Medical device with haptic feedback for ridge deployment

Abstract

Techniques disclosed herein include an actuator subsystem for a medical probe that includes an actuator, a pawl, and at least one catch. The actuator is designed to move the end effector between an expanded configuration and a collapsed configuration. When the actuator is moved, the catch in combination with the pawl provides haptic feedback regarding the position of the end effector of the medical device.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 581,435 (Agent File Number: BIO6817USPSP1–253757.000426), previously filed on September 8, 2023, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present technology relates generally to medical devices, and particularly to medical probes having electrodes, and further, but not exclusively, to medical probes suitable for inducing irreversible electroporation (IRE) of cardiac tissue. Background Art

[0004] 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 irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disrupting the source of the signal causing the arrhythmia and disrupting the conduction pathways for such signals. By selectively ablating cardiac tissue through 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.

[0005] Many current ablation methods in the art utilize radiofrequency (RF) electrical energy to heat tissue.RF ablation can have certain risks associated with thermal heating that can result in tissue charring, burning, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0006] Cryoablation is an alternative to RF ablation that generally reduces the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electroablation devices.

[0007] Some ablation methods use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers short pulses of high voltage to tissue and generates irreversible cell membrane permeabilization. It has been previously proposed in the patent literature to use a multi-electrode probe to deliver IRE energy to tissue. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, each of which is incorporated herein by reference.

[0008] Areas of cardiac tissue may be mapped by the catheter to identify abnormal electrical signals. Ablation may be performed using the same or a different medical device. Some example probes include a plurality of ridges on which electrodes are disposed. These probes must be able to ablate the internal flare of the pulmonary vein (PV) as well as the entrance surface of the PV without excessively pulling back the ridges. In addition, these catheters must be able to fit within a 13.5 French (Fr) sheath. Summary of the invention

[0009] According to the technology disclosed in the present invention, an end effector for a medical device is provided. The end effector may include an integral spine frame. The integral spine frame may include a proximal end, a distal end including a crown, and a plurality of ridges integral with the crown. The plurality of ridges are configured to bend radially outward from the longitudinal axis and move between an expanded configuration and a collapsed configuration. The integral frame is a teardrop-shaped profile in the collapsed configuration. The teardrop-shaped profile has a bulbous distal region that tapers to a proximal region. The bulbous distal region includes a plurality of ridges that expand outward from the crown relative to the longitudinal axis in a proximal direction, and the plurality of ridges taper toward the longitudinal axis of the smaller proximal region, with a transition region between the bulbous region and the tail region. At least one electrode is disposed on each ridge in the bulbous distal region. At least two electrodes are disposed on each ridge in the tail region.

[0010] According to the technology disclosed in the present invention, a housing assembly for a medical device is also provided. The housing assembly may include a housing, an actuator, a pawl and a first catch. The housing defines a cavity. The actuator can slide along a longitudinal axis in the cavity and is configured to move an end actuator between an expanded configuration and a collapsed configuration. The pawl engages with one of the housing and the actuator. The first catch is integrated with the other of the housing and the actuator and is configured to selectively engage the pawl. The engagement of the pawl and the first catch provides tactile feedback about the collapsed configuration, intermediate configuration or expanded configuration of the end actuator.

[0011] According to the technology disclosed in the present invention, a medical device is also provided. The medical device may include a first shaft, an end actuator and a housing assembly. The first shaft extends along the longitudinal axis and is attached to the actuator. The end actuator is attached to the first shaft at the proximal end of the end actuator and is configured to move between an expanded configuration, an intermediate configuration and a collapsed configuration. The housing assembly may include an actuator, a pawl and a first catch. The actuator is attached to the first shaft and can slide along the longitudinal axis. The sliding movement of the actuator slides the proximal end of the first shaft and the end actuator. The first catch is configured to selectively engage with the pawl. The first catch is configured to provide tactile feedback that the end actuator is in one of an expanded configuration, an intermediate configuration and a collapsed configuration. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a schematic illustration of a medical system including a medical device according to the technology disclosed herein, the distal end of the medical device including a medical probe having electrodes;

[0013] Figure 2 is a schematic illustration showing a perspective view of a medical device in accordance with the presently disclosed technology with a portion of an elongated shaft cut away;

[0014] Figure 3 is a schematic illustration showing a detailed schematic view of a portion of a handle according to the technology disclosed herein;

[0015] Figure 4 is a schematic illustration showing a detailed cross-sectional view of a portion of a handle and actuator subsystem in accordance with the presently disclosed technology;

[0016] Figure 5 is a schematic illustration showing a perspective view of an end effector of a medical device according to the technology disclosed herein;

[0017] Figure 6 is a schematic illustration of a medical device shown from a distal end of the medical device according to the disclosed technology;

[0018] Figure 7 is a schematic illustration showing a side elevation view of an end effector disposed within a sheath in accordance with the disclosed technology;

[0019] Figure 8 is a schematic illustration showing a side elevation view of a unitary spine frame in accordance with the presently disclosed technology;

[0020] Fig. 9 is a schematic illustration of a detailed side cross-sectional view of a distal end of an end effector according to the technology disclosed herein;

[0021] Fig.10 is a schematic illustration showing a perspective view of a distal end of an end effector according to the technology disclosed herein;

[0022] Fig.11 is a schematic illustration of a ring of an end effector according to the technology disclosed herein;

[0023] Fig.12 is a schematic illustration of a detailed perspective view of a proximal end of an end effector according to the presently disclosed technology with a ridge retention collar removed;

[0024] Fig.13is a schematic illustration showing an end effector in a position just after initiating actuation of an actuator subsystem in accordance with the disclosed technology;

[0025] Fig.14 is a schematic illustration showing an end effector in a position intermediate between a collapsed configuration and an expanded configuration in accordance with the presently disclosed technology; and

[0026] Fig.15 is a schematic illustration showing an end effector in an expanded configuration in accordance with the presently disclosed technology. DETAILED DESCRIPTION

[0027] The following detailed description should be read in conjunction with the accompanying drawings, in which the same elements in different drawings are labeled the same. The accompanying drawings (not necessarily drawn to scale) depict selected examples and are not intended to limit the scope of the present disclosure. The detailed description illustrates the principles of the technology disclosed in the present invention by way of example and not by way of limitation. This description will clearly enable those skilled in the art to prepare and use the technology disclosed in the present invention, and describes several embodiments, adaptations, variations, alternative forms and uses of the technology disclosed in the present invention, including the best mode currently believed to implement the technology disclosed in the present invention.

