Medical device with monolithic spine framework

Abstract

To provide a monolithic framework for an end effector of a medical device.SOLUTION: The disclosed technology includes a monolithic framework for an end effector of a medical device. The monolithic framework includes cylindrical stock. The cylindrical stock includes a crown and a plurality of spines. The crown extends along a longitudinal axis, defines a crown lumen, and defines a plurality of crown recesses that, in use, connect to an annulus. The plurality of spines also extend along the longitudinal axis and bow outwardly relative to the longitudinal axis. Each spine extends from the crown to a spine terminal end and, in use, connects to a connecting hub.SELECTED DRAWING: Figure 8

Description

[Technical field]

[0001] TECHNICAL FIELD The present technology relates generally to medical devices, and more particularly, but not exclusively, to medical probes having electrodes, and further to medical probes suitable for use for tissue mapping and ablation. [Background technology]

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

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

[0004] 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.

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

[0006] Basket-type catheters are typically formed from multiple metal pieces cut from a sheet, which require assembly to form the basket. Furthermore, a typical basket catheter only assumes a spheroid shape when expanded. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there is a need for improved techniques for forming basket catheter end effectors that have fewer components and different configurations in the expanded and collapsed configurations. [Means for solving the problem]

[0008] In accordance with the disclosed technology, a monolithic framework for an end effector of a medical device is provided. The monolithic framework can include a cylindrical stock. The cylindrical stock can include a crown and a plurality of spines. The crown extends along a longitudinal axis, defines a crown lumen, and defines a plurality of crown recesses configured to connect to an annulus. The spines extend along the longitudinal axis and are configured to bend outward relative to the longitudinal axis. Each spine extends from the crown to a spine terminal end and is configured to connect to a connection hub.

[0009] There is further provided an end effector for a medical device according to the disclosed technology. The end effector may include a monolithic framework, an annulus, a connection hub, and one or more electrodes. The monolithic framework may include a cylindrical stock including a crown and a plurality of spines. The crown extends along a longitudinal axis and defines a plurality of crown recesses. The spines extend along the longitudinal axis and are configured to bend outward relative to the longitudinal axis. The spines are movable between a collapsed configuration and an expanded configuration. The annulus is connected to the crown recesses. The connection hub is connected to the spines. One or more electrodes are connected to each spine.

[0010] There is also provided a method of manufacturing a monolithic framework for a medical device in accordance with the disclosed technology. The method may include the steps of: forming a generally cylindrical stock to include a crown and a plurality of spines; the crown extending along a longitudinal axis, defining a crown lumen aligned with a stock lumen defined by the generally cylindrical stock, and defining a plurality of crown recesses configured to connect to the annulus; the spines extending along the longitudinal axis; each spine extending from the crown to a spine terminus configured to connect to a connection hub; and heat setting the spines to bend outwardly relative to the longitudinal axis. [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 distal tip of a medical device, such as a medical probe, in accordance with the disclosed technology. [Diagram 3] FIG. 1 is a schematic pictorial diagram showing a perspective view of an end effector with sleeve and coil removed for clarity, in accordance with the disclosed technology; [Figure 4A] FIG. 2 is a schematic pictorial diagram showing a detailed perspective view of a framework distal end of a monolithic framework with an annulus removed in accordance with the disclosed technology. [Figure 4B] FIG. 1 is a schematic pictorial diagram of a detailed perspective view of a distal end of a framework with an annulus partially assembled therewith, in accordance with the disclosed technology; [Figure 4C] FIG. 1 is a schematic pictorial diagram of a detailed perspective view of a distal end of a framework with an annulus partially assembled therewith, in accordance with the disclosed technology; [Diagram 5] FIG. 5 is a schematic pictorial diagram showing a cross-sectional view of the framework distal end and annular portion taken along line 5-5 of FIG. 4C in accordance with the disclosed technology. [Figure 6A] FIG. 1 is a schematic pictorial diagram showing a detailed perspective view of the proximal end of an end effector with a connection hub detached therefrom, in accordance with the disclosed technology; [Figure 6B] FIG. 1 is a schematic pictorial diagram showing a detailed perspective view of a proximal end of an end effector with a connection hub connected to a framework proximal end 102B in accordance with the disclosed technology. [Figure 7] FIG. 7 is a schematic pictorial diagram showing a cross-sectional view of a proximal end of a framework connected to a connection hub, taken along line 7-7 of FIG. 6B, in accordance with the disclosed technology. [Figure 8]FIG. 2 is a schematic pictorial diagram illustrating a generally cylindrical stock formed into a monolithic framework with multiple jackets formed and / or positioned on the spine of the framework in accordance with the disclosed technology. [Figure 9] 9 is a flow chart illustrating a method of manufacturing a monolithic framework according to the general procedure shown in FIG. 8 in accordance with the disclosed technology. [Figure 10] FIG. 1 is a schematic, pictorial diagram showing a perspective view of another configuration of an end effector of a medical device in accordance with the disclosed technology; [Figure 11] FIG. 11 is a schematic pictorial diagram showing a perspective view of the end effector of FIG. 10 with the proximal sleeve and coil removed for clarity, in accordance with the disclosed technology. [Figure 12] 12 is a schematic pictorial diagram showing a cross-sectional view of the end effector of FIG. 10 taken along line 12-12 of FIG. 10. 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 terms "about" or "approximately" or "generally" with respect to any numerical value or range indicate 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 device / 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 a basket assembly 28, configured to sense IEGM signals. In the embodiments described herein, the electrodes 26 can 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 can 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 can 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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 direct current pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0033] 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 for performing real-time calculations of catheter position and executing ECG calculations.

