Flexible irrigation tube for medical catheter

Abstract

To provide an irrigation tube for a medical catheter.SOLUTION: The disclosed technology includes an irrigation tube for a medical catheter. The irrigation tube can include a flexible tube extending along a longitudinal axis from a proximal end to a distal end. The irrigation tube can include a pull wire attached to the flexible tube, the pull wire configured to deflect at least the distal end of the irrigation tube radially outward from the longitudinal axis. The irrigation tube can include an aperture proximate to the distal end of the flexible tube, the aperture configured to direct an irrigation fluid outwardly from the irrigation tube so that irrigation fluid is directed generally in a direction of the deflection by the pull wire.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to earlier U.S. Provisional Patent Application No. 63 / 514,494, filed July 19, 2023 (Attorney Docket No. BIO6817USPSP1-253757.000352), the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present invention relates generally to medical devices, and more particularly, but not exclusively, to medical catheters with irrigation, and further to medical catheters including a flexible irrigation tube configured to provide irrigation to an electrode. [Background technology]

[0003] Cardiac arrhythmias, such as atrial fibrillation (AF), occur when an area of ​​cardiac tissue abnormally transmits electrical signals to adjacent tissue. This disrupts the normal cardiac cycle and causes an asynchronous rhythm. Certain procedures that exist to treat arrhythmias include surgically destroying the source of the signals that cause the arrhythmia and destroying the conduction pathways of such signals. By selectively ablating cardiac tissue with the application of energy via a catheter, it is sometimes possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another.

[0004] Many current ablation approaches in the art utilize radiofrequency (RF) electrical energy to heat tissue. RF ablation can have certain risks associated with thermal heating that can lead to tissue charring, burning, steam popping, phrenic nerve paralysis, pulmonary vein stenosis, and esophageal fistulas.

[0005] Cryoablation is an alternative approach to RF ablation that reduces the thermal risks typically associated with RF ablation. However, manipulating cryoablation devices and selectively applying cryoablation is generally more difficult compared to RF ablation, and thus cryoablation is not feasible in certain anatomical geometries that can be reached by electrical ablation devices.

[0006] Some ablation approaches use irreversible electroporation (IRE) to ablate cardiac tissue using a non-thermal ablation method. IRE delivers short pulses of high voltage to tissue, causing irreversible permeabilization of cell membranes. Delivery of IRE energy to tissue using multi-electrode probes has been previously proposed in the patent literature. Examples of systems and devices configured for IRE ablation are disclosed in U.S. Patent Application Publication Nos. 2021 / 0169550(A1), 2021 / 0169567(A1), 2021 / 0169568(A1), 2021 / 0161592(A1), 2021 / 0196372(A1), 2021 / 0177503(A1), and 2021 / 0186604(A1), each of which is incorporated by reference into this specification and is attached in an appendix hereto. Summary of the Invention [Problem to be solved by the invention]

[0007] Ablation procedures, and other procedures utilizing electrodes (e.g., electrophysiological mapping), can result in thrombus due to the geometry of the end effector and, in some cases, localized temperature increases near the electrodes. Accordingly, many existing ablation and mapping catheters include irrigation elements configured to deliver irrigation fluid to areas proximate the electrodes, or generally to the distal end of the end effector. For example, some existing ablation catheters are configured to deliver saline to areas proximate the electrodes via an irrigation hub located near the proximal end of the end effector. Unfortunately, many existing irrigation elements are unable to effectively deliver irrigation fluid to the distal end of the end effector. Furthermore, many existing irrigation elements are unable to precisely direct irrigation fluid to a selected area. Thus, there is a need in the art for an irrigation element that increases the effectiveness of irrigation provided by the irrigation element. [Means for solving the problem]

[0008] According to one example of the present invention, an irrigation tube for a medical catheter is provided. The irrigation tube may include a flexible tube extending along a longitudinal axis from a proximal end to a distal end. The irrigation tube may include a pull wire attached to the flexible tube, the pull wire configured to deflect at least a distal end of the irrigation tube radially outward from the longitudinal axis. The irrigation tube may include an opening proximate the distal end of the flexible tube, the opening configured to direct irrigation fluid outward from the irrigation tube such that the irrigation fluid is directed generally in the direction of deflection by the pull wire.

[0009] The disclosed techniques may include a medical probe. The medical probe may include a tubular shaft extending along a longitudinal axis. The medical probe may include a plurality of spines configured to bend radially outward from the longitudinal axis. The medical probe may include a plurality of electrodes, each electrode of the plurality of electrodes being attached to one of the plurality of spines. The medical probe may include an irrigation tube disposed between the plurality of spines and extending distally from a distal end of the tubular shaft. At least a portion of the irrigation tube is configured to deflect radially outward from the longitudinal axis such that the irrigation tube directs irrigation fluid to an inward-facing surface of the one of the plurality of electrodes.