[0028] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the purpose it is intended to achieve as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 110%. In addition, as used herein, the terms "patient", "receptor", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject technology in human patients represents a preferred embodiment. Similarly, the term "proximal" refers to a position closer to an operator or physician, while "distal" refers to a position farther away from an operator or physician.

[0029] As discussed herein, the vasculature of a "patient," "recipient," "user," and "subject" can be that of a human or any animal. It should be understood that the animal can be of any suitable type, including, but not limited to, a mammal, a veterinary animal, a livestock animal, or a pet animal, etc. For example, the animal can be a laboratory animal (e.g., a rat, dog, pig, monkey, etc.) that is specifically selected to have certain characteristics similar to those of a human. It should be understood that the subject can be, for example, any suitable human patient.

[0030] As discussed herein, an "operator" may include a physician, surgeon, technician, scientist, or any other individual or delivery instrumentation associated with delivering a multi-electrode catheter for treating drug-refractory atrial fibrillation to a subject.

[0031] As discussed herein, when referring to the devices and corresponding systems of the present disclosure, the term "ablation" refers to components and structural features configured to reduce or prevent the generation of unstable cardiac signals in cells by utilizing non-thermal energy (such as irreversible electroporation (IRE)), which are interchangeably referred to as pulsed electric fields (PEF) and pulsed field ablation (PFA) in the present disclosure. "Ablation" as used throughout the present disclosure, when referring to the devices and corresponding systems of the present disclosure, refers to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation as understood by those skilled in the relevant art.

[0032] As discussed herein, the terms "bipolar" and "monopolar" when used to refer to ablation protocols describe ablation protocols that differ in current paths and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, both electrodes being positioned at a treatment site; the current density and electric flux density at each of the two electrodes are generally approximately equal. "Monopolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, wherein one electrode having a high current density and a high electric flux density is positioned at the treatment site, and a second electrode having a relatively lower current density and a lower electric flux density is positioned away from the treatment site.

[0033] As discussed herein, the terms "tubular," "tube," and "shaft" should be interpreted broadly and are not limited to structures that are perfect cylinders or have a completely circular cross section or a uniform cross section throughout their length. For example, tubular / shaft structures are generally illustrated as structures that are substantially perfect cylinders. However, tubular / shaft structures may have tapered or curved outer surfaces without departing from the scope of the present disclosure.

[0034] The present disclosure relates to systems, methods or uses and devices for performing IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically provided to cardiac tissue by a distal portion of a catheter that can deliver ablation energy along the tissue to be ablated. Some example catheters include a three-dimensional structure at the distal portion and are configured to apply ablation energy from various electrodes positioned on the three-dimensional structure. Fluoroscopy can be used to visualize ablation procedures incorporating such example catheters.

[0035] Ablation of cardiac tissue to correct a malfunctioning heart using the application of thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations of the myocardium. In addition, temperature measurements during ablation provide data that can achieve ablation efficacy. Typically, for ablation procedures using thermal ablation, electrode potentials and temperatures are measured before, during, and after the actual ablation. RF methods may have the risk of causing tissue charring, burns, steam bursts, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas. Cryoablation is an alternative to RF ablation that can reduce some of the thermal risks associated with RF ablation. However, manipulating a cryoablation device and selectively applying cryoablation is generally more challenging than RF ablation; therefore, cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0036] The present disclosure may include electrodes configured for irreversible electroporation (IRE), RF ablation, and / or cryoablation. Throughout the present disclosure, IRE may be referred to interchangeably as pulsed electric field (PEF) ablation and pulsed field ablation (PFA). IRE as discussed in the present disclosure is a non-thermal cell death technique that can be used for ablation of atrial arrhythmias. In order to ablate using IRE / PEF, biphasic voltage pulses are applied to destroy the cellular structure of the myocardium. Biphasic pulses are non-sinusoidal and can be tuned to target cells based on the electrophysiology of the cells. In contrast, in order to ablate using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells in the treatment area indiscriminately. Therefore, IRE has the ability to avoid adjacent heat-sensitive structures or tissues, which will have benefits in reducing possible complications known to be affected by ablation or separation modalities. In addition or alternatively, monophasic pulses can be used.

[0037] Electroporation can be induced by applying a pulsed electric field across biological cells to cause holes to be reversibly (temporarily) or irreversibly (permanently) produced in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that is elevated above the static potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, which means that the hole can be closed when the applied pulsed electric field is removed, and the cell can self-repair and survive. If the transmembrane electrostatic potential is elevated above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Therefore, the cell dies due to the loss of homeostasis and usually dies by apoptosis. Typically, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500V / cm, while for bones, the threshold potential is 3000V / cm. These differences in threshold potentials allow IRE to selectively target tissues based on the threshold potential.