[0034] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with appropriate 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.

[0035] 2 is a schematic pictorial diagram showing a perspective view of a distal tip 28 of a medical device 14, such as a medical probe. The medical device 14 includes an end effector 100 at its distal tip 28. The end effector 100 in the currently described example takes the form of a basket assembly including at least one spine 104. The spine 104 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and may include a flexible, resilient material (e.g., a shape memory alloy such as nickel-titanium, also known as Nitinol) forming struts.

[0036] The end effector 100 is connected to the remainder of the medical probe 14 via an elongated shaft or tube 144. The elongated shaft 144 may be tubular in shape and flexible, with certain portions being more flexible than other portions. For example, the tip portion may be more flexible than the rest to allow the end effector 100 to be easily deflected. Both of the elongated shafts 144 may be formed from a flexible, biocompatible, electrically insulating material such as polyamide-polyether (Pebax) copolymer, polyethylene terephthalate (PET), urethane, polyimide, parylene, silicone, etc. 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 extent of the inflammatory response.

[0037] The spine 104 may be integrally formed with the distal hub (referred to herein as crown 110) as seen in FIG. 3 to form a one-piece / monolithic spine framework 102. The crown 110 extends along a longitudinal axis A1. The framework 104 may be formed from a planar or cylindrical tube stock of material using any suitable method. For example, the framework 102 may be formed by cutting, laser cutting, stamping, combinations thereof, and the like. Further description regarding methods of manufacturing the framework is provided below with respect to FIGS. 8 and 9.

[0038] The atraumatic annulus 120 and the coil 148 are connected to the crown 110. In some examples, the coil 116 can include a single axis sensor (SAS). In other examples, the coil 116 can include a dual axis sensor (DAS) or a triaxial sensor (TAS). The coil 116 can include a conductive material wound around a coil, or a coil formed into a flex circuit. The coil 116 can include a conductor for conducting a current induced on the coil to the patient interface unit 30. As can be appreciated, by attaching the coil 116 to the distal end of the end effector 100, it is possible to detect its position. In this manner, the physician 24 can more accurately determine the position of the distal end of the end effector 100 before applying ablation energy to tissue.

[0039] An insulating material, referred to herein as a jacket 106, is provided on each spine. Each jacket 106 functions to enhance the atraumatic nature of the end effector 100, to protect the subject from sharp edges, and for irrigation purposes, as described in more detail below. The jacket 106 may include a polymer. For example, the jacket 106 may be 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 extent of the inflammatory response. Additionally, although the jacket 106 is shown in these figures as being tubular, the insulating material 106 may be shaped, corrugated, ribbed, raised, concave, convex, or otherwise configured such that the overall contour of the insulating material 106 provides the physical and / or mechanical properties, such as stiffness and flexure along multiple axes, required by the end effector 100 referred to above. Additionally, a flexible sleeve 146 is provided over the proximal end of the end effector 100 and the irrigation manifold 120 (FIG. 3), which will be described in more detail below.

