Simplified basket catheter having multiple spines

Abstract

To provide a medical probe.SOLUTION: A medical probe can comprise a tube having a proximal end and a distal end, the tube extending along a longitudinal axis. The medical probe can further comprise a plurality of spines disposed at the distal end of the tube, each spine of the plurality of spines having a first end that is fixed in relation to the tube and a second end that is unattached in relation to the tube. Each spine of the plurality of spines can be configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines forming a basket when in the expanded configuration. The medical probe can further comprise a plurality of electrodes attached to the plurality of spines.SELECTED DRAWING: Figure 2

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 spines.

Background Art

[0002] Cardiac arrhythmias such as atrial fibrillation (AF) occur when areas of cardiac tissue conduct electrical signals abnormally to adjacent tissue. This disrupts the normal cardiac cycle and causes an asynchronous rhythm. Specific procedures that exist for treating arrhythmias include surgically destroying the source of the signals causing the arrhythmia and destroying the conduction pathways of such signals. Electrical signals propagating through the heart can be mapped using a mapping catheter, and then only selected areas of tissue can be ablated to treat AF. By applying energy through a catheter to selectively ablate cardiac tissue, it is sometimes 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 approaches use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method.

Summary of the Invention

Problems to be Solved by the Invention

[0003] To perform the operations of delivering ablation energy and mapping electrical signals propagated through heart tissue, a physician may use the same or different catheters for each. However, it is most beneficial to use a catheter that can perform both functions and even additional functions. In some examples, a basket catheter having a plurality of electrodes disposed along a spine may be used, and the electrodes can not only deliver ablation energy but also map the procedure. However, due to the small size of the spine and electrodes, the manufacture of such catheters can be difficult and / or expensive. Accordingly, what is needed is a system and method for manufacturing a basket catheter in a cost-effective manner using a simplified assembly. This problem and other problems can be addressed by the techniques disclosed herein.

Means for Solving the Problems

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

[0005] The technology of the present disclosure can include a medical probe. The medical probe can include a tube having a proximal end and a distal end, and the tube extends along a longitudinal axis. The medical probe can further include a plurality of spines disposed at the distal end of the tube, each spine of the plurality of spines having a first end and a second end, each being fixed to the tube. Each spine of the plurality of spines can be configured to transition between a collapsed configuration and an expanded configuration. The plurality of spines, when in the expanded configuration, can be folded at approximately the midpoint of each spine and can form a basket by deflecting radially outward from the longitudinal axis. The medical probe can further include a plurality of electrodes attached to the plurality of spines.

[0006] The technology of the present disclosure can include a medical probe. The medical probe can include a tube having a proximal end and a distal end, and the tube extends along a longitudinal axis. The medical probe can further include a single spine disposed at the distal end of the tube, the single spine having a first end and a second end, each end being fixed to the tube. The spine can be configured to transition between a collapsed configuration and an expanded configuration. The spine can form a basket having a plurality of lobes when in the expanded configuration by forming a plurality of bending portions, and the plurality of lobes deflect radially outward from the longitudinal axis. The medical probe can further include a plurality of electrodes attached to the spine.

Brief Description of the Drawings

[0007] The above and further aspects of the present invention will be further considered with reference to the following description in conjunction with the accompanying drawings, in which like numerals in the various drawings indicate like structural elements and features. The drawings are not necessarily to scale, and instead, the main focus is on illustrating the principles of the present invention. The figures depict one or more implementations of the device of the present invention by way of example and not limitation.

Figure 1

Figure 2

Figure 3A

Figure 3B

Figure 3C

Figure 4A

Figure 4B

Figure 4C

Figure 5A

Figure 5B

Figure 5C

Figure 6A

Figure 6B

Figure 7A

Figure 7B

Figure 7C

Figure 8

[0008] The techniques of the present disclosure include a plurality of individual spines connected to an insertion tube and configured to form a basket shape when deployed from the insertion tube. The techniques of the present disclosure can simplify the process of manufacturing a basket catheter by including spines that are heat set to a predetermined shape. Further, the techniques of the present disclosure 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 with the use of one device.

[0009] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the invention. The detailed description is by way of example, not limitation, and illustrates the principles of the invention. This description enables one skilled in the art to make and use the invention and describes some embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently considered to be the best mode of carrying out the invention.

[0010] As used herein, the term "about" or "substantially" with respect to any numerical value or range indicates a reasonable dimensional tolerance that allows a component or collection to function for the intended purpose described herein. More specifically, "about" or "substantially" can refer to a range of values that are ±20% of the recited value. For example, "about 90%" can refer to a range of values from 71% to 110%.