[0038] The technology disclosed herein includes systems and methods for applying electrical signals from catheter electrodes positioned near myocardial tissue to generate ablation energy to ablate myocardial tissue. In some examples, the system and method can effectively ablate targeted tissue by inducing irreversible electroporation. In some examples, the system and method can effectively induce reversible electroporation as part of a diagnostic procedure. Reversible electroporation occurs when the electricity applied by the electrode is lower than the electric field threshold of the target tissue that allows cell repair. Reversible electroporation does not kill cells, but allows physicians to view the effects of reversible electroporation on electrical activation signals near the target location. Exemplary systems and methods for reversible electroporation are disclosed in U.S. Patent Publication 2021 / 0162210, the entire contents of which are incorporated herein by reference.

[0039] The effectiveness of pulsed electric field and its induction of reversible electroporation and / or irreversible electroporation may be affected by the physical parameters of the system and the biphasic pulse parameters of the electrical signal. The physical parameters may include electrode contact area, electrode spacing, electrode geometry, etc. The examples proposed herein generally include physical parameters suitable for effectively inducing reversible electroporation and / or irreversible electroporation. The biphasic pulse parameters of the electrical signal may include voltage amplitude, pulse duration, pulse phase delay, pulse delay, total application time, energy delivered, etc. In some examples, the parameters of the electrical signal may be adjusted to induce both reversible and irreversible electroporation given the same physical parameters. Examples of various ablation systems and methods including IRE are presented in U.S. Patent Publications 2021 / 0169550A1, 2021 / 0169567A1, 2021 / 0169568A1, 2021 / 0161592A1, 2021 / 0196372A1, 2021 / 0177503A1, and 2021 / 0186604A1, the entire contents of each of which are incorporated herein by reference.

[0040] refer to Figure 1, which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes a plurality of catheters that are inserted into a chamber or vascular structure of a heart 12 by a physician 24 through the vascular system of a patient 23 via the skin. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, a plurality of catheters may be inserted into the delivery sheath catheter to reach the desired location. The plurality of catheters may include a catheter dedicated to sensing intracardiac electrogram (IEGM) signals, a catheter dedicated to ablation, and / or a catheter dedicated to both sensing and ablation. An exemplary medical probe configured for sensing IEGM is shown herein, for example, a catheter 14. The physician 24 brings the distal end of the catheter 14 (i.e., in this case, the basket assembly 28) into contact with the heart wall for sensing a target site in the heart 12. The catheter 14 having a distal basket assembly may be referred to as a basket catheter. For ablation, the physician 24 would similarly bring the distal end of the ablation catheter to the target site for ablation.

[0041] The catheter 14 is an exemplary catheter that includes one (preferably multiple) electrodes 26, optionally distributed on a plurality of ridges 104 at a basket assembly 28 and configured to sense IEGM signals. The catheter 14 may additionally 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 that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0042] The magnetic-based position sensor can operate with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predetermined workspace. The real-time position of the basket assembly 28 of the catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patents 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, 6,892,091, each of which is incorporated herein by reference.

[0043] The system 10 includes one or more electrode patches 38 positioned in contact with the skin of the patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and the electrodes 26. For impedance-based tracking, current is directed toward the electrodes 26 and sensed at the electrode skin patches 38 so that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is incorporated herein by reference.

[0044] Recorder 11 displays electrograms 21 captured using surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured using electrodes 26 of catheter 14. Recorder 11 may include pacing capabilities for pacing the cardiac rhythm and / or may be electrically connected to a separate pacemaker.

[0045] The system 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that may be used to achieve irreversible electroporation (IRE)), or a combination thereof.

[0046] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between catheters, electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, positioning pads 25, surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for enabling real-time calculation of the position of the catheter and for performing ECG calculations.

[0047] Workstation 55 includes memory, a processor unit with memory or storage loaded with appropriate operating software, and user interface capabilities. Workstation 55 can provide multiple functions, optionally including: (1) three-dimensional (3D) modeling of endocardial anatomy and rendering of the model or anatomical map 20 for display on display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 on display device 27 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying real-time positions and orientations of multiple catheters within the heart chambers; and (5) displaying sites of interest on display device 27, such as where ablation energy has been applied. A commercial product embodying elements of system 10 is available as the CARTO™ 3 system from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618 USA.

[0048] Figure 2 1 is a schematic illustration 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 presently described example 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 unitary / monoblock spine frame 102.

[0049] The one or more ridges 104 can be moved between an expanded configuration and a collapsed configuration. Such movement can be achieved by an actuator subsystem 200, which includes, among other elements, an actuator 210 and an elongated shaft 200, and is further described below. The elongated shaft 202 connects the end effector 100 to a handle, which, in use, can be manipulated by an operator 24. When the shaft 202 is fixed to the distal end of the basket and connected to an actuator at the proximal handle 300 for translation along the longitudinal axis A1, the elongated shaft 202 may also sometimes be referred to as an actuator shaft. Figure 7 400 is a schematic illustration showing a side view of the end effector 100 within the sheath 400 in a collapsed configuration. Fig.15 ) and in the collapsed configuration, one or more ridges 104 are bent radially outward. Figure 2 and Figure 5 As shown, the spine frame 102 can be a teardrop-shaped profile in the collapsed configuration. When the elongated shaft 210 is unbent, the spine 104, the elongated shaft 202, and the handle 300 are generally arranged along the longitudinal axis A1.

[0050] Figure 3300 is a schematic illustration showing a detailed schematic diagram of a portion of the handle 300. The handle 300 is also referred to herein as a housing assembly. As shown, the handle 300 can have a flip-top design defining a cavity 302. Figure 3 , a portion of the flip cover is removed to schematically depict an exemplary interior thereof. As shown, a portion of the actuator subsystem 200 is housed within the handle 300 and extends parallel thereto along the longitudinal axis A1.