[0040] The spine(s) 104 are movable between an extended configuration and a collapsed configuration. The elongated shaft 144 connects the end effector 100 to a handle that can be manipulated by the operator 24 in use. A connector tube 108 is connected to the crown 110. In some examples, the connector tube 108 is used to facilitate the extension and collapse of the spine 104. For example, the connector tube 108 can be translated along the longitudinal axis A1 to extend / collapse the spine 104. In the extended configuration (FIG. 2) as well as the collapsed configuration, one or more spines 104 can bend radially outward from the longitudinal axis A1. The connector tube 108 can additionally or alternatively be used to deliver irrigation fluid therethrough. The spine 104, the elongated shaft 144, the crown 110, and the connector tube 108 are generally aligned along the longitudinal axis A1 when the elongated shaft 144 is not bent. Additionally, a sleeve 146 is provided on the proximal end of the end effector 100 to enhance its atraumatic nature.

[0041] 3 is a schematic pictorial diagram of a perspective view of the distal end of the end effector 100 with the sleeve 146 and coil 116 removed for clarity. As shown, the framework 102 has a distal end 102A (including a crown 110) and a proximal end 102B. The crown 110 connects with the annular portion 120 as described in more detail below with respect to FIGS. 4A, 4B, and 4C. The proximal end 102B connects with a connection hub 136 and is covered with a sleeve 146 to enhance the atraumatic nature of the end effector 100, as described above. The connection hub 136 may be substantially cylindrical in shape and maintains the position of the ends of the spines 104 relative to one another and is described in more detail with respect to FIGS. 6A, 6B, and 7.

[0042] Figure 4A is a schematic, pictorial view of a detailed perspective view of the framework distal end 102A with the annular portion 120 removed, Figure 4B is a schematic, pictorial view of a detailed perspective view of the framework distal end 102A with the annular portion 120 partially assembled, and Figure 4C is a schematic, pictorial view of a detailed perspective view of the framework distal end 102A with the annular portion 120 partially assembled.

[0043] As shown in FIG. 4A, the crown 110 defines a crown lumen 118 that is coaxial and / or parallel to the longitudinal axis A1. Additionally, a terminal end 114 of the crown 110 defines a plurality of crown recesses 112 that are circumferentially arranged about the longitudinal axis A1. In some examples, the recesses 112 include an inlet section 112A and a receiving section 112B that extends generally perpendicular to the inlet section and forms an L-shape to engage the annular portion 120, as will be described in more detail below. Additionally, between adjacent L-shaped recesses 112 are a plurality of cylindrical crown holes 116.

[0044] 4A, the annular portion 120 is generally tubular in configuration and includes an atraumatic tip 122, a connecting portion 124 connected to the tip 122, a tube portion 126 connected to the connecting portion 124, and a lumen 128 therethrough. The lumen 128 allows for various medical devices, such as a guidewire and / or a mapping catheter, to pass through the annular portion 120. The connecting portion 124 includes adjacent / proximal sets of locking projections 124B and annular holes 124C. Additionally, the connecting portion 124 has a polygonal cross-sectional shape.

[0045] As shown in the order of Figures 4A to 4B and 4C, the crown 110 and the annular part 120 have a complementary design so that the annular part 120 can be easily fixed to the crown 110. As shown by the directional arrows in Figure 4A, the tube part 126 and the connecting part 124 are inserted into the crown lumen 118 when assembled. At this time, the locking protrusion 124B enters the recess 112 through the inlet section 112A (Figure 4B). To lock the annular part 120 to the crown 110, the annular part 120 is rotated (e.g., clockwise) about the longitudinal axis A1, as shown by the directional arrows in Figure 4B. Finally, Figure 4C shows the annular part 120 after being rotated to the locked position. The polygonal connecting part 124 frictionally engages the inner surface of the crown 110 to aid retention. To disassemble, the reverse process can be used.

[0046] 5 is a schematic pictorial diagram showing a cross-sectional view of framework distal end 102A and annular portion 120 taken along line 5-5 of FIG. 4C. When annular portion 120 is rotated to the locked position, crown holes 116 are aligned with annular holes 124C. This alignment allows fasteners, such as screws, rivets, solder, etc., to pass through crown holes 116 and connect with annular holes 124C. Also, as can be seen in this view, connector tube 108 (which defines connector tube lumen 108A) slides within tube portion 126 into axial alignment with annular portion 120.