[0010] Additional features, functions, and applications of the techniques of the present disclosure are discussed in greater detail herein. [Brief description of the drawings]

[0011] [Figure 1] 1 is a schematic pictorial diagram of a medical system including a medical probe having electrodes in accordance with the techniques of the present disclosure; [Diagram 2] FIG. 1 is a schematic pictorial diagram showing a perspective view of a medical probe having electrodes in a deployed state in accordance with the disclosed technology; [Figure 3A] FIG. 2 is a schematic, pictorial diagram illustrating a side view of a distal tip of a medical probe in accordance with the disclosed technology. [Figure 3B] FIG. 2 is a schematic pictorial diagram showing a top view of a distal tip of a medical probe with spines and electrodes omitted for clarity of depiction, in accordance with the technology of the present disclosure. [Figure 4A] FIG. 1 is a schematic, pictorial diagram illustrating a side view of an exemplary irrigation tube having an opening, in accordance with the techniques of the present disclosure. [Figure 4B] FIG. 13 is a schematic, pictorial diagram illustrating a side view of another exemplary irrigation tube having an opening, in accordance with the techniques of the present disclosure. [Figure 4C] FIG. 13 is a schematic, pictorial diagram illustrating a side view of another exemplary irrigation tube having an opening, in accordance with the techniques of the present disclosure. [Figure 4D]FIG. 13 is a schematic, pictorial diagram illustrating a side view of another exemplary irrigation tube having an opening, in accordance with the techniques of the present disclosure. [Figure 4E] 1 is a schematic pictorial diagram showing a cross-sectional view of another irrigation tube having an opening in accordance with the techniques of the present disclosure. [Figure 5A] FIG. 1 is a schematic, pictorial diagram illustrating a side view of an exemplary irrigation tube having an elastic element and a tension string in accordance with the disclosed technology. [Figure 5B] FIG. 13 is a schematic, pictorial diagram showing a side view of another example irrigation tube having an elastic element and a tension string in accordance with the techniques of the present disclosure. [Figure 5C] FIG. 13 is a schematic, pictorial diagram showing a side view of another example irrigation tube having an elastic element and a tension string in accordance with the techniques of the present disclosure. [Figure 6] FIG. 1 is a schematic pictorial diagram showing a perspective view of a medical probe in accordance with the disclosed technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0012] As discussed above, existing irrigation techniques are limited in their capabilities and therefore often fail to achieve their intended results (e.g., cooling or lubricating a particular area proximal to the distal end of a medical catheter). One example of the techniques described herein provides an irrigation tube for a movable and / or steerable medical catheter. In some examples, the irrigation tube includes a flexible tube extending along an axis, a steering mechanism coupled to the flexible tube and configured to radially deflect the distal end of the flexible tube outwardly and / or slide the flexible tube longitudinally, and an opening near the distal end of the flexible tube. In some examples, the opening is configured to direct irrigation fluid outwardly from the irrigation tube to an area or location generally determined by the steering mechanism. The techniques of the present disclosure allow a physician to more precisely direct the irrigation fluid, thereby improving the ability to effectively perform an ablation or mapping procedure.

[0013] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict selected examples and are not intended to limit the scope of the invention. The detailed description illustrates, by way of example and not by way of limitation, the principles of the invention. The description clearly enables one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention.

[0014] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates suitable dimensional tolerances that allow a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the stated value, e.g., "about 90%" may refer to a range of values ​​of 71% to 110%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in human patients represents a preferred embodiment, it is not intended to limit the system or method to human use. Similarly, the term "proximal" refers to a location closer to the operator or physician, while "distal" refers to a location farther from the operator or physician.

[0015] As discussed herein, the vascular system of a "patient," "host," "user," and "subject" may be that of a human or any animal. It should be understood that the animal may be of any of a variety of applicable types, including, but not limited to, mammals, veterinary animals, livestock animals, or pet animals. As an example, the animal may be a laboratory animal (e.g., rats, dogs, pigs, monkeys, etc.) that is specifically selected to have certain characteristics similar to humans. It should be understood that the subject may be, for example, any applicable human patient.

[0016] As discussed herein, a "physician" may include a physician, surgeon, technician, scientist, operator, or any other individual or delivery instrumentation involved in the delivery of a multi-electrode catheter for the treatment of drug refractory atrial fibrillation to a subject.

[0017] As discussed herein, the term "ablate" or "ablation", in the context of the devices and corresponding systems of the present disclosure, refers to components and structural features configured to reduce or prevent the generation of irregular cardiac signals within cells by utilizing non-thermal energy, such as reversible or irreversible electroporation (IRE), interchangeably referred to as pulsed electric field (PEF) and pulsed field ablation (PFA), or thermal energy, such as radio frequency (RF) ablation or cryoablation. In the context of the devices and corresponding systems of the present disclosure, ablation or ablation is used throughout the present disclosure in reference to thermal or non-thermal ablation of cardiac tissue for specific conditions, including, but not limited to, arrhythmias, atrial flutter ablation, pulmonary vein isolation, supraventricular tachycardia ablation, and ventricular tachycardia ablation. The term "ablate" or "ablation" also includes known methods, devices, and systems for achieving various forms of body tissue ablation, as will be understood by those skilled in the art.

