Simplified blue catheter with multiple ridges

Abstract

The invention relates to a simplified blue catheter with a plurality of ridges. The present disclosure relates to a medical probe that may include a tube including a proximal end and a distal end, the tube extending along a longitudinal axis. The medical probe may also include a plurality of ridges disposed at the distal end of the tube, each ridge of the plurality of ridges including a first end fixed relative to the tube and a second end unattached relative to the tube. Each ridge of the plurality of ridges may be configured to transition between a collapsed configuration and an expanded configuration, the plurality of ridges forming a basket when in the expanded configuration. The medical probe may also include a plurality of electrodes attached to the plurality of ridges.

Description

Technical Field

[0001] The present invention generally relates to medical devices and, more particularly, to a simplified design for a basket catheter having a plurality of individually assembled ridges. Background Art

[0002] When an area of heart tissue abnormally conducts electrical signals to adjacent tissue, arrhythmias such as atrial fibrillation (AF) can occur. This disrupts the normal cardiac cycle and results in an irregular heartbeat. Certain procedures are used to treat arrhythmias, including surgically disturbing the source of the signals causing the arrhythmia and disturbing the conduction pathways for such signals. Mapping catheters can be used to map the electrical signals propagating through the heart, and then only selected areas of tissue can be ablated to treat AF. By selectively ablating heart tissue by applying energy via a catheter, it may sometimes be possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. Medical probes can utilize radiofrequency (RF) electrical energy to heat tissue. Some ablation methods use irreversible electroporation (IRE) to ablate heart tissue using a non-thermal ablation method.

[0003] To perform the operations of delivering ablation energy and mapping electrical signals propagating through heart tissue, a physician may use the same or different catheters separately. However, it is most beneficial to use a single catheter that can perform both of these and even additional functions. In some examples, a basket catheter having a plurality of electrodes disposed along ridges can be used, and these electrodes can deliver ablation energy as well as perform mapping procedures. However, due to the small size of the ridges and electrodes, manufacturing such catheters can be difficult and / or expensive. Accordingly, what is needed is a system and method for manufacturing a basket catheter using a simplified assembly and in a cost-saving manner. This problem and other problems can be solved by the techniques disclosed herein. Summary of the Invention

[0004] The disclosed techniques include a medical probe. The medical probe can include a tube that includes a proximal end and a distal end and that extends along a longitudinal axis. The medical probe can also include a plurality of ridges disposed at the distal end of the tube, each of the plurality of ridges including a first end that is fixed relative to the tube and a second end that is not attached to the tube. Each of the plurality of ridges can be configured to transition between a collapsed configuration and an expanded configuration, and the plurality of ridges form a basket when in the expanded configuration. The medical probe can also include a plurality of electrodes attached to the plurality of ridges.

[0005] The disclosed technology may include a medical probe. The medical probe may include a tube that includes a proximal end and a distal end and that extends along a longitudinal axis. The medical probe may further include a plurality of ridges disposed at the distal end of the tube, each of the plurality of ridges including a first end and a second end, each end being fixed relative to the tube. Each of the plurality of ridges may be configured to transition between a collapsed configuration and an expanded configuration. When in the expanded configuration, the plurality of ridges may form a basket by folding approximately at a midpoint of each ridge and bowing radially outward from the longitudinal axis. The medical probe may further include a plurality of electrodes attached to the plurality of ridges.

[0006] The disclosed technology may include a medical probe. The medical probe may include a tube that includes a proximal end and a distal end and that extends along a longitudinal axis. The medical probe may further include a single ridge disposed at the distal end of the tube and including a first end and a second end, each end being fixed relative to the tube. The ridge may be configured to transition between a collapsed configuration and an expanded configuration. When in the expanded configuration, the ridge may form a basket including a plurality of convex corners by forming a plurality of bends that bow radially outward from the longitudinal axis. The medical probe may further include a plurality of electrodes attached to the ridge. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The above and other aspects of the present invention will be further discussed with reference to the following description and in conjunction with the drawings, in which like numerals indicate like structural elements and features in the various figures. The drawings are not necessarily to scale; rather, emphasis is placed on illustrating the principles of the invention. The drawings depict one or more specific embodiments of the apparatus of the present invention by way of example and not by way of limitation.

[0008] Figure 1 is a schematic illustration of a medical system including a medical probe according to an embodiment of the disclosed technology, the medical probe having an end effector with electrodes;

[0009] Figure 2 is a schematic illustration of a medical probe including an end effector according to the disclosed technology.