[0047] FIG. 6A is a schematic pictorial diagram showing a detailed perspective view of the proximal end of the end effector 100 with the connection hub 136 detached from the framework proximal end 102B. FIG. 6B is a schematic pictorial diagram showing a detailed perspective view of the proximal end of the end effector 100 with the connection hub 136 connected to the framework proximal end 102B. In addition to the above, with reference to FIGS. 6A and 6B, the spine 104 has a proximal end 130 shaped to connect to the connection hub 136. Specifically, each spine 104 defines a plurality of spine recesses 132 on at least one side of the spine 104 (e.g., the recesses 132 can be defined on both sides of the spine 104 as shown). Additionally, at least one spine hole 134 is defined through each spine end 130 oriented perpendicular to the longitudinal axis A1. As can be seen particularly in FIG. 6A, the spine holes 134 are disposed between pairs / sets of spine recesses 132 defined on opposing sides of the spine proximal ends 130. The connection hub 136 includes hub reliefs 138 that are complementarily shaped to receive the respective shaped proximal ends 130 of the spines 130. Each hub relief includes one or more relief projections 140 and one or more relief holes 142. In particular, the spine recesses 132 interact with the relief projections 140 when the proximal ends 130 are set in place. FIG. 6B shows the proximal ends 130 aligned and moved radially inward toward the longitudinal axis A1 (compare FIG. 6A showing A1) to connect with the connection hub reliefs 138, as indicated by the directional arrows.

[0048] 7 is a schematic pictorial diagram showing a cross-sectional view of the framework proximal end 102B connected to a connection hub 136, taken along line 7-7 in FIG. 6B. As shown, when the spine proximal end 130 is inserted into the hub relief 138, the spine holes 134 are axially aligned with the relief holes 142. This alignment allows fasteners, such as screws, rivets, solder, etc., to pass through the crown holes and spine holes 134 to connect with the respective relief holes 142.

[0049] Figure 8 is a schematic diagram showing a generally cylindrical stock 101 formed into a monolithic framework 102 with a number of jackets 104 formed and / or positioned over the spines 104 of the framework 102. Figure 9 is a flow chart illustrating a method 1000 of manufacturing the monolithic framework 102 according to the general procedure shown in Figure 8.

[0050] In addition to the above, and with reference to Figures 8 and 9, a method of manufacturing the monolithic framework 102 may include the following steps: A generally cylindrical stock 101 (see the top of Figure 8) is formed to include a crown 110 extending along a longitudinal axis A1, defining a crown lumen 118 adjacent a portion of the stock lumen 101', and defining a plurality of crown recesses 112 configured to connect to an annular portion 120 (step 1002). The generally cylindrical stock is also formed to include a plurality of spines 104 extending along the longitudinal axis A1, each spine 104 extending from the crown 110 to a spine terminal end 130 and configured to connect to a connection hub 136 (step 1002). The spines 104 are heat set (see the bottom of Figure 8) such that the spines 104 are bent outwardly relative to the longitudinal axis A1 (step 1004). The forming steps to form the crown 110 and / or spine 104 include at least one of mechanical cutting, laser cutting, stamping, or combinations thereof. For example, a generally cylindrical stock 101 can be cut along a longitudinal axis A1 to form the spine 104, and a distal end of the stock 101 (not cut to form the spine 104) can be cut to define the aforementioned crown recess 112 and crown hole 116. Steps 1006 and 1008 are discussed in more detail below with respect to Figures 10-12.

[0051] Figure 10 is a schematic, pictorial diagram showing a perspective view of another configuration of the end effector 200 of the medical device 14. Figure 11 is a schematic, pictorial diagram showing a perspective view of the end effector 200 with the proximal sleeve and coil removed for clarity (similar to Figure 3 in conjunction with Figure 2 for the first configuration of the end effector 100). Features not shared with the previously described end effector 100 are highlighted in the following description.

[0052] The end effector 200 in the currently described example takes the form of a basket assembly including at least one spine 204, as in the example of Figs. 2-7. As in the above examples, the spine 204 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross section and may include a flexible elastic material (e.g., a shape memory alloy such as nickel-titanium, also known as Nitinol) forming a strut. Additionally, the spine 204 may be integrally formed with a crown 210 to form a one-piece / monolithic spine framework. The crown 210 may share similar features to the crown 110 described above for connecting with the annular portion 220. Additionally, the proximal end 230 of the spine 204 may include similar features to the spine 104 described above for connecting with the connection hub 236.

[0053] Similarly, a connector tube 208 is connected to the crown 210. In some examples, the connector tube 208 is used to facilitate the expansion and collapse of the spine 104. For example, the connector tube 208 can be translated along the longitudinal axis A1 to expand / collapse the spine 204. In the expanded and collapsed configurations (FIG. 10), one or more spines 204 can bend radially outward from the longitudinal axis A1. The spines 204, crown 210, and connector tube 208 are generally aligned along the longitudinal axis A1.