[0018] As discussed herein, the terms "tubular" and "tube" are to be interpreted broadly and are not limited to right cylindrical structures, or structures that are strictly circular in cross section, or structures that are uniform in cross section throughout their length. For example, a tubular structure is generally illustrated as a substantially right cylindrical structure. However, a tubular structure may have a tapered or curved outer surface without departing from the scope of the present disclosure.

[0019] FIG. 1 illustrates an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a cavity or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location of the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing Intracardiac Electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured to sense IEGMs is illustrated herein. The physician 24 brings a distal tip of the catheter 14 (i.e., end effector 28) into contact with the heart wall to sense a target site within the heart 12. The end effector 28 is shown in this case as a basket catheter 28, however, the end effector 28 may take other forms (e.g., a balloon catheter). For ablation, the physician 24 similarly delivers the distal end of the ablation catheter 14 to the target site for ablation.

[0020] The catheter 14 is an exemplary catheter including one, and preferably multiple, electrodes 26, optionally distributed across multiple spines 22 in a basket catheter 28, and configured to sense IEGM signals. The catheter 14 may further include a position sensor embedded in or near the basket catheter 28 for tracking the position and orientation of the basket catheter 28. Optionally and preferably, the position sensor is a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation. The catheter 14 may include a handle 630 at its proximal end.

[0021] The combination magnetic-based position sensor and force sensor may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the basket catheter 28 of the catheter 14 may be tracked based on the magnetic field generated by the location pad 25 and sensed by the magnetic-based position sensor. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,391,199; 5,443,489; 5,558,091; 6,172,499; 6,239,724; 6,332,089; 6,484,118; 6,618,612; 6,690,963; 6,788,967; and 6,892,091, each of which is attached in an appendix hereto.

[0022] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a positional reference for the location pads 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed at the electrode skin patch 38, so that the location of each electrode can be triangulated via the electrode patch 38. Details of impedance-based position tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, each of which is attached as an appendix hereto.

[0023] Recorder 11 displays electrograms 21 captured by the body surface ECG electrodes 18 and intracardiac electrograms (IEGMs) captured by electrodes 26 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0024] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes at the distal tip of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy, including unipolar or bipolar high voltage direct current pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0025] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheters, the electrophysiological equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capabilities to implement real-time calculations of the catheter positions and perform ECG calculations.

[0026] The workstation 55 includes a processor unit having a memory, a memory or storage device loaded with appropriate operating software, and a user interface function. The workstation 55 may optionally provide multiple functions including: (1) modeling the endocardial anatomical structures in three dimensions (3D) and rendering a model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual display or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying real-time positions and orientations of multiple catheters within the cardiac chambers; and (5) displaying sites of interest, such as where ablation energy has been applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, available from Biosense Webster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618, USA.

[0027] FIG. 2 is a schematic pictorial diagram illustrating a perspective view of a basket catheter 28 having electrodes 26 attached to spines 22 shown in a deployed state, such as by being advanced from a tubular shaft lumen at the distal end of an insertion tube, in accordance with the technology of the present disclosure. As shown in FIG. 2, the basket catheter 28 includes a plurality of flexible spines 22 formed at the end of a tubular shaft 62 extending along a longitudinal axis 60 of the catheter 14 and connected at both ends. The spines 22 can be configured to bend radially outward from the longitudinal axis 60 passing through the basket catheter 28. During a medical procedure, the physician 24 can deploy the basket catheter 28 by extending the tubular shaft 62 from the insertion tube, transitioning the basket catheter 28 from the folded state to the deployed state as it exits the insertion tube. In the deployed state, the spines 22 form a generally spherical shape. The spine 22 may have an elliptical (e.g., circular) or rectangular (which may appear flat) cross-section and may include a flexible, elastic material (e.g., a shape memory alloy such as nickel-titanium, also known as Nitinol) that forms the struts. The basket catheter 28 may be connected to the remainder of the catheter 14 by a coupler 15 disposed between the tubular shaft 62 and the basket catheter 28.

[0028] The physician 24 can bring the basket catheter 28 into contact with tissue to perform an ablation procedure and / or a mapping procedure. As ablation energy is output by the electrode 26, the electrode 26 and nearby tissue can begin to heat up. To help dissipate heat generated by the electrode 26 and / or to prevent blood clots from forming, the techniques of the present disclosure can include an irrigation tube 100 configured to deliver a fluid 101 (see FIG. 3A ) proximate to the electrode 26 to provide a cooling effect to the electrode 26, as described in more detail herein. The irrigation tube 100 can include a flexible tube extending along a longitudinal axis from a proximal end 104 to a distal end 106, and includes an opening 102, as shown in FIG. 3A . In some examples, the irrigation tube 100 can include a flexible biocompatible material. In some examples, the opening 102 can be configured as a single opening. In some examples, the opening 102 can be configured as multiple openings. In some examples, the opening 102 is defined in a sidewall of the tube 100. In some examples, the opening 102 is defined in the distal tip of the tube 100. In some examples, a combination of openings 102 defined in the sidewall and openings 102 defined in the distal tip of the tube 100 can be employed. As shown in FIGURE 2, the irrigation tube 100 extends distally from the distal end of the tubular shaft 62 and coupler 15 and is at least partially disposed within the spherical shape of the spine 22 when the spine 22 is in the deployed state.