[0051] Figure 4 2 is a schematic 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 may be a handle having an enlarged head ( Figure 4 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 in a manner that allows the two to translate in unison when the actuator 210 is manipulated, which is discussed in more detail below. The elongated shaft 202 ( Figure 5 ) can be connected to the end effector 100 via the collar 102A. The elongated shaft 202 defines a lumen 204 therethrough which receives another elongated shaft 206, also referred to herein as the second elongated shaft 206. The second elongated shaft 206 can be guided through the handle 300 and the first elongated shaft 202 and attached at its distal end to the distal end of the end effector 100 ( Fig. 9 ). The first elongated shaft 202 can slide relative to the second elongated shaft 206, which is discussed in more detail below. The second elongated shaft 206 can be used in part to direct irrigation to the end effector 100 through the lumen 208 of the end effector. For example, the second elongated shaft 206 can be provided with an irrigation hole at a distal portion thereof. Both the first elongated shaft 202 and the second elongated shaft 206 can be formed of a flexible, biocompatible, electrically insulating material, such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, etc. 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, polydioxane, polycarbonate, and polyanhydride, wherein ratios of certain polymers are selected to control the extent of the inflammatory response.

[0052] Continue to see Figure 3 and Figure 4, a ball-shaped release portion 212 may be formed in the wall of the actuator 210 disposed in the handle 300. There are multiple protrusions 214 in the release portion 212 for providing tactile feedback to the operator 14, which is discussed in more detail below. For example, the multiple protrusions / ribs 214 may include a first group of protrusions / ribs 214A used as a first catch, a second group of protrusions / ribs 214B used as a second catch, and a third group of protrusions / ribs 214C used as a third catch. Of course, any number of catches may be used without departing from the essence and scope of the present disclosure. The protrusions 214 are used in conjunction with a pawl 216, which may be connected to the housing 300 or otherwise integral with the housing. In the example currently depicted, the pawl 216 includes a hollow pin 216, wherein a spring 222 is disposed in a cavity of the pin 216 to bias the ball 220 away from the cavity and toward the release portion 212 and the protrusion 214. The pawl 216 is movable in a direction perpendicular to the longitudinal axis A1 towards and away from the projection / catch 214, which has the effect of adjusting the force applied by the pawl 216 to the projection 214. This may be achieved, for example, by threading the pawl 216 with the housing 300.

[0053] Of course, other configurations of this portion of the actuator subsystem may be used. For example, different structural configurations of the pawl 216 may be used. In addition, as an alternative, the protrusion 214 may be provided on a portion of the handle 300, and the pawl 216 is connected to the actuator 210. Operation of the actuator subsystem Figures 13 to 15 Described in more detail below.

[0054] Figure 5 is a schematic illustration showing a perspective view of an end effector 100 of a medical device in accordance with the presently disclosed technology. Figure 6 is a schematic illustration showing the medical device from the distal end of the medical device. Figure 7 is a schematic illustration of a side elevation view of end effector 100 disposed within sheath 400 . Figure 8 is a schematic illustration of a side elevation view of the integral spine frame 102. Figures 5 to 8 , and as described above, an integral spine frame 102 may be employed. The frame 102 may include one or more flexible spines 104 connected to the first elongated shaft 202 at its proximal segment 104B and to the second elongated shaft 206 at its distal segment 104A. During a medical procedure, the operator 24 may move the patient from a slender shaft having a diameter D1 (e.g., a diameter of 12 Fr or 13.5 Fr, see Figure 7) is deployed with the end effector 100 through the sheath 400. The end effector 100 is exited from the sheath 400 by extending the shafts 202, 206 through the sheath 400, at which point the end effector can be transformed into an expanded configuration (discussed in more detail below). The spines 104 can have an elliptical (e.g., circular) or rectangular (which can appear flat) cross-section and include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as Nitinol) forming struts.

[0055] exist Figure 7 , it can be seen that the plurality of ridges define a teardrop-shaped profile, wherein the ridges expand outwardly from the longitudinal axis in the proximal direction. It can be seen that the ridges (126 and 136) expand outwardly by a length L2, at which point the expansion of the ridges ceases and the ridges become substantially tangent to the inner surface of the tubular member 400. This profile of the ridges on L2 is considered the "bulb region" of the end effector. The ridges then taper inwardly (toward the longitudinal axis) over a length L1 extending toward the proximal vicinity 130. This profile on L1 is considered the "tail region". Between the "bulb region" and the "tail region" is the "transition region" in which the ridges are tangent to the inner surface of the tubular member 400. A unique arrangement of electrodes for the bulbous region and the tail region has been designed, which is believed to be the optimal ablation electrode arrangement in a pulmonary vein ablation procedure. Specifically, at least one electrode must be placed in at least one ridge in the bulbous region, wherein at least two electrodes must be placed in the tail region. Likewise, every other ridge in the plurality of ridges must have one electrode disposed in the transition region (i.e., the region of greatest outer diameter defined by the ridges adjacent to the tubular inner surface of member 400). In exemplary ridge 126, it can be seen that this requirement of at least one electrode 26 in the bulbous region is satisfied by electrode 26a, and the requirement of at least two electrodes disposed in the tail region is satisfied by electrodes 26b and 26c. The requirement of one electrode in the transition region is satisfied by electrode 26e.

[0056] Return to see Figure 8, it can be seen that the position of each of the ridges 104 and therefore the overall shape of the basket can be determined via a magnetic field sensor in the form of a plurality of loops forming a spiral loop formed by a wire having two leads 300a and 300b, wherein the wire loop (as shown in dashed lines) surrounds the ridge in a manner that is spirally wound around each of the plurality of ridges. Alternatively, the flat loop can also be defined by a single wire having two leads 300a and 300b. Each ridge will have a wire loop in the form of a spiral (middle ridge) or a flat loop as shown in the lower ridge. Support for a magnetic position sensor and the shape determination of the sensor can be understood by U.S. Patent Publication Nos. US20180344202A1, US20220265194A1, or U.S. Patent No. US10687761B2, each of which is incorporated by reference in a copy provided in the Appendix to priority application No. 63 / 581,435.