[0054] 12 is a schematic diagram showing a cross-sectional view of the end effector 200 taken along line 12-12 of FIG. 10. As shown, in the folded configuration (FIG. 12), the monolithic framework is generally spheroidal in shape. When the spines 204 are actuated to move to the expanded configuration, e.g., via the connector tubes 208, the distal end of the framework is pulled toward the proximal end to form a petal-like structure. The petal structure allows the electrode 26 to ablate at the entrance to the pulmonary veins, while the spheroid structure allows the electrode 26 to ablate deep within the pulmonary veins.

[0055] To form the aforementioned spheroidal shape, each spine 204 has a series of bends. Specifically, each spine includes a first arcuate bend 204A, a second arcuate bend 204B, and a third arcuate bend 204C.

[0056] The first arcuate bend 204A extends from the crown 210, is disposed proximal to the crown 210, and is bent in a first radial direction R1 relative to the crown 210. The first radial direction R1 is centered about an axis perpendicular to the longitudinal axis A1. The first arcuate bend 204A is bent through a first angle θ1. In some examples, the first angle θ1 is within a range of about 120 degrees to about 180 degrees.

[0057] The second arcuate flexure 204B extends in a second radial direction R1 from the first arcuate flexure 204A. The second radial direction R2 is centered about the same axis as the first radial direction R1, which is perpendicular to the longitudinal axis A1, but in the opposite direction. The second arcuate flexure 204B is curved through a second angle θ2. In some examples, the second angle θ2 is in the range of about 240 degrees to about 270 degrees.

[0058] The third arcuate bend 204C extends from the second arcuate bend 204B and is proximal to the spine terminal end 230. The third arcuate bend 204C is bent in a first radial direction R1. The third arcuate bend 204C is bent through a third angle θ3. In some examples, the third angle θ3 is within a range of about 60 degrees to about 150 degrees.

[0059] The spine 204 further has a proximal half and a distal half, with the division point defined approximately at the midpoint of the second arcuate bend 204B along the longitudinal axis A1 (see where θ2 is marked in FIG. 12 ). In this configuration, the electrode 26 is positioned only on the distal half for ablation purposes as described above.

[0060] Returning to the method 1000 described in Figure 9, it will be appreciated that to form the end effector 200 shown in Figure 10, the method 1000 may further include bending the plurality of spines 204 so that each spine 204 has a first arcuate bend 204A (step 1006), bending the plurality of spines 204 so that each spine 204 has a second arcuate bend 204B (step 1006), and bending the plurality of spines 204 so that each spine 204 has a third arcuate bend 204C (step 1008). These steps may be performed prior to heat setting the spines 204, which biases the spines 204 into a spheroidal configuration.

[0061] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses.

[0062] Clause 1. A monolithic framework for an end effector of a medical device, the monolithic framework comprising: a crown comprising a cylindrical stock extending along a longitudinal axis, the crown defining a crown lumen and defining a plurality of crown recesses configured to connect to an annulus; and a plurality of spines extending along the longitudinal axis and configured to bend outward relative to the longitudinal axis, each spine extending from the crown to a spine terminal end and configured to connect to a connection hub.

[0063] Clause 2. A monolithic framework as described in clause 1, consisting essentially of cylindrical stock.

[0064] Clause 3. A monolithic framework described in any one of clauses 1-2, wherein each crown recess comprises a first portion defined in the crown terminal portion and extending parallel to the longitudinal axis, and a second portion extending from the first portion and generally perpendicular to the first portion.

[0065] Clause 4. The monolithic framework of clause 3, wherein the crown further defines a plurality of crown holes extending generally perpendicular to the longitudinal axis, each crown hole being located between adjacent ones of the plurality of crown recesses.

[0066] Clause 5. A monolithic framework described in any one of clauses 1 to 4, wherein each spine defines a plurality of spine recesses on at least one side of the spine, the plurality of spine recesses being configured to interface with a connection hub.

[0067] Clause 6. The monolithic framework of clause 5, wherein each of the plurality of spine recesses includes a first set of spine recesses defined on a first side of each spine and a second set of spine recesses defined on a second side of each spine.

[0068] Clause 7. A monolithic framework as described in clause 6, wherein each spine defines at least one spine hole defined therethrough and extending perpendicular to the longitudinal axis, and wherein the at least one spine hole is positioned between the first set of spine recesses and the second set of spine recesses.

[0069] Clause 8. A monolithic framework as described in any one of clauses 1 to 7, wherein each spine includes a first arcuate bend proximal to the crown in a first radial direction perpendicular to the longitudinal axis, and a second arcuate bend extending from the first arcuate bend in a second radial direction perpendicular to the longitudinal axis.