[0029] In some examples, the irrigation tube 100 may carry one or more marker bands 130 to aid the physician 24 in identifying the orientation of the tube 100 under fluoroscopy. Each marker band comprises a metal ring that is sufficiently radiopaque. The marker band(s) 130 may be placed along any portion of the irrigation tube 100 as long as they do not contact any of the electrodes 26. In some examples, the connection bands used to connect the pull wire(s) 108 to the tube 100 (described in more detail below) may be optionally radiopaque for the same purpose.

[0030] 3A is a schematic pictorial diagram showing a side view of basket catheter 28, with irrigation tube 100 shown in both solid and phantom lines to illustrate exemplary movements thereof. Movement of irrigation tube 100 may be performed to position irrigation tube 100 so that openings 102 can direct irrigation fluid 101 to the inward-facing surface of a particular electrode 26 or the inward-facing surface of a particular set of electrodes 26.

[0031] As shown in FIG. 3A, the irrigation tube 100 may be operable to slide longitudinally along the longitudinal axis 60 relative to its initial position (solid line depiction of the irrigation tube 100 in FIG. 3A) to a distal-most position 1001. For example, the irrigation tube 100 may slide from a proximal end of the spine 22 to a distal-most position 1001 of the spine 22. Alternatively, the initial and / or extended position of the irrigation tube 100 may be intermediate between the proximal and distal ends of the spine 28. At the distal-most position 1001, a gap 103 is formed between the irrigation tube 100 and the spine 22 along the longitudinal axis 60 such that the irrigation tube 100 does not contact the spine 22. At the distal-most position, the gap 103 may be approximately 0.25 millimeters (mm). In other embodiments, the gap may be any value, such as, for example, approximately 1 mm, 2 mm, 5 mm, 10 mm, etc., depending on the particular application.

[0032] As also shown in FIG. 3A, the irrigation tube 100 may be actuable to deflect radially outward from the longitudinal axis 60 to a deflected position 1002 via a steering mechanism. In some examples, the steering mechanism may also, or alternatively, be used to actuate and slide the tube 100 longitudinally (as described in the preceding paragraph). In some examples, the steering mechanism may include a pull wire 108 (shown in FIGS. 5A-5C) that deflects at least the distal end 106 of the irrigation tube 100 radially outward from the longitudinal axis, as described in more detail below. As an illustrative example shown in FIG. 3A, when the irrigation tube 100 is deflected to the right toward the deflected position 1002, the distal end of the irrigation tube 100 faces toward an inward-facing surface of one or more electrodes 26 in the direction of deflection. When the irrigation tube 100 is deflected, the openings 102 generally direct irrigation fluid 101 in the direction of the deflection to achieve a desired cooling effect at the electrode(s) 26. Although the irrigation tube 100 is shown as being deflected to the right relative to the deflected position 1002, in some examples the irrigation tube 100 can be configured to deflect in any direction radially outward from the longitudinal axis.

[0033] In other examples, as illustrated in FIG. 3B, the irrigation tube 100 may be configured for deflection in only a single direction to a rotated position 1003 and may be configured for rotation relative to the basket assembly 28 by the physician 24 (e.g., see the directional arrows in FIG. 3B indicating clockwise and counterclockwise rotation). That is, the irrigation tube 100 may be deflected and then the physician 24 may rotate the irrigation tube 100 to orient the irrigation tube 100 in a desired direction. In some examples, the irrigation tube 100 may be configured to deflect radially outward such that a distal end of the irrigation tube 100 maintains a distance of at least about 0.25 mm from the electrode 26 to prevent potential malfunction of the electrode 26.

[0034] 4A-4E are schematic pictorial diagrams showing side views of exemplary opening configurations. As will be appreciated, the openings 102 can be configured in other ways than those shown in FIG. 4A-4E without departing from the spirit and scope of the technology of the present disclosure. Additionally, as illustrated in FIG. 4E, the irrigation tube 100 can include a lumen 112 extending at least partially therethrough that can guide irrigation fluid along the length of the irrigation tube toward the openings 102. The lumen 112 can be sized for a desired flow rate to ensure that a sufficient amount of irrigation fluid is delivered for a particular application. Similarly, the openings 102 can be sized for a desired flow rate. In this manner, a sufficient amount of fluid can be delivered at a sufficient velocity to a desired location. Additionally, the openings 102 can be configured to direct the fluid in a particular direction rather than simply generally outward.

[0035] 4A , the openings 102 may be in a row along the distal edge of the distal end 106. In this example, in the undeflected position 1001, the irrigation fluid 101 is directed primarily longitudinally and laterally outward from the distal end 106.