[0057] As will be appreciated, the ridge 104 can be electrically isolated from the electrode 26 to prevent arcing from the electrode 26 to the ridge 104. For example, an insulating sheath can be disposed between the ridge 104 and the electrode 26, but one skilled in the art will appreciate that other insulating coverings are also contemplated. For example, an insulating coating can be applied to the ridge 104, the electrode 26, or both. The insulating sheath can be made of a biocompatible, electrically insulating material, such as a polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), polyurethane, polyimide, polyparaxylene, silicone, and 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) (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxane, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the 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, etc.

[0058] In the embodiments described herein, the electrodes 26 may be configured to deliver ablative energy (IRE and / or RF) to tissue in the heart 12. In addition to using the electrodes 26 to deliver ablative energy, the electrodes 26 may also be used to determine the position of the end effector 100 and / or measure physiological properties such as local surface potential at corresponding locations on tissue in the heart 12. The electrodes 26 may be biased such that a greater portion of the electrodes 26 faces outward from the end effector 100, such that the electrodes 26 deliver a greater amount of electrical energy outwardly away from the end effector 100 (i.e., toward the heart 12 tissue) rather than inwardly toward the end effector 100.

[0059] Examples of materials ideally suited for forming electrode 26 include gold, platinum, and palladium (and their respective alloys). These materials also have high thermal conductivity, which allows minimal heat generated on the tissue (i.e., by the ablative 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 on the inside of the ridge), and then to the blood pool in the heart 12.

[0060] like Figure 5 and Figure 6 As particularly shown in FIG. 1 , at least three electrodes 26 may be attached to each ridge 104. For example, four electrodes 26 may be attached to each ridge 104, with at least ten ridges 104 radially disposed around the end effector 100, such that 30 to 40 electrodes sized and designed in conjunction with the second elongated shaft 206 may be disposed on the basket assembly while still fitting within a 12 Fr or 13.5 Fr sheath. Specifically, as Figures 5 to 7 As shown, the electrodes 26 are staggered along the longitudinal axis A1 relative to the electrodes 26 on the adjacent ridges 104. In other examples, the electrodes 26 do not necessarily need to be staggered, but still fit within a 12Fr or 13.5Fr sheath. Figure 7 As shown, the electrode 28 is also generally weighted / positioned on the ridge 104 toward the distal section 104A, so that there is no electrode 28 in the proximal section 104B of the end effector 100. The reference electrode 31 may be disposed at Figure 7 The reference electrode is disposed in the region between L1 and L2 such that the reference electrode is approximately isocentric with the electrode 28 disposed between the region defined by L1 and L2.

[0061] Fig. 9 is a schematic illustration of a detailed side cross-sectional view of the distal end of end effector 100 . Fig.10 is a schematic illustration of a perspective view of the distal end of end effector 100 with coil 124 removed for clarity. Fig.11 is a schematic illustration of the ring 114 of the end effector 100. Figures 9 to 11, and as described above, the 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, and the second elongated shaft 206 is attached to the lumen. The ring includes a circular atraumatic tip 116, a friction ring midsection 118, a locking protrusion 120 radially disposed around the friction ring midsection 118, and an annular shaft 122 opposite the atraumatic tip 116. The annular lumen 114A is axially aligned with the second elongated shaft lumen 208 so that various medical devices can extend therethrough when in use, such as a mapping catheter or a guidewire. The ring 114 is connected to and extends through the distal end 108 of the integral spine frame 102, and the distal end 108 is also referred to herein as the crown 108. Specifically, as Fig.10 As shown, the crown 108 is provided with a plurality of cutouts 110 radially disposed about its circumference, and locking projections 120 engage within the cutouts to lock the crown 108 to the ring 114. In addition, the friction ring midsection 118 frictionally engages the inner annular surface of the crown 108 to help prevent displacement. The annular shaft 122 engages the outer surface of the second elongated shaft 206.

[0062] See also Figure 7 and Fig. 9 , the first coil 124 is integral with the annulus 114 or connected to the annulus. The first coil 124 may be configured to generate a current when subjected to a magnetic field. In some examples, the first coil 124 may include a single-axis sensor (SAS). In other examples, the coil 124 may include a dual-axis sensor (DAS) or a triaxial sensor (TAS). The first coil 124 may include a conductive material wound into a coil or a coil formed as a flexible circuit. The first coil 124 may include an electrical lead for conducting the current induced on the first coil 124 to the patient interface unit 30. As will be understood, by attaching the first coil 124 to the distal end of the end effector 100, its position can be detected. In this way, the physician 24 can more accurately determine the position of the distal end of the end effector 100 before applying ablation energy to the tissue.

[0063] The end effector 100 is also provided with one or more second coils 126 ( Figure 7), the second coil 126 is disposed within the sheath 106 and / or the spine 104. In some examples, the second coil 126 may include a SAS. In other examples, the second coil 126 may include a DAS or a TAS. The second coil 126 may include a conductive material wound into a coil or a coil formed as a flexible circuit. The second coil 126 may include an electrical lead for conducting the current induced on the second coil 126 to the patient interface unit 30. As will be appreciated, by attaching the second coil 126 to one or more spines 104, its position can be detected. In this way, similar to the first coil 124, the physician 24 can more accurately determine the position of the spine 104 of the end effector 100 before applying ablation energy to the tissue.

[0064] At the proximal end of the end effector 100, a third coil 128 ( Figure 5 and Figure 7 ), the third coil is sandwiched between the collar 202A of the first elongated shaft 202 and the ridge retaining collar 130. In some examples, the third coil 128 may include a DAS or a TAS. In other examples, the third coil 128 may include a SAS. The third coil 128 may include a conductive material wound into a coil or a coil formed as a flexible circuit. The third coil 128 may include an electrical lead for conducting the current induced on the third coil 128 to the patient interface unit 30. As will be appreciated, by attaching the third coil 128 at the proximal end of the end effector 100, its position can be detected. In this way, 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 the tissue.