[0011] As used herein, the terms "patient", "host", "user", and "subject" refer to any human or animal subject and are not intended to limit the use of the present system or method to human use, although the use of the claimed invention in human patients represents a preferred embodiment. In addition, the vasculature of a "patient", "host", "user", and "subject" can be that of a human or any animal. It should be understood that the animal can be of any of a variety of applicable types, including but not limited to mammals, veterinary animals, livestock animals, or pet animals. By way of example, the animal can be an experimental animal (e.g., rat, dog, pig, monkey, etc.) specifically selected to have certain properties similar to humans. It should be understood that the subject can be, for example, any applicable human patient. Similarly, the term "proximal" indicates a position closer to the operator or physician, while "distal" indicates a position farther from the operator or physician.

[0012] As contemplated herein, a "physician" or "operator" can include a doctor, surgeon, technician, scientist, or any other individual or delivery device associated with the delivery of a multi-electrode catheter for the treatment of drug-refractory atrial fibrillation to a subject.

[0013] As discussed herein, the term "ablating" or "ablation", when referring to the devices and corresponding systems of the present disclosure, refers throughout the present disclosure to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy such as irreversible electroporation (IRE), which is interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA). When referring to the devices and corresponding systems of the present disclosure, ablating or ablation refers throughout the present disclosure to non-thermal ablation of cardiac tissue for certain conditions, including but not limited to arrhythmias, atrial fibrillation ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablating" or "ablation" also includes known methods, devices, and systems for achieving various forms of physical tissue ablation, as understood by those skilled in the art.

[0014] As discussed herein, the terms "bipolar" and "unipolar", when used to refer to ablation schemes, describe different ablation schemes with respect to current path and electric field distribution. "Bipolar" refers to an ablation scheme that utilizes the current path between two electrodes both positioned at the treatment site. The current density and electric flux density are typically approximately equal at each of the two electrodes. "Unipolar" refers to an ablation scheme that utilizes the current path between two electrodes, where one electrode, including a high current density and high electric flux density, is positioned at the treatment site and a second electrode, including a relatively low current density and low electric flux density, is positioned remotely from the treatment site.

[0015] The techniques of the present disclosure 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 respective 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 the positive phase or only the negative phase.

[0016] To improve a failing heart, ablation of heart tissue applying thermal techniques such as radiofrequency (RF) energy and cryoablation is a well-known procedure. Typically, to successfully ablate using thermal techniques, it is necessary to measure the cardiac potential at various locations in the myocardium. In addition, temperature measurements during ablation provide data that enables the effectiveness of the ablation. Usually, in an ablation procedure using thermal techniques, electrode potential and temperature are measured before, during, and after the actual ablation.

[0017] Exemplary systems, methods, and devices of the present disclosure may be particularly suitable for IRE ablation of heart tissue to treat arrhythmias. Ablation energy is typically supplied to heart tissue by electrodes that can deliver ablation energy along the tissue to be ablated. Ablation procedures incorporating such exemplary catheters can be visualized using fluoroscopy, magnetic-based position sensing, and / or active current localization techniques.

[0018] The IRE considered in this disclosure is a non-thermal cell death technology that can be used for ablation of atrial arrhythmias. 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 waveforms and can be tailored to target cells based on cellular electrophysiology. In contrast, to perform ablation using RF, a sinusoidal voltage waveform is applied to generate heat in the treatment area and indiscriminately heat all cells within the treatment area. Thus, IRE is beneficial in reducing possible complications known in ablation modalities or isolation modalities and has the ability to spare adjacent heat-sensitive structures or tissues. Additionally or alternatively, monophasic pulses can be utilized.

[0019] Electroporation can be induced by applying a pulsed electric field across biological cells to cause reversible (temporary) or irreversible (permanent) formation of pores within the cell membrane. Cells have a transmembrane electrostatic potential that increases beyond the resting potential upon application of the pulsed electric field. The transmembrane electrostatic potential remains below the threshold potential, but electroporation is reversible, meaning that the pores can close and the cells can self-repair and survive when the applied pulsed electric field is removed. When the transmembrane electrostatic potential increases beyond the threshold potential, electroporation is irreversible and the cells become permanently permeable. As a result, the cells die due to loss of homeostasis and typically die by programmed cell death or apoptosis, which is thought 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 about 500 V / cm, while bone has a threshold potential of 3000 V / cm. These differences in threshold potential allow IRE to selectively target tissues based on the threshold potential.

[0020] Refer to FIG. 1, which shows an exemplary catheter-based electrophysiological mapping and ablation system 10. The system 10 includes one or more catheters that are percutaneously inserted by a physician 24 into a cardiac chamber or vascular structure of the heart 12 through the vasculature of a patient 23. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near the desired location of the heart 12. Thereafter, a plurality of catheters can be inserted into the delivery sheath catheter to reach the 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 exemplary catheter 14 (also referred to herein as a medical probe 100) configured to sense IEGM is shown herein. For ablation, the physician 24 moves an end effector 28 including an ablation electrode to a target site for ablation. If the end effector 28 is alternatively or additionally configured for mapping electrophysiological signals (e.g., IEGM signals), the physician 24 similarly contacts the end effector 28 with the heart wall to sense the target site within the heart 12.