[0036] 4B, the openings 102 can form a row on one side of the distal end 106. In this example, most of the irrigation fluid 101 is directed to the right from the openings 102, causing the irrigation tube to oscillate its position, e.g., between a first position and a second position.

[0037] 4C, the openings 102 can extend around the circumference of the distal end 106 that extends partially down the tube 100, allowing additional lateral fluid flow relative to, for example, example 100A. The distal tip of the tube 100 can also be blocked to further promote lateral fluid flow and prevent longitudinal flow.

[0038] 4D , the openings 102 can extend around the entire circumference of the tube 100, allowing the fluid 101 to pass through the openings 102 in all directions along the length of the tube 100. In this manner, the irrigation tube 100 can be configured to deliver irrigation fluid along a longer length of the basket assembly 28.

[0039] 4E is a cross-sectional view (cut against a plane perpendicular to the longitudinal axis 60) of another example 100E. As shown, the openings 102 can also be configured to rotationally oscillate the irrigation tube 100 about the longitudinal axis 60 as irrigation fluid 101 passes therethrough, similar to the depiction shown in FIG. 3B. For example, the openings 102 can be defined in one quadrant of the tube 100 such that the irrigation fluid 101 exits the tube 100 radially inward toward the longitudinal axis 60 (i.e., to deflect the tube 100 away from the undeflected position 1001) and in a tangential direction perpendicular to the radial direction (i.e., to have a propulsive effect that rotates the tube 100 about the longitudinal axis 60).

[0040] 5A-5C, schematic pictorial diagrams are provided showing side views of exemplary irrigation tube 100 configurations. In these figures, various example pull wire 108 and elastic element 110 configurations are used to steer irrigation tube 100 to deflect at least distal end 106 radially outward from longitudinal axis 60, and return irrigation tube 100 to a position aligned with longitudinal axis 60, respectively. Pull wire 108 and elastic element 110 can be made from a biocompatible material, such as nitinol, cobalt chrome, titanium, stainless steel, a biocompatible polymer, or other suitable material.

[0041] In some examples, the pull wires 108 extend from an inner portion of the distal end 106, where the ends of the pull wires are coupled (e.g., via a connecting band), along the inner wall of the tube 100, and out through the proximal end 104 to connect with a deflection drive actuator 632 (described in more detail below). In some examples, the pull wires may be coupled to an outer wall of the distal end 106. In some examples, an adhesive may be used to connect the pull wires 108 to the tube 100. In some examples, a mechanical process may be used to connect them. However, any suitable arrangement and coupling method may be employed in accordance with the disclosed techniques.

[0042] In some examples, the elastic element 110 extends from the distal end 106 of the tube 100 and terminates at the proximal end 104. The elastic element 110 may be attached to or embedded in any suitable location of the tube 100. In some examples, the elastic element 110 may comprise an elongated rod. In some examples, the elastic element 110 may comprise a spring 120, such as a coil spring wrapped around the tube 100 (as shown in FIG. 5C). In some examples, the tube 100 itself may be made from an elastic material such that the irrigation tube 100 may return to a position aligned with the longitudinal axis 60.

[0043] As shown in FIG. 5A, the pull wire 108 can extend along one side of the tube 100. In this example, when the pull wire 108 is pulled, depending on where it is attached to the distal end 106, the distal end is directed radially outwardly from the longitudinal axis 60 either to the left or right (see, for example, deflected position 1002 in FIG. 3A). To bias the tube 100 back to its original position, a resilient element 110 can be attached to or embedded within the tube 100, as described above. In the illustrated example, the element 110 is on the opposite side of the pull wire 108, although other locations are possible. The pull wire 108 and the resilient element 110 work together to ensure correct placement of the distal end 106 so that the irrigation fluid 101 can be delivered to the intended location or area.

[0044] 5B illustrates another example of a configuration of pull wires 108 and elastic elements 110. In this example, two pull wires 108 are coupled to either side of the tube 100, and an elastic element 110 is secured to the tube 100 between the wires 108. In this configuration, pulling one of the pull wires 108 rotates the distal end 106 in a particular direction. As an example, a left pull wire 108 may be coupled to the tube 100 to tilt the distal end 106 to the left when pulled, and a right pull wire 108 may be coupled to the tube 100 to tilt the distal end 106 to the right when pulled. Thus, multiple pull wires 108 can facilitate more customized positioning of the distal end 106 during use.

[0045] FIG. 5C shows yet another example of a tube 100 having a pull wire 108 and a resilient element 110. This example is similar to the example shown in FIG. 5A, except that a coil spring 120 is used as the resilient element 110. While functionally similar to the previous example, as one skilled in the art will appreciate, different structural elements can provide their own unique functional advantages. For example, a coil spring 120 can be used that extends around the tube 100, with the pull wire 108 routed through the coil spring 120. This ensures that the pull wire 108 is held against the tube 100 and cannot extend away from the tube 100 even when the pull wire 108 is pulled.