[0010] Figure 3A is a front perspective view of an end effector according to the disclosed technology, the end effector including a plurality of ridges separated by spacers, wherein the end effector is shown in a collapsed configuration;

[0011] Figure 3B is according to the disclosed technology Figure 3A of the end effector in a front perspective view, wherein the ridges are shown transitioning from the collapsed configuration to the expanded configuration;

[0012] Figure 3Cis according to the disclosed technology Figure 3A Front perspective view of the end effector of Figure 3A in a fully expanded configuration;

[0013] Figure 4A Front perspective view of an end effector including a plurality of inwardly arcuate ridges according to the disclosed technology, the end effector being shown in a collapsed configuration;

[0014] Figure 4B is according to the disclosed technology Figure 4A Front perspective view of the end effector of Figure 4A transitioning from a collapsed configuration to an expanded configuration;

[0015] Figure 4C is according to the disclosed technology Figure 4A Front perspective view of the end effector of Figure 4A in a fully expanded configuration;

[0016] Figure 5A Front perspective view of an end effector including a plurality of outwardly arcuate ridges according to the disclosed technology, the end effector being shown in a collapsed configuration;

[0017] Figure 5B is according to the disclosed technology Figure 5A Front perspective view of the end effector of Figure 5A transitioning from a collapsed configuration to an expanded configuration;

[0018] Figure 5C is according to the disclosed technology Figure 5A Front perspective view of the end effector of Figure 5A in a fully expanded configuration;

[0019] Figure 6A Front perspective view of an end effector including a plurality of ridges according to the disclosed technology;

[0020] Figure 6B is according to the disclosed technology Figure 6A Top view of the distal end of the end effector of Figure 6A ;

[0021] Figure 7A Front perspective view of an end effector including a single ridge and in a collapsed configuration according to the disclosed technology;

[0022] Figure 7B is according to the disclosed technology Figure 7A Front perspective view of the end effector of Figure 7A transitioning from a collapsed configuration to an expanded configuration;

[0023] Figure 7C is according to the disclosed technology Figure 7A Front perspective view of the end effector of Figure 7A in a fully expanded configuration;

[0024] Figure 8It is a flowchart illustrating a method of manufacturing a medical probe according to the disclosed technology. Detailed Description

[0025] The disclosed technology includes a plurality of individual ridges that are attached to an insertion tube and configured to form a basket shape when deployed from the insertion tube. The disclosed technology can simplify the process of manufacturing a basket catheter by including ridges that are heat-set to transform into a predetermined shape. Additionally, the disclosed technology can help reduce the amount of individual components required to manufacture such a catheter, thereby reducing the overall complexity and cost of the basket catheter. The disclosed medical device can be configured to perform multiple procedures and functions by using one device.

[0026] The following detailed description should be read in conjunction with the accompanying drawings, in which like numerals in different drawings refer to like elements. The drawings (not necessarily to scale) depict selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention in an illustrative, but not restrictive, manner. This description will clearly enable one of ordinary skill in the art to make and use the invention and describes several embodiments, adaptations, variations, alternative forms, and uses of the invention, including what is presently believed to be the best mode of carrying out the invention.

[0027] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows for a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" can refer to a range of values of ±20% of the recited value, e.g., "about 90%" can refer to a range of values from 71% to 110%.

[0028] As used herein, the terms "patient," "recipient," "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 invention in human patients represents a preferred embodiment. Additionally, the vasculature of a "patient," "recipient," "user," or "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 mammals, veterinary animals, livestock animals, or pet animals, etc. For example, the animal can be an experimental animal (e.g., rats, dogs, pigs, monkeys, etc.) specifically selected to have certain characteristics similar to humans. It should be understood that the subject can be, for example, any suitable human patient. Similarly, the term "proximal" refers to a position closer to the operator or physician, while "distal" refers to a position farther from the operator or physician.

[0029] As discussed herein, a "physician" or "operator" can include a doctor, 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.

[0030] 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 may be interchangeably referred to as pulsed electric field (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 arrhythmia, 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 ablation of bodily tissue understood by those skilled in the relevant art.

[0031] As discussed herein, the terms "bipolar" and "unipolar", when used to refer to ablation protocols, describe ablation protocols that differ in terms of current path and electric field distribution. "Bipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, both of which are positioned at the treatment site; the current density and electric flux density at each of the two electrodes are typically approximately equal. "Unipolar" refers to an ablation protocol that utilizes a current path between two electrodes as described below, where one electrode, which includes a high current density and high electric flux density, is positioned at the treatment site, and a second electrode, which includes a relatively low current density and low electric flux density, is positioned away from the treatment site.

[0032] The disclosed techniques can be configured to deliver monophasic or biphasic pulses to ablate tissue. For example, the electrodes described herein that are configured to deliver ablation energy to tissue can be configured to deliver monophasic pulses, biphasic pulses, or some combination thereof. The terms "biphasic pulse" and "monophasic pulse" refer to the corresponding electrical signals. A "biphasic pulse" refers to an electrical signal that includes a positive voltage phase pulse (referred to herein as the "positive phase") and a negative voltage phase pulse (referred to herein as the "negative phase"). A "monophasic pulse" refers to an electrical signal that includes only a positive or negative phase.

[0033] The application of thermal techniques, such as radiofrequency (RF) energy and cryoablation, for cardiac tissue ablation to correct faulty hearts is a well-known procedure. Generally, in order to successfully ablate using thermal techniques, it is necessary to measure cardiac electrode potentials at various locations in the myocardium. Additionally, temperature measurements during ablation provide data that can enable ablation efficacy. Typically, for ablation protocols using thermal ablation, electrode potentials and temperatures are measured before, during, and after actual ablation.