[0070] Clause 9. The monolithic framework of clause 8, wherein the first arcuate bend is bent at an angle within a range of about 120 degrees to about 180 degrees.

[0071] Clause 10. The monolithic framework of any one of clauses 8-9, wherein the second arcuate bend is bent at an angle within a range of about 240 degrees to about 270 degrees.

[0072] Clause 11. A monolithic framework as described in any one of clauses 8 to 9, wherein each spine includes a third arcuate bend proximal to the spine terminus in a first radial direction and extending from the second arcuate bend.

[0073] Clause 12. The monolithic framework of clause 11, wherein the third arcuate bend is bent at an angle within a range of about 60 degrees to about 150 degrees.

[0074] Clause 13. An end effector for a medical device, the end effector comprising: a monolithic framework including a cylindrical stock, the cylindrical stock extending along a longitudinal axis, a crown defining a plurality of crown recesses, and a plurality of spines extending along the longitudinal axis and configured to bend outward relative to the longitudinal axis, the plurality of spines being movable between a folded configuration and an expanded configuration; an annular portion connected to the plurality of crown recesses; a connection hub connected to the plurality of spines; and one or more electrodes connected to each of the plurality of spines.

[0075] Clause 14. The end effector of clause 13, wherein the crown defines a crown lumen and the annulus extends through the crown lumen.

[0076] Clause 15. An end effector described in any one of clauses 13-14, wherein the annular portion includes an atraumatic tip portion, a polygonal portion that frictionally engages the inner surface of the crown, and a tubular portion.

[0077] Clause 16. An end effector as described in clause 15, wherein the polygonal portion includes a plurality of locking protrusions projecting radially outward away from the longitudinal axis, each locking protrusion engaging a respective crown recess of the plurality of crown recesses.

[0078] Clause 17. An end effector as described in clause 16, wherein the polygonal portion defines a plurality of annular holes, each annular hole being positioned proximal to a respective one of the plurality of locking protrusions.

[0079] Clause 18. An end effector as described in clause 17, wherein the crown defines a plurality of crown holes extending perpendicular to the longitudinal axis, each crown hole being axially aligned with a respective one of the plurality of annular holes.

[0080] Clause 19. An end effector according to any one of clauses 13 to 18, further comprising a connector tube extending generally parallel to or coaxial with the longitudinal axis and connected to the annular portion.

[0081] Clause 20. The end effector of clause 19, wherein the annular portion defines an annular lumen, and the connector tube is connected to the annular portion within the annular portion lumen.

[0082] Clause 21. An end effector described in any one of items 19 to 20, wherein the connector tube is configured to move the plurality of spines between a collapsed configuration and an expanded configuration and / or to deliver irrigation fluid therethrough.

[0083] Clause 22. An end effector described in any one of clauses 13 to 21, wherein each spine of the plurality of spines has a shaped end defining at least one recess, and the connection hub defines a plurality of hub reliefs, each hub relief shaped to receive a respective shaped end of each spine.

[0084] Clause 23. An end effector described in any one of clauses 13 to 22, wherein each spine of the plurality of spines defines a spine hole, and the connection hub defines a plurality of connection hub holes, each spine hole being axially aligned with a respective connection hub hole of the plurality of connection hub holes.

[0085] Clause 24. An end effector described in any one of clauses 13 to 23, wherein the plurality of spines have a generally spheroidal shape when in the folded configuration.

[0086] Clause 25. An end effector as described in clause 24, wherein each spine of the plurality of spines has a proximal half and a distal half, and the one or more electrodes are disposed on only the distal half.

[0087] Clause 26. A method of manufacturing a monolithic framework for a medical device, comprising: forming a generally cylindrical stock to include: a crown, the crown defining a crown lumen aligned with a stock lumen defined by the generally cylindrical stock and defining a plurality of crown recesses configured to connect to an annulus; and a plurality of spines, the spines extending along the longitudinal axis, each spine extending from the crown to a spine terminal end and configured to connect to a connection hub; and heat setting the plurality of spines such that the plurality of spines bend outward relative to the longitudinal axis.

[0088] Clause 27. The method of clause 26, wherein the forming step includes at least one of mechanical cutting, laser cutting, stamping, or a combination thereof.

[0089] Clause 28. The method of any one of clauses 26-27, further comprising bending the plurality of spines such that each spine has a first arcuate bend proximal to the crown in a first radial direction perpendicular to the longitudinal axis and a second arcuate bend extending from the first arcuate bend in a second radial direction perpendicular to the longitudinal axis.

