configuration.

[0085] Clause 26. A housing assembly as described in any one of clauses 22 to 25, wherein the detent comprises a ball biased towards the first catch.

[0086] Clause 27. A housing assembly as described in any one of clauses 22 to 26, wherein the return stop is movable towards and away from the first catch in a direction perpendicular to the longitudinal axis to adjust the force applied to the first catch by the return stop.

[0087] Clause 28. The housing assembly of clause 27, wherein the detent is threaded to move the detent toward and away from the first catch.

[0088] Clause 29. A housing assembly according to any one of clauses 22 to 25, wherein the actuator partially protrudes from the cavity.

[0089] Clause 30. A housing assembly as described in any one of clauses 22 to 29, wherein the actuator comprises a push / pull rod or a pull wire.

[0090] Clause 31. A medical device comprising: a first shaft extending along a longitudinal axis and attached to an actuator; an end effector attached to the first shaft at a proximal end of the end effector and configured to move between an extended configuration, an intermediate configuration, and a folded configuration; a housing assembly comprising: an actuator attached to the first shaft and slidable along the longitudinal axis, where sliding motion of the actuator slides the first shaft and the proximal end of the end effector; a detent; and a first catch configured to selectively engage the detent, the first catch configured to provide tactile feedback that the end effector is in one of the extended configuration, the intermediate configuration, and the folded configuration.

[0091] Clause 32. A medical device as described in clause 31, wherein the end effector comprises a plurality of spines, each spine having a plurality of electrodes attached thereto.

[0092] Clause 33. A medical device according to clause 31 or 32, wherein the end effector is teardrop shaped.

[0093] Clause 34. A medical device as described in any one of clauses 31 to 33, further comprising a second catch configured to selectively engage the detent, the second catch configured to provide tactile feedback that the end effector is in another of the extended configuration, the intermediate configuration, and the folded configuration.

[0094] Clause 35. The medical device of clause 34, further comprising a third catch configured to selectively engage the detent, the second catch configured to provide tactile feedback that the end effector is in another of the extended configuration, the intermediate configuration, and the folded configuration.

[0095] Clause 36. A medical device as described in any one of clauses 31 to 35, wherein the first catch comprises a pair of ribs defined on a surface of the actuator.

[0096] Clause 37. A medical device as described in any one of clauses 31 to 36, wherein the housing assembly comprises a shell and the detent is threaded into the shell.

[0097] Clause 38. The medical device of any one of clauses 31 to 37, further comprising a second shaft extending along the longitudinal axis and attached to the distal end of the housing assembly and the end effector.

[0098] Clause 39. The medical device of clause 38, wherein the second shaft extends through the first shaft.

[0099] Clause 40. A medical device as described in any one of clauses 38 to 39, wherein the second shaft defines an inner lumen and comprises one or more irrigation holes.

[0100] Clause 41. A medical device described in any one of clauses 38 to 40, wherein the proximal end of the end effector is configured to slide along the second shaft when moving between the extended configuration, the intermediate configuration, and the folded configuration.

[0101] Clause 42. A medical device described in any one of clauses 38 to 41, wherein the proximal end of the end effector and the distal end of the end effector substantially abut each other in the expanded configuration.

[0102] Clause 43. The medical device of clause 32, further comprising a wire disposed on at least one of the plurality of spines to define at least one loop of the magnetic field sensor.

[0103] 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.

[0104] [Embodiment] (1) An end effector for a medical device, comprising: a one-piece spine frame comprising a proximal end, a distal end with a crown, and a plurality of spines integral with the crown, the plurality of spines configured to bend radially outward from a longitudinal axis and move between an expanded configuration and a folded configuration, the one-piece spine frame defining a teardrop-shaped profile in the folded configuration, the teardrop-shaped profile having a bulbous distal region that tapers toward a subsequent proximal region, the bulbous distal region including the plurality of spines that extend outward relative to the longitudinal axis in a proximal direction from the crown, the plurality of spines tapering toward the longitudinal axis due to the smaller proximal region, a transition region being between the bulbous distal region and the subsequent proximal region; at least one electrode disposed on each spine at the bulbous distal region; and at least two electrodes disposed on each spine at the trailing proximal region. (2) Each spine is In the folded configuration, the widest diameter of the plurality of spines is disposed at a first location along the longitudinal axis that is more proximal to the crown than the proximal end; An end effector as described in embodiment 1, wherein in the expanded configuration, the widest diameter of the plurality of spines is movable to be located at a second position along the longitudinal axis, spaced from the first position. (3) An end effector as described in embodiment 2, wherein the second position is spaced apart from the first position in a direction toward the proximal end. (4) An end effector as described in embodiment 1, further comprising a ring extending at least partially through the crown and covering a terminal portion of the crown. (5) An end effector as described in embodiment 1, further comprising a first single-axis sensor attached to the crown.