[0065] Fig.12 1 is a schematic illustration of a detailed perspective view of the proximal end of the end effector 100, with the ridge retaining collar 130 removed for clarity. The proximal end 112 of the ridge 104 has a tab shaped to engage with a ridge coupler 132. The ridge coupler is connected to an irrigation manifold 134 that provides irrigation to the end effector 100. In the illustrated example, the engagement may be employed in a similar manner to the interlocking of the ring 114 and the crown 108.

[0066] See Figure 4 , Figure 7 and Figures 13 to 15, the actuator subsystem 200 will now be described in more detail. With the teardrop-shaped profile geometry of the spine frame 102 in the collapsed 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 segment 104A of the end effector 100, wherein the distance from the proximal end of the spine 104 and / or crown 108 is L1, and the distance from the distal end of the spine 104 is L2. To allow for intracardiac maneuverability, the sum of L1 and L2 is minimized in the disclosed technology. For example, the sum of L1 and L2 may fall within the range of 30 mm to 50 mm. In the collapsed configuration, the pawl 216 engages with the first catch 214A. In some examples, the pawl 216 can be adjusted to lock it with the first catch 214A (and other catches 214B, 214C). This feature allows the operator 24 to maintain the precise desired geometry of the end effector 100, which changes as the end effector 100 expands.

[0067] Fig.13 2 is a schematic illustration showing the end effector 100 in a position just after actuation of the actuator subsystem 200 is initiated. The tapered shape allows for easy placement within the pulmonary vein of the patient 23. More specifically, when the actuator 210 is pulled toward the end effector 100 along the longitudinal axis A1 with sufficient force to further protrude from the handle 300, the pawl 216 disengages from the engagement with the first catch 214A, thereby providing tactile feedback to the operator 24 that the end effector 100 is no longer in the collapsed configuration. As the actuator 210 undergoes this movement, the ridge 104 begins to bend further radially outward (relative to the collapsed configuration). This action is achieved by the first elongated shaft 202 (which slides due to its connection to the actuator 210) sliding in a telescopic manner relative to the second elongated shaft 206, so that the first elongated shaft 202 travels along the second elongated shaft 206.

[0068] replace Figure 7 In the reference electrode 31 in the tissue contacting electrode 28, three reference electrodes 31a, 31b and 31c may be provided 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 relative to near-field signals collected by the electrode 28 in tissue contact.

[0069] Fig.141 is a schematic diagram showing the end effector 100 in a position intermediate between the collapsed configuration and the expanded configuration. In this intermediate configuration, the ridge 104 further bends radially outward as the first elongated shaft slides closer to the ring 114. In addition, the pawl 216 engages the second catch 214B, thereby providing the operator 24 with tactile feedback that the end effector is in the intermediate configuration. As described above, if the operator 24 needs to maintain this position for a period of time or the expanded configuration is not required in a particular treatment area, the pawl 216 can be configured to be threadably adjustable so that the pawl 216 can be moved toward the catch 214B to lock in the intermediate position. In order to unlock and / or continue the movement of the actuator 210, the pawl 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 enables the pawl 216 to leave the engagement with the second catch 214B.

[0070] Fig.15 1 is a schematic diagram showing the end effector 100 in an expanded configuration, wherein the ridge 104 is fully bent / expanded outward, wherein the maximum diameter D2 is greater than the maximum diameter D1 in the collapsed configuration. In this position, the distal end of the first elongated shaft 202 is disposed proximal to the ring 114, and the ridge 104 resembles a flower petal. In some examples, the proximal and distal ends of the end effector 100 may abut or substantially abut each other in the expanded configuration (i.e., there is no space separating the ends or there is only a few millimeters (e.g., 1 mm to 3 mm) of gap separating the ends). To form a teardrop shape, the proximal and distal ends of the end effector may be spaced apart, for example, by about 25 mm. Once the actuator 210 has reached its range of travel, the pawl engages with the third catch 214C, thereby providing the operator 24 with tactile feedback that the end effector 100 is fully expanded. As described above with respect to the other catches, the operator 24 may also manipulate the pawl 216 to lock with the third catch 214C.

[0071] In the expanded configuration, the approximate point along the ridge 104 having the widest diameter D2 is Figure 71. The second position 138 is depicted in FIG. 1. With the petal-like geometry of the ridge frame 102 in the expanded configuration, the maximum diameter D2 along the ridge 104 at the second position 138 is closer to the proximal end of the end effector 100 than the first position 136. More specifically, the second position 136 has a distance L3 (less than L1) from the proximal end of the ridge 104 and a distance L4 (greater than L2) from the distal end of the ridge 104. In some examples, the ratio of L1 to L2 is approximately 10:3, and the ratio of L3 to L4 is approximately 1:1. In some examples, the ratio of the sum of L1 and L2 (and therefore the sum of L3+L4) to D2 can be approximately 1.2:1. In this position, with electrode 26 positioned toward the distal end of ridge 104 , electrode 26 faces substantially forward (i.e., toward the distal end of the end effector) and is able to ablate the entry surface of the PV without excessive pullback at the distal tip of end effector 100 .

[0072] As will be appreciated, operation of the actuator 210 in a direction opposite to that described collapses the end effector 100 back to the collapsed configuration, with the catches 214A, 214B, 214C providing tactile feedback along the actuator's path of travel to provide an indication of the shape configuration of the end effector 100. As noted above, while only three catches 204 are described, any number may be employed without departing from the spirit and scope of the present disclosure.

[0073] Additionally, alternative examples of actuator 210 include pull wires that can be employed in a similar manner as described above. Rather than pushing elongated shaft 202, a pull wire can be routed around, for example, ring 214 and connected to the proximal end of end effector 100, thereby achieving a similar shape configuration as described above.