[0090] Clause 29. The method of clause 28, further comprising bending the plurality of spines such that each spine includes a third arcuate bend proximal to the spine terminus in a first radial direction and extending from the second arcuate bend.

[0091] 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.

[0092] [Embodiment] (1) A monolithic framework for an end effector of a medical device, the monolithic framework comprising a cylindrical stock, the cylindrical stock comprising: a crown extending along a longitudinal axis, defining a crown lumen and defining a plurality of crown recesses configured to connect to the annulus; a plurality of spines extending along the longitudinal axis and configured to bend outward relative to the longitudinal axis, each spine extending from the crown to a spine termination and configured to connect to a connection hub. (2) A monolithic framework as described in embodiment 1, consisting essentially of said cylindrical stock. (3) Each crown recess is a first portion defined in a crown terminal end and extending parallel to the longitudinal axis; 2. The monolithic framework of claim 1, further comprising: a second portion extending from the first portion and generally perpendicular to the first portion. (4) The monolithic framework of embodiment 3, wherein the crown further defines a plurality of crown holes extending generally perpendicular to the longitudinal axis, each crown hole being located between adjacent ones of the plurality of crown recesses. (5) The monolithic framework of embodiment 1, wherein each spine defines a plurality of spine recesses on at least one side of the spine, the plurality of spine recesses being configured to interface with the connection hub.

[0093] (6) The monolithic framework of claim 5, wherein each of the plurality of spine recesses includes a first set of spine recesses defined on a first side of the respective spine and a second set of spine recesses defined on a second side of the respective spine. (7) The monolithic framework of embodiment 6, wherein each spine defines at least one spine hole defined therethrough and extending perpendicular to the longitudinal axis, the at least one spine hole being positioned between the first set of spine recesses and the second set of spine recesses. (8) Each spine is a first arcuate bend proximal to the crown in a first radial direction perpendicular to the longitudinal axis; a second arcuate bend extending from the first arcuate bend in a second radial direction perpendicular to the longitudinal axis. (9) Each spine is 9. The monolithic framework of embodiment 8, further comprising a third arcuate bend proximal to the spine end in the first radial direction and extending from the second arcuate bend. (10) An end effector for a medical device, comprising: A monolithic framework comprising a cylindrical stock, the cylindrical stock comprising: a crown extending along a longitudinal axis and defining a plurality of crown recesses; a monolithic framework including: a plurality of spines extending along the longitudinal axis and configured to bend outward relative to the longitudinal axis, the plurality of spines being movable between a collapsed configuration and an expanded configuration; an annular portion connected to the plurality of crown recesses; a connection hub connected to the plurality of spines; and one or more electrodes connected to each spine of the plurality of spines.

[0094] (11) The end effector of embodiment 10, wherein the crown defines a crown lumen and the annular portion extends through the crown lumen. (12) The end effector of claim 10, wherein the annular portion includes an atraumatic tip portion, a polygonal portion that frictionally engages the inner surface of the crown, and a tubular portion. (13) The end effector of embodiment 12, wherein the polygonal portion includes a plurality of locking protrusions that protrude radially outward away from the longitudinal axis, each locking protrusion engaging a respective crown recess of the plurality of crown recesses. (14) An end effector as described in embodiment 13, wherein the polygonal portion defines a plurality of annular holes, each annular hole being positioned proximal to a respective one of the plurality of locking protrusions. (15) The end effector of embodiment 14, wherein the crown defines a plurality of crown holes extending perpendicular to the longitudinal axis, each crown hole being axially aligned with a respective one of the plurality of annular holes.

[0095] (16) The end effector of embodiment 10, further comprising a connector tube extending generally parallel or coaxially to the longitudinal axis and connected to the annular portion. (17) An end effector as described in embodiment 10, wherein each spine of the plurality of spines has a shaped end defining at least one recess, and the connection hub defines a plurality of hub reliefs, each hub relief shaped to receive a respective shaped end of each spine. (18) The end effector of claim 10, wherein the plurality of spines have a generally spheroidal shape when in the folded configuration. (19) An end effector as described in embodiment 18, wherein each spine of the plurality of spines has a proximal half and a distal half, and the one or more electrodes are disposed only on the distal half. (20) A method for manufacturing a monolithic framework for a medical device, the method comprising: A roughly cylindrical stock, a crown defining a crown lumen extending along a longitudinal axis and aligned with a stock lumen defined by said generally cylindrical stock, the crown defining a plurality of crown recesses configured to connect to an annulus; a plurality of spines extending along the longitudinal axis, each spine extending from the crown to a spine terminus and configured to connect to a connection hub; and heat setting the plurality of spines so that the spines are curved outwardly relative to the longitudinal axis.