[0034] Exemplary systems, methods, and apparatuses of the present invention may be particularly applicable to IRE ablation of cardiac tissue to treat arrhythmias. Ablation energy is typically delivered to cardiac tissue by electrodes that may deliver ablation energy along the tissue to be ablated. Fluoroscopy, magnetic-based position sensing, and / or active current localization techniques may be used to visualize ablation procedures involving such exemplary catheters.

[0035] IRE, as discussed in this disclosure, is a non-thermal cell death technique that may be used for atrial arrhythmia ablation. To perform ablation using IRE / PEF, biphasic voltage pulses are applied to disrupt the cellular structure of the myocardium. The biphasic pulses are non-sinusoidal and may be tuned based on the electrophysiology of the cells to target the cells. In contrast, to perform ablation using RF, a sinusoidal voltage waveform is applied to generate heat at the treatment area, heating all cells indiscriminately in the treatment area. Thus, IRE has the ability to avoid adjacent thermosensitive structures or tissues, which would be beneficial in reducing possible complications known to be affected by ablation or dissection modalities. Additionally or alternatively, monophasic pulses may be used.

[0036] Electroporation may be induced by applying a pulsed electric field across a biological cell to cause pores to be formed reversibly (temporarily) or irreversibly (permanently) in the cell membrane. When a pulsed electric field is applied, the cell has a transmembrane electrostatic potential that rises above the resting potential. When the transmembrane electrostatic potential remains below the threshold potential, electroporation is reversible, meaning the pores may close when the applied pulsed electric field is removed and the cell may self-repair and survive. If the transmembrane electrostatic potential rises above the threshold potential, electroporation is irreversible and the cell becomes permanently permeable. Thus, the cell dies due to loss of homeostasis, typically due to programmed cell death or apoptosis, which is believed to leave less scar tissue compared to other ablation modalities. Generally, different types of cells have different threshold potentials. For example, cardiac cells have a threshold potential of approximately 500 V / cm, while for bone, the threshold potential is 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissues based on the threshold potential.

[0037] Reference Figure 1, which shows an example catheter-based electrophysiological mapping and ablation system 10. The system 10 includes one or more catheters that are inserted by a physician 24 through the vasculature of a patient 23 via the skin into a chamber or vascular structure of the heart 12. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, multiple catheters can be inserted into the delivery sheath catheter to reach that desired location. The one or more catheters can 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 catheter 14 (also referred to herein as a medical probe 100) configured to sense IEGM is shown herein. For ablation, the physician 24 brings an end effector 28 that includes an ablation electrode to a target site for ablation. If the end effector 28 is alternatively or additionally configured to map electrophysiological signals (e.g., IEGM signals), the physician 24 similarly contacts the end effector 28 with the heart wall to sense a target site in the heart 12.

[0038] The catheter 14 is an exemplary catheter that includes an end effector 28 that includes one and preferably multiple electrodes 26 that are optionally distributed on an expandable assembly and the distal end of the end effector 28 and are configured to detect electrophysiological signals and / or deliver ablation energy to tissue. The catheter 14 can additionally include a magnetic-based position sensor that is embedded in or near the end effector 28 for tracking the position and orientation of the end effector 28. The end effector 28 can also include one or more impedance-based electrodes that are disposed in or near the end effector 28 for tracking the position and orientation of the end effector 28.

[0039] The magnetic-based position sensor can operate in conjunction 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 end effector 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 29. The magnetic-based position sensor can be a uniaxial sensor, a biaxial sensor, or a triaxial sensor, depending on the particular configuration. Details of magnetic-based position sensing techniques are described in U.S. Pat. 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 as if fully set forth herein.

[0040] System 10 includes one or more electrode patches 38 that are positioned to contact the skin of patient 23 to establish a position reference for the positioning pad 25 and for tracking of impedance-based electrodes. For impedance-based tracking, current is directed toward the impedance-based electrodes and sensed at the electrode skin patches 38 such 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. 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 as if fully set forth herein.

[0041] Recorder 11 displays an electrogram 21 captured using the body surface ECG electrodes 18 and an intracardiac electrogram (IEGM) captured using the electrodes of catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0042] System 10 may include an ablation energy generator 50 that is adapted to conduct ablation energy to one or more electrodes that are disposed on an end effector and configured to deliver the ablation energy to tissue. The energy generated by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)) or a combination thereof.