[0105] (6) An end effector as described in embodiment 1, further comprising a second single-axis sensor disposed within one of the plurality of spines. (7) An end effector as described in embodiment 1, further comprising a two-axis sensor, a flex circuit, or a three-axis sensor positioned proximal to the proximal end. (8) An end effector as described in embodiment 1, wherein the proximal end of each spine has a tab that engages with a complementary shaped recess in the spine coupler. (9) An end effector as described in embodiment 1, further comprising a wire loop extending along each of the plurality of spines to define a magnetic field position sensor for each spine. (10) An end effector as described in embodiment 1, further comprising at least one wire that forms a helical loop around each of the plurality of spines to define a magnetic field position sensor.

[0106] (11) A housing assembly for a medical device, comprising: a shell defining a cavity; an actuator slidable within the cavity along a longitudinal axis and configured to move the end effector between an extended configuration and a collapsed configuration; a detent engaging one of the shell and the actuator; a first catch integral with the other of the shell and the actuator and configured to selectively engage the detent, wherein engagement of the detent with the first catch provides tactile feedback regarding a collapsed configuration, an intermediate configuration, or an extended configuration of the end effector. (12) The housing assembly of claim 11, further comprising a second catch integral with the other of the shell and the actuator and configured to selectively engage the detent. (13) The housing assembly of claim 12, further comprising a third catch integral with the other of the shell and the actuator and configured to selectively engage the detent. (14) The housing assembly of embodiment 13, wherein the first catch is configured to provide tactile feedback that the end effector is in the folded configuration, the second catch is configured to provide tactile feedback that the end effector is in the intermediate configuration, and the third catch is configured to provide tactile feedback that the end effector is in the extended configuration. (15) The housing assembly of claim 11, wherein the detent is movable toward and away from the first catch in a direction perpendicular to the longitudinal axis to adjust the force applied by the detent to the first catch.

[0107] (16) A medical device, comprising: a first shaft extending along a longitudinal axis and attached to the actuator; an end effector attached to the first shaft at a proximal end of the end effector and configured to move between an extended configuration, an intermediate configuration, and a collapsed configuration; 1. A housing assembly comprising: an actuator attached to the first shaft and slidable along the longitudinal axis, wherein sliding motion of the actuator causes the first shaft and the proximal end of the end effector to slide; and With detents, a housing assembly comprising: a first catch configured to selectively engage the detent, the first catch configured to provide tactile feedback that the end effector is in one of the extended configuration, the intermediate configuration, and the folded configuration. (17) The medical device of embodiment 16, wherein the end effector comprises a plurality of spines, each spine having a plurality of electrodes attached thereto. (18) The medical device of embodiment 16, wherein the first catch comprises a pair of ribs defined on a surface of the actuator. (19) The medical device of embodiment 16, further comprising a second shaft extending along the longitudinal axis and attached to the housing assembly and a distal end of the end effector. (20) The medical device of embodiment 19, wherein the proximal end of the end effector is configured to slide along the second shaft when moving between the expanded configuration, the intermediate configuration, and the folded configuration.