[0046] FIG. 6 is a schematic drawing of a perspective view of the catheter 14, with a mid-portion of the shaft 62 cut away for illustration. Additionally, it will be understood that components are not necessarily drawn to scale for clarity. As shown, a handle 630 is connected at its proximal end to the tubular shaft 62. The handle 630 may include a deflection drive actuator 632 and an irrigation fluid conduit 640. The conduit 640 is in fluid communication with the irrigation tube 100 for delivering irrigation fluid 101 thereto, as controlled by the physician 24. A pull wire 108 extending through the tubular shaft 62 has a proximal end connected to the deflection drive actuator 632. As with the connection of the pull wire to the tube 100, any suitable coupling technique may be employed. When the deflection drive actuator 632 is actuated (i.e., by the physician 24), the pull wire 108 is pulled and the irrigation tube 100 may be deflected radially outward from the longitudinal axis 60. When two or more pull wires 108 are attached to the irrigation tube 100, actuation of the deflection drive actuator 632 in a first direction can deflect the irrigation tube 100 in a first direction, and actuation of the deflection drive actuator 632 in a second direction can deflect the irrigation tube 100 in a second direction. In some examples, the deflection drive actuator can be twisted to wrap the proximal ends of the pull wires 108 around it, thereby causing actuation of the pull wires to steer and / or deflect the irrigation tube 100 in the manner described above. However, other forms of actuation may be employed, such as, but not limited to, a slider that selectively pulls or pushes the pull wires 108 to effect deflection of the tube 100.

[0047] The techniques of the present disclosure described herein can be further understood according to the following sections.

[0048] Item 1: An irrigation tube for a medical catheter, the irrigation tube comprising: a flexible tube extending along a longitudinal axis from a proximal end to a distal end; a pull wire attached to the flexible tube, the pull wire configured to deflect at least a distal end of the flexible tube radially outward from the longitudinal axis; and an opening proximate the distal end of the flexible tube, the opening configured to direct irrigation fluid outward from the irrigation tube such that the irrigation fluid is directed generally in the direction of deflection by the pull wire.

[0049] Clause 2: The irrigation tube described in clause 1, wherein the irrigation tube comprises a flexible biocompatible material.

[0050] Clause 3: An irrigation tube as described in clause 1 or clause 2, wherein the pull wire is configured to be attached to a handle of the ablation catheter, the handle having a deflection drive actuator connected to a proximal end of the pull wire, and the deflection drive actuator is configured to actuate the pull wire to deflect the irrigation tube.

[0051] Clause 4: An irrigation tube described in any one of clauses 1 to 3, further comprising an elastic element configured to return the irrigation tube to a position aligned with the longitudinal axis.

[0052] Clause 5: The irrigation tube of clause 4, wherein the elastic element comprises an elongated rod attached to the irrigation tube.

[0053] Clause 6: The irrigation tube of clause 4, wherein the elastic element comprises a spring attached to the irrigation tube.

[0054] Clause 7: An irrigation tube described in any one of clauses 1 to 3, wherein the irrigation tube is made from an elastic material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

[0055] Item 8: An irrigation tube as described in any one of items 1 to 7, wherein the irrigation tube is further configured to slide longitudinally relative to the multiple spines of the ablation catheter from the proximal ends of the multiple spines to the distal ends of the multiple spines.

[0056] Clause 9: An irrigation tube described in any one of clauses 1 to 8, wherein the opening is configured to direct irrigation fluid towards the electrode.

[0057] Clause 10: An irrigation tube described in any one of clauses 1 to 9, wherein the opening is configured to vibrate the irrigation tube between a first position and a second position when irrigation fluid passes through the opening.

[0058] Clause 11: An irrigation tube described in any one of clauses 1 to 9, wherein the opening is configured to rotationally oscillate the irrigation tube about its longitudinal axis when irrigation fluid passes through the opening.

[0059] Clause 12: A medical probe comprising: a tubular shaft extending along a longitudinal axis; a plurality of spines configured to bend radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes attached to one of the plurality of spines; and an irrigation tube disposed between the plurality of spines and extending distally from a distal end of the tubular shaft, at least a portion of the irrigation tube configured to deflect radially outward from the longitudinal axis to direct irrigation fluid toward an inward-facing surface of the one of the plurality of electrodes.

[0060] Clause 13: The medical probe of clause 12, wherein the irrigation tube comprises a flexible biocompatible material.

[0061] Clause 14: A medical probe as described in clause 12 or clause 14, wherein the irrigation tube is steerable such that a distal end of the irrigation tube can be moved to direct irrigation fluid toward one of the multiple electrodes.

[0062] Clause 15: A medical probe as described in any one of clauses 12 to 14, further comprising a pull wire attached to the irrigation tube, the pull wire configured to steer the irrigation tube.

[0063] Item 16: A medical probe as described in item 15, further comprising a handle attached to a proximal end of the tubular shaft, the handle further comprising a deflection drive actuator connected to a proximal end of the pull wire, the deflection drive actuator configured to actuate the pull wire to steer the irrigation tube.