[0043] Patient interface unit (PIU) 30 is an interface configured to establish electrical connectivity between the catheter, electrophysiology equipment, power supply, and a workstation 55 for controlling the operation of system 10. The electrophysiology equipment of system 10 may include, for example, a plurality of catheters, positioning pad 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 further includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0044] The workstation 55 includes a memory, a processor unit with a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 55 can provide multiple functions, optionally including: (1) performing three-dimensional (3D) modeling of endocardial anatomy and rendering a model or anatomical map 20 for display on a display device 27; (2) displaying an activation sequence (or other data) compiled from the recorded electrograms 21 as representative visual markers or images superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying the real-time position and orientation of multiple catheters within a heart chamber; and (4) displaying a site of interest on the display device 27, such as where ablation energy has been applied. A commercial product embodying the elements of system 10 can be the CARTO TM 3System, which is available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0045] Figure 2 An example medical probe 100 configured to be inserted into an organ (e.g., the heart 12) of a patient 23 is shown. As shown, the medical probe can include a handle 120, which can include a flush port 126, an actuator 124, and be connected to a tube 122. The flush port 126 can be configured to connect to a flush supply and receive flush fluid from the flush supply to deliver the flush fluid to the end effector 28. The actuator 124 can be connected to a pull wire attached near the distal end of the tube 122 or the end effector 28. When the actuator 124 is actuated, the pull wire can be pulled to cause the distal end of the tube 122 to deflect away from the longitudinal axis 150.

[0046] The end effector 28 can be attached to the distal end of the tube 122, and the end effector 28 can include a plurality of ridges 22, which can be configured to bow radially outward from the longitudinal axis 150 of the end effector 28 (e.g., as Figure 3C shown). Each ridge 22 can be configured to transition from a collapsed configuration to an expanded configuration when pushed out of an insertion sheath or other delivery tube. The ridges 22 can each be configured to transition to the expanded configuration by turning inward at the distal end and bowing radially outward from the longitudinal axis 150 of the end effector 28, thereby forming a basket catheter.

[0047] Each of the plurality of ridges 22 may include a first end and a second end such that the first end is attached to the tube 122 and the second end is not attached to the tube 122 (e.g., the second end may be a free end). Additionally, each of the plurality of ridges 22 may include a plurality of electrodes 26 disposed along each ridge 22, wherein the plurality of electrodes 26 extend from the first end of the ridge 22 to the second end. In some examples, each of the plurality of ridges 22 may be made of a shape memory material. For example, the shape memory material may be nitinol or other biocompatible material that may be biased to form a basket shape when deployed from an insertion sheath. For example, the ridge 22 may include nitinol, and the nitinol may be thermally shaped to a predetermined shape (e.g., a deployed configuration) such that when the ridge 22 is inserted into the blood pool at a predetermined temperature, the ridge 22 will transition to the thermally shaped deployed configuration. In some examples, each of the plurality of ridges 22 may be covered in a layer of biocompatible insulating material.

[0048] The electrodes 26 may be made of a biocompatible conductive material (e.g., gold, palladium, silver, platinum) and are configured to deliver ablation energy to tissue. For example, the electrodes 26 may each be in electrical communication with an ablation energy generator 50 and are configured to deliver ablation energy to tissue. The electrodes 26 may be configured to deliver a monopolar signal having a single-phase pulse or a bipolar signal having a biphasic pulse. Alternatively or in addition, the electrodes 26 may be configured to deliver RF ablation energy to tissue. Alternatively or in addition, the electrodes 26 may be configured for mapping electroanatomical signals. For example, the electrodes 26 described herein may be configured to detect electroanatomical signals for mapping procedures, electroanatomical signals for delivering ablation energy to tissue, or both. In some examples, the medical probe may further include a position sensor (not shown) that is configured to generate a current when subjected to an electromagnetic field.

[0049] Figures 3A to 3C An example end effector 28 is shown having a ridge 22 transitioning from a collapsed configuration ( Figure 3A ) to an expanded configuration ( Figure 3C ), the end effector 28 defining a distal end of the tube 122. The end effector 28 is substantially similar to Figure 2The end effector 28 shown, and may also include a spacer 302 disposed between the ridges 22 among the plurality of ridges 22. The spacer 302 may be connected to a pull wire 304 near the distal end of the tube 122, and these pull wires may be pulled proximally to move the spacer 302 between the ridges 22. The spacer 302 disposed between the ridges 22 is configured to cause the ridges 22 to be spaced apart from each other when the end effector 28 is in the expanded configuration and the pull wire 304 connected to the spacer 302 is pulled in the proximal direction. In some examples, the end effector 28 may include a single pull wire 304 connected to the spacer 302, or alternatively may include multiple pull wires 304 connected to each spacer 302. Each of the plurality of ridges 22 may also include a plurality of electrodes 26 disposed on the ridge 22 and extending from a first end (proximal end) of the ridge 22 to a second end (distal end).

[0050] Figure 3A The end effector 28 is shown in the collapsed configuration, in which the end effector 28 is ready for delivery and navigation in an organ (e.g., the heart 12) of the patient 23. In the collapsed configuration, each ridge 22 is fully extended, and the second end (in this case, the distal end) of each ridge 22 is at the greatest possible distance from the tube 122 of the medical probe along the ridge 22. Figure 3B The end effector 28 is shown in the process of transitioning between the collapsed ( Figure 3A ) and expanded ( Figure 3C ) configurations. As can be seen, the pull wire 304 attached to the spacer 302 between the plurality of ridges 22 is partially pulled in the proximal direction so as to further space the ridges 22 apart when the ridges 22 transition to the expanded configuration. Figure 3C The end effector 28 of the medical probe 100, which is now fully in the expanded configuration and forms a basket shape, is shown. In the expanded configuration, the pull wire 304 is fully pulled in the proximal direction, thereby fully spacing the ridges 22 apart near the first end of each ridge 22.