[0021] Catheter 14 is an exemplary catheter that includes an end effector 28 having an expandable assembly and one and preferably a plurality of electrodes 26 optionally distributed over the distal tip of the end effector 28 and configured to detect electrophysiological signals and / or deliver ablation energy to tissue. Catheter 14 can additionally include a magnetic-based position sensor embedded within or near the end effector 28 to track the position and orientation of the end effector 28. The end effector 28 can further include one or more impedance-based electrodes disposed within or near the end effector 28 to track the position and orientation of the end effector 28.

[0022] Magnetic-based position sensors can operate with a position pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the end effector 28 of the catheter 14 can be tracked based on the magnetic field generated by the position 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. Patent Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, each of which is incorporated herein by reference as if fully set forth herein.

[0023] System 10 includes one or more electrode patches 38 positioned for skin contact on patient 23 to establish position references for the position pad 25 and impedance-based electrode tracking. For impedance-based tracking, current is directed to the impedance-based electrodes and sensed at the electrode skin patches 38, whereby 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.

[0024] Recorder 11 displays the electrogram 21 captured by the body surface ECG electrodes 18 and the intracardiac electrogram (IEGM) captured by the electrodes of the catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacer.

[0025] System 10 may include an ablation energy generator 50 adapted to conduct ablation energy to one or more electrodes disposed on an end effector and configured to deliver ablation energy to tissue. The energy generated by ablation energy generator 50 may include high frequency (RF) energy or pulsed field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high voltage DC pulses such that they can be used to effect irreversible electroporation (IRE), but are not limited thereto.

[0026] Patient interface unit (PIU) 30 is an interface configured to establish electrical communication between a catheter, an electrophysiology device, a power source, and a workstation 55 that controls the operation of system 10. The electrophysiology devices of system 10 may include, for example, a plurality of catheters, position pads 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities for performing real-time calculations of catheter position and executing ECG calculations.

[0027] The workstation 55 includes a memory, a processor unit having a memory or storage device loaded with appropriate operating software, and user interface capabilities. The workstation 55 optionally provides a plurality of functions including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering it to display a model or anatomical map 20 on a display device 27; (2) displaying on the display device 27 a representative visual display or image of an activation sequence (or other data) compiled from the recorded electrogram 21 superimposed on the rendered anatomical map 20; (3) displaying the real-time positions and orientations of a plurality of catheters within the heart chamber; and (4) displaying on the display device 27 a site of interest such as a location where ablation energy is being applied. One commercially available product embodying the elements of the system 10 is available as the CARTO (trademark) 3 system, marketed by Biosense Webster, Inc. (31 Technology Drive, Suite 200, Irvine, CA 92618, USA).

[0028] Figure 2 shows an exemplary medical probe 100 configured to be inserted into a patient's organ (e.g., heart 12). As shown, the medical probe can include a handle 120, which can include an irrigation port 126, an actuator 124, and can be connected to a tube 122. The irrigation port 126 can be configured to connect to an irrigation source and receive irrigation fluid from the irrigation source for delivering the irrigation fluid to the end effector 28. The actuator 124 can be connected to a pull wire attached near the distal end of the end effector 28 or the tube 122. When the actuator 124 is actuated, the pull wire can be pulled to deflect the distal end of the tube 122 away from the longitudinal axis 150.

[0029] 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 spines 22 that can be configured to deflect radially outward from the longitudinal axis 150 of the end effector 28 (e.g., as shown in FIG. 3C). Each spine 22 can be configured to transition from a collapsed configuration to an expanded configuration when extruded from an insertion sheath or other delivery tube. Each of the spines 22 can be bent inwardly at the distal end and can be configured to transition to the expanded configuration by forming a basket catheter by deflecting radially outward from the longitudinal axis 150 of the end effector 28.

[0030] Each of the plurality of spines 22 can 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 can be a free end). Further, each of the plurality of spines 22 can include a plurality of electrodes 26 disposed along each spine 22, and the plurality of electrodes 26 extend from the first end to the second end of the spine 22. In some examples, each of the plurality of spines 22 can be made of a shape memory material. The shape memory material can be, for example, nitinol or other biocompatible material that can be biased to form a basket shape when deployed from an insertion sheath. For example, the spine 22 can include nitinol, and the nitinol can be heat set to a predetermined shape (e.g., the expanded configuration) such that the spine 22 transitions to the heat set expanded configuration when the spine 22 is inserted into a blood pool at a predetermined temperature. In some examples, each of the plurality of spines 22 can be covered with a layer of biocompatible insulating material.