[0064] Clause 17: The medical probe of any one of clauses 12 to 16, further comprising an elastic element configured to return the irrigation tube to a position aligned with the longitudinal axis.

[0065] Clause 18: The medical probe of clause 17, wherein the elastic element comprises an elongated rod attached to the irrigation tube.

[0066] Clause 19: The medical probe of clause 17, wherein the elastic element comprises a spring attached to the irrigation tube.

[0067] Clause 20: A medical probe as described in any one of clauses 12 to 19, further configured to allow the irrigation tube to slide longitudinally along the longitudinal axis from the proximal ends of the plurality of spines to the distal ends of the plurality of spines.

[0068] Clause 21: A medical probe as described in clause 20, wherein at a distal-most position of the irrigation tube, a gap is formed between the irrigation tube and the multiple spines such that the irrigation tube does not contact the multiple spines.

[0069] Item 22: The medical probe of item 21, wherein the gap is about 0.25 mm.

[0070] Clause 23: A medical probe described in any one of clauses 12 to 16 and clauses 20 to 22, wherein the irrigation tube is made from an elastic material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

[0071] Clause 24: A medical probe described in any one of clauses 12 to 23, wherein the irrigation tube has an opening configured to direct irrigation fluid toward one of the multiple electrodes.

[0072] Clause 25: A medical probe as described in clause 24, wherein the opening is configured to oscillate the irrigation tube between a first position and a second position when irrigation fluid passes through the opening.

[0073] Clause 26: The medical probe of clause 24, wherein the opening is configured to rotationally oscillate the irrigation tube about the longitudinal axis when irrigation fluid passes through the opening.

[0074] Clause 27: A medical probe described in any one of clauses 12 to 26, wherein the irrigation tube is configured to deflect radially outward such that a distal end of the irrigation tube maintains a distance of at least about 0.25 mm from the electrode.

[0075] Clause 28: A medical probe described in any one of clauses 12 to 27, wherein the plurality of spines are configured to transition between a folded state and an unfolded state.

[0076] Clause 29: The medical probe of clause 28, wherein the plurality of spines form a generally spherical shape when in the deployed state.

[0077] Clause 30: The medical probe of clause 29, wherein the irrigation tube is at least partially disposed within the sphere when the plurality of spines are in a deployed state.

[0078] The above embodiments are cited by way of example, and the present invention is not limited to what has been specifically shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features previously described herein, as well as variations and modifications thereof not disclosed in the prior art that would occur to one skilled in the art upon reading the above description.

[0079] [Embodiment] (1) An irrigation tube for a medical catheter, said irrigation tube comprising: a flexible tube extending along a longitudinal axis from a proximal end to a distal end; a pull wire attached to the flexible tube, the pull wire configured to deflect at least the distal end of the flexible tube radially outward from the longitudinal axis; an opening proximate the distal end of the flexible tube configured to direct irrigation fluid outwardly from the irrigation tube such that irrigation fluid is directed generally in the direction of deflection by the pull wire. (2) The irrigation tube of embodiment 1, further comprising an elastic element configured to return the irrigation tube to a position aligned with the longitudinal axis. (3) The irrigation tube of embodiment 2, wherein the elastic element comprises an elongated rod attached to the irrigation tube. (4) The irrigation tube of embodiment 2, wherein the elastic element comprises a spring attached to the irrigation tube. (5) The irrigation tube of embodiment 1, wherein the irrigation tube is made from a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

[0080] (6) The irrigation tube of embodiment 1, wherein the opening is configured to direct the irrigation fluid toward an electrode. (7) The irrigation tube of embodiment 1, wherein the opening is configured to oscillate the irrigation tube between a first position and a second position when the irrigation fluid passes through the opening. (8) The irrigation tube of embodiment 1, wherein the opening is configured to rotationally oscillate the irrigation tube about the longitudinal axis when the irrigation fluid passes through the opening. (9) A medical probe comprising: a tubular shaft extending along a longitudinal axis; a plurality of spines configured to bend radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes attached to one spine of the plurality of spines; an irrigation tube disposed between the plurality of spines and extending distally from a distal end of the tubular shaft, at least a portion of the irrigation tube configured to deflect radially outward from the longitudinal axis such that the irrigation tube directs irrigation fluid toward an inward-facing surface of one of the plurality of electrodes. (10) A medical probe as described in embodiment 9, wherein the irrigation tube is steerable such that a distal end of the irrigation tube can be moved to direct the irrigation fluid toward the electrodes of the plurality of electrodes.