[0051] Figures 4A to 4C The transition from the collapsed configuration ( Figure 4A ) to the expanded configuration ( Figure 4C)And form an end effector 428 of the basket catheter, the end effector 428 defining the distal end of the tube 122. The end effector 428 may include a plurality of ridges 422, each ridge 422 having a first end connected to the tube 122 and a second end (e.g., a free end) not attached to the tube 122. Each of the plurality of ridges 422 may include a plurality of electrodes 26 disposed along each ridge 422. The electrodes 26 may be positioned along the ridges 422 such that when the end effector 428 is in the expanded configuration and forms a basket, the plurality of electrodes 26 extend from the first end of each ridge 422 to the distal end of the basket. For example, as Figure 4A shown, the electrodes 26 may be disposed closer to the proximal end of each ridge 422 such that when the distal end of the ridge 422 rotates inwardly, the electrodes 26 are disposed on the portion of the ridge 422 configured to contact tissue.

[0052] Figure 4A An end effector 428 in the collapsed configuration is shown, where the end effector 428 is ready for delivery and navigation in an organ (e.g., the heart 12) of a patient 23. In the collapsed configuration, each ridge 422 is fully extended, and the second end of each ridge 422 is the portion of the ridge 422 positioned furthest from the tube 122 of the medical probe 100. As can be seen, the plurality of electrodes 26 are disposed along a portion of the ridge 422. Figure 4B An end effector 428 in the collapsed ( Figure 4A ) and expanded ( Figure 4C ) configurations is shown. As Figure 4B shown, when each ridge 422 begins to transition from the collapsed configuration to the expanded configuration, the second end of each ridge 422 begins to rotate inwardly toward the longitudinal axis 150, and the portion of the ridge 422 near the second end begins to bow radially outward from the longitudinal axis 150.

[0053] Figure 4C An end effector 428 of the medical probe in the fully expanded configuration, thus forming a basket shape, is shown. The plurality of ridges 422 of the end effector 428 may be configured to rotate the second end of each ridge 422 inwardly toward the longitudinal axis 150 such that the second end is disposed near the first end of the ridge 422. The portion of the ridge 422 disposed between the first end and the second end of the ridge 422 may bow radially outward from the longitudinal axis 150, thus forming a basket shape. Thus, a basket is formed, which in turn causes the plurality of electrodes 26 disposed along the ridges 422 to extend from the first end of the ridges 422 to the distal end of the basket. This allows the plurality of electrodes 26 to be disposed on a portion of the basket catheter that will contact the target tissue and positions the electrodes 26 for delivering ablation energy to the tissue.

[0054] Now turning to Figures 5A to 5C , which shows an alternative end effector 528 transitioning from a collapsed configuration ( Figure 5A ) to an expanded configuration ( Figure 5C ). The end effector 428 can include a plurality of ridges 522, where each ridge 522 has a first end attached to the tube 122 and a second end (free end) that is not attached to the tube 122. Each of the plurality of ridges 522 can also include a plurality of electrodes 26 disposed along each ridge 522. Additionally, when the end effector 528 is in the expanded configuration, the electrodes 26 can be positioned along the ridges 522 such that the plurality of electrodes 26 extend from the second end to the distal end of the basket. For example, as shown in Figure 5A , the electrodes 26 can be arranged to be closer to the distal end of each ridge 522 such that when the distal end of the ridge 22 rotates outwardly, the electrodes 26 are disposed on the portion of the ridge 522 configured to contact tissue.

[0055] Each of the plurality of ridges 522 can also include an anchor 504 disposed at the second end of the ridge 522. The anchor 504 can be configured to attach to the tube 122 of the medical probe when the end effector 528 is in the expanded configuration and forms a basket. For example, when the ridge 522 bends outwardly and curls back towards the tube 122, the anchor 504 can attach to the tube 122 to secure the second end of the ridge 522.

[0056] Figure 5A shows the end effector 528 in the collapsed configuration, where the end effector 528 is ready for delivery and navigation within an organ (e.g., the heart 12) of the patient 23. In the collapsed configuration, each ridge 522 is fully extended, and the second end of each ridge 522 is the portion of the ridge 522 positioned furthest from the tube 122 of the medical probe 100. As can be seen, the plurality of electrodes 26 are disposed along the portion of the ridge 522 that is further from the tube 122. Figure 5B shows the end effector 428 in a configuration transitioning between the collapsed ( Figure 5A ) and expanded ( Figure 5C ) configurations. As shown in Figure 5B , when the ridges 522 begin to transition from the collapsed configuration to the expanded configuration, the second end of each ridge 522 begins to rotate outwardly from the longitudinal axis 150, and the portion of the ridge 522 near the second end begins to rotate inwardly back towards the tube 122.