[0031] The electrode 26 can be made of a biocompatible conductive material (e.g., gold, palladium, silver, platinum) and can be configured to deliver ablation energy to tissue. For example, each of the electrodes 26 can be in electrical communication with an ablation energy generator 50 and can be configured to deliver ablation energy to tissue. The electrode 26 can be configured to deliver a monopolar or bipolar signal having a single-phase or two-phase pulse. Alternatively or additionally, the electrode 26 can be configured to deliver RF ablation energy to tissue. Alternatively or additionally, the electrode 26 can be configured to perform mapping of electroanatomical signals. For example, the electrode 26 described herein can be configured to detect electroanatomical signals for mapping procedures, for delivering ablation energy to tissue, or for both. In some examples, the medical probe can further include a position sensor (not shown) configured to generate a current when exposed to an electromagnetic field.

[0032] Figures 3A-3C illustrate an exemplary end effector 28 having a spine 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 the end effector 28 shown in Figure 2 and may further include a spacer 302 disposed between the spines 22 of the plurality of spines 22. The spacer 302 may be connected to a pull wire 304 that can be pulled proximally to move the spacer 302 between the spines 22 near the distal end of the tube 122. The spacer 302 disposed between the spines 22 is configured to move the spines 22 away 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 can include a single pull wire 304 connected to the spacer 302 or, alternatively, a plurality of pull wires 304 connected to each spacer 302. Each of the plurality of spines 22 can further include a plurality of electrodes 26 disposed on the spine 22 and extending from a first end (proximal end) to a second end (distal end) of the spine 22.

[0033] Figure 3A shows the end effector 28 in a collapsed configuration, prepared for delivery and navigation through the patient 23's organ (e.g., the heart 12). In the collapsed configuration, each spine 22 is fully elongated, and the second end (in this case, the distal end) of each spine 22 is at the greatest possible distance along the spine 22 from the tube 122 of the medical probe. Figure 3B shows the end effector 28 in a configuration transitioning between the collapsed configuration (Figure 3A) and the expanded configuration (Figure 3C). As can be seen, the pull wire 304 attached to the spacer 302 between the plurality of spines 22 is partially pulled in the proximal direction to further separate the spines 22 as the spines 22 transition to the expanded configuration. Figure 3C shows the end effector 28 of the medical probe 100 now in a fully expanded configuration, thereby forming a basket shape. In the expanded configuration, the pull wire 304 is fully pulled in the proximal direction, thereby fully separating the spines 22 near the first end of each spine 22.

[0034] Figures 4A - 4C show an end effector 428 transitioning from a collapsed configuration (Figure 4A) to an expanded configuration (Figure 4C) to form a basket catheter, the end effector 428 defining the distal end of the tube 122. The end effector 428 can comprise a plurality of spines 422, each spine 422 having a first end attached to the tube 122 and a second end (e.g., a free end) not attached to the tube 122. Each of the plurality of spines 422 can include a plurality of electrodes 26 disposed along each spine 422. The electrodes 26 can be positioned along the spines 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 spine 422 to the distal end of the basket. For example, as shown in Figure 4A, the electrodes 26 can be disposed closer to the proximal end of each spine 422 such that when the distal end of the spine 422 rotates inwards, the electrodes 26 are disposed on the portion of the spine 422 configured to contact tissue.

[0035] Figure 4A shows the end effector 428 in a collapsed configuration that is prepared for delivery and navigation through an organ (e.g., heart 12) of patient 23. In the collapsed configuration, each spine 422 is fully elongated, and the second end of each spine 422 is the portion of the spine 422 that is positioned most distally from the tube 122 of the medical probe 100. As can be seen, a plurality of electrodes 26 are disposed along a portion of the spine 422. Figure 4B shows the end effector 428 in a configuration that is transitioning between the collapsed configuration (Figure 4A) and the expanded configuration (Figure 4C). As shown in Figure 4B, as each spine 422 begins to transition from the collapsed configuration to the expanded configuration, the second end of each spine 422 begins to bend inwardly toward the longitudinal axis 150, and the portion of the spine 422 near the second end begins to deflect radially outwardly from the longitudinal axis 150.

[0036] Figure 4C shows the end effector 428 of the medical probe now in a fully expanded configuration, thereby forming a basket shape. The plurality of spines 422 of the end effector 428 can be configured to bend the second end of each spine 422 inwardly toward the longitudinal axis 150 such that the second end is disposed near the first end of the spine 422. The portion of the spine 422 disposed between the first end and the second end of the spine 422 can deflect radially outwardly from the longitudinal axis 150, thereby forming a basket shape. As a result, a basket is formed, whereby the plurality of electrodes 26 disposed along the spine 422 extend from the first end of the spine 422 to the distal end of the basket. This enables the plurality of electrodes 26 to be disposed on the portion of the basket catheter that positions the electrodes 26 in contact with the target tissue and for delivering ablation energy to the tissue.