[0081] (11) The medical probe of claim 9, further comprising a pull wire attached to the irrigation tube, the pull wire configured to steer the irrigation tube. (12) The medical probe of claim 11, further comprising a handle attached to a proximal end of the tubular shaft, the handle further comprising a deflection drive actuator connected to a proximal end of the pull wire, the deflection drive actuator configured to actuate the pull wire to steer the irrigation tube. (13) The medical probe of claim 9, further comprising an elastic element configured to return the irrigation tube to a position aligned with the longitudinal axis. (14) The medical probe of claim 9, wherein the irrigation tube is further configured to slide longitudinally along the longitudinal axis from a proximal end of the plurality of spines to a distal end of the plurality of spines. (15) The medical probe of claim 14, wherein at a distal-most position of the irrigation tube, a gap is formed between the irrigation tube and the plurality of spines such that the irrigation tube does not contact the plurality of spines.

[0082] (16) The medical probe of claim 9, wherein the irrigation tube is made from a resilient material so as to be configured to return to a position aligned with the longitudinal axis. (17) The medical probe of claim 9, wherein the irrigation tube includes an opening configured to direct the irrigation fluid toward the electrode of the plurality of electrodes. (18) The medical probe of claim 17, wherein the opening is configured to oscillate the irrigation tube between a first position and a second position as the irrigation fluid passes through the opening. (19) The medical probe of claim 17, wherein the opening is configured to rotationally oscillate the irrigation tube about the longitudinal axis as the irrigation fluid passes through the opening. (20) The medical probe of claim 9, wherein the irrigation tube is configured to deflect radially outward such that a distal end of the irrigation tube maintains a distance of at least about 0.25 mm from the electrode.

Claims

1. 1. An irrigation tube for a medical catheter, the irrigation tube comprising: a flexible tube extending along a longitudinal axis from a proximal end to a distal end; a pull wire attached to the flexible tube, the pull wire configured to deflect at least the distal end of the flexible tube radially outward from the longitudinal axis; an opening proximate the distal end of the flexible tube configured to direct irrigation fluid outwardly from the irrigation tube such that irrigation fluid is directed generally in the direction of deflection by the pull wire.

2. The irrigation tube of claim 1 , further comprising a resilient element configured to return the irrigation tube to a position aligned with the longitudinal axis.

3. The irrigation tube of claim 2 , wherein the resilient element comprises an elongated rod attached to the irrigation tube.

4. The irrigation tube of claim 2 , wherein the resilient element comprises a spring attached to the irrigation tube.

5. The irrigation tube of claim 1 , wherein the irrigation tube is made from a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis.

6. The irrigation tube of claim 1 , wherein the opening is configured to direct the irrigation fluid towards an electrode.

7. The irrigation tube of claim 1 , wherein the opening is configured to oscillate the irrigation tube between a first position and a second position as the irrigation fluid passes through the opening.

8. The irrigation tube of claim 1 , wherein the opening is configured to rotationally oscillate the irrigation tube about the longitudinal axis as the irrigation fluid passes through the opening.

9. 1. A medical probe, comprising: a tubular shaft extending along a longitudinal axis; a plurality of spines configured to bend radially outward from the longitudinal axis; a plurality of electrodes, each electrode of the plurality of electrodes attached to one spine of the plurality of spines; an irrigation tube disposed between the plurality of spines and extending distally from a distal end of the tubular shaft, at least a portion of the irrigation tube configured to deflect radially outward from the longitudinal axis such that the irrigation tube directs irrigation fluid toward an inward-facing surface of one of the plurality of electrodes.

10. The medical probe of claim 9 , wherein the irrigation tube is steerable such that a distal end of the irrigation tube can be moved to direct the irrigation fluid toward the electrodes of the plurality of electrodes.

11. The medical probe of claim 9 , further comprising a pull wire attached to the irrigation tube, the pull wire configured to steer the irrigation tube.

12. 12. The medical probe of claim 11, further comprising a handle attached to a proximal end of the tubular shaft, the handle further comprising a deflection drive actuator connected to a proximal end of the pull wire, the deflection drive actuator configured to actuate the pull wire to steer the irrigation tube.

13. The medical probe of claim 9 , further comprising a resilient element configured to return the irrigation tube to a position aligned with the longitudinal axis.

14. The medical probe of claim 9 , wherein the irrigation tube is further configured to slide longitudinally along the longitudinal axis from a proximal end of the plurality of spines to a distal end of the plurality of spines.

15. The medical probe of claim 14 , wherein a gap is formed between the irrigation tube and the plurality of spines at a distal-most position of the irrigation tube such that the irrigation tube does not contact the plurality of spines.

16. The medical probe of claim 9 , wherein the irrigation tube is made from a resilient material so as to be configured to return to a position aligned with the longitudinal axis.

17. The medical probe of claim 9 , wherein the irrigation tube comprises an opening configured to direct the irrigation fluid toward the electrode of the plurality of electrodes.

18. The medical probe of claim 17 , wherein the opening is configured to oscillate the irrigation tube between a first position and a second position as the irrigation fluid passes through the opening.

19. The medical probe of claim 17 , wherein the opening is configured to rotationally oscillate the irrigation tube about the longitudinal axis as the irrigation fluid passes through the opening.

20. The medical probe of claim 9 , wherein the irrigation tube is configured to deflect radially outward such that a distal end of the irrigation tube maintains a distance of at least about 0.25 mm from an electrode.

Images