[0057] Figure 5CShows the end effector 528 of the medical probe 100 now in an expanded configuration, thereby forming a basket shape. The plurality of ridges 522 of the end effector 528 can be configured to rotate the second end of each ridge 522 outwardly away from the longitudinal axis 150 such that the second end is disposed near the first end of the ridge 522 and the anchor 504 is attached to the outer side of the tube 122. In other examples, the anchor can be configured to alternatively attach to the inner side of the tube 122 when the end effector 528 is in the expanded configuration (e.g., the ridges 522 curl inwardly such that the second end of the ridge 522 is at least partially inserted into an opening formed at the distal end of the tube 122). The portion of the ridge 522 disposed between the first end and the second end of the ridge 522 can be bowed radially outward from the longitudinal axis 150, thereby forming a basket shape. Thus, a basket is formed, which in turn causes the plurality of electrodes 26 disposed along the ridge 522 to extend from the second end of the ridge 522 to the distal end of the basket. This allows the plurality of electrodes 26 to be disposed on the area of the basket catheter that will contact the target tissue and allows the electrodes to deliver ablation energy and / or detect electrophysiological signals.

[0058] Now refer to Figures 6A to 6B , which shows an alternative end effector 628 disposed at the distal end of the tube 122. Figure 6A Shows a front view of the end effector 628 in the expanded configuration. Although the collapsed configuration is not shown, it should be understood that when in the collapsed configuration, the ridges 622 can be substantially straight for delivery in the vasculature. The end effector 628 can include a plurality of ridges 622, each ridge 622 having a first end and a second end, wherein each of the first end and the second end is connected to the tube 122. The plurality of ridges 622 can include a plurality of electrodes 26 disposed along the ridge 622, the plurality of electrodes extending from the first end to the second end.

[0059] Figure 6B Shows Figure 6A a top view of the ridge 622 of the end effector 628 of Figures 6A to 6B . Each of the plurality of ridges 622 can be configured to transition from the collapsed configuration to the expanded configuration by folding approximately at the midpoint of each ridge 622 and bowing radially outward from the longitudinal axis 150. The midpoint of each ridge 622 can be configured to converge towards the longitudinal axis 150 at a convergence point 606. Thus, a basket shape is formed, the basket shape having a distal end formed by the midpoints of each ridge 622 converging towards each other at the convergence point 606. In Figures 6A to 6B , the plurality of ridges 22 includes 3 ridges 622. However, the end effector 628 can include four ridges, five ridges, six ridges, ten ridges, twenty ridges, or any number of ridges suitable for a particular application.

[0060] Figures 7A to 7C Shows an alternative embodiment of an end effector 728 that defines the distal end of the tube 122. Different from the previously described exemplary end effector, Figures 7A to 7C the end effector 728 shown in may include a single ridge 722. The ridge 722 may include a first end and a second end, each end connected to the tube 122. The ridge 722 may be configured to transition between a collapsed configuration ( Figure 7A ) and an expanded configuration ( Figure 7C ), such that when in the expanded configuration, the ridge 722 forms a basket shape including a plurality of convex corners. In Figure 7C , the end effector 728 is shown as having three convex corners. However, the end effector may include four, five, six, ten, twenty convex corners, or any other number of convex corners suitable for a particular application. The ridge 722 may also include a plurality of electrodes 26 disposed along the ridge 722, and the plurality of electrodes 26 extend from the first end of the ridge 722 to the second end.

[0061] Figure 7A Shows the end effector 728 in a collapsed configuration, in which the end effector 728 is ready for delivery and navigation in an organ (e.g., the heart 12) of the patient 23. In the collapsed configuration, the ridge 722 of the end effector 728 is fully extended and a portion of the ridge 722 forms a single bend positioned farthest from the tube 122 of the medical probe. Figure 7B Shows the end effector 728 in a configuration transitioning between collapsed ( Figure 7A ) and expanded ( Figure 7C ) configurations. The ridge 722 may begin to form three convex corners including a plurality of bends in the ridge 722. As shown in Figure 7B , the convex corners of the ridge 722 may be at least partially bowed radially outward from the longitudinal axis 150 of the tube 122. Figure 7C Shows the end effector 728 in an expanded configuration, in which the convex corners of the ridge column 722 are fully bowed radially outward from the longitudinal axis 150, thereby forming a basket shape. In the expanded configuration, the most proximal bend of the plurality of bends converges toward the tube 122, and the most distal bend of the plurality of bends converges toward the distal end of the basket.

[0062] Although not shown, it should be understood that the ridges 22 (22, 422, 522, 622, and / or 722) described herein may include notches, cavities, or other features to allow the ridges 22 to interlock with each other. This can be particularly helpful, for example, if the ridges 22 interlock near the distal end of the basket to reinforce the basket shape to prevent distortion when the basket contacts tissue.