[0037] Figures 5A-5C, referred to herein, show 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 spines 522, each spine 522 having a first end attached to the tube 122 and a second end (free end) not attached to the tube 122. Each of the plurality of spines 522 can further include a plurality of electrodes 26 disposed along each spine 522. Further, when the end effector 528 is in the expanded configuration, the electrodes 26 can be positioned along the spines 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 disposed closer to the distal end of each spine 522 such that the electrodes 26 contact tissue when the distal end of the spine 22 rotates outwardly.

[0038] Each of the plurality of spines 522 can further include an anchor 504 disposed at the second end of the spine 522. The anchor 504 can be configured to be attached 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 spine 522 bends outwardly and curls back towards the tube 122, the anchor 504 can be attached to the tube 122 to secure the second end of the spine 522.

[0039] FIG. 5A shows an end effector 528 in a collapsed configuration that is prepared for delivery and navigation through an organ (e.g., heart 12) of patient 23. In the collapsed configuration, each spine 522 is fully elongated and the second end of each spine 522 is the portion of the spine 522 that is positioned most distally from the tube 122 of the medical probe 100. As can be seen, a plurality of electrodes 26 are disposed along the portion of the spine 522 that is more distal to the tube 122. FIG. 5B shows an end effector 428 in a configuration that is transitioning between the collapsed configuration (FIG. 5A) and the expanded configuration (FIG. 5C). As shown in FIG. 5B, as the spine 522 begins to transition from the collapsed configuration to the expanded configuration, the second end of each spine 522 begins to bend outwardly from the longitudinal axis 150 and the portion of the spine 522 near the second end begins to bend inwardly toward the tube 122.

[0040] FIG. 5C shows the end effector 528 of the medical probe 100 now in an expanded configuration, thereby forming a basket shape. The plurality of spines 522 of the end effector 528 may be configured such that a second end of each spine 522 is disposed near a first end of the spine 522 and bends outwardly away from the longitudinal axis 150 so that the anchor 504 is attached outside the tube 122. In other examples, the anchor may be configured to be alternatively attached inside the tube 122 when the end effector 528 is in the expanded configuration (e.g., the spine 522 curls inwardly such that a second end of the spine 522 is at least partially inserted into an opening formed at the distal end of the tube 122). A portion of the spine 522 disposed between the first end and the second end of the spine 522 can flex radially outwardly from the longitudinal axis 150, thereby forming a basket shape. As a result, a basket is formed, whereby a plurality of electrodes 26 disposed along the spine 522 extend from the second end of the spine 522 to the distal end of the basket. This enables the plurality of electrodes 26 to be disposed over an area of the basket catheter that contacts the target tissue and enables the delivery of ablation energy and / or the detection of electrophysiological signals.

[0041] FIGS. 6A-6B, referred to herein, show an alternative end effector 628 disposed at the distal end of the tube 122. FIG. 6A shows a front view of the end effector 628 in an expanded configuration. Although the collapsed configuration is not shown, it will be understood that the spines 622 can be substantially straight when in the collapsed configuration for delivery through the vasculature. The end effector 628 can include a plurality of spines 622, each spine 622 having a first end and a second end, each of the first end and the second end being connected to the tube 122. The plurality of spines 622 can include a plurality of electrodes 26 disposed along the spine 622 extending from the first end to the second end.

[0042] FIG. 6B shows a top view of the spine 622 of the end effector 628 of FIG. 6A. Each of the plurality of spines 622 can be configured to transition from a collapsed configuration to an expanded configuration by being folded at approximately the midpoint of each spine 622 and deflecting radially outward from the longitudinal axis 150. The midpoint of each spine 622 can be configured to converge toward the longitudinal axis 150 at the convergence point 606. As a result, a basket shape is formed having a distal end formed by the midpoints of the spines 622 that converge toward each other at the convergence point 606. In FIGS. 6A-6B, the plurality of spines 22 includes three spines 622, but the end effector 628 can include four spines, five spines, six spines, ten spines, twenty spines, or any number of spines suitable for a particular application.

[0043] FIGS. 7A-7C show an alternative embodiment of an end effector 728 that defines the distal end of the tube 122. Different from the exemplary end effector described above, the end effector 728 shown in FIGS. 7A-7C can include a single spine 722. The spine 722 can include a first end and a second end, and each end is connected to the tube 122. The spine 722 can be configured to transition between a collapsed configuration (FIG. 7A) and an expanded configuration (FIG. 7C), and when in the expanded configuration, the spine 722 forms a basket shape with a plurality of lobes. In FIG. 7C, the end effector 728 is shown as having three lobes, but the end effector can include four lobes, five lobes, six lobes, ten lobes, twenty lobes, or any other number of lobes suitable for a particular application. The spine 722 can further include a plurality of electrodes 26 disposed along the spine 722, and the plurality of electrodes 26 extend from the first end to the second end of the spine 722.