Claims

1. 1. An end effector for a medical device, comprising: a one-piece spine frame comprising a proximal end, a distal end with a crown, and a plurality of spines integral with the crown, the plurality of spines configured to bend radially outward from a longitudinal axis and move between an expanded configuration and a folded configuration, the one-piece spine frame defining a teardrop-shaped profile in the folded configuration, the teardrop-shaped profile having a bulbous distal region that tapers toward a subsequent proximal region, the bulbous distal region including the plurality of spines that extend outward relative to the longitudinal axis in a proximal direction from the crown, the plurality of spines tapering toward the longitudinal axis due to the smaller proximal region, a transition region being between the bulbous distal region and the subsequent proximal region; at least one electrode disposed on each spine at the bulbous distal region; and at least two electrodes disposed on each spine at the trailing proximal region.

2. Each spine is In the folded configuration, a widest diameter of the plurality of spines is disposed at a first location along the longitudinal axis that is more proximal to the crown than the proximal end; The end effector of claim 1 , wherein in the expanded configuration, the widest diameter of the plurality of spines is movable to be located at a second position along the longitudinal axis spaced from the first position.

3. The end effector of claim 2 , wherein the second position is spaced from the first position in a direction toward the proximal end.

4. The end effector of claim 1 , further comprising a collar extending at least partially through the crown and covering a terminal end of the crown.

5. The end effector of claim 1 , further comprising a first single axis sensor mounted to the crown.

6. The end effector of claim 1 , further comprising a second single axis sensor disposed within a spine of the plurality of spines.

7. The end effector of claim 1 , further comprising a dual-axis sensor, a flex circuit, or a triaxial sensor disposed proximal to the proximal end.

8. The end effector of claim 1 , wherein a proximal end of each spine includes a tab that engages a complementary shaped recess in the spine coupler.

9. The end effector of claim 1 , further comprising a wire loop extending along each of the plurality of spines to define a magnetic field position sensor for each spine.

10. The end effector of claim 1 , further comprising at least one wire helically looped around each of the plurality of spines to define a magnetic field position sensor.

11. 1. A housing assembly for a medical device, comprising: a shell defining a cavity; an actuator slidable within the cavity along a longitudinal axis and configured to move the end effector between an extended configuration and a collapsed configuration; a detent engaging one of the shell and the actuator; a first catch integral with the other of the shell and the actuator and configured to selectively engage the detent, wherein engagement of the detent with the first catch provides tactile feedback regarding a collapsed configuration, an intermediate configuration, or an extended configuration of the end effector.

12. The housing assembly of claim 11 , further comprising a second catch integral with the other of the shell and the actuator, the second catch configured to selectively engage the detent.

13. The housing assembly of claim 12 , further comprising a third catch integral with the other of the shell and the actuator, the third catch configured to selectively engage the detent.

14. 14. The housing assembly of claim 13, wherein the first catch is configured to provide tactile feedback that the end effector is in the folded configuration, the second catch is configured to provide tactile feedback that the end effector is in the intermediate configuration, and the third catch is configured to provide tactile feedback that the end effector is in the extended configuration.

15. 12. The housing assembly of claim 11, wherein the detent is movable toward and away from the first catch in a direction perpendicular to the longitudinal axis to adjust the force applied by the detent to the first catch.

16. 1. A medical device comprising: a first shaft extending along a longitudinal axis and attached to the actuator; an end effector attached to the first shaft at a proximal end of the end effector and configured to move between an extended configuration, an intermediate configuration, and a collapsed configuration; 1. A housing assembly comprising: an actuator attached to the first shaft and slidable along the longitudinal axis, wherein sliding motion of the actuator causes the first shaft and the proximal end of the end effector to slide; and With detents, a housing assembly comprising: a first catch configured to selectively engage the detent, the first catch configured to provide tactile feedback that the end effector is in one of the extended configuration, the intermediate configuration, and the folded configuration.

17. The medical device of claim 16 , wherein the end effector comprises a plurality of spines, each spine having a plurality of electrodes attached thereto.

18. The medical device of claim 16 , wherein the first catch comprises a pair of ribs defined on a surface of the actuator.

19. The medical device of claim 16, further comprising a second shaft extending along the longitudinal axis and attached to a distal end of the housing assembly and the end effector.

20. 20. The medical device of claim 19, wherein the proximal end of the end effector is configured to slide along the second shaft when moving between the expanded configuration, the intermediate configuration, and the collapsed configuration.

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