[0063] Figure 8 FIG. 800 is a flow chart showing a method of manufacturing a medical probe. In some examples, the medical probe disclosed in method 800 is substantially similar to any of the medical probes shown and described herein. Method 800 may include attaching 802 the first end and / or the second end of ridge 22 to tube 122. Method 800 may also include heat shaping 804 ridge 22 into a predetermined shape that forms a basket. In some examples, the basket may include a plurality of convex corners that form a plurality of bends in ridge 22. Method 800 may also include straightening 806 ridge 22 and adding 808 insulation to ridge 22. Method 800 may also include attaching 810 electrode 26 to ridge 22. As described above, each electrode 26 may be configured to detect electrophysiological signals and / or deliver ablation energy to a target tissue of an organ (e.g., heart 12). In some examples, the medical probe may also include a position sensor (not shown) configured to generate a current when subjected to an electromagnetic field. Figures 3A to 7C The disclosed techniques herein may be further understood in accordance with the following clauses:

[0064] Clause 1: A medical probe, comprising: a tube, the tube including a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of ridges, the plurality of ridges disposed at the distal end of the tube, each ridge of the plurality of ridges including a first end fixed relative to the tube and a second end not attached relative to the tube, each ridge of the plurality of ridges being configured to transition between a collapsed configuration and an expanded configuration, the plurality of ridges forming a basket when in the expanded configuration; and a plurality of electrodes, the plurality of electrodes attached to the plurality of ridges.

[0065] Clause 2: The medical probe according to clause 1, wherein each ridge of the plurality of ridges is configured to rotate inwardly at the distal end and bow radially outwardly from the longitudinal axis when deployed from an insertion sheath.

[0066] Clause 3: The medical probe according to clause 2, further comprising a spacer disposed between the plurality of ridges such that the plurality of ridges are spaced apart from each other.

[0067] Clause 4: The medical probe according to clause 3, wherein the spacer is connected to a pull wire configured to cause the spacer to move proximally, thereby causing the plurality of ridges to be spaced apart from each other.

[0068] Clause 5: The medical probe according to any of the preceding clauses, wherein the plurality of electrodes are disposed along each of the plurality of ridges from the first end to the second end.

[0069] Clause 6: The medical probe according to any of the preceding clauses, further comprising a position sensor configured to generate a current when subjected to an electromagnetic field.

[0070] Clause 6: The medical probe according to any one of the preceding clauses, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0071] Clause 7: The medical probe according to any one of the preceding clauses, wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

[0072] Clause 8: The medical probe according to Clause 1, wherein each of the plurality of ridges is configured to rotate inwardly toward the longitudinal axis when deployed from the insertion sheath such that the second end is disposed near the first end, and each ridge is bowed radially outward from the longitudinal axis.

[0073] Clause 9: The medical probe according to Clause 8, wherein when in the expanded configuration, the plurality of electrodes are disposed along the plurality of ridges from the first end to a point along the ridge approximately at the distal end of the basket.

[0074] Clause 10: The medical probe according to Clause 8 or Clause 9, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0075] Clause 11: The medical probe according to any one of Clauses 8 to 10, wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

[0076] Clause 12: The medical probe according to Clause 1, wherein each of the plurality of ridges is configured to rotate outwardly away from the longitudinal axis when deployed from the insertion sheath such that the second end is disposed near the first end, and each ridge is bowed radially outward from the longitudinal axis.

[0077] Clause 13: The medical probe according to Clause 12, wherein when in the expanded configuration, the plurality of electrodes are disposed along the plurality of ridges from the second end to a point along the ridge approximately at the distal end of the basket.

[0078] Clause 14: The medical probe according to Clause 12 or Clause 13, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0079] Clause 15: The medical probe according to any one of Clauses 12 to 14, wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

[0080] Clause 16: The medical probe according to any one of Clauses 12 to 15, wherein each of the plurality of ridges includes an anchor disposed at the second end, and each anchor is configured to attach to the insertion sheath when in the expanded position.

[0081] Clause 17: The medical probe according to any one of the preceding clauses, each of the plurality of ridges comprising a shape memory material.

[0082] Clause 18: The medical probe according to any one of the preceding clauses, the shape memory material comprising nitinol.

[0083] Clause 19: A medical probe comprising: a tube including a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of ridges disposed at the distal end of the tube, each of the plurality of ridges including a first end and a second end fixed relative to the tube respectively, each of the plurality of ridges being configured to transition between a collapsed configuration and an expanded configuration, the plurality of ridges forming a basket when in the expanded configuration by folding approximately at the midpoint of each ridge and bowing radially outward from the longitudinal axis; and a plurality of electrodes attached to the plurality of ridges.

[0084] Clause 20: The medical probe according to Clause 19, the midpoint of each ridge being configured to converge near the distal end of the basket when in the expanded configuration.

[0085] Clause 21: The medical probe according to Clause 20, wherein the plurality of ridges includes three ridges.

[0086] Clause 22: The medical probe according to any one of Clauses 19 to 21, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0087] Clause 23: The medical probe according to any one of Clauses 19 to 22, the plurality of electrodes being configured to deliver ablation energy to tissue.