[0044] FIG. 7A shows end effector 728 in a collapsed configuration, prepared for delivery and navigation through an organ (e.g., heart 12) of patient 23. In the collapsed configuration, spine 722 of end effector 728 is fully elongated, and a portion of spine 722 unfolds a single bend positioned furthest from tube 122 of the medical probe. FIG. 7B shows end effector 728 in a configuration transitioning between the collapsed configuration (FIG. 7A) and the expanded configuration (FIG. 7C). Spine 722 can begin to form three lobes with a plurality of bends in spine 722. As shown in FIG. 7B, the lobes of spine 722 can at least partially flex radially outward from longitudinal axis 150 of tube 122. FIG. 7C shows end effector 728 in an expanded configuration where the lobes of spine 722 are fully flexed radially outward from longitudinal axis 150, thereby forming a basket shape. In the expanded configuration, the most proximal bend of the plurality of bends converges toward tube 122, and the most distal bend of the plurality of bends converges toward the distal end of the basket.

[0045] Although not shown, it will be understood that spines 22 (22, 422, 522, 622, and / or 722) described herein can include notches, holes, or other features to enable the spines 22 to connect to each other. This can be particularly useful, for example, when the spines 22 connect near the distal end of the basket to reinforce the basket shape and prevent distortion when the basket contacts tissue.

[0046] FIG. 8 is a flowchart illustrating a method 800 of manufacturing a medical probe. In some examples, the medical probe disclosed by method 800 is substantially similar to any of the medical probes illustrated and described in FIGS. 3A-7C. Method 800 can include attaching 802 the first end and / or the second end of the spine 22 to the tube 122. Method 800 can further include heat setting 804 the spine 22 into a predetermined shape, which forms a basket. In some examples, the basket can include a plurality of lobes that form a plurality of bends in the spine 22. Method 800 can further include straightening 806 the spine 22 and adding 808 an insulating material to the spine 22. Method 800 can further include attaching 810 the electrodes 26 to the spine 22. As described above, each electrode 26 can be configured to detect an electrophysiological signal and / or deliver ablation energy to target tissue of an organ (e.g., the heart 12). In some examples, the medical probe can further include a position sensor (not shown) configured to generate a current when exposed to an electromagnetic field.

[0047] The techniques of the present disclosure described herein can be further understood in accordance with the following clauses. Clause 1: A medical probe comprising: a tube having a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of spines disposed at the distal end of the tube, each spine of the plurality of spines having a first end fixed to the tube and a second end not attached to the tube, each spine of the plurality of spines being configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines forming a basket when in the expanded configuration; and a plurality of electrodes attached to the plurality of spines.

[0048] Clause 2: The medical probe according to Clause 1, wherein each of the plurality of spines, when deployed from the insertion sheath, is configured to bend inwardly at the distal end and deflect radially outwardly from the longitudinal axis.

[0049] Clause 3: The medical probe according to Clause 2, further comprising a spacer disposed between the plurality of spines such that the plurality of spines are spaced apart from each other.

[0050] Clause 4: The medical probe according to Clause 3, wherein the spacer is connected to a pull wire, and the pull wire is configured to move the spacer proximally, thereby spacing the plurality of spines apart from each other.

[0051] 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 spines from a first end to a second end.

[0052] Clause 6: The medical probe according to any of the preceding clauses, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0053] Clause 7: The medical probe according to any of the preceding clauses, wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

[0054] Clause 8: The medical probe according to Clause 1, wherein each of the plurality of spines is configured to bend inwardly toward the longitudinal axis such that the second end is disposed near the first end and each spine deflects radially outwardly from the longitudinal axis when deployed from the insertion sheath.

[0055] Clause 9: The medical probe according to Clause 8, wherein the plurality of electrodes are disposed along the plurality of spines from the first end to a point along the spine at approximately the distal end of the basket when in the expanded configuration.

[0056] Clause 10: The medical probe according to Clause 8 or Clause 9, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0057] 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.

[0058] Clause 12: The medical probe according to Clause 1, wherein each of the plurality of spines is configured to bend outwardly from the longitudinal axis such that the second end is disposed near the first end and each spine bends radially outwardly from the longitudinal axis when deployed from the insertion sheath.

[0059] Clause 13: The medical probe according to Clause 12, wherein the plurality of electrodes are disposed along the plurality of spines from the second end to a point along the spine at the substantially distal end of the basket in the expanded configuration.

[0060] Clause 14: The medical probe according to Clause 12 or Clause 13, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0061] 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.

[0062] Clause 16: The medical probe according to any one of Clauses 12 to 15, wherein each of the plurality of spines includes an anchor disposed at the second end, and each anchor is configured to be attached to the insertion sheath when in the expanded position.