[0074] The disclosed technology described herein can be further understood according to the following terms:

[0075] Item 1. An end effector for a medical device, the end effector comprising: an integral spine frame, the integral spine frame comprising: a proximal end, a distal end including a crown, and a plurality of ridges integral with the crown, the plurality of ridges being configured to bend radially outward from a longitudinal axis and move between an expanded configuration and a collapsed configuration, the integral spine frame defining a teardrop-shaped profile in the collapsed configuration, the teardrop-shaped profile having a bulbous distal region that tapers gradually to a proximal region, the bulbous distal region comprising the plurality of ridges that expand outward from the crown relative to the longitudinal axis in a proximal direction, and the plurality of ridges taper toward the longitudinal axis of the smaller proximal region, with a transition region between the bulbous region and a tail region; at least one electrode, the at least one electrode being disposed on each ridge in the bulbous distal region; and at least two electrodes, the at least two electrodes being disposed on each ridge in the tail region.

[0076] Item 2. According to the end actuator of Item 1, each ridge is capable of moving so that: in the collapsed configuration, the widest diameter of the multiple ridges is set at a first position along the longitudinal axis, and the first position is closer to the crown than the proximal end, and in the expanded configuration, the widest diameter of the multiple ridges is set at a second position along the longitudinal axis, and the second position is spaced apart from the first position.

[0077] Clause 3. The end effector of clause 2, wherein the second position is spaced apart from the first position in a direction toward the proximal end.

[0078] Clause 4. An end effector according to any one of clauses 2 to 3, wherein the proximal end and the first position are separated by a first length, and the first position and the crown are separated by a second length, and the ratio of the first length to the second length is approximately 10:3.

[0079] Clause 5. An end effector according to any one of clauses 2 to 4, wherein the proximal end and the second position are separated by a third length, and the second position and the crown are separated by a fourth length, and the ratio of the third length to the fourth length is approximately 1:1.

[0080] Clause 6. The end effector of any one of Clauses 1 to 5, wherein the plurality of ridges is at least ten ridges.

[0081] Clause 7. The end effector of any one of Clauses 1 to 6, further comprising at least three electrodes attached to each ridge.

[0082] Clause 8. The end effector of clause 7, wherein the at least three electrodes of each ridge are attached toward the distal end.

[0083] Clause 9. The end effector of any of Clauses 7-8, the at least three electrodes of one ridge being staggered relative to the at least three electrodes of an adjacent ridge.

[0084] Clause 10. The end effector of any one of Clauses 1 to 9, further comprising a ring extending at least partially through the crown and covering a distal end of the crown.

[0085] Clause 11. The end effector of clause 10, wherein the ring has a circular outermost surface.

[0086] Clause 12. The end effector of any of Clauses 10 to 11, the annulus comprising at least one annular protrusion that engages in at least one slot in the crown.

[0087] Clause 13. The end effector of any one of clauses 1 to 12, further comprising a first uniaxial sensor attached to the crown.

[0088] Clause 14. The end effector of any one of clauses 1 to 13, further comprising a second single-axis sensor disposed within a ridge of the plurality of ridges.

[0089] Clause 15. The end effector of any one of clauses 1 to 14, further comprising a dual-axis sensor, a flexible circuit, or a tri-axis sensor disposed proximate to the proximal end.

[0090] Clause 16. The end effector of any of Clauses 1 to 16, the proximal end of each ridge comprising a tab that engages in a complementary shaped recess in the ridge coupler.

[0091] Clause 17. The end effector of any one of clauses 1 to 16, configured to fit within a 13.5 French sheath.

[0092] Clause 18. An end actuator according to any one of clauses 1 to 17, wherein the end actuator further comprises an actuator shaft and at least one reference electrode, wherein the actuator shaft is connected to a distal portion of the ridge and coupled to the actuator, and wherein the at least one reference electrode is disposed on the actuator shaft.

[0093] Clause 19. The end effector of Clause 18, wherein the at least one reference electrode comprises three reference electrodes disposed at three different locations on the actuator shaft.

[0094] Clause 20. The end effector of any one of Clauses 1 to 16, further comprising a wire loop extending along each of the plurality of ridges to define a magnetic field position sensor for each ridge.

[0095] Clause 21. The end effector of clauses 1 to 16, further comprising at least one wire helically wrapped around each of the plurality of ridges to define a magnetic field position sensor.

[0096] Item 22. A housing assembly for a medical device, the housing assembly comprising: a shell defining a cavity; an actuator capable of sliding along a longitudinal axis within the cavity and configured to move an end actuator between an expanded configuration and a collapsed configuration; a pawl engaged with one of the shell and the actuator; and a first latch integral with the other of the shell and the actuator and configured to selectively engage the pawl, the engagement of the pawl and the first latch providing tactile feedback regarding the collapsed configuration, intermediate configuration, or expanded configuration of the end actuator.

[0097] Clause 23. The housing assembly of Clause 22, further comprising a second catch integral with the other of the housing and the actuator and configured to selectively engage the pawl.

[0098] Clause 24. The housing assembly of Clause 23, further comprising a third catch integral with the other of the housing and the actuator and configured to selectively engage the pawl.

[0099] Item 25. According to the housing assembly of Item 24, the first fastener is configured to provide tactile feedback that the end actuator is in the collapsed configuration, the second fastener is configured to provide tactile feedback that the end actuator is in the intermediate configuration, and the third fastener is configured to provide tactile feedback that the end actuator is in the expanded configuration.

[0100] Clause 26. The housing assembly of any one of clauses 22 to 25, the detent comprising a ball biased toward the first catch.