[0088] Clause 24: A medical probe comprising: a tube including a proximal end and a distal end, the tube extending along a longitudinal axis; a single ridge disposed at the distal end of the tube and including a first end and a second end fixed relative to the tube respectively, the ridge being configured to transition between a collapsed configuration and an expanded configuration, the ridge forming a basket including a plurality of convex corners when in the expanded configuration by forming a plurality of bends, the plurality of convex corners bowing radially outward from the longitudinal axis; and a plurality of electrodes attached to the ridge.

[0089] Clause 25: The medical probe according to Clause 24, wherein the basket includes at least three convex corners.

[0090] Clause 26: The medical probe according to Clause 24 or Clause 25, the plurality of electrodes being configured to detect electrophysiological signals.

[0091] Clause 27: The medical probe according to any one of Clauses 24 to 26, wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

[0092] The above embodiments are cited by way of example, and the present invention is not limited to what is specifically shown and described above. On the contrary, the scope of the present invention includes combinations and sub - combinations of the various features described and shown above, as well as their variations and modifications, which will occur to those skilled in the art upon reading the above description and which are not disclosed in the prior art.

Claims

1. A medical probe, comprising: a tube comprising a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of ridges disposed at the distal end of the tube, each of the plurality of ridges comprising a first end fixed relative to the tube and a second end unattached relative to the tube, each of the plurality of ridges being configured to transition between a collapsed configuration and an expanded configuration, the plurality of ridges forming a basket when in the expanded configuration; as well as A plurality of electrodes are attached to the plurality of ridges. 2 . The medical probe of claim 1 , each of the plurality of ridges being configured to rotate inwardly at a distal end and arcuately bend radially outwardly from the longitudinal axis when deployed from an insertion sheath. 3 . The medical probe according to claim 2 , further comprising a spacer disposed between the plurality of ridges such that the plurality of ridges are spaced apart from each other. 4 . The medical probe of claim 3 , the spacer being connected to a puller wire, the puller wire being configured to cause the spacer to move proximally, thereby causing the plurality of ridges to be spaced apart from one another. 5 . The medical probe of claim 1 , the plurality of electrodes being disposed along each of the plurality of ridges from the first end to the second end. The medical probe according to claim 1 , wherein the plurality of electrodes are configured to detect electrophysiological signals.

7. The medical probe of claim 1, the plurality of electrodes configured to deliver ablative energy to tissue.

8. The medical probe of claim 1 , each of the plurality of ridges being configured to rotate inwardly toward the longitudinal axis when deployed from an insertion sheath such that the second end is disposed proximate the first end and each ridge is arcuately curved radially outwardly from the longitudinal axis.

9. The medical probe of claim 8, the plurality of electrodes being disposed along the plurality of ridges from the first end to a point along the ridges approximately at a distal end of the basket when in the expanded configuration. 10 . The medical probe according to claim 8 , wherein the plurality of electrodes are configured to detect electrophysiological signals.

11. The medical probe of claim 8, the plurality of electrodes being configured to deliver ablative energy to tissue.

12. The medical probe of claim 1 , each of the plurality of ridges being configured to rotate outwardly away from the longitudinal axis when deployed from an insertion sheath such that the second end is disposed proximate the first end and each ridge is arcuately curved radially outwardly from the longitudinal axis.

13. The medical probe of claim 12, the plurality of electrodes being disposed along the plurality of ridges from the second end to a point along the ridges approximately at a distal end of the basket when in the expanded configuration. The medical probe according to claim 12 , wherein the plurality of electrodes are configured to detect electrophysiological signals.

15. The medical probe of claim 12, the plurality of electrodes configured to deliver ablative energy to tissue.

16. The medical probe of claim 12, each ridge of the plurality of ridges comprising an anchor disposed at the second end, each anchor configured to attach to the insertion sheath when in the expanded position.

17. The medical probe of claim 12, each ridge of the plurality of ridges comprising a shape memory material.

18. A medical probe, comprising: a tube comprising a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of ridges disposed at a distal end of the tube, each of the plurality of ridges comprising a first end and a second end each fixed relative to the tube, each of the plurality of ridges being configured to transition between a collapsed configuration and an expanded configuration, the plurality of ridges forming a basket by folding approximately at a midpoint of each ridge and arcuately bending radially outward from the longitudinal axis when in the expanded configuration; as well as A plurality of electrodes are attached to the plurality of ridges.

19. The medical probe of claim 18, the midpoint of each ridge being configured to converge near a distal end of the basket when in the expanded configuration.

20. A medical probe, comprising: a tube comprising a proximal end and a distal end, the tube extending along a longitudinal axis; a single ridge disposed at the distal end of the tube and including a first end and a second end each fixed relative to the tube, the ridge configured to transition between a collapsed configuration and an expanded configuration, the ridge forming a basket including a plurality of lobes by forming a plurality of bends when in the expanded configuration, the plurality of lobes arcuately curving radially outward from the longitudinal axis; as well as A plurality of electrodes are attached to the ridge.

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