[0063] Clause 17: The medical probe according to any of the preceding clauses, wherein each of the plurality of spines includes a shape memory material.

[0064] Clause 18: The medical probe according to any of the preceding clauses, wherein the shape memory material includes nitinol.

[0065] Clause 19: A medical probe, which is a tube having a proximal end and a distal end, the tube extending along a longitudinal axis, and a plurality of spines disposed at the distal end of the tube, each spine of the plurality of spines having a first end and a second end each fixed to the tube, each spine of the plurality of spines being configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines being folded at approximately the midpoint of each spine and bending radially outward from the longitudinal axis to form a basket in the expanded configuration, and a plurality of electrodes being attached to the plurality of spines.

[0066] Clause 20: The medical probe according to Clause 19, wherein the midpoint of each spine is configured to converge near the distal end of the basket when in the expanded configuration.

[0067] Clause 21: The medical probe according to Clause 20, wherein the plurality of spines includes three spines.

[0068] 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.

[0069] Clause 23: The medical probe according to any one of Clauses 19 to 22, wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

[0070] Clause 24: A medical probe, comprising a tube having a proximal end portion and a distal end portion, the tube extending along a longitudinal axis, and a single spine having a first end portion and a second end portion disposed at the distal end of the tube and respectively fixed to the tube, the spine being configured to transition between a collapsed configuration and an expanded configuration, the spine forming a basket having a plurality of lobes when in the expanded configuration by forming a plurality of bending portions, the plurality of lobes deflecting radially outward from the longitudinal axis, and a plurality of electrodes being attached to the spine.

[0071] Clause 25: The medical probe according to Clause 24, wherein the basket includes at least three lobes.

[0072] Clause 26: The medical probe according to Clause 24 or Clause 25, wherein the plurality of electrodes are configured to detect electrophysiological signals.

[0073] 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.

[0074] The above embodiments are cited as examples, and the present invention is not limited to those specifically illustrated and described above. Rather, the scope of the present invention includes both the combinations and sub - combinations of the various features described and illustrated above, as well as those variations and modifications not disclosed in the prior art that would occur to those skilled in the art upon reading the foregoing description.

[0075] 〔Embodiment〕 (1) A medical probe, comprising a tube having a proximal end portion and a distal end portion, the tube extending along a longitudinal axis, A plurality of spines disposed at the distal end of the tube, each spine of the plurality of spines having a first end fixed to the tube and a second end not attached to the tube, each spine of the plurality of spines being configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines forming a basket when in the expanded configuration, a plurality of spines, A plurality of electrodes attached to the plurality of spines, a medical probe. (2) The medical probe according to embodiment 1, wherein each spine of the plurality of spines is configured to bend inwardly at the distal end and deflect radially outwardly from the longitudinal axis when deployed from the insertion sheath. (3) The medical probe according to embodiment 2, further comprising a spacer disposed between the plurality of spines such that the plurality of spines are spaced apart from each other. (4) The medical probe according to embodiment 3, wherein the spacer is connected to a pull wire, and the pull wire is configured to move the spacer proximally, thereby spacing the plurality of spines apart from each other. (5) The medical probe according to embodiment 1, wherein the plurality of electrodes are disposed along each spine of the plurality of spines from the first end to the second end.

[0076] (6) The medical probe according to embodiment 1, wherein the plurality of electrodes are configured to detect electrophysiological signals. (7) The medical probe according to embodiment 1, wherein the plurality of electrodes are configured to deliver ablation energy to tissue. (8) The medical probe according to embodiment 1, wherein each spine of the plurality of spines is configured to bend inwardly toward the longitudinal axis such that the second end is disposed near the first end and each spine deflects radially outwardly from the longitudinal axis when deployed from the insertion sheath. (9) The plurality of electrodes are arranged along the plurality of spines from the first end to a point along the spine that is at approximately the distal end of the basket when in the expanded configuration, the medical probe according to embodiment 8. (10) The plurality of electrodes are configured to detect electrophysiological signals, the medical probe according to embodiment 8.

[0077] (11) The plurality of electrodes are configured to deliver ablation energy to tissue, the medical probe according to embodiment 8. (12) Each of the plurality of spines, when deployed from the insertion sheath, is configured such that the second end is disposed near the first end and each spine bends outwardly away from the longitudinal axis such that each spine deflects radially outwardly from the longitudinal axis, the medical probe according to embodiment 1. (13) The plurality of electrodes are arranged along the plurality of spines from the second end to a point along the spine that is at approximately the distal end of the basket when in the expanded configuration, the medical probe according to embodiment 12. (14) The plurality of electrodes are configured to detect electrophysiological signals, the medical probe according to embodiment 12. (15) The plurality of electrodes are configured to deliver ablation energy to tissue, the medical probe according to embodiment 12.