[0101] Clause 27. The housing assembly of any of clauses 22 to 26, the pawl being movable in a direction perpendicular to the longitudinal axis toward and away from the first catch to adjust a force applied by the pawl to the first catch.

[0102] Clause 28. The housing assembly of clause 27, the pawl being threaded to move the pawl toward and away from the first latch.

[0103] Clause 29. The housing assembly of any one of clauses 22 to 25, the actuator partially protruding from the cavity.

[0104] Clause 30. The housing assembly of any one of clauses 22 to 29, wherein the actuator comprises a push / pull rod or a pull wire.

[0105] Item 31. A medical device, comprising: a first shaft extending along a longitudinal axis and attached to the actuator; an end actuator attached to the first shaft at a proximal end of the end actuator and configured to move between an expanded configuration, an intermediate configuration, and a collapsed configuration; and a shell assembly, the shell assembly comprising: an actuator attached to the first shaft and capable of sliding along the longitudinal axis, the sliding movement of the actuator causing the first shaft and the proximal end of the end actuator to slide; a pawl; and a first catch, the first catch being configured to selectively engage with the pawl, the first catch being configured to provide tactile feedback that the end actuator is in one of the expanded configuration, the intermediate configuration, and the collapsed configuration.

[0106] Clause 32. The medical device of Clause 31, the end effector comprising a plurality of ridges, each ridge comprising a plurality of electrodes attached to said each ridge.

[0107] Clause 33. The medical device of any one of Clauses 31 to 32, wherein the end effector is teardrop shaped.

[0108] Clause 34. A medical device according to any one of clauses 31 to 33, wherein the medical device also includes a second latch, the second latch being configured to selectively engage the pawl, the second latch being configured to provide tactile feedback that the end actuator is in another of the expanded configuration, the intermediate configuration, and the collapsed configuration.

[0109] Clause 35. The medical device of clause 34, further comprising a third latch configured to selectively engage the pawl, the second latch configured to provide tactile feedback that the end actuator is in another of the expanded configuration, the intermediate configuration, and the collapsed configuration.

[0110] Clause 36. The medical device of any one of Clauses 31 to 35, the first catch comprising a pair of ribs defined on a surface of the actuator.

[0111] Clause 37. The medical device of any one of Clauses 31 to 36, the housing assembly comprising a shell, the pawl being threadably connected to the shell.

[0112] Clause 38. The medical device of any of Clauses 31 to 37, further comprising a second shaft extending along the longitudinal axis and attached to the housing assembly and a distal end of the end effector.

[0113] Clause 39. The medical device of Clause 38, wherein the second shaft extends through the first shaft.

[0114] Clause 40. The medical device of any of Clauses 38 to 39, the second shaft defining a lumen and comprising one or more irrigation holes.

[0115] Clause 41. The medical device of any of Clauses 38 to 40, the proximal end of the end effector being configured to slide along the second axis when moving between the expanded configuration, the intermediate configuration, and the collapsed configuration.

[0116] Clause 42. The medical device of any of Clauses 38 to 41, the proximal end of the end effector and the distal end of the end effector substantially abutting one another in the expanded configuration.

[0117] Clause 43. The medical device of Clause 32, further comprising a wire disposed on at least one ridge of the plurality of ridges to define at least one loop of a magnetic field sensor.

[0118] The above embodiments are cited by way of example, and the technology disclosed in the present invention is not limited by what is specifically shown and described above. On the contrary, the scope of the technology disclosed in the present invention includes combinations and sub-combinations of the various features described above, as well as variations and modifications thereof, which will occur to those skilled in the art when reading the above description and which are not disclosed in the prior art.

Claims

1. An end effector for a medical device, the end effector comprising: a unitary spine frame comprising: a proximal end, a distal end including a crown, and a plurality of ridges integral with the crown, the plurality of ridges being configured to flex radially outward from a longitudinal axis and to move between an expanded configuration and a collapsed configuration, the unitary spine frame defining a teardrop-shaped profile in the collapsed configuration, the teardrop-shaped profile having a bulbous distal region tapering to a caudal proximal region, the bulbous distal region including the plurality of ridges bulging outwardly from the crown in a proximal direction relative to the longitudinal axis, and the plurality of ridges tapering toward the longitudinal axis to a smaller proximal region with a transition region between the bulbous distal region and the caudal proximal region; at least one electrode disposed on each ridge in the bulbous distal region; and At least two electrodes are disposed on each ridge in the tail proximal region.

2. The end effector of claim 1, each ridge being movable such that: In the collapsed configuration, the widest diameter of the plurality of ridges is disposed at a first location along the longitudinal axis, the first location being closer to the crown than the proximal end, and In the expanded configuration, a widest diameter of the plurality of ridges is disposed at a second location along the longitudinal axis, the second location being spaced apart from the first location.

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

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

5. The end effector of claim 1 further comprising a first uniaxial sensor attached to the crown.

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

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

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

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

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

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

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

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

14. According to the shell assembly of claim 13, the first fastener is configured to provide tactile feedback that the end actuator is in the collapsed configuration, the second fastener is configured to provide tactile feedback that the end actuator is in the intermediate configuration, and the third fastener is configured to provide tactile feedback that the end actuator is in the expanded configuration.

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

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 expanded configuration, an intermediate configuration, and a collapsed configuration; and A housing component, the housing component comprising: an actuator attached to the first shaft and slidable along the longitudinal axis, sliding movement of the actuator sliding the first shaft and the proximal end of the end effector; pawl; and A first catch is configured to selectively engage the pawl, the first catch being configured to provide tactile feedback that the end effector is in one of the expanded configuration, the intermediate configuration, and the collapsed configuration.

17. The medical device of claim 16, the end effector comprising a plurality of ridges, each ridge comprising a plurality of electrodes attached to each ridge.

18. The medical device of claim 16, the first catch comprising 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 the housing assembly and a distal end of the end effector.

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

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