Claims

1. 1. A monolithic framework for an end effector of a medical device, the monolithic framework comprising a cylindrical stock, the cylindrical stock comprising: a crown extending along a longitudinal axis, defining a crown lumen and defining a plurality of crown recesses configured to connect to the annulus; a plurality of spines extending along the longitudinal axis and configured to bend outward relative to the longitudinal axis, each spine extending from the crown to a spine termination and configured to connect to a connection hub.

2. 2. The monolithic framework of claim 1 consisting essentially of said cylindrical stock.

3. Each crown recess is a first portion defined in a crown terminal end and extending parallel to the longitudinal axis; a second portion extending from said first portion and generally perpendicular to said first portion.

4. 4. The monolithic framework of claim 3, wherein the crown further defines a plurality of crown holes extending generally perpendicular to the longitudinal axis, each crown hole being located between adjacent ones of the plurality of crown recesses.

5. The monolithic framework of claim 1 , wherein each spine defines a plurality of spine recesses on at least one side of the spine, the plurality of spine recesses configured to interface with the connection hub.

6. 6. The monolithic framework of claim 5, wherein each of the plurality of spine recesses includes a first set of spine recesses defined on a first side of the respective spine and a second set of spine recesses defined on a second side of the respective spine.

7. 7. The monolithic framework of claim 6, wherein each spine defines at least one spine hole defined therethrough and extending perpendicular to the longitudinal axis, the at least one spine hole being positioned between the first set of spine recesses and the second set of spine recesses.

8. Each spine is a first arcuate bend proximal to the crown in a first radial direction perpendicular to the longitudinal axis; a second arcuate bend extending from said first arcuate bend in a second radial direction perpendicular to said longitudinal axis.

9. Each spine is The monolithic framework of claim 8 including a third arcuate bend proximal to the spine terminus in the first radial direction and extending from the second arcuate bend.

10. 1. An end effector for a medical device, comprising: A monolithic framework comprising a cylindrical stock, the cylindrical stock comprising: a crown extending along a longitudinal axis and defining a plurality of crown recesses; a monolithic framework including: a plurality of spines extending along the longitudinal axis and configured to bend outward relative to the longitudinal axis, the plurality of spines being movable between a collapsed configuration and an expanded configuration; an annular portion connected to the plurality of crown recesses; a connection hub connected to the plurality of spines; and one or more electrodes connected to each spine of the plurality of spines.

11. The end effector of claim 10 , wherein the crown defines a crown lumen, and the annulus extends through the crown lumen.

12. The end effector of claim 10 , wherein the annulus includes an atraumatic tip portion, a polygonal portion that frictionally engages an inner surface of the crown, and a tubular portion.

13. The end effector of claim 12 , wherein the polygonal portion includes a plurality of locking protrusions projecting radially outwardly away from the longitudinal axis, each locking protrusion engaging a respective crown recess of the plurality of crown recesses.

14. The end effector of claim 13 , wherein the polygonal portion defines a plurality of annular holes, each annular hole positioned proximal to a respective one of the plurality of locking protrusions.

15. 15. The end effector of claim 14, wherein the crown defines a plurality of crown holes extending perpendicular to the longitudinal axis, each crown hole being axially aligned with a respective one of the plurality of annular holes.

16. The end effector of claim 10 , further comprising a connector tube extending generally parallel or coaxial to the longitudinal axis and connected to the annulus.

17. 11. The end effector of claim 10, wherein each spine of the plurality of spines has a shaped end defining at least one recess, and the connection hub defines a plurality of hub reliefs, each hub relief shaped to receive a respective shaped end of each spine.

18. The end effector of claim 10 , wherein the plurality of spines have a generally spheroid shape when in the folded configuration.

19. The end effector of claim 18 , wherein each spine of the plurality of spines has a proximal half and a distal half, the one or more electrodes being disposed on only the distal half.

20. 1. A method of manufacturing a monolithic framework for a medical device, the method comprising: A roughly cylindrical stock, a crown defining a crown lumen extending along a longitudinal axis and aligned with a stock lumen defined by said generally cylindrical stock, the crown defining a plurality of crown recesses configured to connect to an annulus; a plurality of spines extending along the longitudinal axis, each spine extending from the crown to a spine terminus and configured to connect to a connection hub; and heat setting the plurality of spines so that the spines are curved outwardly relative to the longitudinal axis.

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