[0078] (16) Each of the plurality of spines includes an anchor disposed at the second end, and each anchor is configured to be attached to the insertion sheath when in the expanded position, the medical probe according to embodiment 12. (17) Each of the plurality of spines includes a shape memory material, the medical probe according to embodiment 12. (18) A medical probe, A tube having a proximal end and a distal end, extending along a longitudinal axis, the tube, A plurality of spines disposed at a distal end of the tube, each spine of the plurality of spines comprising a first end and a second end respectively fixed to the tube, each spine of the plurality of spines being configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines being folded at approximately the midpoint of each spine and forming a basket in the expanded configuration by bending radially outward from the longitudinal axis, a plurality of spines; A plurality of electrodes attached to the plurality of spines, a medical probe comprising. (19) The medical probe according to embodiment 18, wherein the midpoint of each spine is configured to converge near the distal end of the basket in the expanded configuration. (20) A medical probe, A tube having a proximal end and a distal end, extending along a longitudinal axis, a tube; A single spine disposed at a distal end of the tube and having a first end and a second end respectively fixed to the tube, the spine being configured to transition between a collapsed configuration and an expanded configuration, the spine forming a basket having a plurality of lobes in the expanded configuration by forming a plurality of bends, the plurality of lobes bending radially outward from the longitudinal axis, a single spine; A plurality of electrodes attached to the spine, a medical probe comprising.

Claims

1. 1. A medical probe, comprising: a tube having a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of spines disposed at the distal end of the tube, each spine of the plurality of spines having a first end fixed relative to the tube and a second end unattached to the tube, each spine of the plurality of spines configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines forming a basket when in the expanded configuration; a plurality of electrodes attached to the plurality of spines.

2. 10. The medical probe of claim 1, wherein each spine of the plurality of spines is configured to bend inwardly at a distal end and deflect radially outwardly from the longitudinal axis when deployed from an insertion sheath.

3. The medical probe of claim 2 , further comprising a spacer disposed between the spines such that the spines are spaced apart from one another.

4. The medical probe of claim 3 , wherein the spacer is connected to a pull wire configured to move the spacer proximally, thereby moving the spines away from one another.

5. The medical probe of claim 1 , wherein the plurality of electrodes are disposed along each spine of the plurality of spines from the first end to the second end.

6. The medical probe of claim 1 , wherein the plurality of electrodes are configured to detect electrophysiological signals.

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

8. 2. The medical probe of claim 1, wherein each spine of the plurality of spines is configured to bend inwardly toward the longitudinal axis when deployed from an insertion sheath such that the second end is disposed proximate the first end and each spine is deflected radially outwardly from the longitudinal axis.

9. 9. The medical probe of claim 8, wherein the plurality of electrodes are disposed along the plurality of spines from the first end to a point along the spines that is approximately at a distal end of the basket when in the expanded configuration.

10. The medical probe of claim 8 , wherein the plurality of electrodes are configured to detect electrophysiological signals.

11. The medical probe of claim 8 , wherein the plurality of electrodes are configured to deliver ablation energy to tissue.

12. 2. The medical probe of claim 1, wherein each spine of the plurality of spines is configured to bend 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 spine is deflected radially outwardly from the longitudinal axis.

13. 13. The medical probe of claim 12, wherein the plurality of electrodes are disposed along the plurality of spines from the second end to a point along the spine that is approximately at a distal end of the basket when in the expanded configuration.

14. The medical probe of claim 12 , wherein the plurality of electrodes are configured to detect electrophysiological signals.

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

16. 13. The medical probe of claim 12, wherein each spine of the plurality of spines includes an anchor disposed at the second end, each anchor configured to be attached to the insertion sheath when in the expanded position.

17. The medical probe of claim 12 , wherein each spine of the plurality of spines comprises a shape memory material.

18. 1. A medical probe, comprising: a tube having a proximal end and a distal end, the tube extending along a longitudinal axis; a plurality of spines disposed at a distal end of the tube, each spine of the plurality of spines having a first end and a second end fixed relative to the tube, each spine of the plurality of spines configured to transition between a collapsed configuration and an expanded configuration, the plurality of spines collapsing at approximately a midpoint of each spine and deflecting radially outward from the longitudinal axis to form a basket when in the expanded configuration; a plurality of electrodes attached to the plurality of spines.

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

20. 1. A medical probe, comprising: a tube having a proximal end and a distal end, the tube extending along a longitudinal axis; a single spine disposed at a distal end of the tube and having first and second ends fixed relative to the tube, the spine configured to transition between a collapsed configuration and an expanded configuration, the spine forming a plurality of bends to form a basket with multiple lobes when in the expanded configuration, the multiple lobes deflecting radially outward from the longitudinal axis; and a plurality of electrodes attached to the spine.

Images