Medical device with unitary ridge frame

Abstract

The disclosed techniques include a unitary frame for an end effector of a medical device. The unitary frame includes a cylindrical raw material. The cylindrical raw material includes a crown and a plurality of ridges. The crown extends along the longitudinal axis, defines a crown lumen, and defines a plurality of crown grooves that, in use, connect to the ring. The plurality of ridges also extend along the longitudinal axis and are curved outwardly relative to the longitudinal axis. Each ridge extends from the crown to a ridge terminal and, in use, is connected to a connecting hub.

Description

Technical Field

[0001] 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 mapping and / or ablating tissue. Background Art

[0002] 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.

[0003] 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.

[0004] 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.

[0005] 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.

[0006] Basket catheters are typically formed from multiple pieces of metal cut from sheet material, which need to be assembled to form a basket. In addition, typical basket catheters only provide a spherical configuration when expanded. Therefore, there is a need for improved techniques to form an end effector of a basket catheter with fewer parts and having different configurations in the expanded and collapsed configurations. Summary of the invention

[0007] According to the disclosed technology, a monolithic frame for an end effector of a medical device is provided. The monolithic frame may include a cylindrical raw material. The cylindrical raw material may include a crown and a plurality of ridges. The crown extends along a longitudinal axis, defines a crown lumen, and defines a plurality of crown grooves configured to connect to a ring. The ridges extend along the longitudinal axis and are configured to bend outwardly relative to the longitudinal axis. Each ridge extends from the crown to a ridge terminal and is configured to connect to a connecting hub.

[0008] According to the disclosed technology, an end effector for a medical device is further provided. The end effector may include a monolithic frame, a ring, a connecting hub, and one or more electrodes. The monolithic frame may include a cylindrical raw material, which includes a crown and a plurality of ridges. The crown extends along the longitudinal axis and defines a plurality of crown grooves. The ridges extend along the longitudinal axis and are configured to bend outwardly relative to the longitudinal axis. The ridges are capable of moving between a collapsed configuration and an expanded configuration. The ring is connected to the crown grooves. The connecting hub is connected to the ridges. One or more electrodes are connected to each ridge.

[0009] According to the disclosed technology, a method for manufacturing a monolithic frame for a medical device is further provided. The method may include the following steps. A generally cylindrical raw material is formed to include a crown and a plurality of ridges. The crown extends along a longitudinal axis, defines a crown lumen aligned with a raw material lumen defined by the generally cylindrical raw material, and defines a plurality of crown grooves configured to connect to a ring. The ridges extend along the longitudinal axis. Each ridge extends from the crown to a ridge terminal and is configured to connect to a connecting hub. The ridges are heat set so that they bend outwardly relative to the longitudinal axis. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] 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;

[0011] Figure 2 is a schematic illustration showing a perspective view of a distal tip of a medical device, such as a medical probe, according to the disclosed technology;

[0012] Figure 3 is a schematic illustration showing a perspective view of an end effector according to the disclosed technology with the sleeve and coil removed for clarity;

[0013] Figure 4A is a schematic illustration showing a detailed perspective view of a frame distal end of a one-piece frame according to the disclosed technology, with a ring separated from the frame distal end;

[0014] Figure 4B is a schematic illustration showing a detailed perspective view of a distal end of a frame with a ring partially assembled thereto in accordance with the disclosed technology;

[0015] Figure 4C is a schematic illustration showing a detailed perspective view of a distal end of a frame with a ring partially assembled thereto in accordance with the disclosed technology;

[0016] Figure 5 is a diagram showing the relative Figure 4C Schematic illustration of a cross-sectional view of the distal end of the framework and the ring cut along line 5-5 in FIG.

[0017] Fig. 6A is a schematic illustration showing a detailed perspective view of a proximal end of an end effector according to the disclosed technology, with a connecting hub separated from the proximal end;

[0018] Figure 6B is a schematic illustration showing a detailed perspective view of the proximal end of an end effector according to the disclosed technology, wherein a connecting hub is connected to the frame proximal end 102B;

[0019] Figure 7 is to show the relative Figure 6B Schematic illustration of a cross-sectional view of the proximal end of the frame connected to the connecting hub, cut along line 7-7 in FIG.

[0020] Figure 8 is a schematic illustration showing a generally cylindrical stock material formed into a unitary frame according to the disclosed technology, wherein a plurality of sheaths are formed and / or positioned over a spine of the frame;

[0021] Fig. 9 It is to show that according to the disclosed technology Figure 8 A flow chart of a method of manufacturing a unibody frame is shown as a generalized process;

[0022] Fig.10 is a schematic illustration showing a perspective view of another configuration of an end effector of a medical device according to the disclosed technology;

[0023] Fig.11 It is a diagram showing the disclosed technology Fig.10 A schematic illustration of a perspective view of an end effector of with the proximal sleeve and coil removed for clarity; and

[0024] Fig.12 is shown relative to Fig.10 The line in the 12-12 cut Fig.10Schematic illustration of a cross-sectional view of an end effector. DETAILED DESCRIPTION

[0025] 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.

[0026] As used herein, the term "about" or "approximately" or "roughly" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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 example medical device / probe, such as a catheter 14, configured for sensing IEGM is illustrated herein. 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 with 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.

[0039] The catheter 14 is an exemplary catheter that includes one and preferably multiple electrodes 26, optionally distributed on multiple ridges 104 at a basket assembly 28, and configured to sense IEGM signals. In the examples described herein, the electrodes 26 can 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 can also be used to determine the position of the end effector 100 and / or measure physiological properties, such as local surface potentials at corresponding locations on tissue in the heart 12. The electrodes 26 can be biased so that a larger portion of the electrodes 26 faces outward from the end effector 100, so that the electrodes 26 deliver a larger 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.

[0040] 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.

[0041] 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 including 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, a positioning pad 25, surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities for 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 on display device 27 an activation sequence (or other data) compiled from recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20; (3) displaying the real-time position and orientation of multiple catheters within the heart chamber; and (5) displaying on display device 27 sites of interest, such as where ablation energy has been applied. A commercial product embodying elements of system 10 may be CARTO TM 3 System was purchased 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 the 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 presently 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 include a flexible, resilient material (e.g., a shape memory alloy such as nickel titanium, also known as Nitinol) forming struts.

[0049] The end effector 100 is connected to the rest of the medical probe 14 via an elongated shaft or tube 144. The elongated shaft 144 can be tubular in form and flexible, with certain portions being more flexible than other portions. For example, the end portion can be made more flexible than the rest to allow for easy deflection of the end effector 100. The elongated shaft 144 can be formed of a flexible, 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 can include a biocompatible polymer, including, but not limited to: polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response.

[0050] As in Figure 3 As seen in FIG. 1 , the spine 104 can be integrally formed with the distal hub (referred to herein as the crown 110) to form a unitary / monolithic spine frame 102. The crown 110 extends along the longitudinal axis A1. The frame 104 can be formed from planar or cylindrical tubular stock material using any suitable method. For example, the frame 102 can be formed by cutting, laser cutting, stamping, combinations thereof, and the like. Figure 8 and Fig. 9 Further discussion is provided regarding methods of manufacturing the frame.

[0051] The non-invasive ring 120 and the coil 148 are connected to the crown 110. In some examples, the coil 116 may include a single axis sensor (SAS). In other examples, the coil 116 may include a dual axis sensor (DAS) or a three axis sensor (TAS). The coil 116 may include a conductive material wound into a coil or a coil formed as a flexible circuit. The coil 116 may include an electrical lead for conducting the current induced on the coil to the patient interface unit 30. As will be appreciated, by attaching the coil 116 to the distal end of the end effector 100, the position of the distal end 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.

[0052] An insulating material (referred to herein as a sheath 106) is disposed over each ridge. Each sheath 106 is used to enhance the non-invasiveness of the end effector 100, to protect the subject from sharp edges, and for flushing purposes as described in more detail below. The sheath 106 may comprise a polymer. For example, the sheath 106 may be formed of a flexible, 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 a biocompatible polymer, including, but not limited to, polyetheretherketone (PEEK), polyglycolic acid (PGA), poly(lactic-glycolic acid) copolymer (PLGA), polycaprolactone (PCL), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHBV), poly-L-lactide, polydioxanone, polycarbonate, and polyanhydride, wherein the proportions of certain polymers are selected to control the extent of the inflammatory response. Furthermore, while the sheath 106 is shown as being tubular in these figures, the sheath 106 may be shaped, scalloped, ribbed, ridged, concave, convex, or otherwise configured such that the overall profile of the sheath 106 produces the physical and / or mechanical properties required of the end effector 100 as mentioned above, such as rigidity and flexure along multiple axes. In addition, a flexible sleeve 146 is disposed between the proximal end of the end effector 100 and the irrigation manifold 120 ( Figure 3 ), which will be discussed in more detail below.

[0053] The spine 104 is movable between an expanded configuration and a collapsed configuration. The elongated shaft 144 connects the end effector 100 to a handle, which the operator 24 can manipulate in use. The connector tube 108 is connected to the crown 110. In some examples, the connector tube 108 is used to facilitate expansion and collapse of the spine 104. For example, the connector tube 108 can translate along the longitudinal axis A1 to expand / collapse the spine 104. In the expanded configuration ( Figure 2 ) and collapsed configurations, one or more ridges 104 may be bent radially outward from the longitudinal axis A1. The connector tube 108 may additionally or alternatively be used to direct irrigation fluid therethrough. When the elongated shaft 144 is not bent, the ridges 104, the elongated shaft 144, the crown 110, and the connector tube 108 are arranged generally along the longitudinal axis A1. In addition, a sleeve 146 is disposed above the proximal end of the end effector 100 to increase its atraumatic properties.

[0054] Figure 3 1 is a schematic illustration showing a perspective view of the end effector 100, wherein the sleeve 146 and the coil 116 are removed for clarity. As shown, the frame 102 has a distal end 102A (including the crown 110) and a proximal end 102B. The crown 110 is as follows about Figure 4A , Figure 4B and Figure 4C The proximal end 102B is connected to the connecting hub 136 and is covered with a sleeve 146 to increase the atraumatic nature of the end effector 100, as described above. The connecting hub 136 can be substantially cylindrical in form and maintain the positions of the ends of the ridges 104 relative to each other and about Fig. 6A , Figure 6B and Figure 7 Discuss in more detail.

[0055] Figure 4A is a schematic illustration showing a detailed perspective view of the frame distal end 102A with the ring 120 separated therefrom. Figure 4B is a schematic illustration showing a detailed perspective view of the frame distal end 102A with the ring 120 partially assembled thereto. Figure 4C is a schematic illustration showing a detailed perspective view of the frame distal end 102A with the ring 120 partially assembled thereto.

[0056] like Figure 4A As shown, the crown 110 defines a crown cavity 118 coaxial and / or parallel to the longitudinal axis A1. In addition, a plurality of crown grooves 112 disposed circumferentially around the longitudinal axis A1 are defined in the terminal end 114 of the crown 110. In some examples, the groove 112 has an entrance section 112A and a receiving section 112B extending substantially perpendicular to the entrance section, the entrance section and the receiving section forming an L-shape to lock the ring 120, which is discussed in more detail below. In addition, a plurality of cylindrical crown apertures 116 are between adjacent L-shaped grooves 112.

[0057] Continue to refer Figure 4A , the ring 120 is generally tubular in form 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 permits various medical devices (such as a guidewire and / or a mapping catheter) to pass through the ring 120. The connecting portion 124 includes a group of adjacent / proximal locking tabs 124B and ring holes 124C. In addition, the connecting portion 124 includes a polygonal cross-sectional shape.

[0058] If FIG. 4A to FIG. 4B to Figure 4C As shown in the sequence of FIG. 1 , the crown 110 and the ring 120 have a complementary design to allow the ring 120 to be easily fixed to the crown 110. Figure 4AAs shown by the directional arrows in FIG. 1 , the tube portion 126 and the connecting portion 124 are inserted into the crown lumen 118 during assembly. When this occurs, the locking protrusion 124B enters the groove 112 ( Figure 4B ). To lock the ring 120 to the crown 110, the ring 120 is rotated about the longitudinal axis A1 (eg, clockwise), as shown. Figure 4B Finally, Figure 4C The ring 120 is depicted after it has been rotated into the locked position. The polygonal connecting portion 124 frictionally engages the inner surface of the crown 110 to aid retention. For removal, the reverse steps may be employed.

[0059] Figure 5 is shown relative to Figure 4C Schematic illustration of a cross-sectional view of the frame distal end 102A and the ring 120 cut along line 5-5 in FIG. When the ring 120 is rotated to the locked position, the crown aperture 116 is aligned with the ring aperture 124C. This alignment enables fasteners (e.g., screws, rivets, solder, etc.) to pass through the crown aperture 116 to connect with the ring aperture 124C. It is also seen in this view that the connector tube 108 (which defines the connector tube lumen 108A) slides within the tube portion 126 to axially align with the ring 120.

[0060] Fig. 6A is a schematic illustration showing a detailed perspective view of the proximal end of the end effector 100 with the connection hub 136 separated from the frame proximal end 102B. Figure 6B 1 is a schematic illustration showing a detailed perspective view of the proximal end of the end effector 100, wherein the connecting hub 136 is connected to the frame proximal end 102B. In addition to the above, reference is made to Fig. 6A and Figure 6B , the ridge 104 has a proximal end 130 that is shaped to connect to the connecting hub 136. Specifically, each ridge 104 defines a plurality of ridge grooves 132 in at least one side of the ridge 104 (e.g., the grooves 132 may be defined in both sides of the ridge 104, as shown). In addition, at least one ridge hole 134 is defined through each ridge end 130 that is directed perpendicular to the longitudinal axis A1. As shown in Fig. 6A As particularly seen in the drawings, the ridge apertures 134 are disposed between pairs / groups of ridge recesses 132 defined on opposing sides of the ridge proximal end 130. The connecting hub 136 includes a complementarily shaped hub ridge 138 shaped to receive the correspondingly shaped proximal end 130 of the ridge 130. Each hub ridge includes one or more ridge protrusions 140 and one or more ridge apertures 142. Specifically, the ridge recesses 132 abut with the ridge protrusions 140 when the proximal end 130 is disposed in position. Figure 6B As shown, as shown by the directional arrow, the proximal end 130 is aligned and moved radially inwardly toward the longitudinal axis A1 (with respect to the diagram depicting A1). Fig. 6A Compared with) to connect with the connecting hub convex pattern 138.

[0061] Figure 7 is shown relative to Figure 6B 1 is a schematic illustration of a cross-sectional view of the proximal end 102B of the frame connected to the connecting hub 136 cut along line 7-7 in FIG. As shown, when the ridge distal proximal end 130 is inserted into the hub ridge 138, the ridge holes 134 are axially aligned with the ridge holes 142. This alignment enables fasteners (e.g., screws, rivets, solder, etc.) to pass through the crown hole ridge holes 134 to connect with corresponding ridge holes 142.

[0062] Figure 8 1 is a schematic illustration showing a generally cylindrical stock material 101 formed into a unitary frame 102 with a plurality of sheaths 104 formed and / or positioned over a spine 104 of the frame 102 . Fig. 9 It shows that according to Figure 8 The generalized process shown is a flow chart of a method 1000 of manufacturing a unibody frame 102 .

[0063] In addition to the above, see Figure 8 and Fig. 9 The method for manufacturing the monolithic frame 102 may include the following steps: Figure 8 The generally cylindrical stock material is also formed to include a plurality of ridges 104 extending along the longitudinal axis A1, each ridge 104 extending from the crown 110 to a ridge terminal 130 and configured to connect to a connecting hub 136 (step 1002). The ridges 104 are heat set so that they are bent outwardly relative to the longitudinal axis A1 (see FIG. 10). Figure 8 The forming steps for forming the crown 110 and / or the ridge 104 include at least one of mechanical cutting, laser cutting, embossing, or a combination thereof. For example, the generally cylindrical raw material 101 may be cut along the longitudinal axis A1 to form the ridge 104, and the distal end of the raw material 101 may be cut (which is not cut in the same manner as the ridge 104 is formed) to define the crown groove 112 and the crown cavity 116 discussed previously. Figures 10 to 12Steps 1006 and 1008 are discussed in more detail.

[0064] Fig.10 is a schematic illustration of a perspective view showing another configuration of an end effector 200 of the medical device 14 . Fig.11 is a schematic illustration showing a perspective view of end effector 200 with the proximal sleeve and coil removed for clarity. Figure 3 In relative to Figure 2 Features not shared with the previously described end effector 100 are emphasized in the following description.

[0065] Similar to Figures 2 to 7 In an example of the presently described example, the end effector 200 in the example is in the form of a basket assembly including at least one ridge 204. Similar to the previously described examples, the ridge 204 may have an elliptical (e.g., circular) or rectangular (which may 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 a strut. In addition, the ridge 204 may be integrally formed with the crown 210 so as to form a unitary / monolithic ridge frame. The crown 210 may share features similar to those of the previously described crown 110 to connect with the ring 220. In addition, the proximal end 230 of the ridge 204 may include features similar to those of the previously described ridge 104 to connect with the connecting hub 236.

[0066] Similarly, the 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 translate along the longitudinal axis A1 to expand / collapse the spine 204. Fig.10 ), one or more ridges 204 may be bent radially outward from the longitudinal axis A1. The ridges 204, the crown 210, and the connector tube 208 are generally arranged along the longitudinal axis A1.

[0067] Fig.12 is shown relative to Fig.10 Schematic illustration of a cross-sectional view of the end effector 200 cut along line 12-12 in FIG. As shown, in the collapsed configuration ( Fig.12 ), the monolithic frame is generally spherical in shape. When the spine 204 is actuated via, for example, the connector tube 208 to move to the expanded configuration, the distal end of the frame is pulled toward the proximal end to form a petal-like structure. The petal structure allows the electrode 26 to ablate at the entrance of the pulmonary vein, while the spherical structure allows the electrode 26 to ablate deep in the pulmonary vein.

[0068] In order to form the aforementioned spherical shape, each ridge 204 has a series of curved portions, specifically, each ridge includes a first curved portion 204A, a second curved portion 204B, and a third curved portion 204C.

[0069] The first arcuate curved portion 204A extends from the crown 210 and is disposed proximal to the crown 210, and is curved in a first radial direction R1 relative to the crown 210. The first radial direction R1 is about an axis perpendicular to the longitudinal axis A1. The first arcuate curved portion 204A is curved at a first angle θ1. In some examples, the first angle θ1 falls within a range of about one hundred and twenty degrees to about one hundred and eighty degrees.

[0070] The second arcuate bend 204B extends from the first arcuate bend 204A in a second radial direction R1. The second radial direction R2 is about the same axis perpendicular to the longitudinal axis A1 as the first radial direction R1, but in the opposite direction. The second arcuate bend 204B is bent at a second angle θ2. In some examples, the second angle θ2 falls within a range of about two hundred and forty degrees to about two hundred and seventy degrees.

[0071] The third arcuate bend 204C extends from the second arcuate bend 204B and is proximal to the ridge terminal 230. The third arcuate bend 204C bends in the first radial direction R1. The third arcuate bend 204C bends at a third angle θ3. In some examples, the third angle θ3 falls within a range of about sixty degrees to about one hundred and fifty degrees.

[0072] The spine 204 further has a proximal half and a distal half, the dividing point being defined along the longitudinal axis A1 at approximately the center point of the second arcuate bend 204B (see Fig.12 In this configuration, the electrode 26 is provided only on the distal half for the above-mentioned ablation purpose.

[0073] Return to Fig. 9 In the method 1000 discussed in Fig.10 , the method 1000 may further include the steps of: bending the plurality of ridges 204 such that each ridge 204 has a first arcuate bend 204A (step 1006); bending the plurality of ridges 204 such that each ridge 204 has a second arcuate bend 204B (step 1006); and bending the plurality of ridges 204 such that each ridge 204 has a third arcuate bend 204C (step 1008). These steps may be performed prior to heat setting the ridges 204, thereby biasing the ridges 204 into a spherical configuration.

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

[0075] Item 1. A monolithic frame for an end effector of a medical device, the monolithic frame comprising a cylindrical raw material, the cylindrical raw material comprising: a crown extending along a longitudinal axis, defining a crown lumen, and defining a plurality of crown grooves, the plurality of crown grooves being configured to connect to a ring; and a plurality of ridges extending along the longitudinal axis and being configured to bend outwardly relative to the longitudinal axis, each ridge extending from the crown to a ridge terminal and being configured to connect to a connecting hub.

[0076] Clause 2. The one-piece frame of Clause 1, consisting essentially of the cylindrical raw material.

[0077] Clause 3. A one-piece frame according to any one of clauses 1 to 2, wherein each crown groove comprises: a first portion defined in the crown terminal end and extending parallel to the longitudinal axis; and a second portion extending from the first portion and substantially perpendicular to the first portion.

[0078] Clause 4. The unibody frame of Clause 3, the crown further defining a plurality of crown pockets extending generally perpendicular to the longitudinal axis, each crown pocket being located between adjacent ones of the plurality of crown pockets.

[0079] Clause 5. The one-piece frame of any of Clauses 1 to 4, each ridge defining a plurality of ridge grooves in at least one side of the ridge, the plurality of ridge grooves being configured to interface with the connecting hub.

[0080] Clause 6. The unitary frame of Clause 5, each plurality of ridge grooves comprising a first set of ridge grooves defined in a first side of the respective ridge and a second set of ridge grooves defined in a second side of the respective ridge.

[0081] Clause 7. In the unitary frame of Clause 6, each ridge defines at least one ridge hole, the at least one ridge hole being defined as extending through the ridge and perpendicular to the longitudinal axis, the at least one ridge hole being positioned between the first set of ridge grooves and the second set of ridge grooves.

[0082] Clause 8. In the monolithic frame described in any one of clauses 1 to 7, each ridge comprises: a first arcuate bend, the first arcuate bend being 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.

[0083] Clause 9. The one-piece frame of Clause 8, wherein the first arcuate bend is bent at an angle within a range of about one hundred twenty degrees to about one hundred eighty degrees.

[0084] Clause 10. The one-piece frame of any of clauses 8-9, wherein the second arcuate bend is bent at an angle within a range of about two hundred forty degrees to about two hundred seventy degrees.

[0085] Clause 11. The unitary frame of any one of clauses 8 to 9, each spine comprising: a third arcuate bend proximal to the spine terminal end in the first radial direction and extending from the second arcuate bend.

[0086] Clause 12. The one-piece frame of Clause 11, wherein the third arcuate bend is bent at an angle within a range of about sixty degrees to about one hundred fifty degrees.

[0087] Item 13. An end actuator for a medical device, the end actuator comprising: a monolithic frame, the monolithic frame comprising a cylindrical raw material, the cylindrical raw material comprising: a crown, the crown extending along a longitudinal axis and defining a plurality of crown grooves; and a plurality of ridges, the plurality of ridges extending along the longitudinal axis and being configured to bend outward relative to the longitudinal axis, the plurality of ridges being capable of moving between a collapsed configuration and an expanded configuration; a ring, the ring connected to the plurality of crown grooves; a connecting hub, the connecting hub connected to the plurality of ridges; and one or more electrodes, the one or more electrodes connected to each of the plurality of ridges.

[0088] Clause 14. The end effector of Clause 13, wherein the crown defines a crown lumen, and wherein the ring extends through the crown lumen.

[0089] Clause 15. The end effector of any of Clauses 13 to 14, the ring comprising an atraumatic tip portion, a polygonal portion that frictionally engages an inner surface of the crown, and a tube portion.

[0090] Clause 16. The end effector of Clause 15, wherein the polygonal portion comprises a plurality of locking projections projecting radially outwardly away from the longitudinal axis, each locking projection being engaged in a corresponding crown groove of the plurality of crown grooves.

[0091] Clause 17. The end effector of Clause 16, wherein the polygonal portion defines a plurality of annular apertures, each annular aperture being positioned proximal to a respective locking projection of the plurality of locking projections.

[0092] Clause 18. The end effector of Clause 17, wherein the crown defines a plurality of crown apertures extending perpendicular to the longitudinal axis, each crown aperture being axially aligned with a corresponding annular aperture of the plurality of annular apertures.

[0093] Clause 19. The end effector of any one of Clauses 13 to 18, further comprising a connector tube extending generally parallel to or coaxially with the longitudinal axis and connected to the ring.

[0094] Clause 20. The end effector of Clause 19, wherein the ring defines a ring lumen, and wherein the connector tube is connected to the ring within the ring lumen.

[0095] Clause 21. The end effector of any of Clauses 19 to 20, the connector tube being configured to move the plurality of ridges between the collapsed configuration and the expanded configuration and / or to direct irrigation fluid therethrough.

[0096] Clause 22. An end actuator according to any one of clauses 13 to 21, wherein each of the plurality of ridges has a formed end defining at least one groove, the connecting hub defines a plurality of hub ridges, and each hub ridge is formed to receive a corresponding formed end of each ridge.

[0097] Clause 23. An end actuator according to any one of clauses 13 to 22, wherein each of the plurality of ridges defines a ridge hole, the connecting hub defines a plurality of connecting hub holes, and each ridge hole is axially aligned with a corresponding connecting hub hole of the plurality of connecting hub holes.

[0098] Clause 24. The end effector of any of Clauses 13 to 23, said plurality of ridges comprising a generally spherical shape when in said collapsed configuration.

[0099] Clause 25. The end effector of clause 24, each ridge of the plurality of ridges having a proximal half and a distal half, the one or more electrodes being disposed only on the distal half.

[0100] Item 26. A method of manufacturing a monolithic frame for a medical device, the method comprising: forming a generally cylindrical raw material to include: a crown extending along a longitudinal axis, defining a crown lumen aligned with a raw material lumen defined by the generally cylindrical raw material, and defining a plurality of crown grooves, the plurality of crown grooves being configured to connect to a ring; and a plurality of ridges extending along the longitudinal axis, each ridge extending from the crown to a ridge terminal end and being configured to connect to a connecting hub; and heat setting the plurality of ridges so that the plurality of ridges bend outwardly relative to the longitudinal axis.

[0101] Clause 27. The method of Clause 26, wherein the forming step comprises at least one of mechanical cutting, laser cutting, embossing, or a combination thereof.

[0102] Clause 28. The method according to any one of clauses 26 to 27, further comprising: bending the plurality of ridges so that each ridge comprises: a first arcuate bend, the first arcuate bend being 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.

[0103] Clause 29. The method according to clause 28, further comprising: bending the plurality of ridges so that each ridge comprises: a third arcuate bend, the third arcuate bend being proximal to the ridge terminal in the first radial direction and extending from the second arcuate bend.

[0104] 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. A monolithic frame for an end effector of a medical device, the monolithic frame comprising a cylindrical raw material, the cylindrical raw material comprising: a crown extending along a longitudinal axis, defining a crown lumen, and defining a plurality of crown grooves configured to be coupled to the ring; and A plurality of ridges extend along the longitudinal axis and are configured to bend outwardly relative to the longitudinal axis, each ridge extending from the crown to a ridge terminal end and configured to connect to a connecting hub.

2. The one-piece frame of claim 1, consisting essentially of the cylindrical raw material.

3. The one-piece frame of claim 1, each crown groove comprising: a first portion defined in a crown terminal end and extending parallel to the longitudinal axis; and A second portion extends from the first portion and is generally perpendicular to the first portion.

4. The unibody frame of claim 3, the crown further defining a plurality of crown pockets extending generally perpendicular to the longitudinal axis, each crown pocket being located between adjacent ones of the plurality of crown pockets.

5. The unitary frame of claim 1, each ridge defining a plurality of ridge grooves in at least one side of the ridge, the plurality of ridge grooves being configured to interface with the connecting hub.

6. The unitary frame of claim 5, each plurality of ridge grooves comprising a first set of ridge grooves defined in a first side of a corresponding ridge and a second set of ridge grooves defined in a second side of the corresponding ridge.

7. The one-piece frame of claim 6, each ridge defining at least one ridge hole, the at least one ridge hole being defined as extending through the ridge and perpendicular to the longitudinal axis, the at least one ridge hole being positioned between the first set of ridge grooves and the second set of ridge grooves.

8. The one-piece frame of claim 1, each ridge comprising: a first arcuate bend proximal to the crown in a first radial direction perpendicular to the longitudinal axis; and A second arcuate bend extends from the first arcuate bend in a second radial direction perpendicular to the longitudinal axis.

9. The one-piece frame of claim 8, each ridge comprising: A third arcuate bend is proximal to the spine terminal end in the first radial direction and extends from the second arcuate bend.

10. An end effector for a medical device, the end effector comprising: A monolithic frame, the monolithic frame comprising a cylindrical raw material, the cylindrical raw material comprising: a crown extending along the longitudinal axis and defining a plurality of crown grooves; and a plurality of ridges extending along the longitudinal axis and configured to flex outwardly relative to the longitudinal axis, the plurality of ridges being movable between a collapsed configuration and an expanded configuration; a ring connected to the plurality of crown grooves; a connecting hub connected to the plurality of ridges; and One or more electrodes are connected to each ridge of the plurality of ridges.

11. The end effector of claim 10, the crown defining a crown lumen, and the ring extending through the crown lumen.

12. The end effector of claim 10, said ring comprising an atraumatic tip portion, a polygonal portion that frictionally engages an inner surface of said crown, and a tube portion.

13. The end effector of claim 12, wherein the polygonal portion comprises a plurality of locking projections projecting radially outwardly away from the longitudinal axis, each locking projection being engaged in a corresponding crown groove of the plurality of crown grooves.

14. The end effector of claim 13, wherein the polygonal portion defines a plurality of annular holes, each annular hole being positioned proximal to a corresponding locking projection of the plurality of locking projections.

15. The end effector of claim 14, said crown defining a plurality of crown apertures extending perpendicular to said longitudinal axis, each crown aperture being axially aligned with a corresponding annular aperture of said plurality of annular apertures.

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

17. An end effector according to claim 10, each of the plurality of ridges having a formed end defining at least one groove, the connecting hub defining a plurality of hub ridges, and each hub ridge being formed to receive a corresponding formed end of each ridge.

18. The end effector of claim 10, said plurality of ridges comprising a generally spherical shape when in said collapsed configuration.

19. The end effector of claim 18, each ridge of the plurality of ridges having a proximal half and a distal half, the one or more electrodes being disposed only on the distal half.

20. A method of manufacturing a one-piece frame for a medical device, the method comprising: The generally cylindrical raw material is formed into a material comprising: a crown extending along a longitudinal axis, defining a crown lumen aligned with a stock lumen defined by the generally cylindrical stock lumen, and defining a plurality of crown grooves configured to be coupled to a ring; and a plurality of ridges extending along the longitudinal axis, each ridge extending from the crown to a ridge terminal end and configured to connect to a connecting hub; and The plurality of ridges are heat set such that the plurality of ridges bow outwardly relative to the longitudinal